cyrilzakka/clinical-trials huggingface dataset:
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants

Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain, noise, and light), which can have a negative impact on their development. And more specifically on the development of oral skills. In the past decades, the standard of care has evolved and is based on less "aggressive" care and the implication of parents as caregivers. Recent data on the incidence of oral disorders in extremely premature babies are not currently available.

These oral disorders have significant short-term and long-term consequences. During hospitalization, it leads to a delay in the acquisition of full oral feeding, which is defined as the absence of need for tube feeding, and is associated with prolonged hospitalization. It is also associated with a delayed development of orality, which is essential for the proper psychomotor, and cognitive development of premature infants.

Strategies have been proposed to support the acquisition of oral feeding autonomy and to prevent oral feeding disorders, including tactile stimulation of orality consisting in stroking cheeks, peri-oral and intra-oral structures, but there is still no consensus on the best way to support the development of orality in this population.

In this context, a tactile stimulation protocol of orality, has been implemented in the past years, in the neonatal unit of the croix-rousse hospital, based on data published in the literature. It is performed on a daily basis by nurses, and physiotherapists.

In this general context marked by a less aggressive management of orality, and the implementation of an orality stimulation protocol, the main objective of ORAPREM study is to determine the corrected gestational age of oral feeding autonomy in a population of extremely premature infants born recently. Secondary objectives are 1) To analyse risk factors of delay in oral feeding autonomy, to define a subgroup of high-risk infants who could benefit from reinforced interventions to stimulate orality, and 2) To calculate the incidence of oral feeding disorders up to 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Infants born at a gestational age ≤ 28 weeks
* Born between January 1, 2018 and December 31, 2021
* Admitted in the first three days of life in the neonatology department of the Croix-Rousse hospital
* Discharged directly to home (or to a nursery)

Exclusion Criteria:

* Infants re-transferred to another department during hospitalization
* Infants with a severe pathology requiring surgical management in the first weeks of life. Inguinal hernia repair is not concerned
* Severe malformation
* Refusal of the parents
Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - MVRCs

Critical illness myopathy (CIM) is a disabling condition that develops in critically ill patients. The syndrome is not only a cause of prolonged intensive care hospitalisation but also a main reason for delayed recovery. Critical illness myopathy presents as diffuse muscle weakness and failure to wean from mechanical ventilation.

The pathogenesis of CIM is unclear. The proposed mechanisms for critical illness myopathy include muscle membrane depolarization, circulating depolarizing factor, and an endotoxin that reduces muscle sodium channel availability at depolarized membrane potentials.

The electrophysiological diagnosis of CIM diagnosis is done by electromyography (EMG). In order to be able to detect changes in EMG, more than 2-3 weeks' time is required. Moreover the findings resemble other myopathies and are unspecific. EMG studies in paralysed muscles and sometimes unconscious patients is difficult or even impossible

Since the 1950s, it has been attempted to investigate the muscle cell membrane properties, but it has not been possible to develop a clinically applicable diagnostic method. The novel electrophysiological method MVRCs is a possible future diagnostic method. It's more sensitive to muscle cell membrane changes than existing methods and it is simple enough to use in multiple clinical settings.

The objective of this study is to investigate the utility of MVRCs in the early diagnosis of critical illness myopathy by investigating the muscle membrane properties in sepsis patients, who are in risk of developing CIM. In addition, this will contribute to a better understanding of the pathophysiology of critical illness myopathy.

The study will enrol 70 participants in total, divided in to 2 groups of 20 patients aged ≥18 years; 1) patients with sepsis at intensive care units and 2) patients with chronic renal failure and uremia, and 30 sex- and aged-matched healthy participants. All subjects are to undergo neurological examinations, electromyography, nerve conduction studies, direct muscle stimulation and MVRCs. Blood tests will be taken in all patients. Patients with sepsis will be examined every week in 3 weeks. The presence of probable CIM will be determined on the 4th examination. Healthy participants and patients with chronic renal failure will only be examined in 1 occasion.

The primary outcomes will be MVRCs parameters which will be compared between patients and healthy participants. Furthermore, MVRCs parameters will be correlated to blood sample results.


Eligibility Criteria:
Inclusion Criteria:

Patients: Fulfilled sepsis criteria of an increase in the Sequential (Sepsisrelated) Organ Failure Assessment (SOFA) score of 2 points or more.

Exclusion Criteria:

Patients and controls:

* Earlier peripheral nervous system disease
* History of malignancy, diabetes mellitus, alcoholism, medicine or other causes of polyneuropathy or myopathy
* Bleeding tendency or anticoagulation therapy
Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children

In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of bloodstream infection in children and many children are co-infected with Plasmodium falciparum (Pf) malaria. NTS bloodstream infection presents as a non-specific severe febrile illness, which challenges early diagnosis and, as a consequence, prompt and appropriate antibiotic treatment.Moreover, at the first level of care, frontline health workers have limited expertise and diagnostic skills and, as a consequence, clinical danger signs that indicate serious bacterial infections are often overlooked.

Basic handheld diagnostic instruments and point-of-care tests can help to reliably detect danger signs and improve triage, referral and the start of antibiotics, but there is need for field implementation and adoption to low-resource settings. Further, it is known that some clinical signs and symptoms are frequent in NTS bloodstream infections. The integration of these clinical signs and symptoms in a clinical decision support model can facilitate the diagnosis of NTS bloodstream infections and target antibiotic treatment.

The investigators aim to develop such a clinical decision support model based on data from children under five years old admitted to Kisantu district referral hospital in the Democratic republic of the Congo. While developing the model, the investigators will focus on the signs and symptoms that can differentiate NTS bloodstream infection from severe Pf malaria and on the clinical danger signs that can be assessed by handheld diagnostic instruments and point-of-care tests. The deliverable will be a clinical decision support model ready to integrate in an electronic decision support system.


Eligibility Criteria:
Inclusion Criteria:

1. Be a child of \> 28 days and \< 5 years old
2. Be admitted to Kisantu Hospital
3. Having a blood cultured sampled according to the criteria for suspected bloodstream infection embedded in the blood culture surveillance, i.e. presence of objective fever, hypothermia or history of fever during past 48 hours + at least one of the following criteria:

   * Hypotension, confusion or increased respiratory rate
   * Suspicion of severe localized infection: pneumonia, meningitis, osteomyelitis, complicated urinary tract infection, abscess, skin/soft tissue infection or abdominal infection
   * Suspicion of typhoid fever
   * Suspicion of severe Pf malaria
4. Having a caregiver willing and able to provide written informed consent

Exclusion Criteria:

* None
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.

The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.


Eligibility Criteria:
Inclusion Criteria:

* Is a Japanese male 16 to 26 years of age
* Has no more than 5 lifetime sexual partners

Exclusion Criteria:

* Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study
* Has a history of external genital warts
* Has a history of severe allergic reaction that required medical intervention
* Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study
* Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
* Has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
* Has ongoing alcohol or drug abuse within the past 12 months
Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)

To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers.

The investigators will perform whole-body and brain kinetic modeling of SNUBH-NM-333(18F) and optimize the image acquisition procedure.

Five young healthy subjects will be participated in Whole-body positron emission tomography /computed tomographic (PET/CT) scans from the midfemoral position to the head after approximately 5-10 mCi of SNUBH-NM-333(18F) injection. For brain PET/CT amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of SNUBH-NM-333(18F), with arterial sampling.

The investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. And then 10 AD patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare SNUBH-NM-333(18F) brain retention in AD patients versus healthy elderly.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young controls who are 20 - 30 years old and have no subjective memrory complaints
* Cognitively normal elderly who have Clinical Dementia Rating score of 0
* Alzheimer's disease (AD) patients who met both the DSM-IV criteria for dementia and NINCDS-ADRDA criteria for probable AD

Exclusion Criteria:

* any present serious medical, psychiatric, or neurological disorder that could affect mental function; evidence of focal brain lesions on MRI; the presence of severe behavioral or communication problems
Autologous Bone Marrow Transplantation for Premature Ovarian Insufficiency

Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.

Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency.

Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.

Premature ovarian insufficiency (POI) has no curative treatment until now. It was noticed that some cases of POI to recover spontaneously. Furthermore, the concept of fixed prenatal pool of oogonia has been challenged and postnatal neo-oogenesis is currently proved.

Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal insufficiency. Data from animal studies showed that stimulation of these stem cells result in regeneration of the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.

Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency. These studies have been followed by researches on human being. Human studies included the use of stem cells from different sites including BM, adipose tissue, and umbilical cord.

Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Although studies proved that these newly developed oocytes to be genetically traced to the recipient; some other studies showed that the newly developed oocytes originate from the donor BM. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Use of autologous BMT also avoids the need for chemotherapy for conditioning and other related complications associated with allogeneic BMT. Human studies mostly used the ovarian injection of the BM. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.

Eligibility Criteria:
Inclusion Criteria:

* Women with POI: For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice \>4 weeks apart).

Exclusion Criteria:

* Abnormal karyotype
* Previous pelvic or abdominal radiotherapy
* Previous surgical management of ovarian pathology
* Chronic disease: renal, liver, cardiac, malignancy
Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness

The aim of the study to examine Optic Nerve Sheath Diameter measurement for prediction of fluid responsiveness in hemodynamically unstable patients


Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation
* 18 years or older
* patients developing hypotension (Mean arterial blood pressure) \<65 mmHg

Exclusion Criteria:

* Patients with Spontaneously breathing activity.
* Patients with a history of intracranial disease e.g. (stroke, TBI, causes of increased intracranial pressure).
* local cause in the eye as (Glaucoma, Single eye)
* Need for high PEEP.
* Known history of cardiac disease.
* Organ/s failure at admission
Prognostic Value of Pre-therapy 18F-FDG PET/CT for the Outcome of 18 FDG PET-guided SIB-IMRT in Patients With Head and Neck Cancer

Head and neck cancer is the fifth most common cancer and represents 5% in the world.

Selecting patients for the most appropriate treatment remains difficult. Approximately 60-65% of patients undergo surgery followed or not by radiotherapy. Patients with early stage disease (I-II) are treated with one treatment modality (surgery or radiotherapy), while patients with more advanced stage disease (III-IV) receive multimodal treatment (surgery together with associated radiotherapy or less to chemotherapy). PET/CT plays a fundamental role in the management of head and neck cancer patients. This investigation is indicated for staging, especially in patients with disease in advanced stages, for evaluating the response to therapy and for looking for recurrences as it is more accurate in distinguishing scar tissue from neoplasm. The objective of this retrospective study is to evaluate the prognostic value of PET/CT in predicting the outcome of patients undergoing SlB-IMRT/intensity modulated radiotherapy). The study proposed here involves the retrospective recruitment of patients who have performed a PET/CT investigation with 18F-FDG (fluorodeoxyglucose) at the U.O. of HSR Nuclear Medicine in the staging and treatment planning phase, between 2005 and 2011. The inclusion condition of the patients was their PET/CT evaluation (planning and treatment) using the "DSTE" PET/CT system installed at the U.O. of Nuclear Medicine HSR on which, in the presence of homogeneous lesions. a particular correction technique is applicable, developed and validated previously by the research group, which allows possible metabolic markers to be extracted from the lesions in a quantitatively accurate way.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from head and neck cancer;
* patients who underwent PET-CT with 18F-FDG.

Exclusion Criteria:

* patients \<18 years
Transcranial Magnetic Treatment (TMS) in Unipolar Depression

Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression.

In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination with antidepressant medication.

Patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. All subjects will receive treatments for 10 days and will be followed for another 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Major Depression
* No physical health problems

Exclusion Criteria:

* History of Epilepsy
* Metal in the head/neck or skull
* Pacemaker
* Pregnancy
ADAPT - a Patient Registry of the Real-world Use of Orenitram®

This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation


Eligibility Criteria:
INCLUSION CRITERIA

Patients are eligible for the registry if:

1. The patient voluntarily gives informed consent to participate in the study.
2. The patient must be at least 18 years of age or older.
3. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days.
4. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study.
5. The patient has the ability to answer surveys and use the diary in English.
6. The patient must have an email address and be willing to access the PRO Portal.

EXCLUSION CRITERIA

Patients are ineligible for the registry if:

1. The patient has previously received Orenitram for more than 182 days.
2. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within
Quantitative EEG Markers in Mild Cognitive Impairment in Epilepsy

Epileptic patients are plighted with limited daily activities, social dysfunction, family conflicts and cognitive impairment. Most of the studies had showed that cognitive disorders were frequent in patients with epilepsy.The cognitive impairment has been reported in around 25% of epileptic patients.

Cognitive consequences in epilepsy are often described in the following domains: verbal memory, language, executive functions, and attention. However, most of the studies focus on one or two domains in a relatively small sample.

Few studies have investigated the influential factors for the epilepsy-related cognitive impairment . However, most of these studies merely focused on one or a few potential factors and failed to consider possible distractions from other influential factors. Therefore, it is crucial to include more potential factors in the analysis and to rule out possible confounding interactions between factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically confirmed epilepsy in adult patients.
* Non-symptomatic epilepsy.
* Normal CT or MRI brain, and
* Education level of primary school at least to respond to the scales correctly were included.

Exclusion Criteria:

* Psycho-neurological illnesses,
* History of alcoholism or drug abuse, or
* Recently on medications that may affect cognitive functions (like antidepressants and antipsychotic drugs).
DiaCon Overnight Closed-Loop Glucose Control Study

The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Type 1 diabetes duration \> 2 years
* HbA1c \< 8%
* Insulin pump user \> 1 year

Exclusion Criteria:

* Use of medication affecting glucose metabolism
* Pregnancy or nursing
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Malaysia

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, and complications in diabetic subjects in Asia.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients registered in the particular centre for more than 12 months.
* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.
* Patients willing to sign informed consent form.

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason.
* Unwilling to participate or unable to comply with protocol requirements.