cyrilzakka/clinical-trials huggingface dataset:
Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications.

II. Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT.

III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been no pulmonary complications.

PROTOCOL OUTLINE:

Patients undergo bronchoscopy with bronchoalveolar lavage (BAL) prior to allogeneic hematopoietic stem cell transplantation (HSCT). ELISA assays for cytokines are performed. Patients are followed post-HSCT for the development of transplant related pulmonary complications. A repeat bronchoscopy with BAL is performed at the time pulmonary complications develop or at day 60 post-HSCT if no complications develop. Cytokine assays are repeated.

Eligibility Criteria:
* Diagnosis of an inborn error of metabolism eligible for allogeneic hematopoietic stem cell transplantation on protocol UMN-MT-1995-01
The Effects of Increased vs. Traditional Squat Stance Width on Performance Indices in Elite Rugby League Players

The back squat is a commonly utilized resistance training exercise for the promotion of both performance and musculoskeletal health. There are a range of manipulations that can be made to the setup of this resistance exercise, with once such adaptation being the stance width when performing the exercise. This intervention aims to explore the effects of increasing the stance with on performance indices in elite rugby league players.


Eligibility Criteria:
Inclusion Criteria:

* Rugby league player contracted to a professional Super League team
* 5-years minimum of back squat experience
* Male
* Injury free for 6-months

Exclusion Criteria:

* Female
* Any injury at baseline
* Any international matches played during the between season break
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, 18-75 years of age;
2. Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;

Exclusion Criteria:

1. Screening and baseline platelet count\< 30×109/L;
2. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening;
3. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
4. Participant has serious bleeding symptoms;
5. Participant has no hepatic metastases, ALT/AST\>3ULN, TBIL\>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN;
6. Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）;
7. History of allergy to the study drug;
8. Participant with HIV;
9. Pregnant or lactating women;
10. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.

The Provider Approaches to Improved Rates of Infant Nutrition \& Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.

   Secondary Outcomes (Hypotheses): Infant Growth
3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits.
4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.
5. Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits
6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.


Eligibility Criteria:
Inclusion Criteria:

* 12-30 weeks pregnant
* receives prenatal care at Centennial women's center of Montefiore Medical Center
* English or Spanish speaking

Exclusion Criteria:

* pregnant with multiples
* breastfeeding contra-indicated
Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

The purpose of this investigator-initiated study is to compare the use of pupilometer and ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if there is a value that could be used to indicate elevated ICP with either modality as these numbers are inconsistent throughout the literature. Patients that have either an external ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt are placed the patient will undergo pupilometer examination (standard of care) followed by ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be recorded. The same patient may have multiple readings performed if there is a change in ICP either spontaneously or due to intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Intracranial pathology requiring either EVD or bolt placement for ICP measurement

Exclusion Criteria:

* Known disorder of lens or orbit including but not limited to glaucoma, cataract, blindness, lens implants.
* Patients unable to close eyelids as this would increase risk of corneal abrasion from ultrasound probe.
Diagnosis of Functional Defecation Disorders in Childhood

Purpose To compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation.

Defecation disorders in children are extremely common especially constipation and fecal incontinence. International studies show that constipation make up approximately 3% of Pediatric Outpatient Clinic11 (192) and 25% of Pediatric gastroenterology consultations. Between 1,5-3% of all 4-12 year olds experience fecal incontinence.

Constipation and fecal incontinence can be extremely physical unpleasant and can have significant ramifications for a child's emotional and social functioning eg. low self esteem.

Though most agree that constipation and faecal incontinence are a considerable problem worldwide there is disagreement when it comes to a definition and diagnostic tools. Several definitions have been used. This has led to great difficulties when trying to estimate prevalence, understand and compare in order to improve different treatments.

Hypothesis:

* It is possible to diagnose constipation accurately by using a combination of anamnesis, stool diary, physical examination and transabdominal ultrasonography
* Transabdominal ultrasonography is a safe and sensitive diagnostic tool and can be used as an alternative or substitute to rectal examination.

Purpose To compare different kinds of diagnostic (tools) investigations in order to identify the most sensitive and least invasive when diagnosing constipation.

Material and methods 60 children referred to the paediatric outpatient clinic with fecal incontinence or suspicion of constipation. The investigations include anamnesis and physical examination with rectal examination and transabdominal ultrasonography. Home registration of a stool diary based on the Bristol Scale for 3 weeks thereafter a Colonic transit time is performed.

Data is compared to data from 30 healthy children that have gone through the same investigations except the CTT that is based on x-rays.

Eligibility Criteria:
Inclusion Criteria:

Referred children

* functional constipation and/or fecal incontinence

Healthy children

* No sign of functional constipation and/or fecal incontinence

Exclusion Criteria:

Referred children

* organic constipation/ fecal incontinence

Healthy children

* constipation/ fecal incontinence
The Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life

Primary dysmenorrheic (PD) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. The pain typically radiates to the back and thighs and lasts for 8-72 hours. The pain is most severe on the first and/or second day of menstrual bleeding. Additionally, systemic symptoms such as nausea, vomiting, diarrhea, fatigue, and insomnia often accompany the pain. In secondary dysmenorrhea, it can result from a range of identifiable pathological conditions, including endometriosis, adenomyosis, fibroids, and pelvic inflammatory disease. Other gynecological symptoms such as intermenstrual bleeding and menorrhagia may also accompany it, depending on the underlying condition. Empirical treatment approaches have been reported as appropriate for patients with primary dysmenorrhea based on symptoms and physical examination results. Recent studies have indicated that during diaphragmatic breathing, all the muscles that make up the thoracic and abdominal walls should expand in a cylindrical manner in all directions through synchronized eccentric activity. Thus, a more effective result will occur with the concentric contraction and 360-degree expansion of the diaphragm during inspiration, which raises intra-abdominal pressure .

Within the framework of this information, the aim of this study is to examine the effects of respiration-based physiotherapy approaches on menstrual symptoms, pain, and quality of life in women with PD.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35,
* Voluntary participation,
* Having a regular menstrual cycle (every 24-35 days) ,
* Menstrual pain intensity of 3/10 or higher on the Visual Analog Scale during the initial assessment,
* Pain radiating to the back, legs, lower abdominal, or suprapubic region during menstruation,
* Restriction of daily living activities due to pain,
* Requirement for medical intervention or self-medication to control the pain.

Exclusion Criteria:

* History of pelvic pathology and/or surgery that could cause pain,
* Neurological or psychological disorders,
* Anovulation,
* Other diseases that could affect chest expansion or the respiratory system (COPD, asthma, pneumonia, bronchiectasis, etc.),
* Being pregnant, having a positive birth control status, or being less than 6 months postpartum,
* Use of an intrauterine device,
* History of childbirth or miscarriage. Individuals who miss two consecutive exercise sessions will be excluded from the study.
Effect of Dried Plum on Bone and Markers of Bone Status in Men

The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.

To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.

Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men (50-79 year-old)

Exclusion Criteria:

* endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
* Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician
* subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.
* body mass index (BMI) \<18 and \>30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
* If subjects smoke 20 cigarettes or more per day, they will be excluded.
* Men who regularly consume dried plum or prune juice will not be accepted into the study.
Tongue Images-based AI Deep Learning Model for the Prediction of Esophageall Varies in Liver Cirrhosis

The goal of this observational study is to compare the tongue images of liver cirrhosis patients with high-risk and low-risk esophageal varies.

The main question of this study is to explore whether there exists a relationship between the degree of esophageal varices and tongue bioinformatics in liver cirrhosis. it aims to answer 2 questions as below:

question 1: If these is a significant difference in tongue images between patients in liver cirrhosis with high-risk and low-risk esophageal varices.

Question 2; If tongue bioinformatics could be used as a diagnostic method for prediction of esophageal varices in liver cirrhosis.

Firstly, participants will be divided into two groups according to their degree of esophageal varices from endoscopic examination and CT report, including high-risk group and low-risk group. Secondly, participants will be asked to show their tongue, including the surface and sublingual veins of tongue, and the tongue images of each participants will be collected by researchers via camera. After finishing tongue image collection, participants will receive a professional tongue diagnosis report in Traditional Chinese Medicine and health suggestion. Finally, tongue images will be analyzed by using AI deep learning model for information extraction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed with liver cirrhosis;
2. Patients who received abdominal enhanced CT scans and upper endoscopic examination;
3. Patients who signed informed consent;

Exclusion Criteria:

1. Patient who has previously received transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, Hepatectomy, balloon occlusion of retrograde veins or liver transplantation;
2. Patient with liver cancer;

(4) Patients with hypertension, cor pulmnale, emphysema, heart failure and other severe systemic diseases;
Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

This study aims to measure the radiation safety climate in the hybrid angiography suite using self-assessment and to investigate the relationship of radiation safety climate with their self-reported safety behaviors.

The hypothesis is that a radiation safety climate does exist and can be measured using self-assessment. Additionally, it is expected that the radiation safety climate positively influences radiation safety behaviors.

Radiation safety in the hybrid angiography suite is a primordial safety component which is relevant for endovascular team members and patients. To date, many interventions which aim to improve radiation safety habits of an endovascular team focus on improving technology and team radiation safety knowledge. Safety literature has indicated that a safety climate can be identified as the shared perceptions of team members or workers about the safety in their workspace and that this safety climate is closely related to safety behaviors and outcomes. In endovascular specialties, the concept of a radiation safety climate remains unexplored. Therefore, this study aims to measure the radiation safety climate in a diverse pool of endovascular team members from different hospitals, using self-assessment questionnaires and to investigate the relationship of radiation safety climate with their self-reported safety behaviors.

Eligibility Criteria:
Endovascular team member group

Inclusion Criteria:

* Vascular surgeon OR surgical trainee OR operating nurse
* Active at one of the participating hospitals

Exclusion Criteria:

* No exclusion criteria apply to this study.

Patient group Inclusion Criteria

* Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm

Exclusion criteria

* Emergency repair (ruptured aneurysm)
* Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)
Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types.

The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up.

Patients report their IBS-related symptoms daily from run-in until end of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
2. It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
3. Male or female aged 18 to 65 years (including the boundary value);
4. The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
5. IBS-SSS score\>175;
6. Signed informed consent voluntarily.

Exclusion Criteria:

1. Patients with IBS-C、IBS-M or IBS-U；
2. Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
3. Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
4. Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
5. Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
6. With history of abdominal surgery (e.g., cholecystectomy);
7. Patients with severe cardiovascular disease, liver, kidney and other major organ diseases, hematopoietic system diseases, tumor, nervous or mental system diseases (such as severe depression, severe anxiety)
8. Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected gastrointestinal motility and function ;
9. Taking emergency medication in the run-in period；
10. Pregnant or lactating women；
11. Those who are allergic to the test drug, emergency drug and its ingredients；
12. Suspected or confirmed history of alcohol and drug abuse;
13. Patients who participated in other clinical trials within one month before enrollment;
14. The researchers believe that others are not suitable for clinical trials.
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers

This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 19 to 55 years inclusive
* BMI within the range 19 to 32 kg/m2 inclusive.

Exclusion Criteria:

* Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
* Female subject is pregnant or lactating.
* Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
* Female subjects using hormonal replacement therapy.
* History of regular alcohol consumption \> 7 drinks week for women and 14 drinks week for men
* Current smokers of 10 or more cigarettes per day