cyrilzakka/clinical-trials huggingface dataset:
HNSCC Immuno-genomics Project

For locally advanced and recurrent / metastatic head \& neck squamous cell carcinoma (HNSCC), the is an unmet need for the development of efficient treatment combinations, particularly with immune checkpoint inhibitors. HNSCC have been characterized at the genetic / molecular level concerning characteristics of malignancy and potential clinical actionability ; currently, however, the integration of molecular characteristics of both the malignant cells and the host immune response are considered fundamental for the selection of treatment that best suits these patients .

The primary objective of the NCR-17-12885 project is to classify HNSCC for the selection of optimal therapeutic interventions for the patients, based on genomic characteristics and mutational processes operating in these tumours and on the prevailing activated immune pathways.

Herein we propose the development of a combined genomic and gene expression assay for the comprehensive evaluation of HNSCC for the classification of tumors into (a) those with activated checkpoint molecules and activated T cells, likely to respond to checkpoint inhibition in the case of non-operable disease or recurrent disease without prior treatment; (b) those with inducible checkpoint and T cell response prior to the administration of checkpoint inhibitors; (c) those with activated early inflammatory response that needs to be transformed to cell mediated activation; and (d) those with stable genomes and no immune activation probably necessitating induction of genomic instability and T cell activation.

The test to be developed will provide information on the genomic integrity of the tumor and on a global immune related gene expression profile, both by next generation sequencing

Eligibility Criteria:
Inclusion Criteria:

-Patients with locally advanced squamous cell carcinoma of the head and neck who were treated with concurrent chemoradiotherapy (CCRT) with or without induction chemotherapy (IC) or radical surgery +/- radiotherapy for laryngeal tumors.

Exclusion Criteria:

* Age \<18 years old
* Non-squamous cell carcinomas of the head and neck.
Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)

This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 and under 65 who meet criteria for bariatric surgery.
* Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
* Signature of the informed consent of the study
* Patients suitable for laparoscopic surgery

Exclusion Criteria:

* Previous bariatric surgery
* 2-stage surgery
* Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
* Other associated surgical procedures in the same intervention.
* Conversion to laparotomy
Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Female Elderly

Background: Taiwan's community population is aging rapidly, and women in the aging community account for the majority of frail elderly.In the process of aging, you must face changes in cognitive function, sleep disorders, and emotional state. Female elders have more impact on physical health than male elders. Precision nursing is a new trend in nursing in recent years. It is based on individual differences in disease type, gender, lifestyle, family, race, social and cultural factors, etc., to provide the most suitable empirical-based nursing treatment. It can also prevent and delay disability in improving the cognitive function, sleep quality and emotional state of frail female elderly in the community.

Purpose: This study explored the effectiveness of precision nursing intervention program on cognitive function,sleep quality and emotional state of frail female elderly in the community.

Methods: This study utilized a quasi-experimental research design. The subjects divided to 35 persons of experimental group and 35 people of comparison group. The experimental group implemented a weekly precision care program course for frail female elderly in the community for a total of 12 weeks; the control group maintained normal daily life. We collected cognitive function、sleep quality and emotional state from before and after intervention among frail female elderly in the community. The statistical methods uses were descriptive analysis, chi square, t test, generalized estimating equation (GEE), and difference-in-differences.

Expected benefit: The precise care plan of this study can benefit the cognitive function, sleep quality and emotional state of frail female elders in the community, and then extend it to various aging communities. According to the characteristics of the community elders and making good use of health policies and local resources, we will arrange and design appropriate courses to create a localized healthy aging life circle, and achieve the goal of preventing and delaying disability for the elderly and frail.


Eligibility Criteria:
Inclusion Criteria:

* (1) Elders over 65 years old can come and return home on their own. (2) Clear awareness and barrier-free communication. (3) Those who are frail or above detected by SOF screening, SOF ≥ 2 or above. (4) Agree to participate in this research and complete the consent form.

Exclusion Criteria:

-(1) Severe visual and hearing impairment, unable to cooperate with the researcher.

(2) Those whose limbs cannot participate in activities normally. (3) For chronic physical diseases, doctors have ordered those who are prohibited from exercising.
Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Patients With Acute and Chronic Pain

Adults and children undergoing medical care (inpatient or outpatient) often experience pain and anxiety either as a result of their medical condition or a side effect of medical procedures. The purpose of this study is to create a registry of patients using virtual reality (VR) mindfulness therapy through different aspects of their medical care to determine if VR mindfulness therapy is more effective than the standard of care (i.e., no technology based distraction) for treating or preventing anxiety and pain in adults and children suffering from chronic pain, GI conditions where pain is a common symptom, or undergoing any painful medical procedure (i.e. IV access, blood draws, endoscopy, surgery). The anticipated primary outcome will be reduction of pain and anxiety for both acute and chronic pain.

Inpatient: Inpatients will be presented with an informed consent. If they sign the consent, they will then be given a VR headset pre- programmed with content that they may use for the duration of their stay. GI patients headsets will be collected when they are discharged. There are pain and anxiety analog scales at the end of each program. This data will be downloaded to Stanford. Patient's will not be entering their PHI. we will know who has headsets, as they will be numbered. Patient who are hospitalized for chronic pain will be allowed to take the VR headset home for month and be asked to return it at their followup outpatient visit.

Outpatient: Patient's who are about to undergo gastrointestinal disease testing or be seen for an outpatient GI appointment will be presented with an informed consent. If they sign the consent, they will be given the VR headset to use prior to their procedure. There are pain and anxiety analog scales at the end of each program. This data will be downloaded to Stanford Medicine Box.Patient's will not be entering their PHI. we will know who has headsets, as they will be numbered.

Eligibility Criteria:
Identify inclusion criteria.

Participants must:

1. be between ages of 5-80 years of age
2. have comprehension of instructions in the English language
3. English speaking
4. Must be able to comprehend ICF
5. Have a medical appointment or procedure at Stanford/LPCH (inpatient or outpatient) that may cause pain or anxiety.

Identify exclusion criteria.

General Exclusion Criteria are as follows:

1. Significant cognitive impairment/developmental delays
2. Seizure Disorder
3. history of motion sickness with virtual reality
4. severe visual impairment
Fungal Infection on a Joint Prosthesis

It is generally accepted that the fungal infection on a joint prosthesis is to be treated in two surgical time: implant removal and prosthetic reconstruction. The service took the option for over 10 years to treat bacterial infections in joint replacement by a change in time. In four recent cases the diagnosis initially suspected of bacterial infection has been restated on intraoperative bacteriological examinations fungal infection. It is therefore a potentially harmful side effect of the chosen treatment option, but 4 patients in question were all cured of their fungal infection after a postoperative antifungal therapy. The objective of this study is to report these cases for discussion on the therapeutic choices in fungal infections on joint replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patient having surgery for the management of fungal infection after change in one step in joint replacement prothesis in the participating services in 2014.

Exclusion Criteria:

* Patients under 18 years
A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.

Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. The aim of the current study is to compare the efficacy and safety of a subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two anti-TNF agents with mavrilimumab. The design of the study was exploratory and not formerly statistically powered.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 80 years
* Written consent
* Diagnosis of adult onset Rheumatoid Arthritis (RA) as defined by the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) classification criteria
* Moderately active disease as defined by disease activity score in 28 joints C-reactive protein (DAS28\[CRP\]) greater than or equal to (\>=) 3.2 at screening and DAS28 erythrocyte sedimentation rate(ESR) ≥ 3.2 at Day 1
* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
* At least 4 swollen joints
* Inadequate response to one or two anti-TNF agents other than the study comparator, as defined by the protocol
* Receiving oral or injectable methotrexate, as defined by the protocol.

Exclusion Criteria:

* A rheumatic autoimmune disease or other inflammatory joint disease other than RA
* Previous treatment with biologic therapies other than anti-TNF for RA
* Treatment with other DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs), as defined by the protocol.
* Medical history as defined by the protocol.
Rebamipide AND Sjögren Syndrome

Xerostomia is a major distressing symptom in Sjőgren's syndrome(SS). Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration.We thus hypothesize that rebamipide may be efficacious in the treatment of dry mouth symptoms related to Sjőgren's syndrome.We will recruit SS patients in a randomized placebo-controlled trial for 12 weeks. The main outcome measure that will concern us is patient-assessed improvement of dry mouth symptoms and increase in salivary secretion Safety and efficacy was assessed at each visit.

Xerostomia is a major distressing symptom in Sjőgren's syndrome (SS). Persistent dryness of the mouth causes oral pain, discomfort and significantly interferes with the quality of life. Rebamipide, in addition to its gastro-protective effect has displayed various anti-inflammatory actions including inhibition of neutrophilic leukocyte activation. Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration.

The aim of the present study is to assess efficacy of rebamipide in the treatment of dry mouth symptoms related to Sjőgren's syndrome.

Methods: Fifty-five patients with American European Consensus Criteria Group (AECG)-based diagnosis of SS will participate in this randomized placebo-controlled trial. Inclusion criteria will include SS patients with dry mouth symptoms. Patients with dry mouth due to other conditions will be excluded. Patients will be randomized 1:1 to receive either 300mg/d (100mg x3/day) of rebamipide or placebo for 12 weeks together with their usual therapy. Outcome measures will include patient-assessed improvement of dry mouth symptoms and increase in salivary secretion (evaluation of unstimulated saliva; questionnaires including the visual analogue scale (VAS) for Sicca-syndrome VAS 0-100mm). Subjective and objective findings of dry mouth will be recorded at baseline, two, four, six, eight, ten and twelve weeks. Safety and efficacy will be assessed at each visit.

Eligibility Criteria:
Inclusion Criteria:

* SS patients with dry mouth symptoms

Exclusion Criteria:

* Patients with dry mouth due to other conditions
Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City

The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated postdate pregnancy

The Study Will be a case-control study that will be conducted at Banha University Hospital and AFHSR in Saudi Arabia after the approval of Institutional ethical committee. One hundred pregnant women will be recruited from antenatal clinic. Starting from November 2022. An informed consent will be obtained from the patients . The patients will be subdivided into two groups:

Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.

Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or more.

Inclusion criteria:

1. Singleton, viable fetus in the vertex presentation.
2. History of regular menstrual cycles.
3. Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination.
4. No obstetric or medical complications of pregnancy apart from post-date pregnancy

All patients will be subjected to:

1. Detailed history: including, personal history, menstural history, obstetric history, present history and past history.
2. Physical examination: general, abdominal and pelvic examination.
3. Investigations: including, A- Ultrasound examintion for amniotic fluid index (AFI) measurement.

B- Doppler studies:

i - Middle cerebral artery pulsatility index (MCA -PI) and resistace index(MCA-RI).

ii - Umbilical artery pulsatility index (UA-PI) and resistance index (UA-RI). iii - Cerebro-Placental ratio (CPR).

Eligibility Criteria:
Inclusion Criteria:

1. Singleton, viable fetus in the vertex presentation
2. History of regular menstrual cycles
3. Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination
4. No obstetric or medical complications of pregnancy apart from post-date pregnancy

Exclusion Criteria:

1. Patients unsure of their dates
2. Medical disorders with pregnancy as (hypertension, diabetes mellitus or Rh isoimmunization)
3. Prelabor rupture of membranes
4. Polyhydramnios
5. Women with multiple pregnancy
6. Congenital fetal anomalies
7. Antepartum hemorrhage
8. Previus cesarean section
9. Fetal malpresentation
Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome

Antiphospholipid syndrome (APS) combines thrombotic (venous and/or arterial) and/or obstetrical manifestations, along with biological anomalies related to the presence of antiphospholipid antibodies. Despite actual treatment recommended by international guidelines, the relapse rate in APS is high and survival is 65% at 15 years. Hydroxychloroquine has demonstrated its efficacy and benefits in the treatment of Systemic Lupus Erythematosus, but there is no current consensus concerning the efficacy of this treatment in the secondary prevention of thrombotic events in primary APS, even though several in vitro experimental and animal model data, along with several clinical studies have suggested a beneficial effect of this drug in this indication. Considering the prevalence of primary APS in the general population and of the number of clinical events observed in patients with primary APS and receiving conventional treatment with vitamin K anticoagulants (VKA), the consortium expects a minimum clinically relevant difference of 70%. Considering a prevalence of thrombotic events for the entire studied primary APS population of 10% at 2 years, the consortium expects a 70% decrease in thrombotic events under Hydroxychloroquine treatment administered in addition to VKA treatment in primary APS, i.e. a 3% prevalence in the Hydroxychloroquine group at 2 years. The consortium proposes a drug trial, phase III, national multicentric, comparative, randomized, superiority, double-blind, controlled with 2 compared groups (Hydroxychloroquine versus placebo) study. The enrolment period will be 24 months.

The main aim of this trial is to comparatively assess at 24 months the number of new thrombotic events (venous and arterial) in primary antiphospholipid syndrome in patients treated with VKA plus Hydroxychloroquine versus VKA plus placebo, in a multicentre, prospective randomized, double-blind, versus placebo study.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Presence of a primary antiphospholipid syndrome with previous venous/arterial thrombosis and which needs a treatment with VKA
* Patients with a signed commitment

Exclusion Criteria:

* Secondary APS
* Ocular diseases :

  * retinal disease contraindicating the prescription of hydroxychloroquine
  * cataract
  * monophtalmic
* Past history of intolerance or allergy to hydroxychloroquine
* Known deficit in G6PDase
* Hemolytic anemia
* Porphyria
* Chronic hepatic disease
* Severe renal failure (creatinin clearence \<30ml/min)
* Chronic alcoholism
* Patient with QT interval \>440 ms on the ECG
* Concomitant treatment with drugs raising the QT interval
* Epilepsy
* Pregnant or breastfeeding women
* Women refusing an effective contraception
* Active cancer or malignant hemopathy
* Psychiatric disease unabling the compliance to treatment
* Unaffiliated person or not beneficiary of a social security system
* Concomitant participation at a biomedical trial able to interfere with the actual trial
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter

The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.

Intra-abdominal pressure (IAP) may play a role in patient outcomes during ablation procedures, as increased IAP could indicate potential adverse events. Such adverse events include aspiration of stomach contents, which can lead to respiratory issues post procedure and unplanned admission to the hospital post procedure. Potrero Medical has manufactured a foley based monitoring system that has been FDA cleared for the indication of measuring intra-abdominal pressure. The Accuryn monitor allows for continuous, real-time measurement of IAP and urine output, providing data that may enhance procedural safety and provide insights into any physiological responses unique to Pulsed Field Ablation (PFA). This study aims to compare PFA in terms of safety, efficacy, and IAP changes based on type of anesthesia received.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and/or atrial flutter.
* Eligible for Foley catheter placement with no contraindications to Intra-abdominal pressure (IAP) monitoring.

Exclusion Criteria:

* Patients under the age of 18 will be excluded.
* History of intra-abdominal surgery within the past 6 months.
* Known contraindications to bladder catheterization or catheter ablation; history of prostate issues / Benign prostatic hyperplasia (BPH) or frequent urinary tract infections
* Pregnant or breastfeeding individuals
* History of chronic obstructive pulmonary disease (COPD) with home oxygen use
Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment

The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.

The study will investigate the impact of postoperative supplemental long-acting bupivacaine on patient's pain, quality of life, and analgesic use following treatment for symptomatic irreversible pulpitis on patients with pre-operative pain levels of 5 or above (on a 0-10 analog scale). Bupivacaine will be compared to a placebo/mock injection and no injection to determine the difference in effect.

Eligibility Criteria:
Inclusion Criteria:

1. Medical ASA Class I or II
2. Patients above 18 years old
3. Patients with a blood pressure below 160/100
4. Patients who are treatment planned and have agreed to have emergency endodontic therapy or non-surgical root canal therapy with a pulpal diagnosis of symptomatic irreversible pulpitis according to the AAE Glossary of Endodontic Terms.
5. Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.

Exclusion Criteria:

1. Medical ASA III or above
2. Patients who reported the use of tobacco or nicotine-containing products such as vapes, e-cigarettes, gums, or pouches and will not in the 48 hours following treatment
3. Patients who reported the use of any marijuana products or illicit drugs in the 48 hours prior to treatment and will not in the next 48 hours.
4. Patients who have taken opioids to control pain.
5. Pregnant patients
6. Patients with a blood pressure of 160/100 or greater
7. Patients with a known hypersensitivity or allergy to any local anesthetic agent of the amide group, or any other components of the two anesthetic solutions such as epinephrine, sodium metabisulfite used in the study.
8. Patients who have more than one tooth with odontogenic pain at the time of the screening.
9. Patients who are unable to consent and do not understand or are unable to read the questionnaires.
10. Patients who have had 4 1.7 ml carpules or more of anesthetic (Lidocaine and/ or Septocaine, 1:100,000) during standard care of treatment.