cyrilzakka/clinical-trials huggingface dataset:
Gadofosveset for Axillary Staging in Breast Cancer Patients

The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods.

The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will be regarded as the golden standard for nodal involvement.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
2. Tumor must be a T2 according the TNM 6-classification.
3. The ultrasound of the axilla must be suspect for nodal metastases.
4. Willing and able to undergo all study procedures
5. Has personally provided written informed consent.

Exclusion Criteria:

1. Age \<18
2. History of prior chemotherapy
3. History of prior radiotherapy of the surrounding areas of the axilla.
4. Pregnancy
5. Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.
6. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
7. Being unable to give informed consent in person
8. Acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2).
9. Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Hip Scope Fascia-iliaca (FI) Block Study

Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for outpatient hip arthroscopy
* American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria:

* Prior surgery on ipsilateral hip
* ASA 4-6
* Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
* Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
* Allergy to amide local anesthetics
* Contraindication to regional anesthesia
* BMI \> 40
* Females who are pregnant or plan to get pregnant during the course of the study
Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease

Neuroscientific research has shown a close relationship between physical fitness and cognition, showing a positive effect of physical activity (e.g., aerobic activity) on the maintenance of psycho-cognitive well-being in the elderly. In particular, dancing seems to be very effective, as it involves both motor and multisensory aspects (touch, sight, hearing, proprioception), stimulating memory, motor learning and social interaction. In fact, dance increases sensory-motor skills and cognitive performance in the neurologically healthy elderly. Dance-based therapeutic approaches, in particular Argentine tango, have also been implemented in the context of neurodegenerative pathologies, including Parkinson's disease (PD) where motor (i.e., tremors, postural instability, motor slowdown) and cognitive difficulties (e.g., executive deficits) may coexist. Most of these studies have so far demonstrated a significant improvement in balance and a reduction in motor symptoms, while evidence regarding cognitive and emotional benefits brought about by dance remains limited. When investigated, cognitive benefits have often been evaluated at the level of global cognition (i.e., screening tests), without a detailed characterization of the effects of tango on cognitive and affective functioning (e.g., executive functions, social cognition, depressive symptoms), central aspects in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild-moderate Parkinson's Disease (modified Hoehn\&Yahr Scale 1-3)

Exclusion Criteria:

* Having attended Argentine Tango classes in the past year;
* Having attended Physical Therapy rehabilitation in the past month;
* Other neurological diseases (e.g., stroke, traumatic brain injury, brain tumors)
* Dementia
* Any clinical condition not compatible with physical activity
* Deep Brain Stimulation of infusion pumps implants
Role of Activated Charcoal in Decreasing Blood Urea, Creatinine and Phosphorous

The study aims to explore the ability of Oral activated charcoal to adsorb uremic toxins limiting the progression of chronic kidney disease and delaying the need for hemodialysis in patients with CKD stages III and IV.

To compare its effect with the effect of dry seeds as absorbents of uremic toxins

In recent years, chronic kidney disease(CKD) has become a worldwide public health issue.

The main factors affecting the prognosis of patients with chronic kidney disease are its complications, including cardiovascular and cerebrovascular diseases, malnutrition, inflammation, atherosclerosis syndrome, and anemia.

The accumulation of uremic toxins, such as indoxyl sulfate and p-cresyl sulfate, is implicated in the progression of renal failure and cardiovascular disease.

For many patients, chronic kidney disease (CKD) is a progressive condition marked by deteriorating renal function ultimately leading to end-stage renal disease (ESRD) and many patients refuse to start chronic hemodialysis.

Therapeutic approaches that decrease the level of uremic toxins are a rational method for inhibiting this progression.

Many researches have been done aiming to find alternatives for chronic hemodialysis either for economic issues or psychological issues especially in elderly patients, as example:

* Gum Arabic in the remedy and amelioration of kidney dysfunction and end-stage renal disease
* skin as excretory root for urea, increasing sweat from sweat glands can support kidney function by excreting a good amount of what kidneys naturally excrete.
* The oral charcoal adsorbent reduces serum levels of indoxyl sulfate through adsorption of indole converted from dietary tryptophan in the gastrointestinal tract decreasing serum creatinine and urea level .

In this study, the clinical data supporting the role of oral activated charcoal in a dose of 30gm/ day for slowing the progression of CKD will be reviewed.

In this study, a trial will be done using dry seeds (lentils as an example) as an absorbent for uremic toxins comparing its effect with the effect of oral activated charcoal.

Eligibility Criteria:
Inclusion Criteria:

Patients with CKD stages iii and iv

Patients with age more than 18 years old

Exclusion Criteria:

Patients on regular hemodialysis

Patients with age less than 18 years old
Virtual Realityon Pain, Anxiety and Comfort During Trigger Point Injection

To determine the effects of virtual reality application during trigger point injection on patients' pain, anxiety and comfort levels.This research was planned as a randomized controlled experimental type. The population of the research was planned to include patients who applied to the Algology polyclinic for trigger point injection. The sample of the research will consist of 150 patients who meet the sampling criteria and agree to participate in the research.Inclusion criteria: Trigger point injection applied for the first time, 18 years and over, understand and speak Turkish, understand verbal and written information given.Patients will be divided into two groups: experimental (virtual reality) and control groups.Data will be collected with the Case Report Form, State Anxiety Scale, General Comfort Scale and Visual Analog Scale.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.

Patients in the experimental group will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes.Patients in the control group will continue routine practice.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.

Eligibility Criteria:
Inclusion Criteria:

* The procedure will be applied for the first time

  * 18 years and over
  * Able to understand and speak Turkish
  * Able to understand verbal and written information given
  * Having good cognitive abilities
  * Without visual or hearing loss
  * Patients who agreed to participate in the study

Exclusion Criteria:

* Those who do not understand or speak Turkish
* Does not understand verbal and written information
* Those with impaired cognitive abilities
* Epilepsy
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).


Eligibility Criteria:
* Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
* Previously treated with at least 150 exposure days to any Factor VIII product
* Normal hepatic and renal function tests and no other bleeding disorder
Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women

The purpose of this study is to see if rice enriched in iron will help women with iron-deficient anemia restore their blood counts more efficiently than the standard rice not enriched with iron.

The study will consist of 1 screening visit and 3 study visits. The two-week study will be scheduled to be between menses.

You will then be assigned to eat regular rice dishes or rice dishes fortified with iron for the two-week period. The assignment to the rice group will be made randomly (like flipping a coin). Your chance of being in either rice group will be 50:50. You will be given 14 frozen rice meals in styrofoam containers to take home. You will be expected to eat two rice dishes per day for the next study week and to bring the empty containers to your next study visit.

Eligibility Criteria:
Inclusion Criteria:

* Are a healthy woman.
* Are between 18 and 50 years of age.
* Have iron deficient anemia.

Exclusion Criteria:

* Are pregnant or nursing.
* Are taking a medication or supplement to treat iron deficiency.
* Treatment for iron deficiency within the past month
* Type 1 or type 2 diabetes
* Ongoing cancer
* Active auto-immune disease
* Chronic infections (e.g. HIV/AIDS, hepatitis B, hepatitis C)
* Chronic kidney disease
* Liver cirrhosis
* History of drug or alcohol abuse within the past 6 months
* History of eating disorder within the past 6 months
* Any gastrointestinal surgery affecting nutrient absorption
Tracheobronchomalacia: Treatment Outcomes

The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).

TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM.

Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study.
* Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse

Exclusion Criteria:

* inability to follow commands
* Focal extrinsic compression of the trachea/bronchi by mass or other
S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.

OBJECTIVES:

* Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan.
* Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen.
* Determine the overall toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)

  * Malignant pleural effusion constitutes extensive stage disease
* Must have disease outside area of prior surgical resection or a new lesion must be present
* Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)

  * Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm\^3
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN

Renal:

* Not specified

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy for SCLC

Chemotherapy:

* No prior systemic chemotherapy for SCLC

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy for SCLC except for brain metastases

Surgery:

* See Disease Characteristics
* At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
Study of ASLAN004 in Healthy Subjects

This is an open-label, two-part, single-center, first in human (FIH), single ascending dose (SAD) study to assess the effects of single doses of ASLAN004 when administered to healthy subjects. The objective of this study is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of ASLAN004 in healthy subjects.

The plan is to enroll between 38 to 50 subjects at 1 study center.

The study is divided into 2 parts:

Part A is designed as a SAD study using intravenous (IV) administration of ASLAN004, as a single mg/kg IV dose and will consist of up to 6 IV cohorts.

Part B is designed as a parallel SAD study using subcutaneous (SC) administration of ASLAN004, as a single fixed milligram SC dose and will consist of up to 4 SC cohorts.

All cohorts will have sentinel dosing with the first subject of each cohort being spaced with adequate observation time of 24 to 48 hours before dosing the remaining subjects in the cohort.

All subjects would be follow up for up to 85 days from the last dosing day.

Eligibility Criteria:
Inclusion Criteria:

1. Must be able to sign informed consent form
2. Male and female subjects who are of legal age
3. Healthy, BMI 18.5 to 30 kg/m2
4. Normal or clinically acceptable clinical laboratory value and ECG results

Exclusion Criteria:

1. History of hypersensitivity reaction
2. Have food and/or topical allergies
3. Have recent history of conjunctivitis
4. Have active or history of psoriasis
Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin

Black stains on the teeth, caused by the accumulation of chromogenic microorganisms that produce iron compounds, are more common in the pediatric population and have a negative impact on dental aesthetics and patients' self-esteem. The etiology of these stains remains unclear and is not related to oral hygiene. Currently, there is no definitive treatment that prevents the reappearance of these stains, and they can only be removed by mechanical removal, which can cause injuries to the tooth structure. This study aims to evaluate the effectiveness of erythritol powder air polishers, which have antimicrobial properties, compared to conventional prophylaxis in preventing the recurrence of stains.

A randomized clinical trial will be carried out with a follow-up of 12 months, during which patient satisfaction and duration of treatment will be assessed. The results of this study could provide valuable information to improve treatment and management strategies for dental stains in the affected population, thus contributing to the emotional well-being of patients and reducing damage to their tooth enamel.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 2 or more teeth with black stain

Exclusion Criteria:

* Sistemic diseases
* Patients with physical and/or cognitive impairment which prevents participation in a dental prophylaxis.
* Use of oral antibiotics fifteen days before the intervention
* Allergy to erythritol
A Pilot Study of a Neural Mobilization Intervention Applied to Older Adults With Chronic Musculoskeletal Pain

The goal of this pilot study is to evaluate the feasibility of integrating neural mobilization techniques into a multimodal physical exercise program for older adults with chronic musculoskeletal pain. The main questions it aims to answer are:

* What is the average time to assess secondary outcomes for each participant?
* What proportion of participants adhered and/or withdrew from the study at the end of the intervention protocol?
* Are there adverse events/effects associated with the intervention protocol?
* What is the level of approval/satisfaction of the participants in relation to the assessment and intervention protocols?
* What is the impact of the intervention protocol on participants´ pain, function, physical performance, somatosensory function, and nerve excursion (secondary outcomes)?

Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (8 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program (with or without integration of neural mobilization techniques) to be carried out over a period of 8 weeks at a frequency of twice a week.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults aged 60 years or older, with primary or secondary chronic musculoskeletal pain in any body site and able to walk independently

Exclusion Criteria:

* Individuals with post-surgical pain as a result of surgery performed in the last 6 months;
* Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, neurodegenerative diseases, stroke, uncontrolled diabetes, or at high risk of developing cardiovascular events;
* Those with physical limitations that make it impossible for them to carry out the intervention protocols independently (e.g., wheelchair user);
* Patients who are receiving another physical therapy intervention to treat their pain.
The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children

Research Title: The effect of vitamin D replacement on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children.

Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract and airway hyperreactivity.

Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children.

Design: Double blind placebo control prospective study comparing the effect of Vitamin D replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in asthmatic pediatric population with vitamin D deficiency.

Participant selection: The study group will consist of pediatric patients (age 6-18 years) followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.

Patients with mild-moderate asthma with low or insufficient vitamin D levels that are currently not receiving anti-inflammatory treatment will be recruited.

Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving placebo).

Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance preparation once weekly for 6 weeks between visit two and three.

Three visits will be conducted. Each subject will undergo evaluation including a respiratory questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2 and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC) (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1, 3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled allergens will be performed (visit 2, 3).

Primary end point: Airway reactivity as assessed by methacholine challenge test.

Secondary outcome parameters: All other parameters are the secondary end points.


Eligibility Criteria:
Inclusion Criteria:

* 6-18 years
* Mild-moderate asthma
* No anti inflammatory treatment over the past 2 weeks

Exclusion Criteria:

* Any Chronic Lung Disease
* Febrile Illness in last 2 weeks
* FEV1 \< 65% in study day
* Bronchodilators over the past 24 hours prior to each study
* Participation in any other clinical studies over the past 4 weeks