cyrilzakka/clinical-trials huggingface dataset:
Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal Intubation

In order to evaluate the safety and value of the improved ship-shaped fixing on tracheal intubation patients and provide theoretical basis for clinical therapy, we conducted this research to compare the fixed effectiveness, complications, nursing workload and medical expenses about application of ship-shaped adhesive tape fixation on patient undergoing tracheal intubation.

the fixed effectiveness：Incidence of catheter displacement，Incidence of unplanned extubation.

complications：Incidence f skin damage，Oral care effect，Incidence of ventilator-associated pneumonia.

nursing workload:Oral care is time-consuming medical expenses :Material economic cost

Eligibility Criteria:
Inclusion Criteria:

* Patients with SICU intubation had been intubated for \<8h at the time of entry (the interval of oral care was 8h);
* Patients with brain diseases or septic shock caused by abdominal infection;
* There was no pulmonary infection before endotracheal intubation.
* Facial skin integrity;
* Good oral cavity: no odor, no residue, no oral diseases, oral mucosa integrity;
* Informed consent is given by the family members and the informed consent is signed;
* No adhesive tape allergy.

Exclusion Criteria:

* Oral injury caused by suction;
* Endotracheal intubation time \< 48 h;
* In the experiment is not willing to carry on the experiment, quit voluntarily.
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI\<150)
* Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)

Exclusion Criteria:

* Contraindication for infliximab, adalimumab, or azathioprine
* Lactating woman
* Presence of malignancy
* Within 3 month from intestinal surgery
* Presence of an end stoma
* Planned surgery
Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)

The overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following termination of therapy after one year.

While osteoporosis in women is recognized as a major public health problem, osteoporosis in men also has a profound clinical impact. Men over the age of 75 who sustain hip fractures have a higher mortality than women of the same age (30% versus 9%). Hip fractures in men account for one-third of all hip fractures. In 1995, male osteoporosis accounted for $2.7 billion in health care costs -- nearly one-third of the overall cost of osteoporosis. Alendronate has been shown to improve bone mass and decrease vertebral fractures in men with osteoporosis.

Prostate cancer is the most common visceral malignancy and the second leading cause of death in American men. Almost all men who progress to late stage disease are treated with androgen deprivation therapy for life, resulting in a 5-fold increased risk of hip fractures and a 13-fold increased risk of all osteoporosis fractures. Several studies suggest the merit of inducing androgen deprivation much earlier in the course of therapy for prostate cancer. It is therefore quite likely that androgen deprivation strategies will be employed with increasing frequency in patients with less advanced disease, resulting in longer life expectancy but greater bone loss.

Eligibility Criteria:
Inclusion Criteria:

* Men age 18 and older with stage Do prostate cancer (as defined by asymptomatic disease, rising PSA, and negative bone scans) following attempted curative surgery and/or radiation
* Androgen deprivation therapy (gonadotropin releasing hormone agonists, lutenizing hormone releasing hormone agonists, testosterone antagonists, orchiectomy) for at least 6 months for treatment of prostate cancer

Exclusion Criteria:

* History of any illness known to affect bone and mineral metabolism (renal failure, hepatic failure, Paget's disease, osteogenesis imperfecta, osteomalacia)
* Non-prostate cancer diagnosed within last 5 years (treated superficial basal and squamous cell carcinoma excepted)
* Hyperparathyroidism
* Malabsorption
* Treatment with medications known to affect bone metabolism (chronic high-dose corticosteroid therapy for at least 6 months, thyroid hormone with TSH \<0.1 micrograms, antiseizure medications)
* Active peptic ulcer
* Inability to sit upright or stand for at least 30 minutes
* Kidney stones in the past 5 years
* 24-hour urine calcium value \>400 mg/24 hours
* Esophageal stricture or achalasia
* Hyperthyroidism
* Evidence of chronic liver disease (including alcoholism)
* Treatment within past year for osteoporosis (calcitonin, fluoride, bisphosphonates)
* History of atraumatic fractures, previous fracture due to a fall from standing height or lesser trauma, or clinical osteoporosis
* Metastatic prostate cancer
* Inability to provide written informed consent
Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial

Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, oncologic nutritionist strongly recommends cancer patients (with cachexia) to consume a diet rich in protein and dietary fibers along with balanced essential micronutrients like vitamins and minerals (Van Norren et al., 2009; Yeh et al., 2013). From the above statement, it cleared that nutritional support is a crucial aspect of multi-modal cancer care, by improving the overall health status by suppressing various adverse events as well as enhance treatment regimen for a speedy recovery. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

Eligibility Criteria:
Inclusion Criteria:

* only hospitalized cancer patients with risk of malnutrition and underweight (confirmed with BMI, protein, and pre-albumin level) and must be under NG tube feeding.

Exclusion Criteria:

* avoiding cancer patients under critical conditions, with cardiac, renal, and hepatic disorders. Also, heavy smokers, chronic or chain smokers, and pregnant/lactating women were not included.
Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). The first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.

The secondary objectives of this study are:

A. To assess the prevalence of Abdominal Aortic Aneurysm (AAA) detected by ultrasound measurement of the anterior and posterior longitudinal outer diameter of the sub-renal abdominal aorta in a high cardiovascular risk population consulting with general practitioners (defined according to recommendations stated by the French Society of Vascular Medicine).

B. To assess the prevalence of Peripheral Obliterative Arteriopathy of the Legs (POAL) by measuring the Systolic Pressure Index (SPI) at the toe (ratio of arterial pressure in upper limbs versus lower limbs). Measures are made by a general practitioner in the same population.

C. To assess the quality and interpretability of ultrasound recordings and ultrasound acquistion failure rate. These second measures are made by an expert in vascular medecine. This evaluation with use a 3-level scale:

1. appropriate image was not obtained or not recognized expert - uninterpretable
2. poor image quality - interpretable
3. image of good or very good quality - interpretable

D. To calculate the impact of risk cofactors such as hypertension , smoking, age and family history among patients diagnosed with AAA.

E. Evaluation of general practitioner training from a qualitative and quantitative point of view after 4 h of training organized by Dr. Bobbià .

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient falls into one of the following 4 groups as defined by the French Society of Vascular Medecin (2006):
* (1) Men and women 60-75 years of age who are active smokers or ex-smokers
* (2) Men over 75 years of age
* (3) Women over 75 years of age who smoke and who have known hypertension
* (4) Men and women over 50 years of age with a family history of aneurysm of the abdominal aorta

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The subject has an allergy to the gel used for ultrasound examination.
A Pilot Evaluation of the Pregnant Moms' Empowerment Program

This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.


Eligibility Criteria:
Inclusion Criteria:

* at least 16 years of age
* experienced IPV in the past year
* currently pregnant (\<33 weeks)
* English speaking

Exclusion Criteria:

* insufficient fluency in English to participate in interviews/groups
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts

A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.


Eligibility Criteria:
Inclusion Criteria:

1. a signed written informed consent
2. age 18-40 years
3. healthy, and
4. Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
5. Fully vaccinated against COVID-19.

Exclusion Criteria:

1. significant disease
2. smoking
3. SLCO1B1 poor function genotype
4. oral contraception or other continuous medication
5. pregnancy, planning of pregnancy or breastfeeding
6. participating in a clinical trial less than 3 months ago
7. donating blood less than 3 months ago
8. marked obesity
9. anticipated difficulties in drawing blood samples
10. weight less than 45 kg
11. BMI less than 18.5 kg/m2 or
12. inadequate Finnish language skills
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P

The study will assess the CT-800 and TRK-2P for conformity to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification \[510(k)\] Submissions, and to the applicable Supplemental Information Sheet. This clinical device study will also assess the substantial equivalence of TRK-2P to a predicate device in regard to pachymetry.


Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years of age of either sex and any race or ethnicity;
2. be willing and able to provide written informed consent prior to any study procedures being performed;
3. be willing and able to follow all instructions and attend all study visits;

Exclusion Criteria:

1. have only one functional eye;
2. have poor or eccentric fixation in either eye;
3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
4. have microphthalmos in either eye;
5. have buphthalmos in either eye;
6. be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
7. have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of an artificial tear;
8. be a lid squeezer - blepharospasm;
9. have nystagmus in either eye;
10. have keratoconus in either eye;
11. have any other corneal or conjunctival pathology or infection in either eye;
12. have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Effect of Public Sector Antiretroviral Treatment Programme on Tuberculosis and Immunization Care

A scale-up of public sector antiretroviral treatment (ART) programmes may divert scarce resources from other priority primary care programmes like tuberculosis and childhood immunization.

The purpose of this study is to compare the performance of tuberculosis (TB) and childhood immunization programmes in primary care facilities participating in the South African national antiretroviral treatment programme with those which have yet to be included in the ART programme.

Large-scale public sector antiretroviral treatment programmes, like those planned for sub-Saharan Africa, will compete for scarce resources, in particular scarce human resources, with other priority primary care programmes like tuberculosis and childhood immunization.

This could lead to impaired performance in other priority programmes like childhood immunization while health workers are distracted by the demands of establishing and maintaining ART programmes. On the other hand, ART provisions may have positive spin-offs for related programmes like improved case detection of tuberculosis among HIV-positive patients seeking ART. The impact of the ART programme on primary healthcare more generally must be weighed against the benefits of providing antiretroviral treatment to those with AIDS.

Comparison: Primary care clinics in the Free State province, South Africa. 15 clinics participating in the first phases of the national ART programme will be compared with 24 clinics which have yet to be included in the national treatment programme. The unit of analysis will be the clinic although the outcome data will be collected from individual patients.

Eligibility Criteria:
Inclusion Criteria:

Clinics:

* Intervention: 15 primary care clinics participating in the first phases of the national antiretroviral treatment programme
* Control: 24 primary care clinics yet to be included in the national antiretroviral treatment programme randomly selected after stratification for health district and ranking of clinic size.

Patients:

* All patients attending tuberculosis and childhood immunization programmes at the above 39 clinics one year before and one year after antiretroviral treatment services commenced in these facilities.

Exclusion Criteria:

Clinics:

* Clinics earmarked for the second year of the rollout of the antiretroviral treatment programme.

Patients:

* None.
Targeting School Feeding Programs at Vulnerable Sub-Groups

School feeding programs provide students meals conditional on school attendance, which can have impacts on school participation, cognition and learning, and nutritional outcomes. Although the literature on impacts of school feeding programs is substantial, high quality studies with evaluation designs that provide causal impact estimates are relatively few. Thus program impacts on educational, cognitive and nutritional outcomes are not well-understood, particularly in a field setting. Nutritional impacts in particular are questionable, which may be a result program design. Most studies provide only small transfers to children and examine average macro-nutrient effects of the transfer on the treated children, thus it is not surprising that detection of nutritional gains has been minimal.

This study is a cluster-randomized evaluation of a school feeding program administered by the World Food Programme in the Northern Ugandan Districts of Lira and Pader. The program provides substantially larger food rations than most programs (representing 1/3 of children's daily caloric needs and 99% of iron intake requirements).

The key research objectives are:

1. Impact on the treated: Assess the effectiveness of the program at improving nutritional status, education and cognitive and learning outcomes for school-age children, with particular attention to the anemia status of older school-age girls .
2. Impact on untreated but nutritionally vulnerable sub-groups: Assess the effectiveness of the program at reducing anemia prevalence in mothers and younger siblings.
3. Optimal program design: Assess the differential impacts of a program in which children are fed at school compared with one in which they are given dry rations to bring home.


Eligibility Criteria:
Inclusion Criteria:

* School age children

Exclusion Criteria:

-
Autonomic Modulation in Takotsubo Syndrome

This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home. Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on autonomic measures and quality of life in patients with takotsubo.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed history of takotsubo syndrome
* Healthy person with no significant past history of cardiovascular or neurological disease such as heart failure or heart attack; people with cardiovascular risk factors such as hypertension will be permitted to participate

Exclusion Criteria:

* Pacemaker or defibrillator implanted
* Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy).
* Diabetes
Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender

This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness.

This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. This study utilizes eight vignettes portraying different mental illnesses and genders to measure the levels of mental illness stigma in the general community in rural Uganda.

Eligibility Criteria:
Inclusion Criteria:

* All adults who consider Buyende District their primary residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age
* Persons who do not consider Buyende District their primary place of residence
Impact of Arterial Cannulation Site on Vasopressor Requirement in Cardiac Surgery

Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* More than one arterial cannula at the beginning of the surgery