cyrilzakka/clinical-trials huggingface dataset:
A Real World, Observational Registry of Chronic Wounds and Ulcers

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).

This is a longitudinal, observational study of chronic wounds and ulcers treated at participating hospital based, outpatient wound centers. Data collection began in 2005. Structured data are collected at the point of care in the patient electronic health record and data from all patients at more than 100 wound centers in the USA and Puerto Rico are transmitted to the U.S. Wound Registry which is recognized by CMS as a Qualified Clinical Data Registry (QCDR). Participation in the USWR can satisfy the registry participation option for Stage 2 of Meaningful use. The dataset includes all wound and ulcer types such as diabetic foot ulcers, venous stasis ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, vasculitic ulcers, arterial ulcers, sickle cell ulcers, inflammatory ulcers (e.g. pyoderma gangrenosum), and ulcers related to skin disorders such as scleroderma. Interventions provided include advanced dressings, compression bandaging, off-loading, cellular and/or tissue based therapies, hyperbaric oxygen therapy, negative pressure wound therapy, debridement, and antibiotics. Ulcers are risk stratified for outcomes reporting using the Wound Healing Index.Outcomes measured include healing or wound closure, surgical closure, death, and major and minor amputation. Data on wound care specific quality measures developed by the QCDR are also available.

Eligibility Criteria:
Inclusion Criteria: All wounds in all patients at participating centers -

Exclusion Criteria: none

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Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units

Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure... The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics.

In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.


Eligibility Criteria:
Inclusion Criteria:

* patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection

Exclusion Criteria:

* informed consent lacking
* haematocrit \< 21 %
* arterial catheter lacking
A Study to Assess the Safety of ARGX-109 in Healthy Volunteers

This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.


Eligibility Criteria:
Inclusion Criteria:

* is aged 18 to 65 years, inclusive, when signing the ICF
* has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 kg/m2, inclusive

Exclusion Criteria:

* Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
Effect of Mindfulness Based Stress Reduction (MBSR) Programme for Reducing the Stress Level of Nursing Student

Purpose: This research was planned to determine the effect of mindfulness-based stress reduction program on reducing the stress level and emotion regulation of nursing students.

Design: The research was planned as a pretest, posttest, follow-up and randomized controlled study in order to determine the effect of the mindfulness-based stress reduction program on the stress level and emotion regulation of nursing students.

Hypotheses: H1: The perceived stress level scores of nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease compared to the nursing students in the control group.

H2: The perceived stress level of the nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease according to their pretest scores.

H3: Emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the nursing students in the control group.

H4: The posttest and follow-up emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the pretest.


Eligibility Criteria:
Inclusion Criteria:

* Age range is 18-25 years old
* Being a student in the second or third year of the nursing department
* Regular attendance at school
* Not having a communication problem related to vision or hearing
* It was determined as having a score of 26 or more from the perceived stress scale.

Exclusion Criteria:

* Have a psychiatric illness
Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points

Hypothesis The application of intramuscular electrostimulation will be more effectiveness than the dry needling in myofascial trigger points treatment.

Objetives:

To determine the effectiveness of intramuscular electrostimulation in the treatment of trigger points of the levator scapula muscle for the improvement of pain in mechanical cervicalgia.

Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and active trigger points in levator scapulae muscle, randomly assigned to experimental or control group.

Intervention: Control group: one session of dry needling in active trigger points; experimental group: one session of intramuscular stimulation in active trigger points.

Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion and strength muscle . The measures will be taken before, after and one week after the interventions.

The muscle pain is one of the most common forms of musculoskeletal pain. Within muscular pain, the presence of myofascial trigger points (PG) in the musculature is a important and prevalent problem.

Currently one the techniques most used in the treatment of PG is dry needling. Dry needling has been shown effective in the treatment of neck pain associated with PGs.

To our knowledge, there are no studies that they have compared the effectiveness of dry needling and intramuscular stimulation by applying an electric current.

This study is a randomized clinical trial that aims to demonstrate that the application of an electric current associated with dry needling in the treatment of PG.

In this study we will treat subjects with cervical pain who they have active PGs in the levator scapulae muscle.

Eligibility Criteria:
Inclusion Criteria:

* Cervical pain.
* Active trigger points in levator scapulae muscle

Exclusion Criteria:

* Pain Irradiation toward upper limb
* Psychological disorders
* Whiplash.
* Neuropathic symptoms
* Cervical and / or Shoulder Spine Surgery
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.

OBJECTIVES:

* Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
* Correlate dose with systemic concentration of this drug and its metabolites in these participants.
* Determine the safety of this drug in these participants.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.

Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.

Participants are followed at 2 and 7 days.

PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy participants

PATIENT CHARACTERISTICS:

Age

* 18 to 80

Performance status

* WHO 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count 120,000-450,000mm\^3
* Hemoglobin 10.5-17.5 g/dL for women OR 11.5-19.0 g/dL for men

Hepatic

* Bilirubin 0.05-1.2 mg/dL
* AST and ALT \< 1.5 times normal

Renal

* Creatinine normal
* Urinalysis normal

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile participants must use effective contraception
* Willing to abstain from ingesting large quantities of resveratrol-containing foods
* Willing to spend 24 hours in the hospital
* No cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years except basal cell or squamous cell skin cancer
* No concurrent excessive alcohol intake (\>21 units per week for men; 14 units per week for women)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Concurrent hormone replace ment therapy allowed
* Concurrent oral or depot contraceptives allowed

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 2 weeks since prior and no concurrent vitamin supplements of any type
* More than 6 months since prior and no concurrent participation in any other experimental study
* No other concurrent chronic medications, including over-the-counter medications, herbal/natural preparations, or dietary supplements
* No other concurrent prescribed medication
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients

This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
* Male or female patients from 6 months to ≤ 21 years old at the time of study enrollment
* Confirmation of diagnosis:

  * Phase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis, with measurable or evaluable disease, for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ≥ 1 prior line of therapy.
  * Phase II: patients must have histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma.
  * Patients with solid tumors must have measurable disease (evaluable disease is acceptable for neuroblastoma and Ewing sarcoma). Tumor assessment will be done via computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT). Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion. Bone scans (if clinically indicated) should be obtained within ≤ 4 weeks prior to the start of treatment.
* Performance level: Lansky ≥ 50% for patients ≤ 16 years of age and Karnofsky ≥ 50% for patients \> 16 years of age.
* Adequate bone marrow, renal and liver function.

Exclusion Criteria:

* Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ≥ 2).
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
* Diabetes mellitus.
* Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
* Patients with central nervous system (CNS) malignancies.
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty

Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.

Eligibility Criteria:
Inclusion Criteria:

* All elective brain tumors elligible for craniotomy

Exclusion Criteria:

* Refusal to participare
* Emergency craniotomy
Smoking Cessation Support for Patients With Rheumatologic Diseases Via WhatsApp

Smoking cessation support for patients with rheumatologist diseases is an underestimated issue. In the previous prospective cohort study the investigators determined that with the brief cessation interventions 63.5% of smokers with rheumatologic diseases were willing to quit and the rest 36.4% were not willing. Among the willing group the highest quit rate was detected in the group that admitted to smoking cessation clinic. Therefore to increase the willingness to quit as well as to increase the Access to evidence based tobacco cessation support using new comminication technologies can be relevant. Investigators' aim in this study is to examine the effect of including WhatsApp in the routine smoking cessation practices on the quitting success of active smokers with rheumatic diseases who apply to the Rheumatology outpatient clinic.

In this randomized controlled study, the sample will be randomly divided to 2 arms. In one arm, usual care arm, smoker patients with rheumatologist diseases will be implemented brief smoking cessation interventions and referred to quit lines or smoking cessation services and also directly contacted to get an appointment from the cessation clinic. In the other arm, the intervention arm, smoker patients with rheumatologist diseases will be implemented brief tobacco cessation interventions and directly contacted to get an appointment from cessation clinic and will be send periodically motivational and informative text messages regarding tobacco cessation via WhatsApp.

Primary outcome measures will be the quit rate of both arms at 3rd, 6th and 12th month.

Secondary outcomes will be access to evidence based smoking cessation support, admission rate of smoking cessation clinic and treatment use duration of cessation medications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients applying to the rheumatology outpatient clinic
2. Those aged 18 and over
3. Those who are active smokers
4. Those diagnosed with inflammatory rheumatic disease
5. Those who gave informed written consent to participate in the study

Exclusion Criteria:

1. Those with active psychiatric disease diagnoses such as psychosis, major depression, schizophrenia among their current diagnoses
2. Those with cognitive dysfunction
Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

In this study, the investigators will determine whether patients with documented atherosclerosis are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to patients without atherosclerosis.

Rationale: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming. We hypothesize that trained monocytes augment atherogenesis.

Objective: The main objective is to study whether patients with coronary atherosclerosis show specific epigenetic changes in the promoter regions of pro-inflammatory cytokines and chemokines and whether this correlates with the inflammatory phenotype of these cells.

Study design: Observational study

Study population: Adult patients who have had computed tomography coronary angiography because of chest pain: 20 patients without atherosclerosis and 20 patients with severe atherosclerosis will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male/female),
* aged \>18 years,
* admitted to the acute coronary unit of the CWZ hospital for evaluation of chest pain.
* No coronary atherosclerosis
* Or Severe atherosclerosis

Exclusion Criteria:

* Signs or symptoms of a current infection (fever, chills)
* Auto-immune diseases (such as rheumatoid arthritis)
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven systemic AL amyloidosis.
* Cardiac involvement with septum thickness more than 12 mm (without other causes as published by Gertz et al., hypertension or other potential causes of left ventricular hypertrophy)
* Previously treated with chemotherapy, induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder.
* GPT and GOT less than 3-times ULN.
* Life expectancy more than 12 month.
* Ability of subject to understand character and individual consequences of the clinical trail.
* Written informed consent.
* For women with childbearing potential and men, adequate contraception.

Exclusion Criteria:

* Age less than 18 years.
* Concomitant multiple myeloma stage 2 and 3 (Salmon and Durie)
* Concurrent chemotherapy necessary
* Time to last chemotherapy more than 6 months.
* Chronic liver disease, Bilirubin over 1,5 mg/dl
* Not able to visit Amyloidosis Clinic in Heidelberg every 3 months.
* History of hypersensitivity to the investigational product or to any substance with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials or observation period of competing trials, respectively.
* Pregnant or nursing women.
Hydroxyurea in the Emergency Room to Lessen Pain in Sickle Cell Crisis

This study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg HU (daily) upon hospitalization for painful vaso-occlusive crises .

Sickle cell anemia (SCA) is a hereditary hemoglobinopathy; complications of the disease include, spleen enlargement, acute chest syndrome, pulmonary hypertension, stroke and cumulative damage to multiple organs, and painful vaso-occlusive crises (VOC). In Brazil, about 3,500 children are born each year with DF, and the number of individuals with sickle cell disease (DF) in the country is estimated between 25,000 and 30,000 (ANVISA 2012; BRAZIL, 2012).

Hydroxyurea (HU, or hydroxycarbamide) is the only drug approved to date by the American FDA for use in adults with sickle cell disease. The drug modifies the disease process, improving hematological parameters and the hospitalization time of patients, as well as the frequency of vaso-occlusive crises.In addition to its proven effects during chronic use, experimental data indicate that HU has immediate anti-inflammatory effects.

In addition to its proven effects during chronic use, experimental data indicate that HU has immediate anti-inflammatory effects. This study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg HU (daily) upon hospitalization for VOC.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of homozygous sickle cell anemia (HbSS).
* Hospitalization due to onset of uncomplicated vaso-occlusive crisis (with pain scale≥6 within the last 24 h), confirmed by clinical evaluation.
* Documented and written informed consent

Exclusion Criteria:

* Confirmed or suspected pregnancy.
* Initiation of painful crisis\> 72h.
* Blood transfusion during the last 8 weeks.
* Admission to Emergency Room due to pain in the last 4 weeks.
* Neutrophil count \<2.5 x 109/L or platelet count \<95.0 x 109 / L or Hb \<4.5 g / dL
* Weight \<38 Kg or\> 95 Kg.
* Interval longer than 8h since arrival at center.
* Non-consent to participate in the study.
Effect of Interscalene Block on Heart Rate Variability (HRV)

The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block


Eligibility Criteria:
Inclusion Criteria:

* elective shoulder surgery
* Age 20- 45 years old
* ASA I - II

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurologic deficit in the arm that is going to be operated
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
* Arrythmia
* Ischaemic heart disease
* Diabetes mellitus
* Thyroid function disorders
* Patients with conduction disorders on the ECG
* Electrolyte disorders (K+, Na+, Ca++)
* Patients on medication that affect the ECG