cyrilzakka/clinical-trials huggingface dataset:
Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy

The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).

Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.

We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.

From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:

  1. have cancer located in middle or distal portions
  2. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
  3. have The American Society of Anaesthesiologists (ASA) score of three and less

Exclusion Criteria:

* Patients following criteria:

  1. have simultaneously other cancer
  2. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
  3. have systemic inflammatory disease
  4. have upper gastrointestinal surgery
  5. have the gastric cancer with obstruction
  6. get pregnancy
  7. are treating diabetics with Insulin
  8. are participating or participated within 1 month in other clinical trials
  9. have BMI less than 25
  10. are expected to perform laparoscopy assisted gastrectomy
Visual Stimulation for Pain Relief

The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes
* Participants of diverse ethnic and racial backgrounds
* Participants who speak, read, and understand English and are willing and able to provide written informed
* 18 to 50 years old

Exclusion Criteria:

* Participants with neurologic, endocrine, renal, gastrointestinal, and chronic pain disease
* Participants who use unprescribed drugs or medications
* Chronically medicated participants
* Participants with photosensitivity and epileptic seizures
* Participants who have undergone major surgery within two months of the experiment date
* Participants with cardiac disorders
* Participants who are pregnant
* Prisoners
* Participants who are unable to provide consent
* Participants diagnosed with a psychiatric disorder that is likely to interfere with the conduct of the study
* Participants with implanted electronic devices of any kind, including pace-makers, electronic infusion pumps, stimulators, defibrillators
Role of FGF-23 as a Prognosis Biomarker in Intensive Care Patients

The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.

Observational study of patients admitted in the Critical Care Unit (CCU) of University of Chile Clinical Hospital, admitted with diagnosis of severe sepsis/septic shock.

Exclusion criteria: Pregnancy, organ transplantation. Informed consent is solicited to patients before admission in study. If the patient cannot give it because of his/her clinical condition, it will be solicited to a patient representative.

After admission in CCU and achievement of informed consent, a venous blood sample will be obtained, to determinate plasmatic levels of Fibroblast Growth Factor 23 (FGF-23). New samples will be obtained at 24 and 48 hours after admission. Determination of FGF-23 will be performed by ELISA technique in Integrated Physiology laboratory.

Demographics, clinical and biochemical data will also be obtained. The data will be collected by the Principal Investigator. Confidentially of all data will be preserved during and after the completion of the study.

The study is divided in 2 parts:

1. - Evaluation of a sample of 14 patients to determinate the impact of FGF-23 to predict presence and severity of Acute Kidney Injury (AKI), and to estimate sample size to predict primary outcomes.
2. - Evaluation of a larger sample, to determinate the impact of FGF-23 to predict primary outcomes.

Primary outcomes:

1. - Development of acute kidney injury
2. - Severity of AKI, determinate by AKIN classification
3. - In-hospital mortality

Secondary outcomes:

1. - Requirements of renal replacement therapy
2. - Requirements of mechanical ventilation
3. - Requirements of vasoactive drugs
4. - Duration of ICU stay and hospital stay

As a post-hoc analysis, we performed a measurement of a combined biomarker, including FGF-23 and other 2 biomarkers, Klotho and Erythropoietin, measured in blood samples, to determinate its predictive capacity for AKI diagnosis and mortality.

The protocol was approved by the Ethical Committee of University of Chile Clinical Hospital. The study is monitored by the Clinical Investigation Support Office (OAIC) of the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Admission in Critical Care Unit
* Sepsis

Exclusion Criteria:

* Pregnancy
* Organ transplantation
Zirconia Reinforced Glass Ionomer in MIH

Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. It can be very beneficial in managing MIH-affected molars in communities with limited access to dental care. Zirconia-reinforced GI was recently introduced. It is claimed to serve as a long-term temporary restoration until a more permanent restoration is placed


Eligibility Criteria:
Inclusion Criteria:

* Children free from any systemic disease (ASA I).
* Cooperative children showing positive or definitely positive behavior according to Frankl rating scale
* Hypomineralized first permanent molars that are restorable according to MIH Treatment Need Index (MIH-TNI): Index (2a), (2b), (4a), (4b)
* Teeth with dentinal lesions corresponding to ICDAS II score 5 or 6
* No clinical or radiographic evidence of pulpal involvement.

Exclusion Criteria:

* Index (0), (1), (2c), (3), (4c) on the MIH Treatment Need Index.
* Patients whose parents will not give their consent to participate in the study
* Non-restorable first permanent molars indicated for extraction
A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers

This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A subject who weighs 50 kg or more (45 kg or more for women)
* A subject who does not have clinically significant congenital or chronic diseases
* A subject who is judged to be eligible to participate by the results of diagnostic tests by the principal investigator
* A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of the investigational drug
* A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, the characteristics of the investigational drugs, and expected adverse reactions

Exclusion Criteria:

* A subject who has a known digestive system, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and genitourinary system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmic system or has any past history of them
* A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
* A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month of the first administration or has taken drugs that may affect the study within 10 days of the first administration (however, participation can be possible considering pharmacokinetic·pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs etc)
* A subject who has participated and administered other investigational drugs in other clinical trials or bioequivalence studies within 6 months of the first administration
* A subject who is judged ineligible for participation in this study by the principal investigator
* A female volunteer who is pregnant or lactating
Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors

To evaluate the long-term complete remission rate (\> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

Intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically.

The IPC as a center for interventional endoscopy has been taking care of these lesions for several years.

Resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; Practice has evolved and has not been studied or evaluated in recent years. The purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.

Exclusion Criteria:

* Adenomas with low grade dysplasia
* Endoscopic control not available
Apple Hearing Study

The Apple Hearing Study is a partnership between the University of Michigan and Apple to study sound exposure and its impact on hearing health. This groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. The investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. US residents who own an iPhone, download the Apple Research app and consent to participate will be randomly assigned to two groups, one with a "Basic" user interface in the Research app, and one with an "Advanced" user interface. Users in the "Advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. The study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. This information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the US and globally.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of eligibility screening, ascertained from self-reported date of birth. Potential subjects in the states of Alabama and Nebraska must be 19 or older (legal age of consent in these states), and 21 and older for any subjects in Puerto Rico.
* Live in the United States of America at time of eligibility screening, ascertained from self-report.
* Proficient in written and spoken English, defined by self-report.
* Participants must NOT share their iCloud account, iPhone or other devices such as Apple Watch with anyone else as this would make it challenging for researchers to use their information.
* Possession of the following, ascertained from automatic hardware/software/device pairing check:

  * iPhone with iOS versions capable of supporting the Research app used to complete screening eligibility.
  * Optional: Apple Watch (any model) paired with iPhone; an Apple Watch Series 4 or later is required to share environmental sound levels.
Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation

This is a Multicenter Observational 1-year retrospective cohort study evaluating the predictive value of the Left Atrial Sphericity on the recurrence rate of atrial fibrillation after pulmonary vein ablation procedure.

Inclusion of consecutive patients undergoing AF ablation during 2013 in whom a 3D-imaging of the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when procedural/follow-up data was prospectively collected.

Validation of the predictive value of the Left Atrial Sphericity for AF recurrence of atrial fibrillation after a pulmonary vein ablation procedure in an external, multicenter cohort.

In total, 9 centers will include consecutive patients who underwent AF ablation from january to december 2013 in whom a 3D-imaging of the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when procedural/follow-up data was prospectively collected.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* First AF ablation procedure
* Prior 3D-imaging of the left atrium (CT or MRA)
* Prospective collection procedural and outcome data
* Obtention of Informed Consent

Exclusion Criteria:

* Previous left atrial ablation or surgical procedure
Jaw-thrust on Postoperative Sore Throat

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 2
* Recent sore throat
* Cervical spine disease
* Recent upper respiratory infection
* Recent analgesics
* History of head and neck surgery
* Friable teeth
* Multiple intubation attempts
Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation

Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.

The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. The study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen ensuring a minimal burden to the subjects participating in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be aged \>18 years.
2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. Subject receives a de novo ablation procedure for treatment of atrial fibrillation.

Exclusion Criteria:

1. Pregnant women.
An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

Dietary supplementation is widely used to alleviate various symptoms of PMS and menstruation such as bloating and cramping. Providing a combination of synergistic dietary supplements is hypothesized to significantly reduce self-reported PMS and menstrual discomfort when compared with a baseline without the intervention.

This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.

It is hypothesized that the dietary supplement marketed as Semaine PMS \& Period Support will improve subjective wellbeing and biomarkers in trial participants.

A total of 58 participants will be recruited for the trial following screening, with the expectation that at least 51 will complete the trial. The trial will be fully remote, and all participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle. For both menstrual cycles the participants will complete a subjective wellbeing survey and provide a blood sample for biomarker analysis.

The biomarker analysis will be performed through an at-home fingerprick blood test. To maximize consistency, the tests should be performed on the same days of each cycle - preferably on days 4 or 5. If absolutely necessary, however one day of buffer on either side will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Female, aged 18-40
* Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
* Ability to take oral medication and be willing to adhere to the dietary supplement regimen
* Use of hormonal contraception for at least 3 months prior to screening and agreement to use such a method during study participation. Hormonal contraception must allow for pill bleeds to occur.
* Moderate self-reported discomfort during menstruation related to bloating, pelvic cramps, fatigue or mood swings. On a scale of 1-10, participants must report at least a 4 on two or more symptoms.
* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

* Current use of GnRH agonists and antagonists including Lupron or Orilissa
* Current use of an extended activity hormonal contraception (for example, Depo-provera or Nexplanon)
* Current use of hyperthyroid medication such as methimazole
* Current use of blood thinning medication
* Pregnancy, lactation, or attempting to become pregnant during study
* Known allergic reactions to components of the dietary supplement (sunflower oil, ashwagandha, curcumin, resveratrol, Boswellia, milk thistle, quercetin or catechins)
A Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA

In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group.

Many kinds of cancers are associated with changes in epigenetics, including 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC). This changes may help diagnose cancer. The new detection method for 5-hmC can meet the requirements of liquid biopsy.

The traditional diagnostic methods for colorectal cancer is colonoscopy and pathology which are inconvenient and unpleasant, and sometimes, it is difficult for the very patients to get tissues or get enough tissues. In addition, other screening methods for colorectal cancer,such as guaiac-based fecal occult blood testing and a blood test for methylated SEPT9 DNA, have the shortcomings of relatively low sensitivity and specificity. As a result, it is imperative to find a new detection method for early diagnosis of colorectal cancer with high the advantages of high sensitivity and specificity, minimally invasive and convenient.

The aim of this research study is to establish a model for the early diagnosis of colorectal cancer by the detection of 5-hmC in plasma cell-free DNA. Patients who are diagnosed with colorectal cancer by colonoscopy and pathology and not received any anti-tumor therapy (Arm A) will be eligible for inclusion as well as healthy individuals with normal colonoscopy (Arm B). Then, 5-hmC in plasma cell-free DNA will be detected and compared between the two arms of patients (training group) to establish a model to diagnosis other people (validation group) who may suffer from colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

Arm A

* Histologically proven colorectal adenocarcinoma
* No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* Eastern cooperative oncology group score 0-2
* Informed consent

Arm B

* Healthy people with normal colonoscopy
* No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* Eastern cooperative oncology group score 0-2
* Informed consent

Exclusion Criteria:

Arm A

* Patients received chemoradiotherapy or other anti-tumor therapy before being enrolled
* Patients and/or family members can not understand and accept this study
* Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
* Pregnancy or lactation
* Unsuitable to take part in the clinical trial judged by doctors

Arm B

* Pregnancy or lactation
* Unsuitable to take part in the clinical trial judged by doctors