cyrilzakka/clinical-trials huggingface dataset:
Characteristics of Mast Cells in Mastocytosis

This study will determine what growth factors are involved in promoting and inhibiting mastocytosis-an abnormal increase of mast cells in one or more organ systems. Mast cells release chemicals that can cause itching, blisters, flushing, bone pain, and abdominal pain. Little is known about the disease and there is no cure. Steroids and antihistamines can help reduce some symptoms.

Patients from birth to 80 years of age with increased mast cells in at least one organ system may be eligible for this 3-year study. Family members may also be enrolled for genetic testing.

Patients will be evaluated yearly at the NIH Clinical Center with the following tests and procedures:

* Medical history and physical examination.
* Blood samples.
* Laboratory blood tests, as medically indicated.
* Bone marrow aspiration and biopsy - For the bone marrow aspiration and biopsy, the back hipbone is punctured with a sterile needle. Five milliliters (1 teaspoon) of marrow is withdrawn through a syringe and a 1/2-inch piece of tissue is extracted with a special needle.

The blood and bone marrow samples will be used for clinical care and for research to determine if mastocytosis is due to mast cell growth factors or genetic changes.

Patients who require further evaluation and tests will have recommendations made to their primary physician. Any patient who requires immediate treatment will be admitted to the hospital. Standard medical treatment may include antihistamines for itching; steroids for severe abdominal symptoms such as cramping, diarrhea, and evidence of increased mast cells determined by an upper GI study; and adrenaline for anaphylactic shock. Patients who do not respond to conventional treatment may be offered participation in an experimental therapy study.

Participating family members will have a medical history and a blood sample drawn to look for genetic abnormalities.

This protocol is designed to examine those growth potentiating and inhibiting factors which regulate mast cell number in patients with mastocytosis, and to explore the molecular basis of the disease process in hopes of improving therapy. Patients entered into the study are seen initially and may elect to be reevaluated yearly. The majority of patients to be entered into this protocol are currently followed at NIH on other protocols. Medical workup and treatment are in accordance with standard medical practice. The protocol is for 3 years, to be extended as facilities, faculty, and patients permit.

Eligibility Criteria:
Subjects include children and adults from birth to 80 years of age.

Participants must have histologic evidence of an increased mast cell number in at least one organ system.

Must be willing to be seen at the NIH according to protocol guidelines.

Routine medical care must be available through their referral physician.

Patients with mastocytosis now followed at the NIH on protocol 88-I-0190 will be continued on this study.
Effects of the Intensity and the Timing of the Physical Activity in a Primary School

1. In natural environment, the moderate-intensity break will allow a reduction of the caloric intake at the dinner more important than for the light-intensity break
2. In natural environment, the break taken juste before dinner will allow a reduction of the caloric intake at the diner more important than earlier in the day.


Eligibility Criteria:
Inclusion Criteria:

* Children aged of approximately 5 years old of a of a nursery class of the school Jacques-Barclay, St-Mathieu

Exclusion Criteria:

* Present allergy of the foods in the lunch
* having a handicap or a limitation that avoid walking, running or tkaing part of the physcial activity courses at the school.
* Having a potential surgery
* Having a metabolic disease or taking drugs that could have an impact on the results of the study
* Be vegetarian
* Having intestinal disorders
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

The objective of the study is to collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 18 and older
2. Subject is willing and able to provide written consent before any study-specific test or procedure is performed and agrees to attend all follow-up visits
3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant during the course of the study
2. Life expectancy of less than 1 year (which is defined as documented life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical follow-up, limit the subject's compliance with the standard of care follow-up, or impact the scientific integrity of the trial)
3. Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed)
4. Subject enrolled in an investigational study that has not reached primary endpoint at the time of enrollment or that clinically interferes with the current study assessments (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.

This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven rectal adenocarcinoma.
2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.
3. Resectable tumor, or considered as potentially resectable after CRT.
4. No distant metastases.
5. Patient eligible for surgery
6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.
7. No heart failure or coronary heart disease symptoms (even controlled).
8. No peripheral neuropathy \> grade 1.
9. No prior radiotherapy of the pelvis for any reason and no previous CT
10. No major comorbidity that may preclude the delivery of treatment
11. Adequate contraception in fertile patients.
12. Adequate hematologic function.

13 Adequate hepatic function.

14. Signed written informed consent.

Exclusion Criteria:

1. Metastatic disease
2. Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1
3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
4. Medical history of angina pectoris or myocardial infarction
5. Other concomitant cancer.
6. Pregnant or breast-feeding woman.
7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Determine efficacy of sub tenon kenalog injections for post-operative management of trabeculectomy procedures.

Postoperative sub-Tenon Triamcinolone Acetonide in glaucoma filtering surgery

Objectives: Trabeculectomy is a surgical procedure designed to reduce internal eye pressure by draining fluid from within the eye to the sub-conjunctival (superficial eye lining) space. Scar formation from conjunctival and Tenon's capsule fibroblast proliferation represents the most common cause of failure of trabeculectomies. A number of drugs have been use to prevent failure of trabeculectomies from the scarring process including intraoperative mitomycin C (MMC) and preoperative Triamcinalone Acetonide (TA). Over the past several years, intraoperative MMC has become a preferred method of preventing scar formation. This study looks to determine in a prospective, double-blind, randomized method the long-term efficacy and safety of MMC with postoperative TA compared to the standard practice of intraoperative MMC with postoperative prednisolone acetate drops in preventing scar related failures of trabeculectomies.

Eligibility Criteria:
Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied
Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female Patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening
* Baseline FEV1 of 60% to \>100% of predicted
* Demonstrate a decrease in FEV1 of 15% or greater from baseline after standardized stepped exercise challenge testing
* Taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:

  1. fluticasone, 88 - 440 mcg/d via MDI or 100 to 500 mcg/d via DPI
  2. beclomethasone HFA 80 to 480 mcg/day
  3. budesonide DPI 180 to 1200 mcg/ d
  4. flunisolide 500 to 2000 mcg/d
  5. flunisolide HFA 320 to 640 mcg/d
  6. mometasone 200 to 800 mcg/d
  7. triamcinolone acetonide 300 to 1500 mcg/ d

Exclusion Criteria:

* Patients already on LABAs, systemic corticosteroids, or other combination inhaled steroids/LABA medications.
* Patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.
* Patients who are pregnant or plan to become pregnant during the study period.
* Patients with a history of hypersensitivity reaction to either formoterol or budesonide.
* Patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
* Patients with planned hospitalization during the study
* Current Smokers or those with a history of 10 pack years of tobacco use or more.
Trial of Liposomal Doxorubicin (Doxil) and Weekly Docetaxel (Taxotere)

This study is for patients with advanced cancer that has failed treatment with conventional therapy or for which no standard treatment exists. The purpose of this study is to determine the highest dose that can be given of 2 chemotherapy drugs, docetaxel (also called Taxotere) and liposomal doxorubicin (also called Doxil), when given together and to determine the side effects of this combination. Both Taxotere and Doxil are chemotherapy drugs that can decrease the size of several different tumors. Taxotere is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancers, and Doxil is approved for the treatment of ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological proof of advanced or recurrent solid tumor which has failed prior therapy, or for which no effective therapy is available.
* Ovarian cancer patients (or primary peritoneal carcinoma) whose only manifestation of disease is an elevated cancer antigen (CA) 125 of \> 100 are eligible.
* SWOG performance status 0-2.
* Absolute granulocyte count (AGC) greater than or equal to 1.5; platelets greater than or equal to 100,000.
* Total bilirubin less than or equal to the upper limit of normal (ULN).
* Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is \<= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are \<= ULN. However, patients who have both transaminase elevation \> 1.5 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity).
* Age greater than or equal to 18 years.
* Fully recovered from acute toxicities from chemotherapy, radiation, or surgery.
* Negative serum pregnancy test, if patient is female, still fertile, and sexually active.

Exclusion Criteria:

* Prior treatment with Doxil or weekly docetaxel. Prior docetaxel administered every 3 weeks is allowed.
* Evidence of moderate peripheral neuropathy greater than or equal to grade 2.
* Medical, social, or psychological factors interfering with compliance.
* Known history of cardiac disease (congestive heart failure, coronary artery disease) that would preclude treatment with Doxil in the opinion of the investigator.
* Cardiac ejection fraction \< 50%
* Pregnancy
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ADHD only or ADHD and Dyslexia
* At least 10 years old and no more than 16 years old
* IQ score of 80 or more
* Must be able to swallow capsules

Exclusion Criteria:

* Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Weigh less than 25 kg or greater than 70 kg
* Pregnant or breast feeding
* Documented history of bipolar I or II disorder, or psychosis
* Documented history of autism, Asperger's syndrome or pervasive developmental disorder
Sleep Deprivation's Regulation of Immune System Function and Behavior

The study proposes to investigate whether sleep deprivation will affect a variety of measures, including hormones, immune system functioning, and behaviors related to food intake and hunger. It is predicted that sleep deprivation will affect circulating neutrophil activity, and do so via affects on DNA methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. Finally, it is predicted that sleep deprivation will increase participants' tendencies to pick larger portions of food, and also increase their tendency to purchase foods that are more caloric in a mock supermarket scenario.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-35y
* Healthy (self-reported) and not on medication
* Non-smoking
* Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported)

Exclusion Criteria:

* Major illness
* Taking any serious medications
* Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
* Any dietary issues with the food items provided
* A history of endocrine or psychiatric disorders
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.

This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).

Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

Eligibility Criteria:
Inclusion Criteria:

* At least 15 years of age at time of enrollment
* Ability to provide written informed consent

Exclusion Criteria:

* Currently menstruating or bleeding
* Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days
Heavy Bupivacaine in Peribulbar Block

Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.

Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.

However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.

Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiology (ASA) I or II.
* 30-80 years old
* Patients scheduled for elective unilateral posterior segment surgeries.

Exclusion Criteria:

* Patient's refusal.
* orbital deformity
* axial length( \>28 mm )
* increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) \> 1.5
* allergy to local anesthetics, mentally retarded patients
Repair of Proximal Restoration Resin Bulk Fill. Clinical Trial

Bulk Fill" (RBF) composite resins (RC) has been on the market, with the main advantage of being applied in a single layer, faster and easier than a conventional RC. Repair of RC restorations is a validated treatment option in dentistry, which has been shown to increase the longevity of restorations by minimizing tooth damage such as complete replacement. Currently there are no clinical studies that support the actual performance of RBF repair

Main objective: Compare the clinical performance with FDI of repairs proximal RC restorations between a conventional resin and a RBF in a period of 24 months. Hypothesis: There is not different clinical performance of proximal RC repairs done with RBF when compared to conventional RC repairs. Material and method: 80 volunteer patients will be randomly recruited to attend the clinic of the Faculty of Dentistry of the University of Chile who have two proximal RC restorations with indication of repair according to the FDI system (n per group = 80). Each patient must accept and sign an informed consent. The repairs will be randomly divided into two groups on the same patient. Control Group: Conventional RC repair (Z350 XT). Experimental Group: RBF (Tetric Evoceram Bulk Fill) Repair. For the restorative technique, a three-step adhesive with acid-etched enamel-dentin will be used. It will be evaluated at 2 weeks (Baseline), at 6, 12, 18, 24 months by two blind and calibrated evaluators (Cohen Kappa\> 0.8). The data will be analyzed with the SSPS 21.0 software and the Friedman, Wilcoxon and Mann Whitney tests will be applied with a significance level of 95%.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years,
* healthy
* high cariogenic risk,
* Vital molars and premolars,
* Natural antagonist and proximal
* Indication of repair in the proximal with depth\> 2mm.

Exclusion Criteria:

* Patients has xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients -inability to perform hygiene
* pregnant women
* severe bruxism
* Prosthesis
* Not absolute isolation
* Tooth fracture and / or restoration.
Cleavage Pattern of Embryos and Oxidative Parameters

To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF for the treatment of infertility

Exclusion Criteria:

* Age \<18 or \>45 years old
* Patients with no embryos with direct cleavage