cyrilzakka/clinical-trials huggingface dataset:
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix

The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.

Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* Cervical length as measured on transvaginal examination \< 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
* Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization

Exclusion Criteria:

* Multifetal gestation
* Progesterone treatment after 14 weeks 6 days during current pregnancy
* Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
* Amniotic membranes prolapsed beyond external os
* Preterm rupture of membranes
* Fetal anomaly
* Pregnancy without a viable fetus
* Current or planned cervical cerclage
* Congenital Mullerian abnormality of the uterus
* Contraindication to intra-muscular injections
* Hypertension requiring medication
* Diabetes managed with insulin or oral hypoglycemic agents
* DES exposure
* Cervical surgery such as cold knife conization
* Planned indicated preterm delivery
* Participation in another interventional study that influences age at delivery
* Participation in this trial in a previous pregnancy
* Prenatal care or delivery planned outside a MFMU Network center
Inpatient Sleep Loss: Educating and Empowering Patients

While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is plausible that partnering directly with patients can mitigate sleep loss and improve health outcomes. Patients will be randomized to receive the I-SLEEP education and empowerment program and test the effectiveness of this program on patient sleep and health outcome in the hospital and post-discharge. The aim of the project is to reduce environmental, healthcare-related, and patient-related factors that disrupt sleep of hospitalized patients by use of patient education and empowerment intervention.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the general/hospitalist medicine departments
* Stayed at least one night in hospital since admission

Exclusion Criteria:

* Admitted \>72 hours ago
* Patient has been diagnosed with a sleep disorder such as narcolepsy, insomnia, or sleep apnea
* Patient was transferred from ICU or outside hospital
* Patient under strict, droplet, or airborne isolation precautions
* Unable to ambulate
* Too confused or incoherent to provide consent
* Patient cannot speak English
* Pregnancy
* Residence in a nursing home or assisted living facility
* Patient was admitted in a hospital within two weeks of current admission
Impact of Time to Coronary Angiography on Survival for NSTEMI

This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI.

The use of an invasive strategy for the management of NSTEMI according to estimated risk of 6 month mortality is recommended by international guidelines. NSTEMI appropriate for coronary angiography (and percutaneous intervention) have better outcomes compare with NSTEMI who are medically managed. Whilst the national and international guidelines recommend that the timing of (in-hospital) coronary angiography (\<24, 24-72, 72-96 and \<96 hours) is based upon estimated clinical risk (using the GRACE risk score) there is scientific and clinical uncertainty as to the incremental benefit that more urgent invasive treatments strategies have over and above that of delayed strategies. Moreover, the investigators recent research has shown that in the UK, may NSTEMI (eligible) for coronary angiography fail to achieve care according to the recommended time thresholds, and this is associated with potentially avoidable premature death.

This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI. It will characterise patients according to their estimated risk of death, their time to angiography, and associated outcomes. The investigators anticipate that this observational study will provide Level B evidence for the benefits of the timing of an invasive strategy according to the GRACE risk score. The investigators are aware that the NICE guidelines for the management of acute chest pain are to be updated in 2016.

Eligibility Criteria:
Inclusion Criteria:

* The target population will be all patients aged 18 to 100 years recorded within MINAP from 2004 to 2013 who have been hospitalised with NSTEMI and received coronary angiography.

Exclusion Criteria:

* Age below 18 or above 100 or age missing
* Diagnosis not NSTEMI
* Patients who did not receive coronary angiography - as this is the investigators explanatory variable
The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke

Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.


Eligibility Criteria:
Inclusion Criteria:

* the first-time onset or previous stroke with mRS score ≤1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ;

  * age range of 18 to 80 years old;

    * patients with a clinical diagnosis of acute ischemic stroke; ④ NIHSS score ≥4; ⑤ patients volunteer to participate in this study and signed a written informed consent

Exclusion Criteria:

* ①the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect;

  * the patients exhibited serious heart, live or kidney diseases; ③disturbance of consciousness or mental illness; ④ patients with tumor; ⑤ pregnant and lactating patients.
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)

A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder


Eligibility Criteria:
Inclusion Criteria:

* Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.
* Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level \>40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:

  1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
  2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
  3. a change in duration (absolute change of 2 or more days); or
  4. periods of amenorrhea lasting at least 3 months.
* A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
* A Montgomery and Asberg Depression Rating Scale (MADRS) total score \>=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.

Exclusion Criteria:

* Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
* Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of \>=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
* Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
Study Evaluating rFIX; BeneFIX® in Hemophilia B

The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).


Eligibility Criteria:
Inclusion Criteria:

* Hemophilia B (FIX:C less than 2%)
* Previous treatment of at least 150 exposure days using any FIX product
* 12 years of age and older

Exclusion Criteria:

* The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
* Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
* Patient has a genetic coagulation disorder other than hemophilia B
Use of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.

Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
* In need for CSF drainage based on clinical judgment

Exclusion Criteria:

* intraventricular clots
* intraparenchymal clots causing midline shift
* pregnancy
Bacteriophage Therapy in Patients With Prosthetic Joint Infections

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.

Eligibility Criteria:
General Inclusion Criteria:

* Males or females ≥18 years of age.
* Female patients of childbearing potential who agree to use contraception.
* Candidate for a two-stage exchange arthroplasty.
* Chronic prosthetic joint infection

General Exclusion Criteria:

* Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
* Soft tissue defect requiring reconstruction
* Hardware misalignment or loosening
* Active osteomyelitis
* Septic shock or hemodynamic instability
* Stage 4 or greater chronic kidney disease
* Liver disease
* Decompensated cirrhosis
* Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
* Decompensated heart failure
* Any other clinically significant disease, per judgement of the investigator
* Neutropenia (neutrophil count \< 1000 cells/cubic mm), thrombocytopenia (platelets \< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 3 time the upper limit of normal
* HIV, hepatitis C, hepatitis B infection
* Positive drug screen
* Receipt of chemotherapy, immunosuppressants or immune modulators
* Anti-viral medication
* Any known phage allergy
* Breast feeding or pregnancy
Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery

This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.

Obesity is a public health problem. Currently, the best treatment is surgery. However, 15% of patients after surgery have problems such as nausea, pain, vomiting, heartburn or regurgitation. To investigate these problems, an endoscopy is used. Yet, endoscopy has some disadvantages such as the need for intravenous sedation, need to take time off work, need for special endoscopy units and nurses and a delay in diagnosing because the endoscopy cannot be done at the time of the clinic visit. A new technology called clinic-based nasopharyngoendoscopy can potentially solve many of the problems with the current endoscopy. This study aims to determine that this new technology is just as effective in diagnosing problems as the current gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Post-operative gastric bypass patients at St. Joseph's Healthcare Hamilton
* No previous nasal or pharyngeal surgery
* Foregut dyspeptic symptoms including: nausea, vomiting, regurgitation, epigastric pain, reflux and/or hematemesis
* Require endoscopy for investigation of foregut symptoms
* Able to provide consent

Exclusion Criteria:

* Patients who have not undergone gastric bypass surgery
* Inability to give consent
PRINCE Study - Cohort Study of Healthy Pregnant Women Followed by the Assessment of Children´s Health and Immunity

In the PRINCE study we recruit healthy but also diseased pregnant women into a cohort study, followed by the assessment of children´s health and immunity at birth and during the first 10 years of life. This unique cohort allows for testing the impact of prenatal challenges on children´s health.

Children´s Health is critically dependent of the prenatal well-being of the mother, and a number of observational studies have identified an impaired immunity in children upon prenatal challenges, such as stress perception, medication, nutrition or infection. However, concerted, in-depth studies assessing how such prenatal challenges may alter fetal development and subsequently children´s health in humans are largely lacking. In the present project, we address this limitation by recruiting healthy, but also diseased pregnant women into a cohort study, followed up by the assessment of children´s health and immunity at birth and during the first ten years of life.

Study participants are recruited early in the first trimester (12-15 weeks of gestation). By means of data security all participants receive a study number. Data processing into the data base (Redcap) is performed under this pseudonym.

During the first visit, the study team explains the enrollment conditions and the participants are asked to give their consent. Study visits include the documentation of clinically important conditions, sonographic examination of the fetus, assessment of mother´s height and weight as well as blood collection (21 ml) of the mother. Additionally we document any kind of medication-intake and nutrition data, and the participants are asked to fill in a psychometric questionnaire. Study visits are scheduled according to the week of gestation, i.e. around 13th, 20th (ultrasound only), 24th, 28th, 34th week. If women give birth in our clinic, we are able to collect cord blood after birth.

Blood samples are processed immediately and stored in our laboratory under Biobank-conditions.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* \>18 years of age
* able to understand and sign the papers of consent
* singleton pregnancy

Exclusion Criteria: :

* \<18 years of age
* unable to give consent
* multiple pregnancy
* nicotine abuse
* fetal aberration
Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient

This study evaluates the risk factors for difficult tracheal intubation in in obstructive sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)

OSAHS patients are high risk group of difficult tracheal intubation. In clinical application, unexpected difficult tracheal intubation is not rare. Difficult airway is a significant problem to these patients and the physicans in terms of mortality and morbidity.

This study collects risk factors as physical examinations（including modified Mallampati grade, neck circumference, lateral clinical craniofacial assessment and body mass index ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using statistics method, predictive model to manage risks would be established.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as OSAHS.
* receive UPPP under general anesthesia in Beijing Tsinghua Changgung Hospital
* ASA grade I or II

Exclusion Criteria:

* ASA grade III or above
* had received UPPP
* had fore-teeth loosed
* obstructive sleep apnea hypopnea were caused by hypothyroidism, acromegaly, or vocal cord paralysis.
Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.

Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.

For standardization, the block procedure will be performed by an experienced anesthesiologist who has completed at least 20 previous successful and uncomplicated procedures.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 35 kg/m² Patients with ASA scores I and II

Exclusion Criteria:

* Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA \> 3 BMI \> 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site
Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

The purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. The long-term goal of exposure psychotherapy is to improve the mental health of U.S. service members and veterans with military-related PTSD. Recovery from PTSD will reduce the economic burden not only for those persons experiencing PTSD, but also for the health care system and society as a whole (Galovski \& Lyons, 2004).

This study will provide an evaluation of performance and suitability of the compressed versions of exposure psychotherapy to support the capability gap for the treatment of active duty service members and veterans with PTSD by comparing different exposure psychotherapy modalities. The overall objective of this study is to determine if compressed psychotherapy can be used as an effective alternative treatment for PTSD and to compare the impact of TMT and PE on social, familial, and occupational impairment. The primary objectives will be to compare 1) 3 week TMT with 12 week PE and 2) 3 week TMT with 2 week PE for the effectiveness of reducing PTSD symptoms in a gated approach or some other method to control for multiplicity. Outcomes will be determined based upon self-report, clinician ratings, as well as other aspects of psychopathology, and social/emotional functioning. The addition of the TMT group component will be assessed in particular to determine its impact on social, familial, and occupational impairment. Blood samples should be collected from participants at baseline and at the end of the treatment period in order to identify PTSD biomarkers, e.g. predictors of response, biological subtypes of PTSD, and therapeutic markers. Collection, storage, and transfer of the blood samples to DoD should be performed according to standardized protocols provided by the DoD. One or more site visits may occur in order to assess adherence to standardized protocols.

Eligibility Criteria:
Inclusion Criteria:

* Active duty military personnel with a diagnoses of PTSD
* Traumatic event must have occurred during military service
* Military sexual trauma limited to attempted or completed sexual assault.

Exclusion Criteria:

* Acute cardiac difficulties
* Severe comorbid substance use disorders.
* Diagnosis of schizophrenia or other psychotic disorders
* Diagnosis of antisocial personality disorder
* Moderate or severe traumatic brain injury (TBI)
* Use of benzodiazepines