cyrilzakka/clinical-trials huggingface dataset:
Esophageal Balloon Measurements to Better Characterize Thoraco-abdominal Interrelationship Mechanics.

Esophageal pressure measurements in surgical patients requiring mechanical ventilation during abdominal laparoscopic or robotic surgeries requiring intra-abdominal insufflation.

Decades of research and clinical observation in mechanical ventilation have demonstrated unequivocally that tidal volume (VT), plateau pressure (PPLAT) and PEEP (positive end-expiratory pressure) influence ventilator induced lung injury. Clinicians, however, have struggled in the attempt to find a single indicator of safety and risk. Recent analyses of the large multi-center randomized trials database suggest that Airway Driving Pressure (ADP) and Trans pulmonary Driving Pressure (DTP) are the variables of greatest importance and therefore the best single parameters on which to focus. In attempting to define their optimal values and their correlation between each other in the setting of intra-abdominal hypertension, we would like to compare standard of care mechanical ventilation (control) with mechanical ventilation guided by DTP and ADP (intervention) in patients undergoing abdominal laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring mechanical ventilation for abdominal laparoscopic and robotic surgeries.
* Patients who are passively ventilated (no respiratory efforts) as a result of the sedation plan determined entirely by the primary anesthesia team --research team will not influence or participate on the sedation protocol plan or implementation.
* Patients who are clinically stable and able to tolerate the changes in position that are routinely conducted as part of the standard of care in the operative room.
* Patient/responsible family member signing the informed consent must speak English.

Exclusion criteria:

* Patients with open abdomen prior to surgical procedures.
* Females of childbearing age (18-50) with the potential to become pregnant and no clinically documented negative pregnancy test.
* Patients with clinically evident spontaneous breathing efforts (ventilator wave forms) during surgical procedure.
* Patients with clinical suspicion of elevated intra-cranial pressure (requiring head elevation).
* Contraindication to body position change, as dictated by surgery-specific protocol.
* Unstable cardio-respiratory insufficiency.
* Age less than 18 years.
* Cuff leak in endotracheal / tracheostomy tube.
* Patient/responsible family member unable to understand the informed consent in English.
* Patient with contraindication for nasogastric tube placement:

  * Severe midface trauma
  * Recent nasopharyngeal surgery
  * Coagulation abnormality
  * Esophageal varices, stricture, ulcerations, or tumors
  * Recent banding of esophageal varices
  * Alkaline ingestion
  * Diverticulitis,
  * Sinusitis, epistaxis
Building Social Networks to Enhance Postpartum Weight Loss and Appropriate Infant Feeding Practices

The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices.

The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal and infant development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to prevent obesity from developing by transmitting health information and health behaviors that 1) prevent postpartum weight retention in first time mothers and 2) promote appropriate infant feeding practices. The secondary aim is to assess which individual-level network-related characteristics best predict postpartum body composition and infant feeding practices.

Eligibility Criteria:
Inclusion Criteria:

* Latina (self-defined, or born in Central or South America)
* Spanish-speaking and/or English-speaking,
* 18 years of age or older
* less than 24 weeks pregnant
* did or did not have a termination of a previous pregnancy before 20 weeks
* has not carried a pregnancy to term
* normal, overweight or obese (pre-pregnancy BMI \>18.5 and \<39)

Exclusion Criteria:

* non-Latina,
* non-Spanish-speaking or non-English speaking
* less than 18 years of age
* more than 24 weeks pregnant
* had a termination of a previous pregnancy after 20 weeks
* multiparous
* underweight (pre-pregnancy BMI \< 18.5)
* morbidly obese (pre-pregnancy BMI ≥ 39)
* currently enrolled in another program that targets weight, physical activity, or nutrition
Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients

The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length of stay.

The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce ICU and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Thoracic surgery
* Planned admission to ICU after surgery

Exclusion Criteria:

* Younger than 18
* Pregnant
* Breast feeding
* Known diagnosis of obstructive sleep apnea
* Current or previous lung transplant
* Pneumonectomy
* Home oxygen greater than 4L/minute
* Inability to adhere to assigned treatment prior to 48 hours of surgery or until transferred to a floor
Person Centered Nursing Homes: Impact Assessment Of Centered Person Care In Nursing Homes

Cohort Observational Study. The study will assess differences in quality of life, well-being and mood between persons living in a nursing home following usual care and persons living in nursing homes following a centered person care model.

Initially, the follow up will last 6 months, with the possibility to be extended.


Eligibility Criteria:
Inclusion Criteria:

* Persons living in nursing homes
* Consent from the person (or legal representative, if the person is not able)

Exclusion Criteria:

* Terminal illness
* Living temporary in a nursing home
Effects of Group Music Therapy Interventions on Alzheimer's Disease Patients: a Three-arm Randomized Controlled Blind Study.

The purpose of this study is to determine what type of music therapy (active versus passive) approach has higher effects on clinical symptoms in advanced Alzheimer's disease patients

Ninety AD patients from six nursing homes participated in the study. Nursing homes were randomly and blindly assigned to receive for three months either active music intervention, passive music listening or usual care. Effects on cognition, behaviour, daily living activities and motor function were assessed after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Nursing-home dwelling
* Diagnosis of probable Alzheimer's disease
* Mild or moderate stage (Clinical Classification of the Dementia)

Exclusion Criteria:

* Aphasia
* Hearing impairment that may affect participation in the activities.
Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied

PRIMARY OBJECTIVES:

I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and Rituximab in patients with recurrent B-cell NHL.

SECONDARY OBJECTIVES:

I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression.

II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab on Bcl-2 protein gene expression.

OUTLINE:

Patients receive oblimersen sodium intravenously (IV) continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.

After completion of study treatment, patients are followed up every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Must have recurrent B-cell NHL and measurable disease
* No anti-lymphoma therapy within the past 4 weeks
* Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky)
* Absolute neutrophil count (ANC) greater than or equal to 1,000
* Platelets greater than or equal to 75,000
* Hemoglobin greater than or equal to 10 g/dL
* Bilirubin less than or equal to 1.5 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT) less than or equal to 2 times upper limit of laboratory normals
* Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals
* Serum creatinine less than or equal to 1.8 mg/dL
* Must sign a consent form, and must have a life expectancy of greater than 12 weeks
* No more than 3 prior chemotherapy regimens
* Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy

Exclusion Criteria:

* Human immunodeficiency virus (HIV) positive
* Active infection or history of opportunistic infections
* Pregnant women and women of childbearing age who are not practicing adequate contraception; men who are not willing to use an effective method of contraception
* History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years)
* Active autoimmune disease
* Other significant medical diseases
* Patients with chronic lymphocytic leukemia (CLL)
* Prior exposure to G3139
Quality of Life in IPF - Patient and Physician Perceptions

This study aims to evaluate the differences between patient's and their physicians' perception of quality of life and the effect of disease severity and co-morbidities. Patients and physicians will complete two sets of questionnaires at an initial clinic visit and again six months later.

Idiopathic Pulmonary Fibrosis is a progressive and debilitating disease characterized by progressive scarring of the lung parenchyma of unknown cause. In the US approximately 100,000 individuals have been diagnosed with this disease and the only cure available is lung transplantation. There have been two drugs approved by the FDA for treatment of IPF which have demonstrated the ability to slow disease progression but have no impact on quality of life.

Symptoms of IPF include shortness of breath, cough, and fatigue which all contribute to a decreased quality of life. Additionally, these symptoms and the need for supplemental oxygen use causes significant psychological and social impairment. Multiple questionnaires have been used to measure patient reported quality of life in both clinical and research settings. The King's Brief Interstitial Lung Disease (KBILD) Questionnaire is a disease-specific patient reported outcome measure and has been validated across several different patient groups and countries. Additionally, the EuroQol group has developed the EuroQol five dimensional 5-Level (EQ-5D-5L) questionnaire which is a non-disease specific assessment of health-related quality of life and has not yet been widely used in a population of patients with IPF.

Significant disparity between patient and physician perception of quality of life has been demonstrated across different disease processes. While there are many contributing factors to overall wellbeing the general assumption is that with more advanced disease quality of life predictably decreases. The investigators plan to test this hypothesis to better understand the complex relationship between chronic disease and quality of life in patients with IPF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a multidisciplinary diagnosis of IPF according to the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guidelines.
* All ranges of disease severity based on pulmonary function testing: forced vital capacity (FVC) and diffusing capacity (DLCO).

Exclusion Criteria:

* Any impairment or co-morbid disease that results in an inability to read or understand a questionnaire or provide informed consent. The study team member will make this determination according to their best clinical judgement.
* The questionnaires will be administered in English language only and thus this study will be conducted in patients who are able to read, write, and speak English language.
A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.


Eligibility Criteria:
Inclusion Criteria

* Must have what doctors call measurable disease, which will be evaluated before each participant take part of the study.
* Must have received both a BTKi and a BCL2i treatment, and their disease must have come back or not responded to treatment, or they must not have been able to tolerate the side-effects of the BTKi and/or BCL2i treatment(s).
* Must also have an ECOG performance score of 0 or 1, which means they are able to carry out their normal daily activities without any problems.

Exclusion Criteria

* Heart problems.
* Bleeding disorders.
* Active cancer in their brain.
* Other reasons include:.

  i) Having certain treatments in the past.

ii) Having certain infections that are not under control.

iii) Having certain brain conditions.

- Other protocol-defined Inclusion/Exclusion criteria apply.
Acupuncture-tDCS Convergence Rehabilitation Effect on Stroke Patients

The purpose of this study is to confirm the convergence effectiveness of on acupuncture of the chinese medicine and the tDCS of the western medicine on motor function for patients with acute stroke compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Those who within 2 weeks or more and 6 months after a stroke diagnosis.
* Those who have a lesion with a cortex or subcortex
* Adults over 19 years old
* Inpatients and outpatients who can mediate for 4 weeks
* Those who can understand and follow the purpose of this study

Exclusion Criteria:

* Those who fall under the exclusion criteria for electrical acupuncture or acupuncture or tDCS
* Those who have a experience about adverse reaction to the existing electrical acupuncture or acupuncture or tDCS
* Those who have major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
* A person who judges that it is not appropriate for a researcher to participate in this study
Incisional Hernia Repair Long-term Outcomes

Long-term extension of a previous trial comparing outcomes after open (OVHR) or laparoscopic incisional ventral hernia repair (LVHR), assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up.

Long-term studies comparing outcomes after open (OVHR) or laparoscopic incisional ventral hernia repair (LVHR) are scarce. We carried-out a long-term extension of a previous trial comparing both approaches, assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up.

Patients will be followed to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index surgery (between 2003 to 2006) until recurrence, death or study completion with a clinical revision (between 2017 to 2019) whichever was first. By intention to treat, incidence rates of recurrence, reintervention and death by 1000 person-year of follow-up will be estimated, and also rates of mesh complications by 1000 person-year for the LVHR group excluding conversions. Quality of life, using the European Hernia Society Quality of Life score (EuraHS-QoL), will be assessed for survivors no reoperated patients

Eligibility Criteria:
Inclusion Criteria:

* Incisional hernia between 5 and 15 cm in largest diameter
* No ontraindication for laparoscopic surgery.

Exclusion Criteria:

* Patients with any type of stoma,
* Non-residente in the Valencia región
Educational Intervention in Heart Failure Patients

The main aim of this randomized study was to evaluate the effect of educational intervention on patients with heart failure and their care-giver with regard to patients' prognosis.

Part I: This is a multicenter study on the effect of educational intervention on heart failure patients and their caregivers with respect to patients' prognosis, social support and quality of life. Subsequent patients with heart failure (based on the inclusion criteria) coming to selected, ambulatory physician, were randomized to either a control or intervention group. Both groups underwent questionnaire evaluation regarding clinical assessment and evaluation of familiarity with aspects of heart failure along with social support and quality of life. Clinical assessment included information on demography, social status, medical history, pharmacotherapy, diagnostic procedures, and utilization of health system resources. After recruitment, patients from intervention group and their caregivers underwent one educational training, during which they received materials on the management of heart failure. Before the meeting, data on familiarity with heart failure were acquired from patients' relatives. During further follow up all participants stayed under regular care from their ambulatory physicians. After 6 months patients underwent short term evaluation based on designated questionnaires, with special attention paid to hospitalization and ambulatory visits due to heart failure. Also data on heart failure knowledge, social support and quality of life was collected. Without any further intervention, follow up was continued. Next long term assessment was undertaken after approximately 3 years from the recruitment. As previously patients fulfilled questionnaires regarding information on their familiarity with heart failure management and social support as well as quality of life. Primary end points of the study were: death, hospitalization (including cardiovascular hospitalizations) and ambulatory visits. Secondary end points included social support and quality of life.

Sub-study: genetic polymorphism - blood specimens collected during one of the visits and stored for further evaluation in future. Study population - all main study participants who gave their informed consent to this part of protocol. Aims: to describe the potential of selected genes candidates polymorphism on the heart failure prognosis and survival in patients NYHA class II-IV.

Eligibility Criteria:
Inclusion Criteria

* Symptoms of heart failure
* EF \< 45% (during past 2 years) or abnormal ECG and chest x-ray when echo unavailable
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Severe COPD
* Serious comorbidities, influencing life expectancy or quality of life
* Alcohol and drug addict
* Post MI less than 6 months
* Dementia
* Living in home nursing facilities
Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal

The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
2. Comparison of demographic characteristics between the two groups

   * Group 1: women accepting to participate in RCT
   * Group 2: women refusing to participate in RCT
3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Eligibility Criteria:
Inclusion Criteria :

Inclusion criteria are the same as for the RANSPRE trial.

Any pregnant woman is eligible if:

* monofetal pregnancy
* between 11 and 14 weeks
* legal age
* health insurance coverage

Exclusion Criteria :

Inclusion criteria are the same as for the RANSPRE trial. A history of pre-eclampsia in a previous pregnancy and a contraindication to aspirin are non-inclusion criteria.
Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.
* Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

* There are no specific exclusion criteria for this study