cyrilzakka/clinical-trials huggingface dataset:
Randomized Study of Failed SCS Trials Comparing Outcomes Using the Observational Mechanical Gateway (OMG) Connector

The purpose of this study is to evaluate patient preference of the Boston Scientific Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.

Spinal cord stimulation (SCS) is an established therapy for the treatment of chronic pain of the trunk and/or limbs. Standard practice includes a screening trial, typically lasting from 3 days to 7 days or more, for both the physician and the patient to evaluate whether SCS therapy is appropriate for permanent implantation. Screening trial success (hereafter referred to as a trial) is often considered predictive of long-term success of the therapy, although that has never been definitively demonstrated.

Boston Scientific Corporation (BSC) developed the Observational Mechanical Gateway (OMG) connectors to allow patients who previously underwent an SCS trial using Medtronic or St Jude Medical leads, operating room cables (OR-cables), and external trial stimulators (ETSs), to be able to connect to BSC commercially approved Spinal Cord Stimulation (SCS) trial systems to evaluate the BSC SCS therapy in the physician office setting prior to removal of the non-BSC leads.

Eligibility Criteria:
Key Inclusion Criteria:

* Chronic intractable pain of the trunk and/or lower extremities
* History of trunk and/or lower extremity pain lasting at least 6 months
* Study candidate completed a spinal cord stimulation (SCS) trial of a FDA-approved non-Boston Scientific Corporation (non-BSC) system, exclusively for the treatment of chronic intractable pain of the trunk and/or lower extremities, that will not proceed to permanent implantation due to unsatisfactory treatment or in the physician's opinion received sub-optimal results
* Currently implanted with FDA-approved non-BSC SCS lead(s) exclusively in the thoracolumbar epidural space that are temporarily anchored for non-surgical removal at the termination of the screening trial period and which are approved for use with either the Observational Mechanical Gateway (OMG) A or OMG-M, per the OMG directions for use

Key Exclusion Criteria:

* Primary source of pain is cancer-related, pelvic, visceral or angina
* Investigator-suspected gross lead migration during the non-BSC trial period which may preclude the study candidate from receiving adequate SCS therapy
* Study candidate reports \<10% paresthesia coverage of overall pain while running the preferred stimulation settings on the non-BSC SCS system at the end of the non-BSC SCS screening trial period
* Study candidate unwilling to tolerate implantation with an SCS system
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.


Eligibility Criteria:
Inclusion Criteria:

* Turner Syndrome or SHOX disorder
* SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years
* Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile
* Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL

Exclusion Criteria:

* GH deficiency or known insensitivity
* Evidence of tumor activity
* Diabetes mellitus or history of impaired glucose tolerance
* Any severe illness known to interfere growth
Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain

The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies

Background: Psychological treatments have been successful in the treatment of chronic low back pain (CLBP). However the effect sizes are still modest and there is room for improvement. A way to progress in this line is enhancing treatment adherence and self-management by means of information and communication technologies (ICT). The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment (CBT) group program for CLBP supported versus non-supported by ICTs. A secondary objective is to evaluate the influence of relevant variables in treatment response. Possible barriers in the implementation of CBT with and without ICT will be also investigated.

Methods: A randomized controlled trail with 180 CLBP patients recruited in specialized care will be conducted. Participants will be randomly assigned to three conditions: Control group (CG), Cognitive Behavioural program (CBT), and CBT supported by ICTs (CBT + ICT). Participants belonging to the three conditions will receive a conventional rehabilitation program (back school). The CBT group program will last six sessions. The CBT + ICT will use the Internet and SMS in order to practice the therapeutic strategies between sessions and in the follow-ups in their homes. Primary outcome variables are self-reported disability and pain intensity. Assessment will be carried out by blinded assessors in five moments: pre-treatment, post-treatment and 3-, 6-, and 12-month follow-up. The influence of catastrophizing, fear-avoidance beliefs, anxiety and depression in response to treatment in the primary outcomes will be also analysed.

Discussion This study will show data of the possible benefits of the use of ICTs in the improvement of CBT for the treatment of CLBP

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 65 years
* suffering low back pain for at least 6 months
* availability of mobile phone in order to get SMS
* access to computer with Internet connection in order to be able to use the CBT program supported by ICT

Exclusion Criteria:

* mental retardation
* not proficient in Spanish
* neurogenic claudication or neurologic deficit
* history of vertebral fracture, previous lumbar surgery
* vertebral infection
* spinal or nerve tumor
* severe mental disorder or substance abuse or dependence.
Comparison of Efficacy of Azithromycin and Levamisole Versus of Azithromycin in in the Treatment of Acne

Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated.

Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris.

An investigator blind clinical randomized prospective two months study was designed. One hundred sixty nine acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole ( group 1 ) and azithromycin alone ( group 2 ) .One hundred forty eight patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records .

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had at least 20 papules and/or pustules,
2. Patients with nodule and/or cyst disregarding the number of papules of pustules, were included the study. There was not any age limit

Exclusion Criteria:

1. were using any type of systemic treatment for their acne at the time of visit or during the last month;
2. had any hematological, renal or hepatic disease
3. were pregnant or lactating;
4. had drug-induced acne;
5. were using alcohol, anti-convulsants or anti-coagulants.
Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG)

The purpose of this study is to develop a lung cancer diagnosis tool using a multi-omics approach based on liquid biopsy.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening process to determine eligibility of study entry. Peripheral blood, tissue sample and imaging examinations of eligible patients will be collected for further analysis. Data collected will be used to develop a multi-omics lung cancer diagnosis model.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female, age equal to or greater than 40 years old and less than 75 years old
* Blood sample was collected before surgery for the detection of cfDNA methylation and other biomarkers
* Lung cancer patients diagnosed for the first time within 42 days before blood sampling without any anti-tumor treatment; or patients who are highly suspected of lung cancer through imaging evaluation or other routine clinical diagnosis and confirmed by tissue biopsy or surgical specimens within 42 days after blood sampling
* The subject has not received any local or systemic anti-tumor therapy before blood collection, including (not limited to) any surgery, local or systemic radiotherapy and chemotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines and hormone therapy, etc.

Exclusion Criteria:

* Unable to obtain sufficient and qualified blood samples
* Female subjects who are pregnant or breastfeeding
* Patients who have received organ transplantation or non-autologous bone marrow or stem cell transplantation
* Patients who have received blood transfusion within 7 days before blood sampling
* Patients who have received anti-infection treatment within 14 days before blood collection
* Patients who have receiving anti-tumor drugs for other diseases within 30 days before blood collection, such as methotrexate, cyclophosphamide, mercaptopurine, chlorambucil, tamoxifen, etc.
* Patients who suffered from other malignant tumors or multiple primary tumors at the same time
* Pathological confirmed benign lesions by tissue biopsy or surgery
* Insufficient sample for a confirmed pathological diagnosis
* Lung cancer patients with ground glass nodules on CT imaging.
Diaphragmatic Rapid Shallow Breathing Index for Predicting Weaning Outcome From Mechanical Ventilation

Predicting successful discontinuation from mechanical ventilation has been a focus of interest to all critical care physicians . Various weaning indices have been investigated to optimize the weaning process. Among them, the rapid shallow breathing index (RSBI) has gained wide use but it have different sensitivities and specificities. By substituting tidal volume (VT) with diaphragmatic displacement (DD) in the calculation of RSBI a new index (the diaphragmatic rapid shallow breathing index DRSBI) was proposed and it was independently associated with weaning failure and its accuracy for predicting weaning outcome is expected to be superior to the traditional RSBI.

The rapid shallow breathing index (RSBI), calculated from respiratory rate divided by tidal volume (RR/VT), is a well-known weaning index and one of the most clinical indices used to predict weaning outcome. However, it has some limitations in predicting weaning outcomes. Several previous studies have defined different sensitivities and specificities for RSBI less than 105 to predict weaning success which may lead to errors in predicting successful weaning.

On the other hand, Weaning failure is likely to occur if there is an imbalance between the load on the inspiratory muscles and their neuromuscular capacity, the imbalance between the mechanical load imposed on the diaphragm which is the major muscle of inspiration and its ability to cope with it. Therefore, evaluating the function of diaphragm before any weaning trial could be useful in predicting weaning outcome.

Bedside ultrasonography is an easy, fast, noninvasive, and accurate maneuver for evaluating diaphragmatic function. Diaphragmatic displacement (DD) reflecting the ability of diaphragm to produce force and subsequently tidal volume during inspiration and defined as displacement of less than 10 mm has been found to be a predictor of weaning failure among patients in medical ICUs.

Spadaro et al. proposed substituting VT with DD in the RSBI, and calculating diaphragmatic RSBI (DRSBI) would result in a more accurate predictive index than the traditional RSBI.

Eligibility Criteria:
Inclusion Criteria:

* Patient or relative acceptance
* Mechanically ventilated for more than 48 hours
* Ready to wean and at their first spontaneous breathing trial
* meeting all weaning criteria

Exclusion Criteria:

* history of any neuromuscular disease
* diaphragmatic palsy
* cervical injury
* current chest trauma
* thoracotomy for any reason
* patients in whom neuromuscular blockers are used in the last 48 hours before the study
* patients for whom aminoglycosides are prescribed during their course in ICU
The Effect of Foot Reflexology on Infantile Colic Symptoms

Aim: To compare the effect of foot reflexology and placebo foot reflexology on colic symptoms such as pain, ineffective sleep, and colicky crying periods in infants with colic.

Method: The study was conducted as a single-blind, randomized, placebo-controlled trial in a child hospital between June 2016 and March 2017. To start with, 20 infants with colic were randomly selected for the reflexology group, and 25 babies with colic were randomly selected for the placebo group. Simple randomization was used; the parents and statistician were blinded to group assessment. The researcher could not be blinded because of the role played in the study. Foot reflexology was implemented with reflexology-group infants. Placebo foot reflexology was used with placebo-group infants. Both interventions were performed four times, for 20 minutes, each, by the researcher over the course of two weeks. The data were collected by the researcher using the information form, infantile colic scale, behavioral pain scale, crying and sleeping follow-up forms.


Eligibility Criteria:
Inclusion Criteria:

Infants were included who were aged 1-3 months, Infants who were diagnosed IC by a pediatrician according to Wessel's rule of threes.

Exclusion Criteria (Beckmann \& Le Quesne, 2005):

Infants who were using any of analgesic drug until 3 hours before the applications and antibiotic or steroid due to treating an illness, Infants who had an acute fever, musculoskeletal disease, active shingles or infection, acute shingles, or tissue in the foot and joint, All infants with any non-IC health problems.
The Effect of Sutures Versus Mesh in Umbilical Hernia Repair

Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. This study investigated the cumulated risk of recurrence after open mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk factors were evaluated for chronic pain and recurrence.

Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary, elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were included. Follow-up was performed by a validated questionnaire regarding suspicion of recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical examination. Recurrence was defined as reoperation for recurrence or clinical recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate analyses.

Results

1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain (P\<0.001).

Conclusion Mesh repair halved the long-term risk of recurrence after repair for small umbilical and epigastric hernias without increased risk of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* elective open mesh or sutured repair of small umbilical or epigastric hernia repairs

Exclusion Criteria:

* acute operation
* operation outside region of Zealand
* laparoscopic repair
Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial

Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate...) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups


Eligibility Criteria:
Inclusion Criteria:

* Elective major abdominal surgery
* Patient physical status ASA 2-4
* General anesthesia with positive pressure ventilation
* High risk surgical patient with a per operative Vigileo® cardiac output monitoring decided a priori.

Exclusion Criteria:

* Pregnant female
* Intraoperative hyperthermic chemotherapy procedure
* Patient physical status ASA more than 4
* Patient with allergy to hydroxyethyl starch
* Cardiac arrhythmia
* ventilation with tidal volume inferior 7mL/Kg
Tranexamic Acid and Depot-Medroxyprogesterone Acetate for Perimenopausal Irregular Uterine Bleeding

Abnormal uterine bleeding is a symptom and not a disease. It is one of the most frequently encountered complaints in gynecologic practice. It accounts for more than 70% of all gynecological consultations in the peri- and post-menopausal age group.

Abnormal uterine bleeding may be acute or chronic and is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy.

Chronic heavy or prolonged uterine bleeding can result in anemia, interfere with daily activities. Iron deficiency anemia develops in 21 to 67 percent of cases and raises concerns about uterine cancer.

According to the International Federation of Obstetrics and Gynecology, the classification of abnormal uterine bleeding is based on PALM-COEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed, clinically as peri-menopausal abnormal uterine bleeding with normal pelvic examination.
* Patient's age ranging from 40- 55y.

Exclusion Criteria:

* Post menopausal women
* Presence of fibroids, adenomyosis, polyp, adnexal mass, endometrial hyperplasia with atypia, and breast malignancy).
* Patients with uncontrolled hypertension.
* Patient of abnormal bleeding profile.
* history of liver impairment and renal insufficiency
* Patients seeking for surgical management.
Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled Trial

This is a prospective randomized study. The aim is to investigate the efficacy of a combined SAPB with TTPB for perioperative pain control compared to the standard local anesthetic infiltration technique in adult patients undergoing SICD implantation. The hypothesis is that the combined plane block provides better pain control compared to the standard local infiltration technique.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to provide a written informed consent.
* Patient is scheduled to have an elective SICD implantation procedure.
* Patient has none of the exclusion criteria

Exclusion Criteria:

* Patient is unable to provide a written informed consent.
* Patient is younger than 18 years old.
* Patients with prior thoracotomy or other thoracic surgery altering anatomy.
* Patients with neurological deficits.
* Patients with impaired coagulation (Platelet count \< 50,000 cells/mcl and/or INR \> 1.4).
* Patient on anticoagulation therapy.
* Patient's weight below 50 kg
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment

The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
* Active SLE (SLE Disease Activity Index ≥ 6)
* Skin or joint SLE manifestations

Exclusion Criteria:

* Lupus-nephritis and/or central nervous system affection (neuro-lupus)
* Prohibited treatment
* Pregnant or nursing women
* Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer

The purpose of this study is to assess for changes in a patient's overall energy level and well-being (quality of life) after 8 weeks of dietary intervention.

Primary Objective: To assess for changes in the following measurements after 8 weeks of following a Mediterranean diet-- LDL, HDL, TG, FBS, creatinine, serum testosterone, triglycerides, serum insulin, CRP, 1bs, Waist circumference, blood pressure, body weight

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented carcinoma of the prostate
* On treatment with androgen deprivation therapy for at least 3 months
* Required laboratory values:
* Serum creatinine less than 2.5
* Triglycerides \<300
* Fasting glucose \< 126
* Testosterone level \<50

Exclusion Criteria:

* No diabetes mellitus (Type 1 or 2)
* No renal failure (Serum creatinine \> 2.5)
* No active cardiac disease -no history of myocardial infarction/stroke within the last 12 months, no recurrent unstable angina, uncontrolled/unstable arrhythmias, uncontrolled hypertension (systolic blood pressure \>160, diastolic blood pressure \>100)
* No severe peripheral vascular disease
* No commencement of lipid lowering agent within 8 weeks of enrollment the study or change in dose throughout the study