cyrilzakka/clinical-trials huggingface dataset:
Electroacupuncture Analgesia for Colonoscopy

Background:

Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA) has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.

Objective:

To investigate the efficacy of EA in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.

Design:

Prospective, randomized, double-blind, sham-controlled study.

Subjects:

One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited.

Interventions:

Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA) before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to stabilize the needles and to blind the patients and endoscopists to the treatment allocation. EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.

Outcome measures:

Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.


Eligibility Criteria:
Inclusion criteria:

* Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy
* Patients with American Society of Anesthesiologists (ASA) grading I-II
* Informed consent available

Exclusion criteria:

* Patients with previous experience of acupuncture
* Patients with previous history of colorectal surgery
* Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria
* Patients with chronic pain syndrome
* Patients with psychiatric disorder
* Patients with poor cognitive function
* Patients with renal impairment
* Patients with obstructive sleep apnea syndrome
* Patients with cardiac arrhythmias
* Patients with cardiac pacemaker
* Patients who are pregnant
* Patients who are allergic to the acupuncture needles or Propofol/Alfentanil
Young Adult-Mediated Intervention to Increase Colorectal Cancer Screening

This study will garner preliminary data to develop a young adult-mediated intervention whereby a younger family member encourages their older family member to get colorectal cancer (CRC) screening. In Aim 1, survey data from n=150 younger (25-44 years old) and n=150 older (45-75 years old) adults living in rural communities will be collected. In Aim 2, intervention components will be evaluated using n=9 focus groups. The novel intervention will be assessed via a pilot trial (n=15 adult child/parent dyads) in Aim 3.

Aim 1. Environmental Scan of Health Communications Landscape. Using quantitative methods, examine the health communications landscape of younger (25-44 years old) and older (45-75 years old) adults living in rural communities. N=300 survey responses (n=150 from each age group) will be analyzed to determine the primary channels and sources of health-related information, quantify the extent to which these residents engage in family communications about cancer screening, and identify potential strategies for upward communications. Individual factors (i.e., CRC screening knowledge, health literacy, and numeracy) and specific facilitators of and barriers to upward communication about CRC screening will be also assessed.

Aim 2. Message Development and Refinement. Using qualitative methods, develop and evaluate intervention components to facilitate effective upward communications about CRC prevention and screening. To accomplish this aim, we will: 1) use findings from Aim 1 to design intervention content and materials that leverage relevant communication channels and strategies, and address barriers to upward communication and 2) conduct n=9 focus groups with adult children 25-44 years of age (n=3), CRC screening age-eligible adults, 45-75 years old (n=3), and adult child/parent dyads (n=3), to assess message acceptability and refine key content areas. We will iterate and modify intervention components based on feedback.

Aim 3. Preliminary Testing. Using a single arm, open-label, pre-test post-test design (n=15 adult child/parent dyads), assess the impact of a young adult-mediated intervention to increase CRC screening among a paired age-eligible family member (e.g., parent/grandparent). The focus of the intervention will be on changes in CRC screening awareness and intentions among the age-eligible adult, but we hypothesize that the young adult could benefit as well. Thus, in addition to assessing feasibility and acceptability, we will assess changes in 1) CRC screening intentions among the age-eligible adults and 2) CRC health literacy and awareness of screening guidelines among the younger adult participant.

Eligibility Criteria:
Inclusion Criteria:

* Residents of counties in the Virginia/North Carolina CRC hotspot
* 25-75 years old
* Able to speak, write, and comprehend English
* Younger adult participants in Aims 3 must have an older, screening age-eligible relative with whom they speak with regularly (i.e., ≥ once every two weeks)

Exclusion Criteria:

• Participants in Aims 1 or 2 will be ineligible for Aim 3
The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure

Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal approach for such therapies has not yet been established. As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites. The purpose of this study was to examine the role of targeting an early and substantial increase in mean arterial pressure in the prevention of type 2 HRS.


Eligibility Criteria:
Inclusion Criteria:

1. cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;
2. type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;
3. age 18 to65 years;
4. absence of severe bacterial infection associated with findings of systemic inflammatory response as diagnosedby the presence of at least 2 of the following criteria: body temperature \<36°C or \>38°C, heart rate \>90 beats/min, respiration rate\>20/min, and white-cell count \<4 or \>12 X106/L or \>6% of band forms; patients with bacterial infections, however, could be included in the study if renal failure persisted after infection resolution;
5. the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;
6. the absence of findings suggestive of organic nephropathy;
7. the absence of advanced hepatocellularcarcinoma.

Exclusion Criteria:

1. Patients with history of coronary artery disease
2. Cardiomyopathy
3. Ventricular arrhythmia
4. Obstructive arterial disease of limbs -
Follow-up Study to Previous CARE Trial

To determine comparative 1-year outcomes in renally impaired patients who previously underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial protocol and were evaluable for determination of post-contrast significant renal injury (defined as \>25% increase in SCr or \>25% increase in cystatin C).


Eligibility Criteria:
Inclusion Criteria: (from previous CARE trial)

* • Screening eGFR between 20 and 59 mL/min/1.73m2

  * Baseline SCr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration
  * At least one post dose blood sample available
  * Received randomized contrast agent
  * Underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by PCI was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study
  * Provides written Informed Consent and is willing to comply with protocol requirements;
  * Was included in the patient list provided by Bracco;
  * At least 1 year has passed since the patient's participation ended in the original CARE trial, as determined from the list provided by Bracco

Exclusion Criteria:

* • Screening eGFR outside the range of 20 and 59 mL/min/1.73m2

  * Unstable kidney disease or requiring dialysis upon enrollment
  * Prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function
  * Did not receive randomized contrast agent per CARE protocol
  * Did not undergo a cardiac angiography procedure per CARE protocol
Cerebral Responses to Insulin Induced Hypoglycemia

This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.

The purpose of this study is to better understand the effect of low blood sugar (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious complication of diabetes treatments. It has been previously observed that hypoglycemia causes an increase in blood flow to certain parts of the brain, but it has been difficult to determine which parts of the brain specifically have an increase in blood flow. With new technology, it is now possible to determine the rate of blood flow in very small parts of the brain. The investigator expects that people with type 1 diabetes and hypoglycemia unawareness, poorly controlled diabetes, and normal subjects will have different rates of blood flow to different parts of the brain in response to hypoglycemia. Having a greater understanding of how the brain adapts to hypoglycemia may help us develop better ways to treat diabetes more safely.

Eligibility Criteria:
Inclusion Criteria:

* well controlled type 1 diabetes (hemoglobin A1C \<7.5%)
* healthy controls

Exclusion Criteria:

* History of stroke, seizures, neurosurgical procedures, or arrhythmias
* Use of drugs that can alter GABA (gamma-aminobutyric acid) metabolism (such as benzodiazepines).
* Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers

This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* No evidence of any acute or chronic health disorder
* Not have taken any prescription medication within 15 days of study entry
* Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
* Not have not have any dietary restrictions
* Have a body mass index (BMI) of ≥18 to ≤34
* Weigh at least 50kg (110 pounds)

Exclusion Criteria:

* Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
* Have a history of symptomatic hypotension, orthostatic hypotension or syncope
* Have a history of headaches or other symptoms attributable to caffeine withdrawal
* Have a history of any bleeding diathesis
* Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening

Other protocol defined inclusion/exclusion criteria could apply
Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy

This is an observational, multicenter, single-arm, prospective study conducted in Italy

Primary data will be collected over a period of three years. Medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of the effects of siponimod treatment on an individual basis.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent: patient must provide written informed consent before any study assessment is performed.
2. Male/female participants aged between 18 and 60.
3. Documented diagnosis of active SPMS.
4. Siponimod treatment as routine medical care: patients newly treated with siponimod (starting not more than 7 days before baseline visit), for whom the decision to start treatment has already been taken independently of study inclusion based on clinical practice and according to SmPC and AIFA criteria, and who successfully qualified for treatment with siponimod (i.e. passed the screening procedure mandated by the SmPC and Risk Management Plan (RMP) for this treatment, including genotyping for CYP2C9 to determine CYP2C9 metaboliser status).

Exclusion Criteria:

1. Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC.
2. Pregnant or lactating women.
3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the investigator's judgement.
4. Current participation in an interventional trial.
5. Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).
Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a neuro-behavioral disorder associated with repetitive movements. The role of physical therapist towards an autistic child is most neglected one. Therefore, the objective of this study was to see the effectiveness of different ball exercise on stereotypic behavior of children with ASD. Different ball exercises were implemented for 2 months, 3 sessions per week and every session consist of 35 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with ASD through experts
* Having recognized stereotypic behavior
* Having Intellectual Deficit (ID) and Attention Deficit Hyperactive Disorder (ADHD)
* Age ranging between 4-16 years
* Consented to take part

Exclusion Criteria:

* Having co-morbidities like schizophrenia and developmental delays
* Severe cases of ASD
* Showing aggressive behavior
* Having disease of cardiovascular or respiratory system
* Children unable to follow the command for exercise completely
Breast Cancer Prevention Education

We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are:

1. To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research.
2. To evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.


Eligibility Criteria:
Inclusion Criteria:

* African American women
* Ages 35-70
* No personal history of cancer
* Resident of Philadelphia metropolitan area

Exclusion Criteria:

* Non-African American
* Male
* Under 35 or over 70 years of age
* Personal history of cancer
* Not a resident of Philadelphia Metropolitan Area
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Hypertension Receiving Bevacizumab for Breast Cancer

This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with hypertension receiving bevacizumab for breast cancer. Studying samples of germline DNA in the laboratory from patients with hypertension receiving bevacizumab for breast cancer may help doctors learn about changes that occur in DNA and identify biomarkers related to hypertension.

PRIMARY OBJECTIVES:

I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of hypertension in patients from the clinical trial Eastern Cooperative Oncology Group (ECOG)-5103 (E5103).

OUTLINE:

Previously collected germline DNA samples are analyzed via whole exome sequencing.

Eligibility Criteria:
Inclusion Criteria:

* European American patients with deoxyribonucleic acid (DNA) available and designated case or control
* Patients who developed grade 3-4 bevacizumab-induced hypertension during their treatment with bevacizumab
* Patients who did not develop hypertension following a full course of treatment with bevacizumab
Activating Transversus Abdominis Muscle

Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers between ages of 18-25

Exclusion Criteria:

* Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.
Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)

Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization.

Healing assessment of external inflammatory Root Resorption after Revascularization Technique of Avulsed permanent Central Incisor (Case study)

Eligibility Criteria:
Inclusion Criteria:

* traumatic teeth
* external inflammatory root resorption

Exclusion Criteria:

-
Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

The purpose of this study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device.

The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ MCP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed MCP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint.

Eligibility Criteria:
Inclusion Criteria:

* patient is in need of a revision of failed MCP prosthesis(es)
* patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic MCP joint

Exclusion Criteria:

* patient is not in need of a revision of a failed MCP prothesis(es)
* patient is eligible to use an alternative implant
Leukocytes - ObeSity - Spontaneous Labour

This is a single-centre observational, prospective study carried out at the maternity unit of Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will evaluate in these patients, the activation and migration capacities of circulating leukocytes and their association with the onset of spontaneous labour.

Patients who meet the inclusion criteria will be informed about the study during their consultation at the 7th or 8th month, and their gynecologist will invite them to take part. If the answer is positive, the patients will be seen again at a specific consultation for the study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU. During this consultation, the gynecologist will conduct a medical examination, while the Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and 1 x 7ml tube).

If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood sample (1 x 6ml tube and 1 x 7ml) will be taken.

The patients will be followed until childbirth and will be split into two groups according to whether or not they gave birth after the onset of spontaneous labour.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given its written consent
* Please affiliated to a social security scheme
* Body Mass Index Preconception ≥ 30 kg / m²
* Age\> 18 years
* Unique Pregnancy
* Having a plot of Normal Fetal heart rate

Exclusion Criteria:

* Pathology changing the mode of delivery or induction of labor (pre-eclampsia, chronic hypertension or gestational, diabetes under unbalanced diet, ...)
* Scheduled Caesarean
* Infectious Disease suspected or proven, including HIV infection, hepatitis C, hepatitis B
* Pathology inflammatory or autoimmune
* Anti-inflammatory or immunosuppressive therapy
* Patient under guardianship
* Patient in safeguarding justice

  • SECONDARY EXCLUSION CRITERIA:
* Caesarean section before labor
* Delivery before 37 Weeks of amenorrhea
* Anti-inflammatory or immunosuppressive therapy during study participation
* Fetal Heart Rate abnormal during study participation
* Premature rupture of fetal membranes without formal labor spontaneously within 48 hours
* Induction of labor or cervical ripening before 41SA