cyrilzakka/clinical-trials huggingface dataset:
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

Malaria causes significant morbidity and mortality in children in developing countries, despite the availability of highly effective antimalarial therapy. One of the key contributing factors is the delay in the initiation of treatment.

ArTiMist is a sublingual formulation of the established antimalarial treatment, artemether. In previous studies good bioavailability has been demonstrated. In an exploratory study (ART003) ArTiMist demonstrated a non statistically significant improvement of 26% (when compared to intravenous quinine) in the numbers of patients experiencing a parasite reduction of \>= 90% within 24 hours of the initiation of treatment.

This Phase 3 study is being conducted to establish whether treatment with ArTiMist in children with severe falciparum malaria or uncomplicated falciparum malaria with gastrointestinal complications is at least 20% superior in providing parasitological success (defined as \>= 90% reduction in parasite count at 24 hours after start of treatment) when compared to intravenous quinine.

Eligibility Criteria:
Inclusion Criteria:

1. The patient's legally acceptable representative has provided informed consent and the patient has assented (where relevant) to participation in the trial
2. The patient is a child that weighs between 5.00 kg and 15.00 kg inclusive
3. The patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500 P Falciparum per mcl (patients with mixed infections may be included provided ≥ 500 P Falciparum per mcl)
4. The patient has either:

   * severe or complicated falciparum malaria as determined by the investigator based on the WHO criteria for severity, and/or
   * uncomplicated falciparum malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

Exclusion Criteria:

1. The patient's legally acceptable representative does not provide informed consent for participation, or the child if capable, does not assent to participation in the trial.
2. Ability to tolerate oral therapy
3. Patient has received any antimalarial therapy within the 7 days prior to first study drug administration.
4. Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
5. Patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .
Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

The study hypothesis is that changes in serially obtained nerve conduction study data obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict the development of a clinically significant / disabling drug induced neuropathy six and twelve months following the start of treatment. Patients with breast cancer, colon cancer, gastroesophageal cancer, and non-Hodgkins lymphoma will be enrolled. Six lower extremity nerves--three in each leg--will be electrically stimulated and their responses recorded at three to four week intervals coinciding with patient's scheduled chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of untreated breast cancer, treated (advance stage) or untreated colon cancer, untreated non-Hodgkins lymphoma, or advanced gastroesophageal cancer scheduled to begin chemotherapy with either Taxol, oxaliplatin, or vincristine

Exclusion Criteria:

* Individuals with an implanted electronic medical devices (cardiac pacemaker or defibrillator, vagus nerve stimulator, deep brain stimulator, intrathecal pump, others)
* Individuals whose chemotherapy regimen will include nerve toxic drugs other than Taxol, oxaliplatin, or vincristine, or includes more than one of these three drugs in combination
* Individuals whose screening nerve conduction studies show peroneal motor amplitude \< 1 mV bilaterally or sural sensory amplitude \< 3 uV bilaterally or no result obtainable
Mitochondrial Apoptotic Pathway Induced by Myocardial Ischemia-Reperfusion Injury in Human

Background: The cardiomyocytes apoptosis induced by ischemia-reperfusion(I/R) is one of the most important factors in the myocardial I/R injury(MIRI) undergoing cardiac valve replacement with cardiopulmonary bypass(CVRCPB),and Ischemic postconditioning (I-postC) can inhibit apoptosis of myocardial cells. Consequently, this study investigated the key genes and apoptosis signaling pathways of myocardium in patients undergoing CVRCPB.

Methods: A total of 36 New York Heart Association class II or III patients with rheumatic heart disease (RHD) of both sexes, aged 21-59 years, who were scheduled for first cardiac valve replacement with CPB in the investigators' hospital from February 2014 to May 2015, were randomly divided into the following three groups (n=12 each): negative control group (NEG group); I/R group (POS group); and I-postC group (Treat group). In the Treat group, the procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened. The NEG and Treat groups were not treated. Thirty-six patients were assessed for arrhythmia and recovery of myocardial contractile function after reperfusion by electrocardiograms and degree of dependence on vasoactive drugs. The myocardial tissues of the right atrial appendage were obtained at 3 min before CPB was established in the NEG group, and at 45 min after opening the aorta in the POS and Treat groups. In all three groups, the myocardial tissues of the right atrial appendage were obtained and preserved at -80°C for further experiments. The right atrial appendage of three patients randomly selected in each group was fixed with RNA later (Qiagen, Hilden, Germany) in a centrifuge tube overnight at 4°C, and then preserved at -20°C for RNA extraction. Human 12×135K Gene Array profiling of mRNA expressions was undertaken in human cardiac muscle cells. Differentially expressed mRNAs verified by quantitative real-time RT-PCR were subjected to pathway analysis. The mRNA expressions of AIF, APAF1, CYCS, Bax, caspase-3, caspase-9, caspase-6, caspase-7, BCL2, BAG1, and PI3K were assessed by real-time RT-PCR and western blot analysis. The levels of myocardial apoptosis induced by I/R were investigated by TUNEL assays. The changes in MIRI induced by myocardial apoptosis were investigated by pathologic examination of the myocardium.


Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association class II or III
* aged 21-59 years
* scheduled for first cardiac valve replacement with CPB

Exclusion Criteria:

* The patient with a history of heart operation or diabetes,
* with a history of liver and/or kidney dysfunction,
* with a history of coronary heart disease and the left ventricular ejection fraction(LVEF)\<0.4, receiving drugs with pretreatment effectssuchas hormones, ATP-sensitive potassium (KATP) channel openers，insulin，et al. within preoperative one week,
Evaluation of Maternal Mental Health Following Ultrasonography Detection of Fetal Congenital Anomalies

The purpose of this study is to evaluate maternal mental health during antenatal and postnatal periods after Ultrasonography diagnosis of fetal anomalies.

Fetal congenital anomalies are responsible for a great deal of abortions in desired pregnancies . In clinical practice, prenatal screening programs in 1st and 2nd trimester target both chromosomal and structural abnormalities. These congenital anomalies are classified as minor and major anomalies than may lead to death or stillbirth . Half of all anomalies are detectable during weeks 18-22 of pregnancy. Due to the advances occurring in Ultrasonography and screening paradigms, the rate of diagnosed anomalies is increasing dramatically which in turn leading to psychological distress in the pregnant mother. Receiving a diagnosis of fetal anomaly is a highly stressful and potentially traumatic event that can elicit immediate feelings of grief, loss, anger, depression, and anxiety. However, the foreknowledge of a fetal anomaly during pregnancy may enable the mother to prepare mentally resulting in reduced maternal stress after delivery. The American College of Medical Genetics recommends underscoring the importance of psychological assessment and substantive communication with parents facing a prenatal diagnosis of fetal anomaly. Despite the accessibility of establishing the significant symptoms of maternal psychological distress, the evidence on the definite nature of this distress in consideration to other life stressors and an accurate the prediction of women vulnerability in the critical period have not been clear yet due to many methodological issues. Identification of women at highest risk for poor adaptation to the diagnosis may allow for targeted psychological support services for those most vulnerable.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with confirmed pregnancy with viable fetus (whether singleton or multiple)
* Fetal anomaly should be diagnosed with ultrasonography (whether minor or major) after 12 weeks of gestational age

Exclusion Criteria:

- Women with history of psychiatric disorders.
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD2693 administered as an subcutaneous injection in male and female participants with mild, moderate, or severe hepatic impairment compared with male and female participants with normal hepatic function (as control). Eight participants with mild impairment (CP Class A); 8 participants with moderate impairment (CP Class B); 8 participants with severe impairment (CP Class C); and 8 to12 participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired participants are planned for study intervention with the goal of having at least 6 evaluable participants within each group. Study participants who self-withdraw after study intervention may be replaced to ensure that at least 6 participants per group are evaluable and complete the study per protocol. An evaluable participant is defined as having adequate plasma PK profile to meet the primary study objective. Child-Pugh scoring, detailed in Table 2, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6).

Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).

Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).

Group 4: Participants with normal hepatic function.

Study Arms and Duration:

* Planned screening duration per participant: up to 4 weeks.
* Planned study duration (screening to follow-up) per participant: up to 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

For Hepatic:

* Participant with a diagnosis of chronic and stable hepatic impairment

For Healthy:

* Participant with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECGs,

All participants:

- Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening

Exclusion Criteria:

* Participant with impaired hepatic function has eGFR \< 60 mL/minute/1.73 m2 and participant with normal hepatic function has eGFR \< 90 mL/minute/1.73 m2
* Positive test for HIV at screening
* History or presence of clinically significant thyroid disease
* History or presence of clinically significant or unstable medical or psychiatric condition
* History of any major surgical procedure within 30 days prior to study intervention
Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries

A randomised and controlled trial to people diagnosed with rotator cuff injuries who are divided into 3 groups of treatment: shoulder myofascial trigger points release, manual diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. The pain and range of shoulder movement are assessed before and after the treatment in all the participants.

Hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or active mobilization, has impact on rotator cuff injury symptoms comparing with a standard treatment of shoulder myofascial trigger points release.

Discussion: The relation between shoulder and diaphragm muscle, through innervation (phrenic nerve and brachial plexus), embryology and myofascial connections, could lead to include in clinical practice the examination and treatment of other structures besides shoulder girdle such as diaphragmatic region in rotator cuff injuries.

This study is a randomised controlled trial evaluating clinical effects of a diaphragm treatment, via manual release or active mobilization, comparing with a standard treatment of shoulder myofascial trigger points release.

A description of the 3 groups of treatment:

1. - Experimental group 1: 3 diaphragm stretching techniques according to Chaitow, Ward and Ricard, performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position.
2. - Experimental group 2: diaphragm mobilization through active hipopressive gymnastic exercise according to Caufriez in two different postures.
3. - Active comparator group: A ischemic compression technique in most painful myofascial trigger points in the infraespinatus and supraespinatus muscle during one minute each one.

The shoulder flexion, abduction and external rotation range of motion will be assessed pre and postinterventions, as well as the pressure pain threshold with an algometer and the pain experienced by the individual in shoulder mobility with a Numerical Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Participants of both genders aged between 18 and 65 years old
* Ultrasound and/or magnetic resonance imaging diagnosis of rotator cuff injury
* Pain or range of movement restriction in active shoulder flexion and/or abduction

Exclusion Criteria:

* Use of analgesic or anti-inflammatory drugs 72 hours prior to the study
* Individuals with glenohumeral instability due to shoulder luxation or subluxation or Bankart labrum injury
* Individuals who have received physical therapy treatment in last week
* Individuals who underwent thoracic or shoulder surgery or people suffering from rheumatisms
* Diabetic patients
* People with a diagnosed neurological pathology
* Individuals with a diagnosed mental health problem
* Not being able to understand and sign the informed consent and information sheet
Computer-Delivered PFI for Anxiety Sensitivity/Alcohol Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity

Hazardous alcohol consumption is one of the leading causes of preventable deaths in the United States. Further, it is highly comorbid with anxiety and depressive symptoms and disorders; hazardous alcohol use is associated with increased anxiety/depression. Indeed, 'affectively-vulnerable hazardous drinkers' (i.e., drinkers with elevated negative mood states or psychopathology) are 'at risk' for higher drinking rates, more problematic drinking, worsened mental health, and greater disability. Specialty care options are needed to address the unique 'affective needs' of hazardous drinkers. One promising intervention approach is to employ personalized feedback interventions (PFI). These interventions are brief, efficient, and have been shown to be effective in a number of settings and across an array of populations. However, PFIs have not been evaluated among affectively vulnerable hazardous drinkers.

In order to address the heterogeneity of negative mood states and disorders among hazardous drinkers, there is a need to theoretically orient the intervention approach on underlying transdiagnostic processes that underpin affective psychopathology. Anxiety sensitivity (AS), the tendency to fear anxiety-related sensations, is a core transdiagnostic vulnerability factor underlying the etiology and maintenance of anxiety disorders, other emotional disorders, and hazardous drinking. AS is malleable in response to psychosocial interventions, making it a prime risk factor to target in prevention/intervention programs, including PFI approaches. Integrated treatments that address hazardous drinking via AS are nonexistant. As most hazardous drinkers typically do not access treatment because of such barriers as cost, time commitments, stigma, and logistics (e.g., travel, scheduling appointments), there is a need to develop an accessible, brief, integrated tool to explicitly address the drinking-affective vulnerability comorbidity via AS. To address this public health gap, the current proposal seeks to employ a computer-delivered integrated PFI that directly addresses hazardous drinking-AS in a personalized manner. Hazardous drinkers with elevated AS will be randomly assigned to receive one session of PFI or attention information control with follow-up assessments at one week and one month post-intervention. The PFI will focus on targeted feedback about drinking behaviors, AS, and adaptive coping strategies.


Eligibility Criteria:
Inclusion Criteria:

* elevated anxiety sensitivity, hazardous drinking

Exclusion Criteria:

* current mental health/substance treatment
Telehealth Monitoring in Chronic Obstructive Pulmonary Disease

The the aim of this study is to determine the benefits of Telehealth monitoring in the management of patients with chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is a major burden on healthcare systems worldwide. The current management of patients with COPD includes well established interventions such as pulmonary rehabilitation and inhaled therapies which have demonstrated variable impact on reducing rates of exacerbation and improving health related quality of life.

Telehealth is a home monitoring system used to record clinical observations and carry out question and answer sessions. It has been proposed that Telehealth medicine may offer an alternative strategy to the overall management of these patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)
* a minimum of two: Emergency Department admissions; hospital admissions or emergency GP contacts in the 12 months previous to the study

Exclusion Criteria:

* any respiratory disorder other than COPD
* patients cognitively unable to learn the process of monitoring
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)

To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.

The duration of treatment is 6 years.

Eligibility Criteria:
Regular PSA testing and study biopsies required.
The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy

1. To evaluate expression levels of circANKRD36 in the development and progression of DN.
2. To investigate correlation between expression levels of circANKRD36 and stages of DN.
3. To investigate correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in T2DM patients with CKD.

Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders that's become a global health burden affecting 463 million people worldwide according to the International Diabetes Federation (IDF). Diabetic nephropathy(DN) is one of the most common secondary complications of DM and is becoming a major cause of morbidity and mortality among diabetic patients . DN is a microvascular complication occurring in approximately 20-40% of patients with T2DM . DN has been described as a glomerular disorder with the following phases: glomerular hyperfiltration, incipient nephropathy, microalbuminuria, overt proteinuria and end-stage renal disorder. Microalbuminuria is the gold standard for the early diagnosis of DN. However, many studies have suggested that it is inadequate and has some drawbacks. Recent novel biomarkers have been accepted for early diagnosis and progression of DN in patients with T2DM . Renal cells are capable of synthesizing pro-inflammatory cytokines such as tumor necrotic factor-alpha (TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6), these cytokines acting in a paracrine or autocrine manner that leading to the development and progression of several renal disorders .Circular RNAs are class of endogenous non coding RNAs and are associated with numerous diseases like T2DM. Circular ankyrin repeat domain 36 (circANKRD36) involved in T2DM and inflammation-associated pathways via interaction with miRNAs, including hsa-miR-3614-3p, hsa-miR-498, and hsa-miR-501-5p. The expression of circANKRD36 was upregulated in peripheral blood leucocytes and was correlated with chronic inflammation in T2DM. Therefore, circANKRD36 can be used as a potential biomarker for screening chronic inflammation in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as Type 2 Diabetes Mellitus

Exclusion Criteria:

* Any other clinically systemic acute or chronic inflammation disease/s.
* Autoimmune disease.
* Any endocrine disease other than T2DM.
* Cancer.
* Chronic hepatic or renal failure.