cyrilzakka/clinical-trials huggingface dataset:
Developing Advanced MRI Methods for Detecting the Impact of Nutrients on Infant Brain Development

The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.

The purpose is to study the effect of infant nutrition on brain development, as measured using Magnetic Resonance (MR) techniques. The investigators will collect detailed information about the diet of each of the infants, and seek to correlate this information with multiple MR measurements, including structural imaging, diffusion imaging, and functional connectivity. The MR scans will be performed at birth and 3 months of age. Dietary information collected will include detailed food diaries describing the feeding habits of the infants, and food frequency questionnaires to characterize the diet of the mother.

Eligibility Criteria:
Inclusion Criteria:

* full-term babies whose mothers have no known medical conditions or complications during pregnancy.

Exclusion Criteria:

* preterm babies
* babies whose mothers have significant medical conditions and/or significant complications during pregnancy.
Effect of Crossed Legged Position on Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients.

To investigate if sitting in flexed cross legged position for neuraxial techniques in term pregnant patients widens the size of the ultrasound acoustic window as measured by the visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using longitudinal paramedian view, in comparison to the standard sitting flexed position.

This is a prospective observational study involving a total of 30 healthy term gestation pregnant patients with singleton fetuses.Patients will be randomly allocated to sit crossed leg or in standard position first. Using ultrasonography, the acoustic window for lumbar spinal anesthesia at L3-4 will be evaluated in both traditional sitting and crossed leg positions. Ultrasonography will be performed sequentially to measure the best visualized length of posterior longitudinal ligament,ligamentum flavum and interlaminar distance in the paramedian view.The scanned image will be saved to be remeasured by a third observer. Patients will be asked to score their comfort level while sitting in both positions.

Eligibility Criteria:
Inclusion Criteria:

Term gestation Singleton pregnancy 18 years or older Patients having elective cesarean delivery or induction of labor or in early labor

Exclusion Criteria:

* Allergy to ultrasound jelly
* Spinal Deformities/Previous spinal surgery
* No contraindication to neuraxial placement
* Any fetal concerns
* Morbid obesity
* Language barrier
Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following:

1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)


Eligibility Criteria:
Inclusion Criteria:

1. Age 50-85 years
2. Diagnosis of Parkinson's disease
3. Constipation as defined by the Rome III committee
4. BSFS of more or equal to 1 and less or equal to 3
5. Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
6. All women subjects will be post menopausal or surgically sterile.

Exclusion Criteria:

1. Known hypersensitivity reaction to Amitiza ( Lubiprostone)
2. Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
3. Renal dysfunction with creatinine clearance less than 15 ml/min
4. Abnormal liver enzymes or history of chronic liver disorder
5. History of bowel obstruction, , or abdominal adhesions .
6. Abnormal Colonoscopy ( obstructive lesions within the colon)
7. Inability to give informed consent
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)

The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw
* Patients must be experiencing moderate to severe pain following the dental procedure

Exclusion Criteria:

* Previous molar extraction within the past 45 days
* Personal or family history of an inherited bleeding disorder
* Uncontrolled high blood pressure
Action Observation in Knee Replacement

Postoperative rehabilitation is required for a successful outcome following total knee arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.

Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Primary total knee replacement.

Exclusion Criteria:

* bilateral knee replacement
* previous total knee replacement.
* pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);
The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain

Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy applied to articular branches (genicular nerves) in treating knee joint pain.

The knee joint is innervated by articular branches of various nerves (femoral, common peroneal, saphenous, tibial and obturator) (Kennedy et al. 1982; Hirasawa et al. 2000). These articular branches around the knee joint are known as genicular nerves. Several genicular nerves can be easily approached percutaneously under fluoroscopic guidance. In our study, genicular nerves were effectively blocked with local anesthetics under fluoroscopic guidance, leading to a significant reduction in knee pain. Rf neurotomy is based on the theory that cutting the nerve supply to a painful structure may alleviate pain and restore function. we evaluate the efficacy of RF neurotomy in reducing pain and improving function in the elderly with chronic knee OA.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic knee pain (i.e., knee pain of moderate intensity or greater on most or all days for ≥ 3 months)
* patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, evaluated by a radiologist)

Exclusion Criteria:

* acute knee pain
* prior knee surgery
* other connective tissue diseases affecting the knee
* serious neurologic or psychiatric disorders
* injection with steroids or hyaluronic acids during the previous 3 months
* sciatic pain
* anticoagulant medications
* pacemakers
* prior electroacupuncture treatments
Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12

The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental social skills necessary to build and maintain relationships. The manualized curriculum addresses skills such as joint attention, eye contact, play, and peer engagement. Currently individual goals are set for each child who participates and this is documented in the daily treatment note. In order to research group outcomes, the investigators will use parent questionnaires (an addition to current clinical practices) to measure changes in behavior after each 12 week session for up to one year of treatment. The investigators hypothesize that maladaptive behaviors will decrease and adaptive behaviors will increase in children with ASD after participation in the SMART program.


Eligibility Criteria:
Inclusion Criteria:

* Ages 2 to 12.5
* Diagnosis of ASD OR who meet a minimum ASD cutoff score on a screening questionnaire (SCQ or ASQ:SE, depending on age)

Exclusion Criteria:

* Non-English speaking
* Uncorrected vision disorder
* Moderate to severe hearing loss
* Non-ambulatory
* Previous participation in a SMART group
* Accompaniment by aide
* Extreme behavioral disorder
Leaders Free III: BioFreedom™ Clinical Trial

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding

Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or MORE of the following:

1. Adjunctive oral anticoagulation treatment planned to continue after PCI
2. Age ≥ 75 years old
3. Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)
4. Any prior intracerebral bleed
5. Any stroke in the last 12 months
6. Hospital admission for bleeding during the prior 12 months
7. Non skin cancer diagnosed or treated ≤ 3 years
8. Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 12 months)
10. Renal failure defined as: Creatinine clearance \<40 ml/min
11. Thrombocytopenia (PLT \<100,000/mm3)
12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
13. Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

1. Pregnant and breastfeeding women
2. Patients expected not to comply with 1 month DAPT
3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
4. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
5. Active bleeding at the time of inclusion
6. If patient requires a stent \<2.5mm
7. If patient requires a stent \>3.5mm
8. Cardiogenic shock
9. Compliance with long-term single anti-platelet therapy unlikely
10. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated
11. PCI during the previous 12 months for a lesion other than the target lesion
12. Participation in another clinical trial (12 months after index procedure)
13. Patients with a life expectancy of \< 1 year
Thinking Zinc: a Study of Zinc Supplements on the Navajo Nation

This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.

Communities living in proximity to abandoned uranium mines have documented exposures to metals in drinking water, soil and dust. Exposure to these metals, principally uranium and arsenic, and metal mixtures is associated with dysregulation of immune function and other health effects. The objective of this study is to conduct an intervention trial to assess the effect of dietary zinc supplementation to mitigate the toxicity of metal exposures. The current project is part of a larger research effort funded by the NIH Superfund Program to study environmental metals exposures in tribal communities in New Mexico.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between the ages of 21 and 64 years of age
* Lives in or near the participating communities of Blue Gap-Tachee Arizona or Red Water Pond Road Community New Mexico
* Willing to provide blood and urine samples
* Willing to attend study visits on scheduled dates
* Willing to take a daily zinc supplement

Exclusion Criteria:

* Women who are pregnant or nursing or women who plan to become pregnant during the course of the study.
* Individuals who have self-reported diabetes, report that they are undergoing treatment for diabetes, or are currently taking medication for diabetes.
* Known or suspected allergy to zinc.
* Individuals previously diagnosed with syndromes of copper homeostasis (Menkes disease or Wilsons disease).
* Individuals consuming zinc supplements or multivitamins and are unwilling to stop for the duration of the study.
The Interplay Between Inborn Error of Immunity and Blood Disorders: Unravelling Immune Defects Behind Common Haematological Diseases

The universe of Inborn errors of Immunity (IEI) is rapidly expanding: their clinical spectrum is not only characterised by infections but often includes haematological complications. Moreover, an increasing number of "IEI phenocopies" due to somatic mutations in specific cell types are progressively being unveiled and complicate the genetic plot of IEI, which are therefore not only caused by germline mutations. However, these aspects have never been studied by large prospective studies.

This study aims to fill this gap by prospectively recruiting patients \<25 y/o with haematologic disorders that fall into one of the following 4 subgroups: autoimmune cytopenia (AICs), polyclonal lymphoproliferation (PL), monoclonal (malignant) lymphoproliferation (ML), bone marrow failure/myelodysplasia (BMF/MDS). Recruited subjects will undergo an extensive immunologic workup (extended immunophenotyping, cytokine and autoantibody dosage) together with genetic testing (NGS) to detect both germline and somatic variants. Bulk RNA sequencing will be performed either as functional validation of variants or to identify altered pathways in selected cases with inconclusive genetics. Patient advocacy organisations (PAOs) will be pivotal to assist patients' needs throughout the project and to raise awareness of predictive and yet unknown signs of IEI.

The study involves recruitment a total of almost 700 children over a 3-year period. Considering recent studies on AICs and BMF/MDS, a global detection rate of 30% "hidden" IEI is expected, with higher rates in the AIC subgroup and lower ones for ML, given the complexity of lymphoma pathogenesis. New IEI candidate genes or new examples of IEI phenocopies are expected to be identified.

The immunological workup should detect early disease biomarkers or currently unknown molecular signatures of specific disorders. These may increase the chance of identifying an IEI in a specific subgroup and promptly address the patient to a targeted treatment or to hematopoietic stem cell transplantation, avoiding late complications, increasing patients' survival, and abating the economic burden of the disease on healthcare services. Finally, involvement of PAOs may foster patients' knowledge about their condition, increasing their compliance to disease follow-up and treatment and ameliorating their quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age \< 25 years
2. Patients with diagnosed autoimmune cytopenias (AIC), polyclonal lymphoproliferation (PL), lymphoma (ML), bone marrow failure, and myelodysplastic syndrome (BMF/MDS) (see details below)
3. Signed Informed Consent

Exclusion Criteria:

1. Patients with Lymphoma secondary to HIV or transplant
2. Patient with self-resolving or post-infective AICs
Biomarkers for the Early Diagnosis, Prediction, Prognosis for Colorectal Cancers

Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognostics, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. CTCs measures may be useful to guide change in treatment decisions.

Colorectal cancer (CRC) is one of the most frequent malignancies and is also the third major cause of cancer-related death in Taiwan, with over 11,000 new cases of CRC were diagnosed and more than 4,400 Taiwanese died from CRC in 2008 (Department of Health). CRC is regarded as the accumulation of acquired genetic and epigenetic changes causing disorders in cell growth, differentiation and apoptosis resulting in transformation of normal colonic epithelium to colon adenocarcinoma.

Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognosis, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. The investigators divide the current project into three dimensions to include all the biomarkers related to diagnostic, prognostic and predictive roles for the potential clinical implication. Sub-project 1: prognostic validation and economic evaluation of biochips/biomarkers. Sub-project 2: evaluation of biomarkers for tailored therapy. Sub-project 3: identification and validation of novel biomarkers for early detection. After accomplishment of three sub-projects, a comprehensive network including early diagnostic, prognostic and predictive biomarkers/biochips for high-risk screening, postoperative surveillance, therapeutic strategies of CRC patients will be formed.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 y/o
2. Histological / pathologic and image study proved colorectal cancer
3. Patients with adequate tissue for biomarkers analysis
4. Patients voluntary sign informed consent

Exclusion Criteria:

* Patients who are not met with either one of items which mentioned above.
MESNA for Prevention of Acute Deterioration of Renal Function Following Contrast Agent Application

The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy

Contrast-induced nephropathy remains a common complication of radiographic precedures. Pretreatment with Mesna (Sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure.

The aim of this study is therefore to determine laboratory and clinical benefit of MESNA, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic renal insufficiency
* serum creatinine concentration \> 1,5 mg/dl

Exclusion Criteria:

* Dialyzed patients
* patients with acute renal failure
* received iodinated contrast media within 7 days before study entry
* known allery to Mesna, pregnancy, and administration of dopamine, mannitol or N-acetylcysteine
Japanese Pediatric H5N1 Vaccine Study

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese pediatric population aged 6 months to 17 years


Eligibility Criteria:
Inclusion Criteria:

* Participant is 6 months to 17 years old at time of screening.
* Participant is born at full term of pregnancy (≥37 weeks) with a birth weight ≥2 kg (for participants aged 6 to 35 months only).
* Participant is generally healthy, as determined by investigator's clinical judgment through collection of medical history and a physical examination.
* If female of childbearing potential, participant has a negative pregnancy test within 24 hours prior to first scheduled vaccination and agrees to employ adequate birth control measures for study duration.
* Participant and/or their parents/legal guardians is/are willing and able to comply with protocol requirements.

Exclusion Criteria:

* Participant has a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
* Participant is at high risk of contracting H5N1 influenza infection (e.g. contact with poultry).
* Participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder.
* Participant has any inherited or acquired immunodeficiency
* Participant has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to:

  * systemic or inhaled corticosteroids
  * radiation treatment
  * or other immunosuppressive or cytotoxic drugs.
* Participant has a history of severe allergic reactions or anaphylaxis.
* Participant has a rash, dermatological condition or tattoos which may interfere with injection site reaction rating.
* Participant has received a blood transfusion, immunoglobulins or other blood derivatives within 90 days prior to study entry.
* Participant has donated blood or plasma within 30 days prior to study entry.
* Participant has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study.
* Participant has a functional or surgical asplenia.
* Participant has a known or suspected problem with alcohol or drug abuse.
* Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
* Participant is a family member or employee of the investigator.
* Participant is pregnant or lactating at the time of enrollment.
* Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.