cyrilzakka/clinical-trials huggingface dataset:
Hirschsprung Disease Trends in the United States: Analysis of the National Inpatient Sample

Hirschsprung disease (HD) is associated with significant morbidities including long-term bowel dysfunction. The aim of this study was to update national and regional trends in the epidemiology and inpatient care utilization of HD in the United States between 2009 and 2014 using the National Inpatient Sample (NIS).

Hirschsprung disease (HD) is a congenital condition characterized by the absence of ganglion cells in the myenteric and submucosal plexuses of the distal intestine, which results in lack of peristalsis and functional intestinal obstruction. The aganglionosis involves the rectum or rectosigmoid in most cases, but it can extend for varying lengths, and in 5-10% of cases can involve the entire colon or even a significant amount of the small intestine. The incidence of this disease is approximately 1 in 5000 live births and is approximately three times more common in males. HD is a multifactorial disease caused by both genetic and environmental factors, and HD may also be part of a syndrome, most commonly Trisomy 21.

The principal purpose of surgical management of HD is to remove aganglionic bowel and reconstruct the intestinal tract by connecting the normally innervated bowel just above the anus so that normal sphincter function is preserved. Over the last decades, surgical management has changed from original three-stage approach to recent introduction of minimally invasive one-stage procedures, which appears to be safe, and facilitates early feeding and discharge. Although surgical treatment definitively removes the histologically defined pathological intestinal segment, many patients with HD continue to experience bowel dysfunction, obstructive symptoms and recurrent enterocolitis requiring frequent hospitalizations.

Huang et al had shown that HD discharges, associated demographics, and numbers of pull-through procedures remained stable from 1997 to 2006. There is a paucity in the literature regarding cost components associated with care of hospitalized patients with the primary diagnosis of HD. An information update regarding inpatient care utilization for HD is needed to better understand current HD disease burden and inpatient care practice. The primary objective of this study was to analyze cost of HD-related admissions in the United States between 2009 and 2014 using the National Inpatient Sample (NIS) database. Secondary objectives were to update national and regional trends in the epidemiology of HD related hospital utilization, and to examine changing demographics, hospital mortality and length of hospital stay (LOS) in these HD patients.

Eligibility Criteria:
Inclusion Criteria:

* We included all patients who were 18 years or younger with an ICD-9-CM code of 751.3 for HD among the first 10 diagnosis.

Exclusion Criteria:

* Data from 2015 to 2018 were not included since diagnoses and procedures were reported using the ICD-10-CM coding system.
Work-To-Rest Ratios

The purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 18-39 year old individuals
* Physically active

Exclusion Criteria:

* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* Hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, resting heart rate ≥ 100 bpm)
* Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin)
* Any form of tobacco or nicotine use in the past six months
* Current musculoskeletal injury impacting physical activity
* A positive pregnancy test at any point in the study
* Study physician discretion based on any other medical condition or medication
Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.

The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question:

1. what is the effect of Shock Wave Therapy on low back pain and sciatica caused by post-laminectomy fibrosis? patients in the study group will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).


Eligibility Criteria:
Inclusion Criteria:

1. Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring.
2. Both genders will be recruited.
3. Their age will range from: 30-50 years (Sharaf, et al., 2022).
4. Recruited patients will be randomly assigned in to two equal groups.
5. Unilateral radicular sciatica.
6. Constant back pain OR aggravated by movement,
7. Restricted lumbar range of motion.
8. Tenderness at the site of incision.
9. Duration of symptoms: three weeks to six months postoperatively

Exclusion Criteria:

1. Past history of vertebral fracture.
2. Spinal cord compression.
3. Vertebral tuberculosis.
4. Polyneuropathy.
5. Diabetic peripheral neuropathy.
6. Spinal tumor.
7. Recurrent disc herniation after surgery.
8. Spondylolisthesis.
9. Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases.
10. Potential pregnancy.
The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients

To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients

The increase of Corrected QT (QTc) interval is associated with age. It is known that most inhalation anesthetics or intravenous anesthetics can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years ASA class I-II who received surgery with endotracheal intubation

Exclusion Criteria:

* emergency surgery
* electrocardiography abnormality
* hypertension
* diabetes mellitus
* end stage renal disease
* moderate to severe cardiac disease
* moderate to severe liver dysfunction
First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4

The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, aged \>= 18 and \<= 55 at screening.
* Willing to consent to using an effective contraceptive method for at least 3 months after test substance administration.
* Non-smokers, or ex-smokers abstinent from tobacco for at least 1 year.
* Body mass index (BMI): 19 - 29 kg/m2 (extremes included).
* Haematology and chemistry parameters within normal range or showing no clinically relevant deviations, as judged by the Medical Investigator. For haematology, haemoglobin and white blood cell (WBC) count must be within normal limits. For chemistry, calcium, alkaline phosphatase (ALP), (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) must be within normal limits.
* Normal electrocardiogram, showing no clinically relevant deviations, as judged by the Investigator. QTc \<= 450 ms.
* No history or presence of diseases of the kidneys, heart, lungs, liver, gastrointestinal tract or endocrine organs, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* No history of clinically relevant allergies.
* Obtained, signed and dated informed consent.
* Ability and willingness to comply with protocol requirements.

Exclusion Criteria:

* Intake of any prescribed systemic or topical medication within 14 days prior to dosing.
* Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
* History of thrombosis.
* Chronic infection or acute significant infection or fever within the last 5 weeks prior to the start of test substance administration.
* Subjects with any abnormality of the spleen (confirmed by echography) or history of splenic disease, or subjects that underwent splenectomy in the past.
* Blood donation (\>500 ml) or a comparable blood loss within three months prior to the start of drug administration.
* Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason, with special emphasis on eligibility for the aphaeresis procedure.
* Participation in an investigational drug study within 60 days prior to drug administration, or within less than 6 times the terminal elimination half-life of the test substance used in the respective trial (whichever is longer).
* Malignancy, or prior malignancy, with a disease-free interval of \< 5 years after diagnosis and intervention, except curative treatment for non-melanoma skin cancer or resected carcinoma in situ.
A Study of LC542019 in Healthy Subjects and Subjects With T2DM

to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).

The study will be conducted in 2 parts:

Part 1 (Single Ascending Dose) This part will include 6 sequential dose cohorts (S1-S6).

Part 2 (Multiple Ascending Dose) This part will include 5 sequential dose cohorts (M1-M5). Cohorts M1-M4 will enroll healthy subjects. Cohort M5 will enroll subjects with T2DM.

Eligibility Criteria:
For healthy subjects:

Inclusion criteria

* Adults ≥ 18 to ≤ 55 years.
* Body mass index (BMI) ≥18.5 to ≤ 30.0 kg/m2
* Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
* Ability to provide written informed consent.

Exclusion Criteria

* History of or current diagnosis of Diabetes Mellitus Type 1 or Diabetes Mellitus Type 2
* History of or current significant diagnosis of cardiovascular, respiratory, hepatic, renal, gastrointestinal endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease
* History of or presence of clinically significant ECG findings
* History of or acute significant gastrointestinal disorder

For T2DM subjects:

Inclusion criteria

* Adults ≥ 18 to ≤ 70 years.
* Body mass index (BMI) ≥18.5 to ≤ 35.0 kg/m2 with stable body weight by history for 3 months
* Subjects with T2DM \> 6 months, on stable therapy with metformin monotherapy.
* Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
* Ability to provide written informed consent.

Exclusion Criteria

* History of or current diagnosis of Diabetes Mellitus Type 1
* A subject who has acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, especially autonomic neuropathy
* Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
* Current use of any prescribed or non-prescribed drugs (other than current treatment for diabetes mellitus or birth control methods)
CROSSROAD II: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening

The goal of this project is to develop and pilot test an innovative approach for overcoming barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon. Many studies have shown that people with disabilities receive fewer indicated cancer screening services and are more likely to have poor cancer-related outcomes, such as late stage at diagnosis, compared to those without disabilities.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 50-75 at time of screening
* No personal history of breast, cervical or colorectal cancer
* Not being up-to-date with at least one screening test for breast, cervical, and/or colorectal cancer
* Meets the study definition of disability per screening survey OR
* Be a woman who does not meet the definition of disability per screening survey, but has been matched to a participant who does (observation group).

Exclusion Criteria:

* Non female
* Personal history of breast, cervical, or colorectal cancer
* Coming into clinic for an urgent care issue
Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* BMI \[body weight divided by height squared (in kg/m2)\] \> 23,
* lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
* the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* overuse of alcohol,
* viral hepatitis,
* type 1 or 2 diabetes,
* gastrointestinal or connective diseases,
* chronic pancreatitis,
* liver cirrhosis,
* kidney stones, or renal failure;
* use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
* supplementation with vitamins or antioxidants
The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay May Improve ICSI Outcome.

In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes.

The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS).

The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.


Eligibility Criteria:
Inclusion Criteria:

females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples

Exclusion Criteria:

frozen embryos surgically extracted sperm preparations embryo-biopsy cycles
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery

To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery


Eligibility Criteria:
Inclusion Criteria:

1. cataract patients（age 40-80）
2. complex symptom（such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc）
3. dry eye disease

Exclusion Criteria:

1. simplex age-related cataract
2. contact lens use
3. ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months
4. any systemic diseases such as heart diseases, diabetes and psychosis
Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge

The noval coronavirus disease 2019 (COVID-19) would cause physical and psychological dysfunctions in infected patients. We expect that an intelligence-based remote pulmonary rehabilitation scheme could improve patients' health status after hospital discharge. The intelligence-based remote pulmonary rehabilitation program is designed in a real-world and prospective manner, aiming to evaluate the efficacy of rehabilitation among 200 patients in the epicenter of China (Wuhan City) according to their varied adherence. An eight-week rehabilitation scheme, including two weeks for physicians and physiotherapists remotely guided training, and six weeks for patient self-management, will be addressed. The primary outcome of current study is six-minute walking distance and lung function, and secondly respiratory muscle strength, physical fitness assessment, symptoms and quality of life, etc. will also be assessed. Recruited patients will be followed up at week 2, 4, 8 after enrollment and at month 1, 3, 6, 12 after the rehabilitation training completed, respectively. The study has been approved by the ethics committee of China-Japan Friendship Hospital and three participating centers in Wuhan City.


Eligibility Criteria:
Inclusion criteria:

* patients diagnosed as COVID-19 pneumonia according to the Chinese diagnostic criteria (Trial 7th Edition), aged 20 years or above;
* patients who did not participate in any other rehabilitation training scheme;
* patients who did not participate in any other intervention clinical trials;
* patients who signed the informed consent and were able to adhere to a long-term follow-up for at least one year.

Exclusion criteria:

* pregnant women;
* patients with previous mental disorders or undergoing mental health treatment;
* patients with previous personality disorder, intelligence disorder, brain injury or brain disease;
* patients with serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity;
* patients with tumors and underwent treatment.

One will be considered as withdrawal if consent is revoked, lost to follow-up, or unable to take the pulmonary rehabilitation scheme due to severe exacerbation, comorbidities, injury or trauma, etc.
The Effect of Team-Based Learning on Nursing Students' Skill Acquisition in Fundamental Nursing Education

Nursing education is a practical education where theoretical knowledge is combined with laboratory and clinical skills. Skill practices that students should gain during nursing education constitute one of the most important components of the nursing profession. New methods are gaining popularity due to the fact that traditional learning methods do not attract the attention of today's student profile and cannot meet the needs at the desired level. This situation has led to the emergence and spread of active teaching and learning methods, including the cooperative learning approach. Since the learner is directly involved in the learning process in cooperative learning, active participation contributes to the development of the student in many ways. Team-Based Learning (TBL), one of the cooperative teaching methods, is a teaching method that encourages students to think critically and solve clinical problems not only individually but also as a team, and also develops problem solving, effective teamwork and communication skills. TBL is an interactive teaching strategy designed to increase student engagement. Introduced in higher education in the late 1970s, this method is based on constructive learning theory, in which students develop new personal and mental frameworks based on their prior knowledge. TBL is a method that encourages the development of student competencies, including self-directed learning, critical thinking, analysis and application, as well as team collaboration and interpersonal skills. TBL is a teaching strategy planned to be implemented in multiple stages. TBL begins with students' pre-lesson preparation, students apply preparation assurance tests individually and as a team, and the method ends with the evaluation and application of course concepts by the instructor. It is thought that the use of the TBL method in nursing education will contribute to the development of important clinical skills by using clinical experience, knowledge, and problem-solving skills. In the literature, it has been reported that TBL is an effective teaching strategy in improving problem-solving ability, knowledge and clinical performance, that it promotes learning and contributes significantly to the academic performance of students. One of the important factors that should be evaluated regarding the clinical competence of nursing students is their academic success level. Academic success can be measured by different methods including problem-solving skills, clinical competence, general grade point average and skill assessment exams (OSCE). OSCE (Objective Structured Clinical Examination) is among the methods used to evaluate the academic success of nursing students. This study aimed to evaluate the effect of TBL on the academic success of students in skills training.


Eligibility Criteria:
Inclusion Criteria:

* first time learning nursing care skills
* volunteering to participate in the study

Exclusion Criteria:

* not attending class and being absent
* not wanting to participate in research