cyrilzakka/clinical-trials huggingface dataset:
Fetal Pulse Oximetry Trial (FOX)

The purpose of this study is to determine if the information provided to the physician by a fetal pulse oximeter during labor will reduce the chances of a cesarean delivery.

Information on fetal well-being during labor is of great importance to the managing physician. The current use of the fetal heart rate monitor provides some information on fetal condition, and is the primary tool used to determine if immediate operative delivery is required. The fetal pulse oximeter can provide additional information regarding fetal oxygen saturation.

Intervention: A fetal oxygen saturation sensor is placed in the uterus, between the fetal cheek or forehead and the uterine wall. In half of the patients, the managing physician will have access to fetal oxygen saturation and fetal heart rate monitoring. In the other half of the patients, labor will be monitored by fetal heart rate alone.

Study hypothesis: The additional information provided by the use of the fetal pulse oximeter will reduce the chances of a cesarean delivery. The primary outcome is cesarean section for any indication and secondary outcomes are cesarean delivery for non-reassuring fetal heart rate or dystocia, and neonatal morbidity.

Eligibility Criteria:
Inclusion criteria:

* Nulliparous
* Singleton, cephalic pregnancy
* Gestational age at least 36 weeks, 0 days
* Cervical dilatation \>= 2 cm
* Station -2 or below (5ths scale)
* Ruptured membranes
* Internal monitoring devices placed

Exclusion criteria:

* Need for immediate delivery
* Planned cesarean delivery
* Cervical dilatation \> 6 cm
* Known fetal anomaly or demise
* Multifetal gestation
* Maternal fever
* Placenta previa
* Previous uterine surgery
* Active HSV infection
* Known HIV or hepatitis infection
* Diabetes requiring insulin
* Heart disease requiring medication
* Known chronic renal disease
* Enrollment in another labor study
A Home Visiting Program for Pregnant Youth to Promote Early Brain Development II

Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 21 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Low socioeconomic status
* Mother's age between 14-19
* Mother being a primapara
* Gestation between the 8th and 16th week

Exclusion Criteria:

* High-risk gestation
* Mother's Intellectual, visual or auditory disability
Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.


Eligibility Criteria:
Inclusion Criteria:

* AHI \>15 on the diagnostic portion of the study
* \>18 years of age

Exclusion Criteria:

* Significant Central Apnea
* Congestive Heart Failure
* Inability to give informed consent
* Patient intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate
A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users

This single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. The abuse potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety Follow-up visit (Visit 4).

Subjects will be randomized to 1 of 10 treatment sequences according to a two 5 x 5 William squares design. To maintain blinding, subjects will be required to ingest eight capsules with approximately 240 mL water on each study drug administration day.

Serial pharmacodynamic (PD) evaluations will be conducted up to 24 hours after each study drug administration. Pharmacokinetic (PK) samples will be obtained to confirm exposure to EB-1020. Safety monitoring will include recording of adverse events (AEs), regular assessments of vital signs measurements, 12-lead electrocardiogram (ECG) findings, and continuous telemetry monitoring for at least 3 hours after study drug administration.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be healthy male nondependent recreational drug users
2. Subjects must be 18 to 55 years old, inclusive.
3. Subjects must have greater than or equal to 10 lifetime nontherapeutic experiences with central nervous system (CNS) stimulants (e.g., amphetamines, cocaine, methylphenidate), greater than or equal to 1 nontherapeutic use of prescription stimulants within the 12 months prior to Screening, and greater than or equal to 1 nontherapeutic use of a CNS stimulant within the 12 weeks prior to Screening.

Exclusion Criteria:

1. Subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason.
2. Subjects who do not pass Qualification Phase criteria to be eligible for the Treatment Phase.
Cognitive Impairment and Balance in Elderly

One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.

Mild cognitive impairment is described as a transitional stage between normal ageing and dementia, and reflects the clinical situation where a person has memory complaints and objective evidence of cognitive impairment but no evidence of dementia. Mild cognitive is important in older people and it is also important to evaluate its repercussion in balance.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents.

Exclusion Criteria:

* Surgery on lower limbs.
* Traumatic damage on lower limbs.
* Severe cognitive impairment in order not to complete the assessment.
Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU

There is currently no good description of patients surviving an episode of acute hypercapnic respiratory failure in the ICU. For instance, the prevalence of OSA and sleep hypoventilation in a stable clinical condition is not known in this population.

This prospective cohort describes the clinical profile, predictors of readmission (followed over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a stable clinical condition 3 months after ICU discharge) in patients treated for an episode of acute hypercapnic respiratory failure in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years Informed consent surviving an episode of acute hypercapnic respiratory failure

Exclusion Criteria:

* iatrogenic hypercpania pregnant woman
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).


Eligibility Criteria:
Inclusion Criteria:

.1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either

* Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
* Medical intolerance to anti-viral therapies including:

  * 2 renal toxicity with cidofovir or other \> grade 2 toxicities secondary to cidofovir And/or
* known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

1.3 Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test

Exclusion:

1. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion
2. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
4. Thymoglobulin (ATG) or Alemtuzumab within 30 days
5. Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.
7. Any medical condition which could compromise participation in the study according to the investigator's assessment
8. Known HIV infection
9. Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
10. Known hypersensitivity to iron dextran
11. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
12. Known human anti-mouse antibodies
Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience

over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.

Data was collected from records in a retrospective cohort study


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with newly diagnosed colorectal cancer
* Age \> 18 years old
* recurrent cases of colorectal cancer

Exclusion Criteria:

* Pediartric patient less than 18 yr
* In operable or metastatic cancer colon
* No other malignancies
Reminders Through Association & Prescription Adherence

The purpose of this study is to develop behavioral interventions that provide effective tools that policy makers can use to help individuals avoid forgetting to follow-through on important behaviors and for individuals to use to help themselves. In the investigators past research, they have shown that reminders through association work in the lab setting. The investigators seek to understand how this strategy can work in the field, especially when people are trying to fulfill a health outcome.

Participants enter an online survey where they are asked to confirm that they plan to pick up a prescription, state what day they plan to pick up their prescription, and indicate the type of location where the prescription will be picked up (e.g., pharmacy, hospital, doctors office, etc.). Participants are asked to participate in a prescription reminder program in which they will receive up to eight text messages from the researchers and send up to three text messages to the researchers. Participants are then quizzed about the reminder program to ensure they understand what they are signing up for. Participants are further told that if they follow the directions outlined in the program they will be compensated for participating in this survey via their phone number.

Participants who wish to enroll in the reminder program will initiate the text messaging by texting "STARTXXXX" to number provided. This validates that the participants received the message, have the capacity to text, and are willing to text. Participants are then randomly assigned to one of three conditions. In the treatment condition, participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription. In the active control condition, participants will be asked to think about where they will store their prescription. Participants in the baseline control condition will simply be thanked for enrolling.

Participants in the treatment and active control conditions then receive a series of text messages prior to the scheduled pick up date reminding them to pick up their medication. In addition, the text message will prompt participants to text a picture of their prescription receipt to validate that they followed-through on their behavior. If participants text us a picture of their receipt that follows the guidelines outlined in the survey, participants are compensated.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be capable of sending and receiving text and picture messages on their phone.

Exclusion Criteria:

* Participants will only be excluded if they participated in the pilot study in which the investigators enrolled 150 participants. These participants will be excluded when they attempt to text the investigators to enroll.
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.

In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age 18\~80 years old
3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
4. Fasting TG≤4.5mmol/L by central laboratory at screening
5. Statin intolerance subject must have a history of statin intolerance as evidenced

Exclusion Criteria:

1. History of hemorrhagic stroke
2. NYHA III or IV heart failure, or known LVEF\< 30% within 1 year before randomization
3. Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
5. Planned cardiac surgery or revascularization
6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \> 160 mmHg or diastolic BP (DBP) \> 100 mmHg
7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
8. Others factors not suitable for participation judged by PI
An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on fMRI in the Treatment of Tic Disorder

continuous theta burst stimulation (cTBS) is a safe and effective device for Gilles de la Tourette's syndrome treatment. GPi is an agreed curative target of deep brain stimulation. GPi-based functional connectivity peak voxel in the SMA can be the cTBS target.

Tic disorder is a common neuropsychiatric disorder in children and adolescents. Medication is not effective and has side effect. Exploring new treatment methods is one of the research pathway of this disease.Continuous theta burst stimulation (cTBS) is relatively safe and effective, and its efficacy in psychiatric diseases has been gradually recognized. However, the results of current researches of tic disorder treatment are varied, and the evaluation method is relatively single. This project intends to adopt fmri-guided stimulation target and navigated cTBS to intervene patients with tics and explore individualized cTBS treatment parameters of tics, including stimulation frequency, intensity, type, time and stimulation target. Previous studies for deep brain stimulation reported that the medial globus pallidus (GPi) showed an obvious curative effect. And a deep brain area can be modulated indirectly by a superficial target via functional connectivity. Therefore, the present study attempts to stimulate the superficial target in supplementary motor area (SMA), lateral motor area (M1) which functionally connected with GPi or thalamus since the thalamus also a commonly reported abnormal brain area of Tic. Combined with clinical symptoms and neuroimaging, the therapeutic effect of cTBS in children with tic disorder was comprehensively evaluated in order to provide a new therapeutic method and a better therapeutic effect for the disease.

Eligibility Criteria:
Inclusion Criteria:

1. meet the diagnostic criteria of chronic tic disorder or tourette syndrome;
2. Yale Global Tic Severity Scale (YGTSS) score is greater than 20;
3. the symptoms lasted more than 1 year, and the drug regimen was not adjusted within one month;
4. right-handedness;
5. age 6-20 years;
6. able to receive continuous theta burst stimulation (cTBS) therapy, participants and their guardians agree to receive treatment and observation.

Exclusion Criteria:

1. age is under 6-year old;
2. can not tolerate MRI or cTBS treatment;
3. adjust medication during treatment.
Improved Patient Handoffs to Prevent Sentinel Events

The overall aim of this project is to improve the quality of the handoffs between hospitalists on the general medicine service at Durham Regional Hospital with the intent of improving transitions of care. The intervention will be an improved and more structured face to face sign-out process using a standardized admission sign-out sheet, which is not part of the official medical record. Daytime admitting physicians will assign an acuity score to their patients in which the severity of illness will be scored from 1-7, with 7 being the most sick / likely to have rapid response team (RRT) or adverse event. The assignment of this score would be based off of the clinician's judgment in the patient's overall assessment. All patients, age \>18 years, admitted to the non-resident hospital medicine general medicine service at DRH will be study eligible. Data analysis will examine aggregate hospitalist perception of sign-out practice before and after intervention, total number of RRTs, unplanned transfers, and rapid responses pre and post intervention, percentage of hospitalist based patients of overall rapid responses pre and post intervention, percentage of hospitalists using acuity scores, and average and mean severity score of patients with rapid responses compared with those admitted. Patients have a risk of loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* patients age \>18 years
* admitted to the non-resident hospital medicine general medicine service at Durham Regional Hospital (DRH). (This would include transfers from outside hospital, the Emergency Room, intensive care units, and the Durham Rehab Institute.)
* Additionally, hospital medicine faculty who round on the non-resident general medicine service at DRH will be included for the purposes of completion of perception surveys.

Exclusion Criteria:

* Patients presenting for consults, rapid responses handled by surgical services and rapid responses as reason for transfer from Durham Rehabilitation Institute.
The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients

Parkinson's disease (PD) is a chronic, progressive disease that causes motor and non-motor symptoms due to dopaminergic neuron loss. Today, the treatment of PD in addition to optimal medical and surgical treatments, physiotherapy and rehabilitation approaches have an important place in the treatment. Recently, it has been stated that intensive rehabilitation interventions in the field of physiotherapy and rehabilitation can be more effective than traditional rehabilitation approaches. Lee Silverman VoiceTreatment- BIG (LSVT-BIG) is a high-intensity exercise model aimed at improving bradykinesia and hypokinesia in PD. There are many studies showing improvements in balance, walking, motor performance, reaching ability, postural control, quality of life and cognitive status after LSVT-BIG training in PD. However, it is seen that there is no study investigating the effect of LSVT-BIG training directly by applying it as a home program. For this reason, there is a need for studies investigating whether this intensive treatment method can be an alternative to the clinical environment by applying it as a home program.

This study is planned as a randomized control trial. Patients will be randomly divided into two groups a clinical group and a home group. The clinical group will be received LSVT-BIG training four times a week for four weeks in the clinic. The home group will be received LSVT-BIG training two times a week for four weeks at the home and two times a week for four weeks at the clinical.

All assessments will be done before and after the 4-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken. The outcome measures are balance and gait assessments.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* Having diagnosed with "Parkinson's Disease" by a specialist physician
* Having between 1-3 stages according to the Hoehn and Yahr Scale
* Mini-Mental Test score more than or equal 24

Exclusion Criteria:

- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results