cyrilzakka/clinical-trials huggingface dataset:
The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on cardiovascular risk factors, physical activity level, physical activity behavior, and gait parameters in kidney transplant recipients.

The Transtheoretical Model evaluates readiness for behavior change. The Transtheoretical Model has been frequently used to determine how individuals adopt and maintain physical activity. In kidney transplant recipients (KTRs), increased physical activity level is associated with better graft function, and decreased physical activity is associated with increased cardiovascular and all-cause mortality. Therefore, it is important to evaluate the level of physical activity and to gain physical activity habits in KTRs. The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on on cardiovascular risk factors, physical activity level, physical activity behavior, and gait parameters in KTRs.

28 KTRs who meet the inclusion criteria will be assigned to the physical activity program or control group by non-randomization method. In the physical activity group, a 12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model. Assessments will perform just before starting to study, at the end of 12 weeks (just after the physical activity program), and the end of 24 weeks. In the control group, information about physical activity will be given without applying the physical activity program. Control group's assessments will be performed when they are included in the study, at the end of 12 weeks and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* to be at least 18 years old
* to have had a kidney transplantation at least 6 months ago

Exclusion Criteria:

* Pregnancy
* Multiple organ transplantation
* Severe cognitive impairment (Mini Mental Test score less than 24)
* Uncorrected visual impairment
* Certain neurological pathology (parkinson, stroke, epilepsy)
* Orthopedic surgery or injury to the lower extremity that will affect individuals' participation in daily life
* Inability to walk independently
Ketone Supplementation and Exercise Performance

The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age).

Some believe very high fat diets (\>70% energy) can enhance exercise performance by providing additional fuel (ketones) for energy metabolism, at least for very prolonged exercise (\>3-4h). Regardless, this diet is difficult to maintain so it has been suggested that ingesting ketone salts along with a normal carbohydrate (CHO) diet might be more practical. The purpose of this study is to observe the effects of ketone salt ingestion on shorter term (up to \~15 min) exercise performance. Endurance trained (≥2 year training experience; ≥7 h/week) collegiate athletes (n=20) of similar body mass (♀; 55-60kg; ♂; 75-80kg) and age 18-25y) consuming 5-6g CHO•kg-1•d-1) will be tested before and after 1 and 7d of ketone salt (Prüvit, Carrollton TX, US) supplementation (0.6-0.8g•kg-1•d-1). Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) before and after supplementation. Blood samples (glucose, lactic acid, and ketone concentration) will be taken at: baseline and following each performance test. It is hypothesized that ketone salt supplementation will increase blood ketone concentration but will not enhance these exercise performance tests.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female Collegiate Endurance Trained Athletes
* ≥2 year training experience; ≥7 h/week
* Ages 18-25

Exclusion Criteria:

* Smoker
* Injury that will affect exercise performance
* Sedentary Behaviour
* Currently following a High Fat diet/Ketogenic diet
* Taking Beta Blockers or Hypertension Medication
* Has Respiratory, Cardiovascular and/or Neuromuscular disease that is not cleared for exercise by a physician.
The Influence of Juggling on Selected Cognitive Functions and Postural Stability Variables.

The purpose of the study is to verify the effect of juggling exercises on selected cognitive functions (reaction time, attention) and postural stability variabilities (based on center of pressure signal) in two different protocols: \[1\] a randomised crossover study design, \[2\] a randomised repeated measurement design.

Juggling is a form of exercise, that can engage humans, both cognitively and physically. One of the positive aspects of taking up this form of exercise is the growing evidence indicating that juggling improves the well-being of exercisers. Most importantly, the juggling intervention causes an increase in the volume of the gray matter and white matter in the human brain, and thus shows potential for neuroplasticity. In addition, unhealthy aging is observed nowadays, which causes both physical and cognitive decline in daily functioning, further interfering with the elderly's ability to perform daily activities. Therefore, the addition of juggling exercises may have a positive effect on the changes that occur with aging.

However, currently there are hardly any data on the juggling effect on cognitive functions and on postural stability. Therefore, the study aims to examine the effect of juggling exercises on selected cognitive functions and postural stability variables in two different randomised trials.

Eligibility Criteria:
Inclusion Criteria:

* physically active
* over 65 years old
* with no injuries of pathologies involving the upper limb
* without neurological issues
* with no significant visual impairments

Exclusion Criteria:

* mixed or left-handedness
* sedentary lifestyle
* prior experience in juggling
* under or above the required age
* contraindications to physical activity
TENS for Suction Evacuation for Termination of 1st Trimester Pregnancies

To study the effectiveness of the pain relief method of transcutaneous electrical nerve stimulation (TENS) for women who will undergo suction evacuation under conscious sedation for first trimester termination of pregnancy.

Suction evacuation is a minor gynecological procedure commonly performed at an outpatient setting for termination of pregnancy. Although it is a simple surgical procedure lasting 5-10 min and can be done under various methods of pain control, 78-97% of women still report at least moderate procedural pain, especially during injection of paracervical block, cervical dilation, suction aspiration and postoperatively with uterine cramping. In addition, those pharmacological analgesic methods are often associated with numerous adverse effects and cannot be applicable to all women.

The transcutaneous nerve stimulation (TENS) method is commonly used to treat labour pain. It is an inexpensive, quick, easy to use and noninvasive pain relief method. A recent study by Lison et al. on TENS for office hysteroscopy demonstrated a significant decrease in pain scores when compared to control and placebo groups.

The rationale of TENS lies in achieving pain reduction when electric stimulation alters the nociceptive transmission in the dorsal horn of the spinal cord; this means the electrode has to be adequately applied in the right receptive field of the body to achieve pain control. For the setting of TENS there is evidence supporting superior pain relief by random high frequencies TENS over fixed frequency. Increasing the pulse duration to above 250 microseconds also produces better analgesics effect.

In suction evacuation, the nerve roots of T10-L1 and S2-S4 becomes relevant as they correspond to the nerve supply to the whole uterus and cervix. Lison et al placed electrodes at these levels parallel to the spinal cord in their study and have instructed their subjects to increase the TENS intensity to the maximum nonpainful level, allowing further increase when their stimulus perception decrease as a result of nerve accommodation.

Its use in suction evacuation however, remains undetermined as there is no published study in this area.

Eligibility Criteria:
Inclusion Criteria:

* Chinese aged 18 years or above and mentally competent
* Up to 12 weeks gestation on the day of STOP
* Size of the uterus on pelvic examination compatible with estimated duration of pregnancy, or dating confirmed with ultrasound scan
* Normal general and gynecological examination

Exclusion Criteria:

* Skin damage or allergy at site of TENS pads application
* Previous experience with TENS
* History of pacemarker insertion
* History of severe respiratory or cardiac disease
* Severe and recurrent liver disease
* Allergic to lignocaine
* Myasthenia gravis
* Psychiatric conditions requiring medication
* Disorders that constitute contraindications to use of prostaglandins
Evaluation of Microcirculation in Colon Wall and Bowel Anastomosis by Laser Induced Fluorescence Video Angiography

The aim of the study is to describe utility of dynamic fluorescence videoangiography of indocyanine green (ICG) in gastrointestinal surgery, for evaluation of microcirculation in colon wall and anastomosis before and after surgical resection; and if this technique can guide the surgeon to peroperative decision making considering recreate a new anastomosis or stoma for preventing anastomotic failure or stomia necrosis.

In our study the investigators prospectively include patients with colon cancer requiring elective surgical operation. All types of colon resection were carried out according to standard procedures. Guidelines for preoperative examination according to NGICG (Norwegian Gastro-Intestinal Cancer Group) to grade the disease, select the most suitable patients and plan further treatment.

Microcirculation of colon wall was assessed by dynamic laser-induced-fluorescence-videoangiography (IC-VIEW, PULSION Medical Systems AG, Munich, Germany) of indocyanine green (ICG). ICG is a water-soluble tricarbocyanine dye that binds strongly to plasma proteins after intravenous injection and is exclusively distributed in intravascular space. Additionally this system houses a laser (energy Pi = 0.16 W, wavelength = 780 nm) that causes excitation/illumination of the fluorescence light from intravascular plasma bound ICG. This light has a spectral range near-infrared energy (NIR) with a maximum at 805 nm and emits fluorescence at 835 nm. It passes through infrared filter on a digital video camera and results in recording of real time fluorescent image from perfusion of plasma bound ICG within small plexus of blood vessels in the bowel wall. Besides that it also demonstrates perfusion from surrounding structures such as appendix epiploic and pericolic fat. The maximum penetration of the laser into tissue is 3-5 mm and general normal thickness of colon wall is 3-5 mm. This method makes it a presentable tracer for tissue perfusion of anterior bowel wall.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colon cancer requiring elective surgical operation.

Exclusion Criteria:

* Pregnancy
* Children or patients below the age of 18 years
* Advanced renal or hepatic failure
* Previous allergic reactions to ICG and iodide
* Chronic anemia
* Active haematologic disease
* Women of fertile age needed a negative pregnancy test to be included
* Patients with previous colectomy or anorectal surgery were also excluded due to anatomical insult on mesenterial circulation
A Comprehensive Self-Management Intervention for Individuals with Inflammatory Bowel Disease

This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare provider diagnosis of inflammatory bowel disease
* Report current symptoms
* Able to read and write in English

Exclusion Criteria:

* Live outside of Washington state
* Bowel-related surgery within the past month
Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 administered as a single agent in adults with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility Criteria:
Inclusion Criteria:

* Male ≥18 years of age at the time of signing informed consent
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
* Adequate organ function

Exclusion Criteria:

* Prior solid organ transplant
* Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies
* Clinically significant cardiovascular disease
* Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome

In this study, investigators seek to determine whether the timing of antibiotics given to mothers during an elective C-section affects the composition of their infant's gut microbiome. To do this, a randomized controlled trial (RCT) was carried out with women undergoing elective C-sections. These women were either given antibiotics before the skin incision (AB+) or after the umbilical cord was clamped (AB-).

Rationale: During a caesarean delivery, umbilical cord clamping can occur before or after administering a perioperative prophylactic antibiotic to the mother. If the cord is clamped before the antibiotic administration, this antibiotic cannot reach the infant. Conversely, if the cord is clamped after the antibiotic administration, these maternal antibiotics cross the placenta and enter the infant's circulation. In this study, investigators hypothesize that such antibiotics modify the composition and functionality of the neonatal gut microbiome. A changed neonatal microbiome associates with the onset of asthma, allergies, type 1 diabetes, and obesity later in life. Such a small intervention could influence the future health of the infant significantly.

Objective: The primary aim of this study is to contrast the composition and functionality of the neonatal gut microbiome from mothers given antibiotic prophylaxis before skin incision with the microbiome of neonates from mothers given the antibiotic after umbilical cord clamping during an elective caesarean delivery.

Study design: Randomized controlled trial

Study population: Pregnant women at \>38 weeks of gestation undergoing elective caesarean section at the UMCG will be randomized into two groups. The gut microbiome of the neonates from both groups will be analyzed.

Intervention: The timing of umbilical cord clamping differs between the two groups. One gram of Cefazolin (once, intravenous) will be administered to one group before skin incision, while 1g cefazolin will be given to another group after umbilical cord clamping during an elective caesarean section.

Main study parameters/endpoints: The primary endpoint of this study is the variance in the composition and functionality of the neonatal gut microbiome over a year, contrasting neonates from mothers given antibiotic prophylaxis before skin incision with neonates from mothers given the antibiotic after umbilical cord clamping.

Eligibility Criteria:
Inclusion Criteria:

* Females undergoing elective CS at the UMCG
* Gestational age in weeks equal to or above 38 weeks

Exclusion Criteria:

* Cephalosporin allergy
* Exposure to antibiotic agent 2 weeks before CS
* Temperature \>37.5 C before CS
* Pre-labour rupture of membranes
* Emergency CS
* No -20 freezer at home
* No command of the Dutch language
Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 65 at the time of study participation.
* Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
* Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.

Exclusion Criteria:

* History of alcohol or substance abuse within the 5 years prior to study participation.
* Enrollment in another investigational drug or device study within 30 days of study participation.
* Women who are pregnant, nursing, or planning a pregnancy during the study.
Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.

This study is observational :

This substrate ablation method is performed routinely in the centers involved in the study so, patients were not assigned by the investigators to undergo a specific procedure because of the study, in all cases patient would have beneficiate from this substrate mapping ablation method.

We assessed procedural and follow up outcomes of this subatrate ablation group and compared them with an historical control group undergoing conventional ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patient from 18 to 85, with AF\* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)\* \*In accordance with the recommendation of European Society of Cardiology (2010).

Exclusion Criteria:

* organized atrial activity (Atrial tachycardia or Flutter)
Prevention With Oleanolic Acid of Insulin Resistance

Oleanolic acid (OA), a triterpene that is highly present in olive leaves, has been proposed as component of functional foods in the prevention of metabolic syndrome due to its anti-inflammatory activity. In this research project we will study the presence of OA in postprandial TRL in healthy adolescents and in normal weight. Moreover, THP-1 macrophages will be incubated with LPS for 48h after pretreatment with OA at different concentrations. Also, TRL will be isolated from healthy adolescents before and 2 and 5h postprandially after the intake of a meal containing the functional olive oil or common olive oil and incubated with THP-1 macrophages.


Eligibility Criteria:
Inclusion Criteria:

-Participants without digestive, metabolic or oncologic disorders or any other pathology

Exclusion Criteria:

-Not having the informed consent signed by the parents
Motivational Interviewing Integrated With Social Network Counseling for Teens

The purpose of this research is to test the feasibility and efficacy of a brief (one session) preventative intervention using motivational interviewing integrated with social network counseling for substance use among adolescent patients in a primary care setting. One hundred participants will be randomly assigned to either motivational interviewing integrated with social network counseling or attention control conditions. The motivational interviewing integrated with social network counseling condition is expected to show improvement when compared to the attention control condition.


Eligibility Criteria:
Inclusion Criteria:

* 14-18 years old
* Resident of Richmond VA or greater Richmond area
* Patient at Virginia Commonwealth University or Richmond City Department of Health

Exclusion Criteria:

* Ward of the state
* Not fluent in English
* Incapable of providing consent
Study on the Pathogenesis of Retinal Vascular Diseases Based on Body Fluid Metabolomics

Through the analysis of metabolites in body fluids (intraocular fluid, plasma) of patients with retinal vascular diseases (retinal vein occlusion, diabetic retinopathy), the possible pathogenesis of retinal vein occlusion was explored.

1. Clinical data of patients with RVO and DR Were retrospectively studied to analyze their pathogenesis. 2. Metabolomic studies were conducted on body fluids (intraocular fluid and peripheral blood) of patients with RVO and DR And control group to find out the differences and find new targets for the prevention and treatment of RVO and DR.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Confirmed diagnosis of retinal vein obstruction and diabetic retinopathy through ophthalmic specialist examination

Exclusion Criteria:

* Severe systemic diseases
* Pregnant and lactating patients
Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management

Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.

The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Person who does not object to being included in the study
* Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015.
* Age ≥ 18 years old
* Good command of the French language

Exclusion Criteria:

* Refusal or linguistic or psychological inability to answer the questionnaires.
* Caregiver whose general condition does not allow him/her to answer a questionnaire
* Death of the caregiver.