cyrilzakka/clinical-trials huggingface dataset:
Antioxidant Supplementation in Pregnant Women

The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.

Preeclampsia remains one of leading causes of maternal and perinatal mortality and morbidity. Despite intensive research, the cause of preeclampsia has not been established. One of the theories is exaggeration of systemic inflammatory that might induce reactive oxygen species (ROS). It has been proposed that pregnancy will progress uneventfully if adequate antioxidant exists to buffer ROS. The ROS can induce endothelial dysfunction which leads to clinical symptoms of hypertension and proteinuria in preeclampsia. Several large randomized clinical trials of antioxidant supplementation have concluded that there were no benefits of antioxidants supplementation for prevention of preeclampsia. However, there is limited information about benefits of antioxidants in women with low antioxidant status at early gestation that deprived of the antioxidant most. Our aim, therefore, in this study was to assess whether early supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium lowers the risk of preeclampsia in women with low antioxidant status at early gestation.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with 8-12 weeks of gestation

Exclusion Criteria:

* known multiple pregnancy
* known fetal anomaly
* known thrombophilia
* known infections and mola hydatidosa
* chronic renal failure
* uncontrolled hypertension
* known placental abnormalities
* documented uterine bleeding within a week of screening
* uterine malformation
* history of medical and metabolic complication such as heart disease or diabetes
Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

This is a single-center, randomized, prospective, confirmatory study of efficacy of individualized automatic coaching message for glycemic management and depressive symptom in patients with type 1 diabetes. The study will enroll patients with type 1 diabetes who are applying continuous glucose monitoring (CGM) and receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. For 12 weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management. The control group will continue their current treatment and non-face-to-face diabetes management. The aim of this study is to evaluate whether the efficacy of automated, personalized coaching messages for glycemic management and depressive symptoms is non-inferior to the current non-face-to-face management approach in people with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes, age 18-75 years old
* Patients who have used continuous glucose monitoring at least three months and have enrolled in Type 1 Diabetes Home Care Project and Educational Consultation program.
* Patients with at least 70% of 14 days of continuous glucose monitor data within the past month
* Glycated hemoglobin 7% or higher, or Glycated hemoglobin 6% or higher but less than 7% and failing to meet 1 of the continuous glucose monitor blood glucose target values: time in range (70-180 mg/L) 70% or less, or time below range (\<70 mg/L) 4% or more, or time above range (\>180 mg/L) 25% or more, or glucose management indicator (GMI) 7% or more, or coefficient of variation (CV%) 36% or more.
* Currently receiving treatment with multiple insulin injection therapy
* Patients who have access to KakaoTalk via smartphone and are able to communicate with it
* Voluntarily agreed to participate in this clinical study.

Exclusion Criteria:

* Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.
* Breastfeeding or pregnant patients
* Patients who do not voluntarily consent to the study
* Anyone deemed unsuitable by the investigator to participate in the study
The Effectiveness of Telerehabilitation-Based Exercises in Elderly People

An epidemic of pneumonia , which is thought to have developed due to a new coronavirus, was detected in Wuhan, Hubei Province of the People's Republic of China, and this epidemic could not be brought under control, leading to other provinces of China in a short time and then to a pandemic. It has spread all over the world including the European continent. Causative Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) and the disease caused by the new virus (novel) coronavirus-2019 (2019-nCoV) and subsequently the COVID-19. After the virus was officially detected in our country on 11 March 2020, the number of cases increased rapidly and the virus was isolated in 670 patients within 10 days. The group that is most affected by the outbreak and has the highest mortality rate is the elderly with known cardiovascular diseases. It is important to ensure the social isolation of elderly patients and to minimize all hospital applications as much as possible if they do not have life-threatening urgent problems. To this end, Turkey on 21 March 2020, 65 years of age and older people and patients with chronic curfew was implemented.

Individuals moving away from social life are dealing with their body more, their level of depression and anxiety increase, and their physical functions decrease. The therapy service is offered to people who cannot travel with telerehabilitation, which is defined as the transmission of rehabilitation service to long distances by using electronic information and communication technology.

The purpose of this study is to investigate the effects of telerehabilitation exercises given to elderly individuals on sleep quality, quality of life and balance within the scope of geriatric rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 and over,Mini Mental Status Scale 24 and above, To be able to communicate verbally and visually,Those who do not have serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) that may prevent exercise,Having the necessary technological competence to provide remote video communication at home,To be at least 20 m ambassador

Exclusion Criteria:

* Mini Mental Status Scale being lower than 24,Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) that may interfere with exercise,Visual or auditory loss
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:

Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?

Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.

Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:

Receive surfactant replacement therapy by the less invasive surfactant administration technique.

Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. Surfactant replacement therapy by the less invasive surfactant administration (LISA) is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure (CPAP), reducing the need for using an invasive mechanical ventilator. In high-income countries, LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality. However, the impact of LISA is unknown in low-resourced settings without ventilators.

The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates.

PICO Outline:

Population: Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of ≥5, who are spontaneously breathing and on CPAP.

Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.

Comparator: Standard of care - standardized CPAP and Caffeine.

Outcome measures: Primary Outcome: All-cause in-hospital survival.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
* Silverman Anderson Score ≥5 before or after CPAP treatment.
* Admitted to a study site within 24 hours of life.

Exclusion Criteria:

* Major congenital or genetic anomalies.
* Active pulmonary hemorrhage.
* Major craniofacial anomalies that preclude the successful use of CPAP
A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.

Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11 or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. WHO performance status 0 - 2

Exclusion Criteria:

1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria
2. Patients with c-Kit amplifications only and no mutation
3. Patients with any history of brain metastases
4. Patients who have had any prior treatment with TKIs
5. Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit
6. Acute or chronic liver or renal disease considered unrelated to melanoma

Other protocol-defined inclusion/exclusion criteria may have applied.
Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at UAB/Children's of Alabama Hospital, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypothesis of this NINJA NGAL study is that urine NGAL is highly sensitive to detect NTMx-associated AKI. UAB/Children's of Alabama is bringing urine NGAL measurement to the infants in the NICU to detect NTMX-associated AKI.

Nephrotoxic medication-induced acute kidney injury (NTM-AKI) is a relevant yet underdiagnosed morbidity in the neonatal intensive care unit (NICU).

Up to 87% of very low birth weight infants are exposed to at least one nephrotoxic medication (NTM). NTM-AKI is associated with poor short and long-term outcomes.

Presently, no treatments exist for AKI beyond supportive care.

Eligibility Criteria:
Inclusion Criteria:

* all NICU inpatients under 1 year of age; greater than 4 days of age that are

  * Receiving 3 or more nephrotoxic medications on the same day OR
  * Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

Exclusion Criteria:

* Less than 4 days of age

  * Currently being treated for a urinary tract infection
  * Presence of an acute kidney injury prior to enrollment
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen


Eligibility Criteria:
Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
* HIV-1 infected subjects regardless of race or ethnicity
* Use of one of the following taken as a stable, continuous, NRTI-containing antiretroviral (ARV) regimen for ≥ 3 years are allowed (within-class change of agents other than TDF within 3 years of study entry are permitted as specified):

  * TDF plus PI/r-containing regimen including subjects who switched from one TDF plus PI/r regimen to another TDF plus PI/r regimen
  * a TDF plus non-PI/r-containing regimen including subjects who switched from one TDF plus non-PI/r regimen to another TDF plus non-PI/r regimen
  * a Non-TDF NRTI plus a PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus PI/r regimen to another non-TDF NRTI regimen plus PI/r regimen
  * a Non-TDF NRTI plus a non-PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus non-PI/r regimen to another non-TDF NRTI regimen plus non-PI/r regimen
* Of note, subjects in the non-TDF groups must have never taken a regimen that includes TDF (including previous exposure to TDF for pre-exposure prophylaxis (PrEP))
* Subjects included in the TDF groups must have always taken a regimen that includes TDF. Non-PI/r agents include non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors, triple nucleoside inhibitors and non-boosted protease inhibitors
* Male subjects must be ≥ 50 years of age
* Female subjects must be postmenopausal. Menopause can be assumed to have occurred in a woman when there is either appropriate medical documentation of prior complete bilateral oophorectomy or permanent cessation of previously occurring menses \> 12 months as a result of ovarian failure or bilateral oophorectomy with documentation of hormonal deficiency by a certified healthcare provided
* Adequate records available to evaluate medical history for the 3 years prior to study entry

Exclusion Criteria:

* Subject has a contraindication to dual-energy X-ray absorptiometry (DEXA) scans
* Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia

This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

1. Participant had a diagnosis of MDD as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition, clinical trials version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
2. Participant had a diagnosis of Insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnostic criteria using the SCID-5-CT.
3. Participant had an Insomnia Severity Index (ISI) score greater than or equal to (\>=) 15 (moderate to severe insomnia).
4. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

Exclusion Criteria:

1. Participant had attempted suicide associated within the current episode of MDD.
2. Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period.
3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
4. Participant had a medical history of seizures.
5. Participant had active psychosis per Investigator assessment.
Gene-based Personalised Diet and Physical Activity Advice on Adiposity Indices Personalised Diet and Physical Activity Advice on Adiposity Indices in University Students

A longitudinal study to determine the effect of gene-based personalised diet and physical activity advice on adiposity indices in university students.

The study uses a randomised controlled design; data for all variables (participant characteristics, height, weight, body mass index (BMI), waist circumference (WC), body fat percentage (BF%), healthy eating motivation, dietary intake and physical activity) will be collected initially from participants at St Mary's University during September and October 2019. Participants will be genotyped, stratified randomisation (based on genotype and BMI) will be used to allocate participants to three different groups (1. Control: no advice, 2. Non genetic personalised advice: dietary and physical activity advice based on reported dietary intake and physical activity 3. Genotype- based personalised advice: dietary and physical activity advice based on genotype, reported dietary intake and physical activity. Following allocation to groups participants in groups 2 and 3 will receive appropriate dietary and physical activity advice via email (appendix a) and all participants will complete the healthy eating motivation questionnaire for a second time. In April/May 2020 follow up variables (smoking status, weight, BMI, WC, BF%, healthy eating motivation, dietary intake and physical activity) will be measured again. These follow up variables will be measured every September and April/May until September 2022. After each follow up participants in groups 2 and 3 will be resent their dietary and physical activity advice and updated information based on their reported dietary intake and physical activity.

Eligibility Criteria:
Inclusion Criteria:

• Age 18-25 years

Exclusion Criteria:

* Pregnancy and lactation
* Chronic disease
* A history of disordered eating and following a restricted diet.
Reading Performance With a Video Magnifier

The most common goal for patients with vision loss who present for vision rehabilitation is to be able to read. The video magnifier (a device which combines a video camera and a screen to view the print being magnified) is the device which most often allows low-vision individuals to read successfully for extended periods of time. Previous studies on the outcomes of vision rehabilitation have not identified which components of the vision rehabilitation are effective. The hypothesis of this project is that providing a video camera magnifier, with basic training in operating the device, will allow patients to enhance both objective reading ability and subjective report of reading competence.

Patients will be given a video magnifier at initial consultation or at the end of vision rehabilitation

Eligibility Criteria:
Inclusion Criteria:

* Central field loss and decreased visual acuity in the better seeing eye (\<20/40 \& \>20/400).
* New patient at MEEI Low Vision Rehabilitation Clinic

Exclusion Criteria:

* Dementia (Mini-Mental State Examination)
* Clinical depression (Geriatric Depression Scale)
* Patients who previously received vision rehabilitation
* Patients who have previously owned a desktop video magnifier