cyrilzakka/clinical-trials huggingface dataset:
DilaCheck Cervical Dilation Measurement Trial

Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.

The trial seeks to compare the DilaCheck device with standard digital cervical dilation examinations. 50 laboring female participants will be enrolled with 25 randomly assigned to the control arm and 25 to the treatment (DilaCheck) arm. Each participant will receive two cervical dilation examinations from two separate physicians. The main outcome measure is agreement between the two cervical dilation measurements. Secondary outcomes include ease of use of the device and pain levels.

Eligibility Criteria:
Inclusion Criteria:

* The research population is pregnant women in the first stage of labor. Subjects eligible for inclusion in the study must be: pregnant women who are admitted to a Labor and Delivery unit for management or induction of labor in the first stage of labor, are able to give informed consent, are 18 years of age or greater, speak English, and have a gestational age greater than or equal to 37 weeks (i.e. term pregnancy). Patients are only consented if they have adequate pain control, either because they are not yet in labor (i.e. are admitted for an induction of labor) or have a functioning epidural.

Exclusion Criteria:

* Exclusion criteria include progression to the second stage of labor (i.e. known dilation of ten centimeters), known rupture of membranes, any condition that renders labor unsafe for the patient (e.g. cardiac conditions, pulmonary hypertension) and any other condition that necessitates an emergent or urgent cesarean section (e.g. non-reassuring fetal status, placental abruption, hemorrhage, cord prolapse). All participants are necessarily female due to the subject matter. Given the vulnerability of pregnant patients under the age of 18, this study will exclude children. There are no restrictions on eligibility based on race or ethnicity.
Young Adult Hypertension Self-Management Clinical Trial

This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.

Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care.

Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care.

Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Willing and capable of giving written informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Males and females ages 18-39 years old at the start of the study (inclusive)
* A minimum of two hypertension ICD-10 coded visits with a provider (physician \[MD, DO\], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months
* Medically homed at an IRB approved healthcare system

Exclusion Criteria:

* History of medically determined Congestive Heart Failure
* Unable to provide informed consent (i.e., activated healthcare power of attorney)
* Unable or unwilling to travel to local clinic for research visits
* Currently residing in a skilled nursing facility
* Diagnosed with sickle cell anemia or cystic fibrosis
* Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years
* Syncope while exercising or doing strenuous activity within past 12 months
* Currently prescribed warfarin, novel oral anticoagulant, or insulin
* Planned organ transplant or prior transplant in the past 5 years
* Chemotherapy or radiation therapy within 6 the past months
* Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment
* Current participation or planning to participate in another clinical trial in the next 12 months
* Pregnant or planning to become pregnant in the next 12 months
* Planning to leave the geographic area in the next 6 months
* Health condition that will limit both increasing physical activity and changing diet
* Illegal drug use (other than marijuana) in the past 30 days
* Unable to read or communicate in English
* Currently on dialysis or seeing a Nephrologist
* Unaware or denies history of high blood pressure or hypertension
* Between-arm blood pressure difference \>20 mmHg
* White Coat Hypertension (24-hour ambulatory monitoring)
* Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators
* Prisoners
STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)

To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC)

This is a multicentre, randomised, phase II trial which aims to compare the combination of hydroxychloroquine and gemcitabine/carboplatin versus standard carboplatin/etoposide chemotherapy, as first line treat in patients with stage IV disease.

The standard first line chemotherapy treatment remains a platinum-based chemotherapy and this has been unchanged for 20 years. Novel active treatment approaches are urgently needed to improve survival in SCLC.

Patients are randomised to one of two treatment arms; carboplatin/etoposide or gemcitabine/carboplatin/hydroxychloroquine.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed SCLC
* Stage IV disease
* Performance status ECOG 0-2
* Life expectancy \>8 weeks
* Age 18 or over
* Willing and able to give informed consent
* Patient considered able to tolerate chemotherapy
* Adequate renal function - defined by GFR ≥50mL/min as measured by EDTA or C\&G
* Adequate bone marrow reserve: Absolute neutrophil count ≥1.5 x 109/L, haemoglobin ≥90 g/L, platelet count ≥100 x 109/L
* Negative pregnancy test for WCBP
* Highly effective contraception is mandatory for all patients of reproductive potential
* At least one site of measurable disease (target lesion) for RECIST 1.1 evaluation
* Hypersensitivity or history of severe allergic reaction to any of the IMPs
* Able to swallow medication

Exclusion Criteria:

* Mixed cell histology (i.e. NSCLC and SCLC)
* Prior macular degeneration or diabetic retinopathy
* History of glaucoma
* Patients with abnormal LFTs (ALP, ALT/AST\*) that are ≥3 x ULN (≥5 x ULN for patients with liver metastases)
* Patients with abnormal bilirubin levels that are ≥1.5 x ULN
* Prior treatment for this disease e.g. chemotherapy, surgery, radiotherapy (except palliative radiotherapy to bone metastases)
* Documented side effects to chloroquine or related agents
* Treatment with chloroquine or related agents within the last year prior to randomisation
* Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
* Previous medical history of prolonged QT interval
* A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
* Patients with symptomatic brain metastases
* Women who are breastfeeding
* Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs e.g. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine
* Patients who are unable to have their digoxin levels regularly monitored

  * if both ALT and AST performed then both need to be recorded
Study Evaluating rhIL-11 in Active Crohn's Disease

The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index \[CDAI\] score from 220-400).


Eligibility Criteria:
Inclusion Criteria:

* Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
* Men and women age 16 years and over.
* Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease)

Exclusion Criteria:

Use of the following medications within the specified time period prior to randomization:

* Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 \[COX-2\] inhibitors and \>500 mg/day acetylsalicylic acid)
* Codeine-containing compounds
* Corticosteroid enemas
Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

The purpose of this study is to test the effectiveness of evidence-informed mobile apps, Myeloma Coach and CLL Coach. These apps have been developed to help manage the physical and emotional symptoms experienced by multiple myeloma and chronic lymphocytic leukemia survivors. This study hopes to determine if a mobile app is a useful tool to help people manage commonly reported symptoms related to Multiple Myeloma (MM) and chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Be a resident of the United States of America;
* Be able to read and write English
* Consistent access to the internet via a smartphone, tablet or computer
* Have a diagnosis of multiple myeloma or chronic lymphocytic leukemia
Effects of Concurrent Training on Physical Fitness and Body Composition in Obese Individuals

Ample evidence demonstrates the beneficial role of physical activity combined with a structured dietary plan to counteract obesity. International guidelines as the World Health Organization states that to improve fitness levels at least 150 min a week of physical activity at moderate intensity, combined with resistance training composed of 8-12 repetitions with an intensity of 60-70%1RM for each muscle group, are recommended. In this regard, a minimum dosage of 60-90 min of physical activity composed by aerobic exercises in alternation with resistance training protocols, allow a sequential development of cardiorespiratory fitness and muscular strength parameters avoiding potential interference effects. Interference may occur when strength and endurance stimuli both target opposite peripheral adaptations (e.g., hypertrophy vs. muscle capillarization) and this phenomenon seems to be particularly clear during adolescence. Nevertheless, the incorporation of different training stimuli within the same training session is called Concurrent Training. This training mode, thanks to the activation of two different metabolic pathways (e.g., aerobic and anaerobic), has a variety, beneficial effects in terms of muscle mass and strength development, body composition profile regulation and neuromotor function improvement. Concurrent Training seems to be effective not only in normal-weight subjects, but also in obese individuals, reporting positive adaptations on physical fitness and health status compared with a single-mode (i.e., aerobic or strength training). Therefore, the aim of this study is to detect the effects of a 10-week-Concurrent Training protocol compared with a single training modality on physical fitness, body composition and circadian rhythms in adult outpatients with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Physical activity frequency minor of 2 days/week
* BMI major of 30 kg/m2
* informed consent signature

Exclusion Criteria:

* age over 65 years
* knee or hip pain (visual analogue scale score \>7 arbitrary units
* a history of hip, knee or foot replacement or osteoarthrosis
* cardiac infarction
* neurological impairments or any other clinical condition that affects the practice of physical activity
Analysis of Shoulder Muscle Activity During Isokinetic Evaluation of Rotators

The objective of this study is to assess the impact of different positions of the glenohumeral joint on the maximum muscle contraction of different shoulder muscles. The muscles do not contract with the same intensity depending on the position of the arm in relation to the trunk. With the determination of this optimal position to activate the shoulder muscles as much as possible, we will be able to strengthen the patients during their revalidation.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 18-35.
* Playing a sport using the upper limb (handball, volleyball, swimming, tennis) at least 6h/week

Exclusion Criteria:

* Pain in the shoulder
* Shoulder pathologies such as gleno-humeral dislocation, tendinopathy, sub-acromial conflict, etc.
* History of shoulder surgery (prosthesis, stabilizing surgery, etc.)
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.

Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent and comply with study assessment for the duration of one year
* Age \>= 25 years
* Polypoidal Choroidal Vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
* BCVA using ETDRS 20/32 to 20/400

Exclusion Criteria:

* Any history of previous vitrectomy
* Previous cataract or ocular surgery within 2 months of day 0
* Active intraocular inflammation in the study eye
* Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Participation with another investigational drug within the past 30 days
* Prior sodium pegaptanib, verteporfin photodynamic therapy, intravitreal steroids, or bevacizumab within 30 days of study entry
* Blood pressure \>180/110 (use of antihypertensives is allowed as long as hypertension can be controlled and is stable)
* Pregnancy
650nm Low-level Red-light for Myopia Control and Prevention in Children

A multicenter randomized controlled trial, evaluating the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children. Participants included children(aged 6 to 12 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.

This multicenter randomized controlled trial will be conducted in three hospitals: Beijing Tongren Hospital, and another two subcenters. The whole study will last for five years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up and the end of the study. The intervention measure used will be 650 nm low-level red-light. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 12 years
* The cycloplegic spherical equivalent error (SER) is -6D to 1D (\> -6D, ≤1D) in both eyes
* Astigmatism of 2.5 D or less (≤2.5D)
* Willing to participate in the study and sign the informed consent form

Exclusion Criteria:

* Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens
* With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia
* With refractive media opacification (keratopathy, lens opacity, etc.)
* Allergy to cycloplegia drugs
Observational Study of Cortical Spreading Depression in Human Brain Trauma

Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of medical management of TBI is preventing secondary injury that can be life-threatening and worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments.

In preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of TBI patients in the first week after injury. Spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research has shown that spreading depressions can cause secondary injury to the brain.

The primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from TBI. Results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the TBI patient.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* diagnosis of TBI
* craniotomy performed as per required treatment of TBI
* craniotomy surgery \< 7 days after TBI
* GCS\<13 at time of decision for surgery
* expected neuromonitoring for \>72 hr

Exclusion Criteria:

* any failure to meet above criteria
* pregnancy
* GCS 3 with fixed, dilated pupils
Acute Effects of Smoking on Airway Dendritic Cells

Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells.


Eligibility Criteria:
Inclusion Criteria:

* Active smoking (at least 10 cigarettes per day)
* Age \> 18 years

Exclusion Criteria:

* Any chronic diseases
* Any regular medication
* Any signs or symptoms of an acute infection
Inflammatory Response in Appendicitis

Although the presence of SIRS has been described in patients with appendicitis, its progressive response related and together with progression of symptomatology from the onset of symptoms to diagnostic has not been characterized. Continuation of the systemic inflammation in patients with injury and infectious processes may result in multiple organ dysfunction and ultimately failure. As with any acute inflammatory condition, the patients' systemic inflammatory response to appendicitis will progress and become more intense with the passing of time. The purpose of this study is to characterize the systemic inflammatory response to appendicitis from the beginning of symptoms to diagnostic in patients with appendicitis submitted to emergency surgery.

* A prospective non-interventional, observational, descriptive study was conducted.
* At our institution a median of 250 adult patients are submitted to emergency appendectomy every year. From this universe, a sample of 152 patients with a power of 80%, an error of 5% and 95% Confidence Intervals was required to perform this study.
* We included 268 patients in the database, of them 85 cases that did not comply with the inclusion criteria were excluded from the analysis. A total of 183 patients (100%) selected according to the following criteria were studied: Patients with appendicitis confirmed by histology operated on our institutional Emergency Unit with an age range from 15 to 80 years.
* Any patient with immunosuppressive or immunodeppressive known pathological conditions was excluded, as well as any patient with a pathological report describing a normal appendix.
* Patients were divided into four groups according to the interval of time calculated from the onset of symptoms to diagnostic: Group I from 0 to 24 h, Group II from 25 to 48 h, Group III from 49 to 72 h and Group IV more than 73 h.
* At admission demographic, clinical data, and the interval of time from the onset of symptoms to diagnostic was recorded, together with the White Blood Cell (WBC) count, C-reactive protein (CRP) values, and SIRS score.
* The primary outcome measure was to determine the expected systemic inflammatory response to acute appendicitis according to established groups of time intervals from the onset of symptoms to diagnostic using the SIRS for that purpose.
* The secondary outcome measure was the analysis of the CRP to measure the systemic inflammatory response, as another parameter which is habitually included within the diagnostic study of patients with suspected appendicitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with appendicitis

Exclusion Criteria:

* Any patient with immunosuppressive or immunodeppressive known pathological conditions
* Any patient with a pathological report describing a normal appendix
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)

This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites.

The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.

Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age.
* Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP, VABP, and/or bacteremia.
* Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.

Exclusion Criteria:

* none
Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan

The purpose of this observational study was to assess the safety and efficacy of generic mycophenolate mofetil in de novo renal transplant patients in Jordan where no visits or intervention(s) additional to the daily practice were performed.

A single center, observational, open-label, longitudinal, prospective study combined with retrospective data collection for 12 de novo renal transplant patients. Ten patients were prospectively followed for 12 months after receiving MyOra® (mycophenolate mofetil) and two patients were previously on MyOra® (mycophenolate mofetil), thus their data was retrospectively collected from their hospital records and all relevant workup tests results. Outcomes include occurrence of AEs and proportion of patients with normal graft function.

Eligibility Criteria:
Inclusion Criteria:

* Patient received de novo renal transplant
* Patient treated with MyOra® according to the attending physician's judgment (either post-transplant or induction)
* Patient provided written informed consent

Exclusion Criteria:

* Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the constituents of MyOra®