cyrilzakka/clinical-trials huggingface dataset:
Telephone Intervention to Increase Safety in Abused Women

Although abuse by an intimate partner is very common and has serious negative effects on women's health, few studies have been done to test ways to increase safety for women in abusive relationships. This study will test a telephone intervention for women who report physical, emotional, and/or sexual abuse within the past 12 months, to see if

* women use more safety behaviors and access more community resources
* chronic pain, fatigue, depressive, and post-traumatic stress disorder (PTSD) symptoms affect a women's ability to use safety behaviors and access community resources.

Women who experience intimate partner violence (IPV) are at increased risk for serious long term negative health sequelae, injury, and death. Compared to non-abused women, intimately abused women suffer significantly greater prevalence of depression and post-traumatic stress disorder (PTSD), as well as a host of nonspecific physical symptoms including chronic pain and fatigue (Campbell, 2002; Golding, 1999; Asmundson, Coons, Taylor, \& Katz, 2002; Ehlert, Gaab, \& Heinrichs, 2001; Green, Baker, Sato, Washington, \& Smith, 2003; Woods, 2004). These increased negative health problems contribute to a greater prevalence of IPV among primary care patients, with current (past year) IPV rates of 15 - 28%, compared to 1.5% to 3% in epidemiologic surveys (Bauer, Rodruguez, Perez-Stable, 2000; Coker, et al., 2000; Collins, et al.,1998; Kramer, Lorenzon, Mueller, 2004; Richardson, et al., 2002; Tjaden \& Thoennes, 2000). In spite of this high prevalence and serious negative health sequelae, a recent review of interventions for IPV concluded that there is a serious lack of evidence-based approaches in the primary care setting. No studies were identified that examined the effect of physical and mental health symptoms on the ability to access resources or to increase safety promoting behaviors. This intervention pilot study will speak to this gap in the research. Utilizing a randomized controlled clinical trial design, we will follow women who screen positive for current (past year) IPV at a primary care clinic in Baltimore, MD. Women in the control group will receive usual care consisting of a list of community resources for IPV. Women in the a nurse-managed/community health worker intervention group will receive usual care augmented by an individualized counseling session followed by a series of 6 telephone calls over 10 weeks. A woman's stage of readiness for change as well as symptoms of pain, fatigue, depression, and PTSD will be evaluated as barriers to resource access and safety behavior initiation.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18 years of age or older
* speaks English
* reports physical, emotional, and/or sexual abuse by an intimate partner within past 12 months

Exclusion Criteria:

* non-English speaking
* currently pregnant
Medico-economic Evaluation of a Project of Wounds by a Remote Network

Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).


Eligibility Criteria:
Inclusion Criteria:

* Being adult
* Taken up residence on the Languedoc-Roussillon
* Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
* Informed consent signed,
* Patient member of the Security Social
* Patient having a visiting nurse.

Exclusion Criteria:

* Patient in vital or functional emergency situation during the first call or during the consultation
* Tumoral wound
* dialysis patient
* Arteritis of stage 4 and not revascularizable
* Absence of regular doctor and visiting nurse
* patient refusal
* Refusal of one of the health professionals participating in the pathology care
* Anybody incapable to communicate and to answer the questions
* Pregnant or nursing woman
* Subject deprived of freedom by court or administrative order
* Major subject protected by the law
* For the patients in telemedicine: refusal of the collaboration agreement
Virtual Reality Walking for Neuropathic Pain in Spinal Cord Injury

This study will examine the effectiveness of one of two virtual reality treatments on neuropathic pain in individuals with spinal cord injury.

The investigators are investigating the effectiveness of one of two possible investigational virtual reality treatments on neuropathic pain in individuals with spinal cord injury. Participants will be randomized to one of these two treatments.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with complete paraplegic spinal cord injury who report chronic neuropathic pain
* Individuals with persistent spinal cord injury neuropathic pain
* More than one - year post injury
* Stable medication regimen for the past month

Exclusion Criteria:

* Conditions that impair movement of the arms
* Significant cognitive impairment as suggested by apparent incomprehension of screening questions as judged by the evaluator
* For those for whom voluntary arm movement would cause sufficient discomfort (\>4/10) that could prevent trial completion will be excluded from participation
ADAM17 and Vascular Function in Diabetes

The objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (PS), a competitive inhibitor of ADAM17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with T2D.

As part of a randomized (1:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete 4 weeks (+/-4 days) of supplementation with either 900mg of a PS supplement or placebo. Assessment visits (2) will occur pre-intervention and post-intervention and include: 24-hour ambulatory blood pressure measurement (ABPM), Vitals, DEXA scan for body composition, fasting blood work, carotid-femoral pulse wave velocity (cfPWV), brachial and femoral artery FMDs, Femoral blood flow imaging during passive leg movement (PLM), glycocalyx integrity assessment via Glycocheck, and an oral glucose tolerance test (OGTT) with blood flow measurements and beat-to-beat sphygmomanometry via Finometer.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization.
2. T2D patients classified based on physician diagnosis.
3. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled.

Exclusion Criteria:

1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
2. History of chronic renal or hepatic disease
3. Active cancer
4. Autoimmune diseases
5. Immunosuppressant therapy
6. Hormone replacement therapy
7. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
8. Current tobacco use
9. Pregnancy
10. Bodyweight change ≥5% within the last 6 months
Phase I Trial of Emulsified Isoflurane

In this trial, our primary goal is to investigate the safety of intravenous infusion of emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop severe adverse event in any dose group or any volunteer develop fatal adverse event in any group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18\~45 years old (50:50 male:female) healthy volunteer;
* Body Mass Index (BMI) 19\~24;
* health volunteers assessed by medical history and physical examination

  * systolic blood pressure between 100\~140mmHg;
  * heart rate between 60\~100bpm;
  * pulse oxygen saturation \> 97% when inspiring air and reaching 100% after inspiring 100% oxygen for 5 min;
  * with normal result for routine lab test, including complete blood count, chemical test, urine test and stool test;
* Non-smoker and no history of alcohol or drug abuse;
* Fully understand the whole process of this trial and sign the informed consent.

Exclusion Criteria:

* Any history of allergy, especially to isoflurane or intralipid;
* Any suspected history of malignant hyperthermia in the volunteer or his/her relatives;
* Recent use of a medication with a pronounced effect on the central nervous system or any other organ (within 3 month)
* Recent participation in other clinical trial (within 1 month)
* Any history of difficult airway or suspected difficult airway;
* Pregnancy;
* Hyperlipidemia.
Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease

We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).

Alzheimer's disease (AD) is characterized by a progressive decline of memory and intellectual abilities, interfering activity in daily living, the overall quality of life, and ultimately leads to death. Although pharmacologic treatments are currently approved for treating mild- to moderate AD using acetylcholinesterase inhibitors (ACEI) or memantine, the NMDA antagonist, for the advanced stage of AD, the therapeutic efficacies need to be further improved.

For millennia, ginseng or its components have been used to treat medical conditions, and the pharmacologic effects have been demonstrated in cardiovascular, endocrine and immune system (Attele et al., 1999). In means of memory and learning, a number of studies suggested that ginseng can attenuate learning deficits of damaged or ageing brains in rodent models (Kennedy et al., 2003; Zhao and McDaniel, 1998; Nitta et al., 1995). In studies with human healthy participants, correspondently, both acute and chronic dosage of ginseng increased the cognitive performance (Kennedy et al., 2001; Kennedy et al., 2003; D'Angelo et al., 1986; Sorensen and Sonne, 1996).

In this study, we we will investigate the contribution of ginseng treatment in increasing the cognitive improvement of AD patients. In addition, we will test various bio-markers and hematopoietic progenitor cell count in those included patients using their blood samples. Patients with AD as well as memory decline will be included

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease

Exclusion Criteria:

* other neurologic disease
Wearable Technology to Reduce Sedentary Behavior and CVD Risk in Older Adults

This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA).

A recruitment of 40 sedentary men and women ≥ 60 years of age with elevated cardiovascular risk and follow them for 20 weeks. Participants will be randomly assigned (n = 20/group) to 1) an 8-week, twice-weekly, multi-modal, center-based exercise intervention (EX) followed by 12 additional weeks of follow-up assessment, or 2) the same intervention with participants also asked to wear a validated lightweight activity tracker on their hip during waking hours and instructed on how to reduce sedentary behavior increase NEPA within their daily routines (EX + NEPA). Evaluations will be done to 1) the extent to which EX + NEPA modifies sedentary behavior, 2) the impact of the interventions on cardiovascular risk factors, including blood pressure, exercise capacity, waist circumference, and circulating biomarkers, and 3) develop and optimize study procedures to guide the future trial.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle, defined as \<150 min/wk of moderate physical activity by CHAMPS questionnaire
* Moderate to high-risk of CHD events according to ATP-III risk classification algorithm
* Willingness to be randomized to either intervention group
* Willingness to participate in all study procedures

Exclusion Criteria:

* Failure to provide informed consent;
* Regular participation in an exercise training program within the last 3 months
* Absolute contraindication(s) to exercise training (American College of Sports Medicine guidelines)
* Office SBP \> 180 mm Hg or DBP \> 110 mm Hg
* Severe cardiac disease, i.e. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
* Myocardial infarction or stroke within past year
* Significant cognitive impairment, i.e. known dementia or a Mini-Mental State Examination score \< 24
* Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, ALS;
* Severe rheumatologic/orthopedic disease, e.g., awaiting joint replacement, active inflammatory disease
* Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen;
* Hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
* Other significant co-morbid conditions that would impair ability to participate in the intervention
* Simultaneous participation in another intervention trial
MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism

Rational: The first choice of imaging modality for patients with a suspicion of pulmonary embolism is CT pulmonary angiography (CTPA). Our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using CTPA. This carcinogenic effect is greatest in women under 40. In the Netherlands, at least 100,000 CTPA's are performed each year, 10% of which are in women under 40 years old, resulting in at least 10 extra tumors induced per year. The goal is to investigate whether MR Pulmonary angiography (MRPA) can serve as an alternative to CTPA. If it can replace CTPA, this will result in a significant health benefit.

Objective: the primary objective is to determine the sensitivity and specificity of MR Pulmonary Angiography (MRPA) with CT Pulmonary Angiography (CTPA) as the gold standard.

Secondary outcomes: to determine the clinical applicability of MRPA in daily practice, negative predictive value, positive predictive value, accuracy of MRPA (compared to CTPA), and agreement in assessment between radiologists.

Study design: observational-prospective diagnostic study, an additional MRPA will be performed in patients with a suspicion of pulmonary embolism.

Study population: in patients with clinical suspicion of pulmonary embolism, a standard CTPA is made for exclusion or confirmation of the disease. The study population will consist of 272 patients.

Primary outcome parameters: determining the sensitivity and specificity of MRPA compared to CTPA (gold standard) in patients with a (clinical) suspicion of pulmonary embolism.

Secondary outcome parameters: Determining the negative predictive value, positive predictive value, accuracy, inter-observer agreement with respect to MRPA, and applicability in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Mentally competent
* 18 years old

Exclusion Criteria:

* Regular exclusion criteria for MR examination,
* Contrast allergy,
* Hemodynamic instability,
* Severe respiratory insufficiency
* Immobile patient.
* Pregnancy
* Dialysis patients
* COVID-19 positive patients
PTX-200 and Carboplatin in Ovarian Cancer

The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.

The purpose of this study is to investigate the safety and tolerability, and determine the maximum tolerated dose of triciribine when combined with carboplatin in women with platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to evaluate the clinical activity of carboplatin plus triciribine in women with recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate, progression-free survival, and duration of stable disease.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy.
* At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
* A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry
* Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000 mm\^3; absolute neutrophil count ≥ 1500 mm\^3; platelets ≥ 100,000 mm\^3
* Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1.5 mg/dl
* Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2
* Life expectancy of at least 90 days
* The patient should be off chemotherapy, biologic therapy and radiation for 28 days.
* Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4

Exclusion Criteria:

* Prior TCN-PM therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TCN-PM
* Patients must be disease-free of prior invasive malignancies for \>2 years with the exception of basal cell or squamous cell carcinoma of the skin.
* Inability to give informed consent
* Pregnancy
* Corrected QT interval (QTc) prolongation \> 450 milliseconds (msec)
A Bioavailability Study of Methotrexate 25 mg Administered by Needle Injection and a Pre Filled Needle-free Device in Healthy Volunteers.

The objective is to determine whether the test product, Methotrexate 40 mg/mL solution for injection administered subcutaneously by the prefilled and needle-free delivery system Zeneo®, and the reference product, Methotrexate Biodim® 25 mg/mL, solution for injection administered subcutaneously by a conventional syringe with needle are bioequivalent.

ABSTRACT Objective: Zeneo1 is a needle-free injection device. We performed a pharmacokinetic study to investigate the bioequivalence of methotrexate administered subcutaneously using either the needle-free injection device or a conventional needle and syringe.

Research design and methods: This was a single-dose, open-label, laboratory-blind, randomized crossover study performed in adult healthy volunteers. Each participant received two methotrexate injections (each 25mg), one via needle-free injection device and one via conventional injection, with a 21-28 day wash-out interval between dosing. For each participant, the administration site for both injections was either the abdomen or the thigh.

Main outcome measures: The primary pharmacokinetic outcome parameters were AUC(0-t) and Cmax.

Bioequivalence was assessed by standard criteria: whether 90% confidence intervals of geometric mean ratios for the two administration methods were within 80-125%.

Results: Fifty-two individuals completed the study. Bioequivalence criteria were met for AUC(0-t), for the overall analysis (both injection sites: 90% confidence interval: 99.4-103.1%), and for each injection site separately. Bioequivalence was similarly demonstrated with AUC(0-1). Bioequivalence criteria for Cmax were fulfilled for abdominal administration but not for the overall analysis. Injection via the needle- free injection device was well tolerated.

Limitations: Limitations include conducting the study in healthy volunteers and the relatively small subject number (albeit satisfactory for bioequivalence).

Conclusions: This study shows that methotrexate injection via needle-free injection device is bioequivalent to a conventional needle and syringe in relation to AUC(0-t) and AUC(0-1). Studies of needle-free injection device use in patients requiring methotrexate therapy are planned.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* BMI between 18.5 and 30 kg/m2
* Body mass \> 60 kg
* Non-tobacco user
* Written consent given for participation in the study

Exclusion Criteria:

* Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder
* Heavy alcohol consumption and regular exposure to drug of abuse
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients with Sickle Cell Disease

To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.

The trial will consist of a 28-day screening period, 16 weeks of active treatment and a 30-day post-treatment follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell disease (SCD) including:

  * 2 sickle hemoglobin genes \[HbSS\]
  * HbSβ0 thalassemia
  * HbSβ+ thalassemia
  * Heterozygous for hemoglobin S and hemoglobin C \[HbSC\]
* Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF)
* Patients who have had between 2 and 15 episodes of vaso-occlusive crisis (VOC) in the past year (12 months)
* For patients taking hydroxyurea (HU), the dose of HU must be stable for at least 3 months prior to signing the ICD and with no anticipated need for dose adjustment during the study.
* Female patients and male patients with female partners of childbearing potential must use highly effective contraceptive methods for the duration of the study.

Exclusion Criteria:

* Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion), have received an RBC transfusion for any reason within three months of the baseline visit
* Patients who have received a hematopoietic stem cell transplant.
* Patients with inadequate venous access as determined by the Investigator
* Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception during the trial.