cyrilzakka/clinical-trials huggingface dataset:
Healthy Environments Partnership

The Healthy Environments Partnership was established in October 2000, as a part of the National Institute of Environmental Health Sciences "Health Disparities Initiative." The Healthy Environments Partnership seeks to expand the knowledge base of how social and economic inequalities are linked to disparities in cardiovascular health among residents of Detroit. The Healthy Environments Partnership is a project of the Detroit Community-Academic Urban Research Center. The partners are: Brightmoor Community Center, Butzel Family Center, the Detroit Health Department, Friends of Parkside, Henry Ford Health System, Southwest Counseling and Development Services, Southwest Detroit Environmental Vision and University of Detroit Mercy and the University of Michigan School of Public Health, School of Nursing, and the Institute for Social Research.


Eligibility Criteria:
* Age 25 and older
* Resident of three designated areas of Detroit, MI
Cervical Preparation With Mifepristone Prior to Osmotic Dilators

The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures.

No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D\&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.

Eligibility Criteria:
Inclusion Criteria:

A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol

Exclusion Criteria:

A. Allergy or known intolerance to mifepristone

B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:

1. Chronic adrenal failure or insufficiency
2. Concurrent use of long-term corticosteroid therapy
3. Inherited porphyrias

C. Any condition that in the opinion of the investigator could impede study participation or collection of study data
Impact of HI-NPPV Vs LI-NPPV on Tolerance Among AECOPD Patients

To determine whether high-intensity NPPV, compared with low-intensity NPPV, could have an effect on the subjective tolerance in patients with an AECOPD and hypercapnia.

To evaluate the subjective tolerance of high-intensity NPPV and low-intensity NPPV patients in a conscious state by two questionnaire surveys; To assess tolerance of high-intensity NPPV and low-intensity NPPV patients patient in sleeping status by PSG monitoring.

Eligibility Criteria:
Inclusion Criteria:

* AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD);
* Arterial pH \<7.35 and PaCO2 \>45 mmHg at screening entry;
* PaCO2 \>45 mmHg after a 6-hour trial of low-intensity NPPV.

Exclusion Criteria:

* Age \<18 years
* Excessive respiratory secretions with weak cough
* Upper airway obstruction
* Recent oral, facial, or cranial trauma or surgery
* Recent gastric or esophageal surgery
* Presence of restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, or severe abdominal distension)
* Active upper gastrointestinal bleeding
* Cardiac or respiratory arrest
* Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) \<100 mmHg
* Pneumothorax
* Obvious emphysematous bullae confirmed by chest CT scan
* Ventricular arrhythmia or myocardial ischemia
* Severe hemodynamic instability (mean arterial pressure \<65 mmHg)
* Severe metabolic acidosis (pH \<7.20 and bicarbonate \<22 mmol/L)
* Refusal to receive NPPV or give informed consent
* Prior endotracheal intubation or tracheostomy during the current hospitalization
* A do-not-intubate order
Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients

Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.

The previous H1N1 and SRAS-1 pandemics, that required to containment and quarantine, have lead to the emergence of mental symptoms such as stress, anxiety, insomnia... The French COCONEL study during the COVID pandemic have shown the major psychological impact of this crisis on the population, leading to stress and fears.

Stressful life events are well-known factors of chronic inflammatory rheumatisms set-up or flare. The aim of this study is therefore to evaluate the psychological impact of COVID-19 pandemic on chronic inflammatory rheumatism (CIR) affected patients.

A case-control prospective multicentric study will be performed on 212 CIR patients versus 106 controls to compare the stress level in each group. Patient reported outcomes will be evaluated, using electronic questionnaires, as well as classical clinical informations on CIR evolution during a 6-months follow-up period. An ancillary study on 100 patients will also be realized to quantify cytokine serum levels and determinate transcriptomic profiles.

Eligibility Criteria:
For the cases:

Inclusion Criteria:

* adult patient (age over 18 years old)
* patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma...)
* patient without any language difficulty
* affiliated to an health insurance system
* and who agree to participate in the study

For controls :

Inclusion Criteria:

* adult patient (age over 18 years ol
* patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period,
* patient without any language difficulty,
* affiliated to an health insurance system,
* and who agree to participate in the study.

For cases and controls :

Exclusion Criteria:

* pregnant or lactating patient
* psychiatric patient
* patient under guardianship or other legal protection regimen.
Contactless Vital Signs Measurement

This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG) for contactless vital signs and str5ess index measurements from surgical patients in preoperative care. Our primary objective is to determine the feasibility and validity of using video PPG to collect contactless BP, HR and RR measurements when compared medical-grade instruments. Our secondary objective is to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.

The huge impact of the COVID-19 pandemic on global healthcare systems has given rise to an increased need for virtual care. This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG)for contactless vital signs measurements such as blood pressure (BP), heartrate (HR), respiratory rate (RR) and heart rate variability (HRV) from surgical patients in preoperative care. We also aim to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.

This study aims to assess how video PPG technology can be implemented in a clinical and telemedicine. If proven to be effective, this technology can be integrated into any smartphone or tablet and will allow users to monitor their vital signs with just a 1.5-minute video.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
* 18 years or older;
* able to comprehend study instructions in English

Exclusion Criteria:

* refusal to consent for the study
Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock

This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.

This study seeks to assess the tolerability of utilizing low-carbohydrate nutrition in patients admitted to the MICU with bacterial septic shock. Low carbohydrate feeds have been used before in the critical care setting and were well-tolerated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
2. Patients with 35 \> BMI \> 18.5
3. Patients with serum pro-calcitonin \> 1 ng/mL in the first 24 hours of hospitalization

Exclusion Criteria:

1. Patients with chronic kidney disease as defined by glomerular filtration rate \< 60 for \> 6 months
2. Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for \> 6 months
3. Patients with current malignancies
4. Patients with autoimmune disease on current immunotherapy
5. Patients on corticosteroids at doses of prednisone or prednisone-equivalents \> 5 mg for \> 6 months
6. Patients with weight-reduction surgeries
7. Patients with positive viral studies in the first 24 hours of admission
SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm

Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations

Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.

Eligibility Criteria:
Inclusion criteria:

* age 18-70 years;
* Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement.

Exclusion criteria:

* Hunt-Hess grade I-III on admission;
* patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping;
* poor general condition or combined with pregnancy , malignant tumors, etc.
P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma

The main purpose of this trial is to evaluate the safety of the new adjuvant treatment of curative HCC, or the treatment of long-acting interferon P1101 alone, or the use of long-acting interferon P1101 and subsequent treatment of anti-PD1, and any efficacy in reducing the recurrence rate of patients after surgery.

secondary end-point: P1101 and anti-PD1 sequential therapy on hepatitis B (especially on HbsAg).

Eligibility Criteria:
Inclusion Criteria:

* Subject with HCC who meet the following criteria

  1. Subjects diagnosed as having typical HCC on dynamic CT, or dynamic MRI performed within 8 weeks before surgery, or subjects who diagnosed HCC by pathology after surgery resection;
  2. Subjects with the primary occurrence HCC ;
  3. Subjects with the HCC related to hepatitis B virus (HBV) ;
* Subject who have undergone surgical liver reaction within 8 weeks prior to study entry.
* Subjects showing a complete cure shows no findings suggestive of recurrence or remnant. ;
* Subject who are able to begin treatment with the study drug within 12 weeks after liver surgery resection. ;
* Subjects confirmed of satisfying the following conditions based on the screening performed at enrollment: Positive for HBsAg/ Undetectable HBV DNA, with or without current anti HBV treatment/ Grade A on Child-Pugh classification;
* Normal fundoscopic examination by ophthalmologist at screening;
* ECOG 0 to 1 ;

Exclusion Criteria:

* Subjects positive for anti-HCV ;
* Subjects showing vascular invasion of HCC on imaging diagnosis ;
* Subjects who have uncontrolled hypertension;
* Subjects with a history of pneumonitis or interstitial lung disease . cardiac arrest . an active infection requiring therapy .;
* Diabetes mellitus with HbA1c ≥ 7.4% with insulin treatment;
Multicenter Trial of Prednisone in Alzheimer's Disease

This is a randomized placebo controlled, double blind study. Patients who meet eligibility criteria and decide to participate in the study will be randomly assigned to receive either drug treatment or a placebo. Neither the patients nor the participating investigators will know who is receiving the drugs and who is receiving the placebo. Participation involves 15 outpatient clinic visits over a 68 week period. Patients take study medication at varying doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Alzheimer's disease who are in stable medical condition

Exclusion Criteria:

* Patients with diabetes or severe osteoporosis
Improving Balance for Older Adults: Disseminating Tai Chi Fundamentals Through Community Organizations

This study will evaluate how best to disseminate and implement Tai Chi Fundamentals® (TCF) in community settings for older adults with balance problems. TCF is a program designed for older adults with pain and physical limitations to enhance balance, coordination, strength and endurance. Investigator will evaluate program implementation including Aging and Disability Resource Center (ADRC) uptake, reach, feasibility, teaching fidelity, and exercise adherence and also collect outcomes including leg strength, balance, walking ability and executive function before and after the 6-week session. The final product of this study will be recommendations to address key barriers and facilitators for implementation of TCF by community organizations serving older adults.

The primary aim for this study is to evaluate the program implementation. This is not an efficacy study. Within the limits of a Dissemination and Implementation grant budget, Investigators do take advantage of a natural experiment even if it is not the primary aim of this study. By doing so investigators plan to establish the feasibility of this multi-site data collection plan for future studies. Based on the study settings, study team will get a chance to explore the effect of TCF in real world settings since two sessions can be held in a fall season and a spring season. In addition to the pre-post tests of TCF sessions to explore TCF effectiveness, pre-test scores for session 2 are compared to post-test scores of session 1 participants since both are collected at nearly the same time. The larger sample will be for the within group pre-post comparison analyses. This will be a valuable opportunity to test data collection procedures for future trials.


Eligibility Criteria:
Inclusion Criteria:

* being 65 years and older
* dwelling independently in the community
* agreeing to be randomized
* reporting a fall (to the ground or lower level in the last year or having a strong fear of falling.

Exclusion Criteria:

* using a walker indoors
* having a terminal illness
* being hospitalized or in a nursing home in the past 2 months
* anticipated absence from two tai chi sessions and
* receiving physical therapy or a community course or balance exercise program for falls prevention in the prior 2 months
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation

A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation

2) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.

Eligibility Criteria:
Inclusion Criteria:

1. The patients age ranges from 18 to 50 years.
2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.

Exclusion Criteria:

* 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontitis

clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters

In the present study, twenty posterior two or three osseous intrabony periodontal defects were involved . They were grouped in to two groups. Group I included ten intrabony posterior defect received beta tri calcium phosphate (β TCP) bone substitute. Group II included ten posterior intrabony periodontal defect and they received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane. CBCT was used preoperatively and after 6 months for hard tissue evaluation. PDGF and BMP were measured in GCF at days 1,3,7,14.

Eligibility Criteria:
Inclusion Criteria:

* Presence of interproximal osseous defects estimated from radiographic evaluation (Cone Beam CT) and transgingival bone sounding ≥3mm of two or three osseous walls.

  * Probing Depth ≥5mm after initial therapy.
  * Attachment loss ≥4mm.
* full mouth plaque score and bleeding on probing score ≤ 20% after phase I therapy.

  * non vital teeth only involved.
  * no furcation involvement of the teeth presenting the intraosseous defects.
  * Thick gingival biotype more than 1 mm with enough width of attached gingiva.
* Accepts Healthy Volunteers

Exclusion Criteria:

* Patients with systemic disease or compromised immune illness using Cornell medical index
* Smoker's patients.
* Pregnant and lactating females.
* Uncooperative patients (low compliance, bad oral hygiene).
* Decision impaired individuals (prisoners, handicapped and mentally retarded patients).
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy

This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.


Eligibility Criteria:
Inclusion Criteria:

Subjects to be included in the study are:

* Outpatients of either gender, age 18 or older
* Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
* Hyperuricemic: screening serum uric acid must be \>=8 mg/dL.
* The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
* Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide

Exclusion Criteria:

Subjects to be excluded are those for whom any of the following apply:

* Unstable coronary artery disease or uncontrolled hypertension
* History of end stage renal disease requiring dialysis
* History of liver disease, as defined by baseline serum transaminase elevation \>3X the upper limit of normal in the absence of any other known cause
* Organ transplant recipient requiring immunosuppressive therapy
* Concurrent use of prednisone at a dose \>10 mg qd (or equivalent) at or within one week before dosing
* Concurrent use of uric acid-lowering agents
* Prior treatment with Puricase® or other recombinant uricase
* An acute gout flare within one week prior to first treatment with Puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol
* glucose-6-phosphate dehydrogenase deficiency
* A history of anaphylactic reaction to a recombinant protein or porcine derivatives
* Lactation
* Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
* Known allergy to urate oxidase or PEGylated products
* Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements