cyrilzakka/clinical-trials huggingface dataset:
Accelerated Age-related Cognitive Decline: Impact of Exercise on Executive Function and Neuroplasticity

The purpose of this study is to see if 6 months of home-based walking will improve memory, and brain structure and function, compared to health education in older adults that have chronic kidney disease and mild cognitive impairment.

Following informed consent, participants will undergo tests for heart health, physical function, memory testing, and brain structure and function using imaging (taking pictures of the brain with an MRI). Following these tests participants are randomized to a home-based walking program or health education for 6 months. Participants are given a fitness tracker and gets ongoing telephone coaching during the 6 months. After 6 months the tests are repeated.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosed stage 3-4 chronic kidney disease (CKD, estimated glomerular filtration rate (eGFR) \<60 to 20 ml/min);

  * \>55 yrs of age
  * Mild cognitive impairment (18-26 on the MOCA)
  * ability to undergo an MR
  * no history of major head trauma (No head trauma/concussion with loss of consciousness)
  * Speaks, reads, writes English

Exclusion Criteria:

* • Diagnosed Dementia or a Clinical Dementia Rating Scale score of \<2, or a MOCA of \<18

  * Participating in a supervised exercise program with intent to increase fitness levels 3 days/week,
  * Requires assistive ambulation
  * Limited exercise capacity due to claudication; unstable angina, severe arthritis, extreme dyspnea on exertion, unstable coronary artery disease
  * Class III-IV heart failure
  * History of uncontrolled sustained arrhythmias, severe/symptomatic aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy, severe pulmonary hypertension, active myocarditis/pericarditis, thrombophlebitis, and recent systemic/pulmonary embolus
  * Resting systolic BP \>200 mmHg or resting diastolic BP \>110 mmHg
  * Any unforeseen illness or disability that would preclude cognitive testing or exercise training
  * One or more contraindication for MRI; cardiac pacemaker, aneurysm clip, cochlear implants, shrapnel, history of metal fragments in eyes, neurostimulators, diagnosed claustrophobia (MRI only)
  * Any self-reported major psychiatric disorders requiring medical therapy (e.g. schizophrenia, bipolar disorder).
  * Self-reported new diagnosis of clinical depression within 3 months of enrollment or unstable clinical depression requiring medication adjustment within 3 months of enrollment
Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences

The aim of the present study was to compare the effectiveness of two alignment sequences with thermal activated archwires with different Af temperatures applied for the correction of mandibular anterior crowding

A parallel randomized clinical trial was conducted involving 42 patients ages 15 to 25 years (mean: 19.5 years) who required orthodontic treatment including the correction of mandibular anterior crowding. Eligibility criteria were no active caries, exemplary hygiene, non- extraction in the lower arch and no significant tooth size or shape abnormalities. Outcome: The primary outcome was the degree of crowding measured on plaster casts using Little's Irregularity Index. The secondary outcome was crowding survival time until the occurrence of correction in a six-month period. Randomization: The patients were randomly allocated to the different groups using sealed opaque envelopes. Blinding: The patients were blinded to the group to which they were allocated. Intervention: Patients were treatment with a pre-adjusted appliance (0.022 in- Roth prescription). Two nickel-titanium alignment and leveling sequences were employed - NiTi archwire: 0.012 in and 0.019 X 0.025 in; and thermal activated NiTi archwires: 0.018 in and 0.016 X 0.022 in with different austenite finish temperatures (37ºC and 35ºC), which formed the different study groups.

Eligibility Criteria:
Inclusion Criteria:

* Moderate mandibular anterior crowding (crowding: 4 to 6 mm) according to Little's Irregularity Index
* Presence of all teeth in lower arch through to the second molars, no indication for extractions in the lower arch
* No need for therapeutic interventions (use of inter-maxillary elastic bands, inter-dental wear, open NiTi spine, active lip bumper)
* Absence of systemic conditions that could affect tooth movements
* Absence of significant tooth size or shape abnormalities
* No history of trauma and no history of root resorption or alveolar bone loss.

Exclusion Criteria:

* Severe mandibular anterior crowding (crowding: up to 7 mm) according to Little's Irregularity Index
* Absence of any teeth in lower arch through to the second molars
* Indication for extractions in the lower arch
* Need for therapeutic interventions (use of inter-maxillary elastic bands, inter-dental wear, open NiTi spine, active lip bumper)
* Presence of systemic conditions that could affect tooth movements
* Presence of significant tooth size or shape abnormalities
* History of trauma and history of root resorption or alveolar bone loss.
Poster on Dysphagia-specific Food Procedures: Usability and Impact

The aim of this study is to evaluate the use of a poster containing information on dysphagia-specific food procedures at two levels: utility from the point of view of patients' caregivers, and impact on patients' health. Half the patients will have the poster placed in their room, whereas the other half will not.

Dysphagia is a swallowing disorder that can be associated with clinically relevant complications, and caregivers can play a fundamental role in this process, namely because they feed the patient. However, studies show a lack of professional-caregiver communication in dysphagia, and caregivers' need for more information. Communicating dysphagia-specific food procedures through a visual poster might bridge professional-caregiver communication gaps, with consequences for the patient's health.

Eligibility Criteria:
Inclusion Criteria:

* Patients with post-acute dysphagia (lesion occurring at least six weeks prior, approximately),
* remaining in inpatient care for at least one month after the first moment of data collection,
* 18 years of age or older,
* receiving regular visits from their family members or caregivers.

Exclusion Criteria:

* Failing to meet inclusion criteria
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) during sevoflurane anesthesia for Caucasian participants.

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial P05971 was conducted in Europe and set up to establish the dose response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Is of American Society of Anesthesiologists (ASA) class 1 - 3;
* Is at least 20 years but under 65 years of age;
* Caucasian participants;
* Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;
* Has given written informed consent.

Exclusion criteria:

* Participants in whom a difficult intubation because of anatomical malformations was expected;
* Is known or suspected to have neuromuscular disorders impairing neuromuscular blocking (NMB) and/or significant renal dysfunction (for example a creatinine level \> 1.6 mg/dl) and/or severe hepatic dysfunction.
* Is known or suspected to have a (family) history of malignant hyperthermia;
* Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
* Females who were pregnant;
* Females of childbearing potential not using birth control or using only oral contraception as birth control;
* Was breast-feeding;
* Has already participated in P05971, or in another trial with sugammadex;
* Has participated in another clinical trial, not preapproved by the Sponsor, within 6 months of entering into P05971.
Neuroimmune Response to Lipopolysaccharide

In this study, healthy adult volunteers will undergo two positron emission tomography (PET) scans using the radiotracer \[11C\]PBR28 which binds to the 18kDa translocator protein (TSPO). Approximately 3 hours prior to the second \[11C\]PBR28 PET scan, lipopolysaccharide (LPS; endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral cytokine levels will be assayed periodically throughout the experimental session.

Specific aims: Quantify the magnitude of neuroimmune response after a classical immune stimulus.

Secondary aims: Quantify changes in cognitive function after a classical immune stimulus.

Hypothesis: Individuals will exhibit a robust whole-brain neuroimmune response and impaired cognitive function after LPS.


Eligibility Criteria:
Inclusion Criteria:

1) Medically-healthy male and female subjects able to read/write English

Exclusion Criteria:

1. Subjects cannot meet DSM criteria for substance use disorder
2. Any psychiatric symptoms that could put the subject at risk by participating in the study including but not limited to suicidal or homicidal ideation, or suicide attempt within the last year
3. Pregnancy or breastfeeding;
4. Any current medical illness that could put the subjects at risk during the PET scan, or interfere with the PET or immunologic measures
5. Significant hepatocellular injury (as evidenced by AST or ALT levels greater than 5 times normal or a history of cirrhosis) will be exclusionary in order to reduce the risks associated with alcohol consumption
6. Subjects taking corticosteroids or other immunosuppressant drugs
7. Subjects with disorders affecting the brain, including but not limited to multiple sclerosis, history of stroke, brain tumors, intracranial bleeding, infection, or abscess.
Mechanisms of Neuropathic Pain: Investigation by Contact Heat Evoked Potential

In order to clarify the normal components of thermal and painful evoked potentials by heat in normal subjects of both genders and different age group, to clarify the effect of specific anatomy in pain transduction, transmission and modification, and to establish the effect of peripheral nerve and their terminal free ending on the nociceptive transduction, the investigators will use heat stimulation on normal controls and patients with neurological diseases to clarify such issues.

Only a few studies focus on clinical diseases like neuropathic pain or neurogenic pain. Little is known about the differences between normal and pathogenic pain processing. It is an opportunity to apply EEG, ERPs in the clinical fields. In many clinical conditions, brain lesions provide a chance to study the possible roles of one neural structure in pain integration and processing. In addition the applications of EEG/ERPs on clinical conditions may be help in the understanding about mechanism and genesis of pain in pathogenic conditions, the diagnosis of pathogenic pain, and the therapeutic aspects of these abnormal pain senses.

One limit in the study of human pain is the inappropriate stimulation method. Evoked potentials by contact heat have previously been difficult to elicit due to slow temperature rise times associated with thermal stimulators. However recently, the CHEPS (Contact Heat-Evoked Potential Stimulator) is developed, which uses a newly developed heat-foil technology and can create a rapid heating rate (up to 70°C/sec). The baseline and peak temperature and the rising time can be precisely controlled. It provides a non-invasive technique in the investigation of human pain activation related to thermal and nociceptive pathways involved in pain processing. Unlike the heat stimulation delivered by laser, CHEPS can deliver noxious thermal stimuli repeatedly to a large area of skin to evoke a pain response of A-Delta and C fibers. In addition the rate of stimulation can be rapid to lead to the effect of temporal summation. When used with an EEG recording system, a patient's responses to pain perception and evoked potentials (EPs) can be recorded, which provide objective information about integrity of the nociceptive afferents of peripheral nerve system, spinal cord, as well as the brain response of different structures. The CHEPS provide the investigators a practical and convenient tool in clinical application to study pain. The investigators will use the CHEPS as stimulation for studying the heat evoked potentials and analyze the difference between the normal subjects and patients with peripheral nerve diseases. These might help to clarify the mechanism of neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral nerve diseases or other neurological diseased with sensory disturbance
* Normal subjects without:

  * Systemic disease like diabetes mellitus, renal disease or other systemic diseases
  * Abnormal neurological symptoms or signs
  * Psychological disease like affective disorders or psychosis.
The Safety and Efficacy of Recombinant Human Prolactin

Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.

There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.

Eligibility Criteria:
Inclusion Criteria:

Healthy Subjects will meet the following criteria:

1. 18 to 40 years of age
2. Normal weight (BMI 17 to £ 30 kg/m2)
3. Good general health
4. On no medications for at least 3 months before the study
5. Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
6. No evidence of androgen excess
7. Normal TSH, prolactin and hematocrit
8. No current interest in conception
9. No history of osteoporosis
10. No use of medications known to affect bone turnover
11. No alcoholism
12. No smoking
13. No history of medical problems or treatment known to affect bone turnover.

Exclusion Criteria:

Subjects will be excluded for pregnancy or evidence of breast masses.
Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders

A pilot randomized clinical trial was conducted in a random sample of 120 non-demented Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no intervention with respect to change in cognition and whole brain volume determined by repeated neuropsychological batteries and MRI scans. Aims included determining the feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as well as collection of preliminary data on the efficacy of the interventions. The long-term goal of this research program is to determine whether sustained physical and/or mental exercise interventions are efficacious in delaying the onset of dementia and to understand the role and mechanisms of brain growth in this process.

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRI's were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models.

Eligibility Criteria:
Inclusion Criteria:

* living in defined area
* either sex
* aged 60-79

Exclusion Criteria:

* history of stroke, Parkinson's disease or other neurologic disease
* inability to walk unassisted for two kilometers or maintain balance with feet side-by-side or semi-tandem for 10 seconds each
* education-adjusted Chinese Mini-Mental Examination score \< 26 (to exclude individuals with dementia or moderate cognitive impairment
* cardiovascular or musculoskeletal conditions that would be contraindicated for the intervention programs
* contraindications for MRI
* diagnosis of any illness that would preclude participation in the full study
* regular vigorous exercise or Tai Chi practice.
ROLL vs WGLL for Non-palpable Breast Lesions

Here were present a controlled clinical trial comparing wire-guided lesion localization (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable breast lesions at the Instituto Nacional de Cancerología (National Cancer Institute)in Bogotá,Colombia.

The aim of this study was to compare the radioguided occult lesion localization (ROLL) technique with the wire-guided lesion localization (WGLL) technique to assess the optimal localization and excision of nonpalpable breast lesions in patients at a unique reference medical center.

A controlled clinical trial was designed to compare the WGLL and ROLL techniques in women presenting with breast lesions diagnosed by mammography or ultrasound at the Instituto Nacional de Cancerología in Bogotá, Colombia from March 2006 to June 2011.

This study evaluate 129 patients; 64 (49.6%) patients were treated using ROLL and 65 (51.4%) using WGLL.

Eligibility Criteria:
Inclusion Criteria:

* Female patients older than 18 years
* Lesions suggesting malignancy (BIRADS 4 and 5)
* Solid nodules in postmenopausal women (BIRADS 3 mammograms).

Exclusion Criteria:

* Pregnant or nursing
* Patients with suspected multifocal or multicentric disease (suspicious microcalcifications scattered over a wide area on mammography)
* Patients with retro-areola lesions (less than 2 cm away from the nipple)
* Lesions that had previously undergone surgery or excisional biopsies in the compromised breast
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must currently be participating in an Astellas sponsored, single agent ASP2215 trial, receiving ASP2215 and have not met any discontinuation criteria of the parent study and can enroll into this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
* Subject must be deriving benefit from continued treatment without any persistent intolerable toxicity from continued treatment of ASP2215.
* Female subject must either:

  * Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or post-hysterectomy (at least 1 month prior to Screening)
  * Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 180 days after the final study drug administration; And have a negative urine pregnancy test at Day 1; And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration.
* Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
* Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 120 days after the final study drug administration.
* Male subject must not donate sperm starting at Screening and throughout the study period and, for 120 days after the final study drug administration.
* Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

* Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
* Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
* Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.