cyrilzakka/clinical-trials huggingface dataset:
Pectoral Nerve Block for Analgesia After Breast Augmentation

Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.

The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain will be assessed according to a numerical scale. This prospective, randomized, double blind study will include 92 patients successively during two years, randomized into two arms : Pecs group and Control group, which will respectively have the block, and no block. The rest of the anesthesic and surgical care will be identical.

An intervention team (which will be different from the anesthesic team), will be alone with the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous randomisation so that all caregivers taking in charge the patients as well as research observers will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to a national insurance scheme
* Having signed the informed consent for this study
* Score of American Society of Anesthesiology ( ASA) 1-3
* Be hospitalized in the ambulatory care unit (UCA) or plastic surgery service for a scheduled esthetic prosthetic breast expansion surgery.

Exclusion Criteria:

* Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
* Pregnant or breast-feeding women according to French law.
* Vulnerable people.
* Patients participating in another research
* Allergy with local anesthetics.
* Severe coagulopathy.
* Chronic painful Patients (long-term treatment by analgesics)
* Contraindication to use analgesics of the protocol.
* Change of breast prostheses
Effect of Traditional Chinese Medicine of Severe COVID-19

This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.

In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* accord with the diagnosis of severe/critical novel coronavirus infection;
* Age \> 18 years old;
* TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
* Sign the informed consent form.

Exclusion Criteria:

* Pregnant and lactating women;
* Trauma, hematological malignancies, various solid tumors and obstetric complications;
* Dementia, various mental patients and those who are unwilling to cooperate;
* The patient is expected to die within the next 24 hours;
* Combined with neuromuscular diseases affecting respiratory and motor functions;
* people who have been bedridden for a long time for various reasons;
* Clinical trial participants who are taking part in other intervention measures;
* Those who are known to be allergic to the therapeutic drugs in this study.
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia

Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation.
* Informed consent signed.

Exclusion Criteria:

* Fever with etiologic diagnosis.
* Patients with epilepsy.
* Pregnant or lactating women.
* Patients with HIV infection.
* Patients with severe renal failure.
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 16 to 65 year of age
* Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
* Willing and able to comply with the study drug regimen
* Written informed consent before any assessment

Exclusion Criteria:

* Patient has a history of/or clinical signs/symptoms of hepatic decompensation
* Patient has a history of HCC or findings suggestive of possible HCC
* Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
* History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
* Patient has received IFN or other immunomodulatory treatment with 12 months before screening
* Previous treatment history with NRTIs

Other protocol-defined inclusion/exclusion criteria may apply.
The Emerging Role of Resolvins in the Prevention of Chronic Pain After Thoracic Surgery

The aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. In addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo esophagectomy at BWH
* 18-80 years old

Exclusion Criteria:

* pre-existing chronic pain
* current opioid use
* current treatment with corticosteroids
* evidence of active infection
* chronic liver disease
* end-stage renal disease (CKD-5)
* chronic inflammatory disorders
* recent major surgery or illness within 30 days
* use of immunosuppressive medication
* history of organ transplant
* pregnancy or plans to become pregnant
* lactating
* allergies to fish or fish oil
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.

This phase 2b, double-blind, randomized, placebo-controlled, multicenter study will evaluate the effect of HTD1801, 1250 mg twice daily (BID) compared to placebo BID on histologic improvements in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.

The study will enroll approximately 210 subjects with biopsy-confirmed non-alcoholic steatohepatitis and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive investigational product for up to 60 weeks.

Eligibility Criteria:
Key Inclusion criteria:

* Clinical diagnosis of non-alcoholic steatohepatitis (NASH) upon central read of a liver biopsy obtained no more than 6 months before Day 0.
* Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) clinical research network (CRN) scoring of fibrosis.
* Clinically documented diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening or prediabetes at screening.
* BMI \>25 kilograms/meters squared (\>23 kilograms/meters squared if Asian).

Key Exclusion criteria:

* Fibrosis stage 4.
* History of alcohol or substance abuse or dependence.
* Liver disease unrelated to non-alcoholic steatohepatitis.
* History of significant cardiovascular disease.
* History of type 1 diabetes.
* Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.
Effects of Visual Feedback Therapy on Post Burn Children

Visual feedback therapy is a cheap, easy, and, most importantly, patient-directed treatment that may improve the recovery of hand motor functional skills. Visual feedback therapy consists of repeated bilateral, symmetrical movements in which the patient moves the affected body part as much as he/she could while observing the reflection.The hands account for less than 5 % of total body surface area. Many burns requiring hospitalization involve the upper extremity considered severe injuries by the American Burn Association and should be referred to specialized care centers to minimize sequella of thermal injury including nail deformities, hypertrophic scars, boutonniere deformity, digit loss, and contractures. Visual feedback therapy is a treatment method based on neuroplasticity of the brain.Although recent studies have demonstrated the benefit of visual feedback therapy for various diseases, research that applies visual feedback therapy to improve the restorative capability of hand function of patients with reduced hand function due to mutilated injury has not been reported yet.

This study will be a randomized controlled trial. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. Non probability convenience sampling technique will be used and study will be conducted on 36 patients diagnosed with post burn hand contractures 8-12 years old children. Patient will be randomly categorized into two groups by using flip coin method. Experimental group will receive visual feedback therapy and conventional therapy treatment protocol. Control group will receive only conventional therapy. Pre and Post interventions assessment will be made for both groups. Post burn hand contractures of the patients will be assessed by checking ROMS of hands with goniometer. The ABILHAND questionnaire will also be performed to check the functional movements of hands and visual analogue scale will be used for pain assessment. Data will be analyzed by using SPSS 25.0 statistical tool. Appropriate statistical test will be used after checking normality of data.

Eligibility Criteria:
Inclusion Criteria:

* 8 to 12 years old children with post burn hand contractures
* Patients with flame burns
* Patients with 2nd degree burns

Exclusion Criteria:

* Patients with hand burns with any post burn complications
* Patients with wound infections
* Patients with 3rd degree burns Patients with hand fractures
Abdominal Ultrasound Assessment in the Post-cesarean Patient

This study is designed to see if abdominal ultrasound after planned cesarean delivery can identify women with ongoing intra-abdominal bleeding.

Hemorrhage is the second leading cause of maternal mortality in the United States. Women have an increased risk of hemorrhage after cesarean sections.Uterine atony is the culprit in 80% of cases, but in the post-operative patient, an intra-abdominal bleed requiring a return to the operating room must also be considered. The Focused Assessment with Sonography in Trauma (FAST) has been used in the emergency department to evaluate for intra-abdominal bleeding after trauma. FAST evaluation has not been studied in the post-operative period for evaluation for intra-abdominal bleeding. Ultrasound is a rapid and readily-available modality for this type of evaluation, and obstetricians are already familiar with the technology. But one must be cautious, as a certain amount of free fluid on CT is common in the postoperative patient. Before basing clinical decisions on a FAST scan, we much determine how much fluid is normal in a patient after cesarean delivery. We hypothesize that a certain amount of fluid in the abdomen visualized by ultrasound may be normal after a cesarean delivery, and that for ultrasound to become a valuable modality to assess for intra-abdominal bleeding in the post-cesarean patient, the amount of normal fluid must be determined. However, in order to interpret what an "appropriate" amount of fluid would be, we will also need an assessment of patient hemoglobin levels. Thus, we would additionally plan to validate a rapid, non-invasive hemoglobin measurement for use in the post-cesarean obstetric patient. The Pronto7 device measures the blood's absorption of multiple wavelengths of light to determine hemoglobin. The device avoids a blood draw and its associated pain. It also provides immediate results. We anticipate that we will identify an association between the amount of fluid seen on ultrasonographic evaluation after cesarean delivery and adverse outcomes such as larger than expected decrease in hemoglobin, need for transfusion and need for take-back to the operating room. We also anticipate that the use of non-invasive hemoglobin measurements may provide a rapid, painless assessment of postoperative hemoglobin; this may allow us to identify patients who merit earlier postoperative monitoring with a traditional CBC. It may also allow us to identify women who do not need an invasive CBC on postoperative day 1, which may decrease blood draws and costs in the future.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* 18 years of age or older
* English-speaking
* Non-urgent cesarean sections

Exclusion Criteria:

* Preeclampsia/eclampsia
* \<18 years old
* Urgent/emergent cesarean section
* Not English-speaking
* Unable to consent
Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community

The federal research award entitles "Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community" aims to Conduct interviews with justice and treatment experienced PWH (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral ART to LAI ART in prison with continuation during community re-entry; develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 20-30 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of LAI ART in prison, transition of LAI ART to community providers, and to pilot study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period.

R34-funded mixed methods study that will develop and pilot test an LAI ART protocol designed specifically for PWH who are experiencing community re-entry

Eligibility Criteria:
Inclusion Criteria:

* 1) ≥18 years of age; 2) English speaking; 3) HIV positive (confirmed by medical record review); 4) receiving oral ART; 5) documentation of HIV viral suppression (\< 50 copies/mL) on oral ART within 12 weeks of recruitment; 5) eligible to transition from oral ART to injectable CAB/RPV based upon medical record review and pre-treatment evaluation; 6) willing to transition ART to injectable CAB/RPV; 7) anticipated release from MDPSCS facility within 12 weeks; 8) anticipated release to Baltimore City; 9) willing to receive post-release CAB/RPV injections at community-based sites; and 10) able to provide informed consent for study participation.

Exclusion Criteria:

* Persons who are currently prescribed injectable CAB/RPV within MDPSCS will not be eligible for study enrollment, however, we do not anticipate use of injectable CAB/RPV will be common in this population during the conduct of this study given slow roll out in the community to date and no experience within carceral facilities. Potential participants unable to provide informed consent, including people with severe mental illness (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed) requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia), will be excluded.
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult onset RA (functional class I-III) for at least 6 months
* Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
* Must have at least 4 swollen and tender joints due to rheumatoid arthritis

Exclusion Criteria:

* History of recurrent infections requiring antibiotic treatment within 12 months
* Serious local infection or systemic infection within 3 months
* Suffering from rheumatic or autoimmune disease other than RA
* History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness
A Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)

This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.


Eligibility Criteria:
Inclusion:

* Infants with birth weight \< 1500 grams AND/OR \<32 weeks gestational age
* Infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion OR Infants between 28-42 weeks gestational age at risk of nasal septal erosion

Exclusion:

* Infants with major congenital and upper airway anomalies
* Infants requiring ETT (endotracheal tube) mechanical ventilation
* Infants receiving no respiratory support
Psychological Effects of H Pylori Associated Gastritis

The goals of this study

1. Explore association between psychological factors and Hpylori associated gastritis.
2. Assess prevalence and severity of psychology symptoms among patients with H pylori associated gastritis and their effects on their life.
3. Examine relation between demographic and clinical variables .
4. Effect of eradication of H pylori on psychological status of patients.

One of the most prevalant chronic bacterial illness affecting people is it H.plyori infection. it affects at least 50% of people worldwide . it is a human gastrointestinal infection which is believed to be blammed for a number of gastric illness from chronic gastritis up to gastric cancer.

numerous literature data suggest there is strong relation of anxiety disorders, stress or depression to somatic symptoms and this relation can undergo potentialization in case of appearance of pathogenic factors like helicobacter pylori infection , this relation can confirmed with many scientific reports , with the common use of antidepressants and anxiety relieving drugs in duodenal ulcer disease therapy.

The close relationship of gastrointestinal function with brain function and the mental status is known as (gut brain axis).

it has been reported that emotional factors induce changes in gastric physiology that physiological stress induces personality dependant gastric acid secretion changes and avariety of alterations in gastric motility.

. the effect of numerous stress factors which injury mucosa of stomach and modify immunity of the patient so that the patient become more sensitive to be infected with H. Pylori and infection become more aggressive and lead to manifestation of gastritis , duodenitis and gastric ulcer disease.

mental stress is considered a major pathogenic factor for peptic ulcers and it is associated with increasing prevalence of gastric ulcersin patients is with or without H.pyloriinfection.

another study revealed that depression is associated with food related symptoms as nausea and vomiting ,similarly it was showing that gastric information lead to an anxiety and depression like behaviors via neuroendocrine pathways in female not male.

so the investigetors conducted this observational study to determine the most common physiological effect is of H.pylori associated gastritis in patients attending Assiut university hospitals and How to deal with it to improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. all patients with H.Pylori associated gastritis that diagnosed by endoscopy.
2. patients diagnosed by detection of H.Pylori Ag in stool

Exclusion Criteria:

1. patients did not take antibiotics within last 2 weeks
2. patients did not take PPI within last 1 month
3. patients not with acute massive GITbleeding.
4. patients without eradication of H.Pylor
Comparison Between Two Methods of Throat Swabbing

Throat swabbing is an important instrument in the diagnosis of strep pharyngitis and sometimes the main argument for antibiotic treatment. There is no firm knowledge about an appropriate method of the swabbing for receiving maximal sensitivity. We hypothesize that accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to free swabbing. In order to check this hypothesis we will compare two swabs from the same throat. One that will be taken by a physician specifically from the pass and the second will be taken by a nurse as she used to do it. An increase of 10% of positive results will be accepted as a significant advantage.


Eligibility Criteria:
Inclusion Criteria:

* patients with sore throat, classified 2-3 according to Cantor's criteria

Exclusion Criteria:

* patients on antibiotic treatment
* suspected carriers of streptococcus