cyrilzakka/clinical-trials huggingface dataset:
Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections

An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years;
2. ICU admission between November 2012 and December 2015;
3. documented CR-Kp invasive infection;
4. targeted antibiotic therapy lasting ≥ 72 hours

Exclusion Criteria

1. Klebsiella infection, susceptible to carbapenems
2. Duration of antimicrobial therapy less than 72 hours
3. Data not completely available from the electronically medical chart
COVID-19 and the Healthy Minds Program for Educators

This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.

Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.

The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years old and up
* Employees of a K-12 school district in Wisconsin
* Smartphone or device that can download apps from Google Play or the iTunes app store

Exclusion Criteria:

* Individuals under 18 years old
* Significant meditation experience:

  1. Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),
  2. Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or
  3. Previous use of the HMP app.
* Patient-Reported Outcomes Measurement Information System (PROMIS) depression score \> 70
Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia.

OBJECTIVES:

Primary

* Determine remission rates and duration of remission in patients with T-cell large granular lymphocytic (T-LGL) leukemia needing intervention because of anemia or neutropenia and are treated with parenteral methotrexate (MTX) as first-line therapy
* Determine remission rate and duration of remission in patients who fail to respond to MTX therapy and are subsequently treated with fludarabine as second-line therapy.

Secondary

* Determine the side effects of these drugs in these patients.
* Determine the rate of molecular remissions in patients treated with these drugs.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive methotrexate subcutaneously once weekly in the absence of disease progression or unacceptable toxicity. Patients not achieving a response to methotrexate receive fludarabine IV on days 1-3. Treatment with fludarabine repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of T-cell large granular lymphocytic (T-LGL) leukemia
* Must have concurrent anemia or neutropenia

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 2 years
* Not pregnant
* Fertile patients must use effective contraception
* No other malignancy
* No active infection

PRIOR CONCURRENT THERAPY:

* No prior immunosuppressive treatment
* No previous treatment with methotrexate or fludarabine
Myofascial Trigger Points in the Upper Limb in Stroke Patients

One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized, hyperirritable points in the skeletal muscles that are associated with palpable nodules in muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain. Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic neck and shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral shoulder pain and a physician-diagnosed stroke.

Exclusion Criteria:

* Rheumatic inflammatory,
* Systemic diseases,
* Acute traumatic conditions,
* Postoperative conditions, neck and elbow disorders, and
* Serious aphasias in which there was a communication problem.
Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure

Over the last two decades, the number of patients with hematological malignancies (HMs) admitted to the ICU increased and their mortality has dropped sharply. Patients with HMs increasingly require admission to the intensive care unit (ICU) for life-threatening events related to the malignancy and/or treatments, with immunosuppression being a major contributor. Whether the increase in ICU admissions is related to increased referrals by hematologists and/or to increased admissions by intensivists is unknown. The criteria used for ICU referral and admission decisions have not been extensively evaluated. Finally, the links between admission policies and treatment-limitation decisions are unclear, but ICUs with broad admission policies may change the treatment goals based on the response to several days of full-code management.

The aim of this study is to evaluate the impact of a systematic evaluation by an intensivist of HMs patients presenting with acute respiratory and/or hemodynamic failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in a hematology unit
* Patients presenting with criteria for critical respiratory and/or hemodynamic condition and worsening during the next 4 hours

  1. Respiratory : oxygen saturation \<90 % and/or O2 \>3l/min, with either a worsening of saturation or increased oxygen needs within 4h
  2. Hemodynamic : systolic blood pressure \< 90 mmHg and remaining \< 90 mmHg within 4h despite ≥ 1l of crystalloid administration, or becoming \< 80 mmHg no matter the quantity of fluid (even if no fluid administration).

Exclusion Criteria:

* therapeutic limitations decided hematological investigators (moribund patients, uncontrolled allogenic graft,...)
* Do-not-reanimate directives
* Pregnant or breastfeeding women
Effect of Remazolam on Hemodynamics During Hepatectomy

There is high incidence of hemodynamic instability in patients undergoing hepatectomy with low central venous pressure, especially in general anesthesia combined with epidural anesthesia. Remazolam, a new benzodiazepine, has no significant cardiovascular inhibitory effect. Investigators hypothesis that remazolam will provide better hemodynamic when compared with propofol in patients undergoing hepatectomy with general anesthesia combined with epidural anesthesia.

Investigators plan to adopt the following strategies in the clinical study of this project: (1) To compare remazolam and propofol during anesthetic induction and maintenance; (2) Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction. Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction; (3) Epidural analgesia is used during perioperative period, and remifentanil pump injection is used during the operation to assist the subjects to tolerate the tracheal catheter; (4) the haemodynamic instability score (Hemodynamic instability score) is used to comprehensively evaluate intraoperative hemodynamic status. (5) To evaluate the incidence of postoperative complications. Through the above strategies, investigators further determine the optimization effect of remazolam, a novel benzodiazepine drug, on intraoperative hemodynamics in patients undergoing low central venous pressure hepatectomy, and further lay an empirical foundation for the routine use of remazolam in clinical hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign informed consent and are willing to complete the study according to the plan;
2. Over 18 years of age;
3. ASA grade Ⅰ \~ Ⅲ;
4. Elective surgery;
5. General anesthesia combined with epidural anesthesia;
6. Child Pugh is classified as Level A

Exclusion Criteria:

1. Abnormal coagulation function;
2. Abnormal platelet;
3. A history of drug dependence;
4. Neurological diseases;
5. Severe sinus bradycardia (HR\<50 beats/min);
6. Atrial fibrillation;
7. Systolic blood pressure ≥200mmHg and/or diastolic blood pressure ≥120mmHg.
8. Cardiac insufficiency.
9. Child Pugh is classified as B or C.
[68 Ga]-DOTANOC PET/CT in GEP-NETs

Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs.

During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs.

In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 \[68Ga\], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by \[68Ga\]-PET-SSTa.

Currently, three different \[68Ga\]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.

\[68Ga\]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer \[68Ga\]-DOTATATE in patients with GEP-NETs but this requires further evaluation.

It is therefore important to determine the interest of \[68Ga\]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding \[68Ga\]-DOTANOC in the work-up of patients.

The investigators hypothesis is that \[68Ga\]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).

110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).


Eligibility Criteria:
Inclusion Criteria:

1. Age\> 18 years, with affiliation to the Social Security.
2. Written consent of the patient.
3. Patients with any of the following 5 situations:

   * GEPs without metastasis.
   * GEPs with unilateral liver metastases candidates to unilateral hepatectomy.
   * GEPs with unknown primary tumor.
   * GEPS with livers metastases candidates to liver transplantation.
   * Metastatic GEPs with grade 1 or 2 tumour and negative SRS.
4. Reference imaging within the last 3 months : multiphasic total body CT scan, liver MRI and SRS (SPECT/CT).

Exclusion Criteria:

1. minor subject.
2. Pregnant or breast-feeding.
3. Absence of therapeutic alternatives in metastatic GEP.
4. Undifferentiated GEP and/or metastatic GEPs with grade 3 tumours.
Monitoring Key Activity and Physiology of Neonates in Intensive Care

To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Eligibility Criteria:
Inclusion Criteria:

* written informed parental consent

Exclusion Criteria:

-
Dry Needling and Rehabilitatin Carpal Tunnel Syndrome

Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the society, which develops due to compression of the median nerve in the carpal tunnel. With the compression of the median nerve, a pain, numbness and tingling sensation spreading to the hand and wrist affects daily living activities and reduces the quality of life. Thickening and myofascial restriction in the carpal tunnel area also contribute to this situation. For this reason, various treatment methods have been developed for CTS, ranging from conservative treatment to surgery. Dry needling is also an alternative treatment method that can be used for CTS. Dry needling allows the fascial tissue to loosen and re-enter the healing process, leading to a decrease in pain and an increase in quality of life. However, its effectiveness in patients with CTS is unknown. This study aimed to examine the effectiveness of dry needling in patients with CTS.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteering to participate in the study.
2. Being between the ages of 18-65.
3. Being diagnosed with mild or moderate stage CTS as a result of the electroneurophysiological test.

Exclusion Criteria:

1. Having additional neurological, rheumatological and orthopedic disorders.
2. Having had previous hand surgery.
3. Having an additional acute neck, shoulder, elbow and hand problem.
4. Having a BMI of 40 kg/m2 and above.
5. Being pregnant.
6. As a result of the electroneurophysiological test, the data related to the median nerve are at a severe level.
Effect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.

This study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight bearing exercises and the other perform non weight bearing exercises.


Eligibility Criteria:
Inclusion Criteria:

* The patient's age \> 50 years.
* Recent radiographs confirming the presence of knee OA, grade II-III (mild to moderate) Kellgren Lawrence (K/L).
* Body mass index (BMI) from 20 to 30 kg/m2.
* Met the American College of Rheumatology clinical criteria for mild to moderate knee OA.
* knee pain \> 3 cm on a 10 cm visual analog scale (VAS) on most days of the previous week.
* Bilateral knee osteoarthritis.

Exclusion Criteria:

* Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee.
* Patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests.
* Intra articular knee injection of steroids in the past 6 months.
* Patients who had received joint replacement surgery in either Knee or hip.
* Patients with rheumatoid arthritis.
* Patients who received physical therapy sessions on the knee in the past 6 months.
Biomarkers of Sarcopenia and Frailty in Geriatric Patients

During the last decades there has been an increase in the relative proportion and life expectancy of elderly people. Hence, the number of elderly with diseases and disabilities related to aging will increase and consequently, age-related losses in skeletal muscle mass and physical function represents an important current and future public health issue. Sarcopenia is a progressive and generalized skeletal muscle disorder that is considered central to the development of physical deconditioning and untreated sarcopenia is linked to falls, morbidity, and mortality.

The underlying mechanisms behind the progressive loss of muscle mass and function associated with aging are yet unknown but seems to be multifactorial. A decrease in physical activity level and an altered central and peripheral nervous system innervation have been identified as some of the contributing factors. Furthermore, chronic low-grade inflammation has been proposed as a central contributor to sarcopenia and thus physical frailty.

However, it is not yet clear whether the elevated markers of inflammation seen in the elderly are due to aging, chronic illness, or inactivity. But overall, it seems that inflammation plays an important role in the development of muscle loss, and is related to increased risk of falls, fragility, and early death.


Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients referred to out-patient clinic for fall assessments
* equal to or over the age of 65

Exclusion Criteria:

* age under 65 years
* participants who do not understand Danish
* severe communicative problems
* moderate to severe dementia or cognitive deficits
* no independent walking
Evaluation of Pulp Response to Castor Oil

The present study was conducted to evaluate and compare pulp response to Castor oil versus Formocresol as Pulpotomy Medicaments in Primary Teeth


Eligibility Criteria:
Inclusion Criteria:

* healthy cooperative children with sound primary canines indicated for extraction for orthodontic reasons

Exclusion Criteria:

* caries primary canines Presence of systemic pathology
Physical Performance of Women at Different Stages of the Menstrual Cycle, and Photobiomodulation Therapy

Hormonal fluctuations present during the ovarian cycle may have a strong influence on physiological and psychological aspects on physical performance in women. The aspects surrounding performance and ovarian cycles in women during different phases of the cycle, are still current and should be debated in the literature, as the available evidence has conflicting results. In addition to the above, new ergogenic methods have been studied to improve the sports scenario in different populations. Research on the use of ergogenic electrophysical resources so that hormonal effects may possibly be mitigated, allowing women to use this resource and improving their physical performance is still scarce in the current literature.

Objective: To evaluate the physical performance of women during different phases of the ovarian cycle and the influence of photobiomodulation therapy in this setting. Methods: The research will be conducted in two subprojects - Subproject I is a cross-sectional study. Initially the participants will be evaluated in two phases separately, being the first and second day within the ovarian cycle in the follicular phase (FF) and the third and fourth day in the luteal phase (FL). The aspects of body composition, body water volume and skin temperature by infrared thermography will be evaluated, and the physical performance evaluation will be constituted by the evaluation of the muscular performance by isokinetic dynamometer, and by a treadmill supramaximal effort test. , together with analysis of VO2max and blood lactate levels. Subproject II is a double-blind placebo-controlled randomized clinical trial. After completion of subproject I, during the next ovarian cycle within the participants will return to conduct the second part of the study, which will analyze the influence of photobiomodulation therapy on the physical performance of women within their menstrual cycle, related to low hormone rate ( FF). 200 J of energy will be applied before each evaluation, which is muscle performance and endurance. The tests will be performed in the same order, following the same protocol in both phases of the study. For data analysis, a normality test will be used to verify the distribution and statistical tests consistent with the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. A significance level of 5% will be adopted. The effect size will be calculated by Cohens'd.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 to 35 years
* Healthy
* Physically Active (150 min / week)

Exclusion Criteria:

* Eating disorders;
* Hormonal disorders;
* Amenorrhea;
* Pregnancy;
* Polycystic ovary;
* Endometriosis;
* Tumors;
* Musculoskeletal injury in the last 6 months;
* Cardiorespiratory disease;
* Use of alcohol and illegal drugs during the study.