cyrilzakka/clinical-trials huggingface dataset:
Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation

Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.

Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.

Purpose To demonstrate the noninferiority of a 1-clip strategy vs. a 2-clip strategy of MitraClip implantation, when the second clip in the 2-clip study arm is implanted for stabilizing/supporting purposes.

Eligibility Criteria:
Inclusion Criteria:

* Absence of a structural abnormality of the mitral valve giving rise to MR.
* MR severity of US grade 3+ or 4+ of central or noncentral origin
* Patient must consent to randomization in the hybrid operating theater upon successful implantation of a single MitraClip. Written informed consent must be provided prior to the MitraClip procedure.

Exclusion Criteria:

* patients with primary regurgitation
GCF Levels of IL-1Beta, MIP-1 Alfa and G-CSF in Gingivitis and Stage I-II-III-IV Periodontitis Patients

Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gum along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta, MIP-1alfa and G-CSF are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta, MIP-1alfa, G-CSF cytokines in the gum groove fluid of periodontal healthy and diseased individuals.

Plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were used After clinical evaluation, individuals were divided into 6 groups Healthy control groups, gingivitis groups, Stage I groups, Stage II groups, Stage III groups and Stage IV groups GCF samples were collected after clinical periodontal measurement. GCF was obtained using strips of filter paper Kolmogorov-Smirnov and Shapiro Wilk's tests used

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of periodontal diseases
* Individuals must have 16 permanent teeth in their mouth

Exclusion Criteria:

* Diabetes
* İmmunological diseases
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.

Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.

Patients presenting between 24-34 weeks gestation diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.

Eligibility Criteria:
Inclusion Criteria:

* Singleton and twin gestations
* Intact amniotic membranes
* No contra-indications to tocolysis
* 24-34 weeks gestation by last menstrual period and/or ultrasound
* Documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement

Exclusion Criteria:

* Ruptured amniotic membranes
* Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness)
* Non-reassuring fetal heart rate tracings
* Contra-indications to indomethacin or nifedipine
* Contra-indications to tocolysis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis

The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiogram (PTC)) within the previous 12 months
* Serum alkaline phosphatase (ALP) \> 1.67 x upper limit of the normal range (ULN)
* For individuals on ursodeoxycholic acid (UDCA), the dose of UDCA must have been stable for at least 12 months prior to screening through the end of treatment. For individuals not on UDCA, no UDCA use for at least 12 months before screening through the end of treatment
* For individuals being administered biologic treatments (eg, antitumor necrosis factor (TNF) or anti-integrin monoclonal antibodies), immunosuppressants or systemic corticosteroids, the dose must have been stable at least 3 months prior to screening and anticipated to remain stable throughout the trial
* Screening FibroSURE/FibroTest® \<0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin.

Key Exclusion Criteria:

* Alanine aminotransferase (ALT) \> 10 x ULN
* Total bilirubin \> 2 x ULN
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography)
* Other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions. Individuals with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy;
* Ascending cholangitis within 60 days of screening
* Presence of a percutaneous drain or bile duct stent
* Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
* Cirrhosis of the liver as defined by any of the following:

  * Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
  * Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
  * Liver stiffness \> 14.4 kilopascal (kPa) by FibroScan
* Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of \> 1 and/or a score on the Rectal Bleeding domain \> 0.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of the Antihistamine Injection to Prevent Paradoxical Reaction During Sedative Endoscopy

This single-blind prospective study is aimed to investigate the effect of antihistamine as an adjunctive sedative for the patients with histories of severe paradoxical reaction to midazolam during sedative endoscopy. Participating patients are to receive antihistamine intravenously in addition to midazolam. The primary outcome is the reduction of paradoxical reaction in the antihistamine combination group. The secondary outcome is to compare sedation quality, performance quality, reduction of total midazolam dose will be analyzed between antihistamine combination and midazolam only group.

The present study will be conducted at Seoul National University Hospital Gangnam center between May 2019 and April 2020. Participants who have histories of paradoxical reaction to sedative endoscopy in medical record gave consent on the day of the endoscopy and were assigned to receive the combination of chlorpheniramine (4-6mg) with midazolam(1-10mg) Meanwhile, the patients do not want the use of chlorpheniramine and were assigned to midazolam alone as routine clinical practice. Research medication (chlorpheniramine) was administered 2 to 3 minutes before the administration of midazolam outside of endoscopy room. The blinded endoscopist and assistant nurse are going to perform induction for moderate sedation using incremental doses of the intravenous midazolam (1-2 mg) given every 2 minutes. The endoscopists and assistant nurses will assess the occurrence of severe paradoxical reaction (Grade 3) and other major quality outcomes (procedure/intubation time, sedation quality, completeness of procedure \[10 Key image documentation\], the satisfaction of procedure, side effects). The endoscopists and nurses will individually rate outcome measure using a 5-point Likert scale.

Eligibility Criteria:
Inclusion Criteria:

* Previous histories of the paradoxical reaction during a sedative endoscopic examination

Exclusion Criteria:

* inability to execute informed consent
* allergic to antihistamine agent
* pregnancy
* severe cardiopulmonary disease
* prior administration of antihistamine on the same day
Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT

This is a prospective study to investigate the biomarkers in predicting treatment outcome and toxicity in hepatocellular carcinoma (HCC) patients receiving immune checkpoint inhibitors with or without stereotactic body radiotherapy (SBRT).


Eligibility Criteria:
Inclusion Criteria:

First Cohort (SBRT+IO):

1. Unresectable HCC confirmed by multi-disciplinary team
2. Tumor size 5-15cm
3. Number of lesion(s) ≤ 3
4. No main portal vein or inferior vena cava thrombosis
5. ECOG performance status 0-1
6. Child-Pugh class A-B7
7. Liver volume minus gross tumor volume \> 700ml
8. Adequate organ function
9. No prior systemic therapy, immunotherapy, TACE, radiotherapy, or radio-embolization

Second Cohort (IO alone):

1. BCLC stage C HCC
2. ECOG performance status 0-1
3. Child-Pugh class A5-B9
4. Adequate organ function

Exclusion Criteria:

1. Based on the inclusion criteria above. Any eligibility factors that do not fit the inclusion criteria will be considered as ineligible subjects.
A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer

This is not a treatment study. The overall objective is to develop an improved standard of care through studying blood, tissue, biological, etc. samples, that patients have allowed researchers to procure.

The Oncology Research Information Exchange Network (ORIEN) hopes to establish a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of patients with cancer or at risk of having cancer. Their hope is to, over time, facilitate new clinical trials, technology, informatics solutions, and personalized medicine to each cancer patient.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older.
2. Diagnosed with cancer, or may be at risk for cancer.
3. Able to understand and sign the TCCP Informed Consent and Research Authorization form directly or through a legally authorized representative (LAR).

Non-English speaking subjects will also be invited to participate in the TCCP study, in accordance with COMIRB's short-form consent use.

Exclusion Criteria:

1. Members of vulnerable populations including neonates (birth to 30 days), children (under age 18), wards of the State, prisoners or those on probation or alternate sentencing, or decisionally challenged (adults or children that are cognitively impaired, incompetent to consent, proxy consent, or consenting in life threatening situations).
A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.

The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Intent to undergo contouring of both cheeks with 1.5 to 2 ml Restylane SubQ per cheek.
* Sufficient symmetry of the face in order to ensure similar volume to be injected, similar injection technique and time for injection.
* Signed informed consent.

Exclusion Criteria:

* Surgery in the midface including aesthetic facial surgical therapy, sinus surgery or dental root surgery within the past 12 months.
* Chronic infection in head and neck region.
* Ongoing infections in mouth.
* Tendency for edema, puffiness or swelling over the zygomatic prominence.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
* Previous hypersensitivity to hyaluronic acid or local anesthetics.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
* Cancerous or pre-cancerous lesions in the area to be treated.
* Previous tissue augmenting therapy in the area to be treated with non-permanent filler, laser treatment, or chemical peeling during the last 6 months.
* Permanent implant placed in the area to be treated.
* Reduced sensibility in the facial region e.g. due to trauma, facial pareses, previous tissue augmenting therapy, aesthetic facial surgical therapy, laser treatment, or peeling.
* Pregnancy or breast feeding.
* Participation in any other clinical study within 30 days prior to inclusion.
* Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the upper orbital rim, subjects anticipated to be unreliable or incapable of understanding the VAS assessment, insufficient tissue support or cover of the treatment area.
Vitamin D3 Supplementation to Prevent Respiratory Tract Infections

The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.

Influenza-like illness and covid-19 were added to this summary because the protocol uses respiratory tract infections and influenza-like illness interchangeably. Influenza-like illness is more accurate.

Protocol amendments:

Protocol title was amended to include covid-19. Minimum age was changed from 52 to 18, expanding the sample size. Exclusion criteria re vitamin D intake was changed from \>5000 to \>=5000 IU.

Eligibility Criteria:
Inclusion Criteria:

* Hospital worker
* Age 18 years or older

Exclusion Criteria:

* History of hypercalcemia
* History of nephrolithiasis
* History of intolerance to vitamin D3 supplements
* Use of calcium at a dose \> 600 mg/day (individuals using a dose greater than 600 mg of calcium per day will be asked to limit the amount to 600 mg unless they have been directed by their physician to be taking more than 600 mg/day of calcium. If the latter is true the potential subject will be excluded from the study.)
* Use of vitamin D at a daily dose \> 5000 IU\*
* Use of aluminum-containing phosphate binders in patients with renal failure
* Use of calcipotriene
* Use of digoxin
* Use of thiazide diuretics if using:

  * hydrochlorothiazide at a daily dose \> 37.5 mg
  * indapamide at a daily dose \> 1.25 mg
  * chlorthalidone at a daily dose \> 12.5 mg
  * metolazone at a daily dose \> 2.5 mg
  * methyclothiazide at a daily dose \> 2.5 mg
  * chlorothiazide at a daily dose \> 250 mg
  * metolazone at a daily dose \> 0.5 mg
  * bendroflumethiazide at a daily dose \> 2.5 mg
  * polythiazide at a daily dose \> 1 mg
  * hydroflumethiazide at a daily dose \> 25 mg
* Conditions that are associated with a risk of modified vitamin D metabolism
* Known allergy to wool
* Current enrollment in another study
* Life expectancy \<1 month at time of screening
* Cognitive impairment precluding the ability to provide informed consent
* Pregnant or trying to become pregnant
* Employee is team member on the present study

  * If potential participants are found to be using vitamin D supplementation upon screening at a daily dose ≤5000 IU/day, they will be eligible for participation by switching to the study dose. If potential participants are taking a multiple vitamin or calcium supplement and there is less than or equal to 800 IU vitamin D in it, they can continue the multivitamin or calcium supplement along with taking the study vitamin D3. Total vitamin D cannot exceed 5,800 IU per day combined between any supplements that contain vitamin D. Use of vitamin D at a daily dose \> 5000 IU at the direction of a physician will be an exclusion criterion. If a potential subject uses over-the-counter vitamin D not directed by a physician at a daily dose \> 5000 IU they will be eligible to participate by switching to the lower study dose.
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.

* Efficacy of the treatment with Aromasin®
* Safety of the treatment with Aromasin®

NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

* Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Exclusion Criteria:

* Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.
* Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.