cyrilzakka/clinical-trials huggingface dataset:
Medical Device for Drug Allergy Diagnosis

The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a retrospective study, BLC structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device.

A prospective study will be performed for the recruitment of samples corresponding to patients with known IgE hypersensitivity to BLCs based on results from allergy tests and clinical history. Controls will include: non-allergic individuals with known tolerance to betalactams. The samples will be used for the validation of the COBIOPHAD device in real settings.


Eligibility Criteria:
Inclusion Criteria:

- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)

Exclusion Criteria:

* patients with contraindications to BLC allergy work-up
* patient refusal to enter the study
* vulnerable patients according to French regulation
Intervention Comparative Effectiveness for Adult Cognitive Training

The study will compare the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance.

Participants will be randomly assigned to four training conditions: broad training using either 1) Posit Science's web-based "BrainHQ" or 2) the video game Rise of Nations, or to directed training for 3) Instrumental Activities of Daily Living (IADL) training on both driving, American Association of Retired Persons (AARP)'s web-based older driver training program, and training for fraud avoidance, a web-based tutorial on finance and fraud, or 4) to an active control condition of puzzle solving. Training will take approximately 15-20 hr for each treatment condition. Before training begins, participants will take baseline ability tests of perception, attention, memory, and cognition, activities of daily living, as well as a driving simulator test for hazard perception, and a financial fraud recognition test. They will be tested again on these measures following training completion, and at a one-year follow-up from training completion.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and above
* Plans to stay in the Tallahassee, Leon County area for the next year
* Valid driver's license and drives at least once a month
* Adequate cognitive ability assessed via telephone interview using the Wechsler Memory Scale III with story A score \>6 or story B score \>4.

Exclusion Criteria:

* Terminal illness with life expectancy less than 12 months
* Reports or exhibits a disabling visual condition assessed as the inability to read printed material
* Reports or exhibits a disabling speech hearing and comprehension condition assessed by inability to hear and comprehend the screener's instructions
* Reports or exhibits a disabling speech production condition assessed as the inability to respond with comprehensible English speech to the screener's queries
* Reports or exhibits a disabling psychomotor condition assessed as the inability to use a keyboard and pointing device
* Has completed the AARP driver training course
* Has played the Rise of Nations video game
* Has trained with Posit Science's "BrainHQ"
* Has trained on the Mind Frontiers video game.
Personalized Feedback for Distress Intolerant Smokers

This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and distress tolerance. The PFI will focus on feedback about smoking behavior, distress tolerance, and adaptive coping strategies.

The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and distress tolerance to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, increase distress tolerance, reduce anxiety/depressive symptoms, and increase adaptive coping skills compared to a personalized feedback on smoking only control. To address this aim, the investigators will implement a randomized controlled trial that will employ a longitudinal experimental design and involve four stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (Active PFI versus Control PFI with no personalized feedback on distress tolerance), and a post-intervention assessment; (c) 2-week follow-up; (d) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Eligibility Criteria:
Inclusion Criteria:

* Low distress tolerance defined as a DTS mean score of 2.56 or lower
* Daily smoking for at least one year (minimum 5 cigarettes per day and biochemically confirmed via Carbon Monoxide \[CO\] analysis at least 5 ppm)

Exclusion Criteria:

* Currently engaging in treatment for an alcohol/drug problem including smoking cessation
* Legal status that will interfere with participating
* Not being fluent in English
Controlled Exercises Effectiveness in Patients With Sleep Apnea

The aim is to compare a programme of controlled exercises therapy vs a programme of non controlled exercises therapy in patients with sleep apnea


Eligibility Criteria:
Inclusion Criteria:

* sleep apnea

Exclusion Criteria:

* neurologic disease
Patient-controlled Admissions to Inpatient Care

Patient-controlled admissions refer to the possibility for patients with severe psychiatric conditions to admit themselves to inpatient care. Compared to having a healthcare provider make this decision, patient-controlled admissions are believed to decrease the need for involuntary care, decrease symptom levels, and increase quality of life and autonomy for the patient. The current research project aims to evaluate the implementation of patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry.

Patients with severe psychiatric conditions represent a group who have extensive care needs and for whom few effective interventions exist. Diagnoses such as schizophrenia and borderline personality disorder usually have a poor prognostic outlook in terms of recovery, and patients often suffer from life-long disabilities. Meanwhile, their healthcare expenditures are typically high. In case of increased symptoms and novel sickness spells, healthcare providers make an assessment if admission to inpatient care is needed. This gatekeeper-model is typical of most western countries and infers that the decision to be admitted is always made by a third party. Since about a decade, attempts at transferring the responsibility of admissions to patients themselves is being implemented and tested in several countries and contexts, referred to as patient-controlled admissions. The idea is to increase patient involvement, enhance self-determination, and improve their ability to manage signs of illness. Patient-controlled admissions involve signing an agreement between inpatient care, outpatient care, and those patients that are deemed to have the highest care needs, whereby the patients can contact an inpatient ward and be admitted when required. Previous research have revealed that patient-controlled admissions decrease involuntary admissions and that both healthcare providers and patients are positive towards its use. These studies have however been small and used limited outcome measures. The current research project aims to study the results of implementing patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry. Apart from determining the possible impact on both number of admissions and days in admission (voluntary and involuntary), self-report measures will be used to assess the effects on symptom levels, quality of life, and autonomy.

Eligibility Criteria:
Inclusion Criteria:

* Have an on-going contact with outpatient care.
* Have an individual care plan and crisis plan.
* Have had at least one inpatient care period the previous year.
* Are expected to have the greatest need of inpatient care.
* Are interested in, and understand the concept of, patient-controlled admissions.

Exclusion Criteria:

* No informed consent to participate in the research project.
Rest Time on Gain Aerobic and Anaerobic Performance

Based on studies of high intensity interval training (HIIT) in the literature, higher gains in VO2max and performance are obtained in short periods of training time. However, different designs training configurations, for example, changing the time interval, could influence such gains on VO2max and aerobic performance. The aim of the study was to observe the possible influences of diferetes types of rest intervals in high intensity interval exercise protocol on VO2max, and the aerobic and anaerobic performances in 12 weeks of training.

12-week experiment will be conducted, with a total of 30 high intensity interval training (HIIT) sessions in cycle ergometer. Both the first and the last week will serve to stabilize the basic values and also repeated after training. So, every other day will be held: 1) risk stratification for coronary artery disease, anthropometric measurements, cardiopulmonary test maximum effort; 2) stabilization of cardiopulmonary test values, determining the aerobic dependent variables: VO2max, peak power - PP, occurrence of power VO2max - PVO2Máx, maximum heart rate - HRMax, as well as familiarization with the HIIT protocol; 3) anaerobic performance test of 30 seconds determining the anaerobic dependent variables: peak lactate - LA, anaerobic power peak - PP, average power - PM. After the dependent variables have established, the subjects will be randomly distributed among three groups: two experimental and one control, and subjected to 30 sessions of HIIT (all out)with 30 seconds of stimulation in cycle ergometer, differentiated only by the recovery time (60 seconds and 120 seconds). The control group had only one continuous aerobic exercise (50-55% VO2max) with an average time similar to other training.

Eligibility Criteria:
Inclusion Criteria:

* practitioners of aerobic activities for 6 mounths
* negative prognosis for cardiovascular or metabolic disease

Exclusion Criteria:

* muscle injuries
* use ergogenic resources
* cardiovascular disease
* other limitations
Cognitive Control Training for Urgency in a Naturalistic Clinical Setting

This study is designed to test whether computer-based cognitive exercises are helpful for reducing a specific type of impulsivity. Also, the study is testing whether these are exercises are associated with specific changes in behavior and in the brain. Participants will be psychiatric patients enrolled in a partial hospitalization program. Half of these participants will receive usual treatment, and half will complete computer-based cognitive exercises in addition to usual treatment.

Impulsivity has different components. One personality trait related to impulsivity, known as "urgency," is strongly related to many different mental health symptoms and risky behaviors. Urgency refers to impulsivity specifically in the context of strong emotions.

Research shows that higher levels of urgency are related to specific deficits in cognition. Problems with response inhibition--the ability to cancel or withhold a planned action--are associated with urgency. Also, research shows that difficulties in another aspect of cognition--working memory--may moderate the relationship between inhibition deficits and urgency. One previous study found that people who practiced computerized response inhibition and working memory tasks for two weeks reported significant decreases in urgency.

It is unknown if these computerized tasks would be helpful for reducing urgency in adults with psychiatric disorders. Furthermore, it is unknown if changes in urgency are related to changes in the brain mechanisms that help to support response inhibition. This study will collect data on brain activity while people are completing response inhibition tasks.

Eligibility Criteria:
Inclusion Criteria:

* Currently receiving treatment at the McLean Hospital Behavioral Health Partial Hospital Program (PHP)
* Report an average score of 3.0 or greater on the Negative Urgency scale, the Positive Urgency scale, or 3.0 or greater on both scales, upon admission to the PHP
* Right-handed (if enrolled in EEG arm)

Exclusion Criteria:

* Currently undergoing electroconvulsive therapy (ECT)
* Current symptoms of acute mania
* Current symptoms of acute psychosis
* History of traumatic brain injury
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy

The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
* Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.
* An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy

Exclusion Criteria:

* Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention
* Acute intestinal or gastric ulceration
* Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon
* Undergoing colonoscopy for foreign body removal or decompression
* Reduced level of consciousness or inability to swallow without aspiration
* Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures
* Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)
* Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites
* Severely reduced renal function (\<30 mL/min/1.73 m2)
* Pregnant or lactating women
* Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1
* Rhabdomyolysis
* Chronic nausea and vomiting
* Hypermagnesemia
* Undergoing treatment with Lithium
Cardiopulmonary Rehabilitation for Post-acute COVID-19 Symptoms

The purpose of this RETROSPECTIVE study was to compare the effect of a hospital and home-based cardiopulmonary rehabilitation (CPR) program on exercise endurance and quality of life in post-acute COVID-19 patients.

88 post-acute COVID-19 patients were divided two groups according to receiving hospital (n=45) or home-based CPR (n=43)in our rehabilitation clinic between January and July 2021. Both protocols consisted of aerobic, breathing and flexibility exercises. Hospital-based CPR: three or four days per week for a total of 20 sessions. Home-based CPR: three or four days/a week over a period of six weeks. The results of six meters walk test (6MWT) for exercise endurance as a main outcome measure, and Borg-dyspnea/fatigue, the visual analog scale (VAS) for pain and the Short Form-36 (SF-36) as secondary outcome measures before and after treatment were recorded.


Eligibility Criteria:
Inclusion Criteria:

* being 18 years or older
* having COVID-19 treatment (home quarantine/hospital/intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest computed tomography (CT)
* participating in a home-based exercise program (for 6 weeks) or hospital-based CPR (for 12-20 sessions) due to post-acute COVID-19 symptoms (fatigue, myalgia, dyspnea).

Exclusion Criteria:

* Patients who had both a negative PCR test and chest CT
* Patients who had not completed the six minute walk test (6MWT), Borg scales, Short Form-36 and Visual analog scale-pain.
* Acute COVID-19 patients (patients whose symptoms had started less than one month previous)
Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study

Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy. It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene and increased risk for genitourinary tract infection. These women suffer from a combination of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses. Though anal incontinence may subside in the postpartum period, a subset of women will have continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or as they age. As of December 2012, only one study has explored the effects of pelvic floor muscle training (PFMT) on reducing the development of this condition in the pregnant population. However, that study took place in Scandinavia with little demographic correlation to a US population and lacked postpartum followup. Although their results showed little effect of PFMT on anal incontinence, they recommended further research to be performed prior to making definitive conclusions.

Multiple studies have explored the effects of PFMT on urinary incontinence, and the general consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as an initial test to explore whether such a positive relationship holds for anal incontinence throughout pregnancy and postpartum period for a diverse population. The format will be a prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle training course at the first prenatal visit with at home instructions for continued exercise. This group will be compared to a control group which receives a hand-out regarding PFMT but no personalized instruction. The progress of the participants and their symptoms of incontinence will be monitored during pregnancy and at the postpartum visit using standardized validated pelvic floor questionnaires, based on previously designed surveys. A sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and "control or standard therapy" group. The investigators' hypothesis is that the intervention group will show a 50% risk reduction, similar to the urinary incontinence studies. The results of this study will then allow us to design a broader intervention study for which to study the effects of PFMT and anal incontinence during pregnancy and the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* parous women
* ages 20-40year old
* a new Ob visit prior to 20 weeks gestation
* confirmed singleton live intrauterine pregnancy

Exclusion Criteria:

* prior history of anal incontinence or prolapse
* history of surgery or procedures for urinary or anal incontinence or pelvic organ prolapse
* tobacco use
* diabetes mellitus
* history of sexual trauma
* chronic cough
* chronic constipation based on Rome criteria
* known connective tissue disorder
The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction

Introduction: Birth is a period in which biological, physical, emotional and social changes are experienced. Supportive care provided by the midwife ensures the adaptation of the woman to labor and improves her ability to cope with labor. Supportive care has positive effects on labor and maternal and infant health.

Purpose: This project aimed to determine the birth pain, comfort and satisfaction levels by considering the continuous midwifery care at birth with a holistic approach.

Method: The universe of this study, which will be conducted in randomized controlled experimental type, will consist of pregnant women who applied to Adana City Training and Research Hospital, Gynecology and Obstetrics Clinic, Delivery Room. The number of samples was calculated by G\*power analysis, and it was aimed to carry out the research with 30 participants in the intervention group and 30 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. Data will be collected using face-to-face interview technique. The pre-test will be applied to pregnant women who apply to the delivery room in the latent phase. While the continuous midwifery care model will be applied to the intervention group, standard midwifery care will be applied to the control group. The final test will be done between 1-4 hours postpartum. The independent variable of the study is continuous midwifery care. The dependent variable is the introductory characteristics of women, labor pain, comfort and satisfaction levels. The data will be analyzed with appropriate analysis methods after performing normality tests.

During childbirth, women need someone's support. Providing continuous care to women with a supportive and holistic approach by midwives who care for women is seen as a potential that can improve labor pain management, birth comfort and satisfaction. The aim of this research is to determine the effect of continuous midwifery care at birth on labor pain, comfort and satisfaction levels.

For this purpose, the objectives are:

* To apply the continuous midwifery care model,
* To increase women's normal birth comfort and satisfaction,
* To create social awareness that midwives play a key role in normal birth,
* Reducing preventable maternal and infant and infant deaths due to care deficiencies,
* To reduce cesarean rates.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate
* Knowing Turkish and being literate,
* Don't be in the latent phase.

Exclusion Criteria:

* high risk pregnancy
* Multiple pregnancy
* Breech presentation
* Induction of labor
* Emergency cesarean section indication