cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C virus (HCV)
* Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
* Males and females 18-65 years old
* Body mass index 18 to \< 35 kg/m\^2
* Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion Criteria:

* Cirrhosis or extensive bridging fibrosis
* History of cardiac disease
* Positive screen for certain drugs or alcohol
* Abnormal laboratory results
* Significant sensitivity to any drug
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing
Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia

The study aims to investigate the impact of preeclampsia on hemostasis.

In comparison to healthy pregnant women and non-pregnant woman, this study analyses parameters of primary hemostasis and plasmatic coaguation in preeclamptic pregnant woman. Detailed analyses of the platelet function is performed using the Multiple Electrode Aggregometry, detailed analyses of the plasmatic coagulation syste is performed by isolated coaguation factor analyses and conventional coagulation analyses.

Eligibility Criteria:
Inclusion Criteria:

* Platelet count \> 100 / nll
* In study group and control group 1: Week of Pregnancy: 35-40
* in control group 2: healthy, not pregnant woman

Exclusion Criteria:

* Hereditary coagulopathy
* Missing content of the patient / proband
* Eclampsia
* HELLP syndrome
* CRP \> 1 mg/dl
* Fever (\> 38°C)
The Effect of Progressive Relaxation Exercise on Fatigue in Intensive Care Nurses

This study was planned as a randomized controlled experiment. It was aimed to examine the effect of progressive relaxation exercises applied to intensive care nurses on fatigue. The sociodemographic information of the participants will be collected with the 'Personal Information Form' and their fatigue levels with the 'Fatigue Severity Scale'. SPSS 22.0 package program will be used in the analysis of the data. p\<0.05 will be considered significant.

Intensive care nurses experience high levels of fatigue due to the physically and mentally demanding tasks they undertake. For example; Conditions such as prolonged seizures, difficulty sleeping, and heavy workload trigger this fatigue. One of the non-pharmacological interventions used in the management of fatigue experienced by intensive care nurses is progressive relaxation exercise (PGE). PGE involves voluntary, continuous and systematic stretching and subsequent relaxation of various muscle groups and was first described by Jacobson in 1938. The purpose of PGE is to focus attention on skeletal muscles and relax the whole body. While doing the exercise, the individual feels the difference between tension and relaxation in the muscles. Thus, when needed, it learns to relax in order to reduce the tension in the muscles. In the literature, it has been shown that PGE reduces the severity of fatigue caused by different chronic diseases. In this context, in this study, it is aimed to examine the effect of progressive relaxation exercise applied to intensive care nurses on fatigue and to contribute to the literature and to the fatigue management of nurses in line with the results obtained.

Eligibility Criteria:
Inclusion Criteria:

* Working for at least 6 months
* Having a Fatigue Severity Scale score of 2.8 and above
* Volunteer to participate in research

Exclusion Criteria:

* Having a problem that prevents breathing through the nose
* Having a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma
* Being pregnant
* Having physical and mental health problems that prevent communication
* Practicing any complementary method (relaxation exercise, yoga, etc.) during the study
* Informed about the research but willing to participate in the research
Esthetic Expectations of Edentulous Patients Followed in a French Dental Clinic

Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic project plays a crucial role in denture acceptance and patient satisfaction. Historically, teeth choice and arrangement were made according to Frush and Ficher's recommendations focusing on natural looking of esthetics. Dentists may also propose to restore the dentate state looking for denture when preextraction data are available. Recently, a patient-centered approach based on attractivity has been proposed and may lead to in an appearance transcending the laws of nature.

The aim of the present study was to investigate actual denture esthetic expectations in a French edentate population followed in a university dental clinic (Rothschild Hospital , AP-HP).

Inclusion criteria : being currently edentulous within at least within the maxillary arch, literate French speakers, willing and able to complete the survey in a single sitting. Clinical data collection was made by a unique examiner and concerned length of edentulism, antagonist arch, existence of preextraction data, smile attractivity opinion. The respondents completed a questionnaire identifying their age, sex, educational and income level. Patients were also asked for their denture look preference among 4 esthetic projects: 1) restoring pre-extraction (dentate) looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion. Each project was explained similarly by the same examiner. Statistical analysis using a Pearson Chi-squared test at a 0.05 level of significance was conducted for associations between esthetic projects preference and tested variables.

Eligibility Criteria:
Inclusion criteria : Currently edentulous maxillary arch, literate French speakers, willing and able to complete the survey in a single sitting. Inclusion Criteria:

Exclusion Criteria: Aged under 18 years.
Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme

This is a safety study of tandutinib in combination with temozolomide and bevacizumab after people have received radiation therapy and temozolomide treatment. This study will determine the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and evaluate the safety of the combination treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glioblastoma multiforme
* Received radiotherapy for glioblastoma multiforme
* Patients who have not had previous treatments for glioblastoma multiforme (except for surgery, radiation and temozolomide therapy)
* Females that are postmenopausal for at least 1 year prior to screening visit
* 18 years of age and older

Exclusion Criteria:

* Other brain cancers that are not diagnosed as glioblastoma multiforme
* female patients who are lactating or are pregnant
* HIV positive and/or any other active infection requiring therapy
* Known hepatitis B or hepatitis C infection
* Diagnosed or treated any other cancer within 2 years before the first dose
* History of cardiovascular conditions and/or vascular disease
* Allergic to any component of bevacizumab
Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor

The aim of the study was to evaluate any possible associations between engagement and position of the fetal head and the outcome of labor in women with induced labor, and to compare the value of ultrasound measurements in predicting the time from induction to delivery and operative deliveries.

Fetal head engagement measured by ultrasound as a predictive factor of labor outcome in women with induced labor

T. EGGEBØ, L. K. GJESSING, I. ØKLAND, C. HEIEN, P. ROMUNDSTAD\*, K. Å. SALVESEN\*\* Department of Obstetrics and Gynaecology, Stavanger University Hospital, Norway \* Department of Public Health, NTNU, Norway, St Olavs Hospital, Trondheim University Hospital

\*\* National Center for Fetal Medicine, Department of Obstetrics and Gynaecology, Trondheim University Hospital (St. Olav's Hospital) and Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology

KEYWORDS:

Ultrasound, induced labor, cervical length, engagement of fetal head, occiput posterior, Bishop score, outcome of labor

Objective The aim of the study is to evaluate any possible associations between engagement of the fetal head, the cervical status or occiput posterior position and the outcome of labor in women with induced labor, and to compare the value of ultrasound measurements with Bishop score in predicting operative deliveries.

Methods The ultrasound examinations will be carried out in 275 women immediately before induction of labor. A transabdominal scan will be performed to determine the position of the fetal occiput, a transperineal scan with transverse view to determine the degree of engagement and a transvaginal examination to evaluate the cervical length and the cervical angle.. The Bishop score will be performed by another examinator who is blinded to the results of the ultrasound examinations. The time from induction to delivery will be tested in a Cox regression analysis with fetal head engagement, cervical length and parity as possible predictive factors and maternal age, BMI, gestational age, birth weight and head circumference as possible confounders.

Inclusion and exclusion criteria:

Women were eligible for the study if they had a live singleton pregnancy with cephalic presentation and a gestational age of more than 37 completed pregnancy weeks according to a mid-trimester scan.

Statistical analysis Appropriate statistical tests for comparisons, such as Mann Whitney U test, chi-square test, Fisher's exact test, Pearson correlation, Kaplan Meier survival analysis and Cox regression analysis will be used. For receiver-operating characteristics (ROC) curves, the area under the curve will be used as discriminator. P-values \< 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Indication of induced labor

Exclusion Criteria:

* More than one fetus
* Less than 37 weeks of pregnancy
* Previous cesarean section
* Breach position
* Dead fetus
Xenon MRI in Stable Pulmonary Hypertension (Jupiter AUGEAN)

The objective of this project is to determine how pulmonary vascular remodeling in Pulmonary Arterial Hypertension (PAH) at cellular and pathological level is associated with gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.

The clinical and research need for noninvasive biomarkers in pulmonary arterial hypertension (PAH) has led the study team to develop 129Xe magnetic resonance imaging (129Xe MRI) to image pulmonary vascular pathology through quantitative 3D maps of gas transfer across the pulmonary blood-gas barrier. 129Xe MRI, in combination with 129Xe spectroscopy (MRS), has a unique signature in PAH and can simultaneously measure capillary blood volume and hemodynamic changes associated with pulmonary vascular remodeling (Wang '19a). This project aims to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is related to gas exchange physiology changes and hemodynamics (monitored with 129Xe MRI/MRS) and the change in these signals over one year in patients with "stable" PAH. Our central hypothesis is that patients with "stable" PAH will display persistent abnormalities on 129Xe MRI/MRS consistent with pulmonary vascular remodeling and that some patients may have worsening of their disease while appearing to be "stable" disease.

The study team will assess the ability of 129Xe MRI to longitudinally monitor disease progression in patients with "stable" PAH. First, the team will enroll "stable" PAH patients and obtain detailed clinical information to be stored in the REDCAP database. The study team will then follow this cohort of PAH subjects for one year, performing 129Xe MRI scans at baseline, 3 months, 6 months and one year in addition to their standard-of-care assessments including appointments labs, echo, and 6MWTs.

Eligibility Criteria:
Inclusion Criteria:

1. Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months
2. Outpatients of any gender, Age 18-75
3. WHO functional class (FC) 1-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) \> 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)
4. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
5. Women of childbearing potential must have a negative urine pregnancy test before MRI

   Exclusion Criteria:
6. Sarcoidosis
7. Active cancer
8. Sickle cell anemia
9. Liver disease (Childs-Pugh class C)
10. Any conditions that prevent the performance of 129Xe MRI scans.
11. Prisoners and pregnant women will not be approached for the study
12. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
13. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors

This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed.
* Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition.
* ECOG performance status \<1
* Ability to understand and the willingness to sign a written informed consent document.
* Patients must have measurable disease
* Ability to swallow oral medications

Exclusion Criteria:

* Participants who have had chemotherapy or radiotherapy within 3 weeks
* Participants may not be receiving any other investigational agents.
* Active hepatitis B or hepatitis C infection.
* Active or untreated gastric or duodenal ulcer
* Symptomatic bowel obstruction within 3 months prior to screening visit.
* Symptomatic ascites in the last 4 weeks

Other protocol defined inclusion/exclusion criteria may apply.
Bio-CAR-T BS Study

The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.

This Study is characterized by several biological sub-studies, reported as below:

* Post-infusion CAR-T expansion and persistence analysis by both Flow Cytometry and digital PCR (dPCR): the aim of this point are the evaluation and enumeration of CAR T cells (CD4+ and/or CD8+) during patients follow-up and set up of specific panels for longitudinal evaluation and monitoring of CAR-T subsets.
* Circulating Extracellular Vesicles quantification and analysis on peripheral blood and CNS (Central Nervous System) liquor: the aim are the identification of alterations in small EVs (Extracellular vesicles) ( number and cargos composition (proteins or miRNA) after CAR-T cell infusion and identification of small EVs markers which may distinguish patients "good responders" from patients "not responders" and/or which may predict particular post-infusion complications.
* Evaluation of neurological markers for ICANS (Immune effector cell-associated neurotoxicity syndrome): the purpose of this substudy are the assessment of previously identified plasma and CSF (Cerebrospinal fluid)biomarkers for inflammation, neuronal damage and glial activation in patients who develop ICANS and the characterize temporal neuronal and glial involvement by assessing plasma and CSF inflammatory, neuronal and glial biomarkers in ICANS and their role on outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed/refractory after two lines of treatments;
* Adequate performance status (0 or 1);
* Adequate organ function;
* No active or uncontrolled infections;
* No thrombo-embolisms within the last 6 months;
* Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Patients with B-cell-ALL \> 25 years
* Patients with DLBCL \<18 or \>70 years
* Patients with PMBCL \<18 or \>70 years
* Performance status \> 1;
* Active or uncontrolled infections;
* Thrombo-embolisms within the last 6 months;
* Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);
* Life expectancy \< 3 months.
Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
* Outpatients
* Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements

Exclusion Criteria:

* Atypical or secondary form of Parkinson's disease
* History of surgical treatment for PD including deep brain stimulation
* Advanced, severe, or unstable disease (other than PD)
* History of malignancy
* Evidence of dementia
* Untreated/ineffectively treated mental disorders
* Treatment with certain prohibited medications
* Abnormal lab values or heart abnormalities
* Pregnant or nursing women
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia

The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 19 and 75
* Defined as a fasting 100mg/dl≤ LDL cholesterol \<220mg/dl and triglyceride level\<400 mg/dl
* Need drug therapy by NCEP ATP III guideline
* Signed informed consent

Exclusion Criteria:

* Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
* Has a presence or history of alcohol abuse or drug abuse
* Active gallbladder disease within 12 months
* Pancreatitis or Hepatic dysfunction (ALT or AST levels \> 2XUNL)
* HbA1c≥ 9% in type 2 diabetes mellitus patients
* SBP \< 90mmHg or \> 160mmHg
* DBP \< 50mmHg or \> 100mmHg
* Myocardial infarction or revascularization procedure within 6 months
* Has significant cardiovascular disease
* Malignant tumor within 5years
* Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
* Uric acid level \> 9 mg/dl
* Thyroid stimulating hormone ≥ 2XUNL
* Active peptic ulcer disease
* CPK levels \> 3XUNL
* creatinine level \> 2 mg/dl
* Negative pregnancy test for women of childbearing age and agreement to use contraception while on study
* Had participated other clinical trial within 4 weeks
* Need systemic administration of corticosteroids intermittently
Uterine Tourniquet at Open Myomectomy

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Eligibility Criteria:
Inclusion Criteria:

* uterine myoma \>12 weeks

Exclusion Criteria:

* Pedunculated myoma, broad ligament myoma
* Hb\<10.5 g /dl
Effect of Kinesiotaping on Postpartum Pelvic Girdle Pain

The purpose of this study is to investigate the effect of kinesiotaping on pelvic girdle pain in postpartum women.

Pregnancy-related pain in the SIJ, lumbosacral region, pubic symphysis, or in any combination of these joints has been coined as pelvic girdle pain (PGP) and has been estimated to affect almost half of all pregnant women. Women with PGP have an increased risk of prenatal anxiety, depressive symptoms and postpartum depression compared with healthy pregnant women.

Kinesio Taping is rehabilitative technique used to facilitate the body's natural healing process while providing support and stability to muscles and joints, without restricting their range of motion. Enhanced rehabilitation is thought to be the effect of stimulated reactivation, proprioceptive training, reduced pain, stimulation of correct movement patterns, and reduction of muscle imbalance.

Kinesio Taping (KT) method has been used to decrease and prevent pain in women suffering from pregnancy related low back pain because of increased muscle relaxation while taping is applied. However, there is lack of knowledge regarding the effect of kinesiotaping on PGP in postpartum women.

Therefore, this study will be conducted to provide physiotherapists with a scientific updated knowledge, concerning the effect of kinesiotaping on pain, level of disability and lumbar flexion and extension ROM in pelvic girdle pain in postpartum women, aiming to improve ADLs of postpartum women. This study may expand the role of physiotherapy in women's health

Eligibility Criteria:
Inclusion Criteria:

* All post-partum women \< 4 months postnatal having pelvic girdle pain.
* They will be diagnosed using Faber test, and active straight leg raising test.
* Their ages will range from 25 to 35 years.
* Their body mass index (BMI) less than 30 kg/ m².

Exclusion Criteria:

* Pregnant women or planning for pregnancy.
* Cardiovascular diseases.
* Previous spinal surgery.
* History of skeletal deformity.
* Participation at any other exercise training program during this study