cyrilzakka/clinical-trials huggingface dataset:
Stress & Social Cognition in BPD (part 2)

The investigators will examine how a combination of pharmacological mineralocorticoid receptor (MR) stimulation and psychosocial stress will influence prosocial behavior in patients with Borderline Personality Disorder (BPD) compared to healthy controls (HC).

The investigators will examine whether MR stimulation enhances prosocial behavior in BPD patients under additional psychosocial stress. Participants will be randomly assigned to receive either fludrocortisone as an MR stimulant or placebo. Afterwards, participants will either undergo the stress or placebo condition of the Trier Social Stress Test ((P-)TSST). Subsequently, cognitive and emotional empathy, as well as sharing and punishment behavior will be measured.

Eligibility Criteria:
Inclusion Criteria "BPD group":

* clinical diagnosis of borderline personality disorder
* female
* BMI between 17.5-30

Inclusion Criteria "control group":

* female
* BMI between 17.5-30
* no clinical diagnosis of any mental disorder

Exclusion Criteria:

* acute depressive episode,
* acute or lifetime psychotic symptoms
* acute substance abuse
* physical illness
Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with serous ovarian cancer
* Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment
* At least one lesion that is suitable for accurate repeated measurements

Exclusion Criteria:

* Patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment
* Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin
Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial

The purpose of this study is to evaluate whether biomarkers of inflammation, genetic thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in patients with symptomatic proximal deep venous thrombosis.

The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. Poor understanding of the pathophysiology and predictors of PTS has hampered progress in its prevention and treatment. Biomarkers reflective of inflammation, genetic thrombophilia and coagulation activation may be of value in predicting PTS development in patients with DVT; they may also provide insight into understanding the underlying mechanisms of PTS, which could result in the development and testing of novel therapies to prevent and treat PTS.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
* Who have no contraindications to standard treatment with heparin and/or warfarin, and
* Who provide informed consent to participate

Exclusion Criteria:

* Contraindication to compression stockings Limited lifespan (estimated \< 6 months)
* Geographic inaccessibility preventing return for follow-up visits
* Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
* Treatment of acute DVT with thrombolytic agents
Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity

Functional dyspepsia (FD) is a common functional gastrointestinal disease. Several patient-reported outcome questionnaires have been established to evaluate the severity of FD, including Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI). Functional Dyspepsia Symptom Diary (FDSD) is a newly symptom-focused patients-reported outcome measure raised by the Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group. The association of the novel FDSD and other scores-related to FD has not been fully investigated. Furthermore, the severity of FD is varied among different patients. It remains unclear how the moderate and severe FD can be defined by the FDSD.


Eligibility Criteria:
Inclusion Criteria:

* 1. 18-70 years old
* 2. Patients who met the Rome IV diagnostic criteria of FD
* 3. Normal upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria:

* 1, Patients with local or systemic diseases which may cause dyspeptic symptoms:

  1. Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.
  2. Known acute or chronic diseases of liver or kidney
  3. Obvious hematological abnormality, or endocrine and metabolic diseases
  4. suspected incomplete or complete bowel obstruction
  5. Known malignancy
  6. Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
* 2, Pregnancy
* 3, Inability to give informed consent
Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and estramustine in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the response rate, time to treatment failure, and overall survival of patients with relapsed or refractory non-Hodgkin's lymphoma treated with paclitaxel and estramustine. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive oral estramustine 2-3 times daily on days 1-3 and paclitaxel IV over 1 hour on day 2 on weeks 1-6. Treatment repeats every 8 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response continue therapy for at least 3 courses or for 1 course after achieving maximum response. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory intermediate, high-grade, or transformed non-Hodgkin's lymphoma Received 1-3 prior treatment regimens (cytoreductive chemotherapy followed by high-dose therapy with stem cell support considered 1 regimen) Measurable disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3\* Platelet count greater than 75,000/mm3\* \* Unless due to lymphomatous marrow involvement Hepatic: Bilirubin less than 1.5 mg/dL\* SGOT/SGPT less than 2 times normal\* \* Unless due to lymphomatous involvement Renal: Creatinine less than 2.0 mg/dL\* OR Creatinine clearance greater than 50 mL/min\* \* Unless due to lymphomatous involvement Cardiovascular: No active uncontrolled angina pectoris No New York Heart Association class II-IV heart disease No myocardial infarction within the past 6 months No history of recurrent deep venous thrombosis not associated with catheter placement Other: No other prior malignancy within the past 5 years except curatively treated cervical cancer or basal cell or squamous cell skin cancer No serious concurrent medical illness that would preclude study No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior paclitaxel, docetaxel, or estramustine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
The Efficacy of a Functional Meta-Cognitive Intervention to Improve Human Factors of Professional Drivers

The objective of the study is to examine the effectiveness of a functional-meta-cognitive intervention program to reduce driving risk factors amongst professional bus drivers.

In Israel, the percentage of professional drivers involved in lethal car accidents is high in relation to their number on the roads. Every car accident involving a bus driver could potentially put at risk the lives of tens of passengers, and cause damages both direct and indirect at high costs. Due to the high risk of the bus drivers and their passengers, it is highly important to identify and improve the driving characteristics which are necessary for safer driving of said drivers. Many studies have assessed and identified the risk factors of safe driving, but there is relatively little research-based evidence concerning the ability to improve the driving skills of drivers in general and in particular of bus drivers, which are considered a high risk group.

According to the National Road Safety Authority, 88% of road accidents are caused by driver errors. Therefore, the real challenge is to provide a better understanding in the role of human factors in causing road accidents to try and develop a variety of effective interventions to reduce these risk factors. This understanding can contribute both to a better assessment of professional drivers' driving fitness and to intervene accordingly. In this study, we have focused on main aspects that exist in relevant literature and are human risk factors: Cognitive-perceptual, ergonomic and personality risk factors, and checked the connection between these risk factors and actual monitored driving scores as recorder by an In-Vehicle Data Recorder (IVDR). In addition, we examined the effectiveness of a functional-meta-cognitive intervention program designed to increase drivers' awareness to their way of driving. The research model is based on previous driving models and the guiding occupational therapy practice framework model in Israel, while adjusting the model to the professional driving in public transportation line of work and its particular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Male gender.
* Having a valid bus driver's license.
* Working for a specific large bus company in the center of Israel.

Exclusion Criteria:

* Drivers who had less than 50 hours of IVDR data were excluded.
Muscle Training Induced Angiogenesis in COPD

COPD patients experiment a peripheral muscle dysfunction which impact their exercise tolerance and health-related quality of life. The capillary to fiber interface is reduced and impact the exercise capacity of the patients. While the muscle capillary creation in response to exercise training is blunted in COPD patients, the maturation of the neo-capillaries could also be blunted and contribute to the impaired aniogionenesis in patients. Because the capillary maturation is a sensitive and dynamic process, only different modalities of exercise training and multiple time-points of measures would allow to capture this microvascular adaptation.

Aim of the study : Compare the muscle capillary maturation in response to training at 5 and 10 weeks, in sedentary healthy subject trained at the intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD patients trained at a similar intensity (60-65% of VO2max)- COPD patients trained at a similar absolute intensity (90% of VO2max).


Eligibility Criteria:
Inclusion Criteria:

* COPD patients :
* FEV1\<80%pred.
* non exacerbation during the past 4 weeks
* no oxygen therapy, -

Healthy subjects:

* \<150min/week of moderate-to-vigorous physical activity,
* Voorrips score \<9

Exclusion Criteria:

* Unstable comorbidity
* Long term oxygen therapy or ventilation
* Rehabilitation program during the past 12 months
* nutritional supplementation during the past 4 weeks
* allopurinol or N-acetylcystein during the past 4 weeks
* long corticosteroid treatment during the past 6 months
* hyperreactivity to xylocain
* anticoagulant or platelet aggregation inhibitors treatment
* participation to an other research study-pregnancy or impossibility to provide informed consent, ...
A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome

This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 12 to 30 years of age, with diagnosis of Down Syndrome
* Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder can participate in the study provided they are on stable medication for at least 8 weeks prior to screening and likely to cooperate and take part successfully in the study assessments

Exclusion Criteria:

* Subjects with DSM-IV axis I and II psychiatric disorders, except those authorized in the inclusion criteria
* Subjects who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment
* Subjects with evidence of dementia or meeting clinical diagnosis for dementia
* Subjects with thyroid dysfunction or diabetes that is not adequately controlled and stabilized on treatment for at least 8 weeks prior to randomization
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.


Eligibility Criteria:
Inclusion Criteria (The following are general criteria; more specific criteria are included in the study protocol):

* Approved and listed for cardiac transplantation.
* Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.

Exclusion Criteria(The following are general criteria; more specific criteria are included in the study protocol):

* Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
* Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
* Presence of any mechanical circulatory support other than intra-aortic balloon pump.
* Therapy with an investigational intervention at the time of screening.
Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.

The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:

* To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
* To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia.
* To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
* Visualization of 2 or more parathyroid glands during the surgical act.
* Normal renal and hepatic functions.
* Absence of a history of hypersensitivity reactions to iodine or indocyanine green.
* Able to understand the nature and protocol of the study and its procedures
* Willingness to participate with the subsequent signing of informed consent.

Exclusion Criteria:

* Age \<18 years
* Hepatic or renal insufficiency
* Hypersensitivity to iodine or to indocyanine green.
* Pregnancy or lactation
* Inability to understand the nature and procedures of the study.
* Patients with known preoperative hyperparathyroidism.
Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log

This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.

Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.

The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.

BCR: breakpoint cluster region

ABL: abelson murine leukemia

RM3log: major molecular response, BCR-ABL level below 0.1% (IS)

Eligibility Criteria:
Inclusion Criteria:

* Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
* Treatment with imatinib for at least 36 months
* BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months

Exclusion Criteria:

* Previous allogeneic stem cell transplantation
* Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
* Imatinib dose escalation at any time, due to loss or inadequate response
* BCR-ABL mutation

IS: International Scale

MR4log: molecular response of 4log or \<0,1% (IS)
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)

The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.

This is a multicenter, open-label, two-group dose-escalation, phase I/II study in 10 severe heart failure patients (five in the low-dose group and five in the high-dose group) with underlying ischemic heart disease.

After screening period is completed, subjects undergo HS-001 CS transplantation. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on either screening cardiac MRI or echocardiographic assessment
* New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening
* Other Criteria apply, please contact the investigator

Exclusion Criteria:

* Patients screened less than 1 month after the onset of myocardial infarction
* Patients with congenital heart disease, or cardiac sarcoidosis
* Other Criteria apply, please contact the investigator
Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke

In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients.

Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
* initial stroke within seven days, with limb dysfunction;
* NIHSS scale consciousness scores of 0 or 1;
* provided informed consent form.

Exclusion Criteria:

* incomplete clinical data;
* having a physical disability or other diseases that affect the limb function;
* having cognitive impairment or other diseases that interfere with participation;
* having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
* having progressive stroke or having severe complications that patients drop the study before completion.