cyrilzakka/clinical-trials huggingface dataset:
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia

The purpose of this study is to investigate whether fish oils may be of benefit to patients with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.

Atrial fibrillation and atrial flutter are two heart conditions that can be successfully treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in the case of atrial fibrillation). Ablation involves the application of high frequency energy waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a normal rhythm with the use of an electric current.

Fish oil supplements may be of benefit to patients with heart problems. Recent evidence suggests that fish oils may benefit those with rhythm disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Chronic atrial flutter requiring radiofrequency ablation.
* Chronic atrial fibrillation requiring internal cardioversion.

Exclusion Criteria:

* Sinus rhythm.
* Pregnancy.
* Patients \> 80 years and \< 18 years of age
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis

Twenty patients with PAH had 1 session of Fractionated microneedle radiofrequency treatment. Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and photographs were taken using the starch-iodine test at every visit and 4 weeks, 8 weeks, and 24 weeks after the treatment. Skin biopsies were obtained from 3 of the enrolled patients before and after treatment. The satisfaction and adverse reactions of the research participants were recorded at every follow-up visit.

Hyperhidrosis Disease Severity Scale (HDSS)Score = 1 My sweating is never noticeable and never interferes with my daily activitiesScore = 2 My sweating is tolerable but sometimes interferes with my daily activitiesScore = 3 My sweating is barely tolerable and frequently interferes with my daily activitiesScore = 4 My sweating is intolerable and always interferes with my daily activities

Eligibility Criteria:
Inclusion Criteria: Meet the following conditions

* Diagnosed according to having a score of 3 or 4 on a Hyperhidrosis Disease
* Severity Scale (HDSS);
* Patients aged 18 to 40 years (to the date of screening);
* Not treatment in Axillary area before;
* Understanding the whole process of the study, voluntary participation and signed the informed consent;
* Patient compliance is good, can guarantee in course of observation.

Exclusion Criteria:One of the following is not included in this study:

* Pregnant women, ready to pregnant or lactating women;
* Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
* Need insulin control of diabetes; High blood pressure did not get good controller ;
* Patients with white blood cells \<4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets \<100 × 109 / L, or other blood disease;
* Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
* Patients suffering from malignant tumor;
* Patients suffering from acute and chronic infectious diseases;
* Mental disorders, history of alcohol abuse, drug or other substance abuse;
* Other cases which researchers believe that can not enroll.
Prospective Cohort Study of Neurogenetic Diseases

Neurogenetic diseases (NGD) represent rare and hereditary forms of neurological diseases. The goal of CNGD is to create a one-window approach for NGDs, to facilitate and accelerate participation in research projects through deep phenotyping and the availability of low-cost biological samples for research teams. It is positioned as a true hub allowing new connections between clinical and basic research teams and ultimately as an incubator for translational projects for NGDs, in order to be able to initiate therapeutic trials, the ultimate objective of clinical and translational research.

Neurogenetic diseases (NGDs) represent rare inherited forms of neurological diseases. They constitute a constellation of different diseases, affecting neurodevelopment (syndromic or non-syndromic intellectual disabilities (ID), with or without autism spectrum disorders (ASD), epileptic encephalopathies, neurodevelopmental disorders (NDD) with or without ID... ) or leading to early neurodegeneration (Huntington's and Huntington-like disease, hereditary ataxias, hereditary spastic paraplegias (HSP), primary dystonias, neurodegeneration due to intracerebral iron accumulation (NBIA), neurometabolic diseases, etc.). Progress in the knowledge of the genetic causes of NGDs is unceasing, with the discovery of new genes involved in their determinism being continuous. As a result, the boundary between routine care and clinical research is extremely narrow and blurred, and the two activities are totally intertwined and interdependent in the care of patients.

For patients with NGDs already characterized by molecular genetics, at an early, intermediate or presymptomatic stage, we will perform a comprehensive annual standardized clinical and paraclinical evaluation for deep phenotyping as part of routine care; collection of biological samples (annual blood and urine sampling, optional skin biopsy and optional cerebrospinal fluid (CSF) sampling), for functional analyses and better understanding of the pathophysiological mechanisms involved. This study will last 3 years

Eligibility Criteria:
Inclusion Criteria:

* Patient-specific inclusion criteria
* Age ≥ 6 years
* Patient with a molecularly identified NGD

  o Specific inclusion criteria for controls
* For the 10 controls with lumbar puncture (LP): person who performed an LP for medical reasons and who consented to participate in the collection of biological samples
* Age ≥ 18 years
* Person matched in age (+/- 5 years) and sex to adult patient with NGD at the time of collection

Exclusion Criteria:

* Participation in an interventional clinical trial that may interfere with our study
* Refusal of blood collection
* Pregnant and breastfeeding women
* Only for patients performing LP: Contraindication to LP
* Specific non-inclusion criteria for controls: Criterion of a neurodegenerative or inflammatory pathology of the central nervous system
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.


Eligibility Criteria:
Inclusion Criteria:

* HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
* Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
* Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
* No more than two prior lines of therapy in the metastatic setting
* Measurable disease per RESIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy \>= 6 months
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

* Prior treatment with trastuzumab emtansine in metastatic setting
* History of exposure to cumulative doses of anthracyclines
* Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
* Current Grade \>= 3 peripheral neuropathy
* Cardiopulmonary dysfunction
* History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* Active hepatitis B, hepatitis C and/or tuberculosis
* Prior allogeneic stem cell or solid organ transplantation
* Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
* Pregnancy or lactation
Inter-Mountain Project on Antimicrobial Resistance and Therapy (IMPART)

This is a four-year study, funded by the Center for Disease Control and Prevention, related to antimicrobial resistance in rural communities. The project consists of four components: A) surveillance of antimicrobial resistance, B) promotion of appropriate antimicrobial drug prescribing, C) preliminary assessment of the environmental impact of antimicrobials, and D) the development of new antimicrobial products. Six rural communities in Utah, and six rural communities in Idaho are participating in this study. Component D is being performed by investigators at Harvard University, under the direction of Co-Investigator Roger Inouye.


Eligibility Criteria:
Inclusion Criteria:

* Suspected upper respiratory infection patients in 12 rural communities in Utah and Idaho

Exclusion Criteria:

-
Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia

The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness.

Despite the high mortality risk of severe wasting (also referred to as severe acute malnutrition or SAM), only a small proportion of children with severe wasting are currently identified and admitted to available outpatient treatment programs (OTP). In 2020, an estimated 4.9 million children with severe wasting received treatment, approximately a third of the total burden. Outside of humanitarian settings, this proportion is even lower (estimated to be around 15%). These figures highlight the urgent need to increase treatment coverage to meet the Sustainable Development Goals (SDG), which aim to reduce the prevalence of child wasting to less than 5% by 2025 and less than 3% by 2030. The continuum of care for SAM, from case identification, referral to treatment, and post-treatment follow-up, is hampered by several barriers including caregiver lack of awareness on the risks and treatment services of SAM, stigma related to SAM, poor accessibility to treatment, frequent stockouts of treatment inputs, and the overall workload faced by first-line health workers.

The R-SWITCH intervention will leverage existing community groups to deliver an integrated package aimed at preventing SAM through behavior change communication (BCC) on child nutrition and health, increasing wasting screening coverage through active screening, family-led MUAC and improved passive screening health posts, increasing treatment coverage through follow-up of earlier referred cases, cases enrolled in OTP, and children who completed OTP and recovered.

The primary objectives of the R-SWITCH studies are:

* To assess the impact of the R-SWITCH intervention on SAM OTP coverage
* To identify implementation barriers and facilitators
* To assess the cost-efficiency and cost-effectiveness of the intervention package and services

Eligibility Criteria:
Inclusion Criteria:

* Child 6-59 months of age
* Suffering from SAM (defined as MUAC \< 115mm or presence of bilateral pitting edema or Weight-for-Length Z-score \<-3) OR currently enrolled in SAM OTP

Exclusion Criteria:

- Anthropometric malformation or being handicapped which hampers anthropometric measurements.
Early Antibiotic Discontinuation in FUO

Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.

Infections are responsible for significant morbidity and mortality in haematological patients, in particular during chemotherapy-induced neutropenia. Guidelines recommend immediate initiation of antibiotic therapy, whose optimal duration is unclear. The primary objective of this study is to evaluate early discontinuation of antibiotic treatment for Fever of Unknown Origin (FUO) in afebrile or febrile neutropenic patients. The secondary objective is to describe the epidemiology of febrile neutropenia (FN) in investigator centre.

Every episode of FN was prospectively identified. In the first phase of the study, empirical antibiotic therapy of FUO patients was stopped after 48 hours of apyrexia, in accordance with ECIL-4 (European Conference on Infections in Leukaemia) recommendations. In the second phase of the study, antibiotics were stopped on day 5 for all FUO patients, regardless of their temperature or their leukocyte count.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* presence of a malignant haematological disease combined with chemotherapy-induced neutropenia (polymorphonuclear neutrophil (PMN) count ≤ 500/mm3)
* fever defined by tympanic temperature of ≥38°C for ≥1 hour or a single temperature of ≥38.3°C

Exclusion Criteria:

* Patients without curative care
* chronic neutropenia (PMN≤ 500/mm3 for 3 months or more)
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz

The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.

The trial drug FDC of TDF/3TC/EFV is a new formulation combining fixed doses of the nucleoside reverse transcriptase inhibitors lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg with the non nucleoside reverse transcriptase inhibitor efavirenz 600 mg for once daily and one-tablet HAART. Co-formulated TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data). It has not been evaluated in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Evidence of HIV infection
* Age\> 18 years
* On a TDF/3TC/EFV (separated pills) containing HAART regimen with a VL \< 50 copies within 24 weeks or ARV naïve
* eGFR \>70 cc/min
* Currently having no AIDS defining illness
* No history of NRTI/NNRTI/PI failure
* Willing to adhere to the protocol requirements

Exclusion Criteria:

* Any history of taking CYP450 inhibitors or inducers drugs within 14 days of enrollment in the study
* Current pregnancy or lactating or plan to be pregnant
* Active opportunistic infection
* ALT more than 2 x upper limit
* Creatinine more than 1.5 time the upper limit
* Active drug abuse
The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia

The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.

Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve.

In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200).

However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.

Eligibility Criteria:
Inclusion Criteria:

- Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III

Exclusion Criteria:

* Patient refusal
* Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)
* Contraindications or allergy to dexmedetomidine or remimazolam administration
* Emergency surgery
* Pregnancy
Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed consent.
2. Age≥18 year.
3. Subject is cooperative and capable of following instructions.
4. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
5. Phase II: Chronic pulmonary patients with lung volume disorders:

   * COPD
   * Asthma
   * Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.

Exclusion Criteria:

1. Subjects unable or unwilling to give informed consent.
2. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
3. History suggesting upper respiratory infection during the four weeks prior to testing
4. Physical activity during 1 hour prior to the Study.
5. Patients with a tracheostomy.
6. Pregnant women.
Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.

The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography )

ERCP with sfincterotomy or precut is connected with procedural or/and postprocedural bleeding. Estimated risk of bleeding is from 2% to 10%. Procedural bleeding is usually managed by diluted epinephrine injection, balloon tamponade, hemoclip or fully covered metalic self-expanding stent placement. There is no standard preventive treatment for patients with higher risk of delayed post-sphincterotomy bleeding. PuraStat®, 3D Matrix Europe SAS, Caluire-et-Cuire, France) is synthetic self-assembling peptide haemostatic gel indicated to stop bleeding from small blood vessel or oozing from capillaries. Purastat® is easily aplicated through a catheter during the ERCP procedure and it is not significantly prolonging the procedure. The transparent gel is not compromising the endoscopic view and enables to continue in procedure if necessary.

All patients after ERCP sfincterotomy or precut will recieve Purastat® during the procedure Adverse events (bleeding, cholangoitis, pancreatitis) will be monitored during following 4 weeks (ambulatory after hospital discharge) This cohort will be compared to historical control, when Purastat® was not available tu use.

Eligibility Criteria:
Inclusion Criteria:

* . All patients indicated for ERCP with papilosphincterotomy or precut.
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Known allergy to a novel hemostatic agent
* Gravidity
* Inability to sign informed consent
Management of Bone Defects Around the Elbow

Background:

Bone defects of the distal humerus require complex reconstructions, for which standard prostheses may be insufficient. The researchers therefore investigated the clinical and radiological outcome of elbow reconstructions by megaprostheses.

Type of prosthesis:

STRYKER Humerus-HMRS

Eligibility Criteria:
Inclusion Criteria:

* HMRS of the elbow, distal humerus or total humerus

Exclusion Criteria:

* Unwillingness to participate
Safety and Efficacy of Lidocaine Infiltration in Suction Assisted Lipectomy

RCT of S/E of lidocaine infiltration in tumescent technique.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* I or II of the Classification of the American Society of Anesthesiologists.
* Completed high school.
* Between 18 and 40 years old
* At least suction of entire abdomen and back
* Body mass index between 20 and 27
* Accept written informed consent

Exclusion Criteria:

* Associated surgery
* Hypersensibility to (Cefazolin or Clindamycin, Lidocaine, Ketorolac, Morphine, Remifentanyl, Propofol, Tramadol).
* Pregnancy
* Previous surgery to abdominal wall or back, including cesarean.
* Abdominal wall hernia
* Previous liposuction
* Active psychosis
Femtosecond Laser for Cataract Surgery

The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with the treatment/follow-up schedule and requirements
* Able to understand and provide written Informed Consent
* ETDRS visual acuity equal to or worse than 20/32 (best corrected)
* Age between 50 and 80 years old
* Pupil dilates to at least 6 mm
* Subject able to fixate
* Grade 1-4 nuclear sclerotic cataract (LOCS III)
* Axial length between 22 and 26 mm

Exclusion Criteria:

* Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
* Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
* Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
* History of prior ocular surgery
* History of ocular trauma
* Co-existing ocular disease affecting vision
* History or current use of alpha-1 antagonist medication (e.g., Flomax)
* Known sensitivity to planned concomitant medications