cyrilzakka/clinical-trials huggingface dataset:
EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer

RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy.

PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.

OBJECTIVES:

* Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level, tumor size, and stage of disease in patients with stage IIB, IIIB, or IVA cervical cancer.
* Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated with overall survival, progression-free interval, and local control in these patients.
* Determine the relationship between EF5 binding and CD-31 labeling (tumor vasculature) and Ki-67 labeling (cellular proliferation) in these patients.

OUTLINE: This is a multicenter study.

Patients receive EF5 IV over 1-2.5 hours on day 1. Tumor hypoxia is measured using immunohistochemical techniques. Biopsies are collected 1-2 days later. Blood is collected before EF5 is administered and again at the time of surgery.

Patients are followed approximately 1 month after surgery.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix

  * Stage IIB, IIIB, or IVA
  * Primary disease
* No prior treatment
* Must be enrolled on GOG-0191 protocol

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* GOG 0-3

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal
* Hemoglobin less than 13 g/dL

Renal

* Creatinine no greater than 2 mg/dL

Cardiovascular

* No cardiac disease that would preclude safe administration of necessary fluid volumes

Pulmonary

* No chronic pulmonary disease that would preclude safe administration of necessary fluid volumes

Other

* No history of grade 3 or 4 peripheral neuropathy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must weigh no more than 180 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial

In this research study the investigators want to learn more about whether using a fitness tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in turn whether it increases exercise tolerance over the period of one year.

The aim of this study is to evaluate whether the use of a Fitbit device and an exercise prescription is associated with increased daily activity and in turn increased exercise tolerance in young adult patients with cystic fibrosis (CF). The investigators hypothesize that use of the Fitbit and an exercise prescription will be associated with increased exercise tolerance compared to standard counseling and an exercise prescription alone.

For patients with CF, young adulthood and adolescence is a significant time of vulnerability. In addition to normal behavioral challenges of adolescence and young adulthood (seeking independence/autonomy while also choosing rebellion), those with CF are often dealing with significant disease progression. Therefore, working in new innovative ways to improve adherence to regimens that improve lung function such as exercise are needed to continue to support patients during this vulnerable time.

Studies of patients with cystic fibrosis have shown that regular exercise training can decrease rate of lung function decline, potentially improve lung function, and improve aerobic capacity. However, many patients do not include regular exercise in their daily routine. Successful strategies to improve adherence include providing patient specific guidelines for an appropriate exercise program, supporting participation and providing positive feedback. Overall, exercise is a crucial diagnostic and therapeutic modality for patients with Cystic Fibrosis, although awareness somewhat limited. The adult CF program at Boston Children's and Brigham \& Women's Hospital established an inpatient and outpatient exercise program as part of a quality improvement effort. Patients are prescribed an individualized exercise program or exercise prescription based on their assessment during a sub-maximal effort. This program has been successful but given the rigors of daily life (e.g. school, work, family obligations), adherence is a concern with resources limiting more rigorous feedback to maintain this essential life activity.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of Cystic Fibrosis
2. Age 18 and over
3. Must be able to complete at least level 1 of the baseline exercise fitness test
4. Must not have required IV antibiotics for a CF exacerbation within 30 days of starting the program

Exclusion Criteria:

1. Pregnancy at enrollment
2. A history of CF exacerbation requiring IV antibiotics within last month
3. Use of a fitness tracker or similar product within 6 months of enrollment
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.


Eligibility Criteria:
Inclusion Criteria:

* Treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia
* LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L
* Fasting triglyceride less than 4.52mmol/L

Exclusion Criteria:

* History of statin induced myopathy
* Unstable or uncontrolled cardiovascular diseases
* Familial dysbetalipoproteinemia
Silent Lumbar Disc Herniation Syndrome

LDH is a common phenomenon that is often described in association with various pathological processes affecting the neuromuscular and locomotor systems. It is not only associated with pathology but it can also be observed in healthy individuals with no evidence of any dysfunction. Since LDH is observed in such a large percentage of healthy subjects, it is probably more appropriate to perceive it as a physiological phenomenon with silent clinical biomechanical changes

An observational study will be conducted on 180 individuals without any back or lower extremity symptoms. Individuals who agree to participate in the study will be divided into 3 groups based on their MRI findings. Group 1 (silent disc herniation group): has LDH and root compression confirmed by the MRI but has no back or lower extremity symptoms. Group 2 (had a history of disc herniation with an improvement of their symptoms after receiving physical therapy intervention): has LDH and root compression confirmed by the MRI but has no back or lower extremity symptoms. Group 3 (control group): absence of LDH and root compression confirmed by the MRI has no back or lower extremity symptoms. The isokinetic peak torque for knee and ankle muscles and the H reflex will be assessed for all the individual investigating the influence of silent LDH on the isokinetic parameters and the H-reflex of the lower extremity may help in better guiding for lower extremity screening to identify individuals at risk for lower extremity injuries. It is hoped that clinicians will incorporate such information to understand the importance of confirming the improvemnt obtained from the physical therapy intervention with an MRI before discharging the patients to reduce the risk of recurrence............................................................................................................................................................................................................................

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria patients with LDH and root compression with no back or lower extremity symptoms.

Exclusion Criteria:

* Any previous history that would affect the alignment or the motion to lower extremity joints as fractures or surgery.

Any fixed deformity True leg length discrepancy (\>5mm). Any medical condition affecting peripheral nerves as diabetes mellitus. Any neuromuscular dysfunction and vestibular disorder.Sacroiliac pain or dysfunction low back pain.

Radicular or referred or radiating pain Previous lower extremity injury
Effects of Physical Training in Altered Environmental Conditions on Exercise Performance

The main objective of the study is to evaluate the physiological-biochemical effects of physical training under artificially altered climatic conditions (using a hypoxic thermoclimatic chamber) in particular to determine the effect of such training on exercise capacity and physiological response, including the effect of training in high-performance athletes. The study will evaluate the effects of physical training and the simultaneous application of hypoxia and heat/cold on aerobic and anaerobic capacity and the physiological response of the human body. The aim of the study is to find the most favourable environmental conditions for physical training in order to maximise physical performance.


Eligibility Criteria:
Inclusion Criteria:

absence of medical contraindications to high-intensity physical exertion. The medical examination is required (included an exercise ECG, blood tests to exclude anemia or low hemoglobin and iron concentration)

Exclusion Criteria:

any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention
Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative

Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.

Specific AIMS:

AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.

AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:

1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.

AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.

Eligibility Criteria:
Inclusion Criteria:

* Staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment
* Patients receiving methadone at these locations

Exclusion Criteria:

* Patients not receiving methadone at these locations
* Staff not involved in methadone treatment at these locations
Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion

The better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. However, this treatment modality needs to be evaluated as compared to Mini Dental Implants (MDIs) over denture in thin mandibular ridge.

In mandibular edentulous patients having thin ridge, does the mini implant supported over denture, compared to the conventional implant supported over denture after bone expansion affect bone height around implants?

PICO

P: Completely edentulous Patients.

I: Mandibular overdenture supported by mini dental implant.

C: Mandibular overdenture supported by conventional implant diameter after bone expansion.

O: outcomes as follows:

Primary Outcome: Patient satisfaction, Questionnaire Visual analog scale (VAS), Measuring unit: Mm. (Geckili et al.

Secondary Outcome: Bone height change, Measuring device: DIGORA® X ray, Measuring unit: Mm.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients ranging from age 35 to 75 years
* Angle's Class I skeletal relationship
* Normal facial symmetry
* Cooperative patients
* Adequate inter-arch space not less than 12mm

Exclusion Criteria:

* Temporomandibular disorders
* Uncontrolled diabetes
* Bleeding disorders or anticoagulant therapy
* Flabby tissues or sharp mandibular residual ridge.
* Heavy smokers.
* Patient's with neuromuscular disorders
* Patients on chemotherapy or radiotherapy
* Severe psychiatric disorders
* Angle's class II and III skeletal relationship
National Survey of Essential Tremor Plus in China

National Survey of Essential Tremor Plus in China（NSETP-China）is a multicenter cross-sectional study designed to investigate the clinical features of ET-plus in mainland China.

Essential tremor (ET) is one of the most common adult-onset movement disorders, affecting 0.9% of the population across all ages worldwide. ET is a chronic, progressive neurologic disease whose the most recognizable clinical feature is a 4\~12 Hz kinetic tremor of the upper limbs, usually occurring during a variety of voluntary movements. The etiology and pathogenesis of ET remain elusive.

Essential tremor-plus (ET-plus) is a new term coined in 2018 MDS consensus statement on tremor. ET-plus is defined as tremor with the characteristics of essential tremor, with additional neurological signs of uncertain clinical significance, such as impaired tandem gait, questionable dystonic posturing, memory impairment, or other mild neurological signs of unknown clinical significance that do not suffice to make an additional syndrome classification or diagnosis.

ET-plus is a controversial new concept. We will use scales or questionnaires to investigate the common soft neurological signs of ET-plus in mainland China. The details are as follows: (1) The tremor's impact on activities of daily living and clinical measurement of ET severity are evaluated by The Essential Tremor Rating Assessment Scale (TETRAS). (2) Cognitive condition is assessed by Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA). (3) The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS). (4) Clinical assessment of balance and gait in ET-plus: we will use Tandem walk, Berg balance scale (BBS) and 10 meter walk timing test. (5) The Unified Dystonia Rating Scale (UDRS) for evaluation of dystonia in ET-plus. (6) The scale for the Assessment and Rating of Ataxia (SARA) is used to evaluate ataxia in ET-plus.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with ET and/or ET-plus by the Consensus Statement on the Classification of Tremors, from the Task Force on Tremor of the International Parkinson and Movement Disorder Society.

Exclusion Criteria:

Lack of capacity to consent to participate in the project
Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single doses of ARO-ENaC in healthy adult volunteers; and to evaluate the safety, tolerability, PK and efficacy of multiple doses of ARO-ENaC in patients with pulmonary cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Normal electrocardiogram (ECG) at Screening
* Non-smoking
* Normal pulmonary function tests at Screening (NHVs only)
* No abnormal finding of clinical relevance at Screening other than CF for CF patients
* Confirmed diagnosis of CF based on source verifiable medical record (CF patients only)
* All other treatments for CF have been stable for at least 2 months and patient is willing to continue this treatment regimen without change for duration of study (CF patients only)

Exclusion Criteria:

* Acute lower respiratory infection within 30 days of Screening (NHVs only)
* History of asthma (specifically, those subjects at risk of bronchial hyperactivity), anaphylaxis or airway hyper-reactivity
* Clinically significant history of hyperkalemia or presence of hyperkalemia at Screening
* Clinically significant health concerns (other than CF in CF patients)
* Human Immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
* Uncontrolled hypertension
* Excessive use of alcohol within one month prior to Screening
* Use of illicit drugs within 1 year prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
* CF exacerbation within 30 days of Dosing (CF patients)
* History of solid organ transplant (CF patients)
* Diagnosis of hepatic cirrhosis (CF patients)

Note: additional inclusion/exclusion criteria may apply per protocol
Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed before any trial test
* Age equal or less than 80 years
* Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
* Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
* Measurable disease, acoording to RECIST criteria
* ECOG 0-2

Exclusion Criteria:

* Patients who have been irradiated on target lesions
* ECOG \>2
* Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
* History of other cancers except basal cell cancer or cervical cancer adequately treated
* Serious cardiovascular disease
Decrease of Lesions Induced by Mechanical Ventilation During ARDS

Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.

the hypothesis is that ECMO, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, VILI) by drastically reducing minute ventilation (volume reduction). current, Vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of PEEP from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. This ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. In order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ECMO as proposed in the EOLIA study.

Eligibility Criteria:
Inclusion Criteria:

* severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP\> 10 cmH2O and FiO2 = 1
* OR a severe ARDS with a PaO2 / FiO2\> 70 ratio but \<100 mmHg with a plateau pressure\> 35 cmH2O and a pH \<7.20

Exclusion Criteria:

* Patients with associated hemodynamic failure requiring veno-arterial ECMO
* Impossibility of setting up or contraindication to the placement of an esophageal tube
* Impossibility of realization of ventral decubitus
* Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
* Patients assisted by veno-venous ECMO for more than 24 hours.
Investigational On-body Injector Clinical Study

The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.

This study is a monocentric, open-label, cross-over, feasibility and exploratory study with no acceptance criteria. Up to 70 healthy volunteers will be enrolled and followed up for 7 weeks at maximum.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult participants ≥ 18 years
* BMI ≥18.5 kg/m2
* Participant willing and able to complete all required study procedures and to provide informed consent

Exclusion Criteria:

* Participant any self-reported existing chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).
* Participants with treatment interfering with coagulation, platelet function, or pain perception within 12 hrs of in-clinic visit
* Participants with abdominal or arm skin conditions or treatments that may interfere with planned study treatment
* Participants with acute or chronic hepatitis B or C and/or with known history/positive HIV serology.
* Participants who are pregnant, planning to become pregnant, or are breast-feeding.
Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients age 2 to 17 years old
* have a laceration of 4 cm on the face or 7 cm on the remainder of the body
* Require procedural sedation to repair the laceration

Exclusion Criteria:

* Patients with abnormal nasal physiology which would not allow for adequate medication delivery
* Unable to have a guardian present to consent on their behalf
* Allergy to ketamine
* Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
* Presenting with a head injury associated with possible intracranial hypertension
* Pregnancy
* Lacerations that require repair from a consult service