cyrilzakka/clinical-trials huggingface dataset:
Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score

The aim of the study is to develop a screening instrument, based on the nursing activities score, by which we can distinguish medium care patients from the intensive care patients in terms of nurse staffing.

The main study question is: What is the most discriminative NAS cut off for medium care patient?

Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is admitted to the 8 participating units.

Nurses will be asked to answer 3 questions (see detailed description here under)at the end of their working shift concerning each patient appointed to them.

Each morning medical staff and head nurses will be asked 2 questions (see detailed description here under) for concerning patient admitted to there ward.

In order to determine the NAS cut off for medium care patient, all morning questionnaire scores will be compared to the NAS an TISS28 scores of that same morning.

Secondary study questions are:

* Can NAS score based on one nursing shift predict the severity of care in the subsequent nursing shift?
* Is there a difference in appreciation of severity of care between nurses, head nurses and medical staff?
* Which variables influence the perception of severity of care?
* How does NAS relate to TISS28, APACHE and NEMS?

Nursing questionnaire:

1. How many beds were appointed to you?

   1. 1
   2. 2
   3. 3
   4. 4
   5. 5
   6. 6
2. For how many of such patients you could care for maximally?

   1. 1
   2. 2
   3. 3
   4. 4
   5. \>4
3. This patients' burden of care corresponds to:

   1. An intensive care patient who requires more than standard intensive care
   2. An intensive care patient who requires standard intensive care
   3. A medium care patient

medical staff and head nurse questionaire:

1. For how many of such patients you could care for maximally?

   1. 1
   2. 2
   3. 3
   4. 4
   5. \>4
2. This patients' burden of care corresponds to?

   1. An intensive care patient who requires more than standard intensive care
   2. An intensive care patient who requires standard intensive care
   3. A medium care patient

Eligibility Criteria:
Inclusion Criteria:

* admission to one of the 9 critical area's
A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients

Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).


Eligibility Criteria:
* Inclusion Criteria:

  1. Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.
  2. Adult patients (18 years) with documented HIV infection, with high-grade AIN demonstrated by biopsy, and have not received any prior treatment for Anal Intraepithelial Neoplasia in the last 12 weeks.
  3. For women of childbearing potential, negative pregnancy test in urine screening visit. All women of childbearing age should continue effective contraception throughout the study treatment.
* Exclusion Criteria:

  1. Patients who have received previous treatment of Anal Intraepithelial Neoplasia (AIN) in the last 12 weeks. 2. Dermatoses in patients with anogenital area 3. Patients with a history of pre-invasive neoplasia associated with Human Papilloma Virus 4. Patients with a history of previous neoplasm, of any origin and location, in the past 5 years.

  5. Patients with a history of hematologic abnormalities, kidney or liver 6. Pregnant or breastfeeding women or women of childbearing age who do not wish to use adequate contraception at the discretion of the investigator.

  7. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.
Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR

This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.

Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD are unable to relax and often suffer from insomnia. Venlafaxine XR, a drug used to treat depression, has been shown to be effective in the short-term treatment of GAD. However, its benefits over a course of more than 8 weeks have not been assessed. This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment.

Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR. Upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo. After 12 months, participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo. Participants will have 22 study visits over at least 18 months. Follow-up visits will occur 24 months after enrollment. Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale. A variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* GAD diagnosis by structured interview
* Hamilton Anxiety Scale score of 18 or MORE
* Clinical Global Impressions Severity Scale score of at least 4
* Hamilton Depression Scale score of 18 or less
* Hamilton Depression Scale suicide item score less than 2
* Use of an effective form of contraception throughout the study

Exclusion Criteria:

* Hypersensitivity to venlafaxine XR
* History of seizures
* Episode of major depressive disorder in the previous 6 months
* History of any psychotic illness, bipolar disorder, or dementia
* Substance abuse and dependence during the past 6 months
* Other anxiety disorders with the exception of social phobia as long as GAD is primary
* Regular use of anxiolytics or antidepressants within 7 days of study onset
* Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
* Use of other psychotropic medication besides benzodiazepines during the study
Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow Up Study

A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.

Specifications of the individual items of the original Apgar score were suggested. These specifications slightly changed the Apgars' perspective, but did not alter the number of its components. The specified Apgar should therefore be easily applicable to every delivery room around the world. As a result of these specifications, the Apgar score will not express the efforts of the infant but describe its condition, independently of the requirements needed to achieve this condition. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age.

To validate the accuracy of the specified version to predict neonatal mortality and long term neurological outcome in preterm infants the present prospective, observational study is planned. The study will test the hypothesis that the specified APGAR-score predicts mortality and morbidity better at 2 years of age than the conventional Apgar-score. Furthermore, the predictive reliability of the specified Apgar can be improved in combination with perinatal data respectively with the expanded Apgar version of the AAP/ACOG.

The primary outcome "condition at 2 years of age" is composed of death and a major neurological deficit. In this case "neurological deficit" is defined by the presence of one of the followings characteristics: index of mental development (Bayley Scale II) \<85, blindness, deafness, cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants included in the TEST-APGAR Study

Exclusion Criteria:

* Missing parental Consent
Advanced Imaging for Radiotherapy Treatment Planning and Guidance for Low-Intermediate Risk Prostate Cancer (Margin)

The integration of magnetic resonance imaging (MRI) in the treatment planning process for prostate cancer will reduce uncertainties in delineation of the prostate gland, and will enable delineation of the urethra, penile bulb, and internal pudendal artery. The integration of daily cone-beam computed tomography (CBCT) will markedly reduce set-up uncertainties, thereby reducing the minimum planning target volume (PTV) margin. By combining MRI simulation and daily CBCT, and by adapting radiation delivery accordingly, the investigators will reduce dose delivered to the rectum, bladder, urethra, and erectile structures. In this study, the investigators seek to determine whether this dose reduction translates to improved patient outcomes. In a prospective, 2-stage design, up to 190 patients will be enrolled. In the first stage, advanced imaging will be integrated without altering dose planning techniques. Stage 2 will reduce dose delivered to normal tissues, and will collect toxicity outcome measures. This clinical trial will be conducted over 3 years.

Advances in medical imaging, and their integration in the treatment planning and daily guidance of radiotherapy, stand to improve the therapeutic ratio. Improved imaging can reduce uncertainties by 1) improving the accuracy and reproducibility of organ or tumor delineation, and 2) guiding and adapting delivery to account for organ motion. This paradigm has been widely accepted in the radiotherapy community, and much research has addressed the technical and dosimetric aspects for a sound clinical implementation. However, direct evidence of a clinical translation to improved patient outcomes is limited. In this study, we hypothesize that the integration of advanced imaging for treatment planning and guidance will safely enable a reduction of dose delivered to normal tissues, and will improve toxicity and quality of life (QOL) outcomes in patients receiving external beam radiotherapy for low or intermediate risk prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

Low or intermediate risk localized prostate cancer:

* Gleason score ≤ 7
* PSA \<20
* Stage T2a or less (Stage 2 only)
* \<50% of biopsy cores involved with tumor (Stage 2 only)

Exclusion Criteria:

* History of hip replacement
* Inflammatory bowel disease or collagen vascular disease
* Contraindication to fiducial marker placement
* Bleeding diathesis or anticoagulant therapy that cannot safely be ceased temporarily
* Severe adverse event with prior TRUS-guided prostate biopsy
* Patient refuses fiducial marker placement
* Contraindication to MRI
* Patient randomization in PROFIT Trial (Stage 2 only)
* Patients not prescribed 78Gy in 39 fractions to the prostate gland.
Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

Pancreatic cancer has traditionally been treated with chemotherapy and radiation therapy with limited results. Preliminary studies of parts of this program in patients with advanced pancreatic cancer have produced favorable results with acceptable side effects. We feel that this treatment sequence may help to slow and/or control the growth of pancreatic cancer.

This study will help doctors learn whether pancreatic cancer will respond to this treatment. This study will use the combination of two chemotherapy drugs, gemcitabine and cisplatin, before and after treatment with radiation therapy and an oral chemotherapy drug called capecitabine. This sequence of combination chemotherapy before and after radiation therapy, and radiation therapy with the drug capecitabine is what is under study. Parts of this sequence, for example, the combination of gemcitabine and cisplatin, have shown promising results in the treatment of pancreatic cancer. This research study is an attempt to combine these various parts.


Eligibility Criteria:
Eligibility Criteria

1. Patients must have cytologic or histologic confirmation of pancreatic carcinoma.
2. Patients must have unresectable disease with or without distant metastases. A status of unresectable will be based on review of helical CT scan and surgical consultation.
3. Patients with a history of previous abdominal irradiation or chemotherapy for pancreatic cancer are ineligible.
4. Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of ≤ 2 (appendix I).
5. Patients must be 18 years of age or older. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.
6. Patients must have adequate organ function defined as follows: bone marrow - granulocytes ≥ 1500/cmm, platelets \> 100,000/cmm, renal - serum Cre \< 1.5 mg/dl, hepatic - bilirubin \< 3 mg/dl.
7. Patients must be free of other active systemic malignancy or any other serious co-morbid medical or psychiatric condition that would interfere with safe delivery of protocol therapy.
8. Patients must be aware of the investigational nature of the therapy and provide written informed consent as per institutional guidelines prior to the initiation of treatment.
Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis

There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults. Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA. There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results. Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function. If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life. The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA. This will be a randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
* radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
* predominance of pain/tenderness over the medial (inside) region of the knee

Exclusion Criteria:

* articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
* inflammatory arthritic condition
* history of knee or hip replacement surgery
* recent use of corticosteroids (oral or via injection, within last 6 months)
* pain originating predominantly from the patellofemoral joint
* inability to ambulate without a gait aid
* non-English speaking
* recent (within 6 months) arthroscopic knee surgery
* significant hip or back pain (limits the ability to perform the testing)
* Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)
Trial of Antiseptic Irrigation for Pleural Infection

Pleural antiseptic irrigation (PAI) is used in conjunction with open drainage for treating adults with chronic post-thoracotomy empyema. The antiseptic povidone-iodine can safely be instilled into the pleural cavity for the purpose of pleurodesis and has recently been described for pleural irrigation in the acute management of paediatric pleural infection with good outcomes. A recent case report demonstrated the safe use of povidone-iodine pleural irrigation in a patient with complex pleural empyema with successful medical management. In a previous pilot study, antiseptic irrigation led to less referral to surgery and shorter length of hospital stay in comparison to no irrigation.

This study aims to investigate the effect of antiseptic pleural irrigation (using povidone iodine) on the inflammatory response in adults patients with pleural infection in comparison to irrigation with normal saline alone. A reduction in the systemic inflammatory response can be inferred to correlate with reduction in the infection burden in the pleural space.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 year-old or more)
* Pleural infection diagnosed by: the presence of pus in the pleural space, OR any of the following in the setting of acute lower-respiratory tract infection symptoms: pleural fluid PH\<7.2 or pleural fluid glucose \<40 mg/dL, positive gram stain or culture from pleural fluid
* Predominantly unilocular pleural collection treated with chest tube drainage
* Acute response at presentation as evidenced by fever (\>37.80C) and/or blood leucocytosis (\>11X103/mm3) and/or high serum C-reactive protein, CRP (\>50 mg/L)

Exclusion Criteria:

* Known or suspected thyroid disease
* Allergy to iodine
* Persistent large collection on follow-up imaging 24-48 post tube insertion that is deemed to require additional interventions (e.g., another drainage procedure, intrapleural fibrinolytic)
* Evidence or suspicion of broncho-pleural fistula (suspected when there is air-fluid level without previous intervention, or if the participant is coughing large volume of purulent sputum that is physically similar to drained pleural fluid)
* Tuberculous, post-operative or post-haemothorax pleural infections
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism

This study was a single-center randomized controlled trial which lasted 14 days and consisted of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days without potassium supplement. If participants meet the enrollment criteria at the end of stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group (100mmol/d), and then continued to finish stage II. The primary outcome was the change in serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome was the assessment of BP change following a normal sodium / low sodium diet. Patients were given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not provided any potassium supplements during the two stages. If the subject has an increase in BP (\>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60 mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their serum potassium were below 2.8 mmol/L.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years;
2. diagnosed as PA by SIT;
3. no lateralization of aldosterone secretion during AVS;
4. serum potassium ≥ 2.8 mmol/L after the stage I.

Exclusion Criteria:

1. Impaired renal function (Ccr\<60 ml/min);
2. Impaired liver function (ALT, AST \> 2.5 times upper limit of normal);
3. Patients with heart failure (NYHA≥ class 3 or EF \< 50%);
4. Patients with stroke or acute infarction in the last 6 months;
5. Patients who are pregnant or breastfeeding;
6. Patients who cannot tolerate dietary arrangements;
7. Patients with history of malignant tumors in the last 6 months.
LDCT-SC-FI Low-dose CT Screening for Lung Cancer

This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention).


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Age between 50-74
* Smoked ≥ 15 cigarettes/day for ≥ 25 years or smoked ≥ 10 cigarettes/day for ≥ 30 years and are active smokers (smoking during the last two weeks)
* Access to a smartphone (iPhone or Android)

Exclusion Criteria:

* A moderate or bad self-reported health; e.g. unable to climb two flights of stairs
* Body weight ≥ 140 kilogram
* Current or past melanoma, lung, renal or breast cancer
* A chest CT examination less than one year before inclusion
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Subject is unwilling or unable to comply with treatment and trial instructions
* Any condition that study investigators consider an impediment to safe trial participation