cyrilzakka/clinical-trials huggingface dataset:
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease

ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized, triple masked, clinical trial of a selected combination of vitamins and minerals versus placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm design.

Primary aim: To investigate if ASTED or as compared with placebo could affect the course of TED either by enhancing improvement or preventing worsening in patients with Moderate to severe TED thyroid eye disease (TED) based on:

1. Total eye score (NOSPECS severity score) 1 Total eye score is used to assess the severity of TED, which was calculated by multiplying each class of the NOSPECS system1 (except class 0) to its grade of severity (0-3), yielding a maximum total score of 63 and a minimum total score of 0 (the higher the number the worse the severity) The overall ophthalmic outcome is a composite score based on multiple items (Soft tissue, retraction, proptosis, diplopia, and corneal involvement); the use of a composite score circumvents the problem arising from the presence of improvement in one item and simultaneous worsening in another item.

   The severity score in each of the classes 1, 2, 3, and 4 will also be separately compared to evaluate the effect of different treatments on each sign.
2. Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.

Secondary outcomes measures:

To compare possible change in:

1. Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)
2. Serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) at 0, 3 and 6 months. Thyroid function test (Free T4, T3, and TSH) will be measured in all 3 visits0
3. Side effects

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe TED of less than 18 months duration:
* Active state (Clinical activity score of 3 and more).
* No steroid and or any supplement treatment for the last 6 months.
* Euthyroidism
* Age 18-70 years.

Exclusion Criteria:

* Sight-threatening TED
* Pregnancy
* Drug and/or alcohol abuse
* Severe concomitant illness
* Inability to comply with the study protocol
* No informed consent
* Developing more severe TED (Sight threatening TED) in the course of the trial.
* Contraindications of steroid treatment.
Treating Comorbid Pain and Depression in HIV+ Individuals

This study is designed to look at two different programs that may help people who are HIV+ and have pain and depression. The investigators are trying to understand how to help people learn to live better lives even with these chronic illnesses.

The primary aim of this RCT is to evaluate the HIVPass intervention. HIV+ participants (n=236) with chronic pain and depression will be recruited at primary care HIV Clinics through posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone study screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization into one of two study groups (Health Education or HIVPass Counseling). Seven intervention sessions (HE or HIVPASS) will occur during the first 3 months of study participation. For all participants, the first session is a collaborative in-person joint session with the participant, his/her PCP and the study BHS. Session 2 is conducted immediately after this collaborative session, and is also in-person. Sessions 3-7 are conducted by phone. Follow-up assessment interviews will be at months 1, 2, 3 (post-intervention), 4, 6, 9 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Pain (pain duration for at least six months with a mean score of greater than 3.5 on the BPI Pain Interference Scale)
* Pain severity \> or equal to 4 on a Numeric Rating Scale indicating "average pain in the last week"
* At least one trial of PCP-recommended medication (i.e. acetaminophen, NSAIDS, muscle relaxants) judged through interviews with patients and PCPs
* Quick Inventory of Depression Symptoms (QIDS) score of ≥ 9 (depression severity)
* Stable dose of an antidepressant, if using, for the previous 1 months
* Age \> or equal to 18
* HIV+
* Planning to live in the area for the next 6 months
* Access to a telephone that is typically working.

Exclusion Criteria:

* In psychotherapy or a multidisciplinary pain management program
* Planned surgery in the next 6 months
* Pain thought due to cancer
* Current mania
* Past year chronic psychotic condition
* Excessive substance use (Use of cocaine, heroin, or non-prescribe opioids 15 days per month or more; binge alcohol use 4 days per month or more)
* Suicidality requiring immediate attention
* Pregnancy or planned pregnancy in the next 6 months
Electronic Warning Systems in Diagnosis and Treatment of AKI

To set up electronic early warning system of AKI patients; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.

To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.

To set up electronic early warning system according to KDIGO AKI diagnosis standard, real-time monitoring of hospitalized patients with renal function data, real-time detection of AKI patients, notify the diagnosis of renal physician; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.

To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria.

Exclusion Criteria:

Exclusion criteria were initial hospital creatinine 4•0 mg/dL (to convert to μmol/L, multiply by 88•4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease.
The iotaSOFT Insertion System Safety Study

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.

Eligibility Criteria:
Key Inclusion Criteria:

* Candidate for cochlear implantation per indications
* Age 18 years or older

Key Exclusion Criteria:

* Prior cochlear implantation in ear to be treated
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray
* Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy
* Active middle ear infection
A Study of Baricitinib and Omeprazole in Healthy Participants

The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole.

For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy as determined by medical history and physical examination
* Women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause
* Have a body mass index of 18 to 29 kilograms per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria:

* Have known allergies to baricitinib, omeprazole, related compounds, or any components of the baricitinib or omeprazole formulations, or history of significant atopy
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological (including clotting disorders), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Have an absolute neutrophil count (ANC) less than 2 × 10\^9 cells per liter (L) \[2000 cells/microliter (μL)\] at screening or Day -1. For abnormal values, a single repeat will be allowed
* Intend to use over-the-counter or prescription medication (including drugs and substances known to alter gastric potential hydrogen (pH), such as proton pump inhibitors or over-the-counter antacid remedies and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of hormone replacement therapy (HRT) and occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from Day 1 until discharge from the clinical research unit (CRU)
* Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of cytochrome P450 3A4 (CYP3A4) within 30 days prior to dosing and throughout the study
* Are unable to tolerate or unwilling to undergo insertion of a nasogastric pH probe for assessment of gastric pH during the study
Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress

The goal of this observational study is to learn about the role of bedside lung ultrasound in infants born prematurely with breathing problems. The main question this study aims to answer is: Can bedside lung ultrasound performed in the first month of life predict the development of chronic lung disease in premature infants?

This is a multicenter study including preterm infants born less than 32 weeks gestational age and with a diagnosis of respiratory distress syndrome (RDS). Our primary aim is to determine the ability of lung ultrasounds performed in the first month of life to predict the development of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age.

Secondary aims will evaluate the association of lung ultrasound scores with the severity of hemodynamically significant patent ductus arteriosus (PDA) at time of diagnosis, as well as describe lung ultrasound changes pre and post-treatment with systemic steroid course.

Hypothesis:

1. LUS scores would have a predictive ability to identify extreme preterm infants at risk of BPD with AUC\>0.8.
2. Higher LUS scores would correlate with higher severity of hemodynamically significant PDA.
3. LUS scores are expected to be lower after the course of systemic steroids and with lower scores are expected to predict successful extubation following the course of systemic steroids.

Eligibility Criteria:
Inclusion Criteria:

Infants born less than 32 weeks gestation and meet one or more of the below criteria A) Diagnosis of Respiratory Distress Syndrome B) Diagnosis of PDA C) Post-natal steroid treatment for the purpose of weaning off ventilation support

Exclusion Criteria:

Infants with critical congenital heart and lung conditions and those with genetic anomalies.
Effect of Eswt on Muscle Architecture

The aim of the research is to investigate the effect of Ekstracorpereal shock wave treatment (ESWT) on muscle strength, flexibility and architecture of the lower extremity tendinopathies when applied using the frequencies specified in the literature with min and max frequency frequencies.

Our hypothesis as researchers is ESWT treatment has an effect on muscle strength, flexibility and muscle architecture.

The study will conduct in the Physical Therapy and Radiology Department in a private hospital. The Clinical Research Ethics Committee of Gaziantep the univsersity approved ethical compliance of the study with the decision number GO 2018-01. The participants will inform about the study and their write consent will obtain.

Demographic information including the name, age, height, body weight and occupation of the participants will obtain before the evaluation. All the measurements will perform before, soon after the 1st session and after the last session.

Outcome measures will be muscle strength, muscle flexibility, muscle architectures parameters.

Eligibility Criteria:
Inclusion Criteria: Lower extremity tendinopathy

Exclusion Criteria:

* Patients who failed to show up to any treatment and measurement sessions,
* Patients who cannot tolerate treatment
* having systemic inflammatory disease,
* lower or upper motor lesion
Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma

Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.

Urinary tract infection occurs in one in five patients as a complication following severe trauma. A new and approved urinary bladder catheter (Releen NF) has been introduced by the Danish company Coloplast A/S. Releen NF is expected to reduce the number of urinary tract infections, but this effect has not been investigated in trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of multiple trauma
* Age \>/= 18 years
* Direct referral from scene of accident
* Indication for urinary bladder catherization

Exclusion Criteria:

* Major burn injury
* HIV positiv
* Pregnancy
Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects

The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.

fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.


Eligibility Criteria:
Inclusion Criteria:

* patients with at least one intra-bony defect diagnosed clinically and radiographically

Exclusion Criteria:

* Patients with systemic diseases.
* Pregnant and lactating females.
* Smokers and tobacco chewers.
* History of antibiotic and periodontal therapy in the last 3 months.
* Patients not compliant with oral hygiene procedures.
* Patients with a known or suspected allergy to the melatonin or metformin.
* Individuals on systemic drug affecting metabolic bone diseases and medically compromised patients.
POWERMOM, A Healthy Pregnancy Research Community

This study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world health research to answer questions important to a broad population.

* Eligibility determined, Individuals enrolled and consented to join study
* Short Intake Survey (demographic and baseline health information collected)
* Health History Survey (two days after participant enrolls in the study)
* Survey questions about current health and medical history will be sent to participants weekly. If participants had a prenatal visit during the week, a few additional questions will be asked.
* Twins / Multiples survey will begin appearing when a participant indicates they are having more than one baby
* Participants can submit home measurements of, weight and blood pressure as frequently as they want through HealthKit.
* Pregnancy outcome variables. (Miscarriage, stillbirth, birth of healthy baby, or pregnancy ended) will also be asked weekly.
* If the baby is born, questions about labor and delivery, as well as weight, size and birth date of the baby will be asked. A reminder to fill out the outcome survey will be given 4 weeks after a user's due date.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 16 years of age or older
* Pregnant women or within 8 weeks postpartum
* Currently live within the United States
* Own, and comfortable using, a smartphone or tablet

Exclusion Criteria:

• Inability to consent
Development and Evaluation of Somali-adapted Mindfetalness

Development of Somali-adapted Mindfetalness: Interviews with women born in Somalia

A before-after study:

Intervention: pregnant women receive a pamphlet, introduction to Mindfetalness by her midwife during the gestational-week 25 visit. The pregnant woman will well get access to a website concerning Mindfetalness. The pregnant women will be encouraged to start practicing Somali-adapted Mindfetalness during gestational week 28.

Comparison: Intervention period (1/1-2022 to 31/12 2023) compared to 5 years before (1/1 2015 to 31/12 2019)

Development of Somali-adapted Mindfetalness, initial data collection:

Pregnant women or recently given birth. Women born in Somalia with a singleton pregnancy from gestational week 28+0. Interviews focusing on fetal movements, reactions to fetal movements, and facilitating and inhibiting factors for seeking care for pregnancy-related conditions will be carried out. After transcription verbatim, the text will be analyzed with modified content analysis as described by Elo \& Kyngäs.

A before-after study:

Population: Women born in Somalia registered at one of the 31 antenatal clinics where under 2019 ten or more women were registered. The registration will be either 1/1 2022 to 31/12 2023 or 1/1 2015 and 31/12 2019 (1/1 2020 to 31/12 2021 has been omitted to diminish a possible confounding effect of the COVID-19 pandemic.)

Intervention: In the chosen 31 antenatal clinics, midwives will receive an education in Somali-adapted Mindfetalness. Moreover, each pregnant woman registered after 1/1 2022 and before 31/12 2023, will receive a pamphlet, introduction to Mindfetalness by her midwife during the gestational-week 25 visit. The pregnant woman will well get access to a website concerning Mindfetalness. The pregnant women will be encouraged to start practicing Somali-adapted Mindfetalness during gestational week 28.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman living in Sweden but born in Somalia, in gestational age minimum 24+0

Exclusion Criteria:

* None
Gender-Responsive Treatment for Women Offenders - 1

The purpose of this study is to determine whether substance abuse treatment designed specifically for drug-dependent women offenders provides better outcomes than standard drug court treatment (mixed-gender programs).

In this five-year study, a total of 300 women entering court-referred treatment throughout Los Angeles County and who agree to participate in the study will be randomly assigned to a women-focused or to a mixed-gender outpatient treatment program. The study will assess the impact of women-focused substance abuse treatment using outcome measures including recidivism, substance abuse and relapse, and social adjustment (e.g., employment, parenting behaviors, psychological improvement, and HIV risk reduction behaviors), compared to the impact of traditional mixed-gender programs. Assessments will occur at baseline and at 1 month, 12 months, and 24 months after admission.

Eligibility Criteria:
Inclusion Criteria:

* Drug court participant
* At least eighteen (18) years old
* Have had no more than three prior non-violent, non-drug felony convictions
* Do not have a current charge of driving under the influence of alcohol or drugs or a charge of sale or transportation of drugs

Exclusion Criteria:

* Not capable of giving informed consent
Vitamin D and Outcome in Cardiac Surgery

We will use a retrospective data analysis to evaluate the association of the two vitamin D metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will assess the association of the two vitamin D metaboolites with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D metabolite levels.

In a retrospective data analysis, we will evaluate the association of vitamin D metabolites (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) with MACCE (major cardiac or cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,000 data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will also assess the association of vitamin D metabolite levels with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D status

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgical patients aged 18 years and older

Exclusion Criteria:

* age \< 18 years
* heart transplant recipients
* pacemaker or defibrillator implantation
Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)

The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.

This initial proof of concept trial design is intended to explore multiple variables. Fist, it is intended to determine if carvedilol has any statistically significant effect over placebo on the various overall symptoms, symptom clusters, or individual symptoms of post traumatic stress disorder. Next, the flexible dosing trial design is aimed to detect the therapeutic dose, or dosing range for carvedilol when used in the treatment of PTSD

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Post Traumatic Stress Disorder according to DSM-IV
* Must be able to speak, read and understand the English language and be able to provide written informed consent

Exclusion Criteria:

* current, unstable and significant medical condition/illness
* bronchial asthma or related bronchospastic condition
* AV block
* Sick Sinus Syndrome
* Bradycardia
* Peripheral hear disease
* Unstable thyroid disorder
* History of seizure disorder
* Females who are pregnant, lactating or planning to become pregnant
* Bipolar
* Schizophrenia
* Dementia
* Intolerance or hypersensitivity to alpha or beta blockers