cyrilzakka/clinical-trials huggingface dataset:
Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs

The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.


Eligibility Criteria:
Inclusion Criteria:

* current student at the University of Oregon
* subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater

Exclusion Criteria:

* current diagnosis of major depression
* acute suicidal ideation requiring immediate mental health treatment
Monitoring of Symptoms and Cognitive Function Using Telehealth

End-Stage Liver Disease (ESLD) is one of the ten leading causes of death in US. It is marked by episodic acute exacerbations of the underlying liver disease which often leads to severe symptoms, poor quality of life, mental deterioration and repeated hospitalizations.

The overall purpose of this project is to introduce a telehealth based intervention (involving remote monitoring of symptoms and cognitive function initiated at the time of discharge of ESLD patients. This will support enhanced clinical care and improve self-management in ESLD population. In addition, it will reduce healthcare utilization, improve medication adherence and overall health outcomes

This is a single arm study to assess the effectiveness of an experimental telehealth intervention within the treatment of ESLD, and compare it with a historic cohort. All inpatients with advanced liver disease and at least 1 complication will be eligible to participate. the study group receives the Telehealth intervention and will be given an ipad preloaded with the instruments used for symptom monitoring and cognitive function assessment during the hospital admission.

Eligibility Criteria:
Inclusion Criteria:

* End Stage Liver Disease with at least 1 or more complications (Hepatorenal Syndrome, Portal Hypertension, Ascites, Hepatic Encephalopathy)

Exclusion Criteria:

* Cognitive impairment
* Current psychosis
US Post-Market Surveillance Study of the Surfacer System

Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.

Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
3. Subjects are willing and able to give written informed consent

Exclusion Criteria:

1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava
2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
3. Occlusion within the arterial system
4. Occlusion within the coronary or cerebral vasculature
Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion

Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study

Exclusion Criteria:

* patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space
Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?

Computated tomography (CT) is an invaluable medical resource for both physicians and surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an incredibly powerful means of imaging the human body, there are possible complications to the use of contrast including a hypersensitive response and contract induced nephropathy (CIN). The latter will typically occur 48-72 hours after administration.

One recent meta - analysis of serum creatinine levels following contrast enhanced CT found 6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 % had a persisting reduced renal function, with a small minority needing renal replacement therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of contrast given.

The mechanism of injury to the kidney is not definitively established, but is thought most likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free radicals causing direct damage to the kidney and also direct tubular damage.

Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced transient ischaemia at another site could buffer the impact of the contrast medium's effects. This was first demonstrated during cardiac angiograms, with those patients whom received multiple balloon inflations in the coronary arteries were found to have a lower incidence of CIN than those with fewer balloon inflations. Thus it could be hypothesised that any ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity, rather than involving central organs, such as the arm, with ischaemia induced by the use of a blood pressure cuff, inflated to above systolic blood pressure levels.

No studies have been found in the literature attempting to demonstrate this effect in relation to contrast CT studies. Consequently, a randomised control clinical trial of patients to assess the effectiveness of remote ischaemic preconditioning is proposed.

Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs involving IV contrast is nephroprotective.


Eligibility Criteria:
Inclusion Criteria:

* Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning.

Exclusion Criteria:

* Those with an allergy/hypersensitivity to the contrast solution
* Those with a Cr of above 150μmol/dL on admission, as is a contraindication to IV contrast.
* Patients who are not getting IV contrast
* Any patients with a history of renal transplantation
* Any patients with a history of previous acute kidney injury necessitating management by a nephrologist
* Patients taking either a sulphonlurea or nicorandil.
Proposing Forgiveness Therapy Within Prison

Previous studies found that a large number of prisoners experienced unjust treatment from others, which can lead to deep inner pain or anger, prior to criminal perpetration. Such unresolved anger can deepen and linger, be turning to resentment (excessive anger) or rage (very intense, potentially violent anger), compromising one's psychological health and behavior and even contributing to their choice of crime. However, Forgiveness Therapy, as an empirically-verified treatment, can help reduce and even eliminate the excessive anger. Its positive effects have been scientifically supported by numerous studies within diverse populations. Therefore, in the prison context, similarly, the investigator hypothesizes that Forgiveness Therapy will lower rates of anger, depression, and anxiety and raise the levels of forgiveness, empathy, hope, and self-esteem for the experimental (Forgiveness Therapy) group as compared to the alternative treatment control group. This is based upon numerous studies that demonstrate the efficacy of Forgiveness Therapy with comparisons to other treatment methods. Further, the study team expects behavioral change by the men within the correctional institution, as measured by officers' observations as well as the number of misconducts in conduct reports on each participant and the time spent in restrictive housing.

This study is the second part of a two-tiered research project to propose a novel approach--Forgiveness Therapy--to corrections and aims to demonstrate the effectiveness of Forgiveness Therapy in reducing resentment and other negative psychological symptoms such as excessive anger, anxiety, and depression for the prison inmates.

A random sample of 24 participants, who have not participated in forgiveness workshops or forgiveness therapy, were taken from the Study 1(the investigator's previous research from the maximum-security prison of Columbia Correctional Institution "Examining Prison Inmates' Attitudes and Internal Emotional States"). These participants became 12 matched pairs (matched by the type of abuse, the severity of the abuse, and age at which the injustice occurred) with each member of the matched pair randomly assigned to the experimental group or control group. Each inmate participated voluntarily in this study.

Since this study is a continuation of Study 1, the investigator named this study as Study 2.


Eligibility Criteria:
Inclusion Criteria:

* Participants who enrolled in Study 1 and need to satisfy the criteria of:

  1. most serious stories of abuse against them; 2. the least forgiving; and 3. the most psychologically compromised. 4. Also, given the duration of psychological treatments, participants' release date will also be considered.

Exclusion Criteria:

* Inmates who have received Forgiveness Therapy before.
* Inmates would be released or transferred to other institutions during the 12-month treatment.
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg

This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor.
* Requiring hormonal treatment.
* Postmenopausal women (woman who has stopped having menstrual periods)

Exclusion Criteria:

* Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced BC.
* Treatment with more than one previous regimen of endocrine therapy for advanced BC.
* An existing condition that prevents compliance.
Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Scheduled for PEG with propofol sedation

Exclusion Criteria:

* No informed consent
* ASA V
* Emergency endoscopy
* Preexisting hypotension, bradycardia or hypoxemia
Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301

This study is designed to evaluate the safety and efficacy of IN-C006 inj. and RCN301 in postoperative patients requiring central parenteral nutrition.

This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 inj. or RCN301)

Eligibility Criteria:
Inclusion Criteria:

* Age over 19 at the time of obtaining the informed consent form
* Requiring over 3 days of parenteral nutrition via a central vein after an operation
* BMI 16 \~ 30 kg/㎡

Exclusion Criteria:

* Has received parenteral nutrition within 7 days of screening
* Severe dyslipidemia
* Uncontrolled diabetes
* Clinically significant liver disease
* Clinically significant kidney disease
Safety and Efficacy of Herbal Tea in Type 2 Diabetics

Nearly 25% of the world's population relies on traditional medicinal systems but for professionals their effectiveness and even more safety are the main concern. Therefore, the aim of this preliminary study is to assess safety and effectiveness of herbal tea mixture on the control of glycaemia in Type 2 diabetics.The mixture consists of nine plants which have well-documented traditional use for the control of glycaemia.

The study will include Type 2 Diabetics who are taking only oral hypoglycemic medications (without insulin). Their therapy has to be stable for at least 3 months prior enrollment. Besides anthropometric measures, patient's glycaemia, renal and liver function will be monitored. Safety and adverse events will be closely monitored and these are the primary outcomes of the study. The main outcome measure of the effectiveness is HbA1c (glycated hemoglobin). Patients will be given detailed instructions on how to prepare the tea and the dosing. The intervention will last 3 months and during that time patients will be asked not to change their dietary or lifestyle habits.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* Croatian-speaking
* stable therapy for at least 3 months prior enrollment
* not taking any dietary supplements, especially herbal-based
* not taking any other herbal medicine (as a tea or a supplement)
* stable dietary and lifestyle patterns for at least 3 months prior enrollment

Exclusion Criteria:

* type 1 diabetes
* severe somatic disorder (oncological disease, hepatic, renal or autoimmune disease)
* pregnancy
* inability to fill in questionnaires in Croatian
* cognitive impairment
* psychiatric disorder
* undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder
* clotting disorders
* having nutritional deficiency (e.g. iron deficiency)
* current or history of eating disorder (anorexia, bulimia or EDNOS)
* current use of weight loss interventions (drugs; exercise interventions)
* regular use of dietary supplements, especially herbal-based
* regular use of herbal medicine (as a tea or a supplement)
* significant changes in diet or lifestyle patterns (e.g. increased physical activity) in the last 3 months prior the enrollment
A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
* The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:

  1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
  2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:

     1. The presence of a mass in the pancreas OR
     2. A history of resected pancreatic carcinoma
* Measurable disease per RECIST (ver. 1.1)
* ECOG Performance Status of 0 or 1.
* Adequate hepatic, hematologic and renal functions.

Exclusion Criteria:

* A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
* A diagnosis of pancreatic islet neoplasms.
* Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
* Presence of biliary obstruction requiring external drainage
* Brain metastases.
* Unstable cardiovascular function within the last 6 months of screening
* Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
* Known HIV infection.
* Uncontrolled hypertension at Screening
* History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
* Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
* Uncontrolled systemic fungal, bacterial or viral infection
* Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study
Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)

This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.

To ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive ESL has to be made before and independently of his/her decision to include the patient in the study. At all circumstances during the study the patients will be treated and followed according to routine clinical practice. ESL and concomitant medication should be managed by the neurologist according to the respective Summary of Product Characteristics (SPC).In order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. Intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient, 18 years or older;
* The patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive ESL;
* The patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive ESL;
* The neurologist's decision to prescribe ESL has been made before and independently of his/her decision to include the patient in this study;
* The patient's treatment is in accordance with the SPC of ESL;
* Written informed consent from the patient (or legally acceptable representative, if the subject is unable to provide informed consent).

Exclusion Criteria:

* Known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients;
* Patient with 2nd or 3rd degree atrioventricular block;
* Patient treated with an experimental drug within four weeks prior to the introduction of ESL;
* Female patient who is pregnant, lactating, or who is planning to become pregnant during the study period;
* Patient starting ESL outside the approved SPC at enrolment.
Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis

The aim of this study is to determine whether prophylactic vaccines recommended are effective and safe in patients with multiple sclerosis(MS) under MS-specific therapy.

Protective vaccines against communicable diseases are of major importance in patients with autoimmune diseases or impaired immune response. In patients with multiple sclerosis bacterial or viral infections may lead to disease progression and vaccines can protect from these infections and prevent disease progression. Fear of possible side effects of vaccines have led to a general restraint regarding vaccination of patients with MS. However, previous studies have not shown an increased risk of disease progression following Hepatitis B vaccination and even a reduced progression rate in relapsing-remitting MS after tetanus/diphtheria vaccination.

Various disease modifying treatments (DMT) are available for MS, most of these therapies lead to an impairment of the immune system affecting the immune response to vaccination. Additionally, live attenuated vaccines may lead to severe side-effects if used in patients under DMT treatment. Testing immune response after vaccination may be prudent in subjects undergoing DMT to assure vaccination success since only a limited number of studies have investigated immune response after vaccination in patients with MS undergoing DMT.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Multiple Sclerosis
* Age: 18 - 70 years
* Indication for vaccination (according to public recommendation)
* Written informed consent

Exclusion Criteria:

* Current relapse of MS
* Unstable disease
* Contraindication for vaccination (acute infection, fever, allergy to vaccine)
* Unable to comply with study procedures
Active Navigation Training

Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of mild cognitive impairment
* absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)
* age ≥ 60

Exclusion Criteria:

* the presence of acute stroke/transient ischemic attack;
* the presence of other concomitants severe neurological/psychiatric diseases;
* history of traumatic brain injury with loss of consciousness;
* physical/functional deficits that could affect the use of immersive virtual reality;
* severe visual deficiency;
* the presence of recurrent vertigo.