cyrilzakka/clinical-trials huggingface dataset:
A Long-term Follow-up Study of Participants Who Received an Allogeneic CAR T-Cell Product

The goal of this study is to collect information on the long-term safety of study participants who received Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in a Precision BioSciences, Inc. (PBI) Clinical Study. The main questions it aims to answer are:

-What were the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?

Participants will visit a study center 3 times during the first year, and once per year after that for a physical exam and other assessments to check for CEI.

This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in a PBI clinical study involving PBCAR product dosing. This study protocol does not include administration of a PBCAR product; however, subjects may receive investigational products other than a PBCAR product through participation in other clinical studies during the period of this observational study.

Eligibility Criteria:
Inclusion Criteria:

* Receipt of at least 1 dose of PBCAR product in a PBI clinical study.
* A signed informed consent form (ICF).
* Willingness and ability to adhere to the study schedule and all other protocol requirements.

Exclusion Criteria:

* No unique exclusion criteria apply to this study.
Free Time For Wellness Pilot Effectiveness Trial

Physical inactivity is pervasive and prevalent in the United States, particularly among women of low socioeconomic position, and women with children. Structural and social barriers make active leisure time a rare commodity creating a pressing health issue because physical inactivity increases the risk of chronic diseases and poor health. The broad objective of this study is to pilot test the Free Time for Wellness (FT4W), an innovative multilevel physical activity intervention to increase physical activity among low-resourced mothers.

Physical inactivity is particularly prevalent in women of low socioeconomic position (SEP) (60% are inactive), suggesting that there are structural barriers to being physically active. This study will pilot test the intervention to increase physical activity among mothers of low SEP, where there is high risk of chronic disease and significant potential to make an impact on these health disparities.

This study comprises a 3-arm parallel cluster randomized controlled trial with low-resourced mothers living in New York City. The study team will randomize fitness class sites (clusters) into Arm A (contact control), receipt of free weekly fitness classes; Arm B, receipt of free childcare combined with free weekly fitness classes; and Arm C, receipt of free childcare combined with free weekly fitness classes and, plus peer support activities. The study team will recruit 90 participants into 3 fitness classes. Physical activity is the primary outcome measured using accelerometers, a self-reported questionnaire, and attendance data. Secondary outcomes (e.g., health status) and mediators/moderators (e.g., social support and cohesion) will be assessed with a baseline and follow-up questionnaire. Ethnographic methods will be used to examine how intersecting forms of social inequality shape women's experiences of physical activity and to understand how real-world conditions shape the intervention implementation. The intention-to-treat analysis will employ linear mixed-effects models (LMM) to assess the main intervention effects on physical activity outcomes and other secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Understand/speak English or Spanish
* Have children \<12 years old
* Own a mobile phone
* Live in the zip code surrounding as Shape Up NYC sites

Exclusion Criteria:

- Total household income being greater than 165% of the area median income (calculated by household size).
GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment

This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinson's disease (PD). Globus pallidus interna (GPi) stimulation is an established treatment for the motor symptoms in PD, but it does not treat the cognitive symptoms that can also be seen in this condition. It is theorized that we can improve cognitive dysfunction by stimulating a part of the brain called the nucleus basalis of Meynert (NBM), which releases a chemical (acetylcholine) and plays a role in memory and attention. By using a novel DBS system (Vercise device) with 2 electrodes that are designed to stimulate the GPi and NBM, we can potentially target the motor and cognitive symptoms of PD with a single intervention.

Neuronal loss within the cholinergic nucleus basalis of Meynert (NBM) correlates with cognitive decline in dementing disorders such as Alzheimer's disease and Parkinson's disease (PD). Deep Brain Stimulation targeting the Globus Pallidus interna (GPi) is an established treatment for the motor symptoms in Parkinson's Disease, and stimulating the NBM is believed to stimulate cognitive function. Targeting these two regions was previously impossible because they require different frequency stimulations, but recent developments in DBS technology allow for the dual stimulation of these nuclei at different frequencies.

This phase-II double-blind cross-over pilot trial will investigate the motor and cognitive effects as well as the presence of adverse effects of combined NBM and GPi DBS. The main goal of this pilot trial is to demonstrate the feasibility and safety of the multi-targeting approach in 6 patients with PDD and disabling motor symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. PD-MCI that affects multiple cognitive domains (including memory, visuo-spatial deficits etc.). diagnosis based on a comprehensive neuropsychological assessment (gold-standard) allowing the application of Level II MDS diagnostic criteria (Dubois et al. 2007)
2. PD fulfilling standard criteria for bilateral GPi DBS surgery
3. Patient's ability to provide informed consent and comply with study protocol.

Exclusion Criteria:

1. Severe Parkinson's disease dementia, preventing completion of the neuropsychological assessment, compliance with the study protocol, or ability to provide informed consent.
2. Inability to be fluent in English.
3. Unstable dose of any cognitive enhancing medication.
4. Presence of other neurological disorders, severe active psychiatric conditions or previous brain surgery.

Other conditions contraindicating DBS, PET scanning or MRI scanning.
Tissue Perfusion Indices as Predictor of Outcome in Poly Trauma Patients

Early intervention and resuscitation based upon a lot of clinical, laboratory findings make a big difference regarding outcome in poly trauma patients, the study uses the dynamic lactate change and the difference between arterial and venous CO2, oxygen tension or content as indicators for tissue perfusion.

Poly trauma patients have high incidence of mortality and morbidity in spite of improvements and advances in facilities. However, no doubt that early resuscitation and interventions make a big difference upon the overall outcome.

A lot of methods, indices, laboratory and biomarkers have been utilized to evaluate the progress and quality of resuscitation and the early hospital interventions in such group of critically ill patients including central venous pressures, urine output, mixed venous oxygen saturation, and gastric tonometry. Most of recent means focus upon the regional tissue perfusion rather than global, however some researches have tried the difference between arterial and venous CO2,oxygen tension or content ( Pv -a co2\& Pa -v O2 ) in addition to dynamic changes in lactate(3) as predictors for tissue perfusion in sepsis patients after establishment of sepsis campaign (bundle).

Eligibility Criteria:
Inclusion Criteria:

* multiple trauma patients Adult patients

Exclusion Criteria:

* cardiac renal chronic chest disease diabetic more than 3 years
Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery

The goals of this study were to investigate whether two anesthesia regimens, with and without N2O, and bacterial colonization influence respiratory complications after major abdominal surgery for cancer.

A study was approved by institutional ethics committee. All patients were informed on the study protocol by attending anesthesiologist on the day of the surgery and written informed consent was obtained. Patients with clinically or radiologically confirmed acute respiratory infections or those using antibiotics due to the respiratory infections a week prior to the surgery were not included in the study. Following risk factors were recorded in all patients: age, sex, weight loss in the last 6 months, comorbidities and operative time. Comorbidities were rated using ASA status and Charlson comorbidity index by 3 independent observers. Charlson comorbidity index was calculated after pathological examination. An advanced malignant disease was considered if tumor had infiltrated other organs or surrounding tissues, or when positive lymph nodes or metastases were confirmed.

A group of 120 colorectal, gastric, or pancreatic cancer patients scheduled for surgery in the single centre were included in the prospective randomized study regardless of their ASA physical status. Nasopharyngeal smears were obtained in the preoperative area and tracheal aspirates were obtained in the operating room at the end of the surgery with a sterile suction catheter in a closed system.

Postoperative Hgb; CRP and lung auscultation were done in all patients on the second and fourth postoperative day.

Outcome measures registered were:

* Postoperative pneumonia
* Productive and difficult cough
* Dysphonia
* Congestive heart failure
* postoperative complications, including hypertensive crisis, thromboembolic and infective complications were summarized one year after surgical treatment was finished \& one year survival

Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosis of gastric cancer, or colorectal cancer or pancreatic cancer
* Scheduled for major abdominal surgery with organ resections
* Written informed consent
* Nasopharyngeal smears taken in the preoperative area
* Tracheal aspirates taken at the end of the surgical procedure

Exclusion Criteria:

* Patients unable to understand study protocol and patients who refused study participation at any time
* patients with clinically or radiologically confirmed acute respiratory infections at admission
* antibiotic therapy due to the respiratory infections a week prior to the surgery
DIAFAX I+II-Effects of Inhalative Anesthetics on Left Ventricular Diastolic Function

Anaesthetics may impair the diastolic function of the heart, but the importance of this finding for patients has not been sufficiently examined. Specially the effects on diastolic function in patients with diastolic dysfunction has to be determined. The aim of this study is to examine the effect of isoflurane (only part I), sevoflurane and desflurane (part I+II) on the diastolic left ventricular function by doppler echocardiography.

In part I, 60 healthy young subjects free from cardiovascular disease will be examined. In part II, 50 patients with impaired diastolic but preserved systolic function, i.e., patients with arterial hypertension and ejection fraction \> 50%. Doppler echocardiography will be performed at baseline before induction of anaesthesia, during anaesthesia in the spontaneously breathing patient, and in the mechanically ventilated patient.

Eligibility Criteria:
Inclusion Criteria:

* part I: 18- to 50-year-old patients undergoing surgical procedures under general anesthesia
* part II: 50-years-old patients or older with arterial hypertension under chronic antihypertensive medication subsequently undergoing surgical procedures under general anesthesia, EF \>50%

Exclusion Criteria:

* part I: any cardiac or pulmonary disease, any medication with cardiovascular effects or side effects, body mass index \> 30 kg/m2, esophageal reflux, emergency
* part II: History of myocardial infarction or coronary revascularization, severe lung disease, body mass index \> 30 kg/m2, esophageal reflux, emergency
Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection


Eligibility Criteria:
Inclusion Criteria:

* CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
* Naïve to nucleoside/nucleotide analogues except for LVD
* HBV DNA \> 17,200 IU/mL
* Compensated liver function
* Serum ALT \<10 × ULN

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Evidence of decompensated cirrhosis
* Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD

COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is obscure, therefore more insight is needed to design effective anti-inflammatory agents. We hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and aberrant inflammatory response to cigarette smoke. This susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment.

Objective:

* To define mediators involved in the early induction of COPD in susceptible smokers (and so to define new drug targets)
* To develop new biological and clinical markers for the early diagnosis and monitoring of COPD
* To compare between susceptible and non-susceptible individuals the corticosteroid responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of smoking-induced corticosteroid unresponsiveness.
* To study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs.

Primary study parameters/outcome of the study:

* Local inflammation before and after cigarette smoking assessed by exhaled breath condensate, microprobe sampling and bronchial biopsies.
* Systemic inflammation before and after cigarette smoking assessed by the expression of established and newly developed markers on innate immune cells associated with pre-activation.
* Extensive clinical characterisation including life style factors, lung function, CT scanning of the lung.
* Corticosteroid responsiveness of epithelial cells in vitro.
* Distribution of candidate genes (SNPs) for COPD between the 5 different groups ( see description below) and associations with the inflammatory responses on acute smoking.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above.
* Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour
* Physically and mentally able to undergo the total study protocol
* Written informed consent

Exclusion Criteria:

* Participation in another study
* Alpha-1-antitrypsin deficiency
* Selected grade 1-3 co-morbidity listed in the ACE-27
* Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
* Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc
* Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis
* Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc
* Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol
Labor Scale Versus WHO Partograph for Management of Labor (ScaLP)

The current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard WHO partograph, in the management of primiparous women, including CD rate, maternal and neonatal outcomes of labor.

Since the procedure was first introduced to clinical practice, Cesarean delivery (CD) has significantly contributed to peripartum maternal and fetal safety when appropriately indicated. Nevertheless, CD rate has significantly increased over the last two decades without parallel improvement in maternal or neonatal outcomes. Globally, one out of three pregnancies would be delivered by CD, resulting in growing surgical, obstetric and financial burden. Over years, long-term sequelae of current CD rate have become evident such as increased incidence of placenta accreta spectrum and exponential rise in CD trend, since 90% of women who had CD are susceptible to CD in future pregnancies. These concerns have triggered a global act to control CD rates within the margins of safe obstetric practice.

The most common indication of CD is labor dystocia. However, the definition of labor dystocia is inconsistent, and standardization of diagnosis has been heavily investigated. The WHO partograph was established at the end of the last century to serve as a tool to recognize labor dystocia and has been universally accepted to verify CD decision However, a cochrane review by Lavender et al. revealed that role of WHO partograph, in improving clinical outcomes, is lacking. In addition, there is no evidence that any published modification of the current partograph is superior to another. The "labor scale," a novel alternative to the classic partograph, was first introduced to literature in 2014. The tool was designed based on evidence-based guidelines and integrates both diagnosis and interventions to manage labor dystocia. Initial data showed that labor scale contributed to decreased incidence of CD and oxytocin administration. However, further studies are required to verify these results.

Eligibility Criteria:
Inclusion Criteria Pregnant women aged 18 to 45 years old with the following criteria: nulliparous, had been pregnant for 37 to 41 weeks with a singleton viable fetus, and vertex presented, and with estimated fetal weights between 2,500 and 4,500 g.

Exclusion Criteria Women with following criteria will be excluded: significant maternal medical or surgical comorbidity, previous uterine scar
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers

The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.


Eligibility Criteria:
Inclusion Criteria:

* Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception until they are discharged from the study
* Willing to give written informed consent
* 18 to 50 years of age
* BMI of 19-30 Kg/m2
* Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
* Good general health as determined by medical history, physical examination, ECG and clinical laboratory tests
* Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing

Exclusion Criteria:

* Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and MDT would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
* Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
* History of significant nasal irritation from nasal inhalation of medication
* History of malignancy
* History of clinically significant alcohol or drug abuse
* Positive drug screen for drugs of abuse
* Positive test for HIV, Hepatitis B or Hepatitis C
* Allergy to lactose, or lactose intolerance
* Use of prescription medication within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
* Positive serum pregnancy test at Visit 1
* Inability to perform reproducible spirometry
* Abnormal FEV1, FVC, or FEV1/FVC (FEV1and FVC \< 85% of predicted and variability of \<5% or FEV1/FVC ratio \< 0.7)
* Abnormal QTc interval at Visit 1(\>450 msec in males or \> 470 msec in females)
* Significant blood donation (or testing) in previous 8 weeks
Establishing the Validity and Reliability of a Dexterity Assessment Tool

Every year, thousands of Canadians are diagnosed with degenerative cervical myelopathy (DCM), a form of non-traumatic injury caused by spinal cord compression in the neck. While DCM causes a range of symptoms, one of the most disabling is loss of hand dexterity. Surgical decompression is standard treatment for DCM, but reduced dexterity often remains.

The investigators have developed a portable, easy-to-use dexterity assessment tool for measuring hand dexterity. Hand function is often assessed using tools incapable of measuring subtle changes in function, limiting a clinician's ability to monitor progression of or recovery from a disease over time. The hope is that if subtle changes in function are identified early, leading to an early DCM diagnosis and treatment, this may prevent patients from experiencing a greater loss of hand function.

The goals of this study are to determine the relationship between dexterity and myelopathy severity, as well as to establish the validity and reliability of the dexterity tool. This will be done by assessing dexterity using the dexterity tool in DCM patients (to determine the relationship between disease severity and dexterity, and measure validity) and healthy participants (to establish reliability).


Eligibility Criteria:
Inclusion criteria for patient participants

* Has been diagnosed with DCM
* Are between the ages of 35 and 75 years
* Has no other neurological disorder Inclusion criteria for healthy participants
* Are between the ages of 35 and 75 years
* Has no neurological disorder

Exclusion criteria for all participants:

• Does not fluently speak and read English