cyrilzakka/clinical-trials huggingface dataset:
Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules

Investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.

At present, low-dose scanning protocol is widely used in computed tomography-guided interventions because these procedures usually require repeat scans, which causes more radiation exposure to the patients. Computed tomography-guided core needle biopsy is widely used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. Compared with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules might require more scanning to adjust the position of needle tip. Therefore, it might expose the patients to more radiation. However, studies regarding computed tomography-guided core needle biopsy for lung nodules are still lacking.

In this study, investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.

Eligibility Criteria:
Inclusion Criteria:

1. Non-diagnostic lung lesions (no definitive pathological diagnosis);
2. Lesion size between 5 and 30 mm;
3. Solid lung lesions.

Exclusion Criteria:

1. The lesion which has been punctured previously;
2. A lesion that had shrunk in size or a lesion with a stable size for 1 year;
3. Severe dysfunction in heart, lung and coagulation function;
4. Patients who refused to provide informed consent.
Pre-Pregnancy Weight Loss and Baby Behavior Study

This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.

The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.

Eligibility Criteria:
To be eligible to participate in this study...

Mother

-Current or previous participation in the PLAN study resulting in a live birth.

Child

* Mother participated in PLAN study during child's gestation
* Infant birth weight (From PLAN study records) appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set (Oken et al, BMC Pediatrics 2003).
* Infant is 3.0 to 6.0 months old at Consent.
* Biological mother is legal guardian by maternal report.
* Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time).
* Infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report.
* Stated willingness by mother to comply with all study procedures and availability for the duration of the study.
Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia

Pre-procedural ultrasound for Spinal \& Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.

The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.

We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
* ASA physical status 1 - 3
* Written informed consent
* Gestational age ≥ 37 weeks.

Exclusion Criteria:

* Patient's refusal.
* Body mass index ≥ 45
* Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).
Nonthyroidal Illness Syndrome in SBS

Nonthyroidal illness syndrome (NTIS) is prevalent in critical illness; it is associated with poor outcomes. However, few studies have focused on the relationship between NTIS and short bowel syndrome (SBS). The aim of this study was to investigate the incidence, etiology, and prognosis of NTIS and its correlation in clinical variables in adult patients with SBS.

Nonthyroidal illness syndrome (NTIS), also known as euthyroid sick syndrome or low triiodothyronine (T3) syndrome, is a condition characterized by decreased serum concentrations of T3 and low or normal plasma concentrations of thyroxine (T4) without a compensatory increase in the serum levels of thyroid stimulating hormone (TSH). However, such typical changes differ from those in primary or secondary thyroid disorders. NTIS refers to distortions in thyroid function without thyroid disease caused by various critical illnesses. This condition has been described in different acute and chronic disease states over the past 30 years, including sepsis, starvation, trauma, burns, myocardial infarction, Crohn's disease, enterocutaneous fistulas, chronic kidney disease, and major surgery.

Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. Therefore, SBS can cause various metabolic and physiologic disturbances, many of which are associated with growth, intestinal adaptation, and hormone secretion. Many previous studies of SBS have evaluated growth hormone, glucagon-like peptide-1, glucagon-like peptide-2, vitamin D and parathyroid hormone, peptide YY, and ghrelin. However, few studies have reported the association between SBS and the hypothalamic-pituitary-thyroid axis and its balance.

The present study was performed to evaluate the association of thyroid hormone disturbance and SBS in adult patients. Because NTIS is the main type of thyroid hormone disturbance, we further investigated the incidence, underlying mechanisms, and correlation with clinical variables and prognosis of NTIS in adult patients with SBS.

Eligibility Criteria:
Inclusion Criteria:

(1) Adult patients with SBS, defined as intestinal malabsorption disorder resulting from extensive bowel resection with a remnant small intestine length of greater than 200 cm, admitted to a clinical nutrition center.

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Exclusion Criteria:

1. age less than 18 years;
2. previous history of thyroidal, hypophyseal or hypothalamic disease;
3. lactational or gestational period;
4. medication history of thyroidal hormone or antithyroid drugs;
5. craniocerebral injury;
6. attack of coronary heart disease, myocardial, or cerebral infarction in the past month;
7. intracranial infection or hemorrhage in the past month. -
Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* females must be of nonchildbearing potential (more than 1 yr postmenopausal)or use effective contraception for at least 2 months prior to the baseline visit and through 30 days after the last dose of study medication
* confirmed diagnosis of AA amyloidosis demonstrated by positive biopsy using congo red staining and immunohistochemistry or immunoelectronmicroscopy. Mass spectroscopy will be used upon approval of the sponsor on a case to case basis.
* persistent proteinuria greater than 1 g/24h at 2 distinct 24-hr urine collections
* must have CrCl greater than 25 ml/min/1.73 m2 at 2 distinct 24 hr urine collections

Exclusion Criteria:

* evidence or suspicion of chronic kidney disease secondary to a disease other than AA amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney disease, recurring polynephritis, or systemic lupus erythematosus)
* history of kidney transplantation
* evidence or suspicion of a cause of potentially reversible acute renal failure within 3 months prior to baseline visit
* presence of concomitant diseases or medication that could interfere with the interpretation of study results or compromise patient safety
* presence of condition that could reduce life expectancy to less than 2 yrs
* Type 1 or 2 diabetes mellitus
* significant hepatic enzyme elevation
* unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 6 months prior to the baseline visit; presence of NY Heart Assoc class III or IV heart failure
* presence of, or history of stroke or transient ischemic attack within 6 months prior to baseline visit
* initiation of, or any changes in, angiotensin converting enzyme inhibitor, angiotensin II receptor antagonist therapy, or renin inhibitor within 3 months prior to baseline visit
* initiation of, or any changes in, cytotoxic agents, anti-tumor necrosis factor agents, anti interleukin-1 or 6 agents, or colchicine therapy within 3 months prior to baseline visit
* previous use of Kiacta
* history of malignancy within 5 yrs prior to study entry, except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has been surgically cured
* use of investigational drug within 30 days prior to the first screening visit
* active alcohol and/or drug abuse
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension

The purpose of this study is to investigate the efficacy and safety of Bunazosin with Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential hypertension accompanied by metabolic syndrome.

This clinical study will comprise a 1 to 2-week washout period, a 5-week mono therapy period with AngiotensinⅡantagonist, and an 8-week alpha blocker add-on treatment period. Total study period will be 15 weeks.

Eligibility Criteria:
Inclusion Criteria:

Subjects with mild to moderate essential hypertension, with the following criteria:

1. Washout period (Week -2)

   * Male or female subjects aged 20 to 80 years
   * Systolic blood pressure (SBP):140 mm Hg but \<180 mm Hg and/or diastolic blood pressure (DBP):90 mm Hg but \<110 mm Hg
   * Subjects who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol
2. Angiotensin II antagonist mono-therapy period (week 0)

   * Subjects with systolic blood pressure \>= 140 mm Hg but \<180 mm Hg and/or diastolic blood pressure \>= 90 mm Hg but \<110 mm Hg
   * Presence of any 2 of the following 4 risk factors
   * Waist circumference: male \> 90 cm, female \> 80 cm
   * Triglycerides \>= 150 mg/dl
   * HDL cholesterol: male \< 40 mg/dl, female \< 50 mg/dl
   * Fasting glucose \>= 110 mg/dl
3. Angiotensin II antagonist with add-on Bunazosin or Doxazosin treatment period (Week 5)

   * SBP \>=140 mm Hg or decrease \< 10 % OR
   * DBP \>=90 mm Hg or decrease \< 10 % comparing the blood pressure at the entry of the Angiotensin II antagonist mono-therapy period.

Exclusion Criteria:

Subjects with the following conditions are not eligible for participation：

a) Washout period (Week -1 or -2)

* Subjects with severe hypertension (SBP\>=180 mm Hg or DBP\>=110 mm Hg).
* Subjects who have proven or suspected hypersensitivity to quinazoline derivatives
* Subjects who have a history of alcohol or drug abuse.
* Subjects with past or present evidence of cancer
* Subjects who have a past history of arterial fibrillation, heart failure (LVEF\<40%), acute coronary syndrome, myocardial infarction, stroke or severe arrhythmia.
* Subjects who are severely obese (BMI\>30 kg/m2)
* Women who are pregnant or lactating or suspected of being pregnant.
* Subjects who have previously participated in any clinical trial of new or unapproved substances within the 12 weeks before starting of washout period
* Subjects on other anti-hypertensive or lipid-lowering medication
* Inability to return for scheduled visits or comply with any other aspect of the Protocol
* Subjects with poorly controlled diabetes mellitus (HbA1c \> 10%)
* Subjects with concurrent serious hepatic or renal disorders (defined as AST and/or ALT \> 3 times upper normal limit or Cr \> 2mg/dl).
* Subjects who, in the opinion of the investigators, are poor medical candidates or pose any other risk for therapy with an investigational drug.
The Role of Autoimmunity and Obesity in Polycystic Ovary Syndrome

The goal of the study is to detect autoantibodies in the serum of the women with PCOS and evaluate the obesity markers to investigate the the role of autoimmunity and obesity in PCOS


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with PCOS according to the Rotterdam (2003) criteria.

Exclusion Criteria:

* Patients with other causes of hyperandrogenism as congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, virilizing ovarian or adrenal tumors and those taking drugs affecting insulin resistance, such as estrogens, oral contraceptives and corticosteroids during the previous three months before the study.
Tranexamic Acid in Total Hip Arthroplasty.

The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.

The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months)
* Consent of the patient or a family member or the support person.

Exclusion Criteria:

* Contraindication to tranexamic acid.
* Contraindication to apixaban.
* Pregnancy.
* Patient receiving a curative anticoagulating treatment in the preoperative period.
A Low ChloridE hyperTonic Solution for Brain Edema

This pilot study will compare the two hypertonic solutions currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if the reduction of chloride load is safer, and as efficacious as the classic hypertonic solution.

This pilot study aimed to collect high-quality randomized and prospective information to help plan a future, larger multicenter trial. The study will compare the two hypertonic solutions currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if the reduction of chloride load by using a sodium acetate and sodium chloride mixture can lead to a relative reduction of serum chloride, reduce kidney injury, and as efficacious as the classic hypertonic solution.

Hyperosmolar therapy is one of the mainstay treatments for SAH-related cerebral edema and vasospasm, in order to reduce delayed cerebral ischemia. Recent evidence from the literature correlates high chloride load when applying IV fluids with worse outcome in a variety of critically-ill patients. Hypertonic saline, with which most hyperosmolar treatment is done, contains a supra-physiologic chloride load. It is possible that by changing the hypertonic solution to a "chloride-lean" one, the study team would be able to reduce the side effects of hypertonic sodium-chloride without losing its efficacy in treating SAH-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous SAH with an identified aneurysmal source as identified on neuroimaging obtained at admission to Emory University Hospital or with imaging at an outside hospital
* Age ≥ 18 years

Exclusion Criteria:

* SAH related to non-aneurysmal vascular anomaly
* SAH thought due to trauma
* SAH occurring in relation to another medical procedure (cardiac catheterization, LVAD placement, etc.)
* SAH with a negative workup for cause ("angio-negative")
* Patients who arrive in a brain-death state or in a devastating clinical status that will be presumed to lead to brain death or early withdrawal of treatment
* Patient who suffer from end-stage renal disease at baseline and who are routinely treated with dialysis
* Known pregnancy
Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients

The main purpose of this study is to evaluate the cognitive changes after administration of tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in patients with mild to moderate Alzheimer's disease.

After the 26 week core treatment period, the patients may continue in the study under blinded conditions for an optional extension period up to a maximum of 39 additional weeks (total study duration up to 65 weeks), until the last patient in the study has completed the 26 week of treatment.

This double-blind, placebo-controlled, randomized, parallel group study will be conducted at multiple centers in the European Union. Patients with mild to moderate Alzheimer's disease will undergo a screening period, and then they will be randomized to one of these four groups: tideglusib 1000 mg once daily (Q.D.), tideglusib 1000 mg every other day (Q.O.D.), tideglusib 500 mg Q.D., or matching placebo, for a 26-week, double-blind, placebo-controlled treatment period.

Eligibility Criteria:
Main Inclusion Criteria:

1. Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease.
2. Age of 50 to 85 years.
3. MMSE score 14 to 26.
4. Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose

Main Exclusion Criteria:

1. Significant psychiatric on medical disease.
2. Any chronic liver disease as indicated by out of range values of ALAT, ASAT or direct bilirubin, clinically relevant hepatic steatosis or other clinical manifestations of liver disease
3. Chronic daily drug intake of excluded concomitant medications.
4. Enrollment in another investigational drug study within 3 months before the baseline visit.
Relationship Between Postpartum Mood Disorders and Delivery Experience

The purpose of this study is to evaluate potential risk factors for developing postpartum depression or posttraumatic stress disorder during the first year postpartum in patients who have no preexisting history of PTSD or PPD.

It is theorized that poor pain control during labor and cesarean delivery, non-elective inductions, unplanned surgeries such as urgent/emergent cesarean delivery or operating room management of postpartum hemorrhage, and opioid abuse/addiction are risk factors for developing postpartum depression (PPD) or post-traumatic stress disorder (PTSD) after delivery. This study will, through questionnaires, interviews, and examination of the medical record, seek to identify whether and how strongly such correlations exist during the first year postpartum in patients who have no preexisting history of these conditions.

Eligibility Criteria:
Inclusion Criteria:

* Woman planning on giving birth at the University of Michigan
* Speaks English without translator
* Live pregnancy not desiring termination
* Smartphone owner
* Woman whose delivery date is \>28 weeks gestational age

Exclusion Criteria:

* History of previous postpartum depression (PPD) or posttraumatic stress disorder (PTSD) from a birth experience
* Non-English speaker requiring a translator
* Patients who have a fetus with major fetal anomalies
* Positive screening at 28 weeks antepartum for Edinburgh Postnatal Depression Scale (EPDS) or Primary Care PTSD (PC-PTSD) screen
Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population

This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with Type 1 diabetes for at least one year
* HbA1c less than 12%
* Willing to administer at least 3 injections per day
* Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary