cyrilzakka/clinical-trials huggingface dataset:
Rotavirus Vaccine in Premature Babies

This study will establish the duration of excretion of rotavirus vaccine in stool following vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.

Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be transmitted between people in the same way as the normal virus. Premature babies often receive their initial vaccines while they are still hospitalised in neonatal units. There are no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there was inadequate staff hand washing). Some countries have therefore advised against immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.

This is an observational study of babies admitted to the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus vaccine during their hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Participant's parent is willing and able to give informed consent for participation in the study.
* Current inpatient in the neonatal unit and expected to remain an inpatient for at least 14 days following immunisation with rotavirus vaccine.
* Due to receive rotavirus vaccination during their admission.
* Born at less than 37 completed weeks gestation (i.e. up to and including 36 weeks and 6 days)

Exclusion Criteria:

• Parent is listed on the study delegation log.
Fish Intervention and Learning Abilities

In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.

Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.

Eligibility Criteria:
Inclusion Criteria:

* 4-6 years

Exclusion Criteria:

* severe illness
* child dislikes fish
ICAN Symptoms Duke-NUS

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and cultural sensitivity of a cross-cultural cognitive behavioral therapy (CBT) multi-symptom management protocol targeting distress (anxiety, depression), pain, and fatigue in women with advanced stage breast cancer in Singapore and the US.

Up to two-thirds of women with advanced breast cancer experience significant symptom burden (e.g., distress, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to improve their symptom management may be helpful in alleviating multiple symptoms. The efficacy of CBT protocols for reducing distinct symptoms in early-stage breast cancer has been shown in Western countries; however, the role of CBT protocols for multiple symptoms in late-stage cancer is less clear. This study aims to investigate the feasibility and acceptability and obtain estimates of efficacy of a novel, cross-cultural multi-symptom (i.e., anxiety and depression, pain, fatigue) CBT protocol in advanced breast cancer patients. A randomized controlled design will compare patients receiving the CBT protocol to a waitlist control condition in both Singapore and United States patients. The goal of this collaborative effort is to determine the scalability of the cross- cultural intervention. This IRB protocol only represents the Duke US portion of the project; Duke-NUS will obtain their own IRB approvals.

Eligibility Criteria:
Inclusion Criteria:

* being at least 21 years of age
* a diagnosis of stage IV breast cancer
* being able and willing to attend study appointments
* being able to speak/read English
* estimated survival of at least 3 months.

Exclusion Criteria:

* they have an active serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
* if visual, hearing, or cognitive impairment will interfere with intervention.
Allogeneic Bone Marrow Mesenchymal Stem Cells for Patients With Interstitial Lung Disease (ILD) & Connective Tissue Disorders (CTD)

Researchers are trying to find out more about the safety of a new treatment, Allogeneic (coming from a healthy donor) Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs) which is still experimental, for Interstitial Lung Disease (ILD) associated with Connective Tissue Disorder (CTD).


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age and less than 80 years of age
* Both female and male
* Patients with new diagnosis of interstitial lung disease associated with connective tissue disorders, Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitis or idiopathic pneumonia with autoimmune features (IPAF) or established diagnosis of ILD associated with CTD under conventional therapy for at least 6 months but less than 24 months, with no evidence of improvement.
* Competent and able to provide written informed consent, and ability to comply with protocol

Exclusion Criteria:

* Patients with interstitial lung disease without evidence of a concomitant rheumatologic autoimmune disorder
* Exposure to rituximab or cyclophosphamide on the previous 2 months
* Severe interstitial lung disease defined by the presence of severe hypoxemia at rest (SO2 \< 88% at rest)
* Clinical assessment that indicates active chronic infections such as osteomyelitis or active tuberculosis (TB), or acute infections such as pneumonia, active bronchitis, cellulitis, etc. or active solid tumors or hematologic malignancies
* Previous treatment with mesenchymal stem cells
* Clinically significant medical conditions within the six months before administration of BMD-MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
* Medical history of human immunodeficiency virus (HIV), Hepatitis B or C
* Abnormal complete blood count (CBC), creatinine, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) at screening
* Pregnant or breast feeding
* Unwilling to agree to use acceptable contraception methods during participation in the trial
* Inability to provide informed consent
Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
7. American Society of Anesthesiology score (ASA) class I, II, or III
8. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
6. History of other malignant disease within past five years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within past six months
9. History of cerebrovascular accident within past six months
10. History of continuous systematic administration of corticosteroids within one month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
14. Rejection of laparoscopic resection
15. Preoperatively confirmed tumors invading the dentate line or duodenum
16. History of allergy to iodine agents
17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy
Benefit of Rehabilitation Program in Colorectal Surgery

Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Colorectal cancer
* Inform and consent form signed
* Patient has valid health insurance/coverage
* Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)
* Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection

Inclusion Criteria (arm : Laparoscopy + Rehabilitation program):

* Tobacco and alcohol weaning

Exclusion Criteria:

* MBI \< 18kg/m2
* severe malnutrition
* Metastatic colorectal cancer
* Buzby Index \<83
* Combined surgery (hepatic resection or segmental resection of small intestine)
* Urgent surgery
* Pregnancy or maternal breastfeeding
* Body mass index (BMI)\> 30 kg/m2
* Abdominoperineal resection
* Subtotal colectomy
* Total proctocolectomy
* Cons to Naropin Xylocaine, droperidol, ketamine
* Patient with a history of peptic ulcer
LLLT for Reducing Waste Circumference and Weight

The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.

This will be an open label clinical trial with all study participants receiving LLLT. Preliminary data will be collected on the efficacy of LLLT based on varying frequency of treatments. The focus of this study on 60 overweight adults with a BMI of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). Participants will be randomized to receive LLLT treatments either 3 times a week; 2 times a week; or once a week.

Eligibility Criteria:
Inclusion Criteria:

1. over 18 years of age;
2. body weight of greater than 50 kg (110 pounds);
3. BMI between 25-29.9 kg/m2;
4. able to participate fully in all aspects of the study
5. understood and signed study informed consent

Exclusion Criteria:

1. used weight loss medications or participated in a weight loss program within past 30 days
2. currently taking supplements known to affect weight (garcinia cambogia, etc.)
3. weight fluctuations of 20 pounds or more in the past 6 months
4. implanted device (including pacemaker or lap band) in the targeted area of LLLT
5. known active eating disorder
6. known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
7. used an investigational drug within 30 days of study enrollment
8. currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception
9. history of any major cardiovascular events
10. current uncontrolled hypertension
11. clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease
12. Prior surgical intervention for body sculpting/weight loss
13. medical, physical, or other contraindications for body sculpting/weight loss
14. any medical condition known to affect weight levels or to cause bloating or swelling
15. diagnosis of, and/or taking medication for, irritable bowel syndrome
16. active infection, wound or other external trauma to the areas to be treated with the laser
17. known photosensitivity disorder;
18. current active cancer or currently receiving treatment for or within 1 year of cancer remission
Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)

To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent
2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
3. ECOG PS:0-1,Life expectancy of more than 6 months
4. main organs function is normal

Exclusion Criteria:

1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
2. Subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
5. Patients with factors that could affect oral medication (such as dysphagia etc.)
6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
7. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
Study of Silodosin to Facilitate Passage of Urinary Stones

The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age or older
* Male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal
* Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter

Exclusion Criteria:

* Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis
* History of previous ureteral surgery or ureteral stricture on affected side
* History of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer
* Moderate to severe renal impairment or severe liver insufficiency
* History of significant postural hypotension
* Is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study
* History of allergy to alpha-blockers or oxycodone
Longitudinal Changes of Brain Functional Connectivity in Migraine

The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine.

Migraine is associated with functional alterations in specific brain networks. The investigators aimed to identify network abnormalities which remain unchanged throughout the longitudinal course of migraine. The investigators also aimed to identify networks which change in association with changes in migraine frequency and associated psychiatric conditions. The investigators expect these can serve as neuroimaging biomarkers for diagnosis of migraine brain and monitoring of disease severity.

Eligibility Criteria:
Inclusion Criteria:

Migrainuers :

1. age 18-50 years
2. migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
3. if female, before the onset of menopausal

Controls:

1. age 18-50 years
2. no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta

Exclusion criteria:

1. contraindicated to MRI
2. pregnancy
3. require sedation treatment because of claustrophobia when performing MRI
4. predicted to be unable to write the headache diary due to cognitive decline
5. refuse study procedure
Differences in Coagulation Test Kits

The aim of this study is to assess the effect of Innovin® reagent on laboratory results when compared with the Thromborel® S.

Thromboplastins are the screening tests which are used in the diagnosis of acquired or inherited disorders of the coagulation system but still, alterations between various thromboplastin preparations in the measurements remains a problem.Blood samples are going to drawn from patients receiving and not receiving oral anticoagulant therapy (OAT) during their routine laboratory tests. Samples are subjected to analysis by using Thromborel® S and Innovin® reagents. Mean International Normalized Ratio (INR), prothrombin time and fibrinogen values are going to compared. To further study the importance of this phenomenon the cohort will be divided into three subgroups according to the INR values as Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.

Eligibility Criteria:
Inclusion Criteria:

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria:

Hemolytic and/or lipemic samples were excluded.
An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia

The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18-79 inclusive
* Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
* Fasting, untreated triglyceride (TG) level in the high to very high range
* Provide written informed consent and authorization for protected health information

Exclusion Criteria:

* Pregnancy
* Use of lipid-altering drugs which cannot be stopped
* History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
* Body mass index above 40 kg per square meter
* Allergy or sensitivity to omega-3 fatty acids or to statin drugs
* Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
* Certain muscle, liver, kidney, lung or gastrointestinal conditions
* Certain medications
* Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Low-Cost Handgrip Dynamometer in Healthy Adults

The gold standard device for measuring grip strength is the Jamar® Hydraulic Hand Dynamometer. The Jamar® Hydraulic Hand Dynamometer is a high-priced device. It has an analog reading feature. The Jamar hydraulic hand dynamometer is recommended by the American Association of Hand Therapists and is considered the gold standard because of its high validity and reliability. Due to its cost, the use of this dynamometer is quite limited in certain countries and settings. However, there is a new version, the JAMAR Plus+, which has a digital reading feature. This version is even more expensive. In recent years, the use of less expensive dynamometers for measuring grip strength has become increasingly common in clinical settings and scientific research. In particular, the Camry Dynamometer, which is ten times cheaper, is frequently used. Despite its frequent use in scientific research, a review of the current literature has shown that the validity and reliability of the Camry has not been examined in healthy populations. Our study compares the Jamar® Hydraulic Hand Dynamometer, the gold standard device for measuring grip strength, with the lower cost and lighter handheld digital Camry dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* Healty volunteers with 18-65 years

Exclusion Criteria:

* Using any assistive device,
* Having rheumatoid arthritis, gout, neuromuscular disease or any acute/chronic disease that may affect grip strength,
* Pregnancy,
* Previous subluxation, dislocation or fracture in the upper extremity,
* Type 1 or Type 2 DM,
* Unstable chronic and systemic diseases
Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer

Pilot study using \[18F\]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast cancer. Correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. CT, MRI, Bone Scan, Ultrasound, FDG PET/CT)
* Plan to start new systemic therapy for metastatic disease.
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.
* Inability to tolerate imaging procedure in the opinion of an investigator or treating physician.
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.