cyrilzakka/clinical-trials huggingface dataset:
Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)

Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.

This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.

The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.

The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.

The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.

Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.

The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease

Eligibility Criteria:
Inclusion Criteria:

* Working age adults 18-65
* Low back pain (current episode of 2-4 weeks)
* Self-reported physically demanding work
* Sick-listed or at risk
* Speak, read and understand Danish
* Accept workplace visit by the occupational physicians
* Be in gainful employment for at last 30 hours/week

Exclusion Criteria:

* Severe somatic or psychiatric comorbidity
* Pregnancy
* Cancer or metastatic disease
* LBP treatment or referral to outside providers (e.g. back-surgery)
* Contraindications for having a MRI.
Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome

A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.

The experimental group received STM and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. Numeric Pain Rating Scale (NPRS) was used to assess the pain intensity, while Neck Disability Index (NDI) was used to assess the neck-related disability. The data was collected pre-, during, and post-intervention. Repeated measure analysis of variance (RM ANOVA) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. Data were analyzed by using SPSS version 21.

This study describes the comparative effectiveness of STM when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of TNS. According to the results of this study, STM in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.

Eligibility Criteria:
Inclusion Criteria

:• Age above 30 and below 75 years

* Patients having local neck pain included
* Female included
* With chronic neck syndrome (\> month)

Exclusion Criteria:

* Age below 30 and more than 75 years
* Patients having radiating pain excluded
* Male excluded.
* With acute neck syndrome (\< 3 month)
Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness

In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires.

Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated.

Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study.
* Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society
* Symptoms for \> 3 months of moderate to severe intensity according to the dizziness handicap inventory \[0 (minimum score) -100 (maximum score)\] between 30 to 90 points.
* ≥18 years of age
* Legally competent male or female outpatient.
* Signed informed consent.
* Not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding.

Exclusion Criteria:

* Having taken within the last 2 months or currently taking Vertigoheel®.
* Debilitating acute or chronic illness (i.e. psychiatric illnesses).
* History of sensitivity to any component of the study drug under observation.
* Unwilling or unable to comply with all the requirements of the study protocol.
* Any relationship of dependence with the sponsor or with the investigator.
Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras

The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis colorectal carcinoma
* Metastatic disease
* Signed informed consent

Exclusion Criteria:

* Prior treatment of metastatic colorectal cancer
* Refusal or incapability of providing informed consent
Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury

The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.

The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury. In particular, we will be assessing renal replacement adequacy for patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction ratios, venous and arterial pressures. We will also be monitoring infection rates. We will compare these outcomes in patients receiving tunneled catheters and patients receiving temporary catheters.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy

Exclusion Criteria:

* End stage renal disease
* Chronic kidney disease 5 progression to end stage renal disease
* Outside hospital catheter placement
Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty

This study evaluates the effect of balance circuit in patients with more than one year of postoperative total hip or knee arthroplasty. Patients were randomized between intervention group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The evaluations were conducted by blind examiners.

Balance Exercise Circuit (BEC) program, includes exercise that specifically challenge sensory inputs from mechanoreceptors as well as from the visual and vestibular systems. It is composed of 13 stations, involving static and dynamic balance exercises, including tandem walking, forward-backward stepping, wide-stance gait, functional reach, heel lift, toe press, balance on unstable surfaces, and standing on one leg. The BEC lasts 50 min, two times per week for a total of 12 weeks. Progression of exercises occurred every 3 weeks and was closely supervised to ensure safety. Each BEC session comprised of warm-up and stretching (10 min), exercise circuit (30 min), and cool-down (10 min).

Eligibility Criteria:
Inclusion Criteria:

* more than one year of postoperative total hip or knee arthroplasty

Exclusion Criteria:

* total hip AND knee arthroplasty
* other surgeries of the lower limbs and spine
* autoimmune disease
* contraindication for physical exercise
ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery

Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient centred outcomes such as quality of recovery.

Minimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain, reduce tissue trauma and contribute to better recovery as compared to open thoracotomy. However, it still causes significant acute post-operative pain. Our Mater research group has shown that fascial plane blocks such as the Erector Spinae Plane block (ESP) contribute to post-operative analgesia after MITS. Case reports have described the improved quality of analgesia following ESP using programmed intermittent boluses (PIB) instead of continuous infusion. It is hypothesised that larger, repeated bolus doses provide superior analgesia, possibly as a result of improved spread of the local anaesthetic. Evidence for improved spread of local anaesthetic may be found in one study which demonstrated that PIB increased the number of affected dermatomal levels compared to continuous infusions for continuous paravertebral blocks. Similarly, with regard to labour epidural analgesia, PIB provides better analgesia compared with continuous infusion.

Because fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To the best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient-centered outcomes such as quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female aged \> 18
* Able to provide written informed consent
* ASA grade I - V
* VATS surgery
* Weight \> 55kg

Exclusion Criteria:

* Absence of or inability to give informed consent
* Pre-existing infection at block site
* Severe coagulopathy
* Allergy to local anaesthesia (or another contraindication to block performance)
* Previous history of opiate abuse
* Pre-existing chronic pain condition
* Pre-existing dementia (due to need to co-operate in completing QoR-15 score day after surgery
* Postoperative admission to ICU for continued ventilation
* BMI \> 40 kg/m2
Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes (World Health Organization \[WHO\] classification).
* Are at least 30 years of age and less than 75 years of age.
* Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
* Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or
* Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter \[mmol/l\]).
* Have given written informed consent to participate in this study in accordance with local regulations.

Exclusion Criteria:

* Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion.
* Have a body mass index greater than 40 kilograms per meter squared (kg/m2).
* Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
* Have congestive heart failure.
* Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
Biochemical Pregnancy Loss. A Multicenter Retrospective Study

Biochemical pregnancy loss (BPL) is a very frequent issue in human reproduction. After the implantation of the embryo, hCG disappears very soon from the maternal bloodstream and no evidence of a clinical pregnancy is seen. Different studies showed that factors such as age, oocyte and embryo quality, and endometrium receptivity may have something to do with the occurrence of biochemical pregnancy loss post assisted reproduction treatment.

The main aim of this study is to evaluate the incidence of biochemical pregnancy loss (BPL) in three different cohort populations; patients undergoing frozen embryo transfer (FET) from own oocytes after preimplantation genetic testing for aneuploidy (PGT-A), patients undergoing FET from own and donated oocytes and with endometrial receptivity array (ERA), and patients undergoing FET from own or donated oocytes (without PGTA or ERA test).

We will analyse the incidence of BPL in these populations and try to determine the role of the euploid status embryo in the first group, the endometrium in the second group and the third one as control group. We are waiting to find the value of both players in the origin of BPL.

Human embryo implantation is a poorly understood process. Once the embryo implants in the endometrium, it starts to secrete hCG that can be measured in the maternal blood as early as 9 days after implantation. Only a minimal number of pregnancies get to newborn, and the majority are lost before reach the first trimester (Larsen et al., 2013).

We are looking for the role of the embryo after controlling its chromosomal ploidy, and the endometrium after controlling its transcriptomic expression. We will also use a no exposed group to the controlled euploid embryo factor neither endometrial factor that is the oocyte donation group. This analysis expects to provide more information about the key role of embryo or endometrium in BPL.

Eligibility Criteria:
Inclusion Criteria:

Patients with the following selection criteria:

* IVF/ICSI patients aged between 18 and 44
* BMI 18-30 kg/m2
* Frozen embryo transfer from own oocytes after PGT-A
* Frozen embryo transfer with ERA test (from own or donated oocytes)
* Frozen embryo transfer (from own or donated oocytes)
* Single embryo transfer (SET) in all cycles
* Patients without uterine malformations
* Patients without recurrent miscarriage (≥ 3)
* Patients with adequate endometrial thickness (\> 7mm)
* Patients without thyroid autoimmunity
* Patients without thrombophilia
* Exclude cycles with exclusively PGT-M
* Exclude FET in ovarian stimulated cycles

Exclusion Criteria:

Exclude cycles with exclusively PGT-M Exclude FET in ovarian stimulated cycles

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Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction

To investigate the differences between the two methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for young federated male football players. After surgery with quadricipital tendon graft or semitendinosus tendon graft, a two-year follow-up and the rate of return to sport are proposed.

The anterior cruciate ligament is one of the most common traumatic injuries in football, and surgery is proposed to restore knee stability. However, following surgery, few studies have focused on functional recovery of the knee with a wide arsenal of physical tests. Therefore, this study aims to study the efficacy for young football players of two types of grafts based on the most common tendons, the quadricipital and the semitendinosus (without the semimembranosus). Follow-ups will be performed at three months, six months, one year and two years after reconstruction. The variables measured will be isokinetic strength of flexors and extensors, unipodal jump test, self-perceived function, pain and tendon architecture with ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed anterior cruciate ligament rupture by MRI.
* Prognosis of anterior cruciate ligament reconstruction surgery.
* Be a registered or recreational football player.

Exclusion Criteria:

* Previous knee surgery.
* Having articular cartilage lesions of Outerbridge grade greater than III-IV.
Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)

Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.

COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. COPD is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Treatment usually includes inhaled bronchodilator or steroid medications that work by relaxing the muscles around the lung airways and reducing inflammation. Zileuton, a medication that is used to prevent asthma symptoms, may be beneficial in treating people who experience COPD exacerbations. Zileuton works by blocking the formation of substances that cause inflammation, fluid retention, and constriction in the lungs. The purpose of this study is to evaluate the effectiveness of zileuton at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation.

This study will enroll adults who are admitted to the hospital due to severe COPD symptoms. Participants will be randomly assigned to receive either zileuton or placebo four times a day for up to 14 days. While in the hospital, lung function testing and urine collection will occur. Study visits will occur at Days 14 and 30, and will include lung function testing, a medical history review, and a study drug adverse effects review.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the hospital for a COPD exacerbation
* FEV1 less than 60% of predicted level
* At least 10 pack years of smoking

Exclusion Criteria:

* Any uncontrolled systemic disease
* Known hypersensitivity to zileuton
* Asthma
* Lobar pneumonia or pulmonary edema
* Interstitial lung disease
* Medical condition that is likely to limit survival to less than 30 days at the time of study entry
* History of liver disease
* Current use of theophylline
* Participation in another clinical trial in the COPD Clinical Research Network
* Incarceration
* Institutionalization
* Pregnant
* History of a suicide attempt
* Prior inpatient admission for a psychiatric disorder
* Bipolar disorder

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