cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Individual Placement and Support in Chronic Pain Patients

Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic pain. In fact, employment support is rarely provided in pain clinics, despite an increasing focus on integrating work and health in all patient treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic.

Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. IPS represents a relatively new approach to vocational rehabilitation and incorporates following principles: (1) Every person that wants to work, can work given that the person is provided with the appropriate work and environment. (2)The goal is employment in regular, competitive employment. (3) IPS is integrated with treatment. (4) Job search is individualised; based on the participants' preferences and competence. (5) Work incentives planning is provided; which includes counselling about how work can influence social security and other public benefits. The intention of this benefits counselling is to enable the participant to make informed decisions about work (job starts and changes). (6) The job support is not time-limited. (7) Finally, IPS differs from more traditional employment services in that it does not involve pre-vocational training, often referred to as "train, then place". (8) In IPS job search starts as soon as the client expresses an interest in work. Therefore, IPS follows the principle "place, then train".

The effectiveness of IPS for patients with severe mental illness is well documented. International research shows that IPS is more effective than other types of employment programs for this group of clients. However, the effect of IPS on patients with chronic pain in an outpatient hospital clinic is largely unknown.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the pain clinic and eligible for interdisciplinary treatment
* Not currently working (long-term sick leave, disability pension or unemployed)
* Expressed desire to work

Exclusion Criteria:

* Living too far away from the pain clinic (outside of Oslo)
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Eligibility Criteria:
Inclusion Criteria:

* Male and females 18 years of age or older,
* diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

* Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
* ocular hypertension.
Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation.

Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days.

After the inclusion, at baseline will be performed :

* Paediatric visit
* antropometric valutation
* number of the daily crying minutes, number of regurgitation and number of daily evacuation

The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:

* Paediatric visit
* antropometric valutation
* number of daily crying minutes
* numbers of regurgitation
* numbers of evacuations

Primary outcome :

To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation.

Inclusion criteria

* neonates of 37-42 week gestational age and appropriate birth weight
* Recruitment age: until 7 days of life
* Informed consent signed

Exclusion criteria

* Presence of other gastrointestinal diseases.
* Use of FANS, aspirin or other drugs
* Use of antibiotics and/or PPIs e/o anti-H2
* Participation to other clinical trials


Eligibility Criteria:
Inclusion Criteria:

* neonates of 37-42 week gestational age and appropriate birth weight
* Recruitment age: until 7 days of life
* Informed consent signed

Exclusion Criteria:

* Presence of other gastrointestinal diseases.
* Use of FANS, aspirin or other drugs
* Use of antibiotics and/or PPIs e/o anti-H2
* Participation to other clinical trials
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure

The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.


Eligibility Criteria:
Inclusion Criteria:

Delivery of a 14-16 French Transcatheter aortic valve replacement system

Exclusion Criteria:

* Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
* Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure.
* Any use of glycoprotein inhibitors or cangrelor.
* Use of sheathless guides.
* Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral leg.
* Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
* Inability of the patient to personally consent for the study. (no surrogate consent)
* Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)

The study will evaluate the efficacy of metacognitive training for depression in later life (MCT-Silver) vs. cognitive remediation (mybraintraining©) in reducing depressive symptoms among older adults.

The study examines the efficacy of Metacognitive Training for depression in later life (MCT-Silver). The study intends to investigate the extent to which MCT-Silver leads to a significant reduction in depressive symptoms compared to an active control group (mybraintraining©) (primary outcome: change in clinician-assessed depressive symptoms from t0 to t1 and t2). Secondary outcomes include change in self-reported depressive symptoms and dysfunctional (meta) cognitive beliefs, as well as quality of life, rumination, self-reported anxiety, attitudes toward aging and neuropsychological functioning from t0 to t1 and t2. The study design is a randomized-controlled trial with one intervention group and one active control group.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* age 60 years or older
* diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI)
* sufficient command of the German language
* willingness to participate in intervention over a period of 8 weeks (participants who do not attend the intervention will also be included in the analysis)
* Visual and auditory acuity adequate for neuropsychological testing and participation in group sessions

Exclusion Criteria:

* lifetime psychotic symptoms (i.e., hallucinations, delusions or mania)
* acute suicidal tendency
* intellectual disability (estimated IQ \< 70)
* dementia or other neurological illness
Physician-nurse Team to Reduce Emergency Department (ED) Overcrowding

The objective of this study is to explore the impact of a physician-nurse team supervising patient's flow on ED length of stay

A physician-nurse team will be in charge of patients flow in the ED during intervention periods. During control periods, no team will be present. The impact of this team on Ed length of stay will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients \> 16 years presenting to the ED

Exclusion Criteria:

* no
Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis

The aim of this exploratory randomized controlled trial was to investigate the efficacy of a disease specific Expert Patient Programme compared to usual care in patients with bronchiectasis. Hypothesis: Disease specific EPP will increase self efficacy compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomography scan were included in the study

Exclusion Criteria:

* Primary diagnosis of cystic fibrosis
* Patients with methicillin-resistant Staphylococcus aureus infection
* Patients with any condition that would have an impact on the assessment procedures (e.g. sensory impairment, pregnancy, language barriers)
* Any factor that would prevent adherence to the self-management programme.
Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes

The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.

In the presence of stage 3 anterior wall prolapse (cystocele) with second stage apical prolapse (uterine or vault prolapse) there are 2 optional ways to repair with vaginal mesh: (a) to use 2 separated meshes: anterior mesh to correct the anterior compartment and posterior mesh to correct the apical prolapse to the sacrospinous ligament (SSL). (b) To correct both anterior compartment and the apical prolapse with the same mesh while using the posterior arms of the mesh to fix the apical prolapse to the SSL. Each way has its advantages and disadvantages. The first way was described at the beginning of mesh use and might be more anatomical then the second newest way. The addition of apical support to the anterior mesh might theoretically shorten the vagina. There are several recent studies describing the anatomical outcomes both for anterior compartment and apical compartment with a single mesh. Mesh-related complications, which can be also related to the amount of vaginal meshes, can potentially decrease with one mesh as compare with 2 meshes.

The aim of the study:

If the anatomical results, vaginal length and quality of life, will be with no significant differences between the two groups, the investigators will recommend to use a single mesh, in order to avoid / minimize potential complications of vaginal mesh.

If there will be no differences in complications in both groups but will be a significant difference in vaginal length and sexual function, the investigators will recommend using two meshes.

Eligibility Criteria:
Inclusion Criteria:

* At least anterior compartment prolapse stage III and uterine prolapse stage II.

Exclusion Criteria:

* Women without uterine prolapse, or with uterine prolapse \< stage 2.
* Women with uterine prolapse \> stage 2.
* Hysterectomy in the past.
* Women with an indication for hysterectomy.
Study of bb21217 in Multiple Myeloma

Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort.

Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (bb21217). Following manufacture of the drug product, subjects will receive lymphodepletion prior to bb21217 infusion. All subjects will then be followed for up to 60 months in Study CRB-402.

All subjects who complete the study, as well as those who withdraw from the study after receiving bb21217 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at the time of signing informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy with previous exposure to PI, IMiDs, and a CD38 antibody. Have undergone at least 2 consecutive cycles of treatment for each therapy, unless PD was the best response to the therapy. Refractory to their last line of therapy.
* Subjects must have measurable disease

Exclusion Criteria:

* Subjects with known central nervous system disease
* Inadequate hepatic function
* Inadequate renal function
* Inadequate bone marrow function
* Presence of active infection within 72 hours
* Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
* Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
* Known human immunodeficiency virus (HIV) positivity
* Known hepatitis A virus (HAV), hepatitis B virus (HBV) or hepatitis C virus (HCV) positivity with evidence of ongoing infection.
* Pregnant or lactating women
* Previous history of an allogeneic bone marrow transplantation, treatment with any gene therapy based therapeutic for cancer, or BCMA-targeted therapy
* Inadequate pulmonary function defined as oxygen saturation (SaO2) \<92% on room air
* Subjects who have a history of plasma cell leukemia, active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS, or clinically significant amyloidosis
Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.

Study Design:

Eligibility Criteria:
Inclusion Criteria:

Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.

Patients over 40 years old

Exclusion Criteria:

Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma

* Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction
* Patient with known moderate to severe renal impairment (i.e.,creatinin clearance\<=50ml/min)
* Pregnant or nursing women
* Patient with any significant disease other than COPD which would exclude him/her from participating in the study
* Patients with any conditions listed in \[special precautions\], \[drug interactions\], and \[contraindication\] of Spiriva® China package insert
* Patients with signed informed consent of any other study
Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Participants at least 18 years old
* Participants with moderate to severe RA not previously treated with TCZ (Intravenous \[IV\] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)

Exclusion Criteria:

* Participants taking part in a clinical trial on RA at the time of inclusion
* Participants with a contra-indication to TCZ SC therapy
Assessment of Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation (cTBS) Effects in Generalized Epilepsy Patients.

The goal of this clinical study is to assess the efficacy of multifocal theta burst transcranial magnetic stimulation in the prevention of epileptic seizures in adult patients with generalized epilepsy. The main questions it aims to answer are:

* How does multifocal continuous theta burst stimulation (cTBS) impact the frequency and severity of epileptic seizures?
* Does cTBS influence the quality of life in patients with generalized epilepsy?
* What is the safety and tolerability profile of the experimental multifocal cTBS protocol?


Eligibility Criteria:
Inclusion Criteria:

- Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).

Exclusion Criteria:

* refusal to sign the informed consent;
* focal, combined or unknown epilepsy (according to ILAE criteria);
* drug-resistant form of epilepsy (according to ILAE definition);
* history or symptoms of renal or hepatic failure;
* history of oncological disorder;
* uncontrolled high blood pressure;
* cognitive impairment;
* psychiatric disorders;
* signs of structural brain injury or focal neurological symptoms;
* use of opioids or muscle relaxants;
* history of substance abuse;
* ferromagnetic implants in head and neck regions;
* cardiac pacemakers;
* pregnancy or lactation.
Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS)

Dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (ALS). These symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of ALS mortality. Unfortunately, treatments to prolong and maintain these vital functions are currently lacking. Although the use of exercise in ALS is controversial, recent evidence suggests that mild to moderate intensity exercise applied early in the disease slows disease progression, improves motor function, preserves motor neuron number, reduces muscle hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of ALS and human clinical trials.

This research study is designed to determine the impact of respiratory strength training on breathing, airway protection and swallowing in persons with Amyotrophic Lateral Sclerosis (ALS).

This research study will measure the maximum inspiratory and expiratory pressure with secondary measures of respiration, swallow, cough, quality of life and global disease progression following twelve-weeks of treatment compared to the sham group.

As a participant two evaluations at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. Each will take approximately two-hours and these will be spaced exactly three-months apart. During each evaluation tests will be performed to look at breathing, swallowing, and ability to cough doing standard clinical exams. In addition, some surveys about eating, speaking and quality of life will be taken.

Breathing Exercises: a home research therapist will train the participants how to use the hand-held respiratory trainer. Training for both treatment groups will be very similar, except the PowerLung trainer device will have an additional spring load valve inside it that will place a force on the respiratory muscles during training. The other breathing trainer will not have this spring so that no resistance will be placed on the respiratory muscles during training and this will represent an aerobic respiratory treatment. The breathing exercises will be completed five days a week for a total of three months (a total of 60 therapy sessions). During each session, a total of three sets of ten repetitions of breathing exercises will be performed. Once a week the home research therapist will visit and guide participants through the breathing exercise.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS),
* Amyotrophic Lateral Sclerosis Rating Scale Revised score greater than 34,
* forced vital capacity greater than 70%,
* cognition within normal limits as determined by Montreal assessment of cognition score \>25

Exclusion Criteria:

* allergies to barium,
* tracheotomy or mechanical ventilation,
* diaphragmatic pacer,
* concurrent respiratory disease (e.g. COPD),
* pregnant at the time of the study due to radiation exposure
3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection

The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each patients will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of hepatitis C virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last post-therapy follow-up visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.

Eligibility Criteria:
Inclusion Criteria:

* Have previously participated in a Phase IIb or Phase III study
* Must have received at least one dose of TMC435 in that study
* Has completed the last post-therapy follow-up visit of the previous (LPVPS) study

Exclusion Criteria:

* Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device
* Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study