cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System for until such a time that the drug is approved, the participant withdraws from the study, or the study is terminated.

New patients will be trained to use the nebuliser at the first treatment visit. All patients will use the eFlow nebuliser to administer AP01. Hands on training for use and cleaning of the eFlow nebuliser will be performed by site personnel with patients using the study specific instructions for use and quick reference guide provided. The first treatment for new patients will be overseen by clinic personnel.

A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.


Eligibility Criteria:
Inclusion Criteria:

* Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician. Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).
* Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.

Exclusion Criteria:

* Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
* Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
* Subjects who experienced an acute exacerbation of IPF or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
* Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.
* History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.
Comparison Trial of Enema vs. PEG 3350 for Constipation

The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.

Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.

Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.

Eligibility Criteria:
Inclusion Criteria:

* Constipated children who have one of the following three conditions:

  * Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
  * Functional fecal retention (large diameter stools as determined by caregiver \<twice/week and retentive behaviors, or
  * Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician

Exclusion Criteria:

* Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
* Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
* Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
* Non-English speaking patients and families
* Patients with milk allergy
* Patients with molasses allergy
* Patients who are pregnant
* Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
* Patients who are admitted to an in-patient unit
Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients

The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC) initiates autonomic nervous system response and affects the prognosis in patients with acute ischemic stroke.

Remote ischemic postconditioning (RIPostC) has proven effective in reducing the ischemia-reperfusion injury. But the defensive mechanism of RIPostC still unclear. Stroke is frequently associated with autonomic dysfunction. Heart rate variability (HRV) represents the autonomic nervous system activity.This study aims to investigate whether RIPostC correlates with autonomic function and thus predicts prognosis of stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as ischemic stroke according to the Chinese guideline of diagnosis and treatment of acute ischemic stroke 2010
2. Age between 18 to 85 years old
3. initial ischemic stroke within 14 days or less.
4. National Institutes of Health Stroke Scale (NIHSS)score 0-15
5. Modified Rankin Scale(mRS)score 1-4
6. Informed consent

Exclusion Criteria:

1. Intravenous or arterial thrombolysis, or revascularization
2. Acute myocardial infarction,atrial fibrillation,arrhythmia,or cardiogenic cerebral embolism
3. Systolic Blood Pressure(SBP)\>200mmHg after medication treatment
4. Plasma fibrinogen\>7g/L
5. Upper limb fracture or percutaneous injury
6. Subclavian artery stenosis
7. With severe cardiac,respiratory,hepatic,and renal dysfunction or malignant tumor
8. Simultaneous participation in another interventional study
9. Pregnancy
Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation

OBJECTIVES:

I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.

PROTOCOL OUTLINE:

Patients undergo blood draw. Insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) are measured. Patients whose IGF-I and IGFBP-3 levels are average or above are tested for the presence of mutation in the insulin-like growth factor-I receptor.

Eligibility Criteria:
* Intrauterine growth retardation (IUGR), defined as birth weight less than 2 standard deviations below the mean by Usher and McLean Deficient "catch-up" growth (stature less than 5th percentile on growth chart after age 18 months) Normal or elevated circulating concentrations of insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) IGF-I or IGFBP-3 within or above the 95th percentile confidence interval for age No other clinical explanation for poor prenatal and postnatal growth No IUGR due to maternal toxemia, endocrine disease, gastrointestinal disease, significant heart disease, or chromosomal abnormalities No other condition known to retard growth
CPX-351 Real-World Effectiveness and Safety Study

CPX-351 Real World Effectiveness and Safety Study (CREST UK) is a real-world evidence study designed to collect data on the potential benefits and/or risks of Vyxeos liposomal (liposomal daunorubicin/cytarabine; CPX-351) in routine clinical practice in the United Kingdom (UK).

This is a retrospective, non interventional, multi-centre, single arm, observational study designed to assess patients with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia related changes (AML-MRC) who have been treated with Vyxeos liposomal (liposomal daunorubicin/cytarabine; CPX-351) in routine UK clinical practice and managed as per standard local practice.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at the start of treatment of AML with Vyxeos liposomal
* Pathological diagnosis of t-AML or AML-MRC according to World Health Organization criteria (with at least 20% blasts in the peripheral blood or bone marrow)
* Patient has received at least one infusion of Vyxeos liposomal, prescribed as per the SmPC
* Patient signs an informed consent form or is included in accordance with an informed consent waiver

Exclusion Criteria:

* Treatment with Vyxeos liposomal as part of a clinical trial or managed access program
* Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts
Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives

To assess the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in Greek women with ICP compared with healthy pregnant women. Moreover, these genetic polymorphisms will be examined in their first-degree relatives.

Introduction: ICP is commolnly manifested in the 2nd and especially in the 3rd trimester of pregnancy. Pathogenesis of ICP is multifactorial implicating genetic, environmental and hormonologic factors. Prevalence of ICP varies. In certain populations in latin America occurrence of ICP is up to 15% of pregnancies. In Caucasian populations incidence of ICP is approximately 1% of pregnancies. Data for the Greek population are scarce. Genes ABCB4 and ABCB11 that are encoding transport proteins in the hepatocyte are implicated in the pathogenesis of ICP.

Aim of the Study: To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives Patients and Methods: To recruit 100 women with ICP. Analyze the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in women with ICP. As control group will be used pregnant women without ICP or known hepatic disease. In these women the same analysis for SNP's as in women with ICP will be performed. Exclusion criteria: women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis) and women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome) Inclusion criteria: pregnant women with ICP. Detailed report of medical history, laboratory and clinical data regarding women and the pregnancy. Follow up of laboratory values before and after the begging of treatment with UDCA.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with ICP

Exclusion Criteria:

* women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis)
* women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome)
The Relationship Between Heart Rate Variation and Athletic Performance in Basketball Players

This study was planned to explain the relationship between heart rate variability and their sportive performance in basketball players.

Basketball is a team sport that develops physical characteristics such as endurance, strength, speed, skill and mobility, starting from childhood or youth and bringing these characteristics to a superior level in adulthood.

The heart rate variability is the period in which the change between two heartbeats is observed and represents the sinus node modulation by the sympathetic and parasympathetic branches of the autonomic nervous system. During exercise, the increase in intensity produces a higher heart rate and a lower heart rate variation due to the increase in sympathetic nerve activity and decreased vagal modulation in the heart. Heart rate variation is measured by the variation in heart rate from beat to beat and the time between each heartbeat. Measurement of heart rate variability is a potentially valuable noninvasive tool as it is a reliable marker of the autonomic nervous system's effect on the heart.

When the literature is examined, although there are studies on the effects of heart rate variation in both basketball and different sports branches, there is no study examining the relationship between heart rate variation and basketball-specific sportive performance. Therefore, it is aimed to study on this subject and to contribute to the literature.

Eligibility Criteria:
Inclusion Criteria:

1. without any known systemic problems
2. without any history of musculoskeletal injuries in the last 6 months
3. men basketball player

Exclusion Criteria:

1. those who do not volunteer to participate
The Development and Efficacy of a Recovery Group for People With Mental Illness

Recovery-oriented approach has been promoted in psychiatric rehabilitation in recent years. This approach emphasizes that people with mental illness can live a hopeful life even though the symptoms still exist. However, few recovery-oriented programs are available in Taiwan. This study aimed to develop of a recovery-oriented program for people with mental illness and investigate its feasibility.

The study participants with mental illness were from a community mental health center in the south of Taiwan. The recovery-oriented program was conducted by a group leader, a senior occupational therapist, with one supervisor and one observer. The program was designed based on Pathways to Recovery, a self-help book published by University of Kansas. Participants attended a 1-hour class per week. The teaching methods included didactic presentation, peer exchange, group discussion, and practice. The group leader, supervisor, and observer reviewed the content and participants' performance after each class and made content adjustments if needed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mental illness

Exclusion Criteria:

-
Pain Sensitivity During Puberty

Aim 1- To examine the differences in pain sensitivity between adolescents at early vs. mid pubertal status Aim 2- To determine the relationships between sex hormone levels and pain sensitivity Exploratory Aim 1- To determine the effect of pubertal maturation on pain sensitivity Exploratory Aim 2- To identify parameters related to who will develop chronic pain during puberty

Hypothesis 1- Adolescents in early pubertal status will have higher pain ratings and lower pain modulation capabilities compared to adolescents in mid puberal status.

Hypothesis 2- Pain sensitivity will be associated with sex hormone levels. Exploratory Hypothesis 1- As adolescents mature, they will have a decrease in pain sensitivity to experimental pain which will be related to changes in sex hormone levels.

Exploratory hypothesis 2- Female adolescents with greater pain sensitivity, lower testosterone levels and with a family history of pain would be at a higher risk to develop chronic pain

At baseline, participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. In addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires.

In the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. The study visits will include the same procedures as the baseline study visit. Additional surveys regarding new symptoms of pain will be completed. In some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only).

Eligibility Criteria:
Inclusion Criteria

1. Healthy males and females
2. 9-16 years old
3. English speakers

Exclusion Criteria

Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:

1. Pregnancy
2. Chronic Pain or frequent headaches (\>5 headache /month)
3. Psychiatric or neurological disorders
4. Lack of sensation in the testable limb
5. Disorders associated with pubertal maturation or usage of contraceptive pills that affect sex hormone levels
6. Regular use of pain medications (e.g., opioids, antidepressants).
Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation

RATIONALE: Music therapy may be effective in relieving pain and emotional distress in patients who are undergoing cancer therapy.

PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and emotional distress in patients with hematologic cancer who are undergoing high-dose therapy and stem cell transplantation.

OBJECTIVES:

* Compare the effects of music therapy vs no music therapy on depression and anxiety in patients with hematologic malignancies undergoing high-dose therapy and autologous stem cell transplantation.
* Compare the effects of these regimens on mood, mucositis pain, pain interference, need for analgesic medication, and length of hospital stay of these patients.
* Compare the immediate effects of these regimens on mood in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to whole body or whole lymphatic irradiation (yes vs no) and diagnosis (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs myeloma/amyloidosis). Patients are randomized to one of two arms.

* Arm I: Patients receive individualized music therapy over 20-30 minutes beginning on day 0 and continuing over 16 days for a maximum of 12 sessions during high-dose therapy and autologous stem cell transplantation.

Patients complete a Profile of Mood States (POMS) quality of life and pain questionnaire on days -2, 0, 1, 4, 7, 10, 13, and 16.

* Arm II: Patients receive standard psychosocial support during high-dose therapy and autologous stem cell transplantation. Patients complete POMS and mucositis pain questionnaires as in arm I.

PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a hematologic malignancy

  * No leukemia
* Planned high-dose therapy and autologous stem cell transplantation (HDT/ASCT) at Memorial Sloan-Kettering Cancer Center

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics
* No prior HDT/ASCT

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Chemoradiotherapy for Advanced Esophageal Cancer

This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of life in patients with unresectable esophageal cancer.

Patients with carcinoma of the esophagus not suitable for definitive radical treatment who have symptomatic dysphagia requiring locoregional palliation, and who have no contra-indications to chemo-radiotherapy will be offered Carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on days 1 and 8 concurrent with external beam radiation therapy of 30Gy/10 fractions over two weeks where the primary goal is relief of dysphagia and other outcomes include toxicity, quality of life and metabolomics.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven carcinoma of the esophagus.
2. Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
3. Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
4. ECOG Performance status ≤ 2.
5. Patients able to begin treatment within 14 days of signing the informed consent form.
6. Patient is at least 18 years old.
7. Hematological function as defined by the following laboratory parameters:

   * Hemoglobin \> 100g/L
   * Platelet count \> 100x10E9/L
   * Absolute neutrophil count \> 1.5x10E9/L
8. Renal function to undergo chemotherapy as defined by the following laboratory parameters:

   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x the upper limit of institutional normal (≤ 5 if liver metastases)
   * Total bilirubin ≤ 1.5x the upper limit of institutional normal
   * Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
9. Patients capable of childbearing are using adequate contraception.
10. Written and informed consent of patient.

Exclusion Criteria:

1. Previous radiotherapy delivered to the chest.
2. Synchronous active malignancies.
3. Pregnant or lactating patients: women of child bearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit 1. Women or men of child bearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). Subjects must start using birth control from the time they have signed the Informed Consent Form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the eCRF.
4. Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
5. Tracheo-esophageal fistula.
6. Esophageal stents in situ.
7. Previous chemotherapy for esophageal cancer
8. Unable to complete surveys in English without aid of interpreter.