cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)

The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)

Hearing impairment is highly prevalent and independently associated with cognitive decline. Little is known about the various types, degrees, and configurations of hearing loss and how it relates to uptake of a hearing intervention and possible long-term benefits of using the intervention. The purpose of this study is to investigate the comparative effectiveness within an observational study design to determine the long-term effects of hearing intervention, in the form of osseointegrated devices (OID), among patients with either conductive, mixed, or single-sided hearing loss. Participants will be followed for 3 years (36 months) to answer the following aims:

Aim 1: To compare the effect of OID intervention versus no audiological intervention on rates of decline in global cognitive function (primary outcome measure) in 18-85 year-old well-functioning and cognitively-normal older adults with hearing loss. We hypothesize that there will be a significant difference in cognitive function between patients that utilized OID hearing intervention compared to no audiological intervention.

Secondary Aims: To compare the effect of OID intervention on secondary outcomes of hearing, social, mental, physical, and cognitive functioning. We hypothesize that there are significant differences in secondary outcomes between patients that utilized OID hearing intervention compared to no audiological intervention.

Eligibility Criteria:
Inclusion Criteria:

* age 18-85 years
* community dwelling
* residency: participants must plan to reside in the local area for the study duration.
* fluent English-speaker
* Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.
* Mini-Mental State Exam (MMSE) score \> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.
* willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years)

Exclusion Criteria:

* self-reported disability in \>2 or more Activities of Daily Living (ADL)
* medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded
Early Rheumatoid Arthritis Lung Disease Study

Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The goals of this study are to investigate and characterize lung disease and its prevalence in early RA participants. This will be done through pulmonary function and high resolution chest computed tomography (CT), questionnaires, and serum studies. Another goal is to find novel biomarkers, such anti-malondialdehyde-acetaldehyde (MAA) antibodies, as predictors of lung disease in RA participants.

Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The purpose of this study is to characterize the prevalence and classification of lung disease in participants with newly diagnosed rheumatoid arthritis by prospectively gathering information on lung imaging and function, comorbidities and novel biomarkers, such as anti-malondialdehyde-acetaldehyde (MAA). Specifically, the study would determine whether (MAA) adduct antibody concentrations predict computed tomography (CT) changes consistent with RA-lung involvement and determine whether anti-MAA antibody concentrations predict pulmonary function abnormalities in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and diffusion lung capacity of carbon monoxide (DLCO). An additional goal is to develop a cohort of newly diagnosed RA patients who can be followed long-term through electronic medical record (EMR) surveys, and biobank samples.

Eligibility Criteria:
Inclusion Criteria:

* 19-90 years of age
* Able to give informed consent
* Diagnosis of RA by a Rheumatologist using 2010 American College of Rheumatology (ACR) criteria within the past 2 years

Exclusion Criteria:

* Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA)
* Pregnant
Vertical and Horizontal Mandibular Ridge Augmentation Techniques

The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Physical status according to the American Society of Anesthesiology (ASA) I or II, which includes patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
* Subjects having at least one free end saddle edentulous area of the posterior area of the mandible with moderate horizontal and vertical bone defects \>≥3mm.
* Capacity to understand and accept the written conditions of the study.

Exclusion Criteria:

* Insufficient oral hygiene.
* Smoking habit of \>10 cigarettes/day (self-reported).
* Abuse of alcohol or drugs.
* Pregnancy or individuals attempting to get pregnant (self-reported).
* Acute local or systemic infections.
* Uncontrolled diabetes or other metabolic disease.
* Severe hepatic or renal dysfunction.
* Autoimmune disorders.
* Patients who underwent radiotherapy in the last 5 years.
* Patients undergoing immunosuppressive therapy or who are immunocompromised.
* Any other contraindications for undergoing surgery.
Plan for Systematic Identification of Lung Cancers of Occupational Origin: Implementation Study

The main objective is to identify obstacles and elements facilitating the implementation of a tracking device Broncho Pulmonary Cancer during the course of care.

The secondary objective is to assess patient knowledge and information received on their previous occupational exposure during their professional activity.

This is a prospective multicenter study of qualitative methodology through in-depth interviews conducted with patients treated at ICLN and CHU Saint-Etienne


Eligibility Criteria:
Inclusion Criteria:

* primitive CBP Patients;
* Patients employees or have been employees of the general scheme and / or the agricultural social security system;
* Patients understand French.

Exclusion Criteria:

* Patients recognized occupational disease for CBP;
* recognized disability in patients for CBP by the social security system;
* Patients who have never been employees of the General or the agricultural social security system plan
* Patients already included in phase 1 of the study;
* Refusal of participation, signed consent major patients protected under guardianship;
* Patients unable to understand the course of the study.
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.

OBJECTIVES:

Primary

* Determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy.

Secondary

* Determine the toxicity and feasibility of treatment with this drug.
* Determine the efficacy of this drug in these patients.
* Compare the duration of remission after first- vs second-line chemotherapy.
* Determine the rate of objective remission.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of mantle cell lymphoma
* Stable disease after first- or second-line chemotherapy
* No uncontrolled cerebral or leptomeningeal disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy ≥ 3 months
* Age ≥ 60 years or patients ≥ 40 and \< 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin \> 9 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* SGPT and SGOT ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN
* No other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer
* No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness)
* No known HIV infection
* No gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis)
* No coagulation or bleeding diatheses
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Patients must have complied with their previous drug prescription

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* See Patient Characteristics
* Recovered from all prior therapy
* At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy
* More than 4 weeks since prior experimental medication
* No chronic therapy with systemic steroids or other immunosuppressants except rituximab
* No prior organ transplantation
* No therapy with vitamin K antagonist, except low-dose coumarin
* No prior mTOR inhibitors
A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture

This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).

This double-blinded randomized clinical trial investigates difference in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Twenty healthy volunteers aged 20-40 years were randomly allocated to the 2 groups and administered eBV and BV on left and right forearm, respectively, in accordance with group allocation. Physician, participant, and outcome assessor were blinded to group allocation. Local pain, swelling, itching, redness, wheals and adverse reactions were recorded by timepoint before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with no prior exposure to bee venom treatment
* Healthy individuals of both genders, 20 to 39 years old
* Individuals able to communicate their thoughts
* Voluntary participants who have provided written consent

Exclusion Criteria:

* Individuals on medications for chronic diseases (i.e. hypertension, hyperlipidemia)
* Individuals with past history of allergic dermatitis
* Individuals with past history of adverse events following bee stings
* Individuals with symptoms of common cold
* Individuals with fear of bee venom intervention or those who refuse to participate
Cupping and Serkangabin Versus Conventional Migraine Treatment

Migraine is the most common recurrent headache. Current therapy of migraine headache consists of multiple drug groups for control of attack and prophylaxis against recurrent attacks. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity, duration and frequency of attacks of migraine headache evaluated in two groups during six months from presentation.

In a randomized controlled trial investigators randomly assigned 76 patients with migraine to cupping therapy plus SERKANGABIN or to receive conventional medical treatment. The use of CAM in migraine is a growing phenomenon. Migraine patients seek and explore both conventional and CAM approaches. Wet cupping is an ancient medical technique still used in several contemporary societies. It is being used in management of hypertension, diabetes mellitus, and headaches, renal and biliary stones and for maintaining health. Little experimental study has been devoted to test its efficacy to treat migraine headache. Investigators planned this study for evaluation of therapeutic efficacy of wet cupping and an Iranian traditional medicine preparation, SERKANGABIN in treatment of migraine headache compared with current medicine protocols. SERKANGABIN is a preparation of honey, vinegar and distilled mint water that in traditional Iranian medicine is believed to have therapeutic effects in many diseases (diabetes mellitus, hypertension, hyperlipidemia, osteoarthritis, chronic obstructive airway disease, interstitial lung disease, hepatitis, fatty liver, ischemic heart disease, migraine, cerebrovascular diseases)

Eligibility Criteria:
Inclusion Criteria:

* migraine headache with or without aura

Exclusion Criteria:

* uncontrolled hypertension
* ischemic heart disease
* cardiac arrhythmia or symptomatic Wolff-Parkinson-White syndrome
* previous stroke or transient ischemic attack
* severe liver or renal impairment
* any other severe or disabling medical condition
* history of alcohol or analgesic or psychotropic drug abuse
* contraindication to or known hypersensitivity to study drugs
* current use or use in the previous 2 weeks of MAO-inhibitors
* a pain disorder other than migraine as the primary presenting problem
* current psychological treatment, psychiatric disorder needing immediate or priority treatment
* current or planned breast feeding or pregnancy or unwillingness to use an established contraceptive method
* non compliance of patients
* not presenting at times determined for treatment and evaluation
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation.

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
4. ECOG 0-1

Exclusion Criteria:

1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
2. Any severe and/or uncontrolled medical conditions
3. Active infection requiring systemic treatment within 7 days
4. Therapeutic radiation therapy within 3 weeks of study day 1
Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)

Acute chest syndrome (ACS) is a frequent and potentially life-threatening pulmonary illness. It is a complication of sickle cell disease and is the leading cause of death from this disease in adults. Several pathologic processes are recognized causes of ACS, including infectious diseases, hypoventilation secondary to chest pain, in situ thrombosis and pulmonary fat embolism. Inhaled nitric oxide (iNO) has been shown to be a pulmonary vasodilatator with minimal systemic effects and has also been shown to improve gas exchange in both animal and human acute lung injury (ALI).

The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching, reducing alveolar and systemic inflammation, modulate the course of acute chest syndrome, which combine the physiopathology of vaso-occlusive crisis and acute lung injury.

We hypothesise inhaled NO will improve oxygenation and clinical outcome of sickle cell disease patients with acute chest syndrome.

Objectives: To compare the outcome and duration of acute chest syndrome (ACS) in patients with sickle cell disease (SCD) treated with iNO to that of similar episodes experienced by patients which receive a placebo.

Study design: Bi-center, prospective, randomized, controlled clinical trial

* Enrollment: 24 months
* Patients will be treated for 72 hours
* Patients will be followed for 15 days or until discharged home

Sample size:

* The study will accrue a maximum of 240 patients
* Progress of the trial will be reviewed by an independent data and safety monitoring committee to determine if randomization should stop for safety reasons.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell disease (Hemoglobin genotypes characterized by standard procedures as homozygous hemoglobin SS, hemoglobin SC, and S beta thalassemia)
* Diagnosis of acute chest syndrome based on the presence of fever, dyspnea or chest pain, associated with new pulmonary infiltrates on chest X-ray

Exclusion Criteria:

* Patient has been hospitalised \< 14 days ago
* Patients presenting with clinically diagnosed bacterial infections
* Patients who have received an exchange transfusion in the last 30 days or are in a transfusion program.
* Current pregnancy or lactation
* Patient who is currently enrolled in any other investigational drug study
* Previous participation in this study
* Any of the following medical conditions:

  * Immediate need of ventilatory support wih orotracheal intubation
  * Hemodynamic instability
The Influence of Rapid Recovery on Sleep Quality Following Total Hip Replacement Surgery

To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery


Eligibility Criteria:
Inclusion Criteria:

* 1. Primary unilateral total hip arthroplasty;
* 2. Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis;
* 3. Able and willing to provide signed informed consent.

Exclusion Criteria:

* 1. Simultaneously bilateral total hip arthroplasty or revision case;
* 2. Surgical History of the hip joint;
* 3. Hip joint cavity paracentesis in recent 3 months;
* 4. Stiffness with hip;
* 5. Blood coagulation disorders;
* 6. History of deep venous thrombosis;
* 7. Concomitant medical problems such as uncontrolled hypertension, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
* 8. Allergic to NSAIDs, opioid analgesics, zolpidem
* 9. Sleep apnea, Parkinson disease, dementia, depression
* 10. Use of sedatives or hypnotics
* 11. Unable to comply with polysomnographic measurement
A Research Study to Examine Cutaneous Allodynia and Cluster Headache

This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-75, inclusive
* Diagnosis of cluster headache, episodic or chronic.
* Patients with episodic CH can be either in active cluster period or not.
* Ability to read and understand an informed consent form, where the study protocol is described.

Exclusion Criteria:

* Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
* Patients who are cognitively impaired, as determined by investigator
* Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
* Patients who had taken an acute pain medication within 24 hours prior to allodynia testing.
* Patients with skin diseases that may cause abnormal skin sensation.
* Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing
* Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing
Association of Vitamin D Intake, and Associated Factors with Low Back Pain: a Retrospective Cohort Study

While there have been studies indicating a connection between insufficient levels of vitamin D and persistent low back pain (LBP), there is still a lack of definitive evidence. The primary objective of this study was to evaluate the correlation between vitamin D intake, and associated factors with chronic lower back pain.


Eligibility Criteria:
Inclusion Criteria:

* We included patients that were presented at our institute with chronic LBP and no associated comorbidities.

Exclusion Criteria:

-
Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion,
* Percutaneous coronary intervention (PCI) planned,
* Evidence of coronary artery disease

Exclusion Criteria:

* Hypersensitivity to statins
* Any cholesterol lowering medication taken within 1 month prior V1
* Sustained ST-segment elevation on ECG