cyrilzakka/clinical-trials huggingface dataset:
The Cyclocapnic Method for Measurement of Chemosensitivity

We aim to test our method for measuring chemosensitivity (the ventilatory response to a change in carbon dioxide), which uses sinusoidal carbon dioxide stimuli.

Hypotheses:

* Carbon dioxide sensitivity is dependent on the cycle time over which we administer the gas (frequency).
* Chemoreflex gain decreases as deadspace increases.

We will apply a new method for the measurement of chemosensitivity (how sensitive a person is to changes in carbon dioxide), which is one of the principle determinants of whether people with heart failure develop abnormal breathing patterns We have shown in a pilot study that administering sinusoidal patterns of inspired carbon dioxide produces similar sinusoidal responses in ventilation. We aim to test our method for measuring chemosensitivity, which uses sinusoidal carbon dioxide stimuli (similar to those that drive the oscillations in ventilation found in periodic breathing). We aim to show that how the cycle time of carbon dioxide administered affects the resulting ventilatory oscillations and therefore that when measuring the chemoreflex clinically, it is important to deliver carbon dioxide stimuli that replicate the cycle time of oscillations in carbon dioxide seen in periodic breathing (typically approximately one minute).

Eligibility Criteria:
Inclusion Criteria:

* Heart failure subjects with stable cardiorespiratory control to be recruited from our institution's specialist heart failure clinic.
* Normal healthy volunteers, with normal systolic function.

Exclusion Criteria:

* We will exclude patients with chronic respiratory disease (every patient will have formal lung function testing on entrance into the study) or unstable coronary artery disease (myocardial infarction or unstable angina within the past 3 months).
* In addition any subjects receiving treatment with morphine and derivatives, theophylline, oxygen, benzodiazepines or acetazolamide will be excluded as these affect chemosensitivity.
The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases

Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers. In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.

At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination test and Semmes-Weinstein monofilament test. We evaluate pain sensations of the reconstructed fingers and donor sites with a visual analog scale. The system consist of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Active motion of the joints is measured using a goniometer. The motion arcs of the reconstructed fingers are compared with the opposite side.

Eligibility Criteria:
Inclusion Criteria:

* the soft tissue defect in one finger or in multiple fingers
* a defect \> 1.5 cm and \< 3 cm in length
* necessity to preserve finger length
* a patient between 15 and 60 years of age

Exclusion Criteria:

* injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
* a defect≤1.5 cm or ≥3 cm in length
* a soft tissue defect of the thumb
Effect of Different Color Lights on the Internal Clock and Alertness in Humans

The main aim of this study is to investigate the effects of cone-modulated light emitted from a visual display on human circadian physiology and cognitive performance in the evening.

The investigators will generate single/multiple cone-isolating contrasts with equivalent stimuli for other cones and melanopsin photoreceptors. The investigators will assess melatonin suppression under three different light scenarios generated using the method of silent substitution by tuning the spectral composition of the light primaries (e.g. LEDs) such that a single target photoreceptor class is maximally stimulated compared to an equal stimulation of the remaining photoreceptors. Additionally, The investigators will examine pupil response, subjective sleepiness, psychomotor vigilance, visual comfort, and skin temperature under three different light scenarios. This allows for new insights into the lights' cone-contribution mechanism to neuroendocrine physiology in the human retina.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 35 years
* Sex: male or female normal color vision, male dichromat (i.e. tested by CCT, HRR, Farnsworth Munsell 100 Hue Test)
* BMI: 18.5 - 29.9 self-reported weight and height (i.e. normal and overweight according to WHO)
* Signed consent form of participants
* Chronotype: Morningness-Eveningness Questionnaire (31 - 69)
* Sleep Quality: Pittsburgh Sleep Quality Index, PSQI (≤5)

Exclusion Criteria:

* High myopia (\> -6 diopters)
* High hyperopia (\< +6 diopters)
* Transmeridian travel (\>2 time zones) \<1 month prior to the first session of the study
* Shift work \<3 months prior to the beginning of the study
* Ophthalmological or optometric conditions (cataract, glaucoma, retinal detachment, macular conditions, chronic inflammations, eye injuries, or operations)
* General health concerns or disorders, including heart and cardiovascular, neurological, nephrological, endocrinological, and psychiatric conditions
* Medication impacting on visual, neuroendocrine, sleep, and circadian physiology
* For females only: pregnancy, use of hormonal contraceptives, lactation or breastfeeding
* Drug (urinary drug screening) and alcohol use
* Non-compliance with sleep-wake times: \>1 deviation from ±30 minute window sleep and wake-up time
* Extreme chronotype (Munich Chronotype Questionnaire \<2 or \>7)
* Current participation in other clinical trials

Exclusion criteria due to study requirements:

* Inability to understand and/or follow study materials or procedures
* Insufficient knowledge of project language
Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)

Safety and effect of SANGUINATE on patients DCI following SAH.

The purpose of this study is to study the safety and effect of SANGUINATE on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent by the subject or his/her legally authorized representative;
* Modified Rankin (mRankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage;
* Ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the Procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and
* Hunt and Hess (H\&H) grade 3 or 4, or World Federation of Neurological Surgeons (WFNS) score 3 or 4 prior to the Procedure, and Modified Fisher (mFisher) grade 3 or 4, prior to the Procedure; or
* Clinical signs of ("symptomatic") delayed cerebral ischemia; or
* Angiographic evidence of cerebral vasospasm

Exclusion Criteria:

* In the judgment of the Investigator the patient is not a good candidate for the study
* Evidence of rebleed following the Procedure
* Subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation
* Diagnosed moderate to severe pulmonary hypertension
* Radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of Kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion)
* History within the past 6 months and/or finding of decompensated heart failure
* Acute myocardial infarction within 3 months prior to the administration of the study drug
* Left ventricular ejection fraction \<40%, as determined by prior echocardiography or clinical signs of CHF
* Medical history or concurrent evidence of moderate to severe renal insufficiency (estimated creatinine clearance \< 30 mL/min)
Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV).

Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates.

Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported.

We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Eligibility Criteria:
Inclusion Criteria:

* Women be at least 18 years of age
* Have symptoms of vaginal odor and or/discharge
* Meet the clinical (Amsel) criteria for BV
* Willing to participate in research

Exclusion Criteria:

* Presence of another vaginal infection or STD
* Allergy to metronidazole
* Pregnant or nursing
* Use of oral or intravaginal antibiotics within the past 2 weeks
* HIV or other chronic disease
* Inability to keep return appointments
* Contraindications for Lactobacillus Vaginal Suppositories（those without sexual history）
Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

There's a scarcity in literature concerning en-masse retraction and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of retraction; Friction or Frictionless Mechanics.

The en-masse technique can be done in one of two ways: through friction or frictionless mechanics. Both are viable options, but, ideally, we want to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these mechanics results in a decreased treatment time is still up for debate.

Eligibility Criteria:
Inclusion Criteria:

* Adults and Adolescent patients (both genders)
* Age range (14-24)
* Patients with maxillary protrusion requiring first premolars extraction (Bimaxillary Protrusion or Class II division 1 cases).
* Patients with fully erupted permanent teeth (not necessarily including the third molar).
* Cases requiring maximum anchorage during retraction.
* Good general and oral health

Exclusion Criteria:

* Patients suffering from any systemic diseases interfering with tooth movement.
* Patients with extracted or missing permanent teeth. (except for third molars).
* Patients with badly decayed teeth.
* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc...).
* Patients with previous orthodontic treatment
Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers.

Purpose: To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers. Methods: This is a clinical, individual, analytical, interventional, longitudinal, prospective, controlled study with convenience sampling. Three groups will be used, as follows: control group 1 (CG1) with 7 participants will be treated with collagenase, control group 2 (CG2) with 7 participants will be treated with a gel composed of 10% unripe banana peel powder, and study group (SG) with 11 patients will be treated with the abovementioned gel combined with lemongrass oil at 0.1% concentration. The ulcer areas will be analyzed once a week for 4 weeks. Afterward, wound areas will be measured and the obtained data will be subjected to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* presence of chronic ulcers,
* 18 years of age and older

Exclusion Criteria:

* Patients who had any type of allergic reaction to the study products during treatment
Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria:

* Previous H. pylori eradication therapy
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Safety and Efficacy of Vilazodone in Major Depressive Disorder

Safety and Efficacy of Vilazodone in Major Depressive Disorder


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-70 years of age
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current major depressive episode must be at least 8 weeks and no longer than 18 months in duration

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control
* Patients with a history of meeting DSM-IV-TR criteria for:

  * any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
  * any depressive episode with psychotic or catatonic features;
  * panic disorder with or without agoraphobia;
  * obsessive-compulsive disorder;
  * Schizophrenia, schizoaffective, or other psychotic disorder;
  * bulimia or anorexia nervosa;
  * presence of borderline personality disorder or antisocial personality disorder; h. mental retardation, dementia, amnesia, or other cognitive disorders
* Patients who are considered a suicide risk
Building Regulations in Dual Generations at KIDTHINK

Neurodevelopmental disorders (NDDs) such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and intellectual disability (ID) are the most frequently diagnosed disability in children, accounting for 7% to 14% of children in developed countries. Developmental concerns emerge early, providing an opportunity to support families years before a diagnosis may occur. Emerging concerns are often predictive of problems with self-regulation, risky behaviours (e.g., substance abuse and over-eating), academic achievement, social functioning, parent-child relationship, and lower overall quality of life. Overall family wellbeing is also commonly affected given the increased challenges faced by parents and caregivers, including socioeconomic disadvantage. Parents facing hurdles to positive parenting, such as poor psychological wellbeing, may struggle further with parenting capacity in the context of the increased parenting demands of caring for a child with specific needs. The objective of this study is to create a novel adaptation of an existing program that is targeted at improving the mental wellness and parenting practices of caregivers (mothers, fathers, guardians) with elevated symptoms of depression who have 3 to 8-year-old children with emerging behavioural, emotional, or developmental concerns. It is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the caregiver, child, and dyad (i.e. parenting interactions) will improve both caregiver capacities and child outcomes. Further, it is hypothesized that this novel adaptation of the program will be tailored to meet the identified needs of this demographic and that the program will show improvement in psychosocial, emotional, and parenting function compared to a services as usual control group. Our current study will be conducted remotely due to the COVID-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. The ultimate goal of this project is to improve parent wellbeing and promote supportive parenting practices that allow children with early developmental needs to reach their full potential.


Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers must have a 3-8 year old child.
* The child must have diagnosed or emerging behavioural, emotional, or developmental concerns, as reported by parents.
* Parents/caregivers must be experiencing elevated symptoms of psychological distress as measured by the Patient Health Questionnaire 9-item (PhQ-9).
* Parents/caregivers must be 18 years of age.

Exclusion Criteria:

* Child is outside of the 3-8 year old age range.
* The child does not have diagnosed or emerging behavioural, emotional, or developmental concerns.
* The parent or caregiver does not have full or joint custody of the child.
* The parent or caregiver is not experiencing elevated symptoms of psychological distress as measured by the Patient Health Questionnaire 9-item (PhQ-9).
* The parent or caregiver is not 18 years of age.
Decision-aid on Breast Cancer Screening

The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.

Breast cancer is the most common cancer in women. In Italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. Results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. Decision aids are an effective way to support lay people in their decisions about health.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45-69, according to the target age of the screening centres involved;
* New invited women in mammography screening programme.

Exclusion Criteria:

* None
Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

Objective:

* To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
* To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.

Methodology:

Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* T2DM diagnosis
* aged between 18 and 65

Health professionals:

* primary health care teams (PHCT) comprising a primary care physician and a nurse practitioner associated to a patient will be selected
* must have a permanent position or a stable substitute position

Exclusion Criteria:

* peripheral vascular disease
* diabetic nephropathy and/or chronic kidney disease
* cognitive impairment, dementia
* major depression
* insufficient level of Spanish
* to be pregnant or planning to become pregnant in the next 6 months
* cancer last 5 years
* ischemic disease or heart failure
* proliferative diabetic retinopathy
Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders

Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use

Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.

Eligibility Criteria:
Inclusion Criteria:

Individuals will be included who:

* Are 18 years of age or older.
* Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days,
* Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up
* Are willing to provide locator information for follow-up, and
* Are fluent in English and have a 6th grade or higher reading level.

Exclusion Criteria:

Individuals will be excluded who:

* Have an untreated bipolar or schizophrenic disorder,
* Have a current legal case pending such that incarceration during the 8-week protocol is likely,
* Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or
* Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).