cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Health Monitoring Platform for Elderly in Home Care Context

This study aims at, as a primary objective, studying acceptability of elderly about a health monitoring platform for home support and home care. The secondary objective consists in studying the correlation of different health data evolution and the frailty trajectory of the subject.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80 years old
* Living at home or in senior residence
* Evaluated as being robust according to the Fried's frailty test (0 met criteria)
* Affiliated or beneficiary of a social protection scheme
* Having given written consent

Exclusion Criteria:

* Hospitalization during the month preceding the first visit
* Subject suffering from cognitive disorders preventing proper use of the device
* Subject being unable to give by himself / herself his / her consent to participate in the trial
* Person subject to legal protection (safeguard of justice, trusteeship, guardianship, persons deprived of liberty)
Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. These children will be likely to develop cerebral palsy or severe cognitive delays.

The purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe IVH and controls. The goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of IVH in premature infants. These baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe IVH.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1500 grams for all inborn infants and age less than 14 post-natal days
* Birth weight \< 1500 grams for all outborn infants transferred to the VCH NICU within the first 72 hours after birth and age less than 14 post-natal days
* Parents agree to their infant's participation and give informed written consent.

Exclusion Criteria:

* Unable to obtain informed consent.
* Congenital brain malformations leading to hydrocephalus
* Genetic and metabolic disorders leading to cerebral pathology
Sonosalpingography After Hysteroscopic Tubal Occlusion

Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller ball electrode.


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients with hydrosalpinges requiring in vitro fertilization
* irreversible contraception

Exclusion Criteria:

* Acute pelvic inflammatory disease
WGS Analysis of COVID-19 Positive Patients

We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written informed consent and fluent in English.
* Men or women between 18-100+ years, inclusive.
* Willing to comply with study procedures.
* SARS-CoV-2 positive test result as confirmed by a RT-PCR assay with a sputum or nasopharyngeal sample (either done prior to or at the screening visit).
Effect of Early Feeding of Breast Milk

Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.

Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.

Therefore, the composition of breast milk is widely believed to be specifically tailored by each mother to precisely reflect the requirements of her infant.

Human milk is uniquely suited to the human infant, both in its nutritional composition and in the non-nutritive bioactive factors that promote survival and healthy development.

Breast milk contains over 400 different proteins which perform a variety of functions; providing nutrition, possessing antimicrobial and immunomodulatory activities, as well as stimulating the absorption of nutrients.

The immune system of preterm infants is immature, placing them at increased risk for serious immune-related complications.

Human milk provides a variety of immune protective and immune maturation factors that are beneficial to the preterm infants poorly developed immune system. The most studied immune components in human milk include antimicrobial proteins, maternal leukocytes, immunoglobulins, cytokines and chemokines, oligosaccharides, gangliosides, nucleotides, and long-chain polyunsaturated fatty acids. There is growing evidence that these components contribute to the lower incidence of immune-related conditions in the preterm infant. Therefore, provision of these components in human milk, donor milk, or formula may provide immunologic benefits.

The effects of breast milk and breastfeeding on neurodevelopment may be quite different in very preterm infants than in those born at full term. Nutritionally, breast milk is considered the optimal food for full term infants. But preterm infants require fortification to match third trimester nutrient accretion rates.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age \<37 weeks.
2. Birth weight \>1000 gm.

Exclusion Criteria:

1. Gestational age 37 weeks.
2. Birth weight \< 1000 gm.
3. Newborns with congenital anomalies.
4. Newborns with suspected metabolic diseases.
5. Newborns on mechanical ventilators.
6. Newborns with suspected neonatal sepsis.
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).


Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Non- valvular atrial fibrillation documented by ECG
* Patients aged 60 years and older or with a risk of stroke

Exclusion Criteria:

* Prior stroke and TIA
* Patients in whom anticoagulants are contraindicated
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.


Eligibility Criteria:
Inclusion criteria:

1. Signed and dated ICF (Informed Consent Form)
2. Male or female on diet and exercise regime and on stable background metformin \> or equal to 1500 mg or maximun dose according to local label
3. HBA1c (Glicoslated Hemoglobin) \> or equal to 8% and \< or equal to 10.5 % at Visit 1
4. HbA1c \> or equal to 7 and \< or equal to 10.5 at Visit 4
5. Age \> or equal to 18 years
6. BMI (Body Mass Index) \< or equal to 45

Exclusion criteria:

1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
2. Use of any other antidiabetic
3. Renal function below 60 ml/min/1.73 m2
4. Antiobesity drugs or aggresive diets
5. Gastorintestinal surgeries
6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
7. Acute coronary syndrome and stroke within 3 months of informed consent
8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors
Usability of the Adapted Rower for People With Spinal Cord Injury

The goal of this clinical trial is to examine usability of a locally built adaptive rower for people with spinal cord injury using an established and tested design.

The main questions it aims to answer are:

1. What exercise intensity of activity do users achieve on the rower for steady state and interval rowing plans?
2. What assistance is required for setup and usage of the adaptive rower?
3. What do users think about the ease of use and what is their satisfaction with the adaptive rower?

Participants will complete a one-time exercise session with two adaptive rower bouts (10-15 minutes each) with a rest period in between.

A single group rolling prospective cohort study with a target of 15 participants will evaluate the initial design prototype using the an existing adaptive rower design. Participants will have one visit to the University of South Carolina Rehabilitation lab. Participants will receive an orientation to the rowing machine and available handle, grip and trunk support options. Training will be provided in proper rowing technique and use of the rate of perceived exertion scale. Participants will be fitted with a heart rate monitoring device and resting heart rate established. Participants will perform two bouts of rowing exercise each with a 2-minute warm up and cool down in addition to the following: (1)10 minutes of steady state rowing with goals to achieve moderate intensity exertion levels, followed by a variable rest period to return exertion and heart rate to initial levels, (2) 10 minutes of interval rowing alternating between one minute of low-moderate intensity and 30 seconds of moderate-vigorous intensity. Participants heart rate will be monitored and recorded throughout the testing period, with rate of perceived exertion at start, midpoint and end of steady state period, and at start, at each interval, and at end in interval period.

Eligibility Criteria:
Inclusion Criteria:

* use a wheelchair for mobility,
* can perform the rowing motion with their arms
* have enough grip strength to maintain grip on the rower handle with or without grip assist straps
* are cleared to exercise through the electronic physical readiness questionnaire or physician release

Exclusion Criteria:

* current self-reported pressure wounds
* pain with rowing motion.
Self Titration With Apidra to Reach Target Study (START)

Primary Objective:

The primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary endpoint for assessment of this objective is the percent of patients reaching a target HbA1c \<=7.0% without severe hypoglycemia at the end of the study.

Secondary Objective:

Secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus HCP-managed) on the following:

* change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36
* satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36
* change in weight at Week 24 and Week 36
* incidence of hypoglycemia
* insulin doses
* resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits, telephone calls, and hospitalizations)
* adherence with the patient-managed monitoring algorithm


Eligibility Criteria:
Inclusion criteria:

Run-in phase:

* T2DM
* Treated for at least 3 months with a basal insulin (insulin glargine, NPH, detemir) +/- oral antidiabetic drugs (OADs) with an HbA1c \>7.0% or insulin naive (2-3 OADs) with an HbA1c \>=7.8% (historic HbA1c result up to 3 months of screening is acceptable)

Randomized treatment phase:

* Completed run-in phase
* HbA1c \>7.0% and \>= 1 episode of confirmed nocturnal hypoglycemia (BG \<4.0 mmol/L) or \>= 2 measurements of FG \<=6.0 mmol/L within the previous week Patients who completed the run-in phase with HbA1c \>7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.

Exclusion Criteria:

* No food intake before lunch (noon)
* Unstable diet intake or significant changes to current diet regimen
* Nightshift worker
* Type 1 Diabetes Mellitus
* Subjects unwilling to inject insulin or perform self-monitoring blood glucose
* Pregnant, alcohol or drug abuse
* Active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study
* Any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study
* Known allergies to study drugs

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus

Aims of the Research :

1. assessment of serum apelin levels in patients with T1DM with comparison to non-diabetic controls.
2. investigate the relation between serum apelin levels and glycemic balance.
3. clarify the the relation between serum apelin and lipid concentrations.

Type 1 Diabetes Mellitus (T1DM) is an endocrine disorder in which pancreatic β cells stop producing insulin due to autoimmune destruction. This results in hyperglycemia and ketosis ; thus insulin replacement is vital in management . Incidence peaks in puberty and early adulthood . Symptoms include polyuria , polydepsia and weight loss. T1DM can cause micro and macrovascular complications which affect the quality of life .

.Studies proved that TIDM is associated with metabolic abnormalities and alteration of adipose tissue hormones (adipokines). Adipose tissue yields many adipocytokines that modulate insulin sensitivity and play essential role in the pathogenesis of diabetes . Given these complications, we strive to discover new targets that enable us to control DM. One of these targets is apelin .

Apelin is an adipocytokine widely distributed throughout the body including skeletal muscle, cardiac muscle, pulmonary tissue, mammary glands, ovaries, brain, kidneys, pancreas and adrenal glands.It was extracted from the bovine stomach by Tatemoto et al., in 1998.

Apelin plays a role in a range of physiological processes including regulation of fluid hemostasis and blood pressure ,improvement of cardiac contractility ,lipid metabolism and metabolic control. It appears to improve insulin sensitivity, reduces blood glucose and increases glucose utilisation .

It has been shown that apelin has a crucial role in energy metabolism and pathogenesis of diabetes mellitus and its level is altered in diabetic patients .High serum apelin level was linked to impaired insulin sensitivity . Thus, it was suggested that serum apelin can be used for the prediction of development of diabetes and its progression .

Serum cholesterol, triglycerides (TG) and LDL are significantly increased in T1DM, but serum HDL is decreased . So, patients with T1DM are at high risk of developing premature atherosclerosis because of hyperlipidemia. A correlation was found between serum apelin and cholesterol, TG and LDL in diabetic patients .

. Apelin was shown to increase the stability of lipid vacuoles making them more resistant to lipolysis. So apelin can be used as a predictor of premature atherosclerosis in T1DM .

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetic patients (treated with insulin ). age between 20 to 30 years , including males and females.

And accepting participation in the study.

Exclusion Criteria:

* patients with acute illness.and pregnancy.
Site of Embryo Transfer in Intracytoplasmic Sperm Injection

The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.

Many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.

Eligibility Criteria:
Inclusion Criteria:

* 1- AVF uterus. 2- BMI less than 30

Exclusion Criteria:

* 1- RVF uterus. 2- BMI more than 30.
Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
* Age at least 18 years
* Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
* Scheduled for surgical procedures in the supine position
* Written informed consent
* Creatinine clearance (CLCR) \< 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing NMB
* Known or suspected (family) history of malignant hyperthermia
* Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
* Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
* Pregnancy
* Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( \> 6 months), intrauterine device, abstinence
* Breast-feeding
* Prior participation in any trial with Org 25969
* Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.304, or for the UK only: Participation in another clinical trial, within 30 days of entering into trial 19.4.304.
Therapy to Elevate CD4 Counts in HIV-1 Disease

For more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment for patients who have inherited alpha-1-proteinase inhibitor deficiency. Adult patients with this condition eventually develop emphysema. Most HIV-1 patients who have low viral load also have alpha-1-proteinase inhibitor deficiency. The number of CD4 cells in blood increases when alpha-1-proteinase inhibitor increases. Patients will be asked to participate in a pilot study to see whether the use of Zemaira® (alpha-1-proteinase inhibitor) can increase blood levels of alpha-1-proteinase inhibitor and consequently increase CD4 counts.

HIV-1 patients will be asked to participate in a pilot study to see whether the use of Zemaira increases blood levels of alpha-1-proteinase inhibitor and consequently increase CD4 counts.

HIV-1 patients will receive weekly treatment with Zemaira for 8 weeks by intravenous infusion. Blood will be collected immediately prior to each infusion. Blood will be collected at each visit. Exploratory assessments and not pre-specified outcome measurements will include complete blood count, lymphocyte phenotype, HIV-1 viral load, lipid levels, blood chemistry, and markers of inflammation from patient medical records. Exploratory and not pre-specified outcome measures will include extended lymphocyte phenotype and lymphocyte function using residual blood collected.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 patients must have confirmed HIV-1 disease, diagnosed using the standard criteria and be on antiretroviral therapy. Patients with inherited alpha-1 proteinase inhibitor deficiency (PIzz) must not have previously received alpha-1 proteinase inhibitor therapy. Uninfected volunteers will be age and gender matched.
2. HIV-1 patients must have measurable disease, defined as HIV-1 infected patients on antiretroviral therapy with undetectable HIV RNA (\<500 HIV-1 RNA copies/ml) and CD4 counts more than 200 and less than 400 cells/uL.
3. Age at least 18 years and under 65 years.
4. HIV-1 patients must have active alpha-1 proteinase inhibitor below 11uM (normal is 18-53 uM).
5. HIV-1 patients must have one year history (prior to the study) with CD4 counts greater than 200 and less than 400 cells/uL.
6. Volunteers must have no evidence of malignancy.

Exclusion Criteria:

1. Recent illness that will prevent the patient from participating in required study activities.
2. Patients receiving other investigational agents.
3. Patients with known malignancies.
4. Patients with more than 500 HIV RNA copies/mL.
5. Patients with more than 400 CD4 cells/uL.
6. Uncontrolled illness including, but not limited to, ongoing or active infection, myeloid dysplastic syndrome, anemia, bone marrow failure, DiGeorge Syndrome, thymic disorders, or psychiatric illness/social situations that would limit compliance with study requirements.
Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'

Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.

Based on national and international consensus statements, institutional practice has developed at Texas Children's Hospital as to which patients require overnight observation following adenotonsillectomy for continuous pulse oximeter monitoring to assess for desaturation events. There is insufficient evidence to suggest which patients need to stay for pulse oximeter monitoring which has led to many patients being admitted unnecessarily. Therefore, the aim of this study is to capture data prospectively on pulse oximetry in children admitted overnight following adenotonsillectomy to identify risk factors for post operative oxygen desaturation.

Eligibility Criteria:
Inclusion Criteria:

* Adenotonsillectomy surgery
* Patient meeting institutional guidelines for postoperative admission (e.g, admitted following surgery from recovery room).

Exclusion Criteria:

* Parental refusal
* Airway Surgery in addition to adenotonsillectomy
* Patient psychological limitations, precluding wearing device (e.g. autism).
* Patient not meeting institutional guidelines for postoperative admission (e.g, discharged following surgery from recovery room).