cyrilzakka/clinical-trials huggingface dataset:
12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of 12-O-tetradecanoylphorbol-13-acetate in treating patients with hematologic cancer or bone marrow disorder that has not responded to previous treatment.

OBJECTIVES:

* Determine the maximum tolerated dose and dose limiting toxicity of 12-O-tetradecanoylphorbol-13-acetate (TPA) in patients with relapsed or refractory hematologic malignancies or bone marrow disorders.
* Determine the pharmacokinetics of TPA in these patients.
* Determine the effects of TPA on the cellular composition of blood and bone marrow in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive 12-O-tetradecanoylphorbol-13-acetate (TPA) IV over 1 hour on days 1 and 8 followed by 2 weeks of rest. Courses repeat in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of TPA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven relapsed or refractory hematologic malignancy or bone marrow disorder for which there is no standard curative therapy, including, but not limited to:

  * Myelodysplasia
  * Multiple myeloma
  * Myeloproliferative syndrome
  * Chronic lymphocytic leukemia
  * Aplastic anemia
  * Non-Hodgkin's lymphoma
  * Acute leukemia
  * Hodgkin's lymphoma
  * Chronic myelogenous leukemia

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* Greater than 1 month

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 3 times ULN

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* Cardiac ejection fraction greater than 40%

Pulmonary:

* FEV_1 greater than 50% predicted

Other:

* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 10 weeks after study participation
* No uncontrolled psychiatric or medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Greater than 3 weeks since prior biologic therapy

Chemotherapy:

* Greater than 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No other concurrent investigational agents
Non-Invasive Brain Stimulation

The study focusses on utilizing neuroimaging modalities, including Electroencephalography (EEG) and Functional Magnetic Resonance Imaging (fMRI) to study the impact of non-invasive brain stimulation on the prefrontal cortex during a cognitive task.

In this study, a total of 40 subjects will be randomly assigned to 2 groups i.e. experimental and sham. Conventional transcranial direct current stimulation (c-tDCS) and high-definition transcranial direct current stimulation (HD-tDCS) will be used to stimulate the prefrontal cortex of the brain. EEG and fMRI will be collected before, during and after stimulation to understand the impact of stimulation on brain dynamics. The investigators hypothesize that the stimulation of the prefrontal cortex will improve performance during cognitive tasks along with changes in the neural processing detected by neuroimaging modalities.

Eligibility Criteria:
Inclusion Criteria:

* Right Handedness,
* Age \> 18

Exclusion Criteria:

* History of any other neurological disease,
* Any psychological or psychiatric disease,
* Significant visual or auditory impairments,
* tDCS contraindications including implanted metallic or electronic devices, seizures or convulsions, and pregnancy.
Virtual Reality-Based Relaxation and Exergaming vs. Traditional Relaxation for Primer Dysmenorrhea

The goal of this clinical trial is to investigate the acute effects of virtual reality-based relaxation (immersive VR relaxation) and exergaming (non-immersive VR) compared to traditional Jacobson's relaxation on symptoms of primary dysmenorrhea (PD) in women aged 18-30 years with regular menstrual cycles. The main questions it aims to answer are:

Does immersive VR relaxation reduce abdomino-pelvic pain and menstrual symptom severity more effectively than Jacobson's relaxation? Does non-immersive VR exergaming provide better pain relief and symptom management compared to traditional relaxation methods?

Hypotheses:

Immersive VR relaxation will result in significantly greater reductions in abdomino-pelvic pain and menstrual symptom severity compared to traditional relaxation.

Non-immersive VR exergaming will also provide better outcomes in pain and symptom management compared to traditional relaxation.

Researchers will compare immersive VR relaxation, non-immersive VR exergaming, and Jacobson's relaxation (control group) to determine the relative effectiveness of each intervention.

Participants will:

Engage in a 20-minute session of one of the assigned interventions. Complete questionnaires on abdomino-pelvic pain, menstrual symptoms, and perceived effectiveness.

Participate in follow-up assessments for sleep quality during menstruation. This study aims to explore innovative, technology-driven approaches for managing menstrual symptoms and their effectiveness relative to traditional methods.

This study seeks to address this gap by investigating whether these innovative approaches can provide superior symptom relief. By evaluating pain intensity, symptom severity, and perceived effectiveness, this research will provide valuable insights into the feasibility and advantages of integrating technology into dysmenorrhea management.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18-30 with no pregnancy history.
* a regular menstrual cycle (28 ± 7 days) over the past 6 months
* menstrual pain with a Visual Analog Scale score \>4 during this period

Exclusion Criteria:

* regular medication use or medical treatment during the study (e.g., oral contraceptives, antidepressants).
* recent musculoskeletal trauma or surgery.
* intrauterine device use or pathological conditions/ultrasound findings of secondary dysmenorrhea
* consumption of painkillers, alcohol, recreational drugs, or similar substances within the last 48 hours.
A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

This study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine regimen when given to patients with metastatic breast cancer. Each agent has well demonstrated antitumor activity in patients with locally advanced or metastatic breast cancer. In addition, in the phase I combination trial of the two agents, a durable tumor response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al. 2000). Therefore, it is reasonable to expect that the combination of pemetrexed and gemcitabine administered may be associated with considerably more anti-tumor activity than either agent alone. If such activity is seen in this study, randomized studies comparing this combination with other active agents or combinations of active agents will be considered.


Eligibility Criteria:
INCLUSION:

1. Have a performance status of 0 to 2 on the ECOG performance status schedule.
2. Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy.
3. Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000):
4. Have adequate organ function including the following

EXCLUSION:

1. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation

The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18
* Patient has no prior history or use of Sodium-Glucose Co-transporter 2 Inhibitors.
* Women who are surgically sterilized, amenorrheic for a year, on long-term contraceptives like intrauterine devices and implantable and injectable contraceptives.
* Willing and able to complete the outcome assessments.

Exclusion Criteria:

* History of cardiac diseases (Heart Failure, NSTEMI/STEMI, cardiomyopathies, myocarditis).
* Diagnosis of Type I Diabetes Mellitus.
* Symptomatic hypotension (symptoms of hypotension + Systolic blood pressure \< 90).
* Estimated glomerular filtration rate \<25 mL/minute/1.73 m2, with renal function test done within a year from the study enrollment date.
* Alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking cigarettes.
* History of dapagliflozin or other Sodium-Glucose Co-transporter 2 Inhibitor sensitivity.
* Other concomitant disease or condition that the investigator deems unsuitable for the study, including psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
* Women who are pregnant or intend to become pregnant
The Bladder Instillation Comparison Study

To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

This study will compare standard of care treatment for patients with non-muscle invasive bladder cancer (NMIBC). Patients will be randomized to one of three arms, Mitomycin C, Gemcitabine or no additional treatment immediately following TURBT in the operating suite. All treatment, surgical procedures and follow up care will be conducted according to standard of care treatment.

Eligibility Criteria:
Inclusion Criteria:

1. sign an informed consent for the study
2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion Criteria:

1. patients unable to consent for themselves
2. individuals under 18 years old
3. pregnant women
4. prisoners
5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine
6. any other sound medical, psychiatric and/or social reason as determined by the investigator.
VR Therapy for Psychosis Negative Symptoms (V-NeST)

Background: Negative symptoms are typically observed in people with schizophrenia and indicate a loss or reduction of a normal function (e.g. reduced motivation and affect display). Despite being important predictors of people's recovery the development of interventions for negative symptoms received only very limited attention. There are currently no evidenced based therapies for these symptoms.

Aims: To test the feasibility and acceptability of a novel virtual reality assisted therapy, called Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis (V-NeST).

Methods: This is a single (rater) blind randomised study with two conditions; V-NeST plus treatment-as-usual (TAU) vs. TAU alone. The study will recruit people with psychosis from NHS community care teams (in England). Assessments will be at baseline and 3-month post-randomisation. A nested qualitative study to identify the key themes associated with the acceptability of the overall study and intervention will be conducted. The study will assess key feasibility parameters such as: consent and availability for screening; eligibility; availability for assessment, randomisation and treatment retention. Acceptability will be assessed by considering: therapy session attendance and drop-out; in-depth feedback from service users interviews; acceptability of the research procedures and measures.

Participants will be assessed with measures of functioning levels and, negative symptoms . Analyses will evaluate the feasibility and analyses of clinical outcomes will be focused on descriptive statistics and confidence intervals for treatment effects. Population variances of the main outcomes will be estimated for future power calculations. A semi-structured interview will explore participants' experience of being recruited to the study, receiving V-NeST and identify barriers (and potential solutions) to treatment engagement.


Eligibility Criteria:
Inclusion Criteria:

* Service users currently under the care of NHS psychosis services;
* Aged over 18;
* in a stable clinical condition (as judged by primary clinician)
* with a documented episode of psychosis and/or a diagnosis of schizophrenia.

Exclusion Criteria:

* Recent antipsychotic medication change (i.e. in the last 3 weeks);
* Moderate to severe learning disability
* Insufficient English for therapy
* Organic impairment.
Functional and Occupational Rehabilitation of Troops

The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.

This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

"patient referred to functional restoration program by provider"

Exclusion Criteria:

"patient not referred to functional restoration program by provider"
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities.

Collagen Cross-Linking (CXL) is widely used in progressive keratoconus. The cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-A radiation. The performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. However, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring.

Epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. The procedure was assisted by femtosecond laser which allows precisely and neatly cutting. The graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Keratoconus
* Age ≥ 18 years old
* Corneal thickness ≥ 400 µm
* Progressive stage 1 to 3 keratoconus (Krumeich classification)

Exclusion Criteria:

* Corneal thickness \< 400µm
* Concomitant corneal disease
* History of corneal surgery
Analyzing the Pharmacodynamic Substances and the Effects of Yiqihuayu Decotion for Acute Ischemic Stroke (PHYSIS)

The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Yiqihuayu Decotion for acute ischemic stroke. The trial is a non-randomized, controlled clinical trial.

Yiqihuayu Decotion is effective for acute ischemic stroke clinically, but there is lack of sufficient and reasonable explanation of its intervention effects currently. In order to further clarify the main pharmacodynamic substances of Yiqihuayu Decotion in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, controlled clinical trial. The primary hypothesis is that, compared with the control group, Yiqihuayu Decotion will produce serial changes in plasma metabolites at pre-dose and 9 days, as well as urine metabolites at pre-dose, 8 days, 9 days and 10 days. The serial changes may be the potential support to explain the intervention effect of Yiqihuayu Decotion. After enrollment, all participants will undergo a 2-day Traditional Chinese Medcine washout period to ensure that the results of pharmacodynamic substances will not be disturbed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute ischemic stroke;
* Symptom onset of 4 to 6 days;
* 40 ≤ age ≤ 80 years;
* Be conscious and able to cooperate with clinical information gatherers;
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
* Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
* Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
* Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
* Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
* Other conditions that render outcomes or follow-up unlikely to be assessed;
* Known to be pregnant or breastfeeding;
* Participating in another clinical study.
A Novel E-health Platform

The purpose of the current trial is to evaluate a novel e-health platform. Overall Hypothesis: Participants who receive Plan Well Guide (PWG) 2.0 will make more progress in their 'preparations' as measured by "Preparedness for the Future Questionnaire (PREP FQ)" at 6 months and, consequently, experience greater improvements in their psychological well-being (PWB), health status, and life satisfaction at 12 months compared to participants receiving PWG 1.0 (Advance Serious Illness module only). Study Design: The investigators propose to conduct a multi-site randomized trial to evaluate a novel e-health platform. Overall Hypothesis: Participants who receive Plan Well Guide (PWG) 2.0 will make more progress in their 'preparations' as measured by "Preparedness for the Future Questionnaire (PREP FQ)" at 6 months and, consequently, experience greater improvements in their psychological well-being (PWB), health status, and life satisfaction at 12 months compared to participants receiving PWG 1.0 (Advance Serious Illness module only).Study Design: We propose to conduct a multi-site randomized trial. Setting: Several sites in Lethbridge Alberta. a sample of primary care clinics as well as recruit online participants. Study Population: The investigators plan to include interested participants that are aged between 25 to 70 years of age. We will exclude participants that don't speak English or do not have internet access/email addresses, and already have a high PWB score. Study Intervention: Eligible participants will then be randomly allocated to 2 groups: PWG 1.0 or PWG 2.0.Outcomes: The primary outcome for this trial will be an overall score of PWB questionnaire; key secondary outcomes include PWB domain scores, SF-12,single-item rating of life satisfaction, all measured at 6 and 12 months. Additional outcomes include 'days off work' and health care utilization. Significance: This study will be the first large multi-centre trial examining the effects of a novel e-health platform aimed at improving people's psychological well-being and health status as well as their preparedness for serious illness decision-making during this time of a global pandemic. Results of this trial will likely affect the state of preparedness of individuals, and if wide disseminated, may have a dramatic effect on the health and well-being of a broad segment of the population.


Eligibility Criteria:
Inclusion Criteria:

* 25-70 years old

Exclusion Criteria:

* don't speak or read English
* no home internet access
* a baseline PWB score of 4.5 or greater
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.


Eligibility Criteria:
Inclusion Criteria:

* Neuropathic bladder secondary to known neurological disorder
* Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

Exclusion Criteria:

* Clinically significant abnormalities as determined by the investigator
* A history of relevant orthostatic hypotension, fainting spells or blackouts