cyrilzakka/clinical-trials huggingface dataset:
Enhancing Postpartum Discharge Instructions

Post-cesarean delivery discharge instructions are not currently at an appropriate health literacy level. Enhancing discharge instructions with a visual aid did not improve scores on comprehension quizzes, either immediately or two-weeks post-discharge. However, participants preferred to have access to visual images with discharge instructions.

Objective:

To evaluate the effect of a visual aid on improving comprehension of hospital discharge instructions for cesarean wound care.

Methods:

A randomized control trial with a 1:1 allocation ratio and an intention to treat analysis was performed at an urban, tertiary care center from June-November 2017. Fifty English-speaking patients ages 18-50 who had undergone a cesarean delivery were randomized to receive either standard or enhanced discharge instructions regarding post-cesarean incision care. Enhanced instructions included a visual aid not present in the standard instructions. Participants completed a comprehension quiz prior to hospital discharge and again 2 weeks after discharge as well as the REALM literacy assessment prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

* Able to consent
* Identified as English speaking
* Had a cesarean delivery during the index hospitalization for delivery of their living newborn

Exclusion Criteria:

* Non-English speaking
* Declined to participate
* Required a translator for communication
* Intellectual disability (as self-identified or as determined by healthcare provider)
* Currently incarcerated
Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia

The primary objective of this study is to determine the long-term safety of DTX401 following a single intravenous (IV) dose in adults with GSDIa.

Only participants who received DTX401 in study 401GSDIA01 (NCT03517085) are eligible to participate in study 401GSDIA02. No investigational product will be administered during study 401GSDIA02.

Eligibility Criteria:
Inclusion Criteria:

1. Received DTX401 in study 401GSDIA01.
2. Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures being performed.
3. Willing and able to comply with all scheduled study visits, procedures, and requirements.

Exclusion Criteria:

1. Planned or current participation in any other interventional clinical study that may confound the safety or efficacy evaluation of DTX401 during this study.
2. Presence or history of any condition that, in the view of the Investigator, poses a risk to subject safety or places the subject at high risk of poor compliance or not completing the study or that would significantly affect the interpretation of study results.
Opioid Use After Traumatic Injury in Adolescents

Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use. Furthermore, by assessing whether pain management and mental health treatment after injury moderates sustained opioid use and prescription opioid misuse, we can create targeted interventions to reduce future nonmedical opioid use in adolescents.

This is a prospective cohort study that will follow participants for 2 years and administer surveys to adolescents both traumatically injured and uninjured on prescription opioid usage, substance use, utilization of pain management and mental health services, and mental and physical health condition conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 12-20 years of age
* Adolescent admitted for trauma OR adolescent with no recent trauma
* English speaking
* Consent can be obtained from a parent or guardian

Exclusion Criteria:

- Patients with severe brain injuries or other injuries that prevent survey participation
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women
2. Age 18 years and older
3. Spinal cord injury within 8 weeks of study entry
4. ASIA AIS A or B
5. Medically stable in the opinion of their physiatrist
6. Able to have dexa performed
7. Able to return for follow-up at 6 and 12 months

Exclusion Criteria:

1. Vitamin D deficiency
2. Hypocalcemia
3. Renal insufficiency (estimated creatinine clearance \<30ml/min)
4. Abnormal thyroid hormone status
5. Abnormal mental status
6. Osteoporosis at the hip or spine by dexa
Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition

Breastfeeding could effectively be associated with a lower risk of future type 2 diabetes (T2D) in women with gestational diabetes mellitus (GDM), but the short-term protective impact of puerperal breastfeeding on maternal metabolic recovery of GDM women remains unascertained. The investigators recruited GDM participants at 6-9 weeks postpartum and retrieved clinical diagnoses of GDM from electronic medical records. Feeding patterns were collected via phone calls. Glucose metabolism parameters and lipid profiling were performed on fasting plasma samples collected from patients 6-9 weeks postpartum (20 breastfeeding cases vs. 15 formula feeding cases).


Eligibility Criteria:
Inclusion Criteria:

1. 18-35 years old;
2. gestational age greater than 37 weeks;
3. Body Mass Index (BMI) before pregnancy 18.5-28kg/m2;
4. Have normal listening and speaking skills, can communicate, and are willing to participate in this study.

Exclusion Criteria:

1. abnormal glucose metabolism or diabetes has been diagnosed before pregnancy;
2. assisted reproduction;
3. GDM patients requiring drug treatment;
4. The use of blood lipid regulation drugs;
5. other pregnancy complications and complications;
6. Suffering from heart, malignant tumor, kidney and other major organ diseases;
7. associated with neurological dysfunction and cognitive impairment;
8. Failure to cooperate with follow-up observers.
Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer

This study has two primary objectives. The first objective is to determine the maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.


Eligibility Criteria:
Inclusion Criteria:1.Lung tumor \>= 5.0 cm.

2.Age \> 18 years,

3.Histologic confirmation of malignancy (primary lung or metastatic tumor)

4.Deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings.

5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria Exclusion Criteria:1. No chemotherapy within 2 weeks of radiation treatment.

2. Refusal to sign informed consent.

3. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.
Collection of Anonymised Blood Pressure Data During High Risk Surgery

This is a single centre, prospective, non-randomised clinical investigation to be undertaken at the Queen Elizabeth Hospital, Edgbaston, Birmingham.

The clinical investigation will collect fully anonymised perioperative blood pressure data from patients undergoing elective high risk surgery.

The Sponsor of this clinical investigation, Directed Systems Limited, is developing a new medical device, BP Assist, which provides guidance to anaesthetists in relation to the real-time management of patient cardiovascular physiology.

This clinical investigation is designed to collect fully anonymised perioperative blood pressure data from patients undergoing high risk surgical procedures.

It is increasingly being recognised that in high risk surgery, the perioperative incidence and duration of hypotensive episodes (MAP \<60mmHg) can adversely impact postoperative outcome.

Collecting continuous perioperative blood pressure data will enable hypotensive episodes to be recorded. Such data will be used to aid the development and testing of algorithms involved in generating the guidance provided by BP Assist.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older; undergoiing elective high risk surgery

Exclusion Criteria:

* \<18 years of age
A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors

This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.


Eligibility Criteria:
Inclusion Criteria:

* Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).

This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis or history of IBD for at least 3 months
* Subject has have active IBD defined by :

  * partial MAYO score (ulcerative colitis subjects) of 2 or more, where at least 1 point has to originate from blood in stool
  * Harvey-Bradshaw Index (HBI) (Crohn's disease subjects) of 5 or more, excluding points for complications
* CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrollment
* Female subject is not breastfeeding at Screening or while participating in this study
* Subject agrees to practice effective birth control from Screening and while participating in this study
* Subject agrees not to participate in another interventional study while participating in this study
* Male partner agrees not to donate sperm starting at screening and throughout the investigational period.

Exclusion Criteria:

* Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrollment
* Subject is unable to swallow oral study medication
* Presence of an ostomy or short bowel syndrome
* Subject has a current diagnosis of toxic megacolon
* Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol
* Subject has been enrolled into this study previously, has taken any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor
* Subject has previously participated in a CDI vaccine study
* Subject has hypersensitivity to FDX or any of its components
* Subject has a condition which, in the Investigator's opinion, makes the Subject unsuitable for study participation
The Pharmacokinetics, and Safety of Brexpiprazole Tablets in Chinese Healthy Subjects

This study is a single-center, open-label study evaluating the pharmacokinetics and safety of multiple dose oral administration of Brexpiprazole (1 mg) tablets in Chinese healthy subject.10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive days.

10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive days.

After receiving the informed consent form the subject themselves, the investigators start the screening 14 days to 1 days prior to taking the study drug (D-14 to D-1).

One day before first dosing (D-1), subjects are hospitalized. On the next day (D1), after completed the hospitalization inspection, eligible subjects will be selected to start with the first dose, and from day 1 to day 14 (D1 to D14), continue once daily dosing and complete the corresponding inspection, observation and blood sampling. They continue hospitalization and are discharged on day 17 (D17) after completing the relevant examinations. On days 19, 21, 23，25 (D19, D21，D23 and D25), blood samples are collected and safety evaluation is performed.

Telephone follow-up is performed on day 44 (D44, 30 days after the last dose of the drug).

Subjects who early terminated the test after taking the study drug should be tested at the end of the study (D25/ET) as far as possible.

Blood samples for pharmacokinetic evaluation are collected before daily dosing; D1 (before dosing, and 1, 2, 3, 4, 5, 6, 8, 12 hours after dosing), D2 (before dosing and 24 hours after first dosing), D10 (before dosing), D11 (before dosing), D12 (before dosing), D13 (before dosing), D14 (before dosing, and 1, 2, 3, 4, 5, 6, 8, 12 hours after dosing), D15 (24 hours after last dosing), D16 (48 hours after last dosing), D17 (72 hours after last dosing), D18 (96 hours after last dosing), D19 (120 hours after last dosing), D21 (168 hours after last dosing),D23 (216 hours after last dosing), D25 (264 hours after last dosing). 31 Blood samples collecting points in total.

Eligibility Criteria:
Inclusion Criteria:

* 1. Sign the informed consent form
* 2. At the age of 18\~45 years old (including upper and lower limits).
* 3. Body weight of not less than 45 kg, body mass index 19 \~ 25kg/m2 range (including the upper and lower limits) \[ body mass index (BMI) = body weight (kg) / height2 (m2)\].

Exclusion Criteria:

* 1. Participated in any drug test within 12 weeks prior to enrollment.
* 2. Drug abuse in the past 2 years or a history of substance abuse.
* 3. Drinking alcohol more than 2 unit per day (1 unit= 360 ml beer , or 45 ml 4.0% alcohol, or 150 ml liquor, or 50 ml wine ) 6 months before the screening, or subjects can not stop drinking during the hospitalization.
* 4. Drug abuse urine test at screening is positive.

Other protocol-defined inclusion and exclusion criteria may apply.
Gastric Tissue Stapler Comparison Study

This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").

The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.


Eligibility Criteria:
Inclusion Criteria:

1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80

Exclusion Criteria:

1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
3. Stomach damaged during extraction
Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers

To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets


Eligibility Criteria:
Inclusion Criteria:

* male and female, non-smoker and non-alcohol user, healthy volunteers, of 21 - 45 years of age. To be eligible, women must not be pregnant or lactating and they must not be taking hormone contraceptives
* Volunteers must not have a history of liver or renal disease or a history of psychiatric disorder. Volunteers will be submitted to the biochemical tests listed below, the results of which must be within expected normal values: complete blood count, erythro-sedimentation rate, GOT (glutamate oxalacetate transaminase) GPT (glutamate pyruvate transaminase), blood creatinine, glycemia, uremia, blood cholesterol, pregnancy test. HIV test (with prior written consent), serum tests for Chagas disease, hepatic b and syphilis, complete urinalysis, ECG (electrocardiogram) and chest x-ray
* Volunteers must have discontinued all pharmacological treatment at least two weeks before entering this trial
* informed written consent, signed prior to the start of this trial

Exclusion Criteria:

* Volunteers requiring any kind of pharmacological treatment or having some known addiction
* Volunteers having participated in any other clinical trial during the four preceding weeks
* Volunteers who must start a treatment incompatible with this trial during its course
* Volunteers who do not comply with the fasting requirements established in the trial or who do not comply with trial requirements such as avoiding intake of coffee, tea, cola soft drinks, etc. for 24 hours prior to the start of the trial
* History of allergy or intolerance to Epinastine
* Uncooperative volunteers
* Previous participation in this trial
Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability

The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

Individuals with intellectual disability (ID) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. As increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. E-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with ID.

The purpose of this study is to examine the effectiveness of an individually tailored PA programme with motivational mobile e-health support on everyday level of PA in youths and adults with ID.

The PA-IDE trial uses a prospective randomized controlled design. In total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. The intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. The intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. Participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). All participants will be assessed at baseline, 3-, and 6 months. Participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the Goal Attainment Scaling (GAS) will be used. Primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. Secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a PA setting, behaviour problems, and goal attainment.

The investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. Technology offers new opportunities to influence healthy behaviours. The trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with ID.

Eligibility Criteria:
Inclusion Criteria:

* Intellectual disability
* Age 15-60 years
* Low physical activity
* Sedentary lifestyle

Exclusion Criteria:

* Medical contradictions for participation
* High levels of physical activity
Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction

Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction

Color Flow Doppler Sonography (CFDS) has become in the last years an increasing procedure to assess the thyroid blood flow. Previous studies showed specific changes of thyroid blood flow in hyperthyroidism, Hashimoto's thyroiditis and thyroid nodules when investigated by CFDS. Subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by normal thyroid hormones concentrations along with ,respectively,decreased or increase Thyroid stimulating hormone (TSH) level. We purpose to investigate thyroid vascularity by CFDS in patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with subclinical hypothyroidism or hyperthyroidism
* patients with thyroid nodules and normal thyroid function

Exclusion Criteria:

* patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone
* patients who had thyroid surgery or radioiodine therapy
* patients with NYHA class 3 or 4 heart failure