cyrilzakka/clinical-trials huggingface dataset:
Safety of Stem Cells Intrabronchial Instillation for Silicosis

The aim of this study was to analyze the safety, pulmonary function, and quality of life data of patients with silicosis treated with intrabronchial instillation of bone marrow derived mononuclear cells (BMDMC, 2x107) through bronchoscopy.

This study will perfume the safety (Phase I) study of 10 patients with silicosis treated with intrabronchial instillation of autologous bone marrow derived mononuclear cells (BMDMC, 2x107) through bronchoscopy. The inclusion criteria is: age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 \<60% and \> 40%, FVC \> 60% and SaO2 \>90%, while the exclusion criteria were: smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy. All patients will be subjected to clinical examination, answered questionnaires of quality of life (SGRQ and SF36) and dyspnea score (Borg), performed high resolution CT of thorax, pulmonary function tests with DLCO and 6-minute walk test and lung perfusion scintigraphy before and 7, 30, 60, 180 and 360 days after treatment.

For each patient, 2×107 cells will be labeled with 99mTc. Briefly, 500 μl of sterile SnCl2 solution is added to the cells and the mixture is incubated at room temperature for 10 min. Forty-five mCi of 99mTc is then added and incubation continued for another 10 min. After centrifugation (500×g for 5 min), the supernatant is removed and the cells are washed in saline solution. The pellet was also resuspended in saline solution. Viability of the labeled cells was assessed by the trypan blue exclusion test, and was estimated to be greater than 93% in all cases. Labeling efficiency (%) was calculated by the activity in the pellet divided by the sum of the radioactivity in the pellet plus supernatant and was estimated to be greater than 90% in all cases. Whole body and planar scans will be performed 2 and 24h after instillation. Perfusion scintigraphy will be performed before and 30, 60, 120 and 180 days after BMDMC therapy. For regional analysis the right and left lungs will be divided into three zones: base, midzone, and apex.

Eligibility Criteria:
Inclusion Criteria:age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 \<60% and \> 40%, FVC \> 60% and SaO2 \>90%

Exclusion Criteria: smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy
Effect of the Consumption of a Fermented Dairy Drink on the Immune Function

The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion
* Able to comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.
* Body mass index (BMI): 18,5 \< BMI \< 30 kg/m².

Exclusion Criteria:

* Contra-indication to any of the products and procedures used for the study purpose
* Participation in another clinical trial
* People currently institutionalised
* Immunocompromised conditions or other conditions that may impact the immune response or the product effect
* Subjects suffering from a not stabilized chronic disease
* Subjects suffering from a sever acute or chronic disease
* Subjects suffering from a condition which is at a stage where it might prevent him/her from being able or willing to comply with the study procedures or completion
* Subject known to be deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Subject identified as employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the centre's employees or the Investigator.
Text Message Nudges for COVID-19 Vaccination

The COVID-19 pandemic has caused significant morbidity and mortality across the world. Effective vaccines are now available but underutilized. In July 2021, Ascension Health implemented a mandate requiring all employees to obtain the COVID-19 vaccine by November 12th. In August 2021, the number of COVID-19 cases in the US increased rapidly, specifically in states with lower vaccination rates, many of which are served by Ascension Health facilities. In this study, we will evaluate a rapidly deployed health system initiative to use text messaging to nudge Ascension employees who have not yet been vaccinated to commit to a date and receive vaccination.

The COVID-19 pandemic has caused significant morbidity and mortality across the world. Effective vaccines are now available but underutilized. In July 2021, Ascension Health implemented a mandate requiring all employees to obtain the COVID-19 vaccine by November 12th. In August 2021, the number of COVID-19 cases in the US increased rapidly, specifically in states with lower vaccination rates, many of which are served by Ascension Health facilities.

Nudges are subtle changes to the way information is framed or choices are offered that can have a significant impact on behavior. Status quo bias is a preference for the current state which is often used as a reference point when making decisions. Changes from the reference point are often faced with high inertia and this prevents changes in behavior. Default options are the setting of the baseline reference point and are often taken as an implicit recommendation. In prior work, changing default options has led to significant changes in health-related behaviors. For example, changing prescription default settings in the EHR from opt-in to opt-out for generic prescriptions increased the rate of generic prescriptions from 75% to 98% across Penn Medicine (Patel et al. Annals of IM. 2014; Patel et al. JGIM 2018). Framing program participation as opt-out has led to a 22% increase in enrollment in a COVID-19 surveillance testing program (Oakes et al. NEJM Catalyst 2021) and triple enrollment in remote monitoring programs for medication adherence (Mehta et al. JAMA Cardiology. 2018) and diabetes management (Aysola et al. AJHP 2016)

Eligibility Criteria:
Inclusion Criteria:

* Ascension Associate Employee

Exclusion Criteria:

* Prior vaccination for COVID-19
* Exemption from COVID-19 vaccination
ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma

The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
* Aged 18 to 60 years
* Non previously treated
* With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
* Negative HIV, HBV and HCV serologies (except vaccination)
* With a minimum life expectancy of 3 months
* Having previously signed a written informed consent

Exclusion Criteria:

* Any history of treated or non-treated indolent lymphoma.
* T-cell lymphoma.
* Central nervous system or meningeal involvement by lymphoma.
* Any Contra-indication to any drug contained in the chemotherapy regimens.
* Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Serious active disease (according to the investigator's decision).
* Poor bone marrow reserve as defined by neutrophils \<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Childbearing woman.
* Patients previously treated with an organ transplantation.
Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease

In recent years, abnormalities in gut microbiota have been identified in patients with Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological therapy to receive treatment with sodium phosphate enema, oral rifaximin and polyethylene glycol to improve motor complications.

We studied consecutive patients diagnosed with PD according to the Queen Square Brain Bank Criteria \[Hughes et al 1992\] in a tertiary care center for movement disorders, from June 2018 to March 2020.

Eligibility Criteria:
Inclusion Criteria:

- patients aged 18-years old or older with moderate to severe dyskinesia and/or motor fluctuations with incomplete or poor response to adjustments in time and dose of levodopa and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher than 8 following pharmacological adjustments.

Exclusion Criteria:

* patients with chronic renal failure, decompensated heart failure, colonic abnormalities precluding the use of evacuating enema, known allergies to prescribed medications to reduce microbiota load and patients who declined to participate in the study.
Telerehabilitation in Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. These symptoms cause significant functional impairment that affects patients' quality of life. Pain neuroscience education (PNE) combined with therapeutic exercise (TE) has shown good results in patients with chronic pain, but the effects of this multimodal treatment via telerehabilitation have not been studied in patients with CTS. Telerehabilitation has demonstrated clinical and functional outcomes as effective as face-to-face interventions, being a good alternative to improve accessibility to rehabilitation care in a context of pandemic and social distancing. The purpose of this study is to provide coordinated, patient-centered care by implementing a Telerehabilitation model for patients with severe CTS. The objective of this study was to compare the effectiveness of a multimodal therapy program (TE plus PNE) versus a unimodal treatment (TE) in patients with CTS.

A Randomized Controlled Trial, simple-blind and multicenter study will be conducted. Patients will be randomly assigned to the multimodal treatment group (TE plus PNE) or to the unimodal treatment group (TE). At admission, an investigator blinded to treatment assignment will conduct data collection. The measurements will be the following outcomes: a) Pain Catastrophizing Scale; b) Tampa Scale for Kinesiophobia-11; c) Numerical Rating Scale (NRS); d) Boston Carpal Tunnel Questionnaire; e) Hospital Anxiety and Depression Scale; f) Quality of Life, using the EQ-5D instrument; g) Patient's global impression of change; h) Katz Diagram; These evaluations will be performed again at week 6 and 12.


Eligibility Criteria:
Inclusion Criteria:

* Over 20 years of age, severe CTS medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study.

Exclusion Criteria:

* Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants will be both males and females, 18-65 years of age included.
* diagnosis of OCD
* all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
* Affiliation to a social security system (recipient or assignee),
* Signed written inform consent form

Exclusion Criteria:

* The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness
* In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
* The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0.
* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
* Patient under curators
* Patient hospitalized under duress
* Patient unable to give his or hers informed consent
Physical Activity Levels of Hypertensive and Healthy Individuals Under Social Isolation During the COVID-19 Pandemic

COVID-19 is an emergency situation which broke out from China in 2020. Health commitees and goverment set some rules and limit people's freedom to leave from their houses and it is called as 'social isolation'.Staying at home and disease bring about sedentary lifestyle, anxiety and depression and changed eating habits of all person. Hypertension is an important cardiovasculary risk factor and physical activity, stress managament are very important for disease control. In that study we aimed to assess hypertensive and healthy person's anxiety level, physical activity and qualit of life level during COVID-19 social isolation.

COVID-19 is an emergency situation which broke out from China in 2020. Health commitees and goverment set some rules and limit people's freedom to leave from their houses and it is called as 'social isolation'. With social isolation people were restricted to go outside from house and with that they had to stay at home. Staying at home and disease bring about sedentary lifestyle, anxiety and depression and changed eating habits of all person. It was very dangerous especially chronically ill persons. Physical activity and exercise are keystones for managing cardiovasculary disease risk factors. Hypertension is important risk factor all around the world. Disease control is important to prevent complications. In that study, we aimed to assess hypertensive and healhty individuals' physical activity, anxiety, healthy lifestyle habits and quality of life with changed life condition during COVID-19 social isolation.

Eligibility Criteria:
Inclusion Criteria:

* Social and occupational restriction because of COVID-19 pandemic
* Not having speech and hearing problems
* To be cooperate
* Not having mental, neurological, orthopedic, cardiovascular or pulmonary problems that prevent physical activity

Exclusion Criteria:

* Presence of medical indications requiring complete restriction of physical activity
* Having symptoms of COVID-19 and suspected disease
* Coronavirus infection in the past month
* Concomitant history of cardiovascular disease
Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients

The objective is to perform a retrospective chart review of patients with cachexia related to cancer in patients treated at UT Southwestern Medical Center and Parkland Hospital to evaluate the prognosis and practice patterns in management of cachexia and associated symptoms.

The definition of cachexia has not been fully elucidated, but there are many similar parameters and guidelines associated with identifying patients with cachexia. Cachexia is a clinical diagnosis associated with weight loss, decreased muscle mass (sarcopenia), decreased strength, fatigue, and an increased inflammatory state. Patients with cachexia have a poorer prognosis than patients who have maintained their weight. Also, patients who have lost weight prior to initiating definitive therapy have worse side effects from subsequent therapy.

This study involves no treatment or invasive procedures. The chart review will attempt to characterize lung and gastrointestinal cancer related cachexia in the setting of a palliative care clinic including both primary treatment and treatment at the time of recurrence. Interventions in cachectic patients for weight control including nutritional support and supplements, pain control, anti-inflammatory medications, and appetite stimulants will be tracked along with clinical markers including weight and laboratory values.

Eligibility Criteria:
Inclusion Criteria:

Medical charts representing patients with a diagnosis of lung or gastrointestinal cancer with a tissue diagnosis from 1/1/2005 and onward treated at UT Southwestern or Parkland.

Exclusion Criteria:

There will be no absolute exclusion criteria as long as the inclusion criteria have been met.
Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement

All subjects used the placebo sample on the left side of their face and the investigational sample on the right side of their face, respectively. The moisturizing levels were detected before use (0 week), after 2 weeks and after 4 weeks. The wrinkles of subjects were also measured on the same date interval as the skin moisture level test.

Twenty-two subjects were initially enrolled in the clinical trial. One subject was excluded by non-compliance with the plan of trials. All subjects used the placebo sample on the left side of their face and the investigational sample on the right side of their face, respectively. The moisturizing levels were detected before use (0 week), after 2 weeks and after 4 weeks. The crow's feet of subjects were also measured on the same date interval as the skin moisture level test.

Eligibility Criteria:
Inclusion Criteria:

* Females with dried skin, aged 30-59 years (average=49.2 yrs).
* The subject has eye wrinkles (crow's feet).
* A person who has voluntarily signed consent after fully explaining the test purpose and content.
* Those who can follow up during the test period.
* A healthy person without acute or chronic physical disease including skin disease.

Exclusion Criteria:

* Pregnant or lactating women and women of childbearing age who do not agree to the contraceptive method prescribed by the protocol.
* A person with a lesion at the test site or suffering from an infectious skin disease.
* People with allergies or hypersensitivity, or irritation to cosmetics, pharmaceuticals, or daily exposure to light.
* Those who have received systemic steroids or phototherapy within 1 month of participating in the trial, or who have received skin treatment (scaling/botox/filler/laser/tattoo) within 3 months of participating in the trial.
* Those who have used drugs with similar functions at the research site within 3 months before the start of the study, or have a mental illness, or mental retardation disorder.
* Other than the above, a person who will make it difficult to conduct a human test based on the judgment of the responsible researcher or the person in charge of the study.
Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma

The purpose of this research is to collect health-related information as well as bone marrow and blood specimens to determine if a new form of treatment for patients with kidney and bladder cancer may be possible.

This research will collect specimens from the bone marrow and blood to determine if a new treatment for kidney or bladder cancer may be possible. This research study will collect a bone marrow sample as well as a blood sample.

Participation in the research study will last approximately 60 days which includes time to determine if the patient is eligible to participate in the study, perform the research procedures and follow-up with the patient following the research procedures to determine if they are experiencing any side effects. Participation will end approximately 30 days following the bone marrow collection.

The bone marrow and blood samples will be collected from all patients in both cohorts only at a single time point, after they have been enrolled on the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically-confirmed, locally advanced unresectable or metastatic RCC (cohort A) or UC (cohort B).
* ECOG performance status of ≤1
* Adequate bone marrow function:

  * Platelet count ≥ 100 × 10\^9/L
  * ANC ≥ 1.0 ×10\^9/L
  * Lymphocyte count ≥ 0.5 ×10\^9/L
* Willingness to undergo bone marrow aspiration (BMA)

Exclusion Criteria:

* Prior hematopoietic stem cell transplantation
* Prior radiation to the pelvic region
* Use of systemic corticosteroids within 28 days of BMA
* History of another primary malignancy that has been diagnosed or required therapy within the past 2 years (except completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site).
* Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. If the autoimmune disease has been treated, it must be stable clinically. (Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is not considered an exclusion criterion.)
* Pregnant females as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 21 days of BMA
* Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of BMA
* Known diagnosis of HIV or CMV infection or active viral hepatitis
* Administration of hematopoietic growth factor support within 14 days before bone marrow aspiration
* Chemotherapy administration within 28 days of BMA
* Unwilling or unable to comply with the protocol
* Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject.