cyrilzakka/clinical-trials huggingface dataset:
Abdominothoracic Muscular Tone in Functional Dyspepsia

Background. Patients with functional dyspepsia report symptoms after eating without detectable cause. A recent proof-of-concept study demonstrated that in healthy subjects, the activity of the abdominal walls influences perception of digestive sensations, specifically, intentional abdominal distension (by a maneuver of diaphragmatic contraction) increased bloating sensation in response to a probe meal.

Aim. To determine the role of the abdominothoracic muscular activity on symptoms of functional dyspepsia.

Design. Parallel study in dyspeptic patients who have an abnormal somatic response to a probe meal (experimental group), and patients who do not (control group), comparing the effect of abdominophrenic biofeedback on dyspeptic symptoms. The probe meal will consist in stepwise ingestion of a comfort meal (hot ham and cheese sandwich plus orange juice) up to maximal satiation.

Intervention. A standard biofeedback technique (3 sessions over a 4-week period) directed at controlling the muscular activity (postural tone) of the abdominal walls, will serve as active intervention in the experimental group, and as a sham intervention in the control (active comparator) group.

The study outcomes will be measured before, immediately after and at 6 months after biofeedback: 1) Clinical symptoms measured by scales during 7 consecutive days. 2) Responses to the probe meal: (a) sensations measured by scales; (b) changes in girth by adaptive belts; (c) diaphragmatic position by abdominal ultrasound.

Relevance. The identification of a pathophysiological mechanism of dyspeptic symptoms could serve as an objective marker for diagnosis and as a target for the development of mechanistic treatments.


Eligibility Criteria:
Inclusion Criteria:

* Rome IV Criteria for functional dyspepsia

Exclusion Criteria:

* organic gastrointestinal diseases
* obesity
* history of anosmia and ageusia
* alcohol abuse
* eating disorders

Age- and-sex-matched healthy subjects will be included in parallel to the 30 first patients, to determine the normal values of the response to the probe meal. Healthy subjects will not undergo the intervention.
Alveolar Recruitment in Brain Injury

Development of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe brain injury has been associated with poor outcome. The application of lung recruitment maneuvers (RM) for a short period of time to open collapsed alveoli and reverse hypoxemia in early ARDS has been recommended. However, little is known about the cerebral and vascular effects of RM in brain injury patients with ALI/ARDS. The aim of this study is to assess the effects of a single standardized RM on oxygenation and on systemic and cerebral hemodynamics in severe brain injury patients with ALI/ARDS.

Patients with severe brain injury comprise a significant portion of admissions to critical care units. These patients are unable to adequately protect their airways and are usually intubated and mechanically ventilated. The goal of mechanical ventilation in patients with brain injury is to optimize blood gas exchange while minimizing intrathoracic pressure to avoid interference with cerebral venous drainage.Over the last 20 years, a plethora of experimental and clinical data have shown that mechanical ventilation can cause or aggravate lung damage in patients with acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS). The aim of this pilot study was to assess the effects of a single standardized recruitment maneuver (RM) on oxygenation and on systemic and cerebral hemodynamics in severe brain injury patients with ALI/ARDS.

Only patients with brain injury, as defined by a Glasgow Coma Score \<13, admitted into the Trauma and Surgical intensive care unit (ICU) will be studied.

After obtaining informed consent, a RM will be performed by switching the ventilator from assist/control ventilation to continuous positive airway pressure (CPAP) and applying a pressure of 40 cmH2O for 40 sec (11). After the RM, patients have been ventilated in pressure control ventilation and PEEP will be gradually reduced in decremental steps every 3 respiratory cycles starting with PEEP at 30 cm H2O, maintaining a maximum peak pressure of 40 cmH2O during this procedure until pre-RM PEEP levels are achieved. The RM will be discontinued if any of the following changes developed during the procedure: (i) ≥20% changes in baseline systemic blood pressure, (ii) ICP ≥20 mmHg, or (iii) SaO2 ≤90%. After the RM is performed, respiratory mechanics, arterial and SjO2 blood samples and systemic and cerebral hemodynamics will be obtained at 30 min and 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain injury who met the ALI/ARDS criteria within 72 hours after ICU admission

Exclusion Criteria:

* \<18 years of age
* Cardiogenic edema
* Hemodynamic instability
* Intracranial hypertension
Transepithelial Corneal Cross-linking Using Iontophoresis

The purpose of the present Randomized Clinical Trial (RCT) is to compare the efficacy and safety of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) to treat progressive keratoconus in comparison with standard cross-linking (standard CL).

Keratoconus is a progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacity. This disorder typically begins during the second decade of life and, in severe forms, may need a corneal transplantation. Corneal cross-linking with riboflavin and UV-A is a procedure intended to halt keratoconus progression. It generates additional chemical bonds between stromal proteins in order to stiffen the corneal tissue. Standard CL includes epithelial removal and stroma soaking with dextran-enriched 0.1% riboflavin solution for 30 minutes before being exposed to ultraviolet-A radiation using a 3mW/cm2 lamp for 30 minutes.

Epithelial debridement exposes the cornea to a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications, such as infection and stromal opacity due to corneal scarring.

Iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of hypotonic 0.1% riboflavin-5-phosphate solution into the corneal stroma through the intact epithelium. After iontophoresis, the corneal tissue is irradiated using a 10 mW/cm2 for 9 minutes (T-ionto CL). From previous experimental work (Lombardo M. et al. JCRS 2014 and JCRS 2015), the investigators provided evidence that T-ionto CL increases the stiffness of human corneas with results almost comparable with standard CL. The new procedure holds the promise to be as effective as the standard procedure while minimizing all the related risks. It is object of the present clinical trial to randomize patients with progressive keratoconus to T-ionto CL and standard CL and compare efficacy and safety of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive keratoconus

Exclusion Criteria:

* Anterior corneal curvature steeper than 61 D;
* central corneal thickness \<400 um
* corneal scarring;
* descemetocele;
* history of herpetic keratitis;
* Concomitant eye diseases;
* Inflammatory eye diseases;
* Glaucoma;
* Cataract;
* Pregnancy
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer

For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For all patients, to collect and explore real-life data on the epidemiology and management of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with Faslodex 500 mg or exemestane.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years Postmenopause ist defined as

  * Age ≥ 60 years and natural menopause with menses \> 1year ago or
  * FSH and E2 levels in the postmenopausal range or
  * Patients who had bilateral ovariectomy (NCCN V.I. 2009)
* Histologically confirmed ER+ locally advanced or metastatic breast cancer
* Not eligible for curative therapy
* Prior treatment with tamoxifen
* Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
* Patient is able to read and understand German

Exclusion Criteria:

* Known hypersensitivity to Faslodex or Exemestane or any compounds of the drugs
* Prior treatment with Faslodex 500 mg or Faslodex 250 mg\*

  * for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
* Prior treatment with Exemestane for patients who receive treatment with Exemestane within this observational study
* Acutely life threatening disease
* Treatment with Faslodex 250 mg/month (previously approved dose)
* Prior palliative chemotherapy
REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness

The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.

This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.

Eligibility Criteria:
Inclusion Criteria:

* Subject requires revision hip arthroplasty
* Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant
* Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
* Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
* Endoprosthesis, femoral osteotomy, or Girdlestone resection
* Subject is at least 18 years of age
* Subject is skeletally mature in Investigators judgment
* Subject is willing to consent to participate in the study
* Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk

Exclusion Criteria:

* Known allergies to any components of the devices
* Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
* Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits
* Subject is facing current or impending incarceration
* Female subject is of child-bearing age and not using an approved method of contraception
* Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study
* Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.
* Skeletal immaturity
* Subject is severely overweight (BMI \> 40)
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* BMI 18.0-32.0 kg/m2
* Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
* Men must refrain from sperm donation for the length of the study and for 90 days
* Sign informed consent

Exclusion Criteria:

* Significant medical illness
* Tobacco use in the last 12 months
* Major surgery within 4 weeks of study administration
* Donation of blood within 4 weeks of study administration
* Current or recent (within 3 months of study administration) of gastrointestinal disease
PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called \[18F\]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).

The purpose of this study is to find out how the radiotracer called \[18F\]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. \[18F\]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.

Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.

A baseline \[18F\]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second \[18F\]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older and willing and able to provide informed consent.
* Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.
* For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.

Exclusion Criteria:

* Severe impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or on dialysis.
* Pregnant female patients; breastfeeding female patients.
* Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
* Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.
* Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy

The main purpose of this study is to evaluate efficacy and safety of an amino acid-based formula Neocate Jr in children with food protein allergy, and to evaluate nutrition sufficiency of Neocate Jr in 1 to 10 years old children with food protein allergy.

This is an open, self-controlled multi-center clinical study. Target population is 1～10 years old children allergic to cow's milk and/or food protein, confirmed by pediatrician. The study plans to recruit about 50 subjects to have an intervention period of 4 weeks. Data will be collected at baseline, week 1, 2 and 4. The hypothesis is that the amino acid formula (Neocate Jr) is effective in relieving food protein allergy symptoms, and meanwhile supporting normal growth in children with food protein allergy. Efficacy parameters are the the improvement of food protein allergy symptoms (SCORAD score, serum IgE), growth and development index (weight, height, weight for height), and nutrition related labs (such as hemoglobin, total blood protein, albumin, pre-albumin).

Eligibility Criteria:
Inclusion Criteria:

* 1～10 years old
* The children with cow's milk/food protein allergy confirmed by pediatrician including sequential feeding/newly diagnosed children, and children with Eosinophilic Esophagitis, Gastroesophageal reflux disease, Food Protein-Induced Enterocolitis Syndrome (clinical symptoms and signs, IgE, oral food challenge, etc.)
* Stable Vital Signs
* Written informed consent from the children's parents/guardian

Exclusion Criteria:

* Allergic to any ingredient in the recipe
* GI function failure
* Complete obstruction of the digestive tract
* Intractable diarrhea
* Noncooperation of neurologic or mental diseases
* Disapproval of pediatricians
Fetal Front-abdominal Wall Thickness and Perinatal Outcome

Abnormal fetal development such as macrosomia can cause some complications on both fetus and mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy examination that it can be obtained during an examination of a pregnant woman by ultrasound. Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and increase childbirth complications and operative birth. There are some studies scrutinizing the relationship between FAWT and diabetes in the literature. However there are few studies which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome regarding with macrosomia in the second trimester.


Eligibility Criteria:
Inclusion Criteria:

A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study and performed 75 gr- oral glucose tolerance test (OGTT).

Exclusion Criteria:

The participants with a positive 75-g OGTT were excluded. Additionally those following criteria were accepted as the exclusion criteria of this study: hypertension, preeclampsia, diabetes, fetal distress, fetal anomaly, multiple pregnancy, preterm labor, preterm premature rupture of membrane, placenta previa, polyhydramnios and intrauterine fetal growth restriction.
Identification of Patients With Age-Related Clonal Hematopoiesis (ARCH) Among Cancer Survivors

The purpose of this study is to see if patients with cancer have a certain amount of genetic mutations in their blood. If certain levels of mutations are found in specific genes, patients may have a condition known as ARCH. The prevalence of ARCH is higher in cancer patients who received prior chemotherapy or radiation. Studying ARCH from your blood samples may also help researchers predict which patients are more likely to be prone to heart disease. Patients who are about to start chemotherapy/radiation, and patients who have completed chemotherapy/radiation will be approached to measure the incidence of ARCH. 5-10mL blood samples will be collected before and after treatment, and if ARCH is detected in a laboratory analysis, another blood sample will be collected. Patients with ARCH will repeat the blood collection yearly, and also be referred to a cardiology clinic for follow up.

This is a non-randomized, single-centre, observational study assessing the incidence of ARCH in cancer survivors. Patients over the age of 60 who had or will receive chemotherapy and/or radiation therapy for solid or hematologic malignancies at the Princess Margaret Cancer Centre will be considered. Based on the time point of treatment, patients will either fall into a post or prior chemotherapy/radiation cohort. Peripheral blood will be taken and will be sequenced for ARCH DNA mutations. Patients who have ARCH-related mutations at a variable allele frequency (VAF) of at least 0.5% we will repeat the genetic sequencing yearly to assess changes in mutational spectrum and VAF over time.

Eligibility Criteria:
* Age ≥ 60
* Completed chemotherapy and/or radiation therapy and are being followed at Princess Margaret Cancer Centre i) Patient must be in remission for \> 3 months after completing chemotherapy or radiation ii) Predicted 5 year survival of \>75% iii) Peripheral blood counts must have returned to normal as defined by:

  1. Platelets ≥ 100 x 109/L
  2. PMN ≥ 1 x 109/L

Or

* Prior to chemotherapy and/or radiation therapy at the Princess Margaret Cancer Centre.
* All histologically/cytologically proven tumour types (solid tumours and hematologic malignancies) will be eligible.
* Received or will receive regimens of chemotherapy or radiation with doses expected to produce transient myelosuppression (PMN\<0.5x109/L) in at least 80% of treated patients (The identification and definition of appropriate myelosuppressive chemotherapy and radiation regimens will be at the discretion of the treating physician and will vary among disease sites).
* Patients must have the ability to understand the requirements of the study and provide written informed consent, which includes authorization for release of protected health information
* Patient must be willing to provide a peripheral blood sample.

Exclusion Criteria:

* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
The Effects of Hot Yoga on Vascular Function

This study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. The investigators are seeking individuals with slightly elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.

This study will examine the effects of a 12 week hot yoga intervention on vascular health by assessing changes of pre-intervention and post-intervention measurements in ambulatory blood pressure, endothelial function, and arterial stiffness in adults between the ages of 20 and 65. The investigators are seeking individuals with elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.

Eligibility Criteria:
Inclusion Criteria:

* Elevated blood pressure or stage I hypertension;
* sedentary (not currently exercising regularly);
* not currently taking blood pressure medications.

Exclusion Criteria:

* Pregnancy;
* renal disease;
* prior heart attack;
* known coronary artery disease;
* history of stroke,
* heart failure, cardiac arrhythmias or chronic obstructive pulmonary disease (COPD);
* recent chest pain;
* heat intolerance;
* body mass index of 40 or more.