cyrilzakka/clinical-trials huggingface dataset:
Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

Primary Objective:

To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.

Secondary Objective:

To compare the clinical safety of the two treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* weighing ≥ 10 kg
* residing in the area covered by the investigating centre throughout the entire follow-up period
* axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours
* Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre

Exclusion Criteria:

* presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure \< 70 mmHg in adults or \< 50 in children, spontaneous bleeding, inability to sit or stand
* serious concomitant disease
* allergy to one of the investigational medicinal products
* pregnant women or breast-feeding women.
* documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.
Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.

The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, depression, BMI \<44,ages between 21-65, female

Exclusion Criteria:

* BMI \>44, \>100 min. of exercise per week, Type 1 diabetes, no diabetes,MI,Stroke, Catheterization, unstable angina in previous 6 months,pregnancy,glucocorticosteroid therapy in last 3 months,bipolar, psychotic disorder or post-traumatic disorder,moving out of area within next 6 weeks
MYeloma Resistance And Clonal Evolution

Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

The MYRACLE cohort study aims at including all patients (\>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of multiple myeloma according to standard criteria
* Age \>18

Exclusion Criteria:

* Minor patient
* Patient under guardianship
* Protected patient
Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training

In this study, the investigators are testing transcranial direct current stimulation (tDCS) in breast cancer survivors. In this pilot study, the investigators want to learn if it is feasible to use this device in memory rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivors treated with chemotherapy between 40 and 65 years of age with no evidence of disease with treatment completed at least six months prior to study participation with or without current endocrine therapy.
* Self-reported new onset since initiation of treatment cognitive dysfunction as determined by telephone screen using the brief (3 questions) assessment established by Ercoli et al. \[3\] (endorsement on all three questions):

  1. Do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment?
  2. Do you think that your mind isn't as sharp now as it was before your breast cancer treatments?
  3. Do you feel like these problems have made it harder to function on your job or take care of things around the home?
* In the judgment of the investigators and/or consenting professional, able to read and comprehend English
* In the judgment of the consenting professional cognitively able to provide informed consent

Exclusion Criteria:

* Patients with prior history of primary Central Nervous System (CNS) cancer or CNS metastases
* As per self report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.)
* Participants with untreated depression or anxiety as assessed by self-report and review of medical history;
* Participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self report and review of medical history;
* As per self report participants who are pregnant or who are breastfeeding
* As per self report participants with pacemakers, intracranial electrodes, implanted defibrillators or any other prosthesis.
Pelvic Floor Muscle Exercises Effect After Stoma Closure

This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.

Sample of study was calculated as 32 using G\*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al. Participants were assigned to the experimental and control groups by the stratified block randomization method. The locks were assigned to layers using Microsoft Excel.

The individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training. The patients received a PFME training booklet prepared by the researcher. Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. Data was collected a day before discharge, first, second, third, and sixth months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 75,
* Being literate,
* Having a stoma due to colorectal cancer,
* Having no previous anal trauma,
* Having no anal surgery other than colorectal cancer surgery,
* Having no congenital anorectal anomaly,
* Having no neurological problem,
* Having no physical disability,
* Having no previous experience of PFMEs before the surgery,
* Being cognitively able to answer questions

Exclusion Criteria:

* Wanting to leave the study,
* Having had previous biofeedback and electrical stimulation therapy applications,
* Having another stoma,
* Not being reachable by phone.
Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial

This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.

The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6 and 12 months after surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Reduced keratinized tissue (less than 2 mm) in inferior incisors area
* Healthy periodontium in inferior incisors area
* Indication for surgery (e.g. pain during tooth brushing, gingival margin mobility, gingival recession...)
* Recessions class I, II or III, maximum 3 mm
* Having signed the informed consent

Exclusion Criteria:

* Systemic diseases
* Smokers
* Pregnant and lactating women
* Root caries lesions
* Previous surgeries at same area
* Accentuated root abrasion
* Malpositioning teeth
* Residual pocket depths greater than 4 mm
* Tooth mobility greater than 1
Prospective, Longitudinal, Observational Registry of Adult Patients with Hypophosphatasia (REG-HYPO)

The purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists.

Hypophosphatasia (HPP) is a rare inherited disease caused by mutations of the ALPL gene. In adult HPP, patients may suffer from fractures, pseudofractures, fracture healing complications, osteoarthritis, chondrocalcinosis, dental diseases, muscle pain and disability, but also headache, muscle weakness, ocular disease, and other symptoms. In some cases the diagnosis is severely delayed. Moreover a number of patients having such symptoms and a low level of serum alkaline phosphatase, without gene mutation can be followed by rheumatologists with difficulties in management of bone fragility and pain. The aim of this register is to describe prospectively the medical events in adult patients having hypophosphatasia, whether or not there is a proven genetic abnormality.

Eligibility Criteria:
Inclusion Criteria:

* men and women,
* aged 18 and over, with no upper age limit, who have had a total alkaline phosphatase value of less than 40 IU/l on at least 3 occasions,
* with at least one rheumatological symptom.

Exclusion Criteria:

* transient hypophosphatasia: absence of confirmation of a value below 40 IU/l on at least 3 samples,
* secondary hypophosphatasia according to the expert rheumatologist (drugs, endocrine disease, other genetic disease...).
New Echocardiographic Methods for Right Ventricular Function.

Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .

Studies of the last years revealed that the right ventricular function is an important predictive value for the survival of patients with congenital heart disease, pulmonary hypertension or chronic heart failure. In 2006 the National Heart, Lung and Blood Institute has pronounced the right ventricular dysfunction including the non-invasive assessment of the right ventricular function as preferential aim of cardiovascular research.

Many parameters are used to describe right ventricular dysfunction, but none of these has a comparable significance like the left ventricular ejection fraction. Because of the limitation of each right ventricular parameter the stepwise combination of these parameters is used to describe right ventricular function what frequently results in further problems, especially in comparison of long-term controls.

Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function. The study is carried out as prospective, monocentric trial at the Department of Cardiology of the University Hospital of Heidelberg. Three different groups are set up for the assessment of the right ventricular function: patients with pulmonary arterial hypertension, patients with chronic heart failure of the left ventricle affecting the right heart and patients without structural heart disease who underwent an echocardiographic examination for other reasons (control group).

All participants are re-examined in constant intervals as clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* persons of 18 years and older who receive a transthoracic echocardiography at our department
* written consent

Exclusion Criteria:

* present atrial fibrillation/flutter
* permanent pacemaker rhythm
* moderate/severe valvular heart disease
* pregnancy
A Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women

The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate the exposure of budesonide to infants.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to comply with study procedures and provide informed consent.
* Be breast-feeding women, aged 18 to 45 years inclusive, and having infants aged 1 to 6 months.
* Be asthmatics that have been on maintenance treatment with Pulmicort Turbuhaler 200 or 400 µg bid for at least 3 months prior to visit

Exclusion Criteria:

* Clinically relevant abnormalities in physical examination, laboratory assessments, blood pressure or pulse as judged by the investigator.
* Clinically relevant disease and/or abnormalities, which in the opinion of the investigator, may either put the patient or infant at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study.
* A suspected/manifested infection of HIV, hepatitis B or C or other infection according to WHO Risk classification 2-4
Augmenting Treatment Effects of Voice Therapy in Parkinson Disease

The purpose of this study is to evaluate the impact of a non-invasive brain stimulation technique called transcranial magnetic stimulation (TMS) on voice/speech treatment in people with Parkinson's Disease (PD), through the use of speech and voice analysis, examination of voice box, and brain imaging methods.

Effective treatment of the speech disorder in IPD is as important as the optimal control of limb motor symptoms. Presently, the Lee Silverman Voice Treatment (LSVTÒ LOUD) - is a time intensive behavioral treatment for Parkinson's hypophonia. Facilitatory TMS is a safe and a complimentary stimulation technique. Brain imaging has also identified suitable target brain regions that are readily accessible to TMS. This combined treatment modality approach should be more effective and efficient the LSVT alone.

The study will enroll patients with Parkinson's disease with moderate to severe hypophonia. A total of 36 patients will be recruited over 3 years and divided into 3 groups (n=12 each). The three cohorts are: 1. LSVT +sham TMS; 2. LSVT +left rTMS and 3. LSVT + right rTMS.

This is a longitudinal double blind randomized controlled clinical trial. All investigators and study personnel will be blind to the study except for the PI responsible for TMS (Dr. Narayana). The entire protocol occurs over 19 weeks. During the first week, the participants will be screened, consented. During the second week, baseline behavioral and imaging data will be collected. Next, the patients will be randomized to one of the three treatment groups. Then the patients will enter a 4-week treatment phase, where they will receive TMS/sham TMS and LSVT 4 days a week for 4 weeks. During the seventh week, patients will undergo post treatment behavioral and imaging assessments. Then the patients will return in week 19 to complete the follow up behavioral measures and imaging session.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Idiopathic Parkinson's disease (IPD) between the ages of 45 and 80 years with moderate to severe hypophonia
* None or mild cognitive impairment or depression
* Stable medication therapy for at least 3 months. Must be "optimally medicated" at the start of the study. This means that there should be no change in mediction type or dosage in 3 months prior to enrolling in the study. The medications should not be causing significant or serious advese effects

Exclusion Criteria:

* History of drug abuse or neurological condition other than or in addition to IPD (for example stroke)
* Individuals with advanced IPD (stage V) or who had LSVT within 3 years
* Pregnant females
* History of seizures, history of major head trauma, metal objects implanted in the head, ferrous metal filings in the eye, brain damage, inflammation of the brain, cardiac pacemaker, implanted medication pump, cardiac lines, heart disease, currently taking certain types of medication for depression or seizures (tricyclic antidepressants or neuroleptics which lower seizure threshold
Office-based Validation of the JVPHome

The JVPHome is a novel medical device that utilizes machine vision in order to facilitate assessment of jugular venous pressure (JVP) height relative to the sternal angle with the ultimate goal of enabling remote JVP monitoring. The current study aims to evaluate the ability of an enhanced version of the JVPHome to enable remote identification of JVP height relative to ultrasound among congestive heart failure (CHF) patients when the device is applied by the study team in the clinic.

CHF is a common and devastating health problem estimated to affect upwards of 26 million individuals worldwide. Following an initial hospitalization for heart failure, approximately 25% of patients are readmitted within the first 30 days of discharge. Repeat heart failure hospitalizations are a major burden on both patients and healthcare systems. To date, there is an absence of non-invasive solutions proven to reduce the risk of re-hospitalization for CHF.

The key feature of the physical examination for assessing the volume status of CHF patients is the JVP, which manifests as a biphasic pulsation along the neck. The height of the JVP relative to the sternal angle is a reflection of right atrial pressure, which increases in response to higher pressures transmitted from the left side of the heart. Pathologic elevation of left sided heart pressures can result in fluid congestion in the lungs, which can cause patients to develop shortness of breath and reduced blood oxygen levels. Although a crucial marker of volume status, accurate identification of the JVP can be challenging for physicians due to its pulsations often being subtle.

The JVPHome is a novel medical device designed to facilitate visualization of JVP height relative to the sternal angle through the use of machine vision. The current study aims to evaluate an enhanced version of the JVPHome in a clinic setting when the device is applied to CHF patients by clinicians. Following its application, the JVPHome will be allowed to record a video of the JVP and images will subsequently be transmitted to a secure cloud and undergo analysis with machine vision software. Visualization of the JVP will be facilitated through simultaneous electrocardiographic and pulse oximetry recordings by the JVPHome. Following its application, data is transferred to a secure cloud server for subsequent processing and clinical review.

JVP height of study participants will be concurrently assessed through the use of ultrasound (gold standard). Clinicians that are blinded to ultrasound determined JVP height values will assess JVP height generated by the JVPHome. Analyses will then assess the accuracy of the JVPHome relative to ultrasound and expert clinical assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Congestive heart failure diagnosis receiving ongoing treatment
* Able to provide informed consent

Exclusion Criteria:

* Conditions which preclude visualization of the JVP, including neck deformity, scarring, and facial hair
To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects

This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.

The evaluation of ADC189/ADC189-I07 in mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and BMI, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* 1) The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial.
* 2) Age 18-75 years old (including the boundary value), both male and female.
* 3) The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0\~30.0 kg/m².

Exclusion Criteria:

* 1) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
* 2) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
* 3) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
* 4) eGFR (CKD-EPI Cr) \<60mL/min/1.73m2.
A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-64 years (both inclusive) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)