cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation for Extremely Preterm Infants

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D \[25(OH)D\]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations \>60ng/mL (\>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (\<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Exclusion Criteria:

* Major congenital/chromosomal anomalies
* Moribund infant with low likelihood of survival, in opinion of the clinical team
Fatigue a Long COVID-19 Symptom Substudy of FSC19-KN Trial

Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.

After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).

And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.

The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.

Eligibility Criteria:
Inclusion Criteria:

Patient must meet ALL of the following criteria.

1. Participation in the FSC19-KN study
2. Consent to participate in the survey

Exclusion Criteria:

1. Failure to give consent to the survey
Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children

This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires

This study is made on children with ulnar shaft fracture and treating their fracture by intramedullary k wires ,dividing them into two groups ,one of them the child ulnar fracture is reduced and fixed by intramedullary antegrade k wire and the other group the fracture is reduced and fixed by retrograde k wire ,and compare the functional, clinical and radiological outcomes between the two groups

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient
* aging from 4 to 15 years old
* diaphyseal ulnar fracture
* either isolated or combined with radius fracture (both bone).

Exclusion Criteria:

* Segmental fractures
* Montaggia variants
* Gelliazzi fracture
* Fractures associated with radial head fracture - Compound fractures
* Fractures with neurovascular affection
Evaluation of Audio-Visual Distraction Technique on Child's Anxiety

Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.

This study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.

\[I\] Recruitment: Children aged 5\~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.

\[II\] Intervention:

-Steps:

1. The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
2. The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.
3. Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
4. Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
5. Above steps will be done in both visits, with and without the intervention.
6. If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.
7. The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
8. The operator will apply topical and dental anaesthesia
9. Pulse rate will be measured every 5 minutes.
10. The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
11. Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.

Intervention modifications:

In case the child interrupted the dental visit for questions or any reason, the last record of pulse oximeter will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-8 years old.
* Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)
* Cooperative children and potentially cooperative
* Physically and mentally normal children.
* No previous dental experience involving local anaesthetic administration for the last 2 years

Exclusion Criteria:

* Children with visual impairment.
* Children with hearing disabilities.
* Children with disability complicating the dental treatment as trismus, or TMJ problems.
* Children with highly inflamed pulp tissue inducing pain during dental visit.
* Patients or caregivers who refuse to sign the consent.
Patients' Perception of Climate Change and Healthcare

This study aims to investigate the patients' perception of the negative impact of the healthcare industry on climate change, their attitude of climate change and their health, and their view of seeing a change in the healthcare system to reduce climate change.

Climate change is a threat to human health which in turn increases burden on our healthcare system. Healthcare is also a very polluted industry which has a huge contribution to climate change. It is important to take action and the intergovernmental panel on climate change (IPCC) has put out a warning of 'Code Red for Humanity' urging immediate action from all of humanity to combat climate change. This is important because if no action is taken, irreversible damage might result on our planet which will become a challenge in terms of living conditions, food source, and health.

Therefore, this study aims to investigate the patients' perception of the negative impact of the healthcare industry on climate change, their attitude of climate change and their health, and their view of seeing a change in the healthcare system to reduce climate change. This will produce data on the knowledge gap in our patients and thereby empower them to request and target our education for patients, and in turn encourage the healthcare system to reflect on their environmental sustainable practices.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients \> age of 18 years old
* Willing and able to read/listen and understand English, on the hospital ward ie. Not Emergency Department

Exclusion Criteria:

* Patient refusal
* Patients are unable to consent
* Confusion or disorientated in time, space and person
Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients

The investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.

The investigators will enroll patients with coronary disease \>1 year after an acute coronary syndrome. Subjects will be randomized to one of two treatment plans. One plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. The other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. Study drugs will be provided to participants at the start of each treatment period. Bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, CRP, and fibrin clot assessment. These are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study. They have to have at least one of these additional risk factors:

  1. Diffuse coronary artery disease.
  2. Peripheral vascular disease
  3. Diabetes
  4. Chronic kidney disease (eGFR\<60 ml/unit/1.73 m2)

Exclusion Criteria:

* Allergy to either rivaroxaban or ticagrelor
* Requirement for anticoagulation or P2Y12 inhibitor therapy
* Anemia (hemoglobin \< 10 g/dL)
* Severe renal impairment (eGFR \< 30 ml/unit/1.73 m2)
* Bleeding disorders
* Significant liver impairment resulting in deranged clotting parameters
* Any history of intracranial hemorrhage
* Stroke within 6 months
* History of gastrointestinal bleed within 6 months
* Major surgery within 1 month
* Patients with inflammatory conditions
* Concomitant treatment with immunosuppressive therapy, inhibitors or inducers of P glycoprotein or CYP3A4 enzymes (eg. azole antifungals, ritonavir, erythromycin, clarithromycin, rifampicin)
* Concomitant treatment with antidepressants (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors)
* Pregnancy
* Inability to give written consent
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.

This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula. First a single dose will be administered. After the patient population is divided into 4 groups by age, an optimal dose will be determined for each group. This optimal dose will be given 3 times a day for a 6 week primary observation period, plus an optional 6 month extension.

NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted.

Patients must have:

* For children \>= 3 months to 13 years of age:
* HIV infection. For children \<3 months of age:
* HIV infection or exposure.
* Newborns must have birth weight \>= 2500 gm.
* Absence at screen of any serious or unstable medical conditions.
* Parent or guardian able to give written informed consent and willing to comply with study requirements.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Children with HIV associated malignancy requiring chemotherapy.
* Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening.

Concurrent Medication:

Excluded:

Chemotherapy.

Prior Medication:

Excluded:

* Protease inhibitors.

NOTE:

* Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines, glucocorticoids or unconventional therapies within one month prior to the day 0 of the study must be evaluated to determine the impact of these treatments on the study. Patients may be included or excluded on a case to case basis.
Evaluation of Oncoxin-Viusid® in Prostate Cancer

A not randomized clinical survey was done in 25 pacients with histological diagnosis confirmed of a prostatic adenocarcinoma and hardy in hormonotherapy at the Calixto Garcia Hospital in Habana (2016-2018).

Researches had as identifying goal the efecctiveness study of Oncoxin-Viusid® nutritional supplement as a support to convencional treatment. The patient were treated with habitual doses of Docetacel and 75 mg per day of supplement during and fiften day after the quimiotherapy. The rest of numbers and severety of adverse reactions were determined as well as its influences on life quality when this co-therapy is performed, the evaluation of progresion spare survival and the porcentage of recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Masculine \>18 years-old patients
* Performans status: Karnofsky ≥ 70 or (ECOG \<2)
* Hormonal treatment alternatives 6 or 8 weeks before the inclusion ,with resistence to hormonal treatments
* Normal laboratory tests to onco-specific treatments.
* Ecocardiogram with a eyección fraction \> 60 %, in patients with history of cardiovascular deseases.
* Patients with life expectative more than 6 months.

Exclusion Criteria:

* Patients who are receiving another onco-specific product in research.
* Patients with known hypersensitivity to anthracyclines and / or mitoxantrone
* Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health and life at risk during the study or your participation in the trial.
* Patients with cerebral metastases.
* Patients with HIV.
Jin-shui Huan-xian Granule in the Treatment of IPF

This study is to evaluate the efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis (IPF), establish the treatment scheme, and obtain the high quality clinical evidences.

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and ultimately fatal interstitial lung disease. With worsened dyspnea and an increasing loss of pulmonary function, IPF patients will have very poor quality of life. It has also brought an increasing social-economic burden. Researches show that pirfenidone and nintedanib could be effective to IPF, which were also recommended by the guideline. However, the application has been limited by side effects and high prices. It is urgent to develop other effective treatments and strategies to manage IPF. The investigators' previous studies shown that Jin-shui Huan-xian granule could be effective to IPF.

This is a multicerter, randomized, double-blind, placebo-controlled trial to assess the efficacy of Jin-shui Huan-xian granule in reducinig the acute exacerbations, improving exercise capacity, and delaying the disease progression for IPF. After a 2-week wash-out period, 312 patients will be randomly assigned into treatment or control group for 52-week treatment. The primary outcomes are frequencies of acute exacerbation, 6-minute walking test, and percentage of patients with progression-free survival. The secondary outcomes include pulmonary function, all-cause mortality, clinical symptoms, dyspnea score, and quality of life. Safety will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis stable IPF.
* Age ranges from 40 years to 85 years.
* TCM Syndrome differentiation meets criteria of pattern of Lung Qi deficiency, yin deficiency and inter heat, and lung-kidney qi deficiency.
* Without participanting in any other trial.
* With signed informed consent.

Exclusion Criteria:

* Pregnant, nursing or may become pregnant women.
* Patients with unconscious, dementia or mental disorders.
* Patients with severe cardiac dysfunction.
* Patients with severe liver and kidney diseases.
* Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic obstructive pulmonary disease, chronic respiratory failure or other severe respiratory diseases.
* Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
* Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
* Patients with long-term bedridden.
* Patients who are allergic to any of the treatment drugs.
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.

The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
* Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
* Written informed consent obtained from parent(s) or from the guardian(s) of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.
* Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
* Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Known severe hypersensitivity to any component of the study vaccines, including neomycin.
* Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.

The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced cancer
2. Age ≥ 18 years
3. Ability to read and understand the forms required for the study
4. Life-expectancy more than 2 weeks.
5. Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)

Exclusion Criteria:

1. Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
2. Chemotherapy or radiation therapy within the last 4 weeks
3. Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MRI scan of the cerebrum is needed before inclusion
4. Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator
5. Pregnancy
Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

This study is to compare the maternal and neonatal outcomes in the patients with PPROM who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient.

Now the current practice is to manage patients with PPROM at hospital, however it is not known yet whether this practice is better than outpatient management as regard maternal and neonatal outcome.

There is some recent evidence that home management of PPROM is safe for both mother and neonate, home management is also more convenient with less expenses.

Eligibility Criteria:
Inclusion Criteria:

1. PPROM with gestational age between 27 to 34 weeks
2. Cephalic presentation
3. Clear amniotic fluid
4. Oral temperature \> 38 C
5. Near distance from the hospital (the patient can reach hospital within one hour )
6. Home environment safe and amenable to rest , availability of family support such as a sister or mother who will help the patient at home .
7. Maternal and fetal condition remain stable after hospitalization for 72 hours

Exclusion Criteria:

1. Patient with equivocal diagnosis of rupture of membranes
2. advanced labor
3. intrauterine infection
4. vaginal bleeding or
5. non reassuring fetal heart rate.