cyrilzakka/clinical-trials huggingface dataset:
Prevention of Recurrent Aphthous Stomatitis Using Vitamins

The purpose of this research study is to find out if taking a multivitamin daily can affect the number of canker sores that people get and how long they last. Previous studies have shown that people who get canker sores are more likely to be deficient in one or more vitamins. It has also been found that correction of such vitamin deficiencies reduces the number and duration of canker sores. However, it is not known if taking a multivitamin daily will reduce the number and duration of canker sores.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing and able to provide written informed consent for the study
* Patients with a history of at least three episodes of minor recurrent aphthous stomatitis (RAS) within the past one year

Exclusion Criteria:

* Patients with a history of other forms of RAS (major, herpetiform)
* Patients who will be using any other vitamins/supplements during the study or those who have used any vitamins/supplements on a regular basis during the 90 days immediately preceding enrollment onto the study (regular use is defined as continuous daily use for at least a two week period)
* Patients who are under the age of 18
* Women who are pregnant or nursing or those who plan to become pregnant
* Patients with a history of gout, kidney stones or iron overload disease
* Patients who currently smoke tobacco products
* Patients who are former smokers who have quit smoking within the past 30 days
* Patients with sulfite allergy
* Patients with a history of any systemic condition associated with oral ulceration. These include: Behcet's syndrome, Sweet's syndrome, Celiac disease, Crohn's disease, ulcerative colitis, HIV infection/AIDS, cyclic neutropenia and PFAPA syndrome (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis)
* Patients on medications commonly associated with causing oral ulceration. These include nicorandil, methotrexate and chemotherapeutic agents used for cancer.
* Patients using oral topical anti-inflammatory agents during the course of the study
* Patients who plan to use any products specifically for management of RAS lesions
* Patients who are routinely using agents that could have an impact on duration of RAS lesions (e.g., antibacterial mouthrinses)
* Patients receiving any other investigational agent during the course of ths study
* Patients with any other condition that might preclude participation in the study in the opinion of the study investigators
the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage

The goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease.

The main questions it aims to answer are:

* Evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease
* Evaluate any relationships between chronic rhinosinusitis and the clinical course of intestinal bowel disease -Evaluate the influence of chronic rhinosinusitis on the response to biologic therapies for intestinal bowel disease
* Evaluate mucosal barrier damage in patients with chronic rhinosinusitis and intestinal bowel disease by collecting blood and stool samples according to clinical practice
* Presence of enterotoxin sensitization to S. Aureus in patients with intestinal bowel disease
* Histopathological evaluation: reevaluation of biopsy slides performed according to clinical practice will be performed in patients with chronic rhinosinusitis and intestinal bowel disease in order to quantify the proportion of eosinophilic infiltrate at the intestinal level and to assess any differences from the population with intestinal bowel disease only.

Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled.


Eligibility Criteria:
Eligibility Criteria

Inclusion Criteria:

* Age between 18 years and 70 years.
* Diagnosis of Crohn's disease or Ulcerative Rectocolitis
* Willingness to participate in the study and ability to comply with and understand the study protocol.
* Patients with a previous diagnosis of Crohn's disease or Ulcerative Rectocolitis for at least 3 months prior to screening
* Signature of informed consent

Exclusion Criteria:

* Age \<18 years
* Refusal of informed consent
Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life

Descriptive pharmacoepidemiological study of patients treated with Iressa

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Iressa

Exclusion Criteria:

* Patient included in a therapeutic trial comprising protocol use of Iressa
* Patient included in a therapeutic trial (Huriet-Serusclat Act)
* Patient refusing to participate in the study
The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

The purpose of the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis.

Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions.

The interventions in this trial can be done at home. Openly discussing the intervention groups with all participants prior to randomization thus poses a high risk of tainting the study because subjects in the one group may start doing the other groups exercises after having heard about it during the consent process as a way to potentially reduce the symptoms and severity of painful muscle cramps. Therefore, this study will conceal information regarding the nature of the interventions. Only participants randomized to the true intervention group will be told during the study period what the behavioral intervention is. Additionally, the title of this trial upon registration is listed slightly differently than it is listed with the Institutional Review Board (IRB), to provide scientific integrity with the masking requirements. When the trial is completed, the title will be amended to match the IRB approved title. At the conclusion of the study, at the time of the final follow-up assessments, all participants will be debriefed on the use of the concealment of the study object in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participants have painful muscle spasms, cramps, or charley horses at night in feet or legs.
* Participants have muscle cramps that happen at least four times in the past month. And the muscle cramps bother them.
* For Cirrhosis patients only: diagnosis of cirrhosis based upon:

  1. liver biopsy, or
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or
  3. 2 of the following 4 criteria:
* Ultrasound (US), computerized tomography (CT) or Magnetic resonance imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
* FibroScan liver stiffness score \>13 kilopascal (kPa)
* Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \>2.0
* CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

Exclusion Criteria:

* Non-English speaking
* Unable or unwilling to provide consent
* Pregnancy via self-report
* Disorientation at the time of enrollment
* History of multiple sclerosis
* History of cerebral palsy
* History of stroke with paralysis
A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.

To screen for and identify subjects with potential undiagnosed hypertension using an optical blood pressure monitoring device across an active workforce population in the US (Nucor employees).

100 voluntary Nucor facility employees with no previous diagnosis of hypertension will be recruited and will receive an optical blood pressure monitoring device (Aktiia G1 Device) that is a miniature bracelet placed in the wrist and measure blood pressure continuously without inflating.

Each participant will wear the device continually during 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects aged 25 to 70 years old.
2. People who self-report that they do not have a diagnosis of hypertension.
3. People employed as a Nucor team member.
4. People who can read and speak English.
5. People who use either an iOS or Android smart phone.
6. Subjects who agree to follow study procedures.
7. Subjects who have signed the informed consent form.

Exclusion Criteria:

1. Subjects with a known diagnosis of i. atrial fibrillation ii. congestive heart failure iii. heart valve disease iv. pheochromocytoma v. Raynaud's disease vi. arm lymphedema.
2. Subjects who take insulin.
3. Subjects who are on hemodialysis.
4. Women who are known to be pregnant.
5. Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
6. Subjects who do not have two arms.
7. Subjects with upper arm circumference \< 22cm or \> 42cm.
8. Subjects with wrist circumference \> 23cm.
Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS)

This study will examine whether the Paula method is an effective treatment for UI and the correlating LUTD symptoms. We assume that the Paula method, a simple, non-aerobic exercise method that significantly decreased urinary incontinence in women with MIX in two randomized controlled trials, would also be effective in Multiple Sclerosis (MS) patients with UI. The secondary aim is to evaluate the effectiveness in terms of MS general physical functioning, quality of life and sexual function and to detect adherence and continuity six months post intervention.

The patient will be examined by the neurologist at the MS clinic, at the Hadassah University Medical Center. Patients who meet the inclusion criteria will receive an explanation, and will sign informed consent. She will be asked to complete the baseline questionnaires. Than the patient will be assigned to an exercise group. After 12 weeks the patient will be asked to complete post intervention questionnaire. Apart from the weekly lesson, women will be asked to exercise at home for 15 minutes a day. After six months she will be invited again for a neurological examination and filling an additional questionnaire.

Eligibility Criteria:
Inclusion Criteria:

women ≥18 years old; who have complained of urine leakage in the past four weeks; MS diagnosed with an Expanded Disability Status Scale (EDSS)≤7.5; literate in Hebrew and/or English; suffering from UI at least in the 4 last weeks prior to recruitment

Exclusion Criteria:

pregnant or breastfeeding women, those within 12 weeks of delivery; 6 weeks of abortion; six months of pelvic surgery; symptomatic urinary tract infection (UTI); more than grade 2 genital prolapse, permanent catheterization for urination; women taking medications for UI less then 3 months and women who exercise on regular basis in Paula method.
Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis

Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.


Eligibility Criteria:
Inclusion Criteria:

* seropositive for Toxoplasma gondii (for patient and parents)
* Infection with genotype II (for patient and parents)
* ocular toxoplasmosis recurrences \>5 (patients only)

Exclusion Criteria:

* Parents seronegative for T. gondii infection
* Infection with others genotypes than type II
Gene Therapy for X Linked Severe Combined Immunodeficiency

A safety and efficacy clinical study of a lentiviral vector to transfer IL2RG complementary DNA to bone marrow stem cells in ten children with genetic diagnosed X-SCID（severe combined immune deficiency ）.The ten children will be followed for 3-5 years and be evaluated by clinical characteristics, vector marking (vector copy number per cell) in blood and bone marrow cells, immune reconstitution vector insertion-site patterns and so on.


Eligibility Criteria:
Inclusion Criteria:

1. X-SCID patients diagnosed by IL2RG single gene mutation
2. No HLA（human leukocyte antigen） matching donor
3. Hematopoietic stem cell transplantation failed and the time from transplantation was more than 18 months
4. Severe and persistent refractory infections
5. Life expectancy of \> : 4 months
6. HIV PCR in peripheral blood was negative
7. the children and their families signed informed consent and were willing to enter the clinical trial and complete follow-up

Exclusion Criteria:

1. The patient has diagnosed with hematological malignant diseases
2. Received chemotherapy within 3 months
3. HIV infection or HBV（hepatitis B virus） infection
4. The patient or his first-degree relative has developed a malignant tumor within the age of 18 or has been diagnosed with malignant tumor prone genes
5. Although the patient with X-SCID was diagnosed as IL2RG single gene mutation , the clinical phenotype was not severe, so they could continue to wait for the donor search;
6. Patients whose family members have no intention to continue the follow-up treatment in any link
This Study Aims to Evaluate the Effect of Rinsing Off or Blot-drying Silver Fluoride on the Retention of Subsequently-applied Resin- and Glass Ionomer-based Fissure Sealants in Permanent Molars Affected by Molar-Incisor Hypomineralization.

The aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. 2. To compare the effects of rinsing off the silver fluoride or not rinsing it off (blot-drying with cotton pellet) on sealant retention when the sealant is placed immediately after silver fluoride application, and 3. To measure the desensitizing effect of fissure sealant application following silver fluoride treatment on hypersensitive MIH molars.

Teeth will be randomized in a parallel design based on the application of restoration time (immediate or one week later), sealant material type (resin or glass ionomer), and for immediate applications, the condition of silver fluoride before restoration (dried with cotton or rinsed gently). A total of 216 permanent molars will be included in the study.

Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:

Eligibility Criteria:
Inclusion Criteria:

* Patients and their parents who consent to participate and have signed the informed consent form.
* Patients with at least one permanent molar diagnosed with molar incisor hypomineralization based on EAPD guidelines.
* Fully erupted teeth with ICDAS I or II lesions that necessitate the application of fissure sealants.
* Teeth displaying demarcated opacities on the occlusal surface and at least one additional surface.

Exclusion Criteria:

* Teeth that have existing restorations or cavities.
* Patients currently receiving orthodontic treatment.
* Patients who are uncooperative during dental procedures.
* Teeth affected by dental fluorosis or enamel defects associated with specific syndromes.
* Children with systemic conditions requiring ongoing medication.
"AIDA" Protocol (LAP 0493)

The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 12 months (1 year) and \< 75 years
* Morphological newly diagnosis of APL
* Presence of the PML-RARa transcript
* No cardiac contraindications to anthracycline chemotherapy
* Serum creatinine \<=2.5 mg/dL
* Serum alkaline phosphatase \<= 3 times the normal upper limit
* Serum bilirubin \<= 3 times the normal upper limit
* Serum SGOT \<= 3 times the upper normal limit
* Negative pregnancy test
* Informed consent

Exclusion Criteria:

* Age \<= 12 months and \>=75 years
* absence of the PML-RARa transcript
* Pregnant of lactating women
* Presence of active serious infections that are not controlled by antibiotics
* Prior treatment with antileukemic therapy (excluded corticosteroids)
* Presence of severe concomitant psychiatric disease
* Presence of other concomitant malignant tumors, except basal cell carcinoma
* Concurrent treatment with cytotoxic chemotherapy or radiotherapy
* Cardiac contraindications to anthracycline chemotherapy
* Serum creatinine \>2.5 mg/dL
* Serum alkaline phosphatase \> 3 times the normal upper limit
* Serum bilirubin \> 3 times the normal upper limit
* Serum SGOT \> 3 times the upper normal limit
* Positive pregnancy test
* Absence of informed consent
High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.

This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:

* To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
* To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
* To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
* To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.

Eligibility Criteria:
Inclusion Criteria

* Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
* Postmenopausal status
* Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry
* Completed systemic chemotherapy and radiation treatments when indicated
* Serum Calcium ≤ 10.3 mg/dL
* Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group
* 24-hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine)
* A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy

Exclusion Criteria

* Known metastatic disease
* History of kidney stones
* History of active primary hyperparathyroidism
* History of Paget's disease of the bone
* History of severe arthritis, rheumatoid arthritis, or severe neuropathy
* Normal 25 OH Vitamin D level (≥ 30 ng/ml)
* Medical or psychiatric condition which may preclude protocol compliance
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Infants 13-59 months of age.

Exclusion Criteria:

* Prior Hib vaccine administration.
* History of serious reaction(s) following vaccination.
* Any vaccination within 7 days of study vaccination.
* Known or suspected immune impairment.
* Premature (before 37th week of gestation) or birth weight less than 2500g
* For additional entry criteria please refer to the protocol.
Bupropion Treatment for Youth Smoking Cessation

The purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion SR (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in adolescents and 2) to examine which factors, such as medication adherence, nicotine dependence, and motivation to quit, affect treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* 14 to 17 years of age
* Smoked at least 6 cigarettes per day
* Exhaled CO greater than or equal to 10 ppm
* Made at least two previous quit attempts
* Weighed at least 90 pounds
* Able to read English at least the 6th grade level
* Motivated to quit smoking as evidenced by willingness to commit to study protocol requirements for the duration of the study
* provided active parental consent and youth assent

Exclusion Criteria:

* Current use of tobacco products other than cigarettes, unless willing to abstain from these products for the study duration
* Current use of other treatments for smoking cessation
* History or current diagnosis of panic disorder, psychosis, bipolar disorder, or eating disorder
* History of abuse or dependence on alcohol or other recreational or prescription drugs in the three months preceding the study
* Current evidence of clinical depression or Attention Deficit/Hyperactivity Disorder
* Use of any psychoactive drug and/or any type of antidepressant with in four weeks of the treatment phase of the study
* Predisposition to seizure or tic disorders or a personal history of a seizure disorder, family history of seizure disorders, or treatment with medication or therapies that increase the risk of seizures
* Significant history of or current clinical evidence of cardiovascular disease
* (Females)Pregnancy (urine pregnancy test), lactation or, if sexually active, unwillingness to use a medically acceptable form of contraception for the duration of the study
* Only one member of a household was allowed to participate in the study concurrently.
Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry

Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of the efficacy and safety of swallowing, determination of appropriate feeding strategies and assessment of the efficacy of different swallowing manoeuvres. The literature furthermore indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at evaluating findings and side effects of FEES in a heterogeneous collective of patients with neurogenic dysphagia.


Eligibility Criteria:
Inclusion criteria:

* suspected neurogenic dysphagia
* Patients being scheduled for a FEES
* written informed consent

Exclusion criteria:

- none