cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A

In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. While the airway of some people narrows and airflow decreases during inspiration due to increasing inspiratory effort, others maintain constant airflow throughout inspiration. Airway neuromuscular reflexes may protect against airway narrowing that occurs due to increasing inspiratory effort. To test this hypothesis, the investigators will initially measure airway neuromuscular reflex and inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal anesthesia to observe the effects on inspiratory flow.

The mechanisms that lead to airway closure are not completely understood. While the airway of some people narrows and airflow decreases during inspiration due to increasing inspiratory effort, others maintain constant airflow throughout inspiration (negative effort dependence, NED). The investigators hypothesize that upper airway neuromuscular reflexes may protect against narrowing that occurs due to increasing inspiratory effort. Topical oropharyngeal anesthesia has been shown to reduce neuromuscular reflexes. Thus, the investigators also hypothesize that patients with stable inspiratory flow will develop NED once the reflexes have been impaired with topical anesthetic. The investigators plan to:

1. measure upper airway muscle EMG to assess how it corresponds to the presence or absence of NED. This aim will allow us to test the hypothesis that robust upper airway muscle reflexes can protect against NED.
2. reduce upper airway muscle activity and reflexes by topical oropharyngeal anesthesia. This will allow us to test the hypothesis that attenuated upper airway muscle activity induced by topical anesthesia can induce NED.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects or patients with OSA

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline HCl
* For women: Pregnancy
A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease

The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Participants, who have already reached end-stage renal disease (ESRD), will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.

Refer to www.studyALECT2.com

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age 18 years or older;
* Renal biopsy-proven diagnosis of ALECT2;
* For patients with kidney disease that could be due to ALECT2, a renal biopsy may be obtained to confirm ALECT2 diagnosis.

Exclusion Criteria:

- There are no exclusion criteria for this observational study.
Autotaxin: a Potential Biomarker for Breast Cancer.

The goal of this clinical trial is to test the efficiency of Autotaxin (ATX) as a biomarker for breast cancer patients.

The main questions it aims to answer are;

* is ATX a reliable tumor marker for breast cancer patients in diagnosis
* can ATX differentiate cancer patients from non-cancer ones

80 breast cancer patients and 30 normal patients with no known cancer history were enrolled in this study. All patients were female. The mean ages of cancer patients were 58.2 and 52.7 consecutively for cancer and non-cancer patients. The mean serum ATX levels of cancer and non-cancer patients were 1570.72 and 121.86 ng/mL consecutively (p=0.001). The cut-off value of ATX serum level was 178.49ng/mL according to the ROC analysis. The area under the ROC curve was 0.901showing that ATX is very efficient in distinguishing between two diagnostic groups (diseased/normal). ATX also showed good correlations with known tumor markers (CEA, CA15-3, CA125 levels). ATX levels were still higher than the cut-off value even in cancer patients with normal or low classical tumor marker levels.

Eligibility Criteria:
Inclusion Criteria:

* Preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders.

Exclusion Criteria:

* Patients with benign breast diseases and no known cancer history.
A Multicenter Trial of PLA vs. Surgery for Treating PTMC

This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).

PLA is the acronym for "Percutaneous Laser Ablation". The treatment consists in the destruction (ablation) of Papillary Thyroid Micro Carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). The procedure is performed under ultrasound imaging guidance (ultrasound-guided). The destruction of the lesion occurs through overheating and coagulation. PLA, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk PTMC in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk.

After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.

The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed PTMC (maximun diameter\> = 5 mm and \< = 10 mm) proved by fine needle aspiration biopsy with good thyroid function;
* Age≥ 18 Y;
* Single nodule without thyroid capsule contact;
* There had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (The distance should up to 5mm after injection of isolation fluid);
* No coarse calcification or eggshell-like calcification;
* Imaging examination without local or distant metastasis;
* Without chemotherapy, radiotherapy and other related therapies;
* A complete clinical, pathological and follow-up information;
* Get informed consent signed by the patient or family member.

Exclusion Criteria:

* Multifocal PTMC;
* Combined with other types of thyroid cancer or hyperthyroidism;
* Lesion contact with thyroid capsule or located in the isthmus;
* Serious coagulation dysfunction;
* Contralateral vocal cord paralysis;
* Imaging examination with local or distant metastasis;
* Active Tuberculosis and HIV-positive patients;
* Patients can not understand or follow research protocol;
* Pregnant woman.
Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms

Minor mental health problems, MMHP, like mild depression and anxiety, and medically unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead to impaired social and cognitive function and could result in reduced work capacity. The investigators have designed the present study as a pragmatic trial to investigate the effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional treatment in patients with MMHP or MUS in primary care. The investigators examined whether the effects of the integrative treatment model differed from those achieved with therapeutic acupuncture or conventional treatment. Primary endpoints were anxiety and depression (assessed with the Hospital Anxiety and Depression scale), health-related quality of life (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment interventions.

Statistical power was calculated based on an expected 50% reduction in HAD anxiety and depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture; and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83% at p \<0.05. Treatment effects were calculated as the difference between values at baseline, after four weeks and after the complete intervention period, i.e. after eight weeks. Nonparametric analyses were carried out to test differences between independent samples (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).


Eligibility Criteria:
Inclusion Criteria:

* one or more symptoms of emotional and physical fatigue
* worry
* anxiety
* depression
* sleep disturbances or somatic pain

Exclusion Criteria:

* 100% sick leave \> 2,5 years
* pregnancy
* cancer
* personality disorders
* substance use disorders or prescribed sedative drugs
A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients. The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment. These may be either: treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions; or treatment-experienced adult patients with at least one darunavir resistance associated substitution

Exclusion Criteria:

* Known hypersensitivity to darunavir/ritonavir or to any of the components of the two agent preparations
* Pregnant or breastfeeding females
* Agrees to protocol-defined use of effective contraception
* Patients taking medication that are highly dependent on Cytochrome P450 3A4 for clearance and for which initial concentrations are associated with serious and/or life threatening events
* Patients with severe hepatic impairment
* History of allergy to sulfa containing drugs or molecules
* Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort (Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil
The Diabetes Medication Choice Cards Trial in Greece

A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus for more than one year
* Agree to be followed for at least 6 months
* Willing to respond to survey questions immediately following the visit
* HbA1c value between 7.5% and 10%
* Need treatment intensification and there are more than one available treatment options

Exclusion Criteria:

* Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
* Is to transfer to another practice within the next 6 months
* Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
* Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
* Enrolled in other studies that require prolonged participation and follow-up
* Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making
* Women known to be pregnant
Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)

The purpose of this study is to assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed metastatic renal cell carcinoma
* Suitable for nephrectomy

Exclusion Criteria:

* Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer
* Significant cardiac event within 3 months of entry
* Any history of coronary angioplasty or history of myocardial infarction
Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)

Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection (PJI)) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.


Eligibility Criteria:
Inclusion Criteria:

* Patients having a bone or joint infection
* Patients treated by a suppressive subcutaneous antibiotherapy with betalactamine

Exclusion Criteria:

* None
The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis

The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula documented in Shang Han Lun) in treating severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis (according to American college of chest Physicians/ Society of Critical Care Medicine (ACCP/SCCM) criteria)
* Informed consent provided by patients or legally authorized representative
* Yin syndrome in syndrome differentiation (according to principles of traditional Chinese medicine (TCM) syndrome differentiation)

Exclusion Criteria:

* Pregnant or nursing female
* Subject receiving immunosuppressive or immunoenhancement therapy in the past 3 months
* Patients with known or suspicious autoimmune diseases
* Patients not expected to survive 28 days due to end-stage disease or other uncorrectable medical condition
* Fasting subjects
* Known or suspicious allergy to any ingredient of Si-Ni-Tang
* Patients not expected to survive 5 days for various reasons
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.

To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers:

* Male and female subjects 18 to 55 years of age, inclusive.
* Subject is judged to be in good general health.

Rheumatoid Arthritis Patients:

* Male and female patients 18 to 75 years of age, inclusive.
* Subject has a diagnosis of rheumatoid arthritis for at least six months.
* Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.

Exclusion Criteria:

* History or evidence of active or latent tuberculosis.
* History or significant allergic reaction to any drug.
* Use of known strong CYP3A and CYP2D6 inhibitors and CYP3A inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer.
* Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.
* History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* Stages IIA and IIB FIGO classification.
* Age between 21 to 70 years.
* ECOG performance status 0-1.
* No history of another neoplastic disease.
* Value of Hemoglobin ≥ 9 g / l.
* Total leukocyte count ≥ 3.0 x 109 / L.
* Absolute neutrophil count ≥ 1.5 x 109 / L.
* Platelets ≥ 100,000 x mm3.
* Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
* Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula)
* Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.
* Life expectancy ≥ 12 months
* Measurable disease
* Informed consent signed by the patient

Exclusion Criteria:

* Pregnancy and lactation period.
* Presence of lymph node metastases or hematogenous extrapelvic known.
* Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
* Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
* Hepatitis B or C active, positive serology for HIV.
* Atopy history of severe / severe asthma.
* A history of autoimmune disease.
* Presence of significant abnormalities in ECG performed within 14 days prior to admission.
* Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.
* Participating in another clinical trial "
BOTOX® in the Treatment of Crow's Feet Lines in Japan

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).


Eligibility Criteria:
Inclusion Criteria:

-Moderate to severe Crow's Feet Lines

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
* Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
* Medium-depth or deep facial peels within 5 years
* Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
Effects of Propofol on Early Recovery of Hunger After Surgery

Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.

The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old women
* American Society of Anesthesiologists (ASA) score 1-2
* Affiliated to a social security system
* Undergoing an ambulatory surgery during more than 15 minutes with general anesthesia and control of upper airways (tracheal intubation or supraglottic mask or facial mask ventilation) for oocytes punction before in vitro fertilization
* General anesthesia occuring between 8 and 10 am with respect of pre-operative fasting rules
* APFEL risk score for nausea and vomiting ≤ 2/4
* Ability to understand and read french
* Signature of understood consent

Exclusion Criteria:

* Other surgery than oocytes punction
* Cognitive dysfunction
* Undernutrition or risk factor of undernutrition (evolutive neoplasia, chronic alcoholism ...)
* BMI ≥ 35 kg/m²
* Eating disorders
* Diabetes mellitus
* Chronic treatment with drugs modifying feeding behavior :

  * Benzodiazepines
  * Inhibitors of serotonin reuptake
  * Others
* Non respect of pre-operative fasting rules
* Indication for rapid sequence induction (gastro-oesophageal reflux, absence of gastric emptying ...)
* Contraindication to propofol (allergia to propofol, soybean or peanuts, past history of propofol infusion syndrome, unstable cardiovascular disease) or to sevoflurane (past history of malignant hyperthermia, epilepsy or liver disorders after administration of a halogenated anesthetic)
* Pregnant or breastfeeding woman
* Involvement in another clinical trial under 4 previous weeks