cyrilzakka/clinical-trials huggingface dataset:
SNP-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants (HSCT)

The goal of this study is to gain new knowledge about genetic risk factors thta may affect the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus following HSCT. The study seeks to understand if different forms of genes result in an increased risk of sores in the mouth and esophagus.

Subjects will be provided with a saliva collection kit which can be used at home. Subjects will return the collection kit in a paid, pre-addressed mailer to the laboratory at Biomodels. The laboratory will isolate and store the DNA located in the cells of the saliva. A portion of this DNA will be used to analyze the different forms of genes. The remainder of the DNA will be destroyed when this study is completed. Biomodels will not be provided with patient identifiers.

The investigators will also collect information from medical records, including information about diagnosis, treatment, stem cell transplantation and post-transplantation outcomes. This information will be de-identified.

Eligibility Criteria:
Inclusion Criteria:

* Have given informed consent to submit a sample of saliva for DNA isolation and SNP analysis
* Have undergone autologous HSCT for treatment of Hodgkin's or non-Hodgkin's lymphoma or multiple myeloma at the Dana-Farber Cancer Institute from 1/1/2006 through 6/30/2010
* Have medical records identifying whether the participants did or did not develop severe mucositis

Exclusion Criteria:

* Received Palifermin (Kepivance) prior to their conditioning regimen
Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis

The objectives of this research grant are to determine the association of hypoxia with the severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in patients with bronchiectasis.

80 patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. Inclusion criteria are: daily sputum \> 10 ml; absence of asthma or other unstable systemic diseases; and "steady-state" bronchiectasis (\< 10% alteration of 24 h sputum volume, FEV1, and FVC, and in the absence of deterioration in respiratory symptoms at baseline visits). Exclusion criteria include: unreliable clinic attendance; regular user of inhaled or oral corticosteroids; history of lung resection and known asthma defined according to American Thoracic Society guidelines.

The lung function and desaturation will be assessed by six-minute walking tests and the severity of disease will be evaluated by HRCT scores. Peripheral blood sample (40ml/person) is performed to analyze the bone turnover markers and the level of Hif in PBMC.

Eligibility Criteria:
Inclusion Criteria:

1. willing to sign a written consent form
2. Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography
3. willing to accept 6-minute exercise pulmonary function test and blood draw
4. Men and women over the age of 20
5. Has undergone chest computed tomography and bone density examination in the recent five years

Exclusion Criteria:

1. pregnant women or lactating women
2. asthma, lung resection history before the screening period
3. active Tuberculosis infection
4. Have received oral steroid treatment within 30 days
5. current acute attack or clinical symptoms instability of bronchiectasis
Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM

This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old, both male and female;
* 2. Histologically confirmed glioblastoma;
* 3. Patients with glioblastoma who have failed standard treatment (surgery, Stupp regimen), were diagnosed by MRI and evaluated by RANO standard to support the first recurrence. Stupp regimen needs to complete at least 6 medication cycles.

Exclusion Criteria:

* 1. Use low molecular weight heparin and warfarin within 35 days before randomization;
* 2. Arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions

Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.

Although there are many studies evaluating adherence to supervised walking programs in patients with fibromyalgia (FM), there are limited studies evaluating adherence to unsupervised walking programs.

Purposes of this study were (1) to assess whether walking as exercise was prescribed by their physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate the frequency of patients who walk regularly as exercise, (3) to clinically compare patients who walk regularly as exercise and those who do not, and (4) to determine factors related to adherence to walking prescriptions.

Eligibility Criteria:
Inclusion Criteria:

* be between 18-70 years old
* female gender
* Pharmacological therapy has been recommended in the last 1 year

Exclusion Criteria:

* neurological disease or orthopedic problem presence that may be the reason of functional impairment
* neurological deficit presence
A Trial Comparing Pharmacokinetics, Safety and Tolerability of Two Subcutaneous Concentrations of Dapiglutide

This is a phase 1, open-label, single-center, randomized, parallel-group trial designed to investigate the pharmacokinetic profiles, safety, and tolerability of a single dose administration of 7.5 mg dapiglutide administered s.c. with two drug product concentrations, 10 mg/mL and 25 mg/mL. The trial will be conducted in participants with a BMI ≥ 27.0 kg/m2.

Dapiglutide is a dual Glucagon-like peptide-1-/Glucagon-like peptide-2 Receptor Agonist (GLP-1R/GLP-2RA) in clinical development for weight management. The purpose of this phase 1 trial is to compare pharmacokinetics (PK) of a single dose administration of 7.5 mg dapiglutide administered subcutaneously (s.c.) with two drug product concentrations, 10 mg/mL and 25 mg/mL and will be conducted in 30 participants with a body mass index (BMI) ≥ 27.0 kg/m2. The development of a drug product with higher drug concentration will facilitate investigation of a wider dose range of dapiglutide in the clinical development program of the compound. The PK profile of a weight management drug should be assessed in people with a wide range of BMI and with a BMI within the range of the target population as body weight is expected to influence PKs of dapiglutide.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 64 years, both inclusive,
* BMI \>= 27.0 kg/m\^2
* HbA1c \< 6.5 %.

Exclusion Criteria:

* Any history or presence of a disorder or a disease, which, in the investigator's opinion, might jeopardize participant's safety, evaluation of results or compliance with the protocol, treatment with dapiglutide (any exposure) or any other drugs, including dual and tri agonists, involving a GLP-1 RA or GLP-2 RA within 180 days prior to screening.
* Any medication (prescription and non-prescription drugs) with the exception of stable treatment with antihypertensive and lipid-lowering drugs as well as thyroid replacement therapy.
* Female participants of childbearing potential who are not willing to use highly effective contraception until 42 days after dosing
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia

Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.

Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.

Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 15 years old
* Newly diagnosed AML or post myelodysplastic syndrome (MDS)

Exclusion Criteria:

* Patients with M3 AML of French-American-British (FAB) classification (APL, Acute Promyelocytic Leukemia)
* World Health Organization (WHO) performance status \>2; (ii)
* Left ventricular systolic ejection fraction below the normal range
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Serum creatinine concentration \> 2x ULN (Upper Limit of Normal laboratory ranges),
* AST or ALT levels \> 2.0 x upper limit of normal (ULN), except if AML-related
Sildenofil in Persistent Pulmonary Hypertension in Newborns

This study hopes to evaluate the effectiveness of early combined use of Sildenafil and nitric oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or hypoxemic respiratory failure and assess whether this would improve oxygenation, improve time on mechanical ventilation for these babies and also prevent rebound hypoxic episodes.

PPHN is characterized by hyper reactivity of the muscle layer in pulmonary arterioles and right to left shunt across the ductus arteriosus and the foramen ovale in the absence of structural heart defects. It could also include right ventricle dysfunction in many cases. The reported incidence of this disease is 0.43 to 6.8/1000 live new born infants with a mortality of 10-20%.

The main objective of therapy in PPHN is to reduce pulmonary vascular resistance. To this purpose, inhaled nitric oxide has been used in developed and several under developed countries. However 30-40% of these patients do not respond to this therapy. Extra corporeal membrane oxygenation is also useful but is an invasive therapy in PPHN with serious adverse effects reported. Recently Sildenafil has been evaluated as an alternative or adjunctive pulmonary vasodilator. It inhibits phosphodiesterase type 5 and elevates the concentration of cyclic guanosine monophosphate in the muscle cells of pulmonary vessels, which in turn decreases pulmonary vascular resistance.

The FDA in the USA has recently approved the use of Sildenafil for use in adults with PPHN.

Recently 3 clinical trials have evaluated Sildenafil versus Placebo or control in newborns with PPHN,all of them showing a significant improvement in oxygenation index, decreased mortality and reduced risk of rebounds after discontinuing iNO. The use of Sildenafil in treating PPHN secondary to Chronic lung disease in older infants had been receiving significant attention over the last few years.

At HMC, Women's hospital, the number of deliveries average 15,000 to 16,000 per year with an admission rate to the NICU of about 10%. The number of PPHN cases admitted to our NICU ranges between 14-20 cases per year.

In this study the investigators plan to compare the effectiveness of the use of early combined Sildenafil and iNO in newborns with PPHN and or hypoxemic respiratory failure and whether it would improve oxygenation, decrease the time spent in mechanical ventilation and prevent rebound hypoxic episodes.

Eligibility Criteria:
Inclusion Criteria:

1. Newborn infants of post natal age less than 48 hours
2. Gestational age equal to or more than 34 weeks
3. Oxygen index of more than or equal to 20 (moderately ill infants)
4. Radiological, clinical and biochemical evidence of acute hypoxic respiratory failure
5. Surfactant therapy has been established when indicated
6. Presence of arterial line

Exclusion Criteria:

1. Congenital diaphragmatic hernia
2. Major congenital abnormalities
3. Significant congenital heart disease
4. Cyanotic congenital heart disease
Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib

The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

Eligibility Criteria:
Inclusion Criteria:

1. Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma
2. Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University.
3. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database.
4. All patients were with Karnofsky performance status over 70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions.

Exclusion Criteria:

1. Cardiac disease and hemorrhagic disease were excluded.
2. Patients with lung cavitation before apatinib treated.
Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses magnetic energy applied to the scalp to modulate activity in the underlying regions of the brain. In this study we will examine the efficacy of treating auditory hallucinations in schizophrenia with rTMS, comparing two methods to target stimulation to a language processing region of the brain. One method targets the stimulation site using scalp landmarks, while the other uses functional magnetic resonance imaging (fMRI) combined with a language task.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Male or female, aged 18 to 60
* Willing to comply with all study procedures and be available for the duration of the study
* Primary diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV (29)
* Currently reporting AHs, rated a minimum of 4 (moderate) on the auditory hallucination item of the Brief Psychiatric Rating Scale (BPRS; 27), and AH will be present daily
* AHs must have failed to resolve after a minimum of two adequate trials (doses within standard therapeutic range for a minimum of 8 weeks each) of psychotropic medication including at least one atypical antipsychotic medication; documented trials of antipsychotic medication limited by intolerable side effects, e. g. extra-pyramidal symptoms, tardive dyskinesia, weight gain, neuroleptic-induced dysphoria, will also be considered as equivalent to adequate trials.
* Weight and girth compatible with the bore of the MRI scanner; generally men over 6 feet tall \< 250 lbs, men under 6 feet tall \< 220 lbs, women over 5'11" tall \< 220 lbs, or women under 5'10" tall \< 200 lbs

Exclusion Criteria:

* Substance abuse or dependence in the past 1 month
* Current or past history of serious medical or neurological illness that could compromise brain function or present an increased risk of seizure, e. g. conditions that may significantly alter electrolyte balance, stroke, epilepsy, any history of seizure;
* Pregnant or trying to become pregnant;
* Inability to tolerate small, enclosed spaces without anxiety;
* Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles, neurostimulators, foil-backed transdermal patches;
* Facial tattoos with metallic ink
* Inability to follow study protocol
* Change in antipsychotic therapy in previous 2 weeks
* Currently under an alternative treatment order
* Unstable symptoms which could, in the judgment of the study team, exhibit symptomatic worsening over the course of the protocol
* Current treatment with another investigational drug or other intervention
* Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study;
* No quantifiable motor threshold such that TMS dosage cannot be accurately determined
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control

This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.

Neuraxial procedures, in which a needle is inserted into the spinal canal through a gap in the vertebrae, are performed at a rate of nearly 13 million per year in the US, across a myriad of diagnostic and therapeutic clinical scenarios.

The standard of care involves manual palpation of the patient's back to detect the spinous processes (SPs) and estimate the location of the interspinous needle insertion site. While providers are trained to perform these procedures with meticulous precision and attention to detail, this technique remains highly inaccurate, often requiring multiple insertion attempts to properly place the needle. These attempts lead to patient pain and complications, such as traumatic taps and post-dural puncture (PDPH) headaches; unpredictable procedure times; and poor facility throughput.

The VerTouch device uses tactile imaging to offer a non-invasive, untethered, non radiation-producing solution for visualizing spinal anatomy in order to identify an ideal location for needle placement in a neuraxial procedure. The device can be used to mark the identified site with a surgical marker, or to begin placement of a needle or introducer at that site.

Study participants will be recruited in two parallel cohorts: the control (palpation) group or the tactile imaging (VerTouch) group, further stratified by procedure setting, including emergency medicine, neurology, and anesthesiology. Once an insertion site is marked with a marker or shallow placement of a needle or introducer, the procedure will continue in the usual manner for subjects in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 18 years and above, inclusive
2. Subjects scheduled for one of the following procedures:

   * Diagnostic LP (collection of CSF and/or measurement of ICP to diagnose hemorrhaging or neurological infections)
   * Therapeutic LP (intrathecal injection of therapeutic agents; drainage of CSF to treat pseudotumor cerebri)
   * Planned orthopedic or obstetric procedure, such as labor/induction, cesarean section, hysterectomy, or total hip/knee replacement, with neuraxial anesthesia (injection of anesthetic into spinal and/or epidural space to reduce pain during procedure)
   * Epidural blood patch (use of autologous blood to close holes in the dura mater and relieve PDPH)
3. Subjects having a BMI ≤42kg/m2

Exclusion Criteria:

1. Patient does not provide informed consent
2. Skin or soft tissue infection near the puncture site
3. Allergy to local anesthetic
4. Uncorrected coagulopathy
5. Acute spinal cord trauma
6. History of lumbar spinal surgery
7. Prior known failed neuraxial anesthesia
8. Diagnosed scoliosis, thoracic kyphosis, lumbar lordosis, scleroderma, or ankylosing spondylitis, or lumbar spinal stenosis
9. Incarcerated subjects