cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation

Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (CRS).

Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances... a phenomenon called "nasal hyperreactivity" (NHR). It is currently not clear why some patients suffer NHR while others do not.

In this study, the investigators want to determine the prevalence and severity of nasal hyperreactivity in patients with chronic upper airway inflammation. To this end, patients and healthy controls will be asked to fill out a questionnaire inquiring presence and severity of nasal symptoms upon exposure to particular environmental triggers.


Eligibility Criteria:
PATIENTS

Inclusion Criteria:

* age 18-65 y
* Nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain)
* Signed informed consent

Exclusion Criteria:

- Current or medical history of malignancy in the last ten years

CONTROLS

Inclusion Criteria:

* age 18-65 y
* No nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain)
* Signed informed consent

Exclusion Criteria:

- Current or medical history of malignancy in the last ten years
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.


Eligibility Criteria:
Inclusion Criteria:

* This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,

Exclusion Criteria:

* Subjects with central nervous system (CNS) metastases
* Prior anticancer therapy for RCC
* Prior investigational therapy/agents within 4 weeks of randomization
DIAMOND AF Post-Approval Study

The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of recurrent symptomatic paroxysmal AF
2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol)
3. Patient is ≥ 18 years of age
4. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System
5. Patient is willing and able to provide written informed consent
6. Patient is willing and able to comply with study requirements

Exclusion Criteria:

1. Prior persistent AF (continuous AF that is sustained \>7 days)
2. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
3. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
4. Patients with contraindications to a Holter monitor
5. Unwilling or unable to comply fully with study procedures and follow-up
Efficacy of Focal Primaquine Mass Administration for Eliminating Plasmodium Vivax Malaria in Northern Myanmar

Plasmodium vivax has become the predominant species in the Greater Mekong Subregion and is a major challenge for regional malaria elimination. Mass primaquine administration has played a decisive role in malaria elimination in many temperate zone countries, but its efficacy in tropical areas remains to be evaluated. This study aims to assess the efficacy of targeted primaquine mass treatment (TPT) for eliminating P. vivax malaria in northern Myanmar.

This study employed a cluster-randomized crossover design in which two groups of villages received TPT at different times. In August-September 2019, Group 1 received TPT (0.25 mg/kg/day primaquine base for 14 days), while Group 2 was the control. In June-July 2020, Group 2 received TPT, while Group 1 served as the control. To evaluate the effectiveness of TPT for preventing relapses of vivax malaria, two indicators were utilized: infection prevalence at 3-month intervals estimated through cross-sectional surveys and monthly malaria incidence by passive case detection. The data were analyzed using descriptive statistics, chi-squared test, cumulative hazard function, and mixed model logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Residents in study villages
* Male/ female
* Consent to participate

Exclusion Criteria:

* Low Hb%
* G6PD deficiency
* pregnant women,
* breastfeeding mothers and
* children under 7 years
Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.

Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.

Eligibility Criteria:
Inclusion Criteria:

Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Patients must have no evidence of macroscopic residual disease or metastatic disease.
2. Male or female, age \>=18 years (age \>=20 years in Japan, Korea and Taiwan).
3. Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):

   * pT2, pN0 or pNx, M0 and ECOG PS 0-1
   * pT3, pN0 or pNx, M0 and ECOG PS 0-1
   * pT4, pN0 or pNx, M0 and ECOG PS 0-1
   * Any pT, pN1, M0 and ECOG PS 0-1
4. Patients must have histologically confirmed preponderant, defined as \>50%, clear cell RCC.
5. Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
6. Patients must not have received any previous anti angiogenic treatment.
7. Patients must have adequate organ function.

Exclusion Criteria

1. Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
2. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage \<4 weeks of date of randomization.
3. Diagnosis of any non-RCC malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
4. Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
5. Gastrointestinal abnormalities
Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

Pseudomonas aeruginosa is a pathogenic bacteria for human, especially in hospital settings. It can sometimes be multi-resistant to many or even to all antibiotics usually used for its treatment.

The aim of the study is to isolate and produce therapeutic antibodies against the bacteria Pseudomonas aeruginosa in order to provide an alternative treatment to antibiotics in case of infection with an antibiotic-resistant strain of Pseudomonas aeruginosa.


Eligibility Criteria:
Inclusion Criteria:

* Patient selected in the retrospective part of the study (patient with serum containing functional anti-Pseudomonas aeruginosa antibodies)
* Patient with weight ≥ 32kg.
* With a follow-up visit at Grenoble University Hospital with a blood sampling for its care
* Having given its written no objection to participate in the prospective phase of this project

Exclusion Criteria:

* Legally protected patient (minor, pregnant or nursing woman, ward or ward curated, hospitalized under duress or deprived of liberty)
Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.

This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
* Body weight greater than 61 kg and not more than 87.3 kg
* HCV RNA greater than 2 million copies/mL
* Elevated measured or historical alanine aminotransferase
* Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
* Calculated creatinine clearance greater than 70 mL/min

Exclusion Criteria:

* Cirrhosis of the liver
* Alanine aminotransferase greater than 3 times the upper limit of normal
* Severe neuropsychiatric disorders
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
* Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)
Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate

After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").

After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with hemodialysis or hemodiafiltration since at least three months.
* Hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly.
* ≥ 18 years of age.
* Patients able and agree to provide signed informed consent.

Exclusion Criteria:

* Contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by Swartz and Port1.
* Planned surgery during study period, including scheduled living-donor kidney transplantation during study period.
* Hypercoagulable state defined as known malignancy, known APC resistance/FV Leiden, known prothrombin gene mutation, known protein C or protein S deficiency, known antithrombin deficiency.
* Mean Qb of \<300ml/min during one of the last 3 dialysis sessions before inclusion.
* 1 or more results of spKt/Vurea \< 1,35 during the last three months prior to study inclusion.
* Need for 2 or more supplementary dialysis sessions on top of the regular 3x4 hours weekly hemodialysis regimen during the last month before inclusion.
* Vascular access dysfunction defined as

  1. use of urokinase the 2 months before study inclusion, including to restore catheter permeability.
  2. non-tunneled hemodialysis catheter use.
  3. known AV access outflow tract stenosis.
  4. planned vascular access intervention.
  5. planned vascular access conversion.
* Known allergy against heparin grafted AN69STmembranes.
* Use of ACE-inhibitor
* Use of vitamin K antagonist
* Use of novel oral anticoagulant therapy.
* Any medical condition, which puts the patient at risk of premature study termination in the opinion of the investigator.
* Planned conversion of dialysis modality during study period or planned absence/leave (including pregnancy or planned pregnancy).
* Symptomatic hypocalcemia.
* Hb \< 8g/dl at screening.
* Hct \> 45% at screening.
* Perdialytic total parenteral nutrition therapy
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the clinical trial
* Able and willing to provide informed consent
* Stable ostomy (no revisions in the last 6 months)
* At least 19 years old
* Medically stable, but may be on medications for chronic conditions

Exclusion Criteria:

* Unable or unwilling to provide adequate informed consent
* Non-English speakers
* Clinically significant disease
* Women who are pregnant, intending to become pregnant, or breastfeeding
* Use of anti-diarrheal medicine
* Suffer gastroparesis
* Opioid use
Pericapsular Nerve Group (PENG) Block Versus Periarticular Injection for Pain Management After Total Hip Arthroplasty

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block provides sufficient analgesia but it is still the potential for quadriceps weakness that might delay ambulation. Periarticular injection has attached attention as an effective analgesic modality with a low prevalence of adverse effects. The investigators will compare ultrasound-guided PENG block with periarticular injection in patients undergoing total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 19 years old or older
2. American Society of Anesthesiologists Physical Status 1-3
3. Scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness
Feasibility of Preoxygenation by Supraglottic Jet Ventilation Before Endotracheal Intubation

The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

The study assumed that supraglottic jet ventilation is an alternative solution as a safe way to do the preoxygenation before endotracheal intubation by contrasting it with mask pressurized ventilation. The investigators also expected that supraglottic jet ventilation won't increase the occurrence of esophageal reflux.

The investigators randomly divided the patients into 2 groups:Group C and Group S.Patients in Group C will be preoxygenation with mask pressurized ventilation while patients in Group S with supraglottic jet ventilation by Wei NASAL JET（WNJ）.The tracheal intubation will be done after the 3 minutes preoxygenation. The investigators will measure the PaCO2 before and after preoxygenation, and the investigators will take the stomach-ultrasonography to find if there are too much gas in the gastro. If pulse oximetry is lower than 95% during the preoxygenation, the investigators will adjust the position of the Wei NASAL JET（WNJ) or use the change the way that the investigators hold the mask or change the pressure of ventilation on the basis of the group.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for any surgery under general anesthesia
* adults age range from 18-64 years old
* American Society of Anesthesiologists Physical Status Classification (ASA class) I-II
* voluntary participation in this clinical trail, signed informed consents

Exclusion Criteria:

* patients with epistaxis, rhinostenosis, the episodes of rhinitis, severe gastroesophageal reflux disease, severe respiratory disease, severe cardiovascular and cerebrovascular disease
* long-term use if anticoagulant drugs
* can't cooperate with intervention
* pulse oximetry \<95% with normal respiration
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors

The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.


Eligibility Criteria:
Inclusion Criteria:

* must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased

Exclusion Criteria:

* refusal to participate
* does not speak French
* deaf/mute
* adult, but under guardianship
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Signed written informed consent.
* Women undergoing sentinel lymph node biopsy.
* Women with breast cancer with known or suspected lymph node involvement.
* Women undergoing sentinel node identification and completion axillary lymph node dissection.
* Women of 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.
* Complete Blood Count (CBC) and basic Metabolic Panel within 6 months

Exclusion Criteria:

* History of liver or kidney failure will not be eligible.
* Allergies to iodine containing products will not be eligible.
* Women who are pregnant will not be eligible.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.