cyrilzakka/clinical-trials huggingface dataset:
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).

The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.


Eligibility Criteria:
Inclusion Criteria:

* Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone.
* Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1.
* Erosive esophagitis according to LA classification Grade A, B, C or D, at the visit 1 endoscopy.
* Have provided Informed consent.

Exclusion Criteria:

Subjects with current or historical evidence of the following conditions are excluded from the study:

* Esophageal stricture.
* Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
* Systemic Sclerosis (scleroderma).
* Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
* Inflammatory bowel disease.
* Zollinger-Ellison syndrome.
* Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months

Subjects with i) history of significant or ii) current significant or unstable:

* Cardiovascular diseases or cardiac chest pain.
* Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
* Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
* Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
* Malignant disease (except for minor superficial skin disease).
* Generalised bleeding disorders.
Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns. For the intervention group, the monitoring system is paired with automated delivery of self-care suggestions tailored to the specific symptom profile the patient reported and also automatically 'alerts' the study oncology nurse practitioner about unrelieved symptoms. The nurse practitioner, utilizing national evidence based symptom guidelines for symptoms at moderate to severe levels calls the patient and further assesses and intensifies symptom treatment. The usual care group called the system daily and reported similar data but did not receive self-care coaching or notification of unrelieved symptoms to the study nurse practitioner. On every call, the usual care group was told to follow the standard procedure of calling their oncology providers for symptom concerns. The specific aims of the study are to test whether the symptom monitoring intervention reduces presence, severity and distress of 11 symptoms. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness \& tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed mood, anxiety, and fatigue. Secondary outcomes tested whether the intervention improved functional performance and decreased interference with activity when compared with the usual care attentional control group. Other aims compare self care strategies utilized and their perceived effectiveness and document patient satisfaction with the monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 or over)
* Have a histological diagnosis of cancer
* a life expectancy of at least 3 months and cognitively able to participate
* Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
* care is under the direction of one of the 8 designated provider teams;
* English speaking;
* has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.

Exclusion Criteria:

* patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
* patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
* Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.
Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

A six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Eligibility Criteria:
Inclusion Criteria:

* Agreement with written informed consent and 40 years of age and older
* Patients with more than 63months history of OA of knee according to ACR criteria
* Radiographic evidence of Kellgren \& Lawrence grade II to III OA of the knee
* The 100mm Pain VAS is over 40mm
* The Lequensne's index is over 5

Exclusion Criteria:

* Treatment with SYSADOA within 3 months
* History of joint surgery within 5 years or Arthroscopic surgery within 1year
* Intra-articular injections within 3 months
* Treatment with NASIDs within 7 days
* Any history of adverse reaction to the study drugs
* clinically significant hepatic, renal, cardiovascular diseases
* Patients with gastrointestinal ulcers or bleeding disorders
* Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
* History of drug abuse or alcoholism
* Patients on any other clinical trial or experimental treatment in the past 4 weeks
* An impossible one who participates in clinical trial by investigator's decision
Behavior, Biology and Well-Being Study

The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation \[HMP without meditation practice\]), and a waitlist control in a sample of United States adults with elevated depression symptoms.

Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of mediation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.

Eligibility Criteria:
Inclusion Criteria:

* Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview
* Proficient in English
* Able to provide informed consent
* Have access to a smartphone that can download apps from Google Play or the Apple App Store
* For payment purposes, must be a US citizen or a permanent US resident

Exclusion Criteria:

* Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
* Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component

  - Previous use of Healthy Minds Program app
* Current suicidal intent and/or high self-injury risk (determined from the interview)
* Self-reported history of psychosis
* Self-reported history of mania
* Current psychopathology that interferes with study participation as assessed by interview
* Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
* Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
* Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men
Comprehensive Heart Failure Disease Management Community Program

The purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.

Heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. Disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. Such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. Designated heart failure clinics were also employed in care given to these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with NYHA-Stage III-IV heart failure recruited in the community;
2. Adult patients with NYHA-Stage II-IV heart failure recruited after hospital admission for decompensated heart failure

Exclusion Criteria:

* Other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; Severe cognitive impairment; People unconnected to telephone
MRI Study of Saccadic Adaptation

Accurate execution of our directed behaviors in the immediate environment allows the vast majority of our daily activities. Through the movements of our eyes and different parts of our body, we perceive, explore and act on our environment and can exchange and communicate with others. The mechanisms of sensorimotor adaptation of saccades (saccadic adaptation) contribute on the one hand to maintain the accuracy of saccades in the short, medium and long term, by opposing the deleterious effects of various physiological changes (development, aging), pathological or environmental (optical corrections).

The aim of this study is to identify neuronal structures and networks involved in saccadic adaptation through the study of brain metabolic activation (BOLD) during the development of the adaptation of reactive saccades. The study will be organized in a single session with 3 runs. Each run include 4 blocks: 3 include the double-step target paradigm RND, U+, U-) and one without target jump (STA). The 'U+'/ 'U-'blocks include saccadic trials with forward/backward displacement of the target during a targeting saccade, the 'RND' block include saccadic trials with random target jump (forward or backward) and the 'STA' block are trials without displacement of the target. Each subject will make 12 repetitions of the 4 blocks.


Eligibility Criteria:
Inclusion Criteria:

- Age: 18 to 40 years included,

Exclusion Criteria:

* Known ophthalmological or neurological pathology,
* Non-stabilized medical condition,
* Taking psychotropic treatment,
* No fluency in reading in French,
* Pregnant and / or breastfeeding woman
Study Evaluating IMA-026 in Healthy Subjects

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026 administered subcutaneously (SC) or intravenously (IV) in healthy adults.


Eligibility Criteria:
* Healthy men and women ages 18 - 50
* Body weight greater than or equal to 50 kilograms
* Nonsmoker or fewer than 10 cigarettes per day
* No serious infection, i.e., requiring hospitalization or IV antibiotics, or an upper respiratory infection within 1 month before dosing
Preoperative Rapid Pou Ultrasound Assessment in Critically Ill Patients Undergoing Emergency Surgery

With the development of society, the number of emergency critical operations is increasing year by year. Traditionally, the patient's systemic and circulatory status is indirectly assessed by testing and blood pressure heart rate. There are cases where the diagnosis is imperfect and the results are unreliable. Preoperative POU rapid ultrasound is a preoperative bedside ultrasound evaluation method first proposed by the Anesthesiology Department of Huaxi Hospital (three engineering units). This project will cooperate with Huaxi Hospital to explore whether the effect of intraoperative anesthesia management under POU guidance is better than traditional anesthesia management. This study will provide a new preoperative evaluation anesthesia management program for emergency critically ill patients with important clinical and social significance.

According to the inclusion and exclusion criteria, the patients will be randomly divided into two groups：In the control group, the anesthesiologist performed according to the existing preoperative evaluation program and existing experience, and guided the anesthesia management with the evaluation results.The experimental group used POU protocol ultrasound to perform a heart scan and a standard scan, a large vascular scan under the xiphoid, a body cavity scan, a standard section, and a lung scan in 10 minutes. Comprehensive preoperative circulation and assessment of systemic conditions, and guided intraoperative anesthesia management with assessment results.

Eligibility Criteria:
Inclusion Criteria:

* 1.pulse oxygen saturation (spO2) ≤ 92% when inhaling air.
* 2.respiratory frequency ≥ 20 beats / min.
* 3.systolic blood pressure (sbp) \<90mmHg.
* 4.heart rate (hr)\>100 times/min.
* 5.requires positive inotropic drugs and/or vasopressors.
* 6.need artificial ventilation.
* 7.Signing informed consent.

Exclusion Criteria:

* 1.age \<14 years old.
* 2.unable to perform ultrasound evaluation (bandage, clam shell).
* 3.participated in other clinical trials in the first 3 months of the study.
* 4.researchers believe that it is not appropriate to include this tester.
* 5.any reason can not cooperate with this study.
* 6.cardiac surgery patient
* 7.organ transplant patient.
* 8.obstetric surgery patient.
* 9.you can start rescue after entering the room (such as CPR, etc.), and you are not allowed to perform ultrasound scans.
Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI

Standard Magnetic Resonance Imaging (MRI) is based on the excitation of hydrogen nuclei that are presents in water molecules, which abundance in human body allows for obtention of superior contrast. However, assessing the presence of other molecules than water in tissues is also of great clinical interest to probe metabolites related to physiological body function and pathological conditions.

Chemical exchange saturation transfer (CEST) allow to overcome some limitations of proton magnetic resonance spectroscopy (1H-MRS) by exploiting chemical properties of the targeted molecule through a continuous process of re-saturation and exchange, and thus detecting it with increased sensitivity, from two orders of magnitude. Moreover, CEST technique is based on imaging sequences and can therefore benefit from well-known fast acquisition strategies, as well as improved spatial resolution.

For this study the investigators propose to include an additional CEST sequence in standard PET/MRI exam in order to obtain a cartography with biochemical informations from tissues in patients with glioma or brain metastases.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the Nuclear Medicine and Molecular Imaging department of ICANS (Institut de cancérologie strasbourg Europe) for a PET/MRI exam dedicated to:

* Preoperative evaluation of a cerebral expansion lesion
* Evaluation of glioma recurrences
* Evaluation of brain metastases
* Evaluation of recurrence of metastases

Exclusion Criteria:

* Contraindication to the realization of an MRI
* Minor or patients placed under guardianship or supervision
* Patients deprived of liberty
* Patients placed under judicial protection
* Patients that are not able to express their consent
* Pregnant and breastfeeding women
When and How to Administer Oxytocin for Active Management of Third Stage of Labour

To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

Eligibility Criteria:
Inclusion Criteria:

* having a singleton pregnancy above 37th gestational week
* normal live vaginal delivery with cephalic presentation
* being in active labor

Exclusion Criteria:

* Fetal demise
* multiple pregnancy
* known coagulation disorder
* presentation anomalies
* placental pathology
* liver disease
* thrombocytopenia
* hypertension or being currently on anticoagulants
* having a cesarean section, operative delivery or deep vaginal tear
* chorioamnionitis
* developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery
Laryngoscope Asssited Lightwand Intubation

To evaluate the success rate for intubation of laryngocope assisted lightwand intubation.

Light wand intubation is well known for safety intubation in cervical injury patiets. Traditional method of using light wand can damage the supraglottic cavity by scooping the apparatus. The investigators try to evaluate the efficacy of laryngoscope assisted light wand intubation compared to traditional method of using light wand alone.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for cervical spine surgery under general anesthesia

Exclusion Criteria:

* congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation, or foreign bodies in the upper airway
* history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
* American Society of Anesthesiologists physical status ≥ 3
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects (male and female) must be between the ages of 18 and 60 years at screening
* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must be treatment naïve
* Subjects must have laboratory values at screening within limits as specified by the protocol

Key Exclusion Criteria:

* Evidence of cirrhosis
* Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
* Any other cause of significant liver disease in addition to hepatitis C
* Human immunodeficiency virus -1 or -2
* Diagnosis of or suspected hepatocellular carcinoma
* History of organ transplant, with the exception of corneal transplants and skin grafts
Study of Electroencephalogram (EEG) Measurement During Different Stimulations of the Lower Urinary Tract

The purpose of this study is to investigate afferent and cortical activities during bladder filling under different stimulations of the lower urinary tract. The participants of the study are healthy test persons and patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Written informed consent

Exclusion Criteria:

* Any psychological diseases
* Any renal, cardiac, and pulmonary diseases
* Pregnancy or breastfeeding
* Problems keeping calm for 60 minutes in the sitting position
* Medication influencing EEG or bladder function
Bowel Function After Minimally Invasive Urogynecologic Surgery

The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.

See above

Eligibility Criteria:
Inclusion Criteria:

* Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.

Procedures may include:

* robot-assisted laparoscopic sacrocolpopexy
* sacrospinous ligament suspension
* uterosacral ligament suspension/paravaginal defect repair
* colpocleisis
* cystocele repair

Additional procedures may include:

* hysterectomy
* adnexectomy
* culdoplasty
* minimally invasive sling procedure (TVT or TOT)
* periurethral collagen injections
* enterocele repair

Exclusion Criteria:

* Planning to undergo laparotomy.
* Undergoing rectocele or perineocele repair as part of surgery.
* Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
* Presence of a colostomy.
* Chronic kidney disease
* Insulin-dependent diabetes mellitus
* Known cardiac disease
* Gastric ulcers
* Difficulty swallowing or esophageal stricture
* Persistent nausea and vomiting
* Signs and symptoms consistent with bowel obstruction