cyrilzakka/clinical-trials huggingface dataset:
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity

The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters, the calculations will be integrated into software in the final commercial product; (ii) obtain human measurements against which both computational models and animal data can be compared.

This is a prospective, observational, non-significant risk study. The study involves using non-invasive devices that measure fetal depth and tissue light scattering on the maternal abdomen. Ultrasound assessment will be performed, and five images taken at the locations indicated on Figure 1. Depth to fetus will be recorded along with measurement of all distinctive layers. All images will be captured with minimal probe pressure applied to allow accurate ascertainment of depth. Images will be anonymized, and all study data will be coded with a unique identifier. Key maternal descriptive statistics will be recorded from the medical record including BMI, height, weight (kg), parity, age and gestational age. The ISS device is a customized commercial frequency domain oximeter (Imagent, ISS Inc.; http://www.iss.com/biomedical/instruments/imagent.html) with multiple laser sources and multiple detectors. This instrument is safe, uses non-ionizing radiation. The Raydiant Oximetry Sensing System (ROSS) device is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The combination of these two devices makes up the Raydiant Oximetry GEN 3 device. This GEN 3 device will be positioned on the maternal abdomen of women volunteers in the late 3rd trimester. This sensor will measure light scattering and absorption for a period of about 10-20 minutes. A second measurement may be obtained for an additional site on the maternal abdomen. The Sponsor anticipates this study will require about 6-12 months to enroll all study subjects at all study sites, and another month to complete primary analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks
2. Age \> 18 years
3. Willing to come in for testing outside of routine business hours (including Saturdays)

Exclusion Criteria:

1. Age \<18
2. Multiple gestation (twins, triplets)
3. Presentation other than vertex or breech
4. \< 36 weeks of gestation
Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG

Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients

Patients who were diagnosed with left ventricular hypertrophy (LVH) by ECG at the start of the study are followed up at 3-month intervals for 1 year.

Increase Fimasartan if blood pressure is not controlled.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been treated or not treated with hypertension from 20 to 80 years of age
* Patients with electrocardiographic left ventricular hypertrophy (In this study, we define left ventricular hypertrophy if one of the following two criteria is met)

  1. RaVL+SV3 \> 20mm(M). 16mm(F)
  2. SV1+RV5 or RV6 \> 35mm.
* Patients who are taking or expecting Fimasartan

Exclusion Criteria:

* Patients with unstable angina or myocardial infarction within 3 months
* Patients with clinically significant severe valve disease, congenital heart disease, peripheral vascular disease, cerebrovascular disease
* Clinically significant severe congestive heart failure patients
* Patients with renal dialysis
* Clinically significant renal disease patients
* Patients with clinically significant hepatic impairment
* Patients with a history of alcohol or substance abuse
* Patients with hypersensitivity to angiotensin-receptor blocker
* Patients needing angiotensin-receptor blocker drugs other than fimasartan
* For women, pregnancy, Patients who are breastfeeding or planning to become pregnant
* A person who is determined to be inappropriate by the Investigator
* Patients participating in other clinical trials
Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.

The deferasirox intervention will begin one week prior to the RPS (Resistant Potato Starch) conditioning phase and both will continue through day +100. The study hypothesis is that a short-term administration of a resistant starch and iron chelation therapy will be capable of both increasing levels of butyrate within the intestine and restoring physiological hypoxia in the intestines, which together will reduce rates of acute GVHD (Graft versus Host Disease) and improve the clinically meaningful outcome of GRFS (Graft versus Host Disease / Relapse-Free Survival) at 12 months post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen
* Age ≥18 years
* Karnofsky performance status \>70%, see Appendix A
* Patients must be able to swallow capsules/tablets
* Ability to understand and the willingness to sign a written informed consent
* Availability of a full-HLA matched related or unrelated donor who is medically eligible to donate cells according to the National Marrow Donor Program criteria

Exclusion Criteria:

* Patients with active inflammatory bowel disease requiring treatment per treating investigator
* Patients with a history of gastric bypass surgery
* Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon
* Patients with active iron deficiency anemia requiring treatment
* Patients with iron overload receiving active treatment with deferasirox
* Known hypersensitivity to deferasirox or any component of Jadenu or Exjade
* Patients actively enrolled on treatment or in follow up phase on any other GVHD prevention trial
* Any physical or psychological condition that, in the opinion of the investigator, would pose an unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
Boston Early-Onset Chronic Obstructive Pulmonary Disease (COPD) Study

Chronic obstructive pulmonary disease (COPD) is often caused by cigarette smoking, but genetic predisposition also influences COPD susceptibility. The purpose of this study is to identify genetic factors that predispose some individuals to develop COPD.

Chronic obstructive pulmonary disease (COPD), which is the third leading cause of death in the United States, affects millions of people around the world. COPD, which can include both emphysema and chronic bronchitis, affects the lungs making it very difficult to breathe. Cigarette smoking is the most common risk factor for developing COPD; however, only 15% to 20% of smokers develop COPD in their lifetimes. The onset of COPD also varies greatly from person to person; while some people do not develop respiratory symptoms until later in life, there are others who develop severe COPD at a very early age. Prior research has led to the discovery of the alpha-1 antitrypsin protein deficiency in association with COPD development. This discovery has generated further interest toward studying other genetic factors which may also affect an individual's likelihood of developing COPD. Therefore, the purpose of the Boston Early-Onset COPD study is to gain a better understanding of COPD risk factors in order to establish new possible methods of treatment for people affected by COPD.

For this study we are enrolling individuals affected with severe COPD (52 years old or younger with an FEV1 \< 40%) and their family members. Each participant will attend one study visit that involves a respiratory questionnaire, a breathing test, and blood draw. This visit can be completed at the participant's home, in the hospital, or by long distance data collection (phone interview, local breathing tests, and local blood draw with mailed samples), whichever is preferred.

Eligibility Criteria:
Inclusion Criteria for Early-Onset COPD Probands:

* Early onset of COPD in individuals younger than 53 years old
* Spirometry results that are indicative of severe COPD (FEV1 \< 40% predicted)
* Physician-diagnosed COPD

Exclusion Criteria for Early-Onset COPD Probands:

* Severe alpha-1 antitrypsin deficiency
* Other chronic lung diseases in participants with COPD (except asthma)
* Pregnant
* Any previous lung surgery including lung transplant or lung reduction volume surgery (LVRS); unless prior Pulmonary Function Tests are available
Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED: a Pilot Study

The aim of the study are: 1) To evaluate the occurrence of acid-base alterations and the incidence of hypophosphatemia during different modalities of Renal Replacement Terapy (RRT) in critically ill patients \[CVVH, CVVHDF and SLED (Sustained Low-Efficiency Dialysis)\] by using a simplified Regional Citrate Anticoagulation (RCA) protocol combined with the adoption of a phosphate-containing solution as dialysate and/or replacement fluid; 2) To optimize the infusion rates of different solutions adopted, including citrate, in order to obtain an appropriate electrolyte and buffer supply. The final aim of this approach will be to reduce the need for frequent monitoring of acid-base status and electrolytes (with special regard to ionized calcium levels), and to avoid the need for frequent adjustments of RCA-RRT parameters (infusion rate of different solutions, electrolytes supplementation in the course of RRT). This approach could allow to simplify anticoagulation protocols with citrate, in order to minimize potential concerns hampering a wider diffusion of RCA in daily practice.

The need for continuous anticoagulation represents a potential drawback of RRT modalities. KDIGO 2012 guidelines on acute kidney injury (AKI) suggest the adoption of RCA as first choice anticoagulation modality for continuous RRT (CRRT) in patients without contraindications for citrate. Citrate has been also introduced as anticoagulant for SLED and its use in the context of a mainly diffusive prolonged intermittent modality has been shown to represent an easy and safe method to maintain the extracorporeal circuit when concentrated citrate solutions, such as ACD-A are used. Hypophosphatemia is a known issue of RRT, and has been reported in up to 50-80% of cases when standard RRT solutions are used, especially in continuous/prolonged intermitted modalities when high RRT doses are delivered. RRT-related phosphate depletion should be avoided in critically ill patients due to the relevant hypophosphatemia-associated complications in this clinical setting. The adoption of phosphate-containing CRRT solutions could reduce the incidence of hypophosphatemia and minimize the need for parenteral phosphorus supplementation.The adoption of a commercially available phosphate-containing CRRT solution, in the setting of RCA-RRT may allow to meet the double target of minimizing RRT-induced hypophosphatemia and ensuring an adequate circuit life, also avoiding electrolyte and acid-base derangements.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for severe acute kidney injury (AKI)
* critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for end stage renal disease (ESRD)

Exclusion Criteria:

* age \< 18 years
Effect of Single Dose Intranasal Insulin On Cognitive Function

The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include:

1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory.
2. Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level

Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.

Insulin signaling in the brain is associated with improved cognitive function in both animal and human studies. Intranasal administration of insulin, which is non-invasive and minimizes the risk of hypoglycemia, may represent a new intervention approach with the potential to improve cognition and real life functioning in this patient with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
* Male or female
* Stable dose of the current antipsychotic drug for at least one month
* Well established compliance with out-patient treatment per treating clinician's judgement.
* Able to complete the cognitive assessment battery (must be English speaking)

Exclusion Criteria:

* Inability to provide informed consent
* Current substance abuse
* On clozapine or olanzapine
* Psychiatrically unstable per treating clinician's judgement.
* Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases etc.
* Incapable to complete the cognitive battery assessment.
Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants

The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race, between 18 and 65 years of age
* In good health, as determined by no clinically significant findings from medical history,12- lead ECG and vital signs measurements, physical examination and clinical laboratory evaluations
* Body mass index between 18.0 and 32.0kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
* Evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study drug, as determined by the investigator (or designee).
* History of malignancy, except for appropriately treated carcinoma in situ of the cervix or nonmelanoma skin carcinoma not requiring ongoing systemic treatment.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
* Participants who have acute gastrointestinal symptoms at the time of screening and or/admission (eg, nausea, vomiting, diarrhea, or heartburn).
Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies

The purpose of this study is to decide which position of the neck affects cerebral spinal fluid (CSF) flow between the spinal cord and the brain. CSF is a fluid that flows up and down your spinal cord, around the brain and into the ventricles of the brain.

This study will be done with patients who have abnormalities of the neck, including Chiari 1 malformations.

In this study, subjects will have a dynamic cervical magnetic resonance imaging (MRI) of the craniovertebral junction (CVJ) coupled with CSF flow studies. The studies will assess changes in CSF flow velocities that are associated with with changing position of the neck at the CVJ and aqueduct of Sylvius.

Eligible patients include those with Chiari 1 malformations and similar malformations to the CVJ. This malformation lead to inherent instability in this region and symptoms such as headaches, dizziness, neck pain and other neurological problems. This study will determine if there is any correlation of these MRI findings to clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers must be 18 yrs of age or older.
* Patients w/Chiari 1 or CVJ malformations aged 12 yrs or older,
* Able to cooperate in flexing and extending their neck within the cervical spine coil used for MR Imaging.
* Pediatric patients will be included only if they can cooperate for additional sequences done for the study who don't require sedation or any form of anesthesia.

Exclusion Criteria:

* Patients who are medically unstable or cannot voluntarily flex or extend their necks.
* Patients who have hardware in the head or necks which are incompatible with MR imaging.
* Patient requiring any form of sedation which can lead to compromise of the airway with maneuvers described above.
* History of prior head trauma or history of neurological conditions which can result in altered CSF dynamics.
Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China

Care practices, mortality and morbidity of very premature infants from two different tertiary centers were collected and compared, in order to discover areas for improvement where these two newborn centers can learn from each other.

This retrospective cohort study was conducted in two hospitals,Qinghai Red Cross Hospital and Jinan University affiliated Shenzhen Baoan Women's and Children's Hospital.Very premature infants born with a gestational age between 22+0 - 31+6 weeks admitted to both centers during 3 years from January 1, 2018 to December 31, 2020 were studied. In both centers, data including maternal characteristics, neonatal characteristics, obstetric practices, delivery room practices, and neonatal outcomes, were collected by data abstractors in each NICU. Anonymous data was transferred to Shenzhen and analyses were performed at the newborn center of SZH.

Eligibility Criteria:
Inclusion Criteria:

* Very premature infants born with a gestational age between 22+0 - 31+6 weeks；
* Admitted to both centers during 3 years from January 1, 2018 to December 31, 2020.

Exclusion Criteria:

* Infants not born at QHH or SZH (out born);
* Infants who had major congenital anomalies;
* Infants admitted after 7 days of life.
Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients

The main objective of the trial is to confirm safety of a new product - Epipad. The main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).


Eligibility Criteria:
Inclusion Criteria:

* Patient suffered from superficial wound of different etiology
* Wounds in terminal phase of healing
* Wounds without visible sign of infection
* Max. size of the wound: 10 x 20 cm (i.e. two pieces of the product)
* Duration of wound treatment of at least 6 weeks
* Subject willing and able to provide written informed consent
* Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study

Exclusion Criteria:

* Sloughy or necrotic wound bed
* Severely contaminated or infected wound
* Age \< 18 years
* Pregnant or lactating woman
* Subject in terminal stage of living
* Subject with cancer disease
* Subject with known hypersensitivity or allergy to any component of the investigational device
* Subject participating in other interventional clinical trial
* Alcohol and/or drug abuse
Kegel Exercise Pregnant Training mHealth App

This pilot feasibility study protocol is to assess the feasibility in the future definitive trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

The aim of this pilot feasibility study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at 26-27 weeks of gestation, any parity with either stress UI or mixed UI will be included.
* Participants are Malaysian citizens who consist of Malay, Chinese, Indian, and native ethnicities.

Exclusion Criteria:

* pregnant women with a chronic medical problem(s) before pregnancy, complicated pregnancies or conditions which are not advisable to practise PFMT will be excluded.
Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the value of induction Erlotinib therapy before thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Stage IIIA non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histological or cytological documented
* Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
* Naive therapy NSCLC
* Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
* Enough tissue samples to perform gene analysis

Exclusion Criteria:

* Small cell lung cancer
* Pregnant or breast-feeding women
* Any unstable systemic disease
* Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial