cyrilzakka/clinical-trials huggingface dataset:
Critical Illness Outcomes Study

We will test whether the way that an intensive care unit is organized can influence patient related outcomes such as mortality. We will test whether who works in the ICU, and how the ICU is managed will affect the care received by patients. The primary study hypothesis is whether the number of clinical protocols present in an intensive care unit is linked to patient mortality

Title: Do ICU Structural and Procedural Factors Influence Patient Related Outcomes: The Critical Illness Outcome Study (CIOS)

Objectives: This is an exploratory ecologic study designed to examine the organizational and structural factors present in adult intensive care units in the United States. A second objective is to determine whether these organizational and structural factors are associated with patient related outcomes. In addition, we intend to examine whether these organizational and structural issues are associated with patient treatments.

Hypotheses: (Ho) A. The number of protocols used in an ICU is inversely associated with ICU and hospital survival for critically ill patients.

B. Compliance with disease specific protocols is not independently associated with hospital survival for critically ill patients

Specific Aims

1. To describe the organizational structure of participating intensive care units
2. To determine whether the number of protocols used in an intensive care unit is associated with ICU and hospital survival for critically ill patients
3. To determine the frequency with which ICU's follow disease specific protocols for patients with sepsis and ALI

Study Design

1. Prospective ecologic study of 50-60 adult intensive care units and admitted patients
2. ICU organizational and structural data will be collected for each participating ICU
3. 125-200 adult patients in each intensive care unit will be enrolled. Patients within the ICU on a varying, specific day each week will be included. Demographic and treatment variables will be collected for that day on that patient. Outcome data will be collected on ICU and hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

- Hospitalized adult patient in a study ICU on the date of data collection. This includes patients who may be in ICU despite not having critical illness for reasons such as lack of floor beds.

Exclusion Criteria:

-

1. Patient enrolled on previous study collection day 2 Previous enrollment into other study ICU 3. Age \< 18 years
ACR | LAB Urine Analysis Test System Evaluation of Performance

The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm.

The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-80 years of age;
* Subjects who are healthy or pregnant; or
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:

  * Diabetes Type I/Type II,
  * Hypertension,
  * Any kidney disease,
  * Other relevant conditions.
* Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion);
* Subject is capable and willing to provide informed consent;
* Subject has facility with both hands
* Subject is capable and willing to adhere to the study procedures.
Family Planning Intentions and Practices Among Women With Poor Obstetric Outcome

Women who have experienced a stillbirth or neonatal death are at higher risk of repeated poor neonatal outcomes if they have short interpregnancy intervals. Understanding the attitudes surrounding future fertility and contraception in this population is critical to propose socially and culturally acceptable interventions to address an unmet need for family planning.

Participants: Women who have experienced a stillbirth or early neonatal death will be recruited from the postnatal ward of Bwaila Maternity Hospital in Lilongwe, Malawi.

Procedures (methods): This will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each.

The investigators propose a qualitative study of up to 60 women who have experienced a stillbirth or early neonatal death. This will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each. In-depth interviews will be conducted in Chichewa in a private room either within the participants' homes or in another private location determined by the participant.

Each interview will take approximately 60-90 minutes to complete. The focus group discussions will be conducted in a private room in a health facility with 6-10 participants. These will take approximately 90-120 minutes to complete. Interviews and the focus group discussion will be audio-recorded, transcribed, and translated to English. If a participant is found to be eligible, she will be invited to participate in the study. After the investigators complete the in-depth interviews, the investigators will analyze the data and modify our focus group discussion guide as needed to integrate new themes that may have emerged during the individual interviews. The investigators will recruit 6-10 women per focus group (24 to 40 total) from the same hospital that were used to recruit for the individual interviews.

The investigators will search for recurrent patterns and themes in data and for ideas that help to explain the presence of these patterns. The data collection and analysis process is designed to be iterative, such that the investigators will be reviewing data as it is collected and adjusting the data collection instrument to reflect new themes that emerge during the data collection process. All interviews will be audio-recorded, transcribed, translated, coded and computerized for analysis.

Eligibility Criteria:
Inclusion criteria:

1. Current admission to the postpartum ward at Bwaila Hospital,
2. Women who have delivered a stillborn fetus over 28 weeks gestation or with a birthweight \>1000 g or experienced a neonatal demise of a liveborn infant, weighing \>1000 g in the first 7 days of life,
3. Ability to speak Chichewa or English fluently, and
4. Age 18-45 years old.

Exclusion criteria:

* Not willing to be audio-recorded
* Have not experienced stillbirth or early neonatal death
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson

The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Having Parkinson's disease diagnosed by a neurological doctor.
* Having an alteration of the gait caused by the neurological disorder.
* Being able to have an independent and voluntary walk of 10 meters as minimum.
* Height more than 150 cm.

Exclusion Criteria:

* Being blind.
* Medical contraindications for walking.
* Being amputee.
* Alcohol or drugs abuse.
* Other diseases that impedes the intervention.
Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia

Retrograde cardioplegia during heart surgery is associated with inadequate myocardial protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte apoptosis when compared to antegrade cardioplegia. 20 volunteer patients under going elective aortic valve surgery will be divided in to two groups: 10 patients receiving only antegrade cardioplegia and 10 patients receiving only retrograde cardioplegia. Pre- and post-operatively cardiac MRI and cardiac ultrasound will be performed. During the surgery ventricular muscle samples will be taken in order to assess cardiomyocyte apoptosis. Aims of the study: 1. whether the cardiomyocyte apoptosis is significantly more induced after retrograde cardioplegia than antegrade cardioplegia, 2. whether the amount of apoptotic cardiomyocytes correlates to conventional markers of myocardial injury after cardiac surgery, 3. whether the extent of irreversible myocardial damage by apoptosis correlates to post-ischemic contractile dysfunction after cardiac surgery, as measured with echocardiography, 4. whether the amount of cardiomyocyte apoptosis correlates to long term outcome and cardiac function as measured with MRI.


Eligibility Criteria:
Inclusion Criteria:

* aortic valve stenosis or combined aortic valve disease

Exclusion Criteria:

* angiographically verified hemodynamically significant coronary artery disease impaired left ventricular function (left ventricular ejection fraction \<50%) surgery including additional procedures other than aortic valve replacement cancer
Retinopathy of Prematurity:Summary of a Decade

The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.


Eligibility Criteria:
Inclusion Criteria:

* Neonates either with a BW of less than 1501 gram (g) or born at a GA of 34 weeks (wk) or less
* selected infants with an unstable clinical course were included
Reconstruction of the Bile Duct With the Round Ligament

The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.

Eligibility Criteria:
Inclusion Criteria:

1. Radiological or operative diagnosis of bile duct Injury or defect
2. Can underwent surgical procedure

Exclusion Criteria:

1) The absence of the round ligament
Investigating the Functional Characteristics of White Matter Fibers During Wakefulness and Sleep Based on SEEG

This study aims to include electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG electrode contacts traversing the brain's white matter. The collected data will be analyzed to investigate the functional characteristics of white matter fibers during wakefulness and sleep.

Sleep is a crucial function, and its disruption can have multiple effects on health. The daily alternation between sleep and wakefulness is one of the most dominant features of our lives and is a manifestation of the intrinsic 24 h rhythmicity underlying almost every aspect of our physiology.

The cerebral cortex makes up about 80% of the brain's volume and is responsible for many complex phereducednomena, including perception, thought, language, attention and memory. Sleep is considered a global state that influences the coordinated activity of the entire brain.

During sleep, studies have shown that the connectivity between neurons in the cerebral cortex weakens. White matter connects different brain regions, facilitating communication between various neural structures.Our scientific hypothesis is that white matter connectivity should also reduced.

Stereoelectroencephalography (SEEG) can directly record brain signals, providing a new method for tracking of connections between different brain areas, providing a new approach for understanding neuronal functional states and cortical excitability.studying the functional characteristics of white matter fibers during wakefulness and sleep.Based on SEEG and CCEP, this study aims to investigate the functional characteristics of white matter fibers during wakefulness and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Drug-resistant focal epilepsy
* Justified SEEG exploration in the context of presurgical assessment of epilepsy
* Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis
* Written non-opposition to study participation

Exclusion Criteria:

* Pregnant women (Contraindication to SEEG exploration)
* Subjects that experience surgical complications during the implant procedure will be excluded from the study
Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors

The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.

By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement
* KPS ≥ 70, lifespan \> 3 months, PD-L1 TPS of 1% or greater
* Platelet count ≥ 80×10\^9/L，white blood cell count ≥ 3×10\^9/L, neutrophil count ≥ 2×10\^9/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis
* Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.
Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

The study hypothesis (or theory) is that monthly loss of iron before menopause may reduce women's risk of hardening of the arteries, or atherosclerosis.

This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in women entering menopause. This will help to determine if there is a correlation between iron accumulation and hardening of the arteries. In addition, blood levels of hormones will be measured to help show differences due to hormone levels vs. iron accumulation.

Atherosclerosis, or hardening of the arteries, is the underlying disease responsible for the vast majority of cardiovascular morbidity and mortality and afflicted over 30 million Americans in 2005. While the prevalence of atherosclerosis is similar in women and men, women enjoy a \~5-10 year lag in onset of cardiovascular events compared to men. After menopause, a state defined by marked reduction in ovarian hormone production, the incidence of events such as heart attack and stroke caused by atherosclerotic plaque rises up to threefold regardless of age range. This has prompted numerous investigations of hormone therapy (HT) to lower cardiovascular risk to premenopausal levels. Therapeutic trials, however, have not realized a cardiovascular benefit; in fact, initiating HT in large randomized trials did not decrease and possibly increased cardiovascular risk. Studies of coronary heart disease prevention have shown mixed results using estrogen alone vs. estrogen plus progestin, while studies of stroke prevention have consistently shown increased risk with HT. Clearly, different therapeutic interventions warrant consideration. This proposal seeks to investigate a novel perspective using longitudinal clinical studies in women at risk of atherosclerosis. The studies involve a new noncontrast, noninvasive MRI method with blood tests that measure cholesterol, hormone levels, and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* women at least 40 yrs of age
* between 1 and 6 menstrual cycles in the past 12 months
* 2 or more of the following risk factors: high blood pressure, diabetes, high cholesterol, smoking
* no known heart or vascular disease

Exclusion Criteria:

* any known cardiovascular disease such as coronary disease, peripheral vascular disease, heart failure
* contraindication to MRI scan (e.g. aneurysm clip, iron-containing metal)

NOTE that orthopedic hardware is usually MRI-compatible. We will go over detailed screening before enrollment.
Greek Childhood Obesity (GRECO) Study

The purpose of the GRECO study were to: a) to provide national data on overweight and obesity prevalence in a representative sample of primary schoolchildren aged 10-12 years old, b) to identify those socio-economic, demographic factors, as well as dietary and physical activity habits and familial characteristics that are associated with childhood and preadolescent overweight and obesity, c) to identify lifestyle and dietary patterns that are associated with elevated blood pressure levels and dietary sodium intake.


Eligibility Criteria:
Inclusion Criteria:

* Within the age range
* 5th and 6th grade public schools children
* Consent form provided by the parents

Exclusion Criteria:

* Not providing signed parental consent forms
* Outside the required age range
Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles

A good quality embryo and receptive endometrium are important aspects in achieving optimal outcomes in assisted reproductive treatment (ART). Endometrial thickness is an important marker of uterine receptivity. A thin endometrium defined by an endometrial thickness ≤7mm was reported as a poor factor associated with significantly lower implantation and pregnancy rates as well as a higher risk of miscarriage.

Nowadays, platelet-rich plasma (PRP) intrauterine infusion is a promising approach for the treatment of refractory thin endometrium in patients undergoing frozen-thawed embryo transfer. This is based on its ability to stimulate proliferation and angiogenesis with a large number of growth factors and cytokines i.e. the endometrium becomes thicker, with higher vascularity. PRP is easily prepared from an autologous blood sample that eliminates the risk of immunological reactions and transmission infections at low cost.

Endometrial blood flow is another important marker reflective of uterine receptivity. Although publications are increasing concerning the efficacy of PRP intrauterine infusion on endometrial expansion and proliferation in frozen-thawed embryo transfer cycles, yet its angiogenetic effects have not been evaluated so far in either thin endometrium or normal endometrium thickness.

Our study aims to evaluate endometrial and sub-endometrial vasculature patterns before and after PRP infusion in frozen-thawed embryo transfer cycles with normal endometrium thickness.


Eligibility Criteria:
Inclusion Criteria:

* Subfertile women undergoing frozen-thawed embryo transfer with at least previously failed one ICSI cycle.
* Age between 20-35 years.
* Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer cycle

Exclusion Criteria:

* Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.
* Women with known hematological or immunological disorders
* Women with uncontrolled endocrine or other medical conditions, such as hyperprolactinemia or thyroid diseases.
* Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum, bicornuate uterus.
* Women who refuse to participate in the study.
Study of FFI-1010 in Pediatric Kidney Disease

The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.


Eligibility Criteria:
Inclusion Criteria:

* Kidney disease patients requiring exact evaluation of kidney function
* eGFR: \>=30 and \<=89 mL/min/1.73m\^2

Exclusion Criteria:

* Edema on the day before start of study treatment
* Oliguria on the day before start of study treatment
* Dehydration on the day before start of study treatment
* Infection or inflammatory disease before administration
* History of epilepsy or organic brain disorder
* History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease
Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

This is a randomized, placebo-controlled, double blind, parallel group, multicenter study of participants, age 12 to 65 years, with SCD. The key purpose for the study is to establish efficacy and safety of voxelotor as compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female study participants with sickle cell disease
2. Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.
3. Age 12 to 65 years
4. Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening
5. For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.

Exclusion Criteria:

1. More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
2. Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a RBC transfusion for any reason within 60 days of signing the ICF
3. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)
4. Hepatic dysfunction characterized by alanine aminotransferase (ALT) \>4 × upper limit of normal
5. Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit; calculated by the central laboratory) \<30 mL/min/1.73 m\^2 or on chronic dialysis