cyrilzakka/clinical-trials huggingface dataset:
Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)

The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are:

* Are the treatments effective?
* Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise).

Researchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.

This is a parallel group, two-arm, randomized, controlled trial comparing the effects of surgical denevation to patient education plus exercise in patients with symptomatic PIP joint osteoarthritis.

The research questions are:

1. Does any of the treatments denervation of the PIP-joint and patient education plus exercise decrease pain, improve patient-reported outcomes, grip strength and range of motion (ROM) in PIP-joint osteoarthritis?
2. Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes grip strength and ROM more effectively than patient education plus exercise for PIP-joint osteoarthritis?

Participants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint or education plus exercise. A block randomization scheme with a fixed block size of 10 will be used. Patients will be stratified according to gender. Sealed opaque envelopes will be used and data analysts will be masked for treatment allocation.

Assesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary enpoint is 12 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Chronic symptomatic osteoarthritis in the PIP-joint.
* Radiological signs of osteoarthritis on posteroanterior and lateral radiographs assessed by the Kellgren-Lawrence classification (grade II-IV) (Kellgren \& Lawrence, 1957).
* Clinical signs of PIP-joint arthritis.

Exclusion Criteria:

* Inflammatory arthritis.
* Ongoing infection in the hand.
* Inability to co-operate with the follow-up protocol.
* Intra-articular glucocorticoid, PRP or Hyaluronic acid injections in the affected joint less than 3 months prior to enrollment.
A Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Adult Participants

The primary objective of this study is to determine if the Infrared Cameras, Inc (ICI) FMX 400 infrared (IR) Class 1 infrared thermal camera (IRT) system is comparable to oral, forehead, and ear thermometers for determining human body temperature.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be able to provide opt-out consent.
2. Participants must agree to have temperature recorded noninvasively using an infrared thermal camera (IRT) Class 1 device, oral thermometer, forehead thermometer, and ear thermometer.

Exclusion Criteria:

1. Participants who opt out of participating; ie, participants who do not agree to have temperature recorded noninvasively using an IRT Class 1 device, oral thermometer, forehead thermometer, and ear thermometer.
2. Participants who are not able to understand that their temperature will be recorded, or who are otherwise unwilling to participate.
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae

The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer:

Can the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result?

Specimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.

This is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for N. gonorrhoeae using an FDA-cleared molecular assay. The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance in N. gonorrhoeae, as compared to a reference standard of Sanger sequencing of the gyrA codon 91. Specimens will be tested via a reference standard of Sanger sequencing and one investigational reflex test. The target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.

Eligibility Criteria:
Inclusion Criteria:

* Be N. gonorrhoeae-positive on an FDA-cleared molecular assay
* Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing
* Undergo proper handling and storage conditions

Exclusion Criteria:

* The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site
* The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source
Observational Prospectif Monocentric Registry of Patients Suffering From VIE

Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),
* diagnosis of venous thromboembolism made within 15 days,
* the previous inclusion in the register (outpatient or inpatient)

Exclusion Criteria:

* person doesn't wish to participate in this study
Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.


Eligibility Criteria:
Inclusion Criteria:

* Weight loss within the past 4 weeks
* Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
* Birth weight greater than or equal to 1500 grams
* Solely enteral fed
* Infants with at least one persistent allergy symptom
* No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
* Signed informed consent

Exclusion Criteria:

* History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
* Metabolic disease requiring special attention
The Cosmetic Effect of Mineral Clay Masks

The aim of this study is to evaluate the cosmetic effects of commercially available mineral clay masks over a 4-week period. Changes in skin pigmentation, shine, wrinkles, and texture will be assessed.

A second aim of the study is to assess the safety and tolerability of mineral clay masks by assessing redness and participant feedback.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-50
* Individuals in good general health
* Individuals free of any autoimmune or systemic disorder, which would interfere with the analysis.

Exclusion Criteria:

* Individuals who have been on any topical prescribed medications for the past 2 weeks
* Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
* Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema) or those who have recently undergone treatment for skin cancer (within the last 12 months) in the area of testing on the forehead, nose and the cheeks
* Female volunteers who are pregnant or planning to become pregnant over the course of the study. The risk to pregnant women is minimal but the facial appearance can be confounded by the altered hormones associated with pregnancy, as is well documented in chloasma which is dyspigmentation that arises in pregnancy. Women who become pregnant during the duration of the study will become ineligible but there are no birth control requirements.
* Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
* Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
* Individuals who are currently using or during the past 14 days have used a retinoid such as tretinoin, adapalene, or retinol containing agents or a hydroquinone containing agent
* Individuals who have used mineral clay masks on their face within the last 14 days
* Individuals with a known history of hypersensitivity to any ingredients to the agent that is being assessed
Efficacy and Safety of Telmisartan Compared With Losartan

A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

A Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared with Losartan in Patients with Diabetic Nephropathy and Hypertension

Eligibility Criteria:
Inclusion Criteria:

* Male of Female subjects aged ≥19 or \<75
* Type II Diabetes Mellitus subjects who have been taken medicine
* Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF

Exclusion Criteria:

* Subjects with Type I Diabetes Mellitus
* Subjects with Primary hyper-aldosteronism
* Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening
* Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period
* Subjects who received other clinical trial drugs within 28 days of screening visit
* Subjects who are unable to participate in this clinical trial at the discretion of the investigator.
Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). One-third of adults who are intubated in the ED or ICU experience symptoms of posttraumatic stress disorder (PTSD). PTSD is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." Critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. Patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). While on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. Patients with PTSD after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that PTSD negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. Ketamine may prevent PTSD symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories In outpatients with chronic PTSD, a single dose of ketamine has been shown to reduce PTSD symptoms for up to 2 weeks. Even a modest reduction in PTSD would translate into tens of thousands of fewer cases of PTSD each year, more cases of PTSD each year than any other medical intervention evaluated to date.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in RSI trial (NCT05277896)

Exclusion Criteria:

* Aphasic or non-verbal prior to tracheal intubation
* Cannot follow commands prior to tracheal intubation
* Non-English speaking
* Deaf
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody

Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment

Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive

Eligibility Criteria:
Inclusion Criteria:

* hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines

Exclusion Criteria:

* hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody
Cobimetinib for BRAF-wild-type or Mutated Histiocytoses

COBRAH is a randomized double-blind 2-steps controlled superiority trial, with 2 parallel groups.

Patients will be randomly assigned in a 2:1 ratio to receive Cobimetinib orally or placebo during the first 12-weeks step, allowing the determination of the primary criteria.

Histiocytoses are rare multisystemic disorders characterized by accumulation of histiocytes in various organs. Virtually all the patients have a somatic mutation in the RAS-RAF-MEK-ERK pathway. BRAF inhibitors are efficacious to treat BRAF-mutated patients but one third of the patients are BRAF-wild type. For these patients, preliminary data have shown an efficacy of the MEK inhibitor cobimetinib. This trial aims to evaluate the efficacy of cobimetinib for treating BRAF-wild type or mutated patients with L or R group histiocytoses.

The primary objective of the COBRAH trial is to demonstrate that the rate of objective metabolic response (complete or partial) according to PERCIST criteria is higher under Cobimetinib versus placebo.

The objective metabolic response according to PERCIST criteria (Haroche, et al. 2015) is defined by the Positron Emission Tomography (PET) response and will be used to evaluate the overall therapeutic response at month 3 (Week 12).

For PERCIST criteria, a quantitative analysis of uptake will be performed using the standard uptake value (SUV). Fitting regions of interest covering pathologic uptake will be used to define target lesions. PERCIST will be used to classify the patients as complete metabolic response, partial metabolic response (reduction of a minimum of 30% in target lesions), stable metabolic disease or progressive metabolic disease.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients should be at least 18 years of age,
* Have a histologically confirmed L or R group histiocytoses without BRAFV600E mutation detected with the use of a real-time polymerase chain reaction or with BRAFV600E mutation AND a contra-indication to BRAF inhibitors
* Have a measurable disease according to the PERCIST criteria with presence of at least one severe organ involvement (heart, vascular, central nervous system) OR a multisystemic disease with ≥3 organ involvement AND failure of a first-line treatment or contra-indication to these treatments,
* Accepting effective contraception during treatment duration (men and women childbearing potential) and 3 months after.
* Signed informed consent

Exclusion Criteria:

* Patients with severe hepatic, renal and cardiac outcomes
* Patients with myopathies at baseline
* Patients with retinal detachment at baseline
* Patients with inherited disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Patients with high bleeding risk.
* Allergies to iodized contrast media
* Simultaneous participation in another medical research
* Pregnancy or breast-feeding.
* No affiliation to the French Health Care System "sécurité sociale" OR no affiliation of European Health within the scope of Regulations (EEC) n° 1408/71 and 574/72 coordinating social security systems.
Genetic Study of Patients Suffering From Congenital Amaurosis of Leber or From an Early Severe Retinal Dystrophy

Retinal dystrophies are responsible for numerous cases of blindness, and there are no therapeutic possibilities today. Gene therapy is efficient in a dog model concerning dystrophy linked to a mutation of the rpe65 gene. If such a therapy is to be considered for humans, it is urgent to select, at a national level, patients suffering from dystrophy linked to a mutation of the rpe65 gene. The systematic correlation of phenotype/genotype is an anatomical-functional approach, but it also identifies patients who may be potentially included in a future gene therapy study. Indeed, identification of people with a mutation of rpe65 is still insufficient in France (compared to other European countries) because of a lack of systemic genotyping of retinal dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical characteristics of amaurosis of Leber
* Patients suffering from an early severe retinal dystrophy
* Patients with social insurance
* Patients with a consent form signed

Exclusion Criteria:

* Retinal dystrophy with autosomal dominant transmission
* Retinal dystrophy occuring after 5 years of age
* Syndromical retinal dystrophy with one or more systemic manifestations
* Familial macular degeneration
* Familial choroid dystrophy
* Non-degenerative retinopathology
Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients

There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior study by Muthala et al. (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In this pilot study, through an endocrine consult team, a weight-based, steroid dose-based insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.


Eligibility Criteria:
For diabetics enrolled on admission:

Inclusion Criteria:

* Age ≥ 18 years old
* Type 2 diabetes mellitus treated with insulin secretagogues or insulin prior to hospitalization
* Diagnosis of lymphoma
* Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day
* Hospitalized for at least 48 hours
* Decision-making capacity to provide own consent

Exclusion Criteria:

* Type 1 diabetes
* Any contraindication to insulin therapy
* Patients only on single agent therapy such as metformin, thiazolidinediones (TZDs), Dipeptidyl peptidase-4 (DPP4) inhibitors, or Exenatide®, for safety concerns
* Insulin requirement of \>1.5 units of insulin/kg
* If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control
* Pregnancy, confirmed with a urine b-human chorionic gonadotropin (HCG) (for all women between the age of 18 and 60 years old)

Patients who develop a blood glucose \> 235 mg/dL after admission will be eligible for study enrollment based on the following:

Inclusion criteria:

* Age ≥ 18 years old
* Diagnosis of lymphoma
* Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day
* Will be hospitalized for at least an additional 48 hours
* Decision-making capacity to provide own consent

Exclusion criteria:

* Any contraindication to insulin therapy
* If a patient required ICU stay during the hospitalization, data from 12 hours before, during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect of critical illness on glycemic control
* Pregnancy, confirmed with a urine b-HCG (for all women between the age of 18 and 60 years old)
Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

The purpose of this study is to determine whether nonsurgical periodontal therapy is effective in the metabolic control of patients with type II Diabetes mellitus.

Type 2 diabetes mellitus (DM2), the most common type of diabetes, is characterized by hyperglycemia, hyperlipidemia, and associated complications. The classic major complications of diabetes are microangiopathy, nephropathy, neuropathy, macrovascular disease, delayed wound healing, and periodontitis. There is an interacting, complex relationship between diabetes and periodontitis.Many studies have shown a greater incidence and a greater severity of periodontitis in diabetic patients.Meanwhile, a number of studies have suggested that periodontitis may actually be a risk factor for diabetic complications as well. This study is performed to investigate the effects of non-surgical periodontal therapy on metabolic control in DM2 patients.

Eligibility Criteria:
Inclusion Criteria:

(1) mild to moderate periodontitis according to the criteria of the American Academy of Periodontology (32); (2) diagnosis of DM2 with glycated hemoglobin (HbA1c) values over 7%; (3) no major diabetic complications; (4) blood sugar controlled with glybenclamide and metformin, without insulin administration; and (5) no systemic antibiotic administration or periodontal treatment within the last 6 months.

Exclusion Criteria:

(1) presence of systemic diseases other than DM2 that may influence the course of periodontal disease; (2) intake of immunosuppressive drugs, steroids, hydantoin, or non-steroidal anti-inflammatory drugs; (3) tobacco use; (4) pregnancy or intention to become pregnant during the study period; (5) fixed orthodontic appliances; and (5) refusal or inability to give informed consent