cyrilzakka/clinical-trials huggingface dataset:
Apoptotic Cell (AC) Uptake by Human Alveolar Macrophages (AM)

The purpose of this study is to compare the ability of two types of white blood cells to eat dead host cells, and how this process affects their ability to protect the body from infection. The two cell types are monocytes, a cell in the bloodstream, and alveolar macrophages, a cell in the lung that is ultimately derived from monocytes

Volunteers, who may be Veterans or non-Veterans, will be screened by a series of questionnaires, chest X-ray, spirometry, EKG, blood work, and a complete history and physician examination by a study physician. Those who qualify for the study and agree via informed consent, will undergo a fiberoptic bronchoscopy on a separate day for the initial visit. Bronchoscopy is a procedure in which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs. During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages. This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy. The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours. The cells collected by bronchoscopy will be studied in the research laboratory, and used entirely in that procedure.

Eligibility Criteria:
Inclusion Criteria:

* Veteran or non-Veteran
* Able to give informed consent

Exclusion Criteria:

* Unstable heart disease
* Other systemic disease and unlikely to survive at least 2 years
* Mental incompetence
* Prednisone \>20 mg/day
* Participation in another interventional protocol within last 6 weeks
* Asthma
* Cystic fibrosis
* Clinically significant bronchiectasis
* Lung cancer or any cancer not in remission for at least 5 years
* Other inflammatory or fibrotic lung disease
* Use of antibiotics for a lung infection within the past 4 weeks
* Autoimmune disease, i.e., Rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, Crohn's disease or other
Group Based Care Versus Individual Care

The Study compares group based care versus individual given care-effects on patient satisfaction and health. Midwives will be randomized to either traditional antenatal care (Individual care) or group based antenatal care(intervention).

In the RCT the midwife is randomized.There are a multicenter study. Before the study started the midwives received education about the study. Then they randomized with simple randomization per site(clinics). The midwives also have follow up meeting with the research team during the recruting period. The parents are informed about the study at the booking appointment, after that they can choose if they want to participate in the study and are allocated to either intervention or control, based on the woman's date of birth. The main aim is to investigate parents' satisfaction of antenatal group based care. The RCT is based on three questionnaires which both women and their partners receive, the first at baseline before they receive different models of care, and the second questionnaire distributed four to six months after birth and the last one year after birth. Descriptive and inferential statistics will be used in the analysis.A power calculation is made and the study schould have a total number of 350 partners.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to Speak Swedish

Exclusion Criteria:

* Non speaking Swedish
Feasibility of Transepicardial Atrial Injection

Single blind feasibility trial using a binary 'traffic light' design to evaluate the feasibility of injecting normal physiological saline into the atria of patients at the time of clinically indicated open chest cardiac surgery.

In this project, The investigators will see if patients can undergo successful transepicardial injection of saline at the time of cardiac surgery as compared to no injection. Patients will be randomised in a 1:1 allocation ratio using a parallel two-arm design. The study is designed to meet the following 3 feasibility objectives before proceeding: reasonable recruitment uptake, successful transepicardial injection of saline into the atria, and adequate retention of patients at follow-up.

Eligibility Criteria:
Inclusion Criteria:

Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.

Exclusion Criteria:

1. Age less than or equal to 18 years of age.
2. Pregnant or breast feeding.
3. Patient is unable or unwilling to provide informed consent.
4. Patient is included in another randomized clinical trial.
5. A history of complex congenital heart disease.
6. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years.
7. Underwent ineligible procedures during or prior to operation (including atrial ﬁbrillation ablation, heart transplantation, pulmonary thromboendarterectomy, isolated thoracic aorta procedures, ventricular assist device insertion, extracorporeal membrane oxygenator insertion, and percutaneous valve replacement).
8. Patients for whom the investigator believes that the trial is not in the interest of the patient.
The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B

Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.


Eligibility Criteria:
Inclusion Criteria:

* 18\<=age at treatment\<=65 years old
* Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass (TCD:BNG040).

Exclusion Criteria:

* Combined with other virus hepatitis or alcoholic hepatitis
* Combined with autoimmune disease
* Combined with liver cancer or cirrhosis
* Combined with severe hepatitis with or without complications
* Combined with unstable cardio-cerebrovascular disease
* Combined with severe lung, kidney, endocrine system, nervous system and hematological system diseases
* Combined with Tuberculosis
* Chronic hepatitis patients with ongoing INF treatment
* Woman with pregnancy or breasting feeding
* Mental disorder and can not express self clearly
* Cannot speak Chinese
* Allergic constitution or allergy to multiple drugs
* Refuse to enroll into the study
Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication

The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.

Atherosclerotic lower extremity PAD affects the living quality of more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most evident symptom. Current claudication therapies reveal significant limitations. Pharmacotherapy and exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication. However, they may not achieve an ideal clinical therapeutic effect. Furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.

The aim of this trial is to verify the hypothesis that SDT can reduce the inflammation of PVAT and improve PWT among PAD patients with symptom of intermittent claudication.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-80 years
* Patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the Gardner protocol)
* Femoral popliteal artery with 50% stenosis by ultrasound
* Stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening
* Written informed consent

Exclusion Criteria:

* Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
* Critical limb ischemia or other comorbid conditions that limit walking ability
* Non-atherosclerotic peripheral artery stenosis
* Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
* Systemic disorders such as hepatic, renal, hematologic, and malignant disease
* Allergic to contrast media with iodine
* Contraindication to CTA
* Allergic to DVDMS
* Diagnosis of porphyria
* Pregnant women and nursing mothers
* Patient who is attending other clinical trial
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children

This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Femoral shaft fracture requiring intra-medullary nailing
* Surgery performed within 24 hours of injury
* Ability of child or family to use patient-controlled analgesia (PCA)
* No allergy or sensitivity to bupivacaine
* Informed consent and assent

Exclusion Criteria:

* Open femur fractures
* Closed fractures needing open reduction
* Fractures associated with neurovascular complications
* Fractures associated with compartment syndrome
* Repeat femoral surgeries
* Patients who received a femoral nerve block more than 1 hour prior to surgery
* Complex associated injuries or pre-existing condition that will delay time to ambulation
* Children who are allergic and/or sensitive to bupivacaine
Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia

Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light nighttime sleep of residents.

Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment. In 2014, the Cochrane published a systematic review of the literature over the last 20 years concerning the use of light therapy in patients with a AD. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light therapy (from 5 a.m to 10 p.m) on nighttime sleep of residents. Secondary objectives were the study of sleep time on the day, anxiety by the COVI scale and behavioral disorders by the NPI scale.

Eligibility Criteria:
Inclusion Criteria:

* EHPAD residents at Les Pastoureaux Valenton having moderate to severe MASA
* More than 60 years
* Presenting motor behavioral disorders and / or anxiety and / or restlessness and / or insomnia .
* No underlying acute medical problems including no delirium

Exclusion Criteria:

* Residents refusing to lend to experimentation
* Resident who are not matching with the inclusion criteria
* total acquired or congenital blindness
* bedridden patient ( loss of physical autonomy)
* Entry to the residence less than 15 days before the start of the experiment.
Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk

The objective of the present study was to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk

A double blind randomized controlled clinical study of an 30-d intervention with 16 nursing mothers was carried out to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk. Once obtained the informed consent; volunteers were ramdomized into two groups (n=8) to either receive 5 mL daily: edible gel with intracellular content of Lb. casei CRL-431 (intervention group) or edible gel without intracellular content of Lb. casei CRL-431 as control (placebo). Both gels were consumed daily. Participants were asked not to change their diet or lifestyle during the intervention. We applied intention to treat for those participants who did not have good adherence and those who withdraw the study. The outcomes between groups were analyzed using a independent samples student t-test, with P value of 0.05 or less (two sided) when there was a statistical differences. Non-parametric data were analyzed with Mann-Whitney test; using statistical software.

Eligibility Criteria:
Inclusion Criteria:

* Nursing mothers between 3 and 52 weeks of lactation

Exclusion Criteria:

* Clinical evidence of chronic disease or gastrointestinal disorders
* Structural defects in the breast (breast surgery, mammary gland hypoplasia, among others)
* Mastitis
* Cancer and/or radiotherapy
* Consumption of: antioxidant supplements, probiotics, symbiotics and/or antibiotics in the month prior to recruitment.
* Alcohol or drugs consumption
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction

To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Eligibility Criteria:
Inclusion Criteria:

* inpatients with a diagnosis of schizophrenia, and
* those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.

Exclusion Criteria:

* mental retardation,
* substance abuse or dependence,
* a history of major head trauma,
* serious medical or neurological disorders, or
* depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months
Population-based Cancer Observatory

Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Evaluating the effectiveness of these policies aiming for improved prevention and management is essential. However to conduct such an evaluation, a baseline reference requiring ongoing, reliable and complete data collection is necessary and can be used for epidemiological research.

There is no cancer registry in the French Region Sud-Provence-Alpes-Côte d'Azur. In view of this situation, the regional Health Agency appointed the public health department of the Nice Côte d'Azur University and the Centre for computerized pathology data collection (CRISAP-PACA) to develop a Cancer Observatory. Since 2005, the public health department collects data concerning invasive and in situ cancers from all the histopathology labs in the French Region Sud-Provence-Alpes-Côte d'Azur, gathered in the CRISAP-PACA, and transmits incidence cancer rates to the regional Health Agency. In 2007, a quality control procedure, comparing a random sample of data collected by the Cancer Observatory with pathology lab reports, confirmed the validity of the collected data with fewer than 3% in disagreement with the report's conclusions. In 2008, the estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. Since 2012, public and private hospitals treating cancer patients as well as the regional cancer network ONCOPACA, coordinating multiple team meetings, have been contacted to transmit to the public health department cases of cancer without histological diagnosis. In addition, patients with cancer have been geolocated to study the influence of environmental exposures on the occurrence of cancers (patients living near of waste incinerator, highways).


Eligibility Criteria:
Inclusion Criteria:

* All subjects with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur.

Exclusion Criteria:

-
Origin of CEC in Patients After Allo-HSCT

We believe that CEC, besides coming from cells shedding from patient vasculature, could partly belong to donor, originating from the cellular graft.

In consideration of the fact that the vascular endothelium has been shown to be a target of GvHD in early stage and that the count of CEC represent a marker of endothelial damage, we want to correlate the presence of donor CEC at engraftment with a putative protective function against GVHD manifestations. We will enroll patients affected by hematologic disorders undergoing allo-HSCT. At time of engraftment and at + 3 months after allo-HSCT, CEC identified and counted by means of the CellSearch system, will be recovered from the counting cartridge and further sorted at the single cell level. STR profile of each single CEC recovered will be performed in order to define host versus donor origin of each CEC analysed.

Through the conduct of this study, we expect to upfront identify patients who will or will not manifest GvHD. This result will allow definitely different clinical approaches: stringent monitoring and early therapeutic intervention, before refractory disease's development, in the formers, while, sparing unnecessarily expensive testing or heavier treatment in the latters.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing allo-HSCT for their neoplastic hematologic diseases
* written informed consent
* achievement of hematopoietic recovery from aplasia post-allo-HSCT
* predictable life expectancy \> 6 months

Exclusion Criteria:

* presence of active malignant hematologic disease at time of allo-HSCT
Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars

This study will be conducted to evaluate clinical and radiographic success of Photodynamic Therapy for root canal treatment of primary molars in comparison to the standard root canal treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-7 years.
* Apparent healthy child not suffering from any mental or physical disability.
* Cooperative children.
* Restorable teeth.
* Each child should have at least one carious primary molar with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Absence of internal and / or external perforation in the furcation area.
* At least 2/3 thirds of the roots should be remained.

Exclusion Criteria:

* Children with compromised health or physical disability.
* Resorption of the roots more than 2/3 thirds.
* Non restorable teeth.
Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
* Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
* Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
* History of intolerance or known sensitivity to any component of the treatments.
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
* Other protocol-defined exclusion criteria may apply.
Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events

The primary aim of this study is to evaluate the CleanSweep™ Closed Suction System on time to first successful spontaneous breathing trial in mechanically ventilated patients in the medical intensive care unit. Secondary aims of this study are to evaluate the use endotracheal tube sweeping compared to closed suctioning effect on length of mechanical ventilation, length of ICU stay, length of total hospital stay, and occurrence of ventilator-associated events.

This is designed as a prospective, randomized control trial, in a large, urban, academic medical center. This study will include mechanically ventilated patients (n = 272) in the medical intensive care unit (MICU) at Rush University Medical Center. It will exclude patients with a tracheostomy on admission, those requiring extracorporeal membrane oxygenation (ECMO), or transferred from an outside facility receiving more than 24 hours of mechanical ventilation. Two groups will be randomly assigned via computer randomization. The experimental group will be placed on the CleanSweep™ Closed Suction System immediately after intubation or upon arrival to the MICU. Endotracheal tubes (ETTs) will be cleaned with the balloon sweeping technology every time a respiratory therapist suctions the patient. The control group will be placed on the standard in-line suction device. Airway suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure). Both groups will also receive a ventilator bundle that consists of head of bed elevation, ETT cuff pressure management, deep vein thrombosis prevention, daily sedation interruption and SBT, and oral care every 4 hours with chlorhexidine at 12pm (noon) and 12am midnight.

Eligibility Criteria:
Inclusion Criteria:

* Orally intubated patient with endotracheal tube
* Mechanically ventilated less than 24 hours prior to enrollment

Exclusion Criteria:

* Less than 18 years old
* Tracheostomy tube
* Extracorporeal membrane oxygenation
* Transfer from outside hospital with more than 24 hours of mechanical ventilation