cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo

Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs. I In case of increasing failure rates, alternative options can be decided ontime.

The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.

This is a phase IV, randomized, open label, 2-arm trial. It will be performed in six malaria sentinel site around the Democratic Republic of the Congo. Children aged 6 to 59 months with confirmed Plasmodium falciparum uncomplicated malaria will be enrolled after informed consent granted by a parent or guardian. They will be randomized to receive either artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed treatment) and then followed up until day 28. At each visit, clinical examination will be done and malaria testing as well. Hemoglobin level will be measured on recruitment day and then every two weeks until day 28.

Eligibility Criteria:
Inclusion Criteria:

* children aged 6 to 59 months
* monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
* axillary temperature ≥ 37.5 °C
* ability to swallow oral medication
* ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule;
* informed consent from a parent or aguardian
* living within the study catchment area

Exclusion Criteria:

* presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
* body weight \< 5kg
* hemoglobin level \< 5g/ dL or hematocrit \< 15%
* presence of severe malnutrition
* presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
* regular medication, which may interfere with antimalarial pharmacokinetics;
* malaria treatment within 2 days prior to recruitment
* history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment
Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy

Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.

Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.


Eligibility Criteria:
Inclusion Criteria:

* Children with Cerebral palsy (medical file)
* Age 12-18
* Global Motor Function Classification System (GMFCS) I-III
* Functional Mobility Scale (FMS) minimum 2 for "50 meters"
* Ability to cooperate, to understand and to follow instructions
* Patient affiliated to the French social security system
* Patient volunteers whose the parents given their authorization to participate

Exclusion Criteria:

* Medical decision for any reason
* Child or parent decision for any reason
* Inability to cooperate, to understand and to follow instructions
Physician Administered Antibiotics in a Prehospital Setting

Sepsis is estimated to affect more than 30 million people globally. Detecting sepsis is notoriously difficult and there are no systems in place utilize prehospitally. In Denmark, the Mobile Emergency Care Unit (the MECU), manned by a physician and paramedic, is able to draw blood cultures and take venous lactate measurements before administering antibiotics.

This study aims to conduct a quality control on the ability of the MECU to recognize and treat sepsis by confirming the amounts of in-hospitally diagnosed cases. Furthermore the study investigates whether the blood cultures falls within an acceptable range of contamination.

In Denmark, the Emergency Medical System (EMS) consists of not only ambulances operated by paramedics and emergency technicians (EMTs) but also of Mobile Emergency Care Unit (MECU) staffed with an emergency physician with specialist training in anesthesiology and a paramedic. Only the physician on the MECU can administer prehospital antibiotics in Denmark; this emphasizes the importance of the first responding emergency units' capability in detecting and realizing the need for antibiotics in a patient so that the MECU can be requested and treatment initiated quickly.

Determining the administration of antibiotics is done at the anesthesiologists' discretion.

The purpose of administering antibiotics prehospitally is to reduce the time gap between suspicion of sepsis arises and the administration of antibiotics.

The purpose of this retrospective study is to conduct a quality control of the obtaining of blood cultures and of the administration of antibiotics in the prehospital setting serviced by the MECU in Odense in the Region of Southern Denmark in a time interval of 5 years (November 2013- October 2018).

The primary purpose is to associate the prehospital tentative diagnosis (assigned by the MECU) with the final diagnosis (ICD10 from hospital charts) including: 1: An indication for antibiotic therapy and 2: An assessment of the feasibility and potential benefit of the blood cultures obtained. 3: A description of the bacteria found in the blood cultures.

The association between initial prehospital diagnosis and final the diagnosis will be compared.

Secondly the patients seen by the MECU will be characterized regarding diagnosis (ICD10-classification), age, sex, medication, and the first set of vital parameters (Heart rate, Blood pressure, Respratory rate, Oxygen saturation, Glasgow Coma Score, Temperature).

Hypothesis The indication for giving prehospital antibiotics is supported by the prehospital blood culture and by additional findings reproduced inhospitally.

The prehospital tentative diagnosis is confirmed in-hospitally. Prehospital blood sampling is associated with an acceptably low range of contamination.

Eligibility Criteria:
Inclusion: Criteria: Antibiotics administrated by prehospital physician

Exclusion: Criteria: Age below 18 years. No prehospital administration of antibiotics. Patients without inhospital medical records or patients released at the prehospital scene following treatment.
Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population

This research project aims to investigate the acute effects of a dance-based cardiac rehabilitation session in the cardiovascular system and autonomic modulation of women with cardiac risk factors. Also, as a secondary outcome, to compare the cardiovascular and autonomic responses of the dance-based session to a conventional exercise-based session.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable
* Previously attending exercise-based cardiac rehabilitation and dance classes for at least 3 months
* Do not present orthopedics or neurologic impairments that could preclude the execution of dance movements
* To be previously diagnosed with at least one of the following cardiac risk factors:

  1. Age ≥ 55 years
  2. Family history: Known myocardial infarction, coronary revascularization, or sudden death in the first-degree relatives before 55 years in male or 65 years in female relatives
  3. Hypertension: values of systolic blood pressure (SBP) equal to or higher than 140 mmHg and/or values of diastolic blood pressure (DBP) equal to or higher than 90 mmHg, or daily use of antihypertensive drugs
  4. Dyslipidemia: values of low-density lipoprotein (LDL) ≥ 130 mg.dL-1, or values of high-density lipoprotein (HDL) \< 40 mg.dL-1, or daily use of lipid-lowering drugs
  5. Obesity: body mass index ≥ 30 Kg.m-2
  6. Cigarette smoking: former smokers for more than six months
  7. Diabetes Mellitus: fasting blood glucose level ≥ 100 mg.dL-1
  8. Physically inactivity: the volunteer will be considered physically inactivity when classified as "sedentary" or "irregularly active A or B" by the International Physical Activity Questionnaire (IPAQ)
  9. Stress: the presence of stress will be evaluated by the Lipp's Stress Symptoms Inventory (LSSI), and the classifications "alert", "resistance", and "exhaustion" will be considered

Exclusion Criteria:

* Volunteers who present errors superior to 5% in the RR intervals time series
* Volunteers who do not attend all study phases
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Ischemic NoIschemic cardiomyopathy
* EROA\> 0,2 cm2 or Regurgitant Volume \> 30 ml (ESC guidelines).
* EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
* MR Grade 3/4
* Eligible for TEE, surgical repair and replacement of mitral valve
* Coronary artery disease with or without the need for coronary revascularization
* Average value LVEDD 62 mm LVEF 42%

Exclusion Criteria:

* Pediatric
* Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
* ruptured papillary
Evaluation of Music on the Level of Anxiety Felt During External Radiotherapy Sessions

This is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device.

The retrospective phase (historical comparator) includes all patients with an initial HADS score \> 7 who were treated with radiotherapy during 6 months preceding the start of the prospective study. The prospective phase involves all patients with an initial HADS score \> 7 who will be treated with radiotherapy and who will benefit from music sessions (MUSIC-CARE). The study will be conducted over a fixed period of 12 months (6 months recruitment and 6 months follow-up) from the first patient receiving music sessions. Anxiety will be assessed by HADS self-questionnaires, before radiotherapy, at the end of the first week and at the end of radiotherapy. These evaluation parameters will therefore be compared to the 6-month period prior to the start of the study (retrospective phase).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients undergoing radiotherapy for curative treatment
* Patients with at least 15 sessions of radiotherapy
* Patients with an anxiety score \> 7 on the total A of the HADS scale at the time of medical consultation

Exclusion Criteria:

* Minor patients
* Pregnant or breastfeeding patients
* Patients with major hearing loss
* Patients with psychotic disorders
* Patients who do not understand or read the French language
* Patients under guardianship or deprived of liberty
* Patients requiring radiotherapy with respiratory servo-control (the MUSIC-CARE cannot be used due to technical constraints)
Compassionate Use Study of Tenalisib (RP6530)

Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be currently receiving treatment with Tenalisib on a previously approved protocol.
2. Patients must have had at least one efficacy evaluation in previous study and should have achieved either SD, PR or CR.
3. Patients must have completed at least 6 cycles of Tenalisib in previous study
4. Ability to swallow and retain oral medication.
5. Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception.
6. Male patients must be willing to use adequate contraceptive measures
7. Willingness and ability to comply with trial and follow-up procedures.
8. Willingness to provide new written informed consent.

Exclusion Criteria:

1. Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial.
2. Patient progressed while receiving Tenalisib therapy in his/her previous study.
3. Pregnant or lactating woman.
4. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
5. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
Innovation to Providing Interprofessional Maternity Care

The aim of this pilot project is to determine if there are differences in patient outcomes and healthcare utilization between patients randomly assigned to usual care (a collaborative model of maternity care with co-located healthcare professionals but with referrals to off-site obstetricians) or to a collaborative model of maternity care with co-located healthcare professionals, including obstetricians. It is hypothesized that by creating a seamless interface between obstetrical consultation and ongoing longitudinal maternity care, patient outcomes (birth outcome data), patient satisfaction and healthcare utilization, including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc, will be improved in the intervention group compared with the group receiving usual care. The results could potentially lead to other sites adopting this innovative model of maternity healthcare delivery.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older
* Attending their intake appointment at the Centre
* Ability to understand English
* Legal status in Canada

Exclusion Criteria:

-
The Effects of Schroth Based Exercise Therapy in Adolescents with Pectus Excavatum

Research on exercise methods for pectus excavatum (PE) is limited, highlighting the need for further studies. This study investigated the effects of Schroth-based exercise therapy combined with vacuum treatment in 35 adolescents with PE, divided into a vacuum + exercise group (n=19) and a vacuum-only group (n=16). Outcomes included deformity severity, sagittal posture, thoracic cage and spinal mobility, muscle endurance, and quality of life. The combination therapy significantly improved sagittal spinal posture (craniovertebral, thoracic, thoracolumbar, lumbar angles) and deformity-specific quality of life (Nuss Questionnaire scores) compared to vacuum-only treatment.


Eligibility Criteria:
Inclusion Criteria:

* having pectus excavatum
* being 10-18 years
* having Haller index more than 2.5

Exclusion Criteria:

* Individuals with pectus excavatum associated with a syndrome Individuals with mixed deformity
* Individuals who have previously received any conservative treatment or surgery for chest deformity or spinal issues
* Individuals with neuromuscular, rheumatic, or chronic systemic diseases
A Sub-study of PREDICT Neurodevelopment Protocol

To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).

Normative data are mostly, if not exclusively, obtained from children in the Western world. Comparing data from Asian children to these norms may lead to the wrong interpretation of the results, as it does not account for cultural differences, translation issues and a possibly different education system. Therefore it is essential to include a matched control group to evaluate the participants of the study to the fullest extent in terms of cognition, memory, behavior and fine motor skills, in all age groups over the full course of the study.

Eligibility Criteria:
Inclusion Criteria: for HIV negative exposed children

* Child from a HIV-positive mother
* Documented negative test for HIV-1 infection
* Between the age from 1-15 years
* Caregiver of the subject is willing and able to sign informed consent, prior to the study
* Thai or Cambodian origin

HIV negative and not HIV exposed:

Inclusion

* Child from a HIV-negative mother (by history)
* Documented negative test for HIV-1 infection
* Between the age from 1-15 years
* Caregiver of the subject is willing and able to sign informed consent, prior to the study
* Thai or Cambodian origin

Exclusion Criteria: for HIV negative exposed children

* The inability of the caregivers to understand the nature and extend of the trial and the procedure required
* Patients with psychiatric disorder
* Patients with a syndrome that affects cognitive performance

for HIV negative and not HIV exposed

* The inability of the caregivers to understand the nature and extent of the trial and the procedure required
* Patients with psychiatric disorder
* Patients with a syndrome that affects cognitive performance
Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults

In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed.


Eligibility Criteria:
Inclusion criteria

* Age between 20 and 70 years, both included.
* Healthy or mildly ill subjects (without any current chronic pharmacotherapy).
* Body mass index between 18.5 and 29.9 kg/m2, both included.
* Subjects who usually follow a balanced diet that are not engaged in any therapeutic lifestyle change involving stringent dietary interventions such as weight-reducing diets.
* Written informed consent to participate

Exclusion criteria

* Patients could not meet any the following criteria at the screening visit to be included in the study.
* Subjects with diseases or disorders affecting the function of the immune system, such as auto-immune diseases, allergies, atopic conditions, hypersensitivity to any kind of stimulus, or immunosupression for any reason; even if they are not currently taken any pharmacotherapy.
* Subjects with relevant functional or structural disorder affecting the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers or chronic inflammatory disease of the intestine; even if they are not in any specific pharmacotherapy at the time of recruitment; or who have underwent surgical procedures with permanent sequels (for example, gastroenterostomy).
* Subjects with any infectious disease requiring antibiotherapy at the time of recruitment.
* Subjects following any treatment modifying the immune response, such as immunosuppressants, corticosteroids, etc.
* Subjects with celiac disease.
* Subjects with chronic background weakening conditions, such as diabetes or neoplasms.
* Subjects with history of renal lithiasis.
* Subjects with deficient nutritional or hydrational status.
* Subjects with relevant deviations in routine haematology or biochemistry parameters.
* Subjects with current and documented alcohol abuse.
* Subjects in whom the investigator expected insufficient collaboration or difficulties to follow the study procedures.
* Subjects who regularly took any of the forbidden products specified in the appropriate section.
Brief Primary Care Intervention Helps Parents With Discipline

Play Nicely, is a 40 minute, interactive, media-rich, CD ROM that teaches parents, health care professionals, counselors, and child care workers/teachers the basics in aggression management for children ages 1-7. For more information about the program and to review results of previous studies, see www.playnicely.org. The objective of this study is to determine if using this brief intervention during the well child visit can affect parents' plans to discipline their children.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking parents of 1-5 year old children presenting to the Vanderbilt Primary Care Clinic for a well child visit.

Exclusion Criteria:

* Caregiver could not speak English or Spanish.