cyrilzakka/clinical-trials huggingface dataset:
Alzheimer's Disease and Related Disorders

The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.

Although gait disorders are frequently associated with Alzheimer's disease and related disorders (ADRD), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin D.

The objectives of this study are to

* Compare characteristics of gait and balance measured among patients with ADRD separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages)
* To determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities
* To determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions
* To establish a database at Angers University Memory Center.

Eligibility Criteria:
Inclusion Criteria:

* All elderly patients from the University Memory Center of Angers University Hospital.
* Able to walk without any walking aid on 15 meters
* Mini-Mental Status Examination score \> 10
* Being affiliated to a social security regime

Exclusion Criteria:

* Mini-Mental Status Examination score ≤ 10
* Subject suffering from pre-existing impellent disturbances
* History of cerebrovascular accident or other cerebro-spinal pathology
* Poor workmanship of the written or oral French language
* Use of walking aid such as walking frame with wheels or tricycle.
* Acute medical or surgical disease in the past 3 months
* Refusal to participate (or trustworthy person)
* Near visual acuity \< 2/10
Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age

Despite marked reductions in cigarette smoking in the general population, smoking among economically disadvantaged women has increased. Smoking among women of reproductive age is a particular concern because in addition to the usual health risks, there are additional risks should they become pregnant. A national nicotine reduction policy for cigarettes has considerable potential to reduce tobacco use, dependence, and improve health in this population. Controlled trials in general population samples have demonstrated that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence severity, and tobacco toxicant exposure.

The goal of the proposed trial is to experimentally examine whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) enhances the effect of altering the nicotine in cigarettes in non-pregnant female cigarette smokers of childbearing age. Additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking.

Daily smokers who are female, aged 21-44 years, and have a maximum educational attainment of graduating high school, will be recruited at Johns Hopkins University and the University of Vermont.

Investigators will study two research cigarettes referred to here as Research Cigarettes 1 (RC1) and Research Cigarettes 2 (RC2). One will be a normal nicotine content cigarette and the other a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (EC2). Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other the e-liquid will be available in multiple flavors from which participants can choose three based on personal preference. Participants will be assigned to one of the following four conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2.

Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), other biomarkers of tobacco toxicant exposure, and cigarette demand assessed by behavioral economic purchase tasks.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 21 to 44 years old

Exclusion Criteria:

* Male
* Under 21 years old
* Over 44 years old
GDT-PPV Protocol in Thoracic Surgery

Peri-operative fluid-therapy is extremely important in thoracic surgery, because excessive administration of fluids during one-lung ventilation is correlated to an increasing risk of postoperative respiratory complications.

Therefore, current guidelines on peri-operative management of patients undergoing thoracic surgery suggest a conservative fluid management strategy, based on intra-operative fluid loss replacement and maintenance of euvolemia.

Nevertheless, intra-operative fluid loss estimation and consequently the correct infusion rate adoption are quite difficult to be addressed in clinical practice, and this often prevents the euvolemia maintenance in the peri-operative period.

This limit claims the necessity to adopt new methods of fluid-therapy administration in thoracic surgery; among these the most promising is the "Goal-Directed Therapy" (GDT). GDT protocols based on Stroke Volume Variation (SVV) or Pulse Pressure Variation (PPV) monitoring have been adopted successfully in major and cardiac surgery but not yet in thoracic surgery.

The aim of this randomized study is to evaluate the effects of a PPV-GDT fluid management protocol versus a conservative "zero-balance" protocol on intrapulmonary gas exchanges, in patients undergoing single-lung ventilation during thoracic surgery.

The intra-operative fluid-therapy (using lactated Ringer) will be based on pulse pressure variation (PPV group) with a target ≤5.8% or on compensation (1:1) of urine output (zero balance group).

In both groups an intraoperative background infusion of lactated Ringer at 1-2 ml/kg/h will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy

Exclusion Criteria:

* Patients who will not sign the informed consent
* Obesity (BMI \> 35 kg/m2)
* Cardiovascular disease (heart failure, arrhythmia)
* OSAS requiring or not C-PAP therapy
* Chronic alcoholism
* intraoperative blod loss\> 1500 ml
* One-lung ventilation duration\< 60 min
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.

B. To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes

Aim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.

Exploratory Aim:

A. To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0)
* Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months.
* Patient is currently married or living with a partner, with relationship duration at least 1 year
* Patient and partner live within a 1 hour commuting distance to recruitment site
* Patient and partner read and speak English
* Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or partner has an IES score greater than or equal to 17.

Exclusion Criteria:

* Patient had a previous definitive treatment for prostate cancer
* Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer)
* Partner is diagnosed with cancer (other than non-melanoma skin cancer)
* Patient or partner have a significant hearing impairment
Comparison Of Effects of MRP Vs NDT For Balance and Gait in Chronic Ischemic Stroke Patients RCT

To determine the comparison between effects of Motor Relearning Program (MRP) and Neuro-Development Treatment (NDT) on balance and gait in chronic ischemic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic ischemic stroke Patients more than 6 months. (55)
2. Patient with good cognitive status minimum 20 or greater out of 30 in Mini mental state examinations.(56)
3. Age between 45-65 years.(57)
4. Patient with limb spasticity equal to 2 or less than 2 on Modified Ashworth scale.(56)
5. Both male and female patients.(58)

Exclusion Criteria:

1. History of neurologic disease(59, 60)
2. History of lower limb fracture.(61)
3. History of spinal cord fracture.(61)
4. Patient with skin discoloration, skin ulcers and skin allergy.(62)
5. Patients with a history of the recurrent stroke. (63)
6. Patients with any peripheral vascular disease.(60)
Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)

The study will to test the levels of innovative biomarkers, such as miRNAs, in the blood of subjects underwent to angioplasty procedure according to standard clinical practice.

Twenty patients with acute coronary syndrome from non-ST-segment elevation myocardial infarction or with chronic coronary syndrome with clinical indication and favorable anatomy for coronary angioplasty will be enrolled. The angioplasty procedure will be performed according to standard clinical practice. Before and after angioplasty, blood samples will be taken upstream and downstream of the coronary lesion, arterial sampling will be performed at the level of the aortic root, and peripheral venous blood will be collected. MicroRNA expression will be analyzed in serum by next-generation sequencing (miRNome). Quantitative analysis of pro- and anti-inflammatory molecules such as IL-6 and the soluble form of IL-33 receptor (sST2) will be performed on various blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for the PCI procedure according to the latest ESC (European Society of Cardiology) Guidelines
* Coronary stenosis treated with angioplasty must be located in the proximal segments of the three main vessels: IVA, CX and CD
* The vessels must have a diameter of their mid-distal section ≥ 3 mm
* Patients with NSTEMI ACS and clinical indication with favorable anatomy for coronary angioplasty, also called percutaneous coronary intervention (PCI), (for the ACS group)
* Patients with clinically incipient SCC with stable angina (or significant anginal equivalents) and clinical indication with favorable anatomy for PCI (for the SCC group)

Exclusion Criteria:

* Contraindications to anticoagulant/antiplatelet therapy
* Extensive calcifications and/or tortuosity of the major epicardial segments
* Evidence of thrombotic occupation
* Patients with hemodynamic instability
* Patients with EF (ejection fraction) \< 35%
* Patients with severe chronic renal failure (e-GFR \< 30 mL/min)
Study of Tissue and Blood Samples From Patients With High-Grade Glioma

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with high-grade glioma.

OBJECTIVES:

* To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG) high-grade glioma trials conducted since 1979.
* To evaluate alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y using PCR analysis of microsatellite repeats and FISH.
* To determine DNA ploidy by flow cytometric analysis.
* To examine various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.
* To evaluate additional markers identified by the Glioma Markers Network.
* To compare the incidence of markers in the major histologic subtypes (anaplastic astrocytoma \[AA\], anaplastic oligoastrocytoma \[AOA\], glioblastoma multiforme \[GBM\]) and to assess their correlation in the total group, as well as within each of these subtypes.
* To compare the ploidy determinations by FISH and flow cytometry.

OUTLINE: Paraffin-embedded tissue and peripheral blood samples, previously or currently collected from clinical trials participants at the time she/he enrolled in the trial, are evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor markers, frequency distributions of all tumor markers and histological and clinical variables by polymerase chain reaction, IHC, flow cytometry, and FISH analysis.

Eligibility Criteria:
* Patients with newly diagnosed high-grade gliomas
* Patients participating in NCCTG/Alliance or Mayo protocols
* Willing to provide mandatory blood and tissue samples for research purposes; note: 15 unstained slides may be submitted in place of a tissue block
Thyromental Height Test Versus Sternomental Displacement in Elderly

The study is designed to evaluate the validity of the SMDD as a predictor of difficult airway in elderly and to compare its validity with that of the TMHT.

The airway assessment for difficulty before anesthesia in the elderly is crucial as the delay in the endotracheal intubation in this age group can lead to fatal consequences due to limited organ reserve and comorbidities. Previous studies revealed that elderly patients are predisposed to an increased incidence of difficult airway due to the age-related anatomic changes of the head and neck. These changes include, but not limited to, teeth loss, narrow dental arch, reduced oral soft tissue flexibility, TMJ dysfunction, degenerative change of ligament and tendons of the intervertebral discs causing compression of the intervertebral discs, cervical lordosis and spondylosis, limited head and upper neck extension, and fixed cervical spine flexion deformity.

Sternomental displacement (SMDD) is a relatively new objective airway measure that represents the difference between Sternomental distance that is measured while the head is extended on the neck (SMD-extension) and the Sternomental distance that is measured while the head is in a neutral position (SMD-neutral). The SMDD is a surrogate indicator of neck mobility. Both TMHT and SMDD were proved to be a good objective predictor for difficult laryngoscopy (DL) in adult surgical patients.

The TMHT was proved to have good predictive ability for difficult airway in elderly patients, but to the best of our knowledge, the SMDD was not previously evaluated in elderly. This study was designed to evaluate the validity of the SMDD as a predictor of difficult airway in elderly and to compare its validity with that of the TMHT. Our primary endpoint is the AUROC curve (area under receiver operating characteristic curve), sensitivity, specificity of the SMDD as a predictor of difficult laryngoscopy in elderly surgical patients. The secondary endpoint is to compare the validity of SMDD for predicting difficult airway with that of the TMHT and (Modified Mallampati test) MMT.

Eligibility Criteria:
Inclusion Criteria:

1. elderly patients aged ≥ 65 years both male \& female .
2. ASA physical status I, II, and III .
3. patients scheduled for elective surgeries under general anesthesia .

Exclusion Criteria:

1. Patients undergoing emergency procedure
2. patients requiring elective awake fiberoptic.
3. patients having neuromuscular disorders or craniofacial abnormalities
4. patients with cervical spine surgeries, neck scars, obvious limited neck extension.
5. morbid obesity (MBI ˃40 kg/m2)
A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>/= 18 years
* Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion Criteria:

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
* Recreational drug use within past 30 days
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.


Eligibility Criteria:
Inclusion criteria (formula-fed group):

healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days

Inclusion criteria (breast-fed group):

healthy infants exclusively breast-fed from birth and mothers intending to breastfeed \>80% until at least 5th month of age (meaning through the 4th month of age).

Inclusion criteria (all infants):

delivered between 37 and 42 weeks of gestation birth weight \>2500 g and \<4000 g parent or the subject's legal representative speak and understand Chinese

Exclusion criteria (formula-fed group):

fully or partially breast-fed infants infants breast-fed \>20%

Exclusion criteria (breast-fed group):

infants fed \>20% infant formula

Exclusion criteria (all infants):

malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics
WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing upper gastrointestinal endoscopy
* age over 18 years old
* Signed informed consent form

Exclusion Criteria:

* a blood coagulation dysfunction or have a tendency of nose bleeding
* a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
* a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer)
* pregnant
* liver disease
* kidney disease
* increase in intracranial pressure
* emergency operation
* multiple trauma
* American Society of Anesthesiologists (ASA) Physical Status classification above IV
* with mouth, nose and throat infection
Is Pentoxifylline Able to Improve Olfactory Sensitivity?

Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.

Olfactory signal processing is conducted by a G-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.

Eligibility Criteria:
Inclusion Criteria:

* hyposmic or functionally anosmic patients TDI-score \<31
* age: 18-50 years
* odor threshold: better than 1
* cause of smell loss: post traumatic, postinflammatory, idiopathic

Exclusion Criteria:

* normosmic patients,
* patients with contraindications for application of pentoxifylline
* patients that cannot give written agreement to the study
* patients under 18 years and over 50 years of age
Comparison of Muscle Specific and Movement Specific Muscle Energy Technique in the Management of Mechanical Neck Pain: a Randomized Controlled Trial.

the purpose of this study is to compare the effects of muscle-specific muscle energy technique and movement-specific muscle energy technique in terms of pain, function and cervical range of motion in persons with mechanical neck pain.


Eligibility Criteria:
Inclusion Criteria:

Mechanical neck pain ranging from 40-80 mm on visual analogue scale (VAS) Age between 19-44 years Pain or limitation on cervical motion

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Exclusion Criteria:

History of fracture, surgery or trauma in the neck Cervical radiculopathy Myelopathy Spondylosis Syringomyelia Thoracic outlet syndrome Infection Malignancy Inflammatory or rheumatic disorders Vascular syndromes