cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Stimulation for Painful Diabetic Neuropathy

The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in this study will be eligible for SCS therapy, and will have already selected therapy with the Advanced Bionics Precision system independent of possible inclusion in this study. The device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.

The management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. Although prevention by means of glycemic control is the first priority, up to 20% of patients will develop Diabetic Peripheral Neuropathy (DPN) and require active drug therapy. Select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. Topical creams have been used to achieve local control. Nonconventional therapies have included acupuncture and magnet therapy. However, all of these treatments have limited utility because of marginal efficacy. Various forms of electric stimulation have been shown to improve the symptoms of DPN. Advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful DPN.

Eligibility Criteria:
Inclusion Criteria:

* Have chronic neuropathic pain in at least one limb with a score of at least 3 using the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2 diabetes
* Have chronic neuropathic pain for at least 12 months
* Be 18 years of age or older
* Be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition
* Be an appropriate candidate for SCS therapy and have already decided to use the Precision system
* Be willing and able to comply with all study related procedures and visits
* Be capable of reading and understanding patient information materials and giving written informed consent

Exclusion Criteria:

* Are a smoker
* Have any other chronic pain condition likely to confound evaluation of study endpoints
* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy
Aseptic Meningoencephalitis in Slovenia

The main objective of this study is:

* to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia
* to assess the clinical course and outcome of tick-borne encephalitis and Lyme neuroborreliosis
* to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis


Eligibility Criteria:
Inclusion Criteria:

* clinical picture compatible with aseptic meningitis/meningoencephalitis
* age 18 years or older
* clear cerebrospinal fluid on macroscopic examination
* cerebrospinal pleocytosis (\> 5 x 106 white blood cells per liter)

Exclusion Criteria:

* younger than 18 years
* pregnant women
We-PAP: A Couples-based Intervention for Sleep Apnea

The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).

This study will develop and test a novel couples-based intervention for the treatment of OSA and sleep health among older couples. The focus of this study is patient who are starting CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health intervention delivered via telehealth or to standard educational support for CPAP. The intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C) and rooted in the idea that older adults with OSA are often also having other sleep problems, and that OSA is best treated in the couples context.

Eligibility Criteria:
Inclusion Criteria:

Patient and partner inclusion criteria:

1. Age \>=50
2. Access to cellular (active data plan) or Wi-Fi, in order to complete the telehealth intervention.

Patients inclusion criteria:

1. Diagnosed with OSA (AHI\>10 or AHI\>5 with impairment) and intend to start PAP treatment
2. PAP naïve or non-use of PAP for at least 3 years
3. Married or cohabiting with a romantic partner for \>1 year
4. Able to read/write English.

Partner inclusion criteria:

1. Able to read/write English
2. PROMIS sleep disturbance score \>55 in either patient or partner, or desire to improve sleep.

Exclusion Criteria:

Patient only exclusion criteria:

1. Concomitant OSA treatments (bariatric surgery planned in the next 3 months or bariatric surgery in the past year, ear nose and throat surgery for sleep apnea occurring in the 3 months before or planning for within the study period).

Exclusion criteria for both patient and partner include the following:

1. High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
2. History of cognitive or neurological disorders (e.g., dementia, Parkinson's, Multiple Sclerosis)
3. Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse reported on the Audit-C (score \>4 for men, \>3 for women), drug use (NIDA-Modified ASSIST score \>3)
4. Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe COPD)
5. Use of ASV, VPAP or supplemental oxygen
6. Overnight work \> 1x per month
7. Pregnancy/ desire to become pregnant in the study period
8. Current participation in behavioral sleep treatment (e.g., CBT-I) or completion of CBT-I in the past 3 years
9. Concurrent participation in another clinical trial
10. Caregiving for an infant \< 2 years old or adult who requires overnight assistance.
Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer

The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for

* accurate staging of patient suspected having ovarian cancer
* early treatment assessment
* detecting tumor recurrence

1. Staging --- (PET-)CT is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. The applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. This allows accurate assessment of operability in a minimally invasive manner.
2. Early treatment assessment --- Although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. Therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. A promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. This could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector.
3. Identifying tumor recurrence --- Identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. But the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.

Eligibility Criteria:
Inclusion Criteria:

* STAGING: patients with suspected ovarian carcinoma
* EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy
* IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months

Exclusion Criteria:

* patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study.
* patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR \< 30 mL/min)and/or Buscopan
Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years old.
* Signed informed consent before inclusion.
* Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
* Subjects who have measurable disease by RECIST after debulking surgery.
* ECOG performance status of 0, 1, or 2.
* Estimated life expectancy of more than 6 months
* Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit

  * Hb ≥ 10g/dl
  * ANC ≥ 1.5×10\^9/L
  * Platelet Count ≥ 100×10\^9/L
  * Serum total bilirubin ≤ 1.5×ULN
  * Serum AST and ALT ≤ 2.5×ULN
  * Serum ALP ≤ 2.5×ULN
  * Serum creatinine ≤ 1.5×ULN

Exclusion Criteria:

* Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
* Subjects who have a history of radiotherapy to pelvis or abdominal cavity
* Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
* Subjects who have other malignancies within the past 5 years
* Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
* Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)
* Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
* Subjects who have serious medical condition

  * Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
  * Uncontrollable infection
  * Previous allergic reactions in connection with paclitaxel and carboplatin
* Subjects who participate another clinical trial within the last 4 weeks before inclusion
The Effect of Inspiratory Muscle Training on Breast Cancer Patients Undergoing Surgery

This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.

Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. There were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types.

Many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. Exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. Exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer.

For breast cancer patients, physiotherapy is a crucial component of treatment. The physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. Respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults.

This study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Post-operative breast cancer female patients
* Age ≥40 years
* All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
* Having to undergo primary treatment with surgery

Exclusion Criteria:

* Severe anemia (Hb ≤ 8 g/dL)
* Presence of underlying chronic cardiac or respiratory disease
* severe infection, neurologic or muscular diseases prohibiting physical activity
* uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
* Contraindications descriped by the physician
Inflammatory Index as a Predictor for Endometrial Cancer: an Observational Study

It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines.

The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.

Surgical treatment for endometrial cancer is class A radical hysterectomy according to Querleu-Morrow and bilateral adnexectomy with systematic pelvic lymphadenectomy. That allows the choice of adjuvant treatment, basing on anatomopathological risk information. Despite the standardization of adjuvant treatments, survival curves are heterogeneous in patients' responses. That is why European guide-lines have proposed a stratification of patients basing on oncological risk and molecular data (Microsatellite instability, aberrant P53, POLE gene mutation). The Investigators want to identify additional parameters to better define risk profiles. Systemic inflammation indices such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and lymphocyte-to-monocyte ratio (LMR) have shown prognostic value in several inflammatory conditions and solid tumors. Therefore, the Investigators have decided to explore their role also in recently diagnosed endometrial cancers, to find correlations with lymphovascular space invasion (LVSI), myometrial infiltration, histotype, and therefore with oncological risk classification. It is a prospective observational trial. Primary goal is identification of an association between alteration of systemic inflammation indices, such as neutrophil-to-lymphocyte ratio (NLR), platelet-t- lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (MRL) and patients risk classification according to European Guidelines.

The population is represented by all women being admitted to the Gynecology Ward, through Emergency, who are affected by endometrial cancer. Participants will undergo surgery, and freely express their consent to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients histologically diagnosed with endometrial cancer.
* Patients undergoing surgical staging of the disease.
* Patients undergoing full-body CT-scan 30 days before enrollment.
* At least 18-year-old patients.

Exclusion Criteria:

* Unfit to plead.
* Patients with chronic inflammatory diseases (IBDs; rheumatic conditions).
* Synchronous tumors or cancer diagnosis in the previous 3 years.
* Patients undergoing steroid therapy in the last 30 days prior to recruitment
Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients

Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-60 years old, ASA physical status II\& III with BMI \> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy

Exclusion Criteria:

* Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has a diagnosis of chronic sinusitis
* Patient has a clinical indication for and has consented to FESS
* Patient CT scan confirms CS diagnosis within 6 months of procedure
* CT sacn confirms presence of disease in ethmoid sinus(es)
* Planned FESS includes unilateral or bilateral total ethmoidectomy

Exclusion Criteria:

* Immune deficiency (IGG subclass deficiency or IGA deficiency)
* Oral-steroid dependent COPD, asthma or other condition
* Clinical evidence of acute bacterial sinusitis
* History or diagnosis of glaucoma or ocular hypertension
* Clinical evidence or suspicion of invasive fungal sinusitis
* Evidence of disease or condition expected to compromise survival or ability to complete follow-up
* Known history of allergy or intolerance to corticosteroids
* History of insulin dependent diabetes
Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia

The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.

Iron deficiency (ID) is the most common cause of the anemia throughout the world, with almost half of the population in developing countries suffering from ID. Children with iron deficiency anemia (IDA) may have functional consequences including impaired motor and physical growth. In the case of IDA, the underlying cause should be identified and treated. Iron supplementation remains an important strategy for the prevention and treatment of IDA and can produce substantial improvements in the functional performance of iron deficient individuals.

The iron-containing preparations available on the market vary widely in dosage, salt, and chemical state of iron (ferrous or ferric form). Current treatment strategy for IDA involves the oral use of Fe2+ salts (Fe SO4) and Fe3+ polymaltose complexes (FeOH3). Most of these preparations vary in their bioavailability, efficacy, side effects, and cost. Animal studies have not shown any significant difference in their oral bioavailability. However, in clinical practice, bivalent iron salts such as ferrous sulfate (Fe-S), ferrous gluconate, and ferrous fumarate are more widely used and are preferred over ferric iron preparations. Fe-S preparations usually present good bioavailability (between 10 and 15 %), while bioavailability of ferric iron preparations is 3 to 4 times less than that of conventional Fe-S. This is due to the extremely poor solubility of ferric iron in alkaline media and the fact that ferric iron needs to be transformed into ferrous iron before being absorbed. For this reason, among ferrous preparations, Fe-S remains the established and the standard treatment of ID due to its acceptable tolerability, high effectiveness, and low cost. The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.

Eligibility Criteria:
Inclusion Criteria:

* The children with IDA, aged between 6 months and 15 years, were randomly included in Fe-S (Ferro Sanol® sp.)(Group I), Fe-OH-PM (Santafer® sp.)(Group II), and Fe-Zn (Ferro Zinc® sp.)(Group III). IDA was defined as hemoglobin (Hgb), serum iron and ferritin levels below -2SD according to age and gender.

Exclusion Criteria:

* The main exclusion criteria were anemia due to other causes except IDA
* Severe concurrent illness (cardiovascular, renal, and hepatic)
* Known hypersensitivity to ferrous or ferric preparations
* Malignancy of any type
* Children with thalassemia major, sickle cell anemia or other hemoglobinopathies, hemolytic anemia or aplastic or hypoplastic anemia.
Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

This study evaluates the efficacy of scaling and root planing with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP) among cigarette-smokers and never-smokers.

The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers; (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b) habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth; and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with adjunct aPDT. Periodontal parameters (plaque index \[PI\], bleeding on probing \[BOP\], clinical attachment loss \[CAL\] and probing pocket depth ≥4mm \[PD\] were measured at baseline and at 1 month and 3 months' follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported habitual cigarette-smokers.
* Self-reported never-smokers.
* Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm.

Exclusion Criteria:

* Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus.
* Habitual smokeless tobacco product and alcohol users.
* Third molars and fractured teeth with embedded root remnants and edentulous individuals.
* Patients with misaligned teeth.
* Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.