cyrilzakka/clinical-trials huggingface dataset:
Implementation of a System-level Tobacco Treatment Intervention

The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.

In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients.

* Adaption of CEASE will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process.
* Effectiveness of CEASE will be measured through questionnaires \& biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (CEASE)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Have an actual or potential diagnosis of thoracic malignancy
* Able to read and write in English.
* Current or recent former smoker (defined as having smoked within past 6 months)
* Must have an active telephone number.

Exclusion Criteria:

* Former smoker greater than 6 months.
* Have any of the below conditions needing immediate medical intervention

  * Hypercalcemia causing lethargy and confusion,
  * Acute respiratory distress
  * Dehydration
  * Hypotension
Evaluation of Accuracy and Consistency of the X-Trodes System

The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device.

The study aims to demonstrate that the performance of the study X-Trodes acquisition system is equivalent to that of an FDA-cleared clinical electrophysiology devices (in measuring electroencephalography , electrooculography, electromyography, and electrocardiogram signals).

Subjects will wear both devices simultaneously while signals are captured in resting state. Following, an evaluation of the similarity of signals between the two devices will be conducted. The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study, subjects must meet all the following inclusion criteria:

* Adults (age 21 - 99)
* Referred to an electrophysiology test by either neurologist or cardiologist in the last 5 years
* Produce interpretable electrophysiological signals by the acquisition devices

Exclusion Criteria:

* Did not sign the informed consent
* Cannot maintain the electrodes attached to their skin (i.e., due to beard on the chin area)
* Diagnosed as suffering from sleep apnea
* Pregnant or lactating women
Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid "rescue" general anesthesia that occur in 20-40 % of patients with plain bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* Newborns less than 60 weeks old post-conceptional, former premature or not
* Newborns requiring inguinal hernia or lower limbs surgery,
* infants needing no more critical care assistance
* Informed consent of parents

Exclusion Criteria:

* Spinal malformation,
* Coagulopathy,
* critical hemodynamics,
* uncontrolled neurologic or metabolic pathology.
* infection at injection point.
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome

This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo.

Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.


Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of NALP3 mutations and clinical picture resembling Muckle-Wells Syndrome.
* Muckle-Wells Syndrome patients who participated in the CACZ885A2102 study, will have the option to participate in this study upon disease flare
* Muckle-Wells Syndrome patients requiring medical intervention either untreated or treated (i.e. under ACZ885, anakinra, or any other investigational IL-1 blocking therapy).

Exclusion Criteria:

* History of being immunocompromised, including a positive HIV at screening test result.
* No live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
* History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial.
* History of recurrent and/or evidence of active bacterial, fungal, or viral infections.
* Positive tuberculin skin test at 48 to 72 hours after administration at the screening visit or within 2 months prior to the screening visit, according to national guidelines.

Other protocol-defined inclusion/exclusion criteria may apply
Effectiveness of Psycho-educational Program on Climate Change Distress and Risk Perception Among Older Adults.

Research design The study followed a quasi-experimental study with two groups (study and control group) with a pre-test and post-test.

Setting:

This study was conducted at three elderly clubs at Damanhour city, El-Behaira Governorate, Egypt. These clubs are affiliated to the Ministry of Social Solidarity, Egypt namely Ahbab Allah, Alfady, and Alrabie Clubs. These clubs opens seven days per week from 9 am to 12 pm. The total attendance rate of older adults in these clubs amounted to 213; 93 older adults in Alfady Club, 70 in Ahbab Allah Club and 50 older adults in Alrabie Club.

* An Official letter from the Faculty of Nursing, Damanhour University was directed to the director of the Ministry of Social Solidarity in El -Behira governorate to obtain permission to conduct the study, then to the directors of the three elderly clubs in Damanhour city to obtain their approval to carry out the study.
* A Socio-Demographic Data and clinical Structured Interview Schedule (tool II) was developed by the researchers based on review of related literature. The Arabic version of tool I (Mini-Mental State Examination) and tool IV (Risk Perception Scale) were used in this study.
* The study subjects who fulfilled the inclusion criteria were interviewed individually in the garden of the clubs in order to collect the necessary data (tool I, II, III, and IV). Then, the researcher interviewed the clients in group composed of 8 older adults to implement program. Each session taken about 30-45 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60 years and above.
2. Able to communicate effectively.
3. Did not have malignancies or psychiatric diseases.

Exclusion Criteria:

-
Effects of Bariatric Surgery in Swedish Obese Subjects

The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of bariatric surgery on overall mortality and obesity-related co-morbidities.

The Swedish Obese Subjects (SOS) study is a prospective non-randomized controlled intervention study designed to examine the long-term effects of bariatric surgery compared to usual care in obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age 37-60 years and BMI ≥34 kg/m2 in men and ≥38 kg/m2 in women.

Exclusion Criteria:

* Exclusion criteria of both groups were: earlier operation for gastric or duodenal ulcer; earlier bariatric surgery
* Gastric ulcer during the past 6 months; ongoing malignancy
* Active malignancy during the past 5 years
* Myocardial infarction during the past 6 months
* Bulimic eating pattern; drug or alcohol (\>0·75 L 40% liquor per week or corresponding amount of ethanol) abuse
* Psychiatric or cooperative problems contraindicating bariatric surgery
* Other contraindicating conditions (such as continuous glucocorticoid or anti-inflammatory treatment).
The Effect of Combined Robotic Hand Therapy and Conventional Therapy in Stroke Patients

RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.

Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications. It is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. Considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. In this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

Unilateral stroke

Between 4 weeks and 6 months after stroke

health status was suitable for rehabilitation

who could understand commands with a mini mental test score of 15 and above

who had Brunnstrom grade 3 and below (≤3).

-

Exclusion Criteria:

Patients with persistent upper extremity pain on the hemiplegic side (VAS\>40)

Patients with severe spasticity in the hand (MAS≥3)

Patients with contractures in the hand

Patients who had fractures or operations on the hemiplegic side in the last 6 months

Patients who received botulinum toxin injection to the upper extremity in the last 6 months

Patients with skin ulcers

Patients with brain stem or cerebellar lesions

Patients with neglect or apraxia

Patients with severe visual impairment and severe depression

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Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease

* Prospective, multi-center, randomized, controlled comparison study
* A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions.
* Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year.
* Patients will be followed clinically for 2 years after the procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years or older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4 or 5)
3. Femoropopliteal artery disease (stenosis \> 50%) with one of following complex lesion characteristics: - long lesion (\>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
4. Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
5. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
4. Age \> 85 years
5. Severe hepatic dysfunction (\> 3 times normal reference values)
6. Significant thrombocytopenia, anemia, or known bleeding diathesis
7. LVEF \< 35% or clinically overt congestive heart failure
8. Pregnant women or women with potential childbearing
9. Life expectancy \<1 year due to comorbidity
10. Previous bypass surgery in the target femoropopliteal artery
11. Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia

To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ≥18 years of age diagnosed with VAP , i.e., pneumonia that arises more than 96 hours after endotracheal intubation documented or suspected to be due to Pseudomonas aeruginosa
2. Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
3. Written Informed consent from the patient's legally acceptable representative or a relative

Exclusion Criteria:

1. Patients with known hypersensitivity to fluoroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a clinically significant history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening
2. Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
3. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score \>25
4. Presence of septic shock at the time of evaluation for study entry
5. History of lung transplant
6. Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count \< 200/mm3
7. Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
8. Patients with impaired renal function
9. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent
Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology

OBJECTIVE:

This study aims to determine wether a geriatric intervention based on an individualized program of physical exercise and nutritional support improves the ability to complete oncological treatment at the doses and time initially planned in patients ≥ 70 years affected by hematological malignancies.

DESIGN:

Prospective, clinical trial, randomized, parallel and open groups.

SETTING:

Patients ≥ 70 years recently diagnosed of malignant hematological pathology in a comprehensive cancer center

INTERVENTION:

All those patients who meet the inclusion criteria and agree to participate, will sign the corresponding informed consent and will be assessed through a CGA (comprehensive geriatric assessment), that includes the performance of a physical condition test (SPPB), and randomized to the study group or control group. Patients in the study group will participate in an intervention program with nutritional support and physical exercise during the period in which they are receiving oncological treatment or for a maximum period of 6 months. The patients of the control group will pass to follow up. All patients, regardless of the branch of study to which they are assigned, will receive the oncological treatment indicated by their doctor and a standard follow-up according to the current care protocols in the center.

DETERMINATIONS:

Main variable: proportion of adherence to treatment calculated as the percentage between the dose administered and the prescribed. Adherence over 80% will be considered acceptable.

Secondary variables: geriatric, nutritional and physical-condition parameters before and after the intervention, quality of life before and after the intervention, toxicity and complications during treatment and response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* hematological pathology (myelodysplastic syndromes, lymphoproliferative syndromes, multiple myeloma)
* considered able to practice physical exercise
* signed informed consent

Exclusion Criteria:

* other hematological pathology
* considered unable to practice physical exercise
Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients

1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
2. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients
* who are treated with chemotherapy or hormonal therapy
* who experience no menstruation after the previous therapy
* who complain of vaginal dryness

Exclusion Criteria:

* other cancer patients
* other severe disease
* poor compliance
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.

Eligibility Criteria:
Inclusion Criteria:

* Good general health with no evidence of pre-existing medical problems
* Fluent in both written and spoken English
* Must be able to review informed consent and is willing to comply with study procedures

Exclusion Criteria:

* Obesity (BMI \>30)
* Known history of heart disease, lung disease, kidney or liver disease
* Prior diagnosis of asthma, sleep apnea, or use of CPAP
* Diabetes
* Clotting disorder
* Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation
* Any serious systemic illness
* Current smoker
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly
* History of fainting or vasovagal response
* History of sensitivity to local anesthesia
* Prior diagnosis of Raynaud's disease
* Unacceptable collateral circulation based on exam by investigators (Allen's test)
* Pregnant, lactating, or trying to get pregnant
* Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures
* Any other condition which in the opinion of the investigators would make them unsuitable for the study
Effect of a Mixture of New Probiotic Strains in Preterm Infants

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.

The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.

The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation.
* Written informed consent signed by the parent or legal guardian.
* Tolerate enteral feeding, at least 10mL / kg / day.
* Postnatal age ≤ 5 days

Exclusion Criteria:

* Child with malformations
* With short bowel syndrome or any surgery in the gastrointestinal tract
* With defect in the intestinal epithelial barrier