cyrilzakka/clinical-trials huggingface dataset:
Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma

The management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications.

A multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. It must combine effectiveness and simplicity with the least risk to the patient. Today, epidural analgesia is the technique of choice, but it has certain disadvantages: difficulties in performing it at the thoracic level, undesirable effects, complications, and numerous contraindications.

The investigator propose to carry out a single-centre, prospective, randomised, controlled pilot study evaluating the impact of loco-regional analgesia following the placement of erector spinae plane catheter in addition to systemic analgesia in patients with unilateral thoracic trauma.

The aim is to demonstrate the effectiveness of this technique, which has fewer disadvantages than epidural analgesia. The interest of this study is thus to decrease the respiratory morbidity of thoracic trauma patients by avoiding a maximum of complications.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Unibilateral chest trauma with fracture \> 2 ribs on one side
* Admission to Intensive Care Medicine
* Non-intubated patient, able to respond to a pain scale score and perform a vital capacity
* Numerical Scale \> 3 on forced inspiration despite use of systemic analgesics
* CV ≤ 80% theoretical at inclusion
* Time \< 24 hours from admission to the service to inclusion
* Time \< 48h between trauma and inclusion
* Patient affiliated to the social security system or entitled to it
* Patient able to understand the protocol, having agreed to participate in the study and having given express oral consent

Exclusion Criteria:

* Intubated, ventilated patient
* Indication for laparotomy or thoracotomy
* Spinal cord injury
* Severe head injury
* Bilateral thoracic trauma
* Patient included in a category 1 clinical interventional study involving analgesic treatment
* Patients under legal protection or deprived of liberty
* Pregnant or breastfeeding women, or women with childbearing potential without effective contraception
* Refusal to participate
* Unable to understand the protocol and its requirements and/or unable to give express oral consent
The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial

66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants will be exposed to regimen including dual zinc plus arginine based toothpaste (Colgate total), (A2) represents participants will be exposed to regimen including zinc based toothpaste (Crest complete) and (A3) represents control group where participants will be used fluoride based toothpaste (Signal). The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T3) . In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T3), third visit (after 6 months: T6) and final visit (after 12 months: T12) to obtain the required data


Eligibility Criteria:
Inclusion Criteria:

* • Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.

  * Subjects of mean age 20-50 years.
  * Patients with high caries risk assessment according to Cariogram.
  * Non cariogenic diet patient
  * High plaque index
  * Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.

Exclusion Criteria:

* • Patients with a compromised medical history.

  * Cariogenic diet patient.
  * Participants with severe or active periodontal disease.
  * Participants with a history of allergy to any of the drugs or chemicals used in the study.
  * Patients on any antibiotics during the past month
Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

To assess the Flash version of EMDR in reductions of the disturbance of upsetting memories at post-intervention, and 1-month follow up within a double-blinded, online 2-arm randomized controlled trial (RCT) with self-report outcomes. We will assess 45 per group, adequate for the detection of a medium effect size.

This double-blinded, RCT will assess the comparative efficacy of these two online interventions designed to reduce memory disturbance.

This double-blinded, RCT compares the efficacy of 2 online interventions (Flash Version - EMDR; EMDR alone) designed to reduce memory disturbance.Inclusion Criteria: (1) approved for engagement assessment by the CloudResearch platform; (2) 25-60 years; 3) US-Canada residence; (4) a recalled disturbing memory of an event that has not repeated and was moderately upsetting, or greater when event occurred; (5) memory remains moderately upsetting or greater on recall. The disturbance of upsetting memories at post-intervention, and 1-month follow up will be assessed with self-report outcomes. We will assess 45 / group, adequate for the detection of a medium effect size. linked to an earlier memory (that is equally or more disturbing). Exclusion Criteria: Diagnosis of: (1) bipolar disorder; (2) borderline personality disorder; (3) obsessive compulsive disorder; (4) schizophrenia; (5) substance abuse/addiction in the past 3 months; (6) any suicidal ideation; (7) suicide attempt in the past 6 months. Interventions: Experimental participants observe video instructions of full FT, while controls receive an online intervention that follows traditional EMDR. Measures: Primary outcome: State Anxiety subscale of the State Trait Anxiety Inventory (STAI) at baseline, post-intervention, and after 1-month follow up; Post Traumatic Stress Disorder symptoms (PTSD) measured by PCL-5 (1 month follow up).

Secondary outcomes: the Subjective Units of Disturbance (SUDs) assessing change in immediately reported disturbance of recalled memories (baseline and post-intervention); depression measured by Patient Health Questionnaire (PHQ9) and Positive-Negative Affect measured by the Positive and Negative Affect Scale (PANAS).

Eligibility Criteria:
Inclusion Criteria:

* Moderately upsetting or \> memory of an event that occurred \> 2 years ago and has since not repeated
* Moderately upsetting or \> memory remains moderately upsetting when recalled
* Memory is not tied to an earlier memory that is equally disturbing or \>

Exclusion Criteria:

* Bipolar Disorder
* Borderline Personality Disorder
* Obsessive-Compulsive Disorder
* Schizophrenia
* Substance Abuse/Addiction in past 3 months
* Suicidal ideation or attempted suicide in the past 6 months
Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes , Sohag Experience.

laparoscopic cholecystectomy nowadays is the most common surgery done by General surgery surgeons , so it is necessary to evaluate the difficulty of each case prior to surgery and from the first look ,to avoid complications and improve outcomes , so scoring systems are needed for better assessment of the overall condition and make good decision .


Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic gall stones

Exclusion Criteria:

* lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.
Glucose Variability With DPP-4 Inhibition

Glucose Variability With DPP-4 Inhibition

Patients with Type 2 Diabetes, age 35-75y., will be included in this double blind randomized placebo controlled study.

The sample size of 50 patients completing the 30 day study period is based on statistical input from Merck Research Laboratories, Rahway NJ.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* receiving a stable dose of metformin ≥ 1500 mg
* HbA1c 7,5% -10/0 %

Exclusion Criteria:

* Type 1 diabetes
* HbA1c \< 7,5% and \> 10,0%
Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target)

The functional prognosis of patients with ischaemic stroke treated by thrombolysis and thrombectomy is associated with complete reperfusion of the occluded artery defined by an mTICI 2C or 3 score at the end of thrombectomy. However, this complete reperfusion is only obtained in 60% of patients. Most often, incomplete reperfusion is due to the persistence of distal occlusions, which are inaccessible to mechanical thrombectomy. Drug treatment, combined with thrombectomy to increase the rate of complete reperfusion, would be a major advance in the management of these patients.

This is a non-randomized, monocentric, open-label, phase II trial to evaluate efficacy of dornase alfa intravenous administration in patients treated with intravenous thrombolysis and eligible for thrombectomy for ischemic stroke of the anterior circulation.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke by proximal intracranial occlusion (internal carotid artery, middle cerebral artery in its M1 or M2 segment) isolated from the anterior circulation eligible for cerebral thrombectomy.
* Transferred to the NRI block for a cerebral thrombectomy.
* Treated by thrombolysis intravenous (Aleplase or Tenecteplase) as recommanded by European stroke organisation
* With DWI-ASPECT score\>5 to MRI

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Known allergy to Dornase alfa or one of its excipients.
Cardiac Autonomic Control in Children of HIV Positive Mothers

To establish the incidence, clinical spectrum, and natural history of cardiac dysautonomia as defined by heart rate spectral analysis in both HIV infected and noninfected children and to evaluate the value of heart rate spectral analysis for predicting dysrhythmias and sudden death in infants and children born to HIV infected mothers.

BACKGROUND:

The magnitude of clinical problems associated with autonomic dysfunction in children with symptomatic HIV infection is great. Hemodynamic abnormalities, dysrhythmias, unexplained arrest and/or sudden death are common in HIV positive children, especially when acute deterioration, interventions or neurologic involvement is present. If cardiac dysautonomia is predictive of adverse outcomes in HIV infected children, then a future prospective trial of beta-adrenergic antagonist therapy may be warranted.

DESIGN NARRATIVE:

An analysis was performed on data collected under the NHLBI-sponsored multicenter study entitled 'Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted Human Immunodeficiency Virus (HIV) Infection' and abbreviated P2C2. The P2C2 study was performed in a prospectively defined cohort of 150 children with HIV infection and 350 uninfected control children born to HIV infected women who had been followed since the first month of life to provide understanding of cardiac dysautonomia in early HIV infection. In addition, 198 children with symptomatic HIV infection were analyzed to provide an assessment of cardiac dysautonomia in later stages of pediatric HIV infection. Heart rate spectral analyses were performed on 2196 Holter monitor recordings from these patients followed at the five P2C2 clinical centers to capture noninvasively the time varying contributions of the sympathetic and parasympathetic nervous system to the control of heart rate throughout the course of a day. The spectral balance parameters and the changing response of heart rate to the electrocardiogram-derived respiratory signal characterized the responsiveness of the sympathetic and parasympathetic nervous system at rest and during the events of a normal day. Autonomic function data were electronically transmitted to the P2C2 data coordinating center at the Cleveland Clinic and analyzed along with other P2C2 data (eg. infectious, immunologic, growth, renal, neuroendocrine, pulmonary and cardiac) to determine their risk factor potential for cardiac dysautonomia.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Primary Objectives:

* To compare the proportion of subjects with HBV DNA levels below the limit of detection (\<400 copies/ml) by week 48 in each treatment group

Secondary Objectives:

* To evaluate the emergence of HBV resistance at 48 weeks
* To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
* To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study
* To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT\>5x ULN)
* To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks
* To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA

Enrollment:

* 24 patients in Clinical trial A (of whom 16 enter substudy A1).

Clinical Trial A:

* Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.

Inclusion Criteria:

* Written informed consent
* Documented HIV infection
* Age 18 - 70 years
* HBV DNA \> 106 copies/ml

Randomization:

* Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
* Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Documented HIV infection
* Age 18 - 70 years
* HBV DNA \> 10E6 copies/ml
* ALT \< 10 x ULN (upper limit of normal)
* Creatinine \<= 2.0mg/dl
* Platelet count \>= 50,000/mm3
* HIV-1 therapy naive
* No prior exposure to anti-HBV agents

Exclusion Criteria:

* Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
* Acute hepatitis (serum ALT \> 1000 U/L)
* Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
* Active opportunistic infection
* Pregnancy or lactation
* Other chronic liver disease
* Concurrent malignancy requiring cytotoxic chemotherapy
* Decompensated or Child's C cirrhosis
* Alfa-fetoprotein (AFP) \> 3X ULN (unless negative computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] within 3 months of entry date)
Transcatheter Mitral Valvuloplasty Pilot Study

This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation


Eligibility Criteria:
Inclusion Criteria:

* Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
* Age 19 and more
* Written informed consent

Exclusion Criteria:

* Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
* Active endocarditis of the mitral valve
* Rheumatic mitral valve disease
* Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
The Value and Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Lymphomas

The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio could help predict the prognosis of DLBCL and PTCL.

The investigators plan to prospectively involve 100 non-hodgekin lymphoma patients, including 50 diffuse large B cell lymphomas and 50 peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.

The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.

All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by enhanced computed tomography or PET-CT.

The peripheral blood would be collected. The Cytodiff flow cytometric technique would be used to test 16 leukocyte subpopulations from peripheral blood at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression.

Progression-free survival (PFS) and overall survival (OS) would be estimated using the Kaplan-Meier method and two-tailed log-rank test.The Cox proportional hazards model would evaluate prognostic factors for OS and PFS. Specificity, sensitivity and cut-off would be established using time-dependent receiver operating characteristic (ROC) curve analysis. Area under curve (AUC) values \>0.7 indicate that the parameter can be used for diagnosis, with values \>0.9 indicating high clinical accuracy.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL)
2. no treatment before
3. hCG(-)
4. 18 years old to 80 years old

Exclusion Criteria:

1. other tumors
2. severe infections
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2.
* Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time
* Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

Other protocol defined exclusion criteria may apply.
SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy

This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) tyrosine kinase inhibitor (TKI).

The study is composed of two parts. Part 1 of the study will determine the safety and tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib in 39 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Signed inform consent form.
2. Age \>= 18 years and \<= 70 years.
3. Histologically or cytologically confirmed small cell lung cancer.
4. ED-SCLC according to Veterans Administration Lung Study Group.
5. Radiographically progression following a platinum-based standard prior chemotherapy regimen.
6. Eastern Cooperative Oncology Group performance status of 0 or 1.
7. Measurable disease as defined by RECIST v1.1.
8. Life expectancy \>= 8 weeks.
9. Adequate hematologic and end organ function.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma.
2. Prior exposure to therapeutic anticancer vaccines; prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies.
3. Prior exposure to anti-VEGF or anti-VEGFR therapy.
4. Active brain metastasis or meningeal metastasis.
5. Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment).
6. Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody.
7. Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening.
8. Other conditions that the investigator thinks unsuitable in this study.
Mild Valvar Pulmonary Stenosis

Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data suggested that most of these patients do well. Nonetheless, the majority of these patients is followed periodically by a pediatric cardiologist and may undergo repeated echocardiographic studies to follow the gradient. Such follow-up can be costly and it is not know if there is any benefit to periodic evaluation.

Young children (less than or equal to 2 years of age) with mild valvar pulmonary stenosis are unlikely to develop worsening stenosis with age and periodic cardiac evaluation is not warranted.

To describe the clinical course of children with mild valvar pulmonary stenosis diagnosed in early childhood. To examine the clinical practice patterns of cardiologists caring for these patients.

Retrospective chart review of all children diagnosed with mild valvar pulmonary stenosis born between 1984 and 2003 and followed by Sibley Heart Center Cardiology. Patient variables will include: pulmonary valve gradient, need for catheterization, exercise intolerance and endocarditis. Practice variables will include: frequency of follow-up, number of echocardiographic studies, exercise limitations.

Eligibility Criteria:
Inclusion Criteria:

* Children's Healthcare of Atlanta medical charts 1984 to 2003 diagnosed with mild valvar pulmonary stenosis Patients less than or equal to two years of age

Exclusion Criteria:

* Those who do no meet inclusion criteria