cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor).

Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and women of non-child bearing potential between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
* A positive urine drug screen.
* Subjects with hepatic dysfunction, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>1.5 times the upper limit of the normal range at Screening. A retest may be done if AST and/or ALT within 1.5- to 2- times the upper limit of the normal range at Screening, and the average of the first and repeated test values should be used to decide the eligibility.
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion

Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion

The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 85 years old, male or female
* Subject's target lesions were stenosis and/or occlusion
* Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent

Exclusion Criteria:

* Pregnant woman or who's pregnancy test is positive
* Lactation period woman or woman/man with fertility plan
Depression Attention for Women Now (The DAWN Study)

Major depressive disorder (MDD) is a common disabling illness that disproportionately affects women, with prevalence rates two times those of men. In addition to suffering, MDD has been shown to have a marked effect on social and vocational functioning, with increased disability, lost productivity, and excess mortality. Women with MDD have an increased prevalence of comorbid anxiety disorders and medical conditions.

Our model of care utilizes a social worker as a depression care manager (DCM) to support both patients and physicians in optimizing care in the OB-GYN clinical setting. This intervention will be compared to usual care for depression.

A large number of women receive their routine care in OB-GYN clinics, including a disproportionate percentage of low-income and minority women. For many of these women, OG-GYNs are the only provider they see on a regular basis. OB-GYNs take care of women across their lifespan, addressing gynecologic, health care maintenance, pregnancy and primary care concerns in their everyday practices. There are multiple aspects of OG-GYN care that are uniquely suited for detection and treatment of depression, but there are also significant barriers to such care that must be addressed.

In this randomized controlled trial, we are testing this depression care management program for women attending two OB-GYN clinics in the University of Washington health care system. Our research aims to test the hypothesis that a depression care management intervention, integrated into the OB-GYN clinic setting, will improve treatment outcomes for depression, functional outcomes, and satisfaction with depression care. The results of our research will greatly impact clinical care by satisfying an unmet need for effective depression services for women seen in OB-GYN clinical settings.

The study compares a depression care management intervention, delivered by a depression care manager, to usual care for depression in the clinics. The primary aims of the study are to evaluate, compared to usual care, a depression intervention consisting of enhanced education, engagement, and depression care management (with a choice of antidepressant medication monitoring and/or provision of brief psychotherapy).

Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 score ≥10 for Major Depressive Disorder (with 1 cardinal symptom) and/or ≥10 for Dysthymia (with 1 cardinal symptom)
* MINI confirmation of PHQ-9 diagnoses
* Access to a telephone
* English-speaking

Exclusion Criteria:

* High suicide risk (PHQ-9 response)
* ≥2 prior suicide attempts
* Lifetime history of schizophrenia or bipolar disorder (MINI response)
* Substance abuse/dependence within the previous 3 months (CAGE-AID)
* Current severe intimate partner violence
* Currently seeing a psychiatrist
Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective.

In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view.

The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid.

This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.


Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years of age with severe meningeal hemorrhage defined by a WFNS≥3 score will be included in the study.
* Treated by endovascular embolization or surgically within 48 hours
* After obtaining the informed consent of the patient, or his relatives if he is not searchable (coma).
* Affiliation to a social security system
* After an adapted preliminary medical examination

Exclusion Criteria:

* Post-traumatic meningeal hemorrhage
* Management time \>48h with respect to bleeding
* Known neurodegenerative pathology (Alzheimer's, Parkinson's, etc.), Creutzfeldt-Jacob disease
* Pregnant woman
* Decision not to treat
* Refusal to participate in the study
* Adult patient protected by law
* Person deprived of administrative or judicial freedom
Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms

The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).

The recent discovery of calreticulin mutations in myeloproliferative neoplasms point to the unexpected role of the endoplasmic reticulum biology in the pathophysiology in these diseases. Otherwise, the association of endoplasmic reticulum stress with solid cancers, in particular in resistance to chemotherapy, is well documented, contrary to hematological malignancies. The study aims to evaluate endoplasmic reticulum stress markers as predictors for the response to hydroxyurea in polycythemia vera and essential thrombocythemia patients. The main objective is to correlate endoplasmic reticulum stress (defined as splicing of XBP1 above 30%) to the rate of complete response after 6 months according to the 2009 ELN criteria. This is an observational retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* ET or PV patients diagnosed before acceleration phase and treated by hydroxyurea with a follow up period of at least 6 months following treatment start.
* Diagnosis criteria of PV :

  * WHO criteria of PV with :

    * Acquired JAK2V617F mutation \> 5%
    * Absence of evident cause of secondary polycythemia
* Diagnosis criteria of ET :

  * Platelet count \> 450 G/L
  * Absence of PV or Chronic Myeloid Leukemia
  * Bone marrow biopsy preferred but not necessary in absence of reactional causes (CRP and ferritin levels normal) and/or presence of acquired JAK2V617F, CALR exon 9 or MPL exon 10
* Availability of RNA sample of total leukocytes before start of treatment.

Exclusion Criteria:

In absence of clonality marker, presence of secondary cause of :

* Thrombocytosis :

  * Inflammatory syndrom (CRP or SV increased)
  * Iron deficiency (decreased ferritin level or increased soluble transferrin receptor level)
* Polycythemia :

  * Increased or normal level of EPO in context of :

    * Hypoxia, respiratory insufficiency
    * Sleep apnea syndrome
    * Hyperaffin hemoglobin
* Absence of treatment by hydroxyurea
* Treatment by anagrelide, P32, pipobroman, interferon without subsequent hydroxyurea treatment.
* Concommitant treatment by other cancer chemotherapy (in a context of solid cancer for example).
* Diagnostic during transformation to acute leukemia
* Treatment by hydroxyurea during less than 6 months
* Bad observance of the cytotoxic treatment
Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas

1. To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas.
2. To evaluate the effect of PRP on wound healing on skin graft donor site.

Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be caused by heat from hot liquids, solids or fire, an less common causes are friction, heat, chemical or electric sources The treatment of burns is complex due to the combination of hypermetabolic physiological response and the need for good functional and cosmetic recovery. Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn raw areas.

The time to complete wound healing ranged from 2 to 75 days. Factors that significantly affected time to complete wound healing were graft loss by seroma, presence of hypergranulation tissue, premorbid conditions, and total body surface area burned.

Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce skin graft take, and even lead to skin graft loss.

Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a 2- to 6-fold concentration of platelets in comparison to normal human platelet concentration. Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These growth factors can promote proliferation of endothelial cells, epithelial cells as well as fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin graft might rely on its haemostasis, adhesive, antibacterial and healing properties.

Eligibility Criteria:
Inclusion Criteria:

1. Age (15- 60 years).
2. Post burn Raw area less than 10 % of total body surface area .
3. Selected donor sites.

Exclusion Criteria:

1. Raw area due to other causes ( trauma, ischemia,..etc)
2. Patients with bleeding tendency.
3. Patients with comorbidities(diabetes, malignancy,..etc)
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.


Eligibility Criteria:
Inclusion Criteria:

* Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
* Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Exclusion Criteria:

* Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)

Other protocol-defined inclusion/exclusion criteria apply.
'WeChat WeQuit' Smoking Cessation Program

This proposed project is to assess whether WeChat-based smoking cessation interventions ('WeChat WeQuit' program) will be effective at helping people in China who smoke, to quit.


Eligibility Criteria:
Inclusion Criteria:

1. Daily Chinese cigarette smokers.
2. 18 years of age and older living.
3. Being able to read and write in Chinese.
4. Owning a smartphone and knowing how to use WeChat.
5. Willing to make an attempt to quit smoking in the next month.
6. Willing to provide informed consent to participate in the study.

Exclusion Criteria:

1. Nonsmokers.
2. Smokers without attempt to quit.
3. Below 18 years old.
4. Unable to use smartphone and WeChat.
5. Unable to read and write in Chinese.
EuroPainClinicsStudy XIr-Zj

Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain

Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome.A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint. Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches. Description of interventional procedures: Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 20 and 80
* positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application
* positive patient history of facet joint pain
* patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS \>=5)
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
* women with positive a pregnancy tests before the trial or who planned to become
* pregnant within the following 3 years
* other patients viewed as inappropriate by the staff
* disagreement with participation in the study
Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control

Hypertension is a leading risk factor for cardiovascular disease and mortality. Lifestyle counseling is recommended as a first line therapy for reducing blood pressure (BP) and risk for cardiovascular events. Recent studies suggest that e-based lifestyle interventions are effective in evoking therapeutic change in BP1. However, BP response and adherence to exercise and diet behavior varies significantly after e-based interventions due to variations in treatment methodologies. Consensus is not yet established for a standardized e-counseling protocol for hypertension. As noted in our systematic review, the two dominant models of e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven (self-guided, collaborative). Expert-driven programs prescribe specific changes for lifestyle behavior which are intended to facilitate compliance to behavioral change. In contrast, the user-driven method actively involves the subject in goal-setting and/or the selection of the intervention used to reach the behavioral goal. One conclusion from the systematic review is that these models are used indiscriminately in e-counseling programs. There is currently inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven in reducing BP while modifying lifestyle behaviour. It is possible that a combination of expert-driven and user-driven features for lifestyle e-counseling is most effective. However, before these two approaches can be combined, it is essential to establish the strengths and limitations of each model.

This study will use a 3-parallel group, randomized controlled design: 3 (Groups: Control, expert-driven, and user-driven e-Counselling) by 2 (Assessments: baseline, 4-month). Controls will receive general e-information on BP management. The expert-driven e-Counselling group will provide a prescribed exercise and a diet plan. The user-driven e-Counselling group will a program that enables the patient to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Eligibility Criteria:
Inclusion Criteria:

* Unchanged prescription for anti-hypertensive medication at least 2 months before enrollment.
* Participants prescribed antihypertensive medication were also required to have SBP ≥130 mmHg and/or DBP ≥85 mmHg, in order to prevent "floor effects".

Exclusion criteria included:

* Diagnosis of kidney disease, major psychiatric illness (e.g. psychosis), alcohol or drug dependence in the previous year, pregnancy and sleep apnea. There was no racial or gender bias in the selection of participants.
Perceived Coping, Meaning, and Joy at Work

The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction.

The study design is cross-sectional. This study will be conducted at a single Magnet-designated facility, Methodist Richardson Medical Center (MRMC), within the Methodist Health System. The sample will be a convenience sample of hospital-registered nurses and para-professional nursing services staff (e.g., patient care technicians and specialty area technicians) who agree to participate in an online survey launched via the Survey Monkey® portal. Survey Monkey® is an online, cloud-based survey delivery portal, and the subscription for the use of the portal is paid for by the Department of Education (DOE) at MRMC. Hence, the data will be owned by MHS. The study is a one-time inquiry. The PI and designated sub-investigators will send institutional emails to staff members who meet the inclusion criteria. The timeline for the study will be a total of four weeks. The study will be introduced for one week, be available for three weeks, and will conclude by the end of week four.

Eligibility Criteria:
Inclusion Criteria:

* The sample of participants will include all willing individuals who are registered nurses (full time, part time, and per-diem) Nursing para-professionals employed by Methodist Health System working at the MRMC campus and provide direct patient care for more than 50% of work hours
* All participants must be able to read and understand English.

Exclusion Criteria:

* employees who do not provide direct patient care for at least 50% of the time
* educators
* managers
* leaders
* advanced practice nurses
* non-nursing service personnel.