cyrilzakka/clinical-trials huggingface dataset:
Impact of Baduanjin Qigong Exercise on Fatigue in Patients With NSCLC Undergoing Adjuvant Chemotherapy

Baduanjin，a type of Qigong which belongs to aerobic exercise, is very popular in China. There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders. In college students, it may enhance cardio respiratory function, lower limb function, and flexibility compared with usual exercise. However, there is no previous relevant randomized controlled trials on the health promoting effects of Baduanjin exercise in targeted fatigued lung cancer patients. Lung cancer survivors can experience fatigue due to multiple reasons that can strongly impact their quality of life throughout the remainder of their life. Therefore, this randomized controlled trial in China was designed to assess the health promoting effects of Baduanjin exercise in fatigued lung cancer patients with the expectation of improvement in physical and psychological health.


Eligibility Criteria:
Inclusion Criteria:

* This trial aims to enroll 18- to 75-year-old patients expected to survive \> 3 months and with a Zubrod performance status of 0 to 2. All patients must have diagnosed as lung cancer and have at least one cycle of adjuvant chemotherapy. Enrolled patients should have a minimal ESAS fatigue as 3. Other inclusion criteria are lack of leptomeningeal disease, adequate hepatorenal function and blood counts (red blood cells, \>3.0 \* 1012/L; white blood cells, \> 3.5 \* 109/L; absolute neutrophil count, \> 1.5 \* 109/L; platelets, \> 100 \* 109/L; hemoglobin \> 90 g/L).

Exclusion Criteria:

* Children
Improving Planned Surgical Case Duration Accuracy by Leveraging the EHR and Predictive Modeling

The investigators are studying the duration it takes surgeons to complete their respective surgical cases. The hospital hopes to improve the overall operating room scheduling accuracy from this project.


Eligibility Criteria:
Inclusion Criteria:

* A surgeon or OR staff member in the Department of Surgery Gynecology and Colorectal service

Exclusion Criteria:

* Any new surgeon that starts their practice during the study
* Surgery will take place at a location other than the Main hospital or Josie Robertson Surgical Center
* Cases where input data was not available prior to the prediction generation including late add-on cases such as urgent and emergent cases that are placed on the schedule less than 24 hours before the surgery
Cognitive Training to Enhance VA Work Program Outcomes

The purpose of this study is to determine whether augmenting work services with cognitive remediation can improve vocational outcomes for psychiatrically disabled participants in VA work services.

Background: Our previous RR\&D funded study demonstrated significantly better vocational outcomes for people with schizophrenia when cognitive training supplemented their participation in Incentive Therapy. We have found in a subsequent NIMH funded study involving cognitive training and supported employment that competitive employment outcomes were better for those who received cognitive training. Moreover, we found that patients with the poorest community function at intake were very unlikely to obtain competitive employment unless they received the cognitive training. The current study will test the effectiveness of cognitive training by extending it to a broader range of VA patients with psychotic disorders participating in all types of VA work services currently available, including Incentive Therapy, Compensated Work Therapy, and Supported Employment. We plan to offer it to any patient with a psychotic disorder who is unlikely to obtain competitive employment without additional services. We will also compare two types of cognitive training to determine whether cognitive game software works as well narrowly focused cognitive exercises.

Design and Method: This is a randomized clinical trial in which 80 VA patients referred for VA work services and who meet criteria for psychotic disorder and impaired community function will be randomized to one of two types of cognitive training. There will be two conditions with approximately 40 subjects per condition. Intake procedures will include psychosocial, neuropsychological, and psychiatric assessments. These assessments will be repeated at 6-months and 12 month follow-up. Cognitive training will consist of computer-based cognitive exercises of attention, memory and problem-solving and a weekly group that focuses on improving work behaviors. One of the computer-based systems employs engaging cognitive game software and the other uses specially designed exercises that narrowly focus on discrete cognitive processes. Work services will be provided as usual to both conditions. Primary endpoints are measures of productive activity including obtaining competitive employment, total hours worked, and money earned. Secondary endpoints include neuropsychological, quality of life and health status changes. The study will be for three years.

Eligibility Criteria:
Inclusion Criteria:

* Participant in VA work services
* Chronic and disabling psychiatric illness

Exclusion Criteria:

* Neurological Disease that may affect cognition
* Primary substance abuse
* Developmental Disability
Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva

Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).

Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.

Eligibility Criteria:
Inclusion Criteria:

1. Adenocarcinoma of the colon or rectum.
2. Age \> 18.
3. Measurable disease according to RECIST criteria.
4. Expected survival more than three months.
5. Adequate bone marrow, liver and kidney function.
6. INR \< 1.5 times upper limit.
7. Adequate contraception for fertile patients.
8. Signed written informed consent.

Exclusion Criteria:

1. Earlier chemotherapy for metastatic colorectal cancer.
2. Adjuvant treatment within 6 months.
3. Surgery or significant trauma within 28 days prior to study entry.
4. Planned radiotherapy against target lesions.
5. CNS metastases.
6. Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.
7. Bleeding diathesis
8. Uncontrolled hypertension.
9. Significant cardiovascular disease.
10. Treatment with anticoagulant drugs.
11. Participation in other clinical trial.
12. Pregnant or lactating.
A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, \[123I\]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD. First-degree relatives of PD will be recruited through PD research sites and national foundations to participate in this study. In addition, first degree relatives of PD patients will be recruited directly through advertising.

First-degree relatives that agree to participate (n=3,000) will be asked to complete a 40-item olfactory identification test provided by mail. 300 subjects (225 with decreased odor identification and 75 with normal olfaction) will be invited to undergo DAT imaging at the Institute for Neurodegenerative Disorders in New Haven, CT. There will also be additional clinical follow-up at participant's clinical (local) site. The primary outcome measure for the study will be the mean striatal uptake of \[123I\]B-CIT in first-degree relatives with a loss of odor identification, which will be compared to an established healthy control database (age 40-70; n=50). 300 relatives will be followed longitudinally with clinical evaluations and a second imaging study completed after two years. Comparing the first and second scans in this subset of subjects will allow us to evaluate the rate of progressive loss in dopamine transporter density during this pre-symptomatic period.

Eligibility Criteria:
At Risk - Inclusion Criteria:

* subject must have a first-degree relative with PD, based on their report
* subject must not carry a diagnosis of PD or other neurodegenerative disorder.
* subject must be either at least 50 yrs old or within 10 yrs of the age of onset of their affected relative
* Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery)
* Subject must not be pregnant if participating in the imaging portion of this study

Non-First Degree Relative - Inclusion Criteria:

* Subject must not carry a diagnosis of PD or other neurodegenerative disorders
* Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery)
* Subject must not be pregnant or be an actively nursing mother if participating in the imaging portion of this study.

Exclusion Criteria:

* diagnosis of PD or other neurodegenerative disorder
* other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery)
* pregnancy, if participating in the imaging portion of this study
Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension

The purpose of this study is to evaluate the efficacy and safety of the combination of ambrisentan and tadalafil in reducing mPAP to below 35mmHg in patients with moderate to severe Portopulmonary Hypertension (POPH) as a means to candidacy for liver transplantation.

The outcome of liver transplantation (LT) in the presence of moderate to severe POPH is significantly poor with a 50% reported mortality rate in LT recipients having a mean pulmonary artery pressure (mPAP) \>35 mmHg and 100% when the mPAP is greater than 50 mmHg; therefore, making moderate to severe POPH a contraindication to liver transplants. Those recipients with significant pulmonary artery pressure (PAP) may be denied the opportunity for transplant unless the mPAP is brought below 35 mmHg with medical treatment. This study will test the efficacy \& safety of the combination of using ambrisentan and tadalfil in reducing the Pulmonary Arterial Pressure to below 35 mmHg in patients with moderate to severe POPH as a means to candidacy for liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class Class A \& B Cirrhosis
* mPAP ≥35mmHg
* Pulmonary Capillary Wedge Pressure (PWCP) \<15mmHg on Right Heart Catheterization's (RHCs)
* mPAP \> 50mmHg will be considered eligible unless they are World Health Organization (WHO) Functional Class IV

Exclusion Criteria:

* End stage renal disease on hemodialysis (ESRD on HD)
* Renal dysfunction and GFR \< 30
* AST, ALT \> 5 times the upper limit of normal
* Total bilirubin ≥ 6.0
* INR \> 2

  * Initially, Child-Pugh Class C patients will be excluded; however, after the first 5 patients are included, if there is no signal of worsening liver function, the protocol may be amended to include patients with Class C cirrhosis.
Uremic Toxins in the Intensive Care Units (ICU): Patients With Lactate Acidosis

Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients with lactate acidosis. The sampling of blood and dialysate will be done during dialysis with different durations (4, 6 and 8 h)


Eligibility Criteria:
Inclusion Criteria:

* Includes ICU patients with lactate acidosis with acute renal failure

Exclusion Criteria:
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
* Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
* A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

* Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
* Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
* Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
* Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

The primary objective of this study is to (1) determine whether local injection of lidocaine used during Mohs surgery will elevate serum lidocaine concentrations to a level that could cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine occur after intralesional anesthesia on the face and neck. This study is a cross-sectional study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and blood draws during their Moh's surgical procedure.


Eligibility Criteria:
Inclusion Criteria

* Age: 18-75
* Basal cell carcinoma or squamous cell carcinoma of the head or neck
* Subjects are in good health
* Subjects that have the willingness and the ability to understand and provide informed consent for the use of their blood and communicate with the investigator

Exclusion Criteria

* Lidocaine sensitivity
* Bleeding disorder
* Pregnancy
* Medical conditions which would impair hepatic blood flow: congestive heart failure, liver dysfunction, peripheral vascular disease.
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.

Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between the ages of 18 and 55 years, inclusive.
* Able to provide written informed consent prior to the performance of any study specific procedures.
* Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.

Exclusion Criteria:

* Participants are excluded from the study if any of the following criteria apply:
* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
* Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice

This work will make it possible to identify the nephron loss of type 2 diabetic patients in the western region and to better define in general practice the impact of the elements put in place to reduce this loss and to raise awareness of the importance of these measures through training in comparison with a control group.


Eligibility Criteria:
Inclusion Criteria:

* Patient consulting his or her investigating general practitioner
* 50 years old or more
* type 2 diabetic for more than 5 years, with a GFR lower than 90 ml/mn and higher than 45 ml/mn (stage 2 and 3a of renal failure) and a nephron loss calculated on the average of the two previous years, higher than 3 ml/mn/year
* a microalbuminuria \> 30 mg/gr of creatinuria.
* Having declared the investigator as the treating physician

Exclusion Criteria:

* Patient under 50 years of age Patients who do not agree to the use of their data (refusal of consent) or are unable to give consent (dementia, other) Patients with other types of diabetes Patients with renal failure other than diabetic or hypertensive glomerulopathy Patients unable to give consent Patients who do not understand the French language Patients with less than 3 months of planned follow-up Patients with a barrier to follow-up Patients undergoing dialysis, transplantation
Young Smokers Have Impaired Airway Defense

Background: Smoking is a key factor for development and progression of chronic obstructive pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease, there are few studies that report physiological or inflammatory changes in the upper airways in young asymptomatic smokers. The investigators investigated physiologic and inflammatory changes in the nasal and lower airways of young smokers and if these changes were related to smoking history.

Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers) participated in this study. The investigators measured nasal mucociliary clearance (MCC), nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.


Eligibility Criteria:
Inclusion Criteria:

* healthy nonsmokers
* asymptomatic smokers
* after obtaining written informed consent

Exclusion Criteria:

* inability to understand and follow commands
* previous nasal surgery
* respiratory infection in the previous 30 days
* reported or diagnosed asthma
Infection Detection by Breath Analysis

The purpose of this feasibility study is to test a device which analyzes breath and may allow doctors and health professionals to immediately determine if an ill patient has a specific type of bacterial infection. This will allow a health professional to provide immediate targeted antibiotics to properly start treatment without delay.

Community acquired, or hospital acquired \[nosocomial\] infections \[pathogens\] are a common cause for morbidity and mortality. Initiation of antibiotic treatment is by best guess or using a broad spectrum antibiotic. The improper administration of antibiotics is known to lead to the developing specter of antibiotic resistant organisms.

Certain community acquired bacterial infection such as Streptococcus upper respiratory tract infections carry increased risk of morbidity secondary to risk of developing abscess, glomerulonephritis, and/or rheumatic fever. Commonly, most upper respiratory tract infections are caused by viruses. However due to the unknown pathogen causing an upper respiratory tract infection, with the risks of potential chronic severe complications from Streptococcus, initial treatment starts with either an antibiotic, or a typical 3day wait for bacterial culture result. Quite often, the wait-and-see approach in the community is not undertaken because of the difficulty in returning for a follow-up appointment.

The risk of a developing antibiotic resistant bacteria is well-known and is one of the greatest health threats worldwide leading to longer hospitalizations, higher medical costs and death, according to the World Health Organization. Thus a point of care device which would enable physicians or other medical practitioners to promptly discriminate between Streptococcal or other antibiotic sensitive pathogens versus non antibiotic sensitive viral causes of specific upper respiratory tract infectious pathogens is needed.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to participate in this study
* Availability of signed informed consent
* Healthy, not on any medication
* Able to provide a breath sample
* Having a condition (eg. suspected strep throat, MRSA, C difficile) which would require a swab/sample for culture

Exclusion Criteria:

* Under the age of 6years
* Eating food or drink (excluding water) within 2 hours of breath test time
* Pregnant or Breastfeeding
* Chronic Obstructive Pulmonary Disease (COPD)
* Inability to comply with study procedure/unable to follow directions
* Currently taking antibiotics or other medication (excluding analgesics)
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with macular edema resulting from retinal vein occlusion
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

* Known anticipated need for ocular surgery within next 12 months
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Diabetic retinopathy
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids
* Use of warfarin/heparin
Evaluation of the Quality of Life of Patients with DBB with the Installation of OPEP

To carry out an assessment of compliance and quality of life in a population (children and adults) with DDB before and after the use of an oscillating PEP. The aim is to determine the impact of the use of oscillating PEP on the daily life of this population in particular.


Eligibility Criteria:
Inclusion Criteria:

* Children (from 8 years of age) and adults over 18 years of age with DDB who doesn't use oscillating PEP.

The study population will be clinically stable and will be seen in follow-up consultations.

Exclusion Criteria:

* Children under 8 years of age.
* Patients who use an OPEP
* Patients in the acute exacerbation phase of their DDB
* Patients who are not under regular consultation
* Patients with severe, uncontrolled co-morbidities
* Patients with cognitive or psychiatric disorders preventing proper adherence to the study protocol
* Patients taking part simultaneously in another clinical study that could interfere with the results of the OPEP study