cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form (ICF) prior to any study related procedures
* Male and female subjects 18 to 55 years, inclusive
* Good general health
* Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
* Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion Criteria:

* Pregnancy, nursing female subjects, or subjects trying to conceive
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* History of ECG abnormalities
* Cancer not in complete remission for at least 5 years
* Clinically significant, symptomatic prostatic hypertrophy
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Clinically significant bladder neck obstruction or urinary retention
* Inadequately treated glaucoma
* History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
* Subjects with pre-existing anemia and/or iron deficiency
Better Together: Reablement and Caregivers

Hospitalization creates opportunities for older adults to accumulate prolonged periods of sitting and lying (defined as sedentary behavior) which can result in mobility loss. We propose a Type 1 Hybrid Effectiveness-Implementation Trial with 1:1 randomization to test the effect of a caregiver intervention on older patients' physical activity at 3 months (home). We will recruit 61 patients and family caregivers from hospital units and follow them for 3 months; the primary outcome is patients' daily step count at 3 months.


Eligibility Criteria:
Inclusion Criteria: Older adults (60 years and older) with a recent hospitalization and their caregiver.

Exclusion Criteria: Caregivers and older adults with a dementia diagnosis, head injury, significant neurological impairment, or receive treatment for medical conditions that preclude exercising.
Detection of Urinary Human Chorionic Gonadotropin (hCG)

The Mira Pregnancy Test is an over-the-counter urine hCG test intended for early detection of pregnancy. The test is indicated for use four days before the expected period. Throughout this study, volunteers with non-medical backgrounds were recruited to test hCG with urine samples using the Mira Pregnancy Test during the not pregnancy cycle or pregnancy cycle. To perform the study, a total number of more than 200 volunteers will be recruited to participate in the study.

The studies include two parts, which are a lay user study and a urine samples test during the trying to conceive cycle.

Part 1: Lay user study Part 2: Detection of hCG in Early Pregnancy Clinical Samples

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 and over
* Willing to give informed consent
* Willing to conduct a personal home pregnancy test and reveal their pregnancy status
* Have a working smartphone

Exclusion Criteria:

* Have a medical background or have been in a related industry/occupation
* Volunteers who are unfit to participate in the research by the researcher
* Used the investigational pregnancy test previously
* Has a medical condition
* Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
Progressive Eccentric VS Bodyweight Exercises on Agility, Power and Functional Performance in Hamstring Strain.

The study is randomized and single blinded. Ethical approval is taken from ethical committee of Riphah international university Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. Subjects in group A will receive Progressive eccentric exercises. Group B will receive Bodyweight exercises.

The objective of the study is to determine the effects of progressive eccentric exercises verses Bodyweight exercises on agility, power and functional performance in athletes with hamstring strain. The study is randomized and single blinded. Ethical approval is taken from ethical committee of Riphah international university Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. Subjects in group A will receive Progressive eccentric exercises. Group B will receive Bodyweight exercises. The outcome measures will be assessed by T test, Vertical jump, Standing Long jump and squat test. The data will be analyzed by SPSS, Version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Athletes older than of 18 years will be added. Athletes having history of Hamstring Strain of Grade 1 and 2.Participants will be added after 4 weeks of recovery period after grade 1 \& 2 hamstring Strain.Male and female Athletes will be added.

Exclusion Criteria:

* Athletes with a complete rupture of the hamstring muscle. Athletes undergone hamstring surgery in the past 6 months will not be considered.Participants with history of back pain.Lower limb injuries in past 6 months.

If the hamstring strain is accompanied by severe associated injuries, such as fracture or significant ligament tear.
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study

Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients.

Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients. The specific aim is to:

Aim: Develop a multi-component behavioral treatment to address psychological risk factors among COPD patients. We will conduct a component analysis using single case design experiments with 15 participants to a) examine the contribution of each treatment component to the behavioral target of smoking for affect regulation, and b) establish proof-of-concept on the clinical endpoint of initial cessation (\>24 hours abstinence).

Eligibility Criteria:
Inclusion Criteria:

Eligible participants will be males and females who are:

* Diagnosed with COPD (as documented in electronic health record \[EHR\]),
* Daily cigarette smokers (5 or more cigarettes per day over past 30 days),
* Intend to quit smoking within the next 60 days,
* Report at least moderate level of smoking for affective regulation (SMQ-R coping subscale score 30 or greater),
* Have access to a smart phone, tablet, or computer, and
* Are able to communicate fluently in English

Exclusion Criteria:

* Any concurrent medical or psychiatric condition which would preclude ability to provide informed consent or perform study procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the treating physician or study PI.
Dependence Receptors and Leukemia

Acute leukaemias (AL) are the first cause of cancer in children, with a majority of B acute lymphoblastic leukemia (ALL). Some of the processes causing leukemogenesis are already identified and well characterized in some AL subtypes such as translocation t (12; 21) of good prognosis in ALL. However, translocations are not sufficient to explain all the different processes of leukemogenesis, and other processes such as genetic / epigenetic mutations leading to oncogene activation / inhibition of tumor suppressor genes are the object research. Among the latter, mutations in tumor suppressor genes such as DCC (Deleted in Colorectal Cancer) have recently been identified in solid cancers, such as in hemopathies. This gene was subsequently characterized as encoding a "dependence receptor" specifically binding to its Netrin-1 ligand.

Dependence receptors (RDs) are transmembrane receptors that cause cell death in the absence of their ligand. RD decreases tumor progression and overexpression of their ligands is observed in many cancers, such as B lymphomatous hemopathies in adults. Inhibition of the RD-ligand interaction constitutes a new and original therapeutic target in oncology.

The aim of this study is to investigate whether RDs, in particular DCC, are expressed in acute leukemia cells at the time of diagnosis or relapse in patients aged 1 to 18 years, and then in these patients at the time of the remission balance. This research will be both qualitative and quantitative.


Eligibility Criteria:
Inclusion Criteria:

* aged between 1 and 18 years
* taken care of at the Institute of Hematology and Pediatric Oncology (Service of Professor Yves Bertrand, IHOPe)
* for acute lymphoblastic or myeloblastic leukemia
* initial diagnosis or relapse
* who do not have a vital emergency criterion at the time of taking care (see exclusion criteria)
* affiliated to a social security scheme (100% assumed)
* after signing the informed consent of the holders of parental authority

Exclusion Criteria:

* less than 1 year, or more than 18 years to diagnosis
* with chronic leukemia
* severe anemia at diagnosis (hemoglobin \<40g / l), or a state of shock whatever the cause (infectious, cardiogenic, hypovolemic)
Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the contribution of this treatment on control of pain in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the objective response and biological observations in these patients after this treatment. V. Determine the effect of this regimen on survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II: Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of life is assessed before treatment, every 4 weeks during treatment, and then every 3 months. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, symptomatic prostate cancer Appearance or aggravation of clinical symptoms with progression of disease Bone pain OR Urethral compression OR 20% decrease in performance status Metastatic disease Local-regional or distant secondary tumors Documented radiologically or scintigraphically Hormone-refractory as defined by progression while on hormone treatment (simple castration or complete androgen blockage) Progressive disease No urethral or cervical stenosis Increase of greater than 25% prostatic volume on endorectal echography No documentation by PSA increase or imagery only Hormone castration verified by testosterone less than 0.5 ng/mL No history of CNS metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: No specified Hematopoietic: Neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Ventricular ejection fraction at least 50% Other: No contraindication to anthracycline treatment No prior primary cancer except basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Arm I: No concurrent chemotherapy Endocrine therapy: At least 1 month since prior hormone therapy, including estramustine, except LHRH agonists, which continue Arm I: No concurrent estramustine Radiotherapy: At least 3 months since prior strontium 89 No concurrent strontium Surgery: See Disease Characteristics
Inhaled Mannitol and Ciliary Beat Frequency in COPD Patients

The main purpose of the study is to evaluate the effect of mannitol on the cilia's beat frequency (ciliary beat frequency) in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* COPD
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years.
* Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.
* Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.
* Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor
* Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included.

Study Specific Inclusion Criterion • Signed informed consent

Exclusion Criteria:

* Infection
* Vertebral body collapse to less than 1/3 (33%) of original height
* Vertebral plana (\>90% vertebral body collapse)
* Spinal stenosis (retro pulsed fragments).
* Unstable spine warranting surgical stabilization
* Prophylactic treatment of any vertebrae with vertebroplasty
* Irreversible life threating bleeding disorders
* End stage kidney disease
* Drug dependence (IVDU)
* Pregnancy

Study Specific Exclusion Criterion:

• Unable or unwilling to follow the standard of care prescribed follow-up visits
Improving Implementation of Evidence Based PTSD Psychotherapy for Veterans in the Community

To further increase the access of evidence based psychotherapies for Veterans with Posttraumatic Stress Disorder, we propose to offer training and intensive consultation to community-based providers in Cognitive Processing Therapy for Posttraumatic Stress Disorder. However, we believe that many clinicians may not implement Cognitive Processing Therapy or take advantage of consultation after initial training. For this reason, we propose to examine the effectiveness of an enhanced training method, which would add Motivational Interviewing to the standard Cognitive Processing Therapy training. Motivational Interviewing is a form of collaborative discussion for strengthening motivation and commitment to change. We hypothesize that augmenting the standard Cognitive Processing Therapy training with these techniques will reduce providers' reluctance to fully implement the interventions.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* currently licensed in their mental health discipline or a graduate level trainee in their mental health discipline

Exclusion Criteria:

* Have completed a 2-day training in Cognitive Processing Therapy
Compliance With Clinical Guidelines and Effect on Patient Outcome of Treatment of Hospitalised Exacerbations of COPD

Rationale. Currently there are well-established guidelines for the management of stable COPD. However, recommendations on the treatment of COPD exacerbations (E-COPD) are based on observational studies and low-quality clinical trials. In addition, there are some controversial aspects, such as treatment with systemic steroids. On the other hand, the available information on the adherence to the recommendations of the clinical practice guidelines (CPG) and its impact on the outcome of patients is scarce.

Main objectives. (1) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the current management of hospitalized exacerbations of COPD; (2) To determine in real-life clinical practice the impact of adherence to CPG recommendations for management of COPD exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days post-discharge readmissions and mortality); (3) To examine the appropriateness of two clinical guidelines (GOLD and GesEPOC) of the treatment of stable COPD at admission and after discharge in patients hospitalized with exacerbated COPD; (4) To determinate in real-life clinical practice the impact of the suitability to CPG recommendations for treatment of stable COPD on 90-day post-discharge mortality and readmission of COPD.

Method. National, multicenter, observational and longitudinal study of the first consecutive 20 patients hospitalized for exacerbations of COPD between December 10 and 23, 2019 in the Internal Medicine Services of the participating Centers. Patients will be followed 90 days after discharge. A total of 400 patients will be recruited in 20 Spanish hospitals (20 per center). Independent variables: age, sex, admission service, body mass index, dyspnea (mMRC), obstruction (FEV¬₁), exacerbations in the previous year, comorbidities, bronchodilator treatment prior to admission, criteria of adequacy to the CPG in the clinical evaluation and treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia and bronchodilator treatment at discharge. Outcomes: in-hospital mortality, mortality at 90 days, re-admission at 90 days. Statistical analysis: Parametric and non-parametric tests, Kaplan-Meier and ROC curves and multiple logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years.
* COPD patient hospitalized with the main diagnosis of exacerbation of COPD and whose main diagnosis is confirmed by the discharge report and the local investigator.

Exclusion Criteria:

* Terminal disease
* Absence of spirometry confirmation of the COPD diagnosis.
* Presence of other diseases that can cause symptoms like those of a COPD exacerbation (e.g. heart failure, pneumonia, etc.), where exacerbation of COPD is not the main cause of admission.
Prognostic Factors Following Ankle Fractures

Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.

Aim of study:

To identify prognostic factors associated with a worse outcome following ankle fractures.

Method:

All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:

Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.

Study participants will at time of diagnosis and 6, 12, 52 and 104 weeks following the injury received a questionaire with Manchester foot and ankle questionnaire (MOXFQ), Self-reported foot and ankle questionnaire (SEFAS), Olerud Molander Ankle Score (OMAS) and Forgotten Joint Score (FJS).

Which of the questionaire that should be used in the study will be determined when the questionaires have been compared in a different study.

Eligibility Criteria:
Inclusion Criteria:

* All patients with ankle fracture.

Exclusion Criteria:

* age below 18 years
* patients who do not speak or understand danish
* mental disable patients
Cardiopulmonary Rehabilitation in Chronic Stroke

This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients.


Eligibility Criteria:
Inclusion Criteria:

* A history of ischemic stroke at least 6 months ago

Exclusion Criteria:

* any cardiac or pulmonary problem that renders the patient unavailable for the program
* mental impairment
* not being able to perform exercise testing
* not being able to walk independently