cyrilzakka/clinical-trials huggingface dataset:
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients

This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting.

This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase.

The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits.

A follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with T1D for at least 6 months at Screening.
* current usage of daily insulin treatment.

Exclusion Criteria:

* pregnant or nursing
* renal insufficiency
* hepatic synthetic insufficiency
* aspartate or alanine aminotransferase \> 3 times the upper limit of normal
* hematocrit less than or equal to 30%
* use of \> 2.0 U/kg total insulin dose per day
* inadequate venous access
* current seizure disorder
* history of pheochromocytoma or disorder with increased risk of pheochromocytoma
* history of insulinoma
* history of glycogen storage disease.
* active use of alcohol or drugs of abuse
* administration of glucagon within 14 days of the first treatment visit
* participation in other studies involving an investigational drug or device within 30 days
Assessment of Activity in Pregnancy Using an Actigraph

We would like to quantify the amount and type of activity a typical pregnant woman engages in and then compare the pregnancy outcomes of women with varying activity levels. To do this, we will have women wear a device known as an accelerometer (that records activity by measuring changes in voltage levels) at certain times in their pregnancies.

General findings that have consistently been demonstrated in the literature are that activity tends to decreased during pregnancy from pre-pregnancy levels and that activity in the third trimester is less than in the first trimester. In non-pregnant patients, increase in physical activity and exercise has been associated with improved mood and self-esteem. Although the data in pregnancy is limited, available studies do suggest that inactivity is associated with worse mood. Regular physical activity is not detrimental in low-risk patients and in fact may be beneficial.

Bed rest or activity restrictions are commonly employed interventions for women with a variety of obstetric complications such as preterm contractions, vaginal bleeding, and fetal growth restriction. There is no compelling data to support bed rest as an effective therapeutic modality. There has been some data that occupational work can increase the risk of preterm birth, but other studies have not demonstrated an effect.5 Furthermore, prolonged bedrest can have detrimental effects such as muscle weakness and increased thromboembolic risk, as well as negatively impact familial relations.

The use of the accelerometer is an attempt to objectively quantify physical activity in pregnancy. The accelerometer assesses activity by measuring voltages, and can thus provide information on the intensity of activity. An additional advantage is that it can be worn on the wrist or ankle, whereas pedometers need to be worn on the waist for maximal accuracy which limits their use in pregnant women. This novel study would contribute to the existing literature on pregnancy activity that consists primarily of survey/subjective data to determine what correlation, if any, exists between activity and pregnancy outcome. Secondarily, the study will survey its participants to see if we can corroborate previous studies that have demonstrated a relationship between activity level and patients' moods.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* First trimester (11-14w)
* No medical contraindications to normal activity

Exclusion Criteria:

* Chronic medical conditions that require restricted activity (cardiac disease, severe asthma, etc)
* Known fetal anomalies
* Morbid obesity (BMI \> 39)
* Maternal age less than 18 years
* Inability to comply with instructions
A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 20.0-29.9 kg/m\^2 (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiography and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day)
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Have personal or family history of myopathy
* Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
* Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper limit of normal plus 10 percent
* Creatine kinase above 5 x upper limit of normal
* Asian subject
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years old at the time the informed consent form is signed
* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
* Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
* Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

Exclusion Criteria:

* Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
* Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.

This is a first-in-human, Phase I, non-randomized, open-label clinical trial designed to evaluate AZD2284, AZD2287, and AZD2275.

This trial will consist of 2 Parts:

Part A (Imaging):

* Part A (Cold Antibody Exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (AZD2275) pre-administration to improve the biodistribution of AZD2287.
* Part A Expansion: aims to explore the prevalence of PSMA and STEAP2 expression by imaging.

Part B (Therapeutic):

* Part B (Actinium-225 Dose Escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of AZD2284 informed by the optimal dosing regimen identified in Part A.
* Part B Expansion Cohorts 1 and 2: aims to explore efficacy of AZD2284.

Eligibility Criteria:
Main Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer.
* Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
* At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior to the first dose of Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases.
* Adequate organ function

Main Exclusion Criteria:

* Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP).
* Radiation therapy (RT) within 28 days prior to the first dose and all RT-related events have not recovered to Grade ≤ 1.
* Administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of IMP or 5 half-lives, whichever is shorter.
* All prior treatment-related adverse events must have resolved to Grade ≤ 1.
* Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements.
* Known or suspected allergies or contraindications to any of the investigational drugs or any component of the investigational drug formulation.
* Clinically relevant proteinuria
Effects Of Dance Movement Therapy On Compassionate Flow In Nursing Students

This study aimed to investigate the differences in compassionate flow among nursing students both before and after an educational intervention.

Background: Only a few studies have explored how compassion is taught to nursing students.

Aim: This study aimed to investigate the differences in compassionate flow among nursing students both before and after an educational intervention.

Design: This study employed a cluster randomised controlled trial design. Settings: This study was conducted in medical schools in Taiwan. Participants: We enrolled first- and second-year nursing students. Methods: The intervention group underwent dance movement therapy, while the control group received yoga training. Compassionate flow was assessed using the Compassionate Engagement and Action Scale and the Fears of Compassion Scale.

Eligibility Criteria:
Inclusion Criteria:

* Freshmen or sophomore nursing students
* Those taking a course in Complementary and Alternative Therapies
* Willingness to participate and agreeing to complete the questionnaire

Exclusion Criteria:

* Deafness
* Limb disorders
Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients

CBT: cognitive behavioural therapy MBT: mindfulness-based therapy

Nurses caring for terminally ill patients suffer from negative emotions and emotional labor, which may lead to a decline in the quality of end-of-life care. CBT and MBT are currently two commonly used psychological methods. They can be effective in improving bad mood. However, to the best of our knowledge, no investigators have used CBT and MBT among nurses caring for terminally ill patients. Could CBT and MBT be effective in alleviating the psychological distress of these nurses? Which psychological method is more effective?

Eligibility Criteria:
Inclusion Criteria:

* (1) Eligible participants were the nurses who nursing patients with stage IV cancer or other incurable diseases;
* (2) agree to participate in this research;
* (3) no history of mental illness.

Exclusion Criteria:

* None
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.

This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all the following criteria in order to be eligible for participation in this study:

1. Subjects qualifying for cataract surgery
2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.

Exclusion Criteria:

* Subjects are ineligible for participation in this study if s/he meets any of the following criteria:

  1. Patients who could not be washed-out of IOP-lowering medications. .
Neoadjuvant Immunochemotherapy for Lung Cancer

We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

1. Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital;
2. At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery;
3. Malignancy was present and confirmed in the pathology before treatment and after surgery;
4. The lung lesion was the primary lesion.

Exclusion Criteria:

1. No lung surgery was performed until 2022.11;
2. No preoperative neoadjuvant therapy was performed or recorded;
3. Neoadjuvant therapy did not include immune drugs;
4. Previous history of malignancy (including surgery and adjuvant therapy);
5. Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.
The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

Exclusion Criteria:

1. pregnancy
2. coagulopathy
3. systemic infection
4. any active infection at the injection site
5. history of allergy to contrast media, local anesthetics, corticosteroid
6. patients unable to communicate or patients with cognitive dysfunction
The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures

This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age and who have closed epiphyses.
* Patients of both genders and all races.
* Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation.
* Patients with a history of an acute injury and an acute Jones fracture defined by Torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress.
* Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks.
* Patients with a baseline visual analog scale (VAS) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight.
* Patients who are in good general health and who have physical examinations that either are within normal limits or are clinically non-significant as determined by the investigator.
* Patients with laboratory evaluations that either are within normal limits or are clinically non-significant as determined by the investigator.
* Patients who have voluntarily signed informed consent forms, including HIPAA Authorization.

Exclusion Criteria:

* Patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses.
* Patients with Jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation.
* Patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures.
* Patients with prior fifth metatarsal fracture(s).
* Patients with prodromal symptoms present for more than 2 weeks.
* Patients with a nonunion or delayed union as defined by the radiographic criteria described by Torg et al.
* Patients who are allergic to any of the individual active ingredients in teriparatide or related compounds.
* Patients with chronic rheumatologic disease, ankylosing spondylitis or other inflammatory arthropathy.
* Patients with associated injuries considered by the investigator as to likely interfere with evaluation of the study drug.
* Patients with a present condition or history of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, endocrine, neurologic, psychiatric, connective tissue, respiratory or other medical disorders.
* Patients with Worker's Compensation claim(s) under dispute or mediation.
* Patients with history of drug or alcohol abuse.
* Patients who are pregnant or lactating.
* Patients who are considered by the investigator for any reason to be an unsuitable candidate for receipt of the study drug.
* Patients who are unwilling or unable to follow the follow-up evaluation schedules.
* Patients who refuse to voluntarily sign the informed consent form.
Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B in Patients With Advanced Solid Tumors

The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B.

Besides the main objective, there are 3 other objectives as follows:

1. To determine dose-limiting toxicity (DLT) of HM781-36B
2. To characterize the pharmacokinetics of HM781-36B, following oral administration of HM781-36B
3. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of HM781-36B

Eligibility Criteria:
Inclusion Criteria:

* 1) Histologically or cytologically confirmed advanced solid tumor 2) Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 3) Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved 4) Aged ≥19 5) Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 6) A life expectancy greater than 12 weeks 7) Adequate bone marrow (WBC≥4,000/mm3 platelet≥100000/mm3, hemoglobin≥9.0g/dl and ANC≥ 1500/mm3, renal (Creatinine≤1.5mg/dl) and liver function (AST/ALT/ALP ≤ 3 x upper limit of normal and total bilirubin≤2mg/dl) and no abnormal heart and lung function However, AST/ALT/ALP ≤ 5 x upper limit of normal for patients with liver metastases and ALP level ≤ 5 x upper limit of normal for patients with bone metastases are allowed 8)Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

* 1) Patients with hematopoietic malignancies,uncontrolled infection, ileus, CNS metastasis.

  2) Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3) Class III or IV heart failure (NYHA Class) or LVEF\<40% 4) Patients who have GI malabsorption or difficulty taking oral medication 5) Patients who have psychiatric or congenital disorder 6) Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 7) Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.) 8) Subjects who have no intention of following the requirements of the protocol or the follow-up management. Subjects who cannot be followed up regularly due to psychological, social, family, logistic, and geographical reasons 9) Subjects who were administered with other investigational products within 30 days before screening.

  10) Subjects who, in the investigator's opinion, cannot be participated.
Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study

This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.

Magnetic seizure therapy (MST) is a novel, experimental therapeutic intervention, which combines therapeutic aspects of electroconvulsive therapy (ECT) and transcranial magnetic stimulation, in order to achieve the efficacy of the former with the safety of the latter. While ECT remains the most efficacious treatment available for severe and treatment-resistant depression, it is hampered by its side effect profile, specially cognitive deficits, which albeit transitory might be particularly distressing for patient, not to mention the stigma that still clings to this method. MST employs high frequency magnetic pulses applied to the head to the patient in order to induce generalized epileptic activity, thus emulating the core feature of ECT. Though distributed over a large area, such pulses do not penetrate deeper areas of the brain, therefore sparing deeper areas such as the hippocampi, which are crucial for memory encoding.

The goal of this study is to compare the antidepressant action of MST to ECT, using a non-inferiority approach. It also aims to compare the cognitive side effects profile of both interventions, as well as investigate possible neuroimaging changes and response predictors before and after treatments.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria
* Score equal to or great than 17 points on the Hamilton Depression Rating Scale
* Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks
* Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist

Exclusion Criteria:

* Pregnancy
* Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency
* Depressive symptoms due to a clinical condition
* Any clinical or neurological conditions without proper management
* ECT or any other neuromodulation treatment on the last six months
* Inability to consent