cyrilzakka/clinical-trials huggingface dataset:
Radiographic Evaluation of Adaptation of Universal Adhesives

Class 2 restorations are analyzed to see whether or not the use of modified universal adhesive will result in similar adaptation to conventional universal adhesive.

The newly modified adhesive with its careful formulation offers:

Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment. Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure. Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics. Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle. A bisphenol A (BPA) derivative-free formulation to alleviate concerns about BPA in dental materials. A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications.

As with any new material or technique, clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. Therefore, the aim of the current study was to evaluate adaptation of class 2 restorations either using radio-opaque universal adhesive or universal adhesive using digital radiography.

Eligibility Criteria:
Inclusion Criteria:

* Small to moderate carious proximal lesions. (International caries detection and assessment system (ICDAS) scores 3,4)
* Good oral hygiene (mild to moderate plaque accumulation)
* Vital teeth with no signs of irreversible pulpitis.
* Presence of favorable occlusion and normal contact with adjacent teeth.

Exclusion Criteria:

* Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates.
* Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia.
* Evidence of parafunctional habits and tempromandibular joint disorders.
* Deep carious defects (close to pulp, less than 1 mm distance).
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Endodontically treated teeth.
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Severe periodontal affection.
Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

Eligibility Criteria:
Inclusion Criteria:

* Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator
* Serious adverse event related to study medication in study A1281134
* Significant prolongation of QT interval in study A1281134
Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects

Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper structures as well as the skin. Whether this is one combined pain syndrome, where for instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical stimulation in deeper tissues in the groin and recording the skin sensory function, this hypothesis will be tested


Eligibility Criteria:
Inclusion Criteria:

* male, age \>18 yr, pain-free, caucasian

Exclusion Criteria:

* previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.
EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME

These will be no effect of transcutaneous electrical acupoint stimulation on premenstrual syndrome Does transcutaneous electrical acupoint stimulation affect premenstrual syndrome (PMS)?

Premenstrual syndrome is a collection of emotional, physiological, and behavioral symptoms that develop around the end of the luteal phase and fade away with or after menstruation Due to limited evidence on the efficacy of sustained progesterone and the side effects of antidepressant and anxiolytics, in some cases, alternative therapies are recommended for patients with PMS TEAS may be more effective than other forms of transcutaneous electrical nerve stimulation (TENS) in modulating brain activity because acupoint areas contain relatively denser neural and neuroactive components than non-acupoint areas TEAS has been reported to have similar efficacy as acupuncture, electrical acupuncture, and TENS

Eligibility Criteria:
Inclusion Criteria:

* Their age will range from 18 to 25 years.
* The regularity of menstrual cycle is 28-35 days.
* All of them suffering from moderate and sever PMS.
* All participants are virgin.
* Their BMI will range from 25-30 kg\\m2.

Exclusion Criteria:

* Any pathological findings in the pelvic cavity as PCO, Endometriosis and pelvic inflammatory disease.
* Any history of gynecological intervention.
* Have any condition impedes the use of electrotherapy.
* Receiving sedatives or any medical treatment.
* Having irregular menstruation.
J-Valve Compassionate Use

J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA

The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis

We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis by changing the immune parameters and the psychological impact factors are associated with ear acupressure treatment outcome.

The purpose of the study is to investigate the clinical potential of ear acupressure in treating seasonal allergic rhinitis. We hypothesize that ear acupressure will be effective in treating seasonal allergic rhinitis by changing the immune parameters and the psychological impact factors such as expectation, stress, depression, and anxiety can moderate the ear acupressure treatment effectiveness in allergic rhinitis by influencing the immune parameters.

Eligibility Criteria:
Inclusion Criteria:

* Seasonal allergic rhinitis was diagnosed both by history and clinical examination and by the presence at positive skin prick tests
* All participants need to have at least 2 years of seasonal allergic rhinitis symptoms and a positive skin prick test to one or more pollen allergens

Exclusion Criteria:

* use of systemic corticosteroids within past 3 months period,
* active asthma,
* hearing aid usage,
* history of adhesive tape allergy,
* history of metal allergy,
* HIV,
* hepatitis B or C,
* history of hematologic, autoimmune, or malignant disease,
* pregnancy or lactation,
* ear acupressure (EAP) or acupuncture for respiratory disease within the last 6 months
Drug-drug Interaction Study

This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.

This was a multi-center, international, open-label, two-period, fixed-sequence crossover study to evaluate the safety and pharmacokinetic effect of single ascending doses of duvoglustat on rhGAA administered 1 hour before initiation of a single rhGAA infusion. During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, diagnosed with Pompe disease and between 18 and 65 years of age, inclusive
* Participant has been on a stable regimen and dose of rhGAA for at least 3 months before screening (stable regimen defined as currently receiving rhGAA every 2 weeks and stable dose defined as not varying by more than ± 10%)
* Participant has an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min at Screening; eGFR to be estimated using the 4-parameter Modification of Diet in Renal Disease (MDRD) equation:

eGFR (mL/min/1.73 m\^2) = 175 x (Scr)\^(-1.154) x (Age)\^(-0.203) x (0.742 if female) x (1.212 if African-American)

* Male and female participants of childbearing potential agree to use medically accepted methods of contraception during the study and for 30 days after study completion
* Participant is willing and able to provide written informed consent and is able to comply with all study procedures

Exclusion Criteria:

* Participant has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before Screening
* Participant has clinically significant unstable cardiac disease (for example, cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV congestive heart failure)
* Participant requiring mechanical ventilation or is confined to a wheelchair
* Participant has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (for example, miglustat, miglitol)
* Participant is pregnant or breastfeeding
* Participant tests positive for hepatitis B surface antigen or hepatitis C antibody
* Participant has received any investigational/experimental drug or device within 30 days of Screening
* Participant has any intercurrent illness or condition that may preclude the participant from fulfilling the protocol requirements or suggests to the investigator that the potential participant may have an unacceptable risk by participating in this study
Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.

This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
* Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors

Exclusion Criteria:

* Direct surgery after hospitalization
* Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
* Initial treatment involving other comprehensive therapeutic regimens
Characterization of the Interruptions of the GAA Expansion and Study of Their Influence on the Severity of Friedreich's Ataxia

Friedreich's ataxia (FA) is the most frequent recessive genetic ataxia with an estimated prevalence of 1/50 000. The first symptoms appear around the age of 10 years with a progressive course and the need for an armchair 10- 15 years after the first symptoms. More rarely the disease can present with a late onset (after the age of 25) with a picture characterized by spastic paraparesis and slower progression ("LOFA" for "Late Onset Friedreich Ataxia" or VLOFA for "Very Late Appearance of Friedreich's ataxia ").

AF is caused in 96% of cases by an expansion of GAAN triplets (N\> 100 repeats) located in intron 1 of the FXN gene, present on the two alleles, and, in the rest of the cases, by an associated expansion a point mutation or a deletion in trans. During molecular diagnostics, it is not uncommon to find the presence of interruptions within the GAA expansion. This results in the absence and / or the shift of peak (s) within the chromatogram.

To date, only the partial correlation between the size of the expansion and the age of onset of Friedreich's ataxia has been established. In particular, very atypical forms of AF with a late onset (after the age of 25) are in particular explained by the low number of repetitions in the expansion, typically between 100 and 500 repetitions. However, the presence of an interruption could stabilize the size of the expansion and, therefore, be mainly associated with expansions of small sizes and therefore with a late onset of the disease.

The objective of this study is therefore to analyse and caracterize the presence and the type of interruptions of the GAA expansions in a group of patients with FA ; this data will be correlated with the age at onset of FA.


Eligibility Criteria:
Inclusion criteria:

* Subjects with diagnosis of genetically confirmed Friedreich's Ataxia (AF) and :
* two expansions of GAAN triplets (\> 100 repetitions or "premutation", corresponding to\> 32 but \<100 repetitions) located in intron 1 of the FXN gene present on the two alleles;
* symptomatic (SARA scale\> 4);
* having signed a consent for the performance of genetic analyzes which also includes the authorization for the conduct of further studies for research purposes and the authorization for the collection, entry and computer processing of medical data, in all confidentiality. A newsletter on the principle of non-opposition will be sent.

Exclusion criteria:

* Patients with Friedreich's ataxia due to an expansion associated with a point mutation or a deletion in trans;
* Patients who, at the time of signing the genetic consent, objected to the use of their data for research purposes.
Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth

To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity.

The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.

Eligibility Criteria:
Inclusion Criteria:

* Absence of active carious lesions;
* Never undergone bleaching therapy;
* Good oral hygiene;
* Do not present hypersensitivity;
* Do not smoke;
* Not being pregnant;
* Presence of at least 28 teeth in oral cavity.

Exclusion Criteria:

* Presence of periodontal disease;
* Presence of cracks or fractures;
* Presence of restorations and prostheses;
* Presence of gastroesophageal dysfunction;
* Patients with severe internal dental dimming;
* Presence of periodontal disease;
* Presence of dentin exposure in anterior and/or posterior teeth.
Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center

The purpose of this study is to determine if an I-gel laryngeal mask airway (LMA) has a higher oropharyngeal leak pressure compared to an Ambu Auragain in adult patients in an ambulatory surgery center.

Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.

Eligibility Criteria:
Inclusion Criteria:

- undergoing outpatient ambulatory surgery under general anesthesia that is amenable to using a laryngeal mask airway

Exclusion Criteria:

* non-English speaking patients
* patients with abnormal airway anatomy
A Study of NBL-012 in Healthy Chinese Subjects

This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to healthy Chinese subjects.

This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics of NBL-012 administered subcutaneously as single ascending doses (SAD) to healthy Chinese subjects. Six dose cohorts will be intended for enrollment. The first dose will be sentinel group which will consist of 2 subjects, both of whom will receive active NBL-012. For subsequent dose cohorts, subjects will be given a single escalating SC dose of NBL-01

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive) at screening.
2. Body Mass Index (BMI) of 18 to 26 kg/m2 (inclusive), body weight for male ≥50 kg and for female≥45 kg.
3. Good general health defined as no clinically significant abnormalities identified by a detailed medical history (thoracic and abdominal examination, nervous and mental system examination, etc.), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG,

Exclusion Criteria:

1. Participated in any drug or medical device clinical trial within 3 months before screening
2. Pregnant or nursing (lactating) women who have a positive blood/urine pregnancy test.
3. Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until the end of study visit (more than 15 weeks after drug administration), or subjects with a plan to give birth wi
The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients

This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 35 kg/m2
* Essential hypertension
* eGFR \> 15 ml/min/1,73m2
* Albumine-to-creatinine-ratio \< 500 mg/g
* Safe anticonception if women in childbearing age.
* Able to adhere to dietary regimen

Exclusion Criteria:

* Secondary hypertension
* Clinically significant heart failure (NYHA 3-4)
* Clinically significant liver disease
* Diabetes mellitus (type 1 and 2)
* Active cancer (except skin cancer)
* Renal transplant
* Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
* Proliferative glomerulonephritis or ANCA-related disease
* Continuous immunosuppressant treatment
* Pregnancy or lactation
* Alcohol abuse
* If the investigator finds the participant unfit to complete the project
Propanolol and Red Cell Adhesion Non-asthmatic Children Sickle Cell Disease

Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose of this pilot study is to administer one dose of propanolol to children with sickle cell disease and to measure pre and post dose red cell adhesion. The hypothesis is that a single dose of propanolol will decrease red cell adhesion to laminin and endothelial cells as compared to baseline.

A similar pilot study has already been conducted in adults and is now being tried in children to gather preliminary data for a grant submission. No safety issues were found in the adult pilot study. This study will evaluate the effect of different doses of propanolol. The risks of this study involve the risks of three (3) blood draws and the risks of propanolol. In order to minimize the risks children with sickle cell disease and asthma will be excluded because asthma is a contraindication to the use of propanolol. In addition, patients will not be hypertensive or bradycardic.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of HbSS or HbSBeta0Thal
2. age 10-17 years
3. Weight 30kg or greater
4. Hb 7mg/dL or greater
5. informed consent

Exclusion Criteria:

1. History of vaso-occlusive crisis during the past 6 weeks, or history of transfusion during the past 3 months.
2. pregnancy
3. history of heart failure, myocardial infarction, asthma, bradyarrythmias, hypotension, thyroid disease, diabetes, renal insufficiency
4. concurrent medications: any antihypertensive medication, diuretics, thyroid replacement medications, any arrythmia medication, insulin, hypoglycaemic medication
5. history of allergy to sulfonamides
6. elevated BUN or creatinine
Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Has adenocarcinoma of the colon or rectum
3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
4. ECOG performance status of 0 or 1
5. Is able to take medications orally
6. Has adequate organ function (bone marrow, kidney and liver)
7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Certain serious illnesses or medical condition(s)
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Is a pregnant or lactating female