cyrilzakka/clinical-trials huggingface dataset:
Cryoablation of Brain Neoplasm

This study will investigate the use of safety and feasibility of cryoablation in brain tumors

Cryoablation is a therapeutic modality that employs extreme cold to induce cell necrosis in tumor tissue. While the application of cryoablation for the treatment of brain tumors remains under investigation, it has been extensively utilized in other organ systems with outcomes often surpassing those of conventional therapies.

The primary objective of this research is to evaluate the safety and feasibility of cryoablation as a treatment option for patients diagnosed with various brain tumors, including gliomas, meningiomas, and metastatic lesions. Participants enrolled in this study will first undergo standard surgical resection of the brain tumor. Prior to resection, a biopsy of the tumor will be performed to obtain a histopathological diagnosis, ensuring accurate characterization of the tumor type.

Subsequently, the tumor will undergo cryoablation utilizing cryoprobes, with a maximum of two cycles of up to 10 minutes each. The specific number and diameter of cryoprobes used will be determined by the tumor's size, aiming to achieve optimal ablation coverage. Following the removal of the cryoprobes, the tumor will be resected, and standard craniotomy closure procedures will be implemented. Patients will receive standardized postoperative care tailored to their clinical needs.

The follow-up period for this study will extend up to three months following the completion of treatment for the last enrolled participant, allowing for comprehensive assessment of treatment outcomes and safety profiles.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Tumor suspected as glioma (1. Astrocytoma, IDH mutant 2. Oligodendroglioma, IDH-mutant and 1p/19q-codeleted 3. Glioblastoma, IDH-wildtype), meningioma (WHO gr. 1 and gr 2), or brain metastasis based on preliminary diagnosis for which the patient will undergo surgery
* Supratentorial or infratentorial localization
* Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
* Karnofsky performance scale 70 or more
* Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher)
* Written Informed consent

Exclusion Criteria:

* \<18 years or \>80 years
* Tumor diameter bigger than 10 cm
* Unsafe trajectory (eloquent structures could be damaged)
* Pregnancy
* Contra-indication for general anesthesia
Breathing Pattern, WOB and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial

There is little evidence about the mechanical characteristics and muscular function in patients with Acute Respiratory Distress Syndrome (ARDS) at the time of weaning of the mechanical ventilation, as well as the behavior of the mechanical properties, breathing pattern, muscular effort, and gas exchange during a successful and failed spontaneous breathing trial.

The study of the respiratory system (RS) mechanics in patients with ARDS has been focused on the initial phase of ventilatory support, with few studies observing the weaning in mechanical ventilation.The RS in patients with ARDS is characterized by a greater or lesser degree of low functional residual capacity (FRC) in relation to normal.

At the time of performing a spontaneous breathing trial, these mechanical characteristics determine the need to develop a high transpulmonary pressure during each breath, with high work of breathing (WOB) to achieve adequate alveolar ventilation.

Inspiratory muscle weakness could alter the ability to generate the necessary transpulmonary pressure over time according to the loads imposed at the time of performing a spontaneous breathing trial, with the consequent development of fatigue and ventilatory failure.

This is why the investigators propose to evaluate the association between elastic WOB and the failure of the spontaneous breathing trial.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* requiring mechanical ventilation for more than 12 hours
* moderate/ severe ARDS according to Berlin Definition
* able to make a Spontaneous Breathing Trial according to the institution protocol

Exclusion Criteria:

* pregnant patients
* history of neuromuscular disease
* patients in palliative care
* bronchopleural fistula
* contraindication of measurement of esophageal pressure
Spatial Cognitive Training for Chronic Vestibular Disorders

In this study the investigators propose to apply cognitive training, which has been largely used in the realm of age-related cognitive decline, dementia, and Alzheimer's disease, in a novel clinical context to individuals with vestibular impairment. In prior work the investigators observed that individuals with vestibular loss have evidence of spatial cognitive impairment. The investigators plan to evaluate the preliminary efficacy and feasibility of a cognitive training program in a sample of participants with chronic vestibular impairment who display deficits in spatial ability. The cognitive training program will focus on visuospatial skills and will be used as an adjunct to traditional vestibular physical therapy (VPT).

Patients with chronic vestibular dysfunction with report symptoms of spatial cognitive impairment will be offered cognitive training. The intervention will consist of a well-validated cognitive training protocol that specifically targets spatial navigation skills. The protocol was developed by Willis et al. for the Adult Development and Enrichment Trial (ADEPT) trial, which trains map reading and route-learning skills through mental rotation training tasks over the course of 5 weeks. Patients will be assessed by study staff pre-intervention, immediately post-intervention and at 3 months post-intervention using spatial cognitive outcomes, quality of life measures, and gait and balance outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic vestibular disorder (\>6months \& diagnosis from laboratory testing by neuro-otologist)

Exclusion Criteria:

* Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.
The Effect of Inspiratory Muscle Strength Training in Healthy Adults With Forward Head Posture

Forward head posture (FHP) is defined as the position in which the head is in front of the shoulder and is one of the most common musculoskeletal problems caused by the increasing use of computers and smartphones. Posture analysis, pulmonary function test, respiratory muscle strength and endurance assessment, and performance test will be performed as the initial evaluation for those who meet the inclusion criteria and volunteer to participate in the study. Participants with a craniovertebral angle of 50 degrees and less than 50 degrees will be included in the head forward posture (FHP, n=34) group, and participants with an angle of more than 50 degrees will be included in the control group (CG, n=34).Participants with HFP will be randomly divided into two groups as study (FHP-S, n=17) and control (FHP-C, n=17). An inspiratory muscle strength training program will be applied to the FHP-C group for 7 days/6 weeks. All assessments performed before the training will be repeated after 6 weeks of inspiratory muscle strength training. No inspiratory muscle strength training will be applied to the FHP-C group. Participants in the CG group will not undergo any additional assessment or training.

Forward head posture (FHP) is defined as the position in which the head is in front of the shoulder and is one of the most common musculoskeletal problems caused by the increasing use of computers and smartphones. Posture analysis, pulmonary function test, respiratory muscle strength and endurance assessment, and performance test will be performed as the initial evaluation for those who meet the inclusion criteria and volunteer to participate in the study. Participants with a craniovertebral angle of 50 degrees and less than 50 degrees will be included in the head forward posture (FHP, n=34) group, and participants with an angle of more than 50 degrees will be included in the control group (CG, n=34).Participants with HFP will be randomly divided into two groups as study (FHP-S, n=17) and control (FHP-C, n=17). An inspiratory muscle strength training program will be applied to the FHP-C group for 7 days/6 weeks. All assessments performed before the training will be repeated after 6 weeks of inspiratory muscle strength training. No inspiratory muscle strength training will be applied to the FHP-C group. Participants in the CG group will not undergo any additional assessment or training.

Eligibility Criteria:
Inclusion Criteria:

* Cranio-vertebral angle (CVA) of 50 degrees and less than 50 degrees

Exclusion Criteria:

* Diagnosed respiratory, neurological, orthopedic, psychiatric or cardiac problems
* Have any infection at the time of assessment and training,
* Having any limitation that prevents assessment and training
* Pregnancy or breastfeeding
* Having a history of neck trauma
* Having undergone lumbar-neck surgery
Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors

Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE injection in patients with suspected or diagnosed with tumors expressing somatostatin receptors. Each included patient will receive an administered dose of 50 mcg or less of the peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE.

The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous studies.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected or proven tumors expressing Somatostatin receptors
2. Informed consent by patient (or parents if patient is less than 18 years of age)

Exclusion Criteria:

1. Pregnancy (confirmed). In the case of a diagnostic procedure in a patient who is or may be pregnant, a clinical decision is necessary considering the benefits against the possible harm of carrying out any procedure.
2. Patient refusal to participate.
3. Impossibility to tolerate a decubitus position for 25 minutes
4. Prior allergic reaction to DOTA-TATE or somatostatin analogs
Safety of Electrotherapy in Patients With Knee Osteoarthritis and Cardiac Diseases

This study aimed to asses whether physyical therapy (e.g. electrotherapy in the form of low, medium or high frequency currents, massage and kinetotherapy) for treatment of knee osteoarthritis can induce or aggravate certain cardiac diseases during or immediately after therapy. The physyical treatment described is not a new method, is currently used and recommended in all guidelines for non-pharmacological and non-surgical therapy of knee osteoarthritis. What is not clear is whether application of electrotherapy in the knee area can alter the preexisting cardiac condition.

An analytical and transversal study was carried out between March 2013 and August 2017. The study included a total of 46 patients previously diagnosed with degenerative knee OA. All the patients included in the study were recruited during inpatient visit in the Clinical Rehabilitation Hospital in Cluj-Napoca, Romania.

Each patient was clinically evaluated and was furthermore prescribed a PT program (ET, massage and kinesiotherapy). They were monitored by 24 hour-Holter ECG in 2 separate days, at the beginning of treatment, before applying the PT methods (day 1), and after completing a 10-day PT program (day 2).

PT modalities prescribed for each patient after clinical evaluation included different types of ET, all currently used and included in the national and international treatment guidelines, as in low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy. The program was performed on a daily basis, for 10 days.

The aim of the PT program was to decrease pain and increase range of motion in the affected joints and did not lead to increases in cardiac frequencies. No hydrotherapy was applied, given that that the Holter ECG was not waterproof. No technical incidents were reported during the study. No alternate positioning of the patient wearing a Holter ECG for ET procedures was necessary, as the region of interest was the knee. No change in current drug therapy was allowed for the whole duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis and imaging diagnosis of knee osteoarthrtitis based on ACR 2000 diagnostic criteria

Exclusion Criteria:

* known cardiac arrhythmias (atrial fibrillation, atrial flutter)
* congestive heart failure class NYHA II, III or IV
* any other general contraindications for PT (infections, psychiatric disorders etc)
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.

This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.

Eligibility Criteria:
Key Inclusion Criteria:

* Give informed consent
* Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)
* Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years
* Body mass index of 18-35 kg/m2
* Be C-peptide deficient (assessed by fasting concentration level)
* Normal renal function (assessed by serum creatinine)
* Be in good general health (besides T1DM)
* Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)

Key Exclusion Criteria:

* Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease
* Unstable glucose control
* Have had a islet cell, kidney, and/or pancreas transplant
* Blood loss or blood donation within 56 days
* Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)
* History or positive test result for Hepatitis B, C, and/or HIV
* Treatment with medication for peripheral neuropathy within 30 days
Sequential Expansion of Comparative Effectiveness of Anticoagulants

This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.


Eligibility Criteria:
Inclusion criteria:

* A recorded diagnosis of atrial fibrillation.
* Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
* At least 18 years of age on the date of anticoagulant initiation.
* Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) score at least 1

Exclusion criteria:

* Patients with missing or ambiguous age or sex information.
* Patients with evidence of valvular disease.
* Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
* Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
* Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation
Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine the impact of erythropoietin treatment of anemia on exercise capacity of patients with chronic obstructive pulmonary disease (COPD).

The development of anemia in patients with chronic obstructive pulmonary disease (COPD) is now taken as a predictor of increased morbidity and mortality. Preliminary data from patients investigated in our department indicate a negative correlation between anemia severity and 6-minute walking distance. Our working hypothesis is that hemoglobin level correction by erythropoietin therapy will improve the effort capacity of patients with COPD and anemia. Our objective is to conduct a pilot study of the efficacy of darbepoetin alfa.

The study will include about 15 patients with COPD recruited at three pulmonology centers based on two selection criteria: COPD stage II or III or IV according to GOLD criteria and hemoglobin level less than 12 g/dL. Effort capacity will be evaluated chiefly by performing a 6-minute walking test and by measuring VO2 at maximum exertion on a bicycle ergometer with increasing loads. Darbepoetin alfa will be given for 2 months. If the hemoglobin increase is less than 1 g/dL after 1 month, the dosage will be increased by 25%.

Effort parameters will be measured at baseline and after 1 and 2 months of treatment. Among secondary objectives, we will evaluate functional ergospirometric parameters and laboratory tests for inflammation. Total study duration will not exceed 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 40-75 years
* Diagnosis of a moderate to very severe COPD (stage II, III or IV according to GOLD criteria)
* A ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) \< 70%
* A FEV1 \< 80% of the predicted value
* Hemoglobin level less than 12 g/dL
* Peak VO2 less than 80% of predict value and 6-min walk test distance less than 500 meters

Exclusion Criteria:

* Hemorrhagic anemia
* Iron deficiency anemia (ferritin \< 30 ng/ml)
* Folate and Vitamin B12 deficiency anemia
* Myelodysplastic Syndrome
* Chronic disease associated with anemia: renal insufficiency, inflammatory disease, neoplastic disease, left ventricular insufficiency (ejection fraction \< 40%)
* Chronic disease likely to interfere with dyspnea or exercise testing (cardiac insufficiency, neurologic disease, claudication)
* Acute exacerbation of COPD within the last 4 weeks
* History of thromboembolic disease
* Contraindications for cardiopulmonary exercise testing
* Contraindications for darbepoetin alfa treatment: uncontrolled arterial hypertension or hypersensitivity reaction to darbepoetin alfa
* Pregnancy or breast-feeding (women of reproductive potential should use adequate birth control measures during the whole duration of study treatment)
Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.

Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices.

Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an ASA score of 1-3.
2. Scheduled for elective surgical procedure
3. Age 18 and above
4. Patients with Mallampati airway classification scores III and IV

Exclusion Criteria:

1. Current pregnancy
2. Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures
3. Patients with obstructive sleep apnea or with a history of difficult ventilation
4. Mouth opening less than 3 cm.
5. Patients with indication for awake fiberoptic intubation or with a history of difficult intubation
6. Patients with cancer of the neck or the upper airway
7. Emergent surgery, patients requiring rapid sequence induction
8. Patients with severe gastroesophageal reflux
9. Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.
A Relative Bioavailability Study of Bupropion Sustained Release 150 mg Tablets Under Fasting Conditions

The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Sustained Release Tablets in Fasted, Normal, Healthy Men.

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Eligibility Criteria:
Inclusion Criteria:

* Is the individual a healthy, normal adult man who volunteers to participate?
* Is he 18-45 years of age, inclusive?
* Is his BMI between 19 and 30, inclusive?
* Is he considered reliable and capable of understanding his responsibility and role in the study?
* Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment

Exclusion Criteria:

* Does the individual have a history of allergy or hypersensitivity to bupropion?
* Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety?
* Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
* Does he have serious psychological illness?
* Does he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
* Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen?
* Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation?
* Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
* Has he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
* Is he unable to refrain from the use of all concomitant medications during the study?
* Has he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
* Has he donated plasma during the two week period preceding study initiation?
* Has he received an investigational drug during the 30 day period preceding study initiation?
* Is he a heavy smoker (usually smoking more than 25 cigarettes per day? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment