cyrilzakka/clinical-trials huggingface dataset:
Intestinal Genes Expression Associated With Necrotizing Enterocolitis

In recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. Therefore, it became a high growing research topic in the last decade.

The development of medical care increases the survival of preterm babies and consequently increase the number of cases with this serious problem. A systematic review shows the incidence of necrotizing enterocolitis is about 2-7% in babies less than 32weeks gestation and 5-22% in baby's birth weight less than 1000gram.

In 2011, study on average cost of necrotizing enterocolitis in United States shows average cost of health service for preterm baby without necrotizing enterocolitis and with necrotizing enterocolitis 74,004 $-198,040 $ respectively.Babies surviving from necrotizing enterocolitis are at risk of long term complication such as short bowel syndrome and intestinal stricture.Furthermore, impairment of neurodevelopment and growth are usually observed in these babies.In spite of decades of researches on the disease, pathogenesis of necrotizing enterocolitis still unclear. We still don't know how to prevent and treat the disease. However, advancement of researches in the field of microbiology and cellular biology of the intestine of preterm infants could lead to more understanding for early diagnosis, prevention and proper treatment. Enteral feeding in preterm pigs lead to upregulation of inflammatory and pattern recognition receptor genes including interleukin8 and Toll like receptor-4 with corresponding condensation of chromatin configuration that lead to initiation of inflammatory process and development of necrotizing enterocolitis. It is not known if these changes are present in human preterm bowel.T cell effector function in preterm infant immune response is characterised by preponderance of interleukin-8 producing T-cells and has the potential to activate neutrophils and γδ T cells.γδ T cells are predominant intra-epithelial lymphocyte in immature preterm gut and has a role in maintaining intestinal integrity.

Eligibility Criteria:
Inclusion Criteria:

* Cases of necrotizing enterocolitis diagnosed by modified Bells criteria, radiological picture and need surgical intervention.

Exclusion Criteria:

* Cases of severe intrauterine growth retardation.
* Cases with severe congenital anomalies.
Oral Microbiome and Pancreatic Cancer

This is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk.

The identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. Thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.

A history of periodontal disease and the presence of circulating antibodies to selected oral pathogens have been associated with increased risk of pancreatic cancer; however, direct relationships of oral microbes with pancreatic cancer have not been evaluated in prospective studies. Investigators examine the relationship of oral microbiota with subsequent risk of pancreatic cancer in a large nested case-control study.

Eligibility Criteria:
Inclusion Criteria:

* DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts

Exclusion Criteria:

-
Study to Evaluate the Safety of Nanoxel M Inj.

Study to evaluate the safety of Nanoxel M inj. administration in patients.

This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥18 years old
2. Patients who have signed written consent form prior to participating in the clinical trial
3. Patients who are assessed as adequate to administer Nanoxel M injection.

Exclusion Criteria:

1) Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs
Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE. A Descriptive Analysis of the Asthma Patient Population in the Emirate of Dubai With Respect to Healthcare Resource Utilization, Costs, and Asthma-related Treatment Pattern

This Retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the Emirate of Dubai with respect to healthcare resource utilization, costs, and asthma-related treatment patterns and outcome.


Eligibility Criteria:
Inclusion Criteria:

* Minimum two claims with asthma diagnosis, 30 days apart, during the identification period
* Minimum 12 months of baseline period
* Age ≥ 18 years on the index date
* Continuous enrolment during the baseline period and at least 180 days of follow-up period; enrolment will be defined based on at least one activity during each 90-day period from the index date

Exclusion Criteria:

• Diagnosis of COPD during the baseline period. Diagnosis of COPD will be defined as ≥1 medical claim with an ICD-10 diagnosis in any position
Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
* Planning to deliver at OSU Wexner Medical Center
* Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

* Abnormal early 50g GCT screen, thereby necessitating 100g OGTT at 24-28 weeks
* Known pregestational diabetes (type 1, type 2, MODY)
* 50g GCT \>200 mg/dl leading to GDM diagnosis without the performance of 3hr 100g GTT
* Abnormal obstetrical ultrasound suspicious for major congenital abnormality
* Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
* Participation in another trial that may influence the primary outcome, without prior approval
* Participation in this trial in a prior pregnancy
* Higher order pregnancy
Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acne vulgaris
* Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria:

* Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
* Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
* Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
* Use of birth control pills strictly for acne control
Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine

This clinical trial is designed to evaluate the efficacy and safety of thread-embedding acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.

Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined 23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline, 4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions (12 and 16 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults aged 19-70
2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
3. 40 or higher low back pain on 100mm pain VAS
4. Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials

Exclusion Criteria:

1. Congenital abnormalities or surgical history on lumbar regions
2. Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
3. Tumor, fracture or infection in lumbar regions
4. Injection treatment on lumbar regions within 1 week
5. Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
6. Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR \> 2.0 or taking anticoagulant)
7. Other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
8. Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication
9. Pregnant women or other inappropriate condition for thread-embedding acupuncture
10. Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen
Post Trial Analysis of a Primary Prevention Study in Asian Indians

An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this study we estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. This will provide comparison of the progression to diabetes among group motivated through text messages and the group educated only during enrollment. A total of 537 participants were enrolled in the primary study and are invited to participate in a follow-up visit 3 years post active trial period.


Eligibility Criteria:
Inclusion Criteria:

Participants of the primary prevention programme - NCT00819455.

Exclusion Criteria:

Unwilling for participation
Eswatini Ring Study: Increasing PrEP Options for Women

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

The two main study components include the following:

1. Prospective, observational cohort of eligible individuals interested in initiating PrEP or continuing PrEP with screening for entry at time of HIV testing and followed throughout the study period (up to 18 months). Data collection will involve quantitative methods and for a subset of participants, data will also be collected using qualitative means, namely in-depth interviews, and focus group discussions.
2. Mixed methods process evaluation that will document implementation of the enhanced service delivery package, assess ongoing perceptions of service delivery (i.e., acceptability and feasibility, barriers and facilitators) among providers and end users, and document other important implementation considerations including the integration of PrEP and family planning.

Eligibility Criteria:
Inclusion Criteria:

* HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.
Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women

The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.

Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years to 45 years
* Pregnancy between 22 and 32 weeks of gestation
* Provides written informed consent
* Covered by French Social Security

Exclusion Criteria:

* Allergy to eggs or other components in the vaccine
* History of severe reactions following previous influenza vaccines
* H1N1 influenza (virologically documented) during the last 6 months
* Febrile episode within one week prior to vaccination
* Known HIV, HBV, HCV infection
* Multiple sclerosis
* History of Guillain-Barré syndrome
* Organ transplant recipient
* Neoplastic disease in the past 3 years
* Other vaccine within 3 weeks prior to study entry or planned within the month following the last injection
* Systemic corticosteroids,immunotherapy,chemotherapy
* Anticoagulant treatment
* Immunoglobulin or blood transfusion within the 3 months prior to enrollment in this study
* History of cardiac disease
* Chronic liver disease
* Diabetes before pregnancy
* History of premature delivery
* History of eclampsia
* Fetal morphologic abnormalities
GLP-1 and Hypoglycemia

Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* 14 (7 males, 7 females) healthy controls age 30-60 yr.
* 14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
* For type 2 DM: HbA1c 6-10.0%
* No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
* Body mass index \>25kg • m-2

Exclusion Criteria:

-
To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults

To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.


Eligibility Criteria:
Inclusion Criteria:

1. Constipated subjects Subjects (less than 3 bowel movements per week and/or Bristol Scale Types 1 and 2); 2. Be able to complete the research according to the requirements of the test plan; 3. Subjects who have signed informed consent; 4. Subjects (including male subjects) have no family planning and voluntarily take effective contraceptive measures from 14 days before screening to 6 months after the end of the trial.

-

Exclusion Criteria:

1. Short-term use of items with similar functions to the subject, which affects the judge of the result;
2. Those who changed their diet type during the study period;
3. People with severe allergies and immune deficiencies;
4. Women who are pregnant, breastfeeding or planning to become pregnant;
5. Patients with serious diseases of cardiovascular, lung, liver, kidney and other vital organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
6. People who have used antibiotics in the past two weeks;
7. People with serious mental and mental illness;
8. Failure to eat the test sample as required, or failure to follow up on time, resulting in uncertain efficacy;
9. Other researchers judged it inappropriate to participate. -
Journey of Hope in Appalachia: Supporting Resilience in the Region's Youth

Rural youth have heightened exposure to adverse childhood experiences (ACES) such as poverty, social isolation, chronic hunger, and drug use in the home. These threats can lead to downstream problems with emotion regulation, substance abuse, and heightened vulnerability to chronic disease. Resilience is the capacity to adapt positively in the face of such disadvantage. Youth resilience interventions can buffer the negative effects of ACES. Unfortunately, rural schools and other youth-serving agencies often have inadequate capacity to provide such interventions. Thus, there is a critical need to develop cost-effective, sustainable, and culturally-relevant youth resilience interventions that can be delivered by trained personnel with dedicated time and resources. WVU, UK, and Save The Children have a long-term goal to establish a sustained community-engaged research partnership to promote resilience in Appalachian youth. This is a community-based participatory research (CBPR)-guided study being conducted for the purpose of developing a culturally relevant, intervention to promote Appalachian youth resilience. The intervention, called Journey of Hope in Appalachia (JOHA), has as it's starting point Save The Children's evidence-based Journey of Hope (JOH) program that targets youth experiencing acute stress from natural disasters and similar events. This program will be culturally adapted to promote resilience among Appalachian youth experiencing ACES. JOHA will incorporate positive aspects of Appalachian culture (e.g., storytelling, theater, music) and will be designed for sustainability and eventual dissemination by Save through the Appalachian Translational Research Network (ATRN) and other regional Networks.


Eligibility Criteria:
Inclusion Criteria:

* Youth or adults who are residents of Appalachia
* Able to read and speak in English

Exclusion Criteria:

* Youth or adults who are not residents of Appalachia Kentucky or West Virginia
* Children under the age of 10
Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively

This study aims to compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer surgery.

This randomized study will be approved by the local ethics committee of South Egypt Cancer Institute, Assuit University, Egypt after written informed consent. This study will include approximately 60 ASA I-II cancer patients with age range (18-60) years, weight (50- 85) kg who will be scheduled for lower abdominal cancer surgery (abdominal hysterectomy, oophorectomy and radical cystectomy). Exclude from the study Patients with known drug allergy to study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorders and those with psychiatric illnesses that would interfere with perception and assessment of pain. Preoperatively, patients will be taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable).

Patients will be randomly assigned using an online research randomizer into two groups, 30 patients in each group:

Group 1:

30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Group 2:

30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Surgery will be performed under standard general anesthesia and ultrasound guided TAP block will be performed before induction of GA.

Eligibility Criteria:
Inclusion Criteria:

* 60 ASA I-II cancer patients with age range (18-60) years,
* weight (50- 85) kg

Exclusion Criteria:

* with patients with known drug allergy to study drugs
* with significant cardiac, respiratory, renal or hepatic disease
* with coagulation disorders
* those with psychiatric illnesses that would interfere with perception and assessment of pain.
IOL Power Calculation Using Dual Schiempflug Analyzer

This study evaluates the various ocular parameters which are necessary for ocular biometry and the calculated IOL powers using both dual Schiempflug analyzer and optical low-coherence refelctometry.

The measured keratometry, axial length, anterior chamber depth, lens thickness, white-to-white corneal diameter, and calculated IOL powers using various formulas including Hoffer Q, Holladay I, SRK II and SRK T measured by dual Schiempflug analyzer and optical low-coherence refelctometry will be compared.

Eligibility Criteria:
Inclusion Criteria:

* axial length between 21.0 and 27.0 mm
* older than 20 years old

Exclusion Criteria:

* other ophthalmic diseases such as severe dry eye, glaucoma, and age-related macular degeneration
* previous ophthalmic surgery including cataract surgery, and refractive surgery
* very dense media which cannot be measured by the optical biometries
* severe zonulysis