cyrilzakka/clinical-trials huggingface dataset:
Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm

The purpose of this research is to learn about how salt in the diet influences blood pressure in young adults who were born prematurely.

Premature birth is an emerging and important risk factor for hypertension and cardiovascular disease, as both preterm birth rates and infant survival increase worldwide. Hypertension and cardiovascular disease begin in early adulthood in individuals born prematurely, but the reasons especially in regard to the role of preterm birth are unknown. An improved understanding of why hypertension and cardiovascular disease occur in early adulthood in individuals born preterm will enable the development of prevention and treatment strategies to mitigate the burden of cardiovascular disease. Investigators propose to investigate these relationships mechanistically in a clinical trial of subjects born preterm to establish the SSBP (salt sensitivity of blood pressure) phenotype and study its relationship to CVD (cardiovascular disease) compared to a control group of healthy term- born peers. Investigators will then propose to determine if blocking UA (uric acid) formation improves SSBP and cardiovascular function in subjects born preterm.

Eligibility Criteria:
Inclusion Criteria:

* Singleton birth
* Born at less than 34 weeks gestational age (preterm cohort)
* Born at greater than 36 weeks gestational age (term cohort)

Exclusion Criteria:

* Twin birth
* Congenital anomalies or genetic syndromes
* Currently pregnant or breast feeding
* Subject-reported history of hypertension
* Current use of antihypertensive medications
* Active cancer
* Chronic kidney disease
* Heart failure
* Liver failure
ASUKI Step Pedometer Worksite Intervention

ASUKI Step is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive.

Study aims were:

1. to have a minimum of 400 employee participants from each university site reach a level of 10, 000 steps per day on at least 100 days (3.5 months) during the trial period;
2. to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day;
3. to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and
4. to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.

ASUKI Step is a 9-month pedometer-based worksite intervention conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona. ASUKI Step used a quasi-experimental design based on the theory of social support. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps.

Eligibility Criteria:
Inclusion Criteria:

* Employed at Arizona State University (ASU)or the Karolinska Institute (KI)
* The ability to read, speak and understand English (ASU only)
* Not currently pregnant or lactating
* Free of physical problems that affect the ability to walk, and e) ages 18 and older

Exclusion Criteria:

* Inability to walk
* Not employed or a graduate student at ASU or the KI
Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme

The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.

After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or above.
* Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
* Be able to provide written informed consent.
* Stable dose of steroids.
* Physically able to complete an exercise programme.
* Healthy controls.

Exclusion Criteria:

* Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
* An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
* A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
* Pregnancy.
* Healthy controls with underlying inflammatory conditions.
Hockey Fans in Training (Hockey FIT): A Pilot Pragmatic Randomized Controlled Trial

The Hockey Fans in Training (Hockey FIT) program aims to improve overweight men's physical fitness, eating habits and health-related lifestyle choices through a lifestyle modification program in collaboration with two Ontario Hockey League teams. In this pilot pragmatic randomized controlled trial, the investigators plan to explore the potential for Hockey FIT to reduce a clinically important amount of weight, increase physical activity levels, and lead to improvements in other health-related outcomes.

In the United Kingdom, the Football Fans in Training (FFIT) program was developed to encourage men to lead a healthier lifestyle through a sport-related medium. FFIT is a gender-sensitized, weight loss and healthy living program developed for delivery to overweight and obese men through professional football clubs. Published results from FFIT show that the program was able to actively recruit and engage men and for the men who participated, sustained weight loss and positive lifestyle change was observed (Hunt et al., 2014).

This study will use a two-arm, pilot pragmatic randomized controlled trial (RCT) design. The investigators will conduct the study in conjunction with two Ontario Junior A Hockey Clubs. Following assessment of eligibility and baseline measurements, men will be individually randomized (1:1; stratified by club) to either the intervention group (receiving the Hockey FIT program) or to the comparison group (usual care wait-list control). The comparison group will be offered to start the Hockey FIT program after a 12-week delay. All men (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. Measurements will be taken at baseline and 12 weeks (both groups) and again at 12 months (intervention group only).

The results of this study will be used to inform a fully-powered RCT where the primary objective will be to determine whether, compared to the usual care wait-list control group, the Hockey FIT group will lose weight (at least 5% weight loss from baseline) at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Objectively-measured body-mass index of at least 28 kg/m2
* Clear Physical Activity Readiness Questionnaire (PAR-Q) (i.e., either by answering "No" to all questions or receiving clearance from a health care provider)

Exclusion Criteria:

* Unable to comprehend letter of information and consent documentation
Respiratory Disease Management

The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning.

The investigators propose to carry out a prospective, randomized, trial at Barnes-Jewish Hospital (1250-bed urban academic hospital). Eligible patients will be identified by a senior study coordinator who will also obtain informed consent for study participation. Adults greater than 18 years of age and less than 65 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: patients with spirometrically confirmed COPD at high risk for repeat hospitalization or ED visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or a course of systemic corticosteroid therapy in the preceding 12 months. Exclusion criteria include patients not expected to survive their hospitalization, presence of metastatic cancer, bed-bound individuals, non-English speaking patients, and patients unable to provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Adults greater than 18 years of age and less than 64 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following:

  * patients with spirometrically confirmed COPD at high risk for repeat hospitalization or emergency department (ED) visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation,
  * chronic home use of oxygen, or
  * a course of systemic corticosteroid therapy in the preceding 12 months.

Exclusion Criteria:

* patients not expected to survive their hospitalization,
* presence of metastatic cancer,
* bed-bound individuals,
* non-English speaking patients, and
* patients unable to provide informed consent.
Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Ultrasound-guided radiofrequency ablation may be effective treatment for thyroid cancer.

PURPOSE: This phase I trial is studying the side effects of radiofrequency ablation in treating patients who are undergoing surgery for thyroid cancer.

OBJECTIVES:

* Determine the frequency of complications associated with radiofrequency ablation (RFA) in patients with low-risk papillary thyroid cancer undergoing thyroidectomy.
* Determine the utility of RFA as a treatment option for these patients.

OUTLINE: This is a pilot study.

An electrosurgical probe is placed by ultrasound guidance into the center of the thyroid tumor. Patients undergo radiofrequency ablation directly to the tumor until the target temperature is reached\* for 5 minutes. Patients then undergo standard thyroidectomy.

NOTE: \*Takes approximately 15-30 minutes to reach target temperature.

After completion of study treatment, patients are followed at day 1, between days 14-21, and then periodically as deemed necessary.

PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically confirmed papillary thyroid cancer by fine needle aspiration

  * Low-risk disease
  * No poorly differentiated cytology
* Intrathyroidal tumor

  * Located within the anterior two-thirds of the thyroid lobe
  * Tumor not adjacent to the trachea by neck ultrasound
* Tumor ≤ 1.5 cm by neck ultrasound
* Requires thyroidectomy
* No cervical lymphadenopathy
* No multicentric tumors by neck ultrasound
* No evidence of lymph node metastasis

PATIENT CHARACTERISTICS:

Age

* Over 21

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Effect of Dexmedetomidine on Quality of Recovery in Non-functioning Pituitary Adenoma Patients Undergoing Endoscopic Transsphenoidal Surgery

In multiple previous studies that have explored the use of dexmedetomidine in transsphenoidal tumor resection surgery, dexmedetomidine showed many beneficial effects like reducing the requirement of analgesics and anesthetics, improving hemodynamic stability and decreasing the emergence time, extubation time and visual analog scale at emergence. Therefore, the investigators hypothesized that dexmedetomidine would decrease neuroendocrine stress response and improve the quality of postoperative recovery.


Eligibility Criteria:
Inclusion Criteria:

* Non-functioning patients undergoing endoscopic transsphenoidal tumor surgery under general anesthesia

Exclusion Criteria:

* Patients who do not agree to participate in the study
* Patients with contraindication to dexmedetomidine
* Patients with previous history of endoscopic transsphenoidal tumor surgery
* Patients who take anticoagulants or have bleeding disorder
* Patients with conduction block or cardiovascular disease
* Patients with psychiatric disease such as dementia, delirium
* Patients have difficulty filling out the QoR-15 questionnaire
* Pregnant or lactating women
* Patients who have allergies to propofol, remifentanil, fentanyl or rocuronium
* Patients with myasthenia gravis or myasthenic syndrome
Emotional Freedom Technique (EFT) on Pain and Stress Levels in Fibromyalgia (FMS)

The main aim of the study was to investigate self-administered emotional to determine the effect of the freedom technique on pain and stress levels.

The sub-objectives of the study are as follows:

1. To determine the effect of self-administration of EFT on pain level.
2. To determine the effect of self-administered EFT on stress level.
3. To determine the effect of EFT self-administration on comfort level.

HYPOTHESES OF THE RESEARCH

H 1 : Between the pain levels of patients with and without self-administered EFT there is a difference.

H 2 : There is a difference between the stress levels of patients who apply EFT to themselves and those who do not. there is a difference.

H 3 : Comfort levels of patients with and without self-administered EFT there is a difference.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of fibromyalgia
* Can speak and understand Turkish
* Have time and place orientation
* No psychiatric illness,
* No vision and hearing problems.

Exclusion Criteria:

* Unstable medical condition
* Non-cooperative individuals
Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke

This study examines whether in-lab training with a myoelectric-computer interface (MyCI) can reduce abnormal muscle co-activation after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Stroke survivors at least 6 months after stroke onset
* Persistent moderate to severe arm impairment
* Increased arm tone

Exclusion Criteria:

* Substantial impairment of vision, memory, language or concentration
* Botulinum toxin use in the affected arm
* Concomitant participation in another research study on the arm
Lipofilling for Healing of Chronic Wounds

Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)


Eligibility Criteria:
Inclusion Criteria:

* Patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive)
* Age of ulcer \> 6 weeks
* Ulcer size \>= 1 cm (minimum diameter)
* Ulcer / wound with complete destruction of the epidermis (including basement membrane)
* Patient age \> 18 years
* Patient Consent

Exclusion Criteria:

* Pregnancy
* Exposed tendons, ligaments, or bone if maximum diameter \> 2 mm
* Ulcer size \> 10 cm
* Immediately preceding vacuum bandage therapy (\< 2 weeks)
* Possibilities for correcting the cause of the ulcer
Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency

The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.


Eligibility Criteria:
Inclusion Criteria:

* The serum zinc concentrations are under the nomal level before registration
* Able to taking a tablet

Exclusion Criteria:

1. Heavy hepatitis
2. Malignant tumor
3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
4. The serum albumin under 2.8 g/dL
5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
7. Pregnant, suspected pregnant, lactating, patients who wish to have a child
8. Patient who participated in other clinical trials within 12 weeks before registration
9. Unsuitable as a target of this clinical trial judged by doctor
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.

Study of safety and efficacy of UNR844 in subjects with presbyopia.

This was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of:

* A 1 week run-in period
* A 3-month treatment course with UNR844 and/or Placebo
* A 9-month treatment holiday period Participants were randomized equally to one of five treatment arms: UNR844 5 mg/mL,UNR844 13.3 mg/mL, UNR844 23 mg/mL, UNR844 30 mg/mL, or Placebo eye drops twice-a-day for three months.

Participants underwent a 1 week run-in period where they were assessed for entry criteria during the Screening visit. During the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. This run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (DCNVA) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. The run-in period was to help exclude participants with a change in DCNVA of 0.10 logMAR difference between Screening and Baseline.

This study was conducted to determine the optimum dose of UNR844 treatment and the duration of effect of UNR844 treatment for further development.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Impaired near vision in each eye and when using both eyes, without any near correction
* Need a certain level of near correction

Exclusion Criteria:

* Impaired distance vision in either eye, with distance correction (if any)
* Severe short- or long-sightedness
* Any significant medical or clinical conditions affecting vision, the eyes or general health
WBV Training on Physical Function and Muscle Strength in Knee OA

In this study compare different frequencies of whole body vibration training on physical function and muscle strength in patients with knee osteoarthritis.

This randomized controlled trial is to compare different frequencies of whole-body vibration (WBV) training on physical function and quadriceps muscle strength in patients with knee osteoarthritis and further will be researched which frequencies are effective for knee OA patients and how much WBV training is useful modality for knee osteoarthritic patients. This research will have significant effects in improving muscle strength and functional level of knee OA patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Both genders
* Kellgren and Lawrance grade 2 and 3.
* Pain symptoms for at least 3 months
* Had no previous experience in WBV

Exclusion Criteria:

* Knee surgery in the past 6 months
* Patient with acute symptomatic knee OA
* Unable to walk unaided
* Diagnosed with other muscular and joint disease that affect the lower limb function
* Patient with any neurological conditions
* History of trauma to knee joint during last week.