cyrilzakka/clinical-trials huggingface dataset:
Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burns

There is a difference in frequency of wound infection, mean pain score, mean of time for skin grafting and hospital stay in pediatric 2nd and 3rd degree burns, between amniotic membrane and duoderm dressings

After informed consent of the patients, patients who will fulfill the inclusion and exclusion criteria will be enrolled in the study from Department of Pediatric Surgery, Mayo Hospital Lahore and will be randomly allocated by lottery method into 2 groups by the doctor. Group A and B with 86 patients in each group. Group A patients will be undergoing amniotic membrane dressing, while group B patients will undergo colloid gel foam dressing. Basic demographic information will be noted. Effect modifiers (hemoglobin level, weight and height) will be noted.

In group A, the wounds will be washed with normal saline and then covered with amniotic membrane over which a layer of Vaseline gauze will be applied and dressing with gauze and the crape bandage will be applied. Every 3-4 days these dressings will be changed and assessed for pain, wound infection and wound c/s will be sent. Placentas from clean vaginal deliveries and elective C-sections will be taken. Blood of mother will be screened. Amniotic membrane will be separated from placenta in a clean sterile bowl. Bowl will be put in refrigerator at 4 degrees.

In group B, wound will be washed with normal saline . The wound site will be covered with Colloid Gel Foam and gauze, and crape bandage will be applied. Dressing will be changed after 3-4 days. The outcome (pain score, wound infection,time for skin grafting and hospital stay) will be compared in both groups.

Eligibility Criteria:
Inclusion Criteria:

* 10-45 % percent 2nd and 3rd degree fresh burns age less than 12 years patients of both gender

Exclusion Criteria:

* patients whose parents are not willing patients whose wound c/s comes positive at the time of admission patients who have associated medical disorder and trauma.
Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery

Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of anesthesia-related adverse events and obstetric complications.


Eligibility Criteria:
Inclusion Criteria:

* all parturients underwent cesarean section at Far Eastern Memorial Hospital during 2012-2016

Exclusion Criteria:

* missing data can't be collect during medical chart review
Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

The study is a single-center prospective cohort study of clinical application of continuously monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose of the study is to evaluate the association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status along with the treatment.

Activity trackers to be used: Fitbit Charge HR (TM)

Data which ware provided by Fitbit app (TM) will be analyzed in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing newly developed or recurrent thyrotoxicosis who are treated and followed-up in Seoul National University Bundang Hospital
* Patients who can use wearable activity trackers and smartphone applications
* In case of Graves' disease, patients who will treated by anti-thyroid drugs

Exclusion Criteria:

* Patients who have thyrotoxic periodic paralysis
* In case of Graves' disease, patients who will treated by radioactive iodine therapy or thyroidectomy
* Patients who have thyrotoxicosis due to toxic nodular disease
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer. Prospective, randomized, parallel group, open-label with blinded endpoint adjudication multicenter clinical trial.To assess, among patients with unfavorable intermediate to high-risk prostate cancer, whether a neoadjuvant combined treatment with leuprorelin (Leuprorelin) and darolutamide is superior to monotherapy in terms of complete or almost complete pathological response.A total of 144 patients with unfavorable intermediate to high-risk prostate cancer scheduled for radical prostatectomy with extended pelvic lymph node dissection will be randomized 1:1:1 to oral darolutamide, SC leuprorelin (Leuprorelin) or both (48 patients per arm) for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥18 years of age;
* Histologically confirmed unfavorable intermediate or high/very high risk non metastatic (by conventional imaging) prostate adenocarcinoma intended for surgery without neuroendocrine differentiation or small cell features;
* Unfavorable intermediate-risk:

  * ISUP grade 3, and/or \> 50% positive biopsy cores and/or at least two intermediate-risk factors. Intermediate-risk factors:

    * Clinical tumor stage T2b or T2c (MRI based);
    * ISUP grade 2 or 3;
    * Prostate-specific antigen (PSA) level of 10-20 ng/mL.
* High-risk or very high-risk:

  * ≥cT3a (MRI based) or ISUP 4-5 or PSA\>20 ng/mL;
  * cN1.
* ECOG 0-1;
* Baseline testosterone \> 230 ng/dL;
* No prior prostate cancer treatment;
* Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the treatment with darolutamide and for 1 week after the end of treatment with darolutamide to prevent pregnancy;
* Written informed consent.

Exclusion Criteria:

* Unresectable prostate cancer;
* Histology of small cell carcinoma prostate cancer or adenocarcinoma with neuroendocrine features;
* Any prior prostate cancer treatment;
* Any active infection requiring IV antibiotics;
* Known additional malignancy that has a life-expectancy \< 2 years;
* Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, heart failure with New York Heart Association Class Functional III or IV;
* Uncontrolled severe hypertension as indicated by a resting systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg despite medical management;
* A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of darolutamide;
* Inability to swallow oral medications;
* Receipt of medications (e.g. finasteride, dutasteride) or agents that are likely to alter serum PSA levels within \<= 42 days or 5 half-lives prior to registration, whichever is shorter.
Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals

Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.

Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.

In this study, three arms will be studied for 3 months: 1 control group, 1 group with whey supplementation at lunch, and 1 group with whey supplementation at lunch and an energy bolus before bedtime. Actions include weight and body composition monitoring, nutritional status and muscle function, as well as mechanistic.

Eligibility Criteria:
Inclusion Criteria:

* Resident on the Accommodation Establishments for Dependent Elderly Persons on the Mutuality of Loire, France
* Risk of undernutrition or moderate undernutrition with one of the following criteria :

  * Either 5-10% of weight loss in 1 month or 10-15% in 6 months.
  * Or Body Mass Index (BMI) between 16 and 21
  * Or Albumin levels between 30 and 35 g/L
  * Or global Mini Nutritional Assessment (MNA) test between 17 and 23.5
  * Or Short Emergency Geriatric Assessment (SEGA) Score \>8

Exclusion Criteria:

* Sub-acute pathology (flu, gastroenteritis, bacterial infections ...) or trauma (fracture, surgery ...) in the 30 days prior to inclusion.
* Hepatocellular insufficiency
* Heart failure with decompensation
* Severe dementia,
* Insulin-treated diabetes
* Renal insufficiency (clearance \<30 ml / min)
* Long-term cortico-therapy
* Cancer undergoing chemotherapy treatment or/and radiotherapy
* Gastrointestinal pathology,
* Diet incompatible with the nutritional protocol (intolerance to milk or lactose, vegetarians, vegans, ...)
* Motor disability leading to the impossibility of doing muscle function tests.
Single Participant Study of an Experimental ASO Treatment for TUBB4A-related Leukodystrophy

This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with TUBB4A associated leukodystrophy.

This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single pediatric participant with a de novo pathogenic gain of function TUBB4A mutation associated with severe leukodystrophy with hypomyelination with atrophy of the basal ganglia and cerebellum (H-ABC)

Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Clinical phenotype and neuroimaging consistent with a diagnosis of TUBB4A-related leukodystrophy/Hypomyelination with Atrophy of the Basal Ganglia and Cerebellum (H-ABC)
* Documented genetic mutation in TUBB4A

Exclusion Criteria:

* Participant has any known contraindication to or unwillingness to undergo lumbar puncture
* Use of investigational medication within 5 half-lives of the drug at enrolment
* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.
Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19

Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).

The Bio-Rad SARS-CoV-2 ddPCR Test is a reverse transcription (RT) droplet digital polymerase chain reaction (ddPCR) test designed to detect RNA from SARS-CoV-2 in specimens (mainly nasopharyngeal, anterior nasal, oropharyngeal and mid-turbinate swab but also nasopharyngeal wash/aspirate and nasal aspirate specimens) collected from individuals who are suspected of COVID-19 infection.

This single assay multiplex test enables a one-well reaction with three sets of the oligonucleotide primers and probes which were reported by CDC. Two were selected from regions of the virus nucleocapsid (N) gene. An additional primer/probe included in the panel is set to detect the human RNase P gene (RP) in control samples and clinical specimens.

RNA isolated and purified from swab specimens is added to the mastermix comprised of reverse transcriptase whereby RNA is converted into cDNA and then amplified, using the Bio-Rad One-Step RT-ddPCR Advanced Kit for Probes.

Briefly, the sample and mastermix RT-ddPCR mixtures are fractionated into up to 20,000 nanoliter-sized droplets in the form of a water-in-oil emulsion. The 96-well RT-ddPCR ready plate containing droplets is sealed with foil using a plate sealer. The emulsions are then thermocycled to achieve reverse transcription to generate cDNA followed by target amplification plus probe hydrolysis in each droplet. After thermocycling is complete, the 96-well RT-ddPCR ready plate is loaded into the Droplet Reader. The Droplet Reader singulates the droplets and flows them past a two-color fluorescence detector (FAM and HEX) in order to determine which contain target (positive) and which do not (negative) for each of the targets identified with the SARS-CoV-2 ddPCR Test: N1, N2 and RP. The ddPCR system uses the QuantaSoft 1.7 and QuantaSoft Analysis Pro 1.0 for analysis software.

Eligibility Criteria:
1. Age ≥ 18 years on the day of signing informed consent.
2. Confirmed diagnosis of any type of solid or hematologic tumor.
3. Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure).
4. Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and/or chest imaging before inclusion.
5. Covered by a medical/health insurance.
6. Signed and dated IRB/ICE approved informed consent form.
The HPV Self-test as a Test of Cure in Madagascar

The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

The efficacy and the availability of cold coagulation render it a valuable technique for the treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV) test performed by women themselves (HPV self-test) could be an efficient method to assess the long-term risk of recurrent/persistent disease in women with a history of HPV infection and cervical intra-epithelial lesions grade 2 or higher (CIN2+).

A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3 years after primary screening will be organized for all HPV-positive women detected at primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV testing will also be collected by the physician. The goal of the study will be the histological search for CIN2+ lesions at one to three years after primary screening.

The investigators expect to see that Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

Eligibility Criteria:
Inclusion Criteria:

* women previously positive at HPV testing

Exclusion Criteria:

* pregnancy
Retrospective Study of Patients With Severe Aplastic Anemia Who Developed High Risk Clonal Evolution With Chromosome 7 Abnormalities After Immunosuppressive Therapy

Background:

Severe aplastic anemia (SAA) is a form of bone marrow failure. It usually results from a

cytotoxic T cell attack on the marrow stem cell. Two treatments can be used for SAA. One is allogeneic hematopoietic stem cell transplant (HSCT). The other is immunosuppressive treatment (IST). In most cases, HSCT or IST works. But for some people, clonal evolution occurs after IST. One of the most common forms of clonal evolution is chromosome 7 abnormalities. These have a poor prognosis. HSCT can be used to treat them. Researchers do not know why clonal evolution happens. They want to look at data from past studies to learn more.

Objective:

To compare the data of people with SAA who developed chromosome 7 abnormalities between those who ultimately received HSCT versus those who received chemotherapy alone or supportive care.

Eligibility:

Adults and children with SAA who were enrolled on NHLBI protocol 12-H-0150, 06-H-0034, 03-H-0249, 03-H-0193, 00-H-0032, or 90-H-0146

Design:

This study uses data from past studies. The participants in those studies have allowed their data to be used in future research.

Researchers will review participants medical records. They will collect clinical data, such as notes, test results, and imaging scans. They will also collect the research data gathered as part of the original study.

Researchers will enter the data into an in-house database. It is password protected. All data will be kept in secure network drives or in sites that comply with NIH security rules.

Other studies may be added in the future.

Severe aplastic anemia (SAA) is a form of bone marrow failure in most cases is the result of a cytotoxic T cell attack on the marrow stem cell. It is effectively treated in most patients with either immunosuppressive treatment (IST) or allogeneic hematopoietic stem cell transplant (HSCT). However, after IST, 'clonal evolution' is a significant complication in about 15% of patients, presenting as either a new cytogenetic abnormality or morphological evidence of myeloid malignancy. In particular, the development of chromosome 7 abnormalities is considered high risk and is associated with poor prognosis. The optimal treatment of chromosome 7 abnormalities following SAA is not defined though HSCT is widely offered.

Eligibility Criteria:
* Subjects will not be recruited for this study. This is a retrospective chart review.

Patients who opted out of future use of data on their prior studies will be excluded from this study.
The Impact of Preoperative Urostomy Education on Patients and Families

This is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("Stoma Bootcamp") on patients and their family/informal caregivers

This study will utilize a qualitative descriptive methodology with a thematic analysis approach. Individual interviews will be held with bladder cancer and caregiver dyads who participated in the Stoma Bootcamp study. Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective. Semi-structured interview guides will be developed using Engel Biopsychosocial Model (BPS),5 one guide geared towards patients and the second toward caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥ 18 years) patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center since 2016, AND
* Participated in the Stoma Bootcamp preoperative educational intervention, AND
* Identified an informal/family caregiver who participated in Stoma Bootcamp with them.
* Patient-caregiver dyads must both consent to participation

Exclusion Criteria:

-
Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level

The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as based on medical history and physical examination
* Fasting serum triglyceride 120 to 200mg/dl
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 1 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction
Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants 12 years and older as of the screening visit. Male or female participants 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult participants only.
* General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study.
* Asthma Diagnosis: The asthma diagnosis must be in accordance with the Global Initiative for Asthma (GINA)

Exclusion Criteria:

* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks before the screening visit. In addition, the participant must be excluded if such infection occurs between the screening visit and the baseline visit.
* Any asthma exacerbation requiring oral corticosteroids within 1 month of the screening visit. A participant must not have been hospitalized for asthma within 6 months before the screening visit.
* Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
* Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular conditions (for example, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine conditions (for example, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal conditions (for example, poorly-controlled peptic ulcer, gastroesophageal reflux disease \[GERD\]), or pulmonary conditions (for example, chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition became exacerbated during the study.

NOTE: Other inclusion and exclusion criteria may apply.