cyrilzakka/clinical-trials huggingface dataset:
Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery

Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block.

Hypotheses:

1. Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min.
2. Recurrent block (TOF ratio \< 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg.

The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose

Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio \< 0.9) after reversal and the occurrence of adverse reactions)

Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.

Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.

Eligibility Criteria:
Inclusion Criteria:

* Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
* ASA I-IV
* Signed informed consent

Exclusion Criteria:

* Patient less than 18 years of age
* Patient participating in another clinical study which could interfere with TOF trial.
* Patient with neuromuscular disease
* Patient from ICU
* BMI \> 30.0 kg/m2
* Patient scheduled for local or regional anesthesia only
* Patient undergoing general anesthesia without rocuronium
* Patient with hypersensitivity to NMBAs or sugammadex. Also hypersensitivity to any active substance or to any of the following excipient: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections .
* Renal dysfunction (GFR\<30 mL/min/1,73m2)
* Hepatic dysfunction
* Patient who have received sugammadex in the last 24 h.
* Pregnant or breastfeeding woman. Women in childbearing age must have a negative pregnant test before inclusion.
* Bradycardia (puls \<40)
* Hypotension (Systolic BP \<90 mmHg)
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).

The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled calibration software for subject calibration. The Sonitus BCD picks up sounds from a microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the natural pinna and ear canal. The signal picked up by the microphone is then transmitted wirelessly to a removeable bone conduction oral appliance located on the upper molars. The oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory signal to the teeth that reaches the skull via bone conduction and routed transcranially to the contralateral cochlea.

Eligibility Criteria:
Inclusion Criteria:

* Must be \>18, \< 80 years old
* Must be fluent in English, as determined by the PI
* Must not be a member of a vulnerable group (IRB defined)
* Must remain in geographic area during duration of the study
* Diagnosis of acquired SSD (Section 3.1), time since onset (≥3 mos)
* Must have a minimum of 6 posterior teeth remaining in the upper arch (3 teeth per side),third molars are acceptable if healthy, fully erupted and substituting for second molars

Exclusion Criteria:

* Must not be current users of devices such as Baha, CROS or TransEar
* Must not have known active medical causes of SSD:

  * Active middle ear pathology
  * Conductive HL (Otosclerosis, otitis media, otitis externa and others)
  * Sudden hearing loss that is not stable
* Must not have known medical problems that might be life-threatening or is a contraindication for elective dental or medical procedures
* Must not have known problems that may interfere with the impression procedure, such as inability to breath through nose (e.g. severe flu, allergies or cold)
* Must not have allergies to polymers
* Must not have known dental abnormalities:

  * Temporary crowns or undergoing dental treatment
  * Poor oral hygiene and/or rampant decay
  * Current orthodontics
  * Active caries in one or more of the possible abutment teeth for the device
  * Active moderate to severe periodontal disease around abutment teeth for the device
  * Suspicious oral/facial lesions or swelling of any type
  * Severe pain on palpation on any area of mouth, face or neck
  * Moderate to severe heat sensitivity on any of the upper teeth
  * Subject currently being treated for temporomandibular joint disorder (TMJ), pain, full mouth reconstruction or posterior dental implants
* Must not have known Audiological conditions:

  * Conductive hearing loss (air-bone gap \>10dB HL at more than 3 frequencies)
  * Word recognition scores inconsistent with pure tone averages
  * Fluctuating hearing loss
* Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate
Predictors of In-hospital and Short-term Clinical Outcomes in STEMI Patients Undergoing Primary PCI

The study aims to assess the culprit-SYNTAX score and no-reflow PIANO scores as possible predictors of in-hospital and short-term outcomes among patients with STEMI undergoing primary PCI

ST-elevation myocardial infarction (STEMI) is the leading cause of death in cardiovascular patients. Percutaneous coronary intervention (PCI) is recommended as the preferred treatment for patients with STEMI. However, patients with (STEMI) undergoing primary (PCI) remain at high risk of adverse events, including death, reinfarction, stent thrombosis, and repeat revascularization. This underlines the need to identify predictors of impaired clinical outcomes in order to recognize higher-risk patients in the contemporary practice of primary PCI. STEMI patients show variable mortality risks, in order to assess individual risk, a number of mathematical models (scoring algorithms) have been developed as TIMI, GRACE 2.0, and ALPHA scores Similarly, angiographic scores were developed to assess the outcomes in STEMI patients, SYNTAX Score, has shown predictive value of in-hospital mortality among STEMI patients. Recently, the culprit-SYNTAX score appears to be as successful as the SYNTAX score in predicting stent thrombosis in patients with ACS and more successful in predicting 30-day deaths and major complications.

The no-flow phenomenon (NRP), one of the most common complications of primary PCI, significantly reduces the benefit of this procedure. The occurrence of NRP following PPCI leads to an unfavorable short-term prognosis by increasing the risk of complications and in some cases, of death. A new score system (the PIANO score) based on six clinical variables was constructed and validated, was variables to predict angiographic no-reflow in STEMI patients undergoing primary PCI, and very recently showed potential prognostic value in patients with AMI undergoing primary PCI.

Eligibility Criteria:
Inclusion Criteria:

Patients presented with 1st episode of STEMI and undergoing primary PCI. For 1 year duration.

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Exclusion Criteria:

1. Patient with STEMI in which thrombolytic therapy was used.
2. Patient with a history of previous CABG surgery.
3. Patient with a history of previous PCI.
4. Patient with a history of previous STEMI.
5. Patients with myocardial infarction with non-obstructive coronary arteries (MINOCA)
6. Patient with spontaneous coronary artery dissection (SCAD).
Observational Study of Long-Term Joint Health Outcome in Hemophilia Patient

Patients with severe hemophilia A can experience repeated bleeding into the same joint (ie, a target joint; most frequently in the ankle, knee, and elbow), which can contribute to hemophilic arthropathy and, over time, ultimately result in chronic pain, functional limitations, deformities, reduced joint of motion and decreased quality of life.

Early use of prophylaxis is recommended following diagnosis of severe hemophilia A to maintain joint health and prevent joint destruction. Eloctate is produced using a human cell line and an addition of an Fc fusion protein to recombinant FVIII (rFVIIIFc) with prolonged half-life and was launched in Taiwan from Nov. 2018. The pivotal studies of rFVIIIFc show that patients maintained a low bleeding rate, with most experiencing a median annualized bleeding rate (ABR) of 0 and 97% of target joints were resolved across adult, adolescent, and pediatric subjects during 4 years of prophylaxis rFVIIIFc treatment. However, in Taiwan we are still lacking the real world treatment outcome data on rFVIIIFc, especially for the joint health evidence in Asian Hemophilia A patients.

Therefore the objective of this study is to evaluate the effectiveness of rFVIIIFc treatment on joint health over a long observational period of 36 month focused on physical and functional changes in hemophilia A patients.

Thermographic assessment has been proposed to be a potential tool in evaluating the inflammatory arthritis patients. Thermography has advantages of simple, time-saving, low skill demanding, no radiation exposure and non-invasiveness. It is possible to conduct a quantitative analysis with thermography. However, it is still unknown whether thermography evaluation can provide clinical information regarding the joint health in hemophilia arthropathy patients. The project will focus on:

1. Investigate the association among thermography findings and functional status in hemophilia arthroplasty
2. Investigate the novel biomarkers in predicting function in hemophilia arthropathy including: soft tissue ultrasound, body composition, thermographic findings of joints, muscle composition and serum biomarkers of joint degeneration.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign inform consent form and complied with study procedure
2. Patient received confirmative diagnosis of Hemophilia A Disease
3. Severe hemophilia A patient currently who are on treatment with Eloctate prior to enrolment visit (Note: Prescription based on physician's clinical judgement and discussion with patients)

Exclusion Criteria:

1. Unwilling to sign inform consent form.
2. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
3. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
4. Significantly impaired vision / hearing
5. Cannot communicate in Mandarin Chinese
6. Recent joint bleeding and trauma 3 months prior to study
Hyaluronic Acid Gels for Lower Lid Retraction

Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. The definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting.

Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by subcutaneous injection and volume addition. These gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. Functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG to be useful in correcting both upper and lower eyelid retraction, with good effect.

The purpose of this investigation is to define the clinical utility of HAG correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity).

Our hypothesis is that HAG correction of lower eyelid retraction will improve patient comfort, clinical signs of dry eye and aesthetic self image.


Eligibility Criteria:
Inclusion Criteria:

1. Lower eyelid retraction of \>1mm in one or both eyes.
2. Complaints of either significant ocular symptoms (OSDI\>13) or cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

1. Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population
2. Age over 65 years of age: as HAG filler effect may be different in this population
3. Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers
4. Have a demonstrated allergy to HAG fillers or lidocaine
5. Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it
6. Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis.
7. Currently active stage Thyroid Eye Disease
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1

The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.

Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) scheduled with a primary care provider (PCP) are eligible to enroll in the study. To see if you might be eligible, fill out a prescreening survey here: https://redcap.link/mynfguide

Background: The majority of individuals with Neurofibromatosis 1 (NF1) in the United States lack access to specialized NF1 clinics and consequently don't receive care aligned with national recommendations. To address this gap in care, researchers are evaluating two interventions to determine which one helps people get recommended NF1-related health screenings at their annual wellness visit with a primary care provider.

Methods: Participants (adult patients or parents) who enroll in the study will complete baseline survey assessments online before their PCP visit and then be randomized to one of two groups. Both groups will be given letters, one for themselves and one for their clinician, that describe NF1 care recommendations. After attending their annual wellness visit, all participants will be asked to complete an online follow-up survey. A small subsample of participants will also be asked to do a virtual qualitative interview. No visits to Massachusetts General Hospital are required for this study.

Eligibility Criteria:
Adult Inclusion Criteria:

* Currently lives in the United States (including Puerto Rico and other United States territories)
* Has a clinical diagnosis of neurofibromatosis 1
* Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
* Has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
* Speaks English or Spanish

Parent/Guardian of a Child with NF1 Inclusion Criteria:

* Currently lives in the United States (including Puerto Rico and other United States territories)
* Cares for a child (age \<18 years) with a clinical diagnosis of neurofibromatosis 1
* Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
* Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
* Speaks English or Spanish

Exclusion Criteria:

* Only one person per household may participate in the study
* Unwilling or unable to give informed consent
Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma

Evaluate the Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Versus Placebo Plus R2 in Relapsed/Refractory Marginal Zone Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years, either sex.
2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
3. At least one and no more than 3 prior lines of systemic therapy (CD20 targeted therapy included in at least one line).
4. Relapsed or refractory disease.
5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
6. ECOG performance status (PS) score of 0-2.

Exclusion Criteria:

1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.
3. Prior treatment with any types of BTK inhibitor.
4. Prior allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or Autologous hematopoietic stem cell transplantation (ASCT) within 6 months prior to the first dose of the study treatment; or prior CAR-T cell therapy.
5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
* Signed consent
* Affiliation to the French social security system

Exclusion Criteria:

* Emergency surgery
* History of laparotomy before ileostoma closure.
* Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
* Lactating or pregnant woman
* Allergy to porcine product or collagen-based product. Allergy to polypropylene.
* Participation to another protocol focusing on ileostoma closure
Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation

The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this approach has been proposed for 20 years. The major concern is the learning curve for axillary vein puncture and its success rate. The investigators try to prove that the success rate of axillary vein puncture is non-inferior to subclavian vein puncture, hence to promote the clinical application of axillary vein puncture to reduce pacemaker implantation complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of pacemaker or ICD implantation
* Personally signed and dated informed consent document

Exclusion Criteria:

* Accompanied with malignant disease or other disease, which cause life expectancy \< 1 year.
* Anatomical variation of axillary vein or subclavian vein, unable to puncture.
* Poor compliance for follow-up.
* Patients with any condition which, in the investigator's judgment, not suitable for enrollment.
Gut Microbiome Based Analysis of High Protein High Fat Diet

The aim of this study was to determine body mass reduction and microbiota composition change after the weight loss diet (50 % fat, 25 % proteins and 25 % carbohydrates).

For high fat group a total of 19 overweight/obese participants (14 females, 5 males, aged 25 to 43) with BMI of 28.9-44.4 kg/m2 were assigned to low-calorie low-carbohydrate high-fat weight loss diet for 4 weeks.

As a control group, 58 subjects (39 females, 20 males, aged 24 to 55 years) were recruited and divided into 3 groups based on BMI: 18-25, 25-30, 30-39 kg/m2 (N=33, N=16, N=9, respectively).

Inclusion criteria for participants included no previous history of gastrointestinal (GI) disease, no reported antibiotic use in preceding 3 months, or taking any medication known to alter bowel motility, no history of food allergies and not taking medications.

Before the study all participants were informed about the study and participants were signed a written consent.

At day 0 baseline samples and data were collected (faecal sample, Bristol score and bowel habits, food diary about the period of at least three days before faecal sampling, body weight). After collection of baseline samples subjects in the high fat group started diet plan for 4 weeks while control group contiunued their habitual diet. After the 4 week intervention period samples and data were collected again (faecal sample, Bristol score and bowel habits, food diary about the period of at least three days before faecal sampling, body weight).

Eligibility Criteria:
Inclusion Criteria for obese group:

* BMI \> 30 g/m2

Exclusion Criteria:

* antibiotic treatment within last three months;
* food restrictions due to allergies, any kind of food intolerance, veganism/vegetarianism or other extremes in food consumption practices;
* chronic illnesses;
* current pregnancy or breastfeeding
* travel to subtropical or tropical regions within one month before the study.
A Comparison of Protein Intake Between ERAS and Conventional Care After Elective Colorectal Surgery

The primary objective of this prospective cohort study is to compare protein intake and adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with patients receiving conventional care. The study will also compare energy intakes, gut function, and clinical outcomes between groups. The ability of nutritional parameters, including preoperative malnutrition risk and postoperative protein intake, to predict length of hospital stay will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* adult patients ≥18 years of age
* elective colorectal resection

Exclusion Criteria:

* co-morbidities that could have interfered with oral intake (e.g., dysphagia)
* concurrent enteral or parenteral nutrition prior to surgery were excluded since food intakes could be influenced by these conditions.