cyrilzakka/clinical-trials huggingface dataset:
Prevalence of FID and QoL in Patients with Oncological and with Haematological Malignancies

Prospective single-center observational study assessing prevalence of FID (Laboratory work-up) and Quality of Life (Questionnaire) in adult patients with oncological and with haematological malignancies within four weeks prior to disease-directed therapy.

Patients included into the study will have a laboratory work-up assessing the occurence of functional iron deficiency using laboratory parameters (full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP, ALAT) and have to fill in once the FACT-An questionnaire generating data on Quality of Life at time of study entry.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with oncological (solid tumors) and with haematological malignancies (non-solid tumors, including Plasma cell myeloma, lymphoma, myeloproliferative neoplasias \[MPN\], myelodysplastic syndromes \[MDS\] and chronic leukemias)
* Within four weeks prior to disease-directed systemic therapy
* Participation in other trials is possible

Exclusion Criteria:

* Known iron deficiency with or without iron substitution p.o. or i.v. within last 8 weeks prior to inclusion into this trial
* Therapy with RBC-transfusions within last 8 weeks prior to inclusion into this trial
* Therapy with ESA within last 8 weeks prior to inclusion into this trial
* Malignancies with acute need for therapeutic intervention (e.g. acute leukemias, superior vena cava obstruction, etc.)
* Pregnancy
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the trial
* Inability to give consent
A Low-residue Diet vs Clear Liquid Diet as a Bowel Colonoscopy Preparation With Polyethylene Glycol (PEG)

This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and tolerability of a prespecified low-residue diet compared with a clear liquid diet and Polyethylene Glycol bowel preparation. Outcome measures included efficacy of bowel preparation, patient preparation tolerability and side-effects.

An adequate examination is dependent on the bowel colonoscopy cleansing of stool. There are many different colon preparations, however endoscopists traditionally recommend the patient remain on a clear liquid diet for at least 24 h prior to their colonoscopy to reduce continued residue inflow into the colon from the small bowel, in addition the large volume preparation with PEG. The most common problems leading to less than adequate colon cleansing include lack of compliance with the clear liquid diet and difficulty taking the large volume preparation.

Eligibility Criteria:
Inclusion Criteria:

* Out-patient scheduled for colonoscopy

Exclusion Criteria:

* Subjects under 18 years of age
* Pregnancy
* Subjects with decompensated metabolic, renal, cardiac and psychiatric disease
* Allergy to PEG
* Refuse participation
An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Advanced and/or metastatic renal cell carcinoma
* Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label
* At least one measurable and non-measurable lesion according to RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate bone marrow, renal and liver function

Exclusion Criteria:

* Contraindications to Avastin and/or interferon alpha-2a as per local label
Vocal Cord Movement Assessment Using Airway Ultrasound.

Total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans.

All 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see vocal cord mobility as a reference value. A proper acoustic window is mandatory for optimal visualization of laryngeal structures. Visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. According to points the acoustic window scoring for glottis aperture will be graded as fair, when both false vocal cords are visible (score1-2), along with false cord when both arytenoids are visible scored good (score3-4) and if single or both true vocal cords are visible then scored as very good(score5-6). After the surgery the same patient will be scanned again for vocal cord mobility at 4hours of extubation . Any change in mobility will be recorded. If any change will be observed, direct laryngoscopy (DL) will be done to confirm the diagnosis. Any complication in the post-operative period will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thyroid surgery between specified age limits.

Exclusion Criteria:

* Retro sternal goiters.
MOTIONPOD (TM) Validation and Calibration Study

In this study we propose 1) to develop a new multisensor monitoring system associating a tri-axial accelerometer and a magnetometer to measure physical activity in free-living adults, 2) to perform its calibration and assess its validity in a series of activity tasks in comparison with the measure of energy expenditure by indirect calorimetry as the criterion measure, and with existing physical activity monitors (cardiofrequencemetry and accelerometers used either alone or in combination). Briefly the subjects will perform a series of standardized activity tasks of different intensities and a 30-min free physical activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors. Physical activity energy expenditure will be measured using a metabolic gas analyser.

Data of the 30 first subjects will be used to develop new algorithms to identify the different activity tasks and to estimate the related energy expenditures. Data of the following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry and existing physical activity monitors


Eligibility Criteria:
Inclusion Criteria:

* Normal-weight, overweight or obesity according to body mass index
* Low,moderate or high level of physical activity as estimated by questionnaire
* No angina and/or peripheral arterial disease symptoms or medical history

Exclusion Criteria:

* Subjects with cardiac implants
* Claustrophobic subjects
* Drug use that could affect energy expenditure
* Medical history or evolving disease which are a contra-indication for moderate physical exercise
Space and Interaction Trial: Room Design and Patient-physician Interaction

The purpose of this study is to improve the clinical encounter through the design of the clinical environment. We will conduct a randomized controlled trial to measure the extent to which a newly designed clinical room, compared to a traditional room, affects the patient-physician interaction. We will judge this outcome by (a) videotaping encounters; and (b) conducting post-visit surveys with patients and an interview with physicians. We will use both qualitative and quantitative tools, including a validated and widely used interaction coding system on the videotapes, to draw inferences from these data.


Eligibility Criteria:
Eligible Clinicians:

1. In the Department of GIM or Preventive Medicine
2. Able and Willing to participate in research study.

Eligible patients:

1. Patient of a clinician participating in the study
2. 18 years or older
3. Seeing clinician for return/summary visit.

Exclusion Criteria:

1.) Not able to give informed consent.
Study on the Effect of Inulin in Infant Formula on Gut Health

In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool.

It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.


Eligibility Criteria:
Inclusion criteria at screening:

* Healthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard
* Fully formula-fed in the 28 days prior to inclusion
* Expected investigational product intake of min 500ml per day
* Written informed consent from the parents

Exclusion criteria at screening:

* Low birth weight (LBW) less than 2,000g.
* Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required)
* Use of systemic antibiotics or antimycotics medication in the 14 days prior to the study
* Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator.
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Exclusion criteria for intervention period:

* Not consuming study product longer than 2 days consecutively
* Intake of study product is less than 500ml per day for 7 days
[C-11]PiB PET Imaging in Alcohol Use Disorders

To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC).

There is a long-established relationship between alcohol use disorders (AUD), cognitive impairments, and the development of dementia. Some, but not all basic data suggest that alcohol abuse can alter the expression of amyloid precursor protein, and the enzymes that process it. Thus, there is a need for in vivo PET studies to further investigate the relationship between AUD and AD and the mechanism through which alcohol abuse exerts its effect on this type of dementia. Here, we propose to use the amyloid Beta (ABeta) radiotracer carbon-11 labeled Pittsburgh Compound-B (\[C-11\]PiB) and PET (Klunk et al., 2004) to determine whether AUD increase the risk to be brain ABeta+ in middle aged adults.

Eligibility Criteria:
\[A\] Alcohol Use Disorder Subjects (AUD)

Inclusion Criteria:

1. Males or females between 40 and 65 years old
2. Fulfill DSM-5 criteria for alcohol use disorder of at least moderate severity
3. Current heavy drinking as defined in SAMHSA criteria (i.e., drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days)

Exclusion Criteria:

1. DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder (SCID-5) and prior history of developmental disorders, such as Autism, Down's Syndrome, Intellectual disability.
2. A positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and PCP
3. History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
4. History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
5. Currently pregnant or breastfeeding
6. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
7. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
8. No first-degree relative with Alzheimer's disease or related dementias

(B) Healthy Control Subjects (HC)

Inclusion Criteria:

(1) Males or females between 40 and 65 years old

Exclusion criteria:

1. Current or past DSM-5 psychiatric and/or addictive disorders
2. Current heavy drinking as defined in SAMHSA criteria
3. History of severe unstable medical or neurological illnesses that could affect neuropsychological testing
4. History of cancer (other than skin or in situ prostate cancer) within the previous 5 years
5. Currently pregnant or breastfeeding
6. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
7. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
8. No first-degree relative with Alzheimer's disease or related dementias
Medical Education for Sepsis Source Control and Antibiotics

Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent studies showed that such treatment is delayed for several hours.

In this study, medical staff of participating hospitals is trained to achieve a duration until antimicrobial therapy of less than 1 hour. Tools of change management are used. The data are compared to a control group (hospitals without intervention).

It is hypothesized that a multifaceted educational program decreases duration until antimicrobial therapy and improves survival.

This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44 hospitals in Germany have confirmed their participation. Hospitals are randomized into two groups: a control and an interventional group. The control group receives conventional CMEs. The interventional group receives tools for increasing awareness such as posters and brochures. Quality measure such as benchmarking and feedback of quality indicators are used. Depending on the improvement process tools such as SWOT analyses and resistance radar will be implemented.

The CRT was preceded by a 5 months observational study (Dec. 2010 - April 2011). In about 1000 patients, participating hospitals documented their patients with severe sepsis or septic shock into a register. These data are used for final sample size calculation of the CRT and for stratification of the randomization.

The groups switch after completion of the CRT and observation continues. Thus, centers of the control group now receive the change management while the former intervention group is now without external support and is assessed for sustainability of the intervention. This study phase is planned for Nov. 2013 until March 2015. Sample size will be calculated when the CRT has been finished.

Eligibility Criteria:
Inclusion Criteria:

1. For the hospitals (cluster):

   * Involved in the primary care of patients with severe sepsis/septic shock
   * Willing to participate in a guideline implementation process
2. For the patients:

   * New onset of suspicion of severe sepsis or septic shock in the following settings:

     1. Prehospital
     2. Emergency department
     3. Operating theatre
     4. Regular ward
     5. Intensive care unit (ICU)/Intermediate Care Unit (IMC)

Exclusion Criteria:

1. For the hospitals (cluster):

   * No intensive care unit available
   * no acute care for patients with severe sepsis and septic shock
2. For the patients:

   * Start of sepsis therapy in a non-study site
   * Patients not admitted to the ICU/IMC
   * No commitment to full medical support (i.e. DNR)
Ivermectin as a Novel Therapy in COVID-19 Treatment

Efficacy of Ivermectin in COVID-19 treatment

Clinical Study Evaluating the Efficacy of Ivermectin in COVID-19 treatment

Eligibility Criteria:
Inclusion Criteria:

* All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR.

Exclusion Criteria:

* Allergy or contraindication to the drugs used in the study.
* Pregnant and lactating mothers.
* Patients with cardiac problems.
A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus

In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.

Venomous snakebites constitute a serious health problem in many Asian countries. In Vietnam, the burden of snakebite on the public health stimulated Calmette to conduct original studies at the Vaccine Institute in Saigon over a hundred years ago and to develop the first snake antivenom ever.

In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus, which is the only krait species giving rise to significant morbidity and mortality in the area. Its venom contains toxins which can cause severe neuromuscular blockade but which do not give rise to swelling or necrosis at the site of the bite.

Supportive care is an important part of the management of snakebites, but antivenom administration is the mainstay therapy in the majority of medically significant envenomings. Such specific therapy may dramatically reduce the consequences of the envenomation. In Vietnam, no specific antivenom against B. multicinctus has been available until recently when it has produced for clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Envenomed by B. multicinctus
* Showed clinical signs of systemic envenomation (neuromuscular signs)
* Provided written informed consent (during the year 2006)

Exclusion Criteria:

* Pregnancy
* Patients had a known history of intolerance to equine serum
An Dose Escalation Study of BIBF 1120 Administered in Patients With Relapsed or Refractory Multiple Myeloma

Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics


Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities.
2. Age 18 years or older
3. Life expectancy of at least six months
4. Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
5. Eastern Cooperative Oncology Group (ECOG) performance score \<2.
6. Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.

Exclusion Criteria:

1. History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing
2. Active infectious disease
3. Uncontrolled, severe hypertension
4. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
5. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
6. Absolute neutrophil count less than 1000 / mm³.
7. Platelet count less than 30 000 / mm³
8. Conjugated Bilirubin greater than 2 mg / dl (\> 34 μmol/L, SI unit equivalent)
9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal
10. Endogenous creatinine clearance (ECC) \<20 ml/min
11. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
12. Pregnancy or breastfeeding
13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
14. Patients unable to comply with the protocol
15. Active alcohol or drug abuse
Awareness Among Hearing Enhancement Interventions and Reimbursement Criteria of Hearing Implants

The following research questions will be investigated:

What is the knowledge of medical interventions for moderate to severe hearing loss and what is the knowledge of the reimbursement criteria for hearing implants of otorhinolaryngologists in a secondary setting in Brabant. This will be evaluated by means of a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phase.

In a second phase, the investigators will investigate how the knowledge of medical interventions for moderate to severe hearing loss and the knowledge of the reimbursement criteria for hearing implants of otorhinolaryngologists in a secondary setting in Brabant can be increased by training the otorhinolaryngologists in a secondary setting in Brabant.

In the third phase, the investigators will evaluate the knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting.

In most developed economies, cochlear implants have been shown to be the most successful neuroprostheses for sensory moderate or severe neurosensory loss. These neuroprostheses are cost-effective with low complication rates. However, the literature indicates that there is a low level of awareness of the benefits of cochlear implants among the general population and among healthcare professionals. In addition, a lack of specific referral pathways has been reported. Utilization rates for adult hearing aids in people with severe or profound loss are 70% to 90%, but uptake in adults for cochlear implants is less than 10%.

Therefore, the aim of this research project is to investigate the knowledge about medical interventions in moderate to severe hearing loss and the knowledge about reimbursement criteria of hearing implants of otorhinolaryngologists in a secondary setting in Brabant.

The study group will consist of a maximum of 100 geographically selected otorhinolaryngologists aged 25-70 years in a secondary setting in Brabant. A subselection will be made from the reachable otorhinolaryngologists in the region of Brabant. Recruitment will be discontinued when a maximum of 100 otorhinolaryngologists has been reached. A specific questionnaire will be systematically reviewed with the participants during an interview in the first and third phase. There is no financial compensation for the participants.

Eligibility Criteria:
Inclusion Criteria:

* Otorhinolaryngologists working in a secondary setting
* Dutch and French speaking

Exclusion Criteria:

* Otorhinolaryngologists working in a tertiary setting attached to a university