cyrilzakka/clinical-trials huggingface dataset:
Remote Ischaemic PreConditioning (RIPC) in Partial Nephrectomy for the Prevention of Ischemia/Reperfusion Injury

"Remote Ischaemic PreConditioning" (RIPC) is performed prior to partial nephrectomy. Postoperative calprotectin dynamics and Blood Oxygen-Level-Dependent (BOLD) MRI are used to to demonstrate the potential renoprotective effect of RIPC

Partial nephrectomy represents the gold standard in organ sparing kidney surgery. Cold ischaemia prevents major bleeding but can yet be associated with impaired kidney function due to reperfusion injury to the tubuli.

Patients undergoing partial nephrectomy (any surgical technique, open, retroperitoneoscopic, transperitoneal, Da Vinci assisted) will be treated with "Remote Ischaemic PreConditioning" (RIPC). RIPC is delivered with a standard blood pressure cuff placed on the upper arm and another standard blood pressure cuff placed on the upper thigh. The cuffs are then simultaneously inflated to 200 mm HG and left inflated for 5 minutes, then deflated to 0 mmHG and left uninflated for 5 minutes. This cycle is repeated twice, so that the RIPC protocol takes 20 minutes in total. If the systolic blood pressure is \> 185mm HG the cuffs are inflated to 15 mmHG above that level. Several studies already demonstrated the reno- and cardioprotective potential of "Remote Ischaemic PreConditioning" (RIPC). It was shown that urinary calprotectin can be used to monitor tubular damage after nephron sparing surgery. Postoperative calprotectin dynamics will be monitored in order to demonstrate the potential renoprotective effect of RIPC. Additionally a BOLD MRI will be performed to to visualize ischemia/reperfusion injury.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Kidney tumor (any entity, benign, malign)
* Partial nephrectomy (any surgical technique, open, retroperitoneoscopic, transperitoneal, Da Vinci assisted)
* 18 years of age
* Sufficient perfusion of all 4 extremities
* palpable distal pulses: A. radialis and A. dorsalis pedis or A.tibialis post.

Exclusion Criteria:

* Women who are pregnant
* Significant peripheral arterial disease affecting upper and/or lower limbs or history of
* Significant renal disease (GFR \<15 ml/min/1.73m2) or undergoing haemodialysis
* Concomitant therapy with glibenclamide or nicorandil (due to potential inference with RIPC)
* Urothelial cancer
* Acute Urinary tract infection
* international normalized ratio (INR) \>2 (haematoma risk at cuff site)
Silent Progression Activity Monitoring - SPAM Study

Real-World Data (RWD) exploring the natural history of MS suggested that relapses do not significantly influence the progression of irreversible disability. Disability progression independent of relapses activity (PIRA) has been confirmed as a frequent relapsing-remitting multiple sclerosis (RRMS) phenomenon based on Randomized Clinical Trials (RCT). Recently, RWD demonstrated that the absence of markers of inflammation (No Evidence of Disease Activity (NEDA) at 2 years did not predict long-term stability. Silent progression has been proposed to describe the insidious disability that accrues many patients who satisfy traditional criteria for relapsing-remitting MS. In this study, the investigators would like to evaluate the occurrence of the SPMS in a population of RRMS patient with an Highly Active Treatment (HAT).


Eligibility Criteria:
INCLUSION CRITERIA: - Patients with RRMS (2017 Mc Donald criteria) treated with highly active treatment in the first 5 years of symptoms onset, at least 1 year, with an EDSS below 4

* HAT start after April 12th 2007 (availability of Natalizumab)
* Naive or failure (or intolerability) to 1 or more first line DMT (injectables, teriflunomide, DMF).
* EDSS \< or equal 4 when starting HAT EXCLUSION CRITERIA:
* Progressive relapsing MS at baseline
* Clinical or basic MRI data unavailable after on-site visit.
* MS diagnostic \> 5 years at baseline
* Immunosuppressive drugs (Azathioprine, Cyclophosphamide, Mycophenolate, Methotrexate) prescribed before HAT initiation
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing anterior resections. Although debate about the use of defunctioning stoma continues, meta-analyses and randomized multicenter trial results support the use of defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to evaluate the efficacy and safety of a new diversion method called spontaneously closed cannula ileostomy (SCCI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.

After low anterior resection(LAR), in the LI group, the operation method was done as surgeons all known. In the cannula ileostomy group, a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall began to turn pale. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.

In the LI group, patients accepted reversal operation at least 3 months after operation if operation condition permission.

In the cannula ileostomy group, the cannula will be removed after 3-4 weeks. If anastomotic leakage occurred, The investigators will keep the cannula until the anastomotic leakage was cured.

Eligibility Criteria:
Inclusion Criteria:

1. Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal.
2. Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
3. Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure

Exclusion Criteria:

1. Bowel Preparation is Satisfied Before Operation(This Means That if Surgeons Find That There is Much Feces Left in the Colon,the Patient Will be Excluded)
2. positive air leakage test
3. fractured anastomotic rings
Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

This study will be investigating the effect of latent tuberculosis infection (LTBI) treatment on glucose tolerance and low-grade inflammation. Almost a century ago, researchers proposed that diabetes (DM) was associated with increased risk of Tuberculosis infection (TB). A more recent systematic review concluded that DM increases the relative risk for TB 3.1 times. Reversely, TB may affect the glycaemic control; TB is in many cases a chronic infection characterised by long term low-grade inflammation and weight loss, and persons with TB are known to be at risk of hyperglycaemia and DM at time of diagnosis. A latent infection with the m.tuberculosis bacteria is "silent" without symptoms.

1,7 billion have LTBI on a global scale. Event though the infected person does not experience symptoms, increased background inflammation has been shown in LTBI patients in previous studies. We also know that an increase in inflammatory markers precedes clinical development of DM, and that subclinical inflammation contributes to insulin resistance. We hypothesise that LTBI contributes to dysregulated glucose metabolism due to increased low-grade inflammation, and that treatment will reduce low-grade inflammation and improve glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the LTBIDM arm:

* 18+ years
* Known DM type 2

Inclusion criteria for LTBI arm

* 18+ years
* LTBI positive
* No diagnosis with or known DM (1 and 2)

Exclusion Criteria (both arms) :

* Previous treatment for TB or LTBI
* Pregnancy
* Type 1 DM
* Known immunosuppression such as: HIV, steroid treatment within 14 days before inclusion, daily NSAID treatment, ongoing chemotherapy, ongoing immunomodulating treatment or splenectomy
* Known contraindication to both study drugs
* Known active liver disease
* Known severe inflammatory or rheumatological diseases with immune activation and need for prolonged systemic treatment such as IBD, RA, Psoriasis and Wegners granulomatosis
* Recent antibiotic treatment (\>2 days) or severe infection within 14 days before enrollment
* Known active cancer
Clinical Study to Evaluate the Efficacy of an Anti-Fungal Supplement

This is a virtual, double-blind, two-arm, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will take the CanXida Remove Candida Cleansing Formula RMV or a placebo product daily and complete questionnaires at Baseline, Week 6, and Week 12. Candida microbiome testing will be conducted via stool sample at Baseline and Week 12.

The participants will all be blinded to the name of the test brand.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18-50.
2. Female.
3. Self-reported recurrent vaginal issues, including:

   * Itching and irritation in and around the vaginal area.
   * Burning sensation during urination or sexual intercourse.
   * Abnormal discharge (e.g. thicker, white, and curd-like in appearance, odorless, or with a mild yeasty smell.
   * Redness and swelling of the vulva and surrounding skin
   * Pain or discomfort in the vaginal area or lower abdomen.
   * Urinary tract infections
   * Vaginal thrush
4. May also experience issues with fatigue, lethargy, and gut or digestive issues.
5. Willing to provide two stool samples during the study.
6. Willing to adhere to the study protocol.
7. Willing to avoid introducing any products or any new forms of regular medication or supplements that target candida overgrowth, gut health, or vaginal health for the duration of the study.

Exclusion Criteria:

1. Anyone with severe chronic conditions including oncological conditions, psychiatric disease, diabetes, or other.
2. Anyone with known severe allergic reactions or is allergic to the test product or placebo ingredients.
3. Currently taking any antibiotics or will be during the trial period.
4. Anymore diagnosed with a sexually transmitted disease within the last three months e.g. Chlamydia, trichomoniasis, gonorrhea, genital herpes
5. Women who are pregnant, breastfeeding, or attempting to become pregnant.
6. Having any planned invasive medical procedures during the study period.
7. Currently participating in any other clinical study.
8. History of substance abuse.
9. Unwilling to follow the study protocol.
Acupuncture Treatment of Dry Eye

The purpose of this study is to determine the safety and efficacy of acupuncture in the treatment of moderate to severe dry eye by replicating the study design of the previous protocol and to see the study through to its completion.


Eligibility Criteria:
Inclusion Criteria:

* Military healthcare beneficiary
* Male and female patients, at least 18 years of age
* Diagnosis of keratoconjunctivitis sicca or xerophthalmia (dry eyes) in one or both eyes
* Persistent signs and symptoms despite conventional therapy for at least three months

Exclusion Criteria:

* Contact lens wear
* Intraocular surgery or laser in the study eye within 90 days prior to enrolling in the study
* History of any medical condition or circumstance that would preclude scheduled visits or completion of the study
* Known history of adverse reaction to acupuncture
* Pregnancy or breast feeding
Pulmonary Hypertension and Anastrozole Trial

The primary objectives of this study are to determine whether the study drug, anastrozole may improve six minute walk distance at six months compared to placebo and to assess safety and side effects up to twelve months in pulmonary arterial hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

* Previous documentation of mean pulmonary artery pressure \> 25 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \< 16 mm Hg and PVR \> 3 WU at any time before study entry.
* Diagnosis of PAH which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection and receiving treatment for PAH.
* Most recent pulmonary function tests with FEV1/FVC \>50% AND either a) total lung capacity \> 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest.
* Ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination.
* If female, post-menopausal state, defined as:

  * \> 50 years old and a) have not menstruated during the preceding 12 months or b) have follicle-stimulating hormone (FSH) levels (\> 40 IU/L) or
  * \< 50 years and FSH (\> 40 IU/L) or
  * having had a bilateral oophorectomy.
* Informed consent.

Exclusion Criteria:

* Age \< 18.
* Current treatment with estrogen, hormone therapy, or anti-hormone therapy (tamoxifen, fulvestrant, etc.)
* WHO Class IV functional status.
* History of invasive breast cancer.
* Clinically significant untreated sleep apnea.
* Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \< 45% on most recent echocardiography (within 1 year).
* Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors, riociguat, selexipag) within three months of enrollment; the dose must be stable for at least three months prior to Baseline Visit. PAH therapy which is stopped and then restarted or has dose changes which are not related to initiation and uptitration will be allowed within 3 months prior to the Baseline Visit.
* Hospitalized or acutely ill.
* Renal failure (creatinine ≥ 2.0).
* Hypercalcemia.
* Severe osteoporosis: T score -2.5 to -3.4 without bone modifying treatment OR T score = - 3.5 or lower
* Child-Pugh Class C cirrhosis.
* Current or recent (\< 3 months) chronic heavy alcohol consumption.
* Enrollment in a clinical trial or concurrent use of another investigational drug or device within 30 days of screening visit.
Dexamethasone as Adjuvant to Bupivacaine in Suprazygomatic Maxillary Nerve Block

Postoperative pain score, Faces, Legs, Activity, Cry, Consolability (FLACC) is the primary outcome. The secondary outcomes are the first-time requested analgesia, the number of children required analgesia, the total amount of analgesic requirements during first the 24 hours.

Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births , requiring early surgery, during the first months of life. The surgical procedure can be complicated by airway obstruction and respiratory complications. CP is painful in the first 24-48 hours following surgery.

Different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory drugs (NSAIDs). However, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia.

The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra-orbital foramen. This sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate. Bilateral infra-orbital nerve block is clearly inefficient for anesthesia of the posterior part of the palate (hard palate). The infrazygomatic route of the maxillary block, useful for trigeminal neuralgia, can present several risks such as penetration of the orbit or the skull and accidental maxillary artery puncture. The palatine nerve block could be efficient for analgesia following cleft palate repair, but the technique requires identifying the first molar, which is absent in infants. Finally, submucosal infiltration performed by the surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia and limits the risks related to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 and 9 years
* Children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts
* Gender: both
* ASA grade I - II.
* Informed consent.

Exclusion Criteria:

* Parent refusal
* History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
* Hypersensitivity to any local anesthetics
* Bleeding diathesis
* Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders
* Skin lesions or wounds at the puncture site of the proposed block
Efficacy of a Stretching Protocol for Lateral Epicondylitis

Evaluation of the applying a stretching protocol to lateral epicondylitis.

Epicondylitis is one of the most common soft tissue disorders of the locomotor system of the upper limb. Despite the existence of a large number of therapeutic alternatives for this type of injury, no agreed treatment protocol has been found. Some authors even suggest treating the patient from a more global biomechanical perspective.

OBJECTIVES. To evaluate the efficacy of applying a stretching protocol to the entire muscle chain involved in this injury and circumscribed to the entire affected upper limb.

METHODOLOGY. The study will be made up of 40 patients of both genders, randomly distributed in two groups: a control group made up of twenty patients to whom the usual Physiotherapy treatment will be applied, and an experimental group made up of the rest of the subjects, in which a stretching protocol will be applied to the whole upper limb affected and defined for this study. The evaluation process will consist of measuring pain perception using a visual analogue scale (VAS) and grip strength with a dynamometer. These measurements will be performed on all study subjects before starting treatment, at week 4 and week 6.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects over 18 years of age.
* Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study.
* Patient's prior informed consent for inclusion in the study.

Exclusion Criteria:

* Patients with significant psychological, neurological and physical impairments that would prevent the recruitment of the information necessary for the research.
* Patients with significant psychological, neurological and physical alterations that would prevent the application of the treatments necessary for the research.
* Patients in a situation of legal litigation that could be affected by their participation in this study.
* Refusal to participate in the study.
Exercise and Blood Pressure in Children: A Meta-Analysis

To use the meta-analytic approach to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in children.

BACKGROUND:

Approximately 50 million Americans suffer from hypertension, a condition associated with increased risk for stroke, heart attack, and kidney failure. While non-pharmacological intervention has resulted in dramatic reductions in resting systolic and diastolic blood pressure for those with elevated pressures, a debate continues over the efficacy of pharmacological intervention because of deleterious side effects. As a result, there has been an increased interest in aerobic exercise as a non-pharmacologic approach in treating hypertension. Recent reviews of literature have synthesized research using the 'traditional' approach (chronologically arranging and describing the studies, perhaps by sub-topic) which may result in subjective, non-replicable conclusions. Consequently, the relationships among such variables as subject characteristics, experimental design quality, training program characteristics, and how they contribute to changes in resting systolic and diastolic blood pressure is not clear.

The meta-analytic approach is used in the study to synthesize research on the relationships among variables associated with aerobic exercise intervention and resting systolic and diastolic blood pressure in adults. Meta-analysis is a method of pooling the results of separate studies. It is a quantitative approach for increasing statistical power of primary end points and subgroups, resolving uncertainty when studies disagree, improving estimates of effect sizes, and answering questions not posed at the start of individual trials.

DESIGN NARRATIVE:

In the first two years of the study, a meta-analysis was conducted of all studies published since 1966 on aerobic exercise and blood pressure. The study was renewed in FY 2000 to conduct meta-analysis of all studies of exercise training in children and youth under age 21 years in which resting BP was measured. This will include both randomized and non-randomized clinical trials of at least eight weeks duration found in English journals and theses between 1966 and 1999. Standard meta-analysis techniques will be applied.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Early Weight Bearing in Distal Femur Fractures

Assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients.
* Distal femur fracture type A2, A3, C1, C2 by X-ray (Arbeitsgemeinschaft für Osteosynthesefragen classification).
* Injury Severity Score below 15.
* Controlled comorbidities.
* Fresh fractures: within 3 weeks of trauma.

Exclusion Criteria:

* Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.
* Open fracture grade 3 Gustilo Anderson Classification.