cyrilzakka/clinical-trials huggingface dataset:
Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali

The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with and without a single dose of 0.25mg/kg primaquine (PQ). Outcome measures will include infectivity to mosquitoes at 2, 7 and 14 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
* 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
* Haemoglobin ≥ 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, such as sudden high fevers, shaking or severe sore throat or ulcers in the mouth during treatment with Amodiaquine
* Current eye disease with retinal damage
* Signs of severe malaria, including hyperparasitaemia (defined as asexual parasitaemia \> 100,000 parasites / µL)
* Signs of acute or chronic illness, including hepatitis
* The use of other medication (except for paracetamol and/or aspirin), including antacids, other medicines used to treat malaria, abnormal heart rhythm, depression or mental illness or HIV/AIDS, and medicines that have antibiotic/antifungal properties
* 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 or HIV/AIDS, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhoea 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 haematology values (laboratory guideline values for exclusion are haemoglobin \< 10 g/dL, platelets \< 50,000/μl, White Blood Cell count (WBC) \< 2000/μl, serum creatinine \>2.0mg/dL, or ALT more than 3 times the upper limit of normal for age.
* Blood transfusion in the last 90 days.
* Known Electrocardiogram (ECG) corrected QT interval of more than 450 ms
* Documented or self-reported history of cardiac conduction problems
* Documented or self-reported history of epileptic seizures
Fidgety Movements of Preterm Neonates Included in COSGOD III

The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain.

Two centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements).

Aim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge.

The investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates included in the COSGOD III trial
* Death
* Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term

Exclusion Criteria:

* Neonates without FM analysis between six to 20 weeks post term
Methadone and Ketamine for Neuropathic Pain Treatment

Methadone and ketamine are effective for neuropathic pain management. However, the benefits of the association of both drugs are uncertain. Here, the investigators conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

Either oral methadone or ketamine have been used in neuropathic pain management, however, the benefits of the association of both drugs are uncertain. Here, we conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

Methods: Fourthly two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive during three months oral methadone (n= 13), ketamine (n=13) or methadone combined with ketamine (n=13). The primary outcome was pain score on visual analogical scale (VAS) assessed on baseline, 8, 15, 30, 60 and 90 days throughout the treatment, and the secondary outcomes were symptoms of neuropathic pain such as allodynia, burning or shooting pain as well the side effects.

Eligibility Criteria:
Inclusion Criteria:

* patients complaining of pain for more than 6 months with neuropathic pain poorly responsive to drugs used to treat neuropathic pain (i.e. opioid, non-opioid, anticonvulsants, antidepressants), who were 22 to 77 years old

Exclusion Criteria:

* patients with a history of severe psychiatric disorder,
* misuse of illegal drugs or
* hepatic disease
Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe dry eye disease
* Literate, able to speak English or Spanish, and able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Diagnosis of epilepsy
* Corneal transplant in either or both eyes
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
* Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE

The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
* single lesion and longest tumor diameter ≤ 5.0 cm
* CP-A or B classification
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
* unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
* rejecting other therapies such as resection, liver transplantation, etc.
* platelet count≥50 × 109/L, white blood count≥1.5 × 109/L
* patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria:

* tumor thrombus
* lymph node involvement
* extrahepatic metastasis
The Effects of Exercise Intensity on Mood and Wellbeing

The study will adopt a between-within group design where participants will exercise at 1 of 4 intensities for 30 minutes at SportsPark Reading. Mood, mental health (e.g., state anxiety and immediate depressive feelings) and physiological parameters (heart rate, blood pressure and body temperature) will be assessed before and after exercise intervention to compare the acute change across time for each intensity condition (no exercise (control), low, moderate, high).


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old

Exclusion Criteria:

* If participants' General Practitioner (GP) has advised them against exercising at low, moderate or high intensities
* Recent injuries within the last 12 weeks
* Physical health conditions that may be affected by exercising (e.g., asthma)
* Taking blood pressure medications
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients

This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, \<10 on a 0-10 NRS (Numeric Rating Scale).
* Inclusive of 40-80 years old.
* Diagnosis of primary knee osteoarthritis

Exclusion Criteria:

* The presence of any inflammatory arthritis
* Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
* Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
* Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
FallFitness Fallprevention Program for Older Adults

The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group.

Research questions of interest in the project are:

1. Can an eight week (eight sessions) high intensity group based fall prevention program increase strength, balance, activity level, quality of life, self-efficacy as well as reduce sedentary behavior, fear of falling and fall frequency in older adults?
2. Can older adults learn fall techniques by participating in an eight-week (eight-session) high intensity group based fall prevention program?
3. What experiences are there from the trained leaders and the participants in the intervention?
4. How can the program be implemented in the organisations for retired persons, facilitators and barriers?

A total of at least 10 volunteers will be recruited from the organisations for retired persons and trained to be instructors of the FallFitness program. These FallFitness instructors will lead the intervention groups in the planned randomised controlled trial.

For the 50 participants randomized to the intervention group a eight program including six different central components, strength, balance, self-efficacy, motor skills, and falling technique will be introduced. Estimation of about ten participants in each group with a total of five groups are planned.

Materials needed are mainly soft judo carpets. The exercise takes place in groups and most of the exercises are done in pairs, which has been a successful concept in previously research on a similar programme, Judo4Balance.

Outcome measures of interest:

Strength, balance, quality of life, activity level, fear of falling, confidence in one's own ability to perform various activities without falling, fall frequency and falling techniques. Further a "train the trainer" approach will be evaluated for implementation and a long term perspective of fallprevention.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age
* Fluent in Swedish language in both speech and writing

Exclusion Criteria:

* Physically weak, cannot sit upright without support and/or holding up the neck in a lying position and or rolls backwards
* Coronary artery disease and unstable angina
* Recently cataract treatment
Efficacy and Safety of LAS41003 in the Treatment of Intertriginous Candida Infections

The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.


Eligibility Criteria:
Inclusion Criteria:

* presence of candida infections in one or more intertriginous areas (trunk), confirmed by positive mycological sample at baseline;
* female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices \[IUDs\], sexual abstinence or vasectomized partner;
* written informed consent

Exclusion Criteria:

* receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
* patients who have been treated with oral anti-fungal agents within the 12 weeks prior to study entry or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks;
* evidence of drug or alcohol abuse;
* pregnancy or nursing;
* symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
* treatment with any other investigational drug in the four weeks preceding the study;
* known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol;
* treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study (e.g. glucocorticosteroids);
* in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to
Validation and Reliability of Iris Cameras in Mucopolysaccharidoses

To assess the reliablity and validity of 2 new iris cameras in the assement of corneal opacification in mucopolysaccharidoses

The mucopolysaccharidoses (MPS) are a group of disorders resulting from accumulation of glycosaminoglycans within various tissues including the eye. This can result in visual loss from corneal opacification. The assessment of corneal opacification is extremely subjective and based on a clinician grading this during slit lamp examination. There can be a significant variability and can prove problematic particularly in clinical trials assessing if corneal opacification is affected by potential new treatments.

The use of imaging could facilitate objective measurement of corneal clouding. A previous study using an iris camera and image analysis to provide a corneal opacification measure score (COM score) demonstrated that it can be used in children with MPS, however it still had limitations- as the system is fully automated, if certain conditions are not met an image is not captured. This can be an issue in younger children who may not be cooperative, and limited its use in younger patient populations.

It is anticipated that these limitations can be addressed by employing a newer iris camera (IriShield MK2120UL). The new camera's advantage is that it takes images monocularly, therefore only the eye under question needs to be aligned. We will also assess a new manual system (IRcamNew) which takes images whenever the shutter is manually pressed. This would be useful in children who cannot fixate with one eye, and can also be used when the child is examined under general anaesthetic which is commonly done in paediatric ophthalmology.

If proven to be comparable to the existing iris camera (IriscamOrig) in terms of validity and reliability, the added benefits of these new iris cameras can open its use in a wider range of patient populations - for instance, in paediatric clinical trials-, as well as allowing longitudinal tracking of corneal clouding from early childhood well into adulthood.

Eligibility Criteria:
Inclusion Criteria:

* Any patient aged 0-100 with MPS type I, type III, type IV and type VI. Type VII MPS patients may also be eligible.

For the control group -

Participants of any age currently being followed at MREH that have an eye condition unrelated to the cornea as established by clinical examination.

Exclusion Criteria:

* MPS II
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence

Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and potassium. LPR was invented to treat the renal stone patients with high risk of stone recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse effect than current standard medicine.

Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants. LPR was tested and verified to be very less toxic in cell culture and animal models. The clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of LPR was very low.

Eligibility Criteria:
Inclusion Criteria:

* Renal stone patients who were identified and stone was removed by surgical method.

Exclusion Criteria:

* Chronic kidney disease, chronic liver disease, history of coronary artery disease, or person who takes any medication that alters urinary metabolic profiles
Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)

The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease.

Participation consists in taking one or several blood samples depending on the group patients/controls.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Patients who have provided written informed consent
* Patients with national health insurance cover
* Age: 50 to 90 years

Patients with Horton' s disease :

* at the diagnosis, before any treatment
* or in remission
* or in relapse

Patients with an infectious disease :

* Bacteriologically or radiologically confirmed
* Presenting an inflammatory syndrome defined by :
* CRP ≥ 10 mg / L
* and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1

Patients with neoplasia ( solid tumour or hemopathy ) :

* At the diagnosis, before treatment by chemotherapy
* Presenting an inflammatory syndrome defined by:
* CRP ≥ 10 mg / L
* and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1

Controls :

These are healthy volunteers recruited among blood donators at Dijon CHU, voluntary hospital personnel ( nurses, doctors and secretaries ), patients at the EPHAD ( Champmaillot centre for geriatric patients ) and patients without infectious, inflammatory, or auto-immune disease ( CRP \< 5mg / L ) or cancer recruited from the investigating departments of Dijon CHU. They will be matched for age and sex.

* Age: 18 - 90 years
* Patients with national health insurance cover
* who have provided written informed consent
* Absence of an inflammatory syndrome ( CRP \< 5 mg / L )

Exclusion Criteria :

* Any patient who does not meet the inclusion criteria
Implementation of WHO Standards for Improving Maternal and Newborn Care

High-quality respectful care around the time of childbirth is a fundamental aspect of human rights and, according to recent global estimates, could prevent more than 100,000 maternal deaths and 1.3 million neonatal deaths annually. Despite some maternal and newborn health indicators in high-income countries being better in comparison to low-income and middle-income countries, existing evidence shows that improvements are needed in the quality of care provided to women and newborns in every country.

In 2016, the World Health Organization (WHO) developed a framework and a list of Standards for improving the quality of maternal and newborn care (QMNC). The WHO Standards define a set of 318 Quality Measures, divided into three key domains - experience of care, provision of care and availability of resources - which can be used to assess the QMNC at facility level. The ongoing project, named IMAgiNE (Improving MAternal Newborn carE), includes all maternities hospitals of the FVG Region and aimed at improving the quality of maternal and neonatal health care in the region. Quality of care is assessed using two complementary perspectives (women and health workers), with two validated questionnaires including about 100 quality measures based on the WHO Standards. It provides data on both the baseline assessment and the Quality Improvement component (progresses made).


Eligibility Criteria:
Inclusion Criteria:

For women:

1. Women who give birth at the nine maternity hospitals of the Friuli Venezia Giulia (FVG) Region, Italy

For health workers

1. All health workers directly involved in maternal/neonatal care at facility level in the FVG Region (i.e. general physicians currently working in maternal or neonatal care, midwives, nurses, neonatologists, obstetrics and gynecology doctors, and medical residents )

Exclusion Criteria:

For women:

1. Age \<18 years;
2. Stillbirth or neonatal death;
3. Psychiatric problems who may interfere with the telephone interview;
4. Hidden pregnancy or women whose child has been adopted or placed in foster care;
5. Refusal to participate.

For health workers

1. Refusal to participate;
2. Prolonged absence with unavailability during the study period.