cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.


Eligibility Criteria:
Inclusion Criteria:

1. For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2 and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult males and females 18 to 45 or 65 to 85 years of age, inclusive.
2. Body mass index (BMI)between 18 to 36 kg/m2, inclusive.
3. Average frequency of ≥ 3 bowel movements per week.

Exclusion Criteria:

1. Persistent symptoms of functional GI disorder (such as irritable bowel syndrome, functional constipation, functional dyspepsia, or other symptom-based GI disorders unexplained by a pathologically based disorder) during the 6 months prior to screening, including a history of major surgery of the GI tract, excluding cholecystectomy and appendectomy.
2. History or presence of clinically significant respiratory, GI, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if the condition is well controlled and not anticipated to interfere with the objectives of the study.
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis

This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of massive hemoptysis


Eligibility Criteria:
Inclusion Criteria:

* Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day or with acute respiratory failure requiring mechanical ventilation or hemodynamic instability (systolic blood pressure \< 90 mmHg), regardless of hemoptysis amount）

Exclusion Criteria:

* Pregnancy
* Patients with a previous history of bronchial artery embolization
* Uncorrectable severe infection, coagulation dysfunction, organ failure or cachexia, severe contrast agent allergy, and other interventional treatment contraindications
Intraoperative Radiation Therapy (IORT) in DCIS

The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.

With advances in technology and screening, the overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) have increased. Minimizing treatment toxicity and cost is a high priority area of research. Intraoperative Radiation Therapy (IORT)is a form of radiation where a single high dose of irradiation is applied to the tumor bed at the time of lumpectomy. Its use has not been previously studied in DCIS. Proposed advantages include decreased toxicity to adjacent tissue and organs, reduction in healthcare costs, and improved quality of life. The investigators hypothesize that IORT is a safe and patient-friendly alternative to whole breast irradiation.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed DCIS of the breast
* Clinical ≤ 3.0 cm unifocal lesion
* No clinical or pathological evidence of nodal involvement
* Operable DCIS, suitable for breast conserving surgery
* Plans to administer irradiation to the breast only
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist
* Must have had a diagnostic mammogram or MRI performed within last 6 months
* Women of child-bearing potential must have a negative pregnancy test in accordance to institutional guidelines
* Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period.
* English or Spanish speaking
* Able to sign informed consent
* Amenable to regular follow-up (according to research policies) for at least 5 years.

Exclusion Criteria:

* Histologic or clinical evidence of invasive breast cancer
* Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
* Synchronous bilateral breast cancer at the time of diagnosis
* Pathologic or imaging evidence of lymph node involvement
* Any severe concomitant disease that may limit their life expectancy to less than 5 years.
* Prior history of breast cancer or in-field radiation in the ipsilateral breast.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breast feeding women
Renal Transplantation in the Elderly - nEverOld Study

An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.

To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this population.

To evaluate whether the polymorphism of the genes that determine the expression of metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the younger population, absorption and metabolism of immunosuppressants.

To evaluate the potential minimization of immunosuppression in this population refers to how does the re-population of peripheral lymphocytes, in this age group, after the use of lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two regimes.

Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is the right to monitor renal function in elderly transplanted.

Objectives: The objective of this study is to evaluate the safety and efficacy of everolimus (EVL) combined with low dose of Tacrolimus in comparison with Mycophenolate Sodium (MPS) combined with standard dose of Tacrolimus as immunosuppressive therapy for elderly recipients of kidney transplantation.

Comparison between the two study arms of:

Primary Objective:

1. Composite efficacy failure demonstrated by graft loss and/or death with functional graft and/or GFR (Glomerular Filtration Rate determined by EDTA-Cr51) \< 50 ml/min at the end of first year after transplantation and every year until the fifth year.

Secondary Objectives:

1. Pharmacokinetic study of immunosuppressive drugs (Tacrolimus, Everolimus and Mycophenolate Sodium) in the study population at days 7, 30, 60, 67, 90 and 180 post-transplant.
2. Serious adverse events (as internationally defined by ICH-GCP) every year, for five years.
3. Biopsy proven acute rejection rated every year, for five years.
4. Identify which of the renal filtration markers existing today, Cystatin C or Serum Creatinine, is more adequate to monitor renal function in elderly transplant and to develop abbreviated equations for eGFR from day 7 on.
5. Evaluation of other metabolic effects (bone density at month 12 post-transplant; vitamin D at months 2 and 12 post-transplant; and gonadal function at months 1 and 12 post-transplant) and Quality of Life at months 1, 12, 18, 24, 36, 48 and 60 post-transplant in the study population.
6. Left Ventricular Mass (LVM) and Left Ventricle Ejection Fraction (LVEF) measured by echocardiography at the end of the first year.

Eligibility Criteria:
Inclusion Criteria:

* All renal (only) male and female recipients aged ≥ 60, years undergoing kidney transplantation from a living or deceased donor, including Expanded Criteria Donors (ECD).
* Panel Reactive Antibody (PRA) \< 30%.
* Patients who consented to participate in the study by signing the informed consent form before the transplant surgery to the 1st post-operative day).

Exclusion Criteria:

* Allergy to any of proposed medications
* Patients with any active infection including HBV, HCV and HIV.
Gaming Apps Post-Stroke

The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.

Study subjects will be randomized to a control or experimental group and allocation will be concealed. The experimental group will consist of the subject utilizing their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily. The control group will utilize their personal mobile or tablet device to perform the non-problem-solving task of watching educational videos of their choice from a pre-selected set of videos for the same amount of time daily. The intervention gaming arm will be provided different gaming apps if they lose interest or find a particular game too easy or too difficult. The control video arm will be provided different educational videos according to their needs that may change throughout their inpatient stay.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-89
2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
3. First time stroke patient
4. mild to moderate problem-solving impairment without severe deficit in any other cognitive domain on admission speech evaluation
5. Have daily access while inpatient to a personally owned Apple or Android smartphone or tablet device prior to the initial session.

Exclusion Criteria:

1. Unable to understand and follow verbal and written instructions in English
2. Presence of aphasia that limits device use or ability to provide consent
3. Presence of pre-stroke speech, language, or cognitive disorder
4. Unable to operate device due to cognitive, physical, or visual impairment
Prognostic Correlation Between the Ratio of the Neutrophil Ratio to the Ratio of CD4+/CD8+ T Cells in Patients With Advanced Non-small Cell Lung Cancer NSCLC) Undergoing Immunotherapy Combined With Chemotherapy

Evaluate the prognostic correlation between the neutrophil ratio and the ratio of CD4+/CD8+ T cells in patients with advanced non-small cell lung cancer (NSCLC) who receive immunotherapy combined with chemotherapy, with the aim of providing references for clinical treatment.

According to the content released in the Global Cancer Statistics Report 2022 (Global Cancer), lung cancer is the leading cause of cancer-related deaths worldwide. Traditional treatment methods such as surgery, radiotherapy, and chemotherapy have limitations in their curative effects. Immune checkpoint inhibitors (ICIs) have greatly changed the treatment landscape of non-small cell lung cancer (NSCLC). Although progress has been made in immunotherapy, the prediction of its efficacy relies on methods such as Tumor Mutational Burden (TMB) and the expression of PD-L1. Therefore, finding more effective treatment strategies and prognostic evaluation indicators has become a key task in lung cancer research. Relevant studies have delved into the prognostic and predictive values of inflammation-related peripheral blood biomarkers in NSCLC patients receiving immunotherapy. The Neutrophil-to-lymphocyte ratio (NLR) has emerged as a potential biomarker for cancer prognosis. However, lymphocyte subsets can be influenced by factors such as race, age, medications, gender, stress, physical activity, and lifestyle. In this study, CD4+/CD8+ T cells were selected to eliminate the influence of individual differences, and it is intended to investigate whether there is a prognostic correlation of CD4+/CD8+ T cells in the immunotherapy combined with chemotherapy for patients with advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* (1)Inoperable stage III or IV NSCLC (AJCC 8th edition TNM staging) confirmed by pathological histology or cytology.(2)Received first - line immunotherapy (PD - 1/PD - L1 inhibitors) combined with chemotherapy, and driver genes are negative.(3)There is at least one measurable lesion in the lungs on CT imaging (RECIST 1.1).(4)Have complete clinical data.(5)The patient or the authorized family member gives informed consent.

Exclusion Criteria:

* (1)Have gene mutations such as EGFR/ALK/ROS1 and have not received standardized targeted therapy.(2)Have a second primary malignant tumor concurrently.(3)Have been infected or used antibiotics within 7 days before blood sampling.(4)Have severe abnormalities in the functions of organs such as the heart, liver, lungs, kidneys, and bone marrow.(5)Have other autoimmune diseases and endocrine and metabolic diseases concurrently.
Laparoscopic Natural Gastric Banding for Morbid Obesity

to do gastric banding using round ligament or omental flap instead of synesthetic band

the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study
* previous restrictive bariatric procedure

Exclusion Criteria:

* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
Stroke - 65 Plus. Continued Active Life.

Since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a Danish region with 1.2 inhabitants have in cooperation with health professionals from a specialized neurorehabilitation in a Danish municipality with 336,000 inhabitants, worked through and is still working with an iterative process in the development of a novel self-management support intervention for elderly stroke individuals.The intervention is going to be implemented into the second phase- a randomized clinical controlled trial (RCT) in the project named 'Stroke - 65 plus. Continued active life'.

Background: Elderly adults represent the majority of stroke cases worldwide. Sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. This makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. Reintegration into the community post-stroke depends highly on support from the family. However, the stroke individual's closest relatives are at risk of developing anxiety and depression.

The aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke

Methods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.

During a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.

Study outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.

Patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.

Discussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.

Eligibility Criteria:
Inclusion Criteria:

* stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home

Exclusion Criteria:

* do not understand danish Montreal Cognitive assessment (MOCA) below 20
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Prepubertal children, Tanner stage 1
* Diagnosis of GHD, confirmed by two stimulation tests
* Bone age not greater than chronological age
* Impaired height and height velocity
* BMI within +/- 2 SD (standard deviations)
* Baseline IGF-1 (insulin-like growth factor)
* Normal fundoscopy
* Stable hormonal replacement therapy (other than hGH)
* Written Informed Consent

Exclusion Criteria:

* Prior exposure to rhGH or IGF-I
* Past or present intracranial tumor; history or presence of malignant disease
* Small for gestational age (SGA)
* Malnutrition
* Psychosocial dwarfism
* Coeliac disease
* Anti-hGH antibodies
* Diabetes mellitus
* Chromosomal abnormalities (e.g. Turner syndrome, SHOX)
* Closed epiphyses
* Known or suspected HIV infection
Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

Acute myeloid leukemia (AML): continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle = standard of care for intensive induction therapy ineligible AML patients in Germany

The VENAZA-5S pilot trial: AZA administration reduced to 5 days within each cycle to improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and less hospitalizations.

Acute myeloid leukemia (AML) is a uniformly fatal disease if untreated. The combination of continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle has recently emerged as the new standard of care for AML patient who are ineligible for intensive induction therapy, and has been widely adopted in Germany.

The VENAZA-5S pilot trial aims to reduce the reported hematological toxicity profile of this currently approved combination, while preserving efficacy, by modifying AZA administration to 5 days within each cycle. The hypothesis is that this modification will not interfere with the response rates achieved by the combination, but will rather improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and hospitalizations, and thus result in better quality of life and favorable long-term outcomes in elderly or comorbid AML patients. This single-arm pilot study is intended to generate first data on the efficacy and toxicity of 5 days AZA + VEN, which will be compared to a historical control cohort treated with the current standard of 7 days AZA + VEN.

Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of AML by World Health Organization (WHO) criteria 2016
* Ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities
* Age ≥ 18 years
* Life expectancy of at least 12 weeks

Key Exclusion Criteria:

* Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following:

  * Hypomethylating agent (HMA)
  * Chemotherapeutic agent
  * Chimeric Antigen Receptor (CAR)-T cell therapy
  * Experimental therapies
  * Note: Prior use of hydroxyurea is allowed
* History of myeloproliferative neoplasm (MPN)
* Diagnosis of acute promyelocytic leukemia (APL)
* Presence of favorable-risk karyotype abnormalities: t(15;17), t(8;21), inv(16) or t(16;16)
Oxycodone vs. Fentanyl in Early Postoperative Pain After Total Hip Replacement

Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.

Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* 19-65 years of age
* ASA physical status classification I or II
* Scheduled for total hip replacement surgery

Exclusion Criteria:

* Allergic to study drugs
* Patient with asthma or COPD, patient who is severely respiratory depressed
* Renal of hepatic insufficiency
* Epileptic status
* Intracranial lesion associated with increased intracranial pressure
* Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus
* Pregnant or lactating women