cyrilzakka/clinical-trials huggingface dataset:
Exercise Intervention for Cancer Survivors and Caregivers

The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.

This was a pilot feasibility study to refine our methodology before a larger Phase II trial.

Eligibility Criteria:
Inclusion Criteria for Cancer Survivors:

* Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.
* Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments
* Have a caregiver willing to participate int he study
* Be able to read English
* Be 21 years of age or older
* Give written informed consent

Inclusion Criteria for Caregivers:

* Be nominated by a cancer survivor
* Be able to read English
* Be 21 years of age or older
* Give written informed consent

Exclusion Criteria:

* have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.
* For caregivers, be currently undergoing active treatment for cancer
Study of IBI363 in Patients with Advanced First-line Gastric Cancer

This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, ≥ 18 years and ≤75 years.
2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
3. Subjects with at least one measurable lesion according to RECIST v1.1.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
5. Expected survival time ≥ 3 months.

Exclusion Criteria:

1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
2. Active uncontrolled bleeding or a known bleeding diathesis.
3. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers

Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic solution, therefore not causing substantial changes in NaCl concentrations, and the use of peripheral veins makes it feasible to use in out of hospital medical centers, for non compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the hypothesis of this study is that it is feasible for a professional team to effectively use the UF for short courses on non compensated HF patients with low or no response to Diuretics, in a dedicated out of hospital HF center.

The patients will be treated in the LIN Heart Failure Center and will not include population defined in the Exclusion criteria.

Up to 60 patients will be recruited and each one will undergo up to 30 treatments in time intervals defined by the cardiologist according to the clinical needs throughout the duration of the study.

Inclusion duration of every patient will be terminated at the end of the treatment course. No prevention in adding more treatment courses per patient according to clinical needs upon the cardiologist's decision.

Operating the UF system:

During the treatment course two of the patient's peripheral veins will be cannulated. One will be used to draw blood from, and the other will be used to return the blood back in to the patient.

The patient will be administered with Heparin IV, or Clexane SC with an ACT target of 180-200 that will be monitored every 4-6 hours.

Fluid removal rate will be according to the cardiologists discretion and will not exceed 500 ml/hour Patient monitoring - Pulse and BP will be recorded at baseline, after 10 minutes for treatment onset and every 1 hour.

Eligibility Criteria:
Inclusion Criteria:

HF patients with peripheral or pulmonic fluid retention, with little or no response to Diuretics as defined by the referring cardiologist

Exclusion Criteria:

1. Age \< 18 years
2. Patient does not fully comprehend the Essence of the study and can not sign the informed consent.
3. Patient is participating in a drug or any other treatment study (no prevention to include patients participating in studies of non invasive monitoring technologies.
4. Presence of Acute MI
5. CR base values \> 3mg/dl
6. Hemodynamic instability requiring Inotropic agents
7. HT base values \> 45%
8. Known pregnancy
9. Presence of contraindication to anticoagulants
10. Post heart transplant or cardiac assist device implantation

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The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy

In order to evaluate the diagnostic and prognostic value of thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and ROC curve analysis was performed according to the biomarker test results.

Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） can evaluate vascular endothelial damage, thrombin and plasminase activation, and have clinical significance in early diagnosis of DIC, thrombotic disease and monitoring of thrombolysis efficacy. However, whether these biomarkers can be used for early diagnosis of SIC is unclear.

In order to evaluate the diagnostic value of TAT, PIC, tPAI·C and TM in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and receiver operator characteristic（ROC） curve analysis was performed according to the biomarker test results. The area under the curve(AUC) was used to determine whether TAT, PIC, tPAI·C and TM could be used as biomarkers for SIC diagnosis. If AUC is between 0.7 and 0.9, this indicator has diagnostic value.

Eligibility Criteria:
Inclusion Criteria:

* Septic patients who meet the diagnostic criteria of sepsis 3.0.

Exclusion Criteria:

* age \< 18 years old, heparin induced thrombocytopenia, thrombotic thrombocytopenic purpura, antiphospholipid syndrome or liver cirrhosis classified as Child-Pugh grade C and patients with a current treatment that interfered with coagulation (anticoagulants).
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

The purpose of this study is to develop and validate a work-model in Primary Health Care for identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory monitoring study.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 75 years.

Exclusion Criteria:

* Cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study.
* Worsened or unstable cardiovascular or cerebrovascular disease.
* Chronic insomnia (\<5h sleep / day).
* Relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease.
* Neuromuscular disease.
* Refusal to participate in the study.
Multicenter Validation of The Evergreen Myometric Strength Test for Lower Extremities (EMST-LE) in Multiple Sclerosis: Protocol for Strength Testing and Reliability Characteristics

A Cross- Sectional study; To assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower extremity strength in patients with multiple sclerosis

Patients will be tested at two visits separated by 1-21 days. At each visit, the patients would undergo bilateral lower extremity strength assessment by two physical therapists, independently and in the same order. Testing would include: hip flexion, knee extension, knee flexion, ankle dorsiflexion Testing performed with 1) HHD (three trials recording maximum voluntary force) and 2) manual muscle testing (MMT), British Medical Research Council grade 0-5)

Eligibility Criteria:
Inclusion Criteria:

* Stable patients with clinically definite MS, aged ≥18, EDSS of 0-7.5
* Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 30 days prior to screening.
* EDSS as described above

Exclusion Criteria:

Contraindications to Strength testing:

* Inflammatory myopathy
* Endocarditis, pericarditis or other unstable heart disease
* Cardiac surgery or myocardial infarction in the last 3 months
* Decompensated congestive heart failure
* Severe aortic stenosis
* Severe pulmonary hypertension
* Pulmonary embolus or infarction in the last 6 months
* Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure \>170, or systolic blood pressure \> 105)
* Marfan's syndrome
* Pacemaker or cardiac defibrillator
* Concomitant neurodegenerative neurological disease, such as ALS or Parkinson Disease or hemiplegic stroke
* Females who are pregnant
* Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
* Anticipated treatment with Novantrone (mitoxantrone) or cancer chemotherapy or surgical procedure during the study period
* Painful orthopedic condition affecting the lower extremities
* Any other serious and/or unstable medical condition
EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography

This is a 2- component, single center study, witch aims to evaluate the efficacy of multisite intracardiac echocardiography (mICE) imaging of left atrial appendage (LAA) and in detecting thrombus located in LAA as compared to transesophageal echocardiography (TEE). The study group will consist of patients eligible for atrial fibrillation (AF) ablation procedure (Component I) or cardioversion (Component II).

First component will enroll 100 patients; these patients will undergo clinically indicated TEE \& cardiac catheterization procedures with ICE(AF ablation). Second component will enroll 15-20 patients with AF or atrial flutter in whom a thrombus in LAA was detected by TEE prior to electrical cardioversion. The ICE probe will be located in multiple positions in the right atrium (RA), coronary sinus (CS), pulmonary artery (PA), right ventricular outflow tract (RVOT) and esophagus. This will enable the investigators to compare sensitivity and specificity of mICE and TEE.

This study will examine two hypotheses in AF patients undergoing invasive cardiac procedures:

Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of LAA from multiple positions (RA,CS,PA,RVOT and esophagus ). This will be evaluated during the component I of the study.

Hypothesis 2: That ICE can identify low risk patients, CHADS Score \< 2,0 in whom immediate cardioversion during the procedure is as safe as based on conventional strategy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with paroxysmal/persistent AF
2. Patients with or without structural Heart Disease.
3. Men or Women aged 18 years or older.
4. Patients undergoing an invasive catheterization procedure including right heart catheterization.
5. Patients who give an informed consent for participation in the study.
6. Patients who have undergone a trans-esophageal echocardiogram within the last 48 hours. Patient witch CHADS2 score \> 2

Exclusion Criteria:

1. Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible (Right atrium or Esophagus).
2. Women of child bearing potential, in whom pregnancy cannot be excluded.
3. Patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia

The proportion of malaria that is the Plasmodium vivax species is increasing in Indonesia. Reducing vivax malaria will require innovative solutions to cure both the blood and liver stages of the disease. This study will evaluate of the feasibility of implementing point-of-care glucose-6-phosphate dehydrogenase deficiency (G6PD) testing. This will be followed by high dose, short course primaquine treatment regimens for patients with vivax malaria, and combined with patient education, surveillance, and pharmacovigilance. We plan to implement the study at 6 health facilities across Indonesia using a staged before-and-after study, with a mixed method evaluation.

Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax. P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allow it to escape detection and treatment. Importantly, they are susceptible only to 8 aminoquinolines such as primaquine however, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence hence ineffective primaquine treatment. Innovative solutions to the radical cure of both the blood and liver stages of P. vivax are urgently required.

The Indonesian Ministry of Health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment regimens for patients with vivax malaria. These interventions are to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance.

This will be a before-after longitudinal health facility-based study implemented at six sites in Indonesia; four in Papua, one in North Sumatra and one in Lampung. We will use a staged approach for the implementation of the revised case management strategy, including patient education and counselling,community-based clinical review, with mixed methods evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with vivax malaria

Exclusion Criteria:

* Patients who are pregnant
* Patients who are breastfeeding
* Patients with a Hb \<8g/dL
* Patients with a previous adverse reaction to primaquine
* Patient with severe malaria
Personalized Asthma Care Team

"Individualized health care" refers to the development of strategies for disease management and health promotion that are informed by specific data on genetics and physiological processes that uniquely determine each person's health profile and potential responsiveness to interventions or susceptibility to environmental exposures.

Asthma, an inflammatory disorder of the airway, appears to be determined by multiple interacting genetic and environmental factors. Such risk factors include allergic responses, small airways, excess body weight, specific properties of airway smooth muscle, airway and generalized metabolic and inflammatory homeostasis, and exposures to environmental irritants, allergens, and psychosocial stressors. To date, asthma treatment strategies have been guided by "severity" guidelines rather than by characteristics of the child's specific phenotype (a child's underlying allergic tendency, extent of airway inflammation and airway smooth muscle dysfunction, or underlying obesity and metabolic perturbations). The growing availability of new classes of asthma medications that more directly target specific pathophysiological derangements will require accessing data on each child's asthma risk profiles to optimize selection of medications and other interventions that most specifically address the underlying pathophysiology while minimizing adverse treatment side effects.

The investigators propose to develop a model program for collecting relevant clinical information and genetic data on a high risk group of asthmatic children, including data on common co-morbidities, specifically obesity and sleep disorders; use this information to develop a comprehensive model database for characterizing children according to their health profiles; and use this characterization to initiate targeted interventions, while continuing long term follow up of these children to determine differential responsiveness to medications.


Eligibility Criteria:
Inclusion Criteria:

* ages 4 to 18 years
* diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma

Exclusion Criteria:

* other severe co-morbidity (cystic fibrosis, sickle cell disease, chronic lung disease of prematurity, interstitial lung disease, cerebral palsy)
* inability of family to provide informed consent
* plans of the family to move out of the greater Cleveland area in the subsequent 24 months
* or inability to participate in regular follow up visits
FAST as a Treatment for Obstructive Sleep Apnea

The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).

Obstructive sleep apnea (OSA) has become a major health problem in the United States. With prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure.

The first and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients exhibit long-term compliance with CPAP.

It is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. In fact there are many surgical procedures performed currently to address tongue based collapse. These include RF ablation of the tongue base, genioglossus advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension.

The current study is designed to evaluate the feasibility of tongue stabilization, and assess safety and treatment of the tongue stabilization.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure
* Age \>/= 20 and \>/= 65
* Body Mass Index ,/= 32 (kg/m\^2)
* Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP
* Signed informed consent to participate in this study

Exclusion Criteria:

* Prior OSA surgery
* Active systemic infection
* Allergy to any medication used during implantation
* Previous history of neck or upper respiratory tract
* Significant dysphagia or speech disorder

Anatomical

* Identified obvious palatal stenosis
* Enlarged tonsils (3+)
* Anatomy unable to accommodate the implant

Other

* Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment
* Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
* Unable and/or not willing to comply with treatment follow-up requirements
* Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment
Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)

This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* gave birth within the 12 weeks prior to the postpartum visit
* postpartum urinary incontinence
* able to understand and give consent in German

Exclusion Criteria:

* treatment for postpartum urinary incontinence that started prior to inclusion
* any neurologic disease that impairs bladder function
Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence

The purpose of this study is to evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Males with stress urinary incontinence with insufficient effect by behavioral therapy or pharmacotherapy persisting more than 1 year after either of the following surgical procedure:

  * Patients with symptoms after radical prostatectomy for localized prostate cancer and currently without relapse/metastasis, and PSA level less than 0.1 ng/mL for over 1 year
  * Patients with symptoms after transurethral prostatectomy or laser prostatectomy for prostatic hyperplasia, and PSA level less than 4.0 ng/mL over 1 year
* Age of 20 or above
* Mild to moderate urinary incontinence on the 24-hour pad test
* Patients who can keep a bladder diary in a satisfactory manner
* Patients who are willing and able to give signed consent

Exclusion Criteria:

* - Concurrent with any other types of urinary incontinence
* History of urinary or reproductive surgery within 6 months
* History of behavioral therapy or pharmacotherapy within 3 months
* Concurrent with diabetes insipidus
* History of radiotherapy in the lower urinary tract
* History of ADRCs treatment for stress urinary incontinence
* History of any type of cell therapy within 6 months
* Participation in any other clinical trial within 3 months
* Concurrent with lower urinary tract obstruction
* Concurrent with urolithiasis, urinary tract infection or interstitial cystitis
* History of recurrent urinary tract infection
* History of malignant neoplasm within 5 years or a suspicion of it
* Life expectancy of less than 1 year
* Any other patients whom the trial investigator deemed ineligible to this study