cyrilzakka/clinical-trials huggingface dataset:
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation

The purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement.

Sufficient alveolar ridge is a prerequisite for successful implant stability, atrophic ridges defects make the placement of regular implants challenging. A variety of materials and surgical techniques are available for bone augmentation procedures prior implant placement. The present study evaluated the effect of sticky allogenic bone graft for the horizontal and vertical ridge augmentation with simultaneous implant placement using autogenous cortical bone plates in maxillary anterior atrophic ridge defects.

Forty-two patients, with severe maxillary anterior horizontal and vertical atrophic ridge deficiencies were randomly assigned to two groups: staged approach group and simultaneous implant placement group. The two groups were grafted using bone plated buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. Radiographic examination was performed immediately before bone grafting procedure and at 6, 12 months postoperatively, to evaluate the change of bone width and height.

Eligibility Criteria:
Inclusion Criteria:

* Good general health at the time of surgery
* At least 3 months of healing after tooth extraction
* Horizontally and vertical compromised alveolar ridges

Exclusion Criteria:

* Thick cortex in the labial/buccal with less cancellous bone inside;
* Obvious undercut on the labial/buccal side
* Uncontrolled periodontal conditions or other oral disorders;
* history of radiotherapy in the head and neck region
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects

This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one second (FEV1), a test of pulmonary function used to assess airway resistance, during sub-maximal treadmill exercise in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* With normal health

Exclusion Criteria:

* Suffered from respiratory, cardiovascular, musculoskeletal, neurological or endocrine disorders
* No allergic to gel
Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit

Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit, Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics like bupivacaine can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Based on "Combination Wisdom", the use of adjuvants to local anesthetics has been promoted a lot .A wide variety of drugs have been used for both neuraxial and peripheral nerve blocks, and the most commonly used drug as adjuvant is the fentanyl .

The addition of dexmedetomidine during US-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years.
* American Society of Anesthesiologists (ASA) physical status I-II,
* Scheduled for elective surgery below the knee.

Exclusion Criteria:

* Allergies to used medications.
* Coagulopathy.
* Septic patients.
* Neurological disease.
* Respiratory or cardiac disease.
* Diabetes mellitus.
* Patients' refusal to participate.
Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia

In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the occurrence of novo mutations (dominant or recessive). Our objective is to test this hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations through whole exome sequencing in a homogenous group of patients.

To elucidate the genetic basis of non syndromic congenital diaphragmatic hernia in a sub group of individuals with similar phenotype: Isolated CDH presenting with postero-lateral-left diaphragmatic defect with good perinatal outcome (n=16) To establish the prevalence of the identified gene(s) in a cohort of identical patients (n=30)

Two complementary approaches will be used:

* Search for pathogenic genomic alterations using microarrays (\~2.106 markers (SNP and CNV) in 16 trios (affected child and 2 parents).
* Sequencing of the whole exome from patient genomic DNA (n=16)
* Selection of unknown or very rare variants according to different criteria: recessive or dominant model, prediction of their pathogenicity, filtered on genes already known in CDH or involved in diaphragmatic development and non annotated CNV or variants of new gene(s) shared by different patients.
* Variants will be validated by Sanger sequencing (for intragenic variants) or quantitative PCR (for CNV) on CDH cases and their parents as well as their absence on 100 controls.

Eligibility Criteria:
Inclusion Criteria:

* Families with one (or more) non syndromic CDH child
* Signed consent form

Exclusion Criteria:

* Syndromic CDH or associated with a known karyotype anomaly
* No signed consent form
* Not affiliated to French social security
Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography

During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine coronary angioplasty

Exclusion Criteria:

* Cardiogenic shock
* Acute myocardial infarction
The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain

The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).

Detailed Description: Neuropathic corneal pain (NCP) is a complex disease affecting the somatosensory nervous system characterized by different underlying etiologies and pathogenesis.

OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and neuropathic corneal pain; and is designed to combat washout through the inclusion of the lipid 'anchor' contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment. Our preclinical studies have shown that treatment with OK-101 abolishes corneal pain in a murine model of NCP.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 18 years.
2. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain.
3. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas.
4. Females of childbearing potential must have a negative pregnancy test.
5. Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200).
6. Satisfying all Informed Consent requirements.
7. Ability and willingness to comply with study procedures.

Exclusion Criteria:

1. Evidence of any active ocular infection.
2. Evidence of any intraocular inflammation.
3. Evidence of any persistent epithelial defect/ulcer.
4. Evidence of any corneal scar/corneal edema.
5. Presence of any other ocular conditions that require topical medications during the treatment phase.
6. History of severe systemic allergy or severe ocular allergy.
7. Inability to suspend topical medications 8 days prior to the starting date.
8. Inability to continue oral medications for NCP without changes during the study duration.
9. No changes or less than 50% improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
10. History of any ocular surgery within three months before study Visit 1(day 0).
11. Ocular surgery expected during the 16 weeks of the trial.
12. Use of refractive/therapeutic contact lenses during the study period.
13. Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
14. Drug addiction/alcohol abuse within the last year.
15. Participation in another clinical trial concurrently.
Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia

Influence of histological concordance on the risk of recurrence:

the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Influence of histological concordance on the risk of recurrence:

the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.

Eligibility Criteria:
Inclusion Criteria:

* patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

Exclusion Criteria:

-
Developing a Self-Management Program for People With Depression and Chronic Medical Illness

This study seeks to adapt an existing chronic disease self-management program for people with both chronic medical illness and depression.

Depression is a common but serious disorder that affects millions of people every year. Depression can severely impact people's lives, causing them to often feel sad and hopeless as well as affecting their sleep patterns, concentration, and energy levels. Treatment typically includes a combination of antidepressant medication and talk therapy. This study will evaluate the effectiveness of an adapted group education program typically used for chronic medical illness in improving the health status, health behaviors, and use of health care services among people with depression and a chronic illness.

Participants in this open-label study will attend a group education program used to manage chronic medical illness. Group sessions will be held for 2.5 hours, once a week, for 6 weeks. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions. Participants will also complete two surveys: one at the beginning of the study and one at the end. The first survey will ask basic questions related to participants' health status and any feelings of stress, anxiety, or sadness. The second survey will include a brief interview that will require participants to describe their experience in the group sessions and to suggest ways of improving the program to better accommodate people with depression and chronic illness. Responses to questions will be used to enhance the effectiveness of the group education program for treating people with both depression and a chronic medical condition.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Currently attending the Edward R. Roybal Comprehensive Health Center or the LAC+USC Outpatient Department for primary care
* English- or Spanish-speaking
* Screens positive for major depressive disorder or minor depression based on the PRIME MD PHQ-9
* Suffers from a chronic medical illness (e.g., lung disease, asthma, emphysema or trouble breathing; heart disease or heart problems; high blood sugar or diabetes; arthritis or rheumatism)

Inclusion Criteria for Group Leaders:

* Prior experience facilitating a chronic disease self-management program within 6 to 9 months of study entry (including the groups held at Roybal Comprehensive Health Center)

Exclusion Criteria for Patients:

* Acutely suicidal
* Screens positive for bipolar disorder, psychotic disorder, or cognitive impairment disorder
* History of alcohol or drug abuse
A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)

The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.


Eligibility Criteria:
Inclusion Criteria:

* Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories
* Medically stable on the basis of physical examination, medical history and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Must provide an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid \[DNA\]) sample for research (where local regulations permit). Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study

Exclusion Criteria:

* Participants requiring renal dialysis
* History of lung or heart transplant (waiting list status or consideration of enlisting is allowed)
* Severe left ventricular dysfunction: Left ventricular ejection function less then (\<) 35 percent (%)
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, aged 18-75 years of age;
* in receipt of first donor kidney;
* eligible to receive immunosuppressive treatment comprising IRL2, CellCept, cyclosporine and steroids;
* eligible to receive oral treatment from the first day post-transplantation.

Exclusion Criteria:

* patients receiving a second or subsequent kidney transplant, or multi-organ transplant;
* history of malignancy in the last 5 years (except successfully treated squamous cell or basal cell cancer and cervical cancer in situ);
* patients with active hepatitis B and/or hepatitis C, or HIV infection.
Genetic Architecture of Plasma T-PA and PAI-1

To determine the effects of six genes on thrombotic risk factors known to be associated with the development of heart disease.

BACKGROUND:

Abnormalities in the plasminogen activator system have been implicated in the pathogenesis of arterial and cerebral thrombosis. In particular, elevated plasma levels of plasminogen activator inhibitor-1 (PAI-1), tissue-type plasminogen activator (t-PA), and t-PA/PAI-1 complexes have been found to correlate with increased risk of myocardial infarction (MI) and/or stroke. Vascular fibrinolytic balance is, to a large part, determined by the competing effects of t-PA and PAI-1, and reflects a complex interplay between genetic and environmental factors. The present collaboration focuses on the common hypothesis that the association between activation of the renin-angiotensin-aldosterone system (RAAS) and atherothrombotic events derives from an interaction between the RAAS and the fibrinolytic system.

The study is part of an initiative "Thrombosis of the Arterial and Cerebral Vasculature: New Molecular Genetic Concepts for Prevention and Treatment" which was released in April 1999. The objective of the initiative is to establish collaborative teams of closely interacting investigators with diverse, complementary areas of expertise to elucidate the molecular genetic mechanisms of thrombosis in the arterial and cerebral vasculature.

DESIGN NARRATIVE:

The investigators will use two population-based samples of unrelated individuals to address their aims: 1) study subjects in the PREVEND study in Groningen, The Netherlands in whom DNA and plasma samples and clinical data have already been collected and 2) an estimated 2000 unrelated study subjects from Ghana, Africa in whom data need to be collected. The collaborative study focuses on the common hypothesis that the association between activation of the renin-angiotensin-aldosterone system (RAAS) and atherothrombotic events derives from an interaction between the RAAS and the fibrinolytic system.

Eligibility Criteria:
No eligibility criteria
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has one of the following genotypes:

  * Homozygous for F508del;
  * Heterozygous for F508del and a gating (F/G) mutation;
  * Heterozygous for F508del and a residual function (F/RF) mutation;
  * At least 1 other TCR CFTR gene mutation identified as responsive to ELX/TEZ/IVA and no F508del mutation
* Forced expiratory volume in 1 second (FEV1) value \>=40% and \<=90% of predicted mean for age, sex, and height for participants currently receiving CFTR protein modulator therapy; FEV1 \>=40% and \<=80% for participants not currently receiving CFTR protein modulator therapy

Key Exclusion Criteria:

* History of solid organ or hematological transplantation
* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Pregnant or breast-feeding females

Other protocol defined Inclusion/Exclusion criteria may apply.
Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality

Cardiac surgery in babies less than 6 kg of weight is a complex and high-risk procedure. Despite advances in medical technology, mortality and morbidity rates remain high. This study seeks to identify risk factors associated with mortality and morbidity in this population


Eligibility Criteria:
Inclusion Criteria:

* neonates undergoing surgery for congenital heart diseases

Exclusion Criteria:

* larger body weights than 5 kg
Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery

Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.


Eligibility Criteria:
Inclusion Criteria:

1. age of at least 18 years
2. normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30
3. Chinese Mandarin as the native language
4. providing informed consent

Exclusion Criteria:

1. pre-existing delirium assessed according to the Confusion Assessment Method (CAM)
2. history of neurological or psychiatric disease
3. impaired vision or auditory function which may effect the assessments
4. unwillingness to participate in the study
Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students

This project aims to develop and evaluate the effectiveness of an Personalized Normative Feedback (PNF) intervention via the internet, through a randomized clinical trial for alcohol consumption among Brazilian college students, as well as evaluating the most effective components of the PNF (normative and list of consequences). The sample is composed of college students aged between 18 and 30 years. Participants allocated into four different groups: control, full intervention (PNF), feedback with normative components (FN) and feedback with list of consequences (FLC). The investigators will use the dismantling design to study the most effective components. Participants will be followed-up at 1, 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* College students
* Age 18-30 years
* Alcohol Use during the last 3 months

Exclusion Criteria:

-