cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex

The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.

Apevinat BC presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin B complex and C, in balanced amounts.

This combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. For the anorexic patients that are common B and C hypovitaminosis, the use of Apevinat BC will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with B and C vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic.

The current study will compare the efficacy and tolerability of Apevinat BC to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and B and C hypovitaminosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who presents lack of appetite;
* Wash out 20 days after ingestion before similar drug;
* Responsible for the least able to understand and maintain their adherence to protocol;
* Patients of all ethnic groups of both sexes, aged 7-14 years;
* Responsible for the minor must consent to participate in the same study, through the signing of consentiment term;
* Responsible for the minor should be able to understand the proper use of medication;

Exclusion Criteria:

* Patients with parasitic infections;
* Patients with angle closure glaucoma or open;
* Patients with a predisposition to urinary retention;
* Patients with peptic ulcer or stenotic pylorus-duodenal obstruction;
* debilitated patients or in acute asthma attack;
* Patients who have poor appetite caused by any serious illness;
* Patients who are taking any medications that depress the central nervous system;
* Patients who take medication monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazine, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotrophin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, Primidone, salicylates;
* Patients with known hypersensitivity to any components of the formula;
* Patients who are participating in another clinical trial;
* Inability to compliance with the protocol;
* Any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.
M-mode Ultrasonography for Epidural Catheter Identification and Confirmation of Correct Catheter Position

In France, 80% of women choose epidural analgesia for delivery and birth. The localization of the epidural space is classically achieved by loss of resistance to saline. This blind technique means the passage of the needle through the ligamentum flavum. However, epidural analgesia failure has been reported in 27-32% of cases.

Currently, lumbar neuraxial ultrasound has become a valuable tool facilitating the placement of an epidural catheter. Although lumbar neuraxial ultrasound has been the source of many studies, few have focused on its use to confirm the exact location of the epidural catheter in the epidural space.

In the Pediatric and Obstetric Anesthesia-Resuscitation Department of the Necker-Enfants Malades Hospital, pre procedural lumbar neuraxial ultrasound for epidural anesthesia is a regular practice.

The objective of this study is to evaluate the ability of M-mode (M-m) and color Doppler (cD) ultrasonography to identify the epidural catheter position for parturients in the delivery room.

In France, 80% of women choose epidural analgesia for delivery and birth. The localization of the epidural space is classically achieved by loss of resistance to saline. This blind technique means the passage of the needle through the ligamentum flavum. However, epidural analgesia failure has been reported in 27-32% of cases.

Currently, lumbar neuraxial ultrasound has become a valuable tool facilitating the placement of an epidural catheter. Although lumbar neuraxial ultrasound has been the source of many studies, few have focused on its use to confirm the exact location of the epidural catheter in the epidural space.

Indeed, only 2 retrospective studies have described this strategy on cohorts with small numbers of adult patients. One demonstrated in a mixed population the possible localization of the epidural analgesia catheter using color Doppler (cD) mode (67.5% of cases) and M-mode (M-m) ultrasonography (M-m) (75%). Only one study identified the position of the epidural catheter in the obstetric context due to the cD mode ; with a low rate of visualization (37.1% of cases).

In the Pediatric and Obstetric Anesthesia-Resuscitation Department of the Necker-Enfants Malades Hospital, pre procedural lumbar neuraxial ultrasound for epidural anesthesia is a regular practice.

The objective of this study is to evaluate the ability of the M-m and cD mode to identify proper catheter placement in parturients in the delivery room.

Eligibility Criteria:
Inclusion Criteria:

* Adult women admitted to the delivery room for a vaginal delivery with an epidural analgesia.
* Written informed consent.
* French speaking patient.

Exclusion Criteria:

* Patient with a contraindication to neuraxial analgesia.
* Visual Analogue Scale score \>7 at epidural analgesia pose.
* No health insurance.
Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.

This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10\^6 MSC/Kg recipient´s bodyweight).

MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.

All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
* Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
* Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
* Patients with ages between 18 and 65 years.
* Signature of informed consent form is required to be done by patient and donor.

Exclusion Criteria:

* Patients whose hematopathology has not been controlled by the transplant or is in progress.
* Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
* Patients with an inadequate cardiac or pulmonary function.
* Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
* Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
* Pregnant females or childbearing potential who are not on adequate contraceptive measures.
* Patients \<18 or \>65 years.
* Patients who do not sign the informed consent.
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients

The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment. Adverse effects and considerations to modify the therapy will be assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy with different seizure types


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from the age of 4 years
* Confirmed diagnosis of epilepsy requiring AED treatment
* Patients already receiving daily AED treatment as a monotherapy or a polytherapy with maximum 2 AEDs within the terms of marketing authorization with the following medications: Carbamazepine, Clobazam, Clonazepam, Gabapentin, Lamotrigine, Levetiracetam, Oxcarbazepine, Phenobarbital, Phenytoin, Pregabalin, Tiagabine, Topiramate, Valproate, Zonisamide
* Treatment must be stable for at least 3 months prior to assessment
* Absence of other severe and/or uncontrolled symptomatic chronic illness
Clinical Situations at High Risk of Placenta Accreta / Percreta

The purpose of this study is to identify what factors -either individual or related to the type of management received- influence the maternal outcomes in pregnant women at high risk for placenta accreta i.e , women with placenta praevia and previous caesarean.

This population-based study conducted in 8 French regions will also provide valid estimation of the incidence of placenta accreta among all parturients and among "at risk "women. Finally, a psychological evaluation of these women up to 1 year after delivery will provide information on the impact of these conditions on women, beyond somatic complications.

Background: No population-based study has assessed the prevalence of placenta accreta, the predictive value of prenatal diagnostic examinations, the maternal morbidity associated with its management, or its psychological effects. Moreover the technical resources necessary for the safest delivery of women at risk have not been clearly identified.

Objectives: The primary objectives are to identify individual risk factors for maternal morbidity, as well as risk factors related to types of management and healthcare facilities for postpartum hemorrhage (PPH). Secondary objectives are to 1) determine the prevalence of placenta accreta among women at risk; 2) assess the predictive value of ultrasound and MRI for the diagnosis of placenta accreta in this population; 3) evaluate psychological impact and physical complications; 4) report maternal physical complications during the year after delivery.

Design: Population-based prospective observational study of pregnant women with a placenta inserted at a uterine scar Setting; A total of 166 centers in 8 French regions, with 260,000 deliveries annually.

Methods: We expect to include 570 women at risk of placenta accreta in two years, of whom approximately 100 (20%) will have placenta accreta.

Main outcome measures: The primary outcome measure is severe maternal hemorrhage; secondary outcome measures are maternal morbidity and deaths, predictive value of ultrasound and MRI, and psychological evaluations at 1, 6 and 12 months after delivery.

Conclusion: This study will be the first prospective population-based study to include women at risk of placenta accreta and to investigate incidence, prenatal detection, type of management, morbidity and maternal psychological consequences.

Eligibility Criteria:
Inclusion Criteria:

Every woman:

* delivering in a maternity unit of the 11 participating perinatal networks.
* With a placenta praevia and at least one previous cesarean delivery, and / or having a placenta accreta
* aged 18 or more

Exclusion Criteria:

Every woman:

* not understanding French.
* refusing to participate in the study.
Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery

The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. The goal is to standardize future practice and improve the care of patients postoperatively. The two techniques used in conjunction with a brachial plexus block are paravertebral nerve block and subcutaneous infiltration.

This study is designed to test the null hypothesis that paravertebral nerve block or subcutaneous infiltration provide similar operating conditions when combined with supraclavicular nerve block for upper arm arteriovenous fistula surgery. The results will help determine which approach to use and guide future research in this area.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) undergoing upper limb arteriovenous fistula surgery at UNC Chapel Hill hospital

Exclusion Criteria:

* Contraindication to regional anesthesia
* Significant peripheral neuropathy or neurological disorder of the upper extremity
* Cognitive or psychiatric condition that will interfere with patient assessment
Evaluating Tumor Pseudoprogression With FLT-PET and MRI

A standard treatment for glioblastoma is a combination of radiation and the drug temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue. When standard monitoring with MRI or CT scans is done within a few months of finishing treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation or tumor growth and worsening of disease. Currently the only way to definitively distinguish inflammation from tumor growth is biopsy.

However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive method to distinguish post-treatment inflammation from tumor growth can help improve care for patients with glioma.

For the PET scans in this research study, the investigators are using a radioactive substance called FLT (3'-deoxy-3'-\[F-18\] fluorothymidine), instead of the standard substance FDG (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation. Because of that FLT may be better than FDG in differentiating cancer cells from inflammation.

An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this research study. The two MRI scans performed will also help give more information about the patient's tumor that is not routinely provided with a routine clinical scan, such as blood flow through the tumor or metabolic activity in the tumor. The information from these special MRI scans may provide more information about the blood supply to the tumor and how this changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may help how to distinguish inflammation due to radiation therapy from tumor growth.

If you are eligible to participate in this study you will have a pre-treatment FLT-PET scan within 7 days before starting treatment with radiation and temozolomide.

Two intravenous catheters (IVs) will be placed for each scan. One IV will be used to inject the FLT for the PET scan and the contrast agent for the MRI scan. The second IV will be used to draw blood for research tests. The PET scan will take about 2 hours. The MRI scan will take about 60-75 minutes. They will be done simultaneously.

About 4 weeks after you finish radiation therapy you will have a second FLT-PET scan and MRI scan.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed newly diagnosed glioblastoma
* Planned treatment for glioblastoma is standard radiation and temozolomide
* Measurable disease
* Life expectancy \>/= 12 weeks
* Lab values must be within limits specified in protocol
* Able to undergo MRI and PET scans
* On stable dose of steroids for 5 days prior to each MRI scan

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or not recovered from adverse events from prior therapy
* Receiving any other study agents to treat tumor
* History of allergic reactions to compounds of similar chemical or biologic composition to FLT
* Uncontrolled intercurrent illness
* Pregnant or nursing
* HIV-positive
Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults

The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients.

The main question\[s\] it aims to answer are:

* Is MI-E feasible?
* Is MI-E safe?

Participants in the intervention group will receive:

* MI-E
* Airway secretions will be removed by endotracheal suctioning, as part of routine airway care.
* Manual hyperinflation will only be used when necessary in an emergency situation. Patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated.

The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). Secondary outcomes are the total number of serious adverse events in relation to MI-E (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).

Bedside nurses, trained in using the MI-E device, will apply MI-E sessions at two moments per calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively ventilated.

MI-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient.

Eligibility Criteria:
Inclusion Criteria:

* admission to one of the participating ICUs;
* receiving invasive mechanical ventilation via an endotracheal tube; and
* expected to need invasive ventilation for more than 48 hours from consideration for inclusion.

Exclusion Criteria:

* use of MI-E before hospital admission, i.e., at home;
* known presence of bullous emphysema;
* known bronchopleural fistula;
* known pneumothorax or pneumomediastinum;
* known rib fractures;
* known barotrauma;
* known unstable spinal fractures;
* unsecured subarachnoidal haemorrhage;
* uncontrollable intracranial pressures; and
* any infection, or colonization with pathogens that requires strict aerogenic isolation. With an exception for patients in cohort isolation due to COVID-19.
The Role of a Virtual Coach in Improving Adherence to an Activity Program for Overweight Adults

Hypothesis: Overweight subjects using a Virtual Coach will demonstrate improved adherence to an exercise regime.

This study is designed to examine the effect of a computer program called a "Virtual Coach" and find out if it helps people become more active. This program acts as a kind of a personal trainer and will give you feedback. All participants in the study will receive an activity monitor to wear during the study and a website to use to track activity. Half of the participants will also receive the virtual coach software. This software will have to be downloaded onto your computer, and we will ask that you check in with the coach using the software three times a week for 12 weeks. The group you will be placed in will be selected by chance.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 20-55 inclusive
* BMI between 25 and 35 inclusive (overweight and Class 1 obese subjects)
* PC Computer with an available USB port, speakers and high-speed internet access in a secure setting (home or private office)
* Fluency in English (spoken and written)
* Have a Primary Care Physician
* Answer "No" to all 7 questions on PAR-Q OR have letter from PCP clearing them to take part in study

Exclusion Criteria:

* Disability, medical or surgical condition preventing or precluding moderate physical activity.
* Cognitive impairment.
Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality

The purpose of this study is to gather information about the long term health of people who have been prescribed the Cologuard test, which is used for colorectal cancer (CRC) screening.

Participates will be consented for prospective follow-up for health outcomes, which will be ascertained through periodic contacts. Participants will complete a baseline health questionnaire survey (T0) and a 1-year follow-up questionnaire survey (T1), allow access to medical records, when available, and allow future contacts for additional surveys.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the United States
* Age 18 years or older
* Able to provide informed consent
* Able to complete surveys in English or Spanish
* Valid order for Cologuard screening

Exclusion Criteria:

* N/A
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease

The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).

This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease \[GERD\[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GORD based on protocol-specified characteristics
* Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
* Caregiver able to complete the I-GERQ-R questionnaire

Exclusion Criteria:

* Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)
* Cause of vomiting/regurgitation other than GORD
* Prior history of cisapride intake