cyrilzakka/clinical-trials huggingface dataset:
Telehealth Support to Increase Physical Activity in Rett Syndrome

This study will recruit families with a daughter with Rett syndrome living in either Australia, Denmark or Israel, and thereafter deliver individually designed participation programs using telehealth strategies. We will evaluate the effectiveness of the programs on reducing sedentary behaviours, increasing physical activity and increasing quality of life.

This project will implement two intertwined strategies that will build the capacity of the carer, clinical and therapy communities to support physical activity in Rett syndrome. Individuals with Rett syndrome experience difficulties with movement and this can make it difficult to participate in regular physical activity. Individuals with Rett syndrome need support to participate in physical activities and it is important to work with primary caregivers when developing strategies to support physical activity. We will conduct a clinical trial that tests the effectiveness of working with primary caregivers to develop strategies suitable to their lives that aim to increase participation in physical activity in the individual with Rett syndrome whom they support. We will use a clinical trial design and work with primary caregivers using Telehealth. We will test whether this approach decreases sedentary time and increases physical activity. We will also test if there are changes in the sleep, behaviour and quality of life. We aim to recruit 60 families for this study, 26 of whom will live in Australia. Data from the three sites will be pooled for a stronger analysis. We acknowledge that physical activity can be associated with a fall and therefore our program will be developed with the primary caregiver to be suitable for their lives and capacity to provide support. However, by practicing more activity, the individuals with Rett syndrome could be stronger and risks of falling could be reduced. The risks for the individual with Rett syndrome are therefore low. To let the Rett syndrome community know our results, we will then develop an online resource documenting the physical activity program and the evidence available to support it, and this will be freely available to families, carers and therapists wherever they live in the world.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed Rett syndrome
* Able to stand (with or without assistance)
* Live in Australia, Denmark or Israel

Exclusion Criteria:

* Individuals who have had spinal fusion over the previous 12 months
* Individuals who have had lower extremity orthopaedic surgery over the previous 6 months
Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine

To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, non-smoking males and females between 18 and 55 years of age, inclusive; Whites of European or North American heritage and Blacks of African or Caribbean heritage.

Exclusion Criteria:

* Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
* Historical, clinical, or laboratory evidence of liver disease including but not limited to transaminase activity concentrations \>2.5 times the upper limit of the reference range.
* Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months.
* History of cholecystectomy.
* History of malignancy within the last 5 years (except basal cell carcinoma, which must be in remission for at least 6 months prior to the study.
* Pregnant or lactating females or females of childbearing potential who are unwilling to use reliable, medically accepted methods of contraception. If subjects who are not sexually active with members of the opposite sex become so during the study, these subjects must agree to use a medically accepted method of contraception.
* History of hypersensitivity or intolerability to either desloratadine or fexofenadine or other antihistamines.
* Treatment with other antihistamines in the last month before study entry.
* Use of any prescription or over-the-counter medications or dietary/herbal supplements (with the exception of oral or implanted contraceptives) within 1 week or 5 half-lives, whichever is longer, of the study.
* History of alcoholism or drug abuse within 12 months of the study.
* Ingestion of alcohol within 1 week of the first dose of study medication.
* Ingestion of grapefruit or grapefruit juice within 1 week of the study and a willingness to abstain from the consumption of grapefruit or grapefruit juice for the duration of the study.
* Participation in any other clinical trial or use of an investigational product within 30 days of entry into the study.
Patterns and Natural History of Insulin Secretion in Islet Cell Transplant Recipients and Controls

This grant is to study patients that have received a kidney transplant AND an Islet Cell transplant and to discover how the transplant is functioning. We will seek to have several patients who have had a kidney transplant but do NOT have either type of diabetes. These patients will serve as the "control group" since they will also be on immunosuppressive medications but are not affected by abnormal blood sugars. This will allow investigators to develop an understanding of how these immunosuppressive medications affect glucose metabolism (blood sugar levels) and insulin utilization (how the body uses insulin).

If Islet Cell transplants are to become a reasonable treatment alternative for patients with type 1 diabetes, there must be knowledge about how the islet cells function after transplant {islet cells are responsible for making the insulin the body needs in order to control blood sugar). This knowledge would allow for improvements in the islet cell transplant procedure itself, as well as possible alterations of the immunosuppressive medications (drugs that prevent rejection) that are prescribed. There are two basic kinds of diabetes, type 1 (formally known as Insulin Dependent or Juvenile diabetes) and type 2 (formally known as Adult-Onset or Non-insulin dependent) diabetes. The patients in this study will be affected by type 1 diabetes. After the transplant, it is hoped they will no longer need insulin injections. It is possible patients may need to take pioglitazone and/or metformin, however, this will be prescribed in Project 1, if needed.

The medications used for this study include: C-peptide. This is a synthetic product (not from human or animal sources) that is man-made and identical to the C-peptide made by the body. C-peptide is made at the same time as insulin, one molecule of insulin equals one molecule C-peptide. By giving C-peptide that is synthetic, researchers can measure how the C-peptide breaks down in the body, which could then be related to how insulin breaks down in the body. Somatostatin will also be used during the same test as the C-peptide. While receiving Somatostatin, the production of insulin by the patient will be stopped. This medication will only be given for 4 hours and the blood sugar will be monitored during the entire procedure. Insulin \& Glucose will also be given by IV during certain tests to regulate the blood sugar. Blood sugars will be maintained within a certain level and this will be achieved through the administration of insulin and/or glucose. The patient's blood sugar will be monitored at frequent intervals throughout the various procedures.

Eligibility Criteria:
Type 1 diabetics that have received a kidney transplant as well as (under Project 1) Islet Cell Transplant. A control group of 8 kidney transplant recipients who do not have diabetes will also be sought. Age range for both groups is expected to fall in the 25-50 year/old range based upon statistical data, although those between the ages of 18 and 65 may also qualify.
Ocular Coil Drug Delivery Comfort Trial

The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.

This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years old
* Informed and having given informed consent
* Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

* Subjects with a history of eye disease that can make them vulnerable for irritation by the coil.
* Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study).
* Subjects using eye drops (during the study).
* Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
* Subjects who do not speak and/or write Dutch properly.
* Subjects with a history of serious adverse reaction or hypersensitivity to components of the ocular coil. or to ophthalmic anaesthetics
* Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later.

The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 90 years
2. Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:

   1. Segmental ileocolic resection with or without diversion
   2. Segmental colon resection with or without diversion
   3. Segmental coloproctectomy with or without diversion
   4. Low anterior resection with or without diversion
   5. Abdominoperineal resection
   6. Total abdominal colectomy with or without diversion
   7. Proctocolectomy with or without end ileostomy or diversion
   8. Closure of end colostomy (Hartmann's reversal)

Exclusion Criteria:

1. Allergies to any of the device components (i.e., adhesive)
2. Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
3. Patients undergoing:

   1. Small bowel resection without colonic resection
   2. Transanal proctectomy without transabdominal approach
   3. Perineal proctosigmoidectomy
   4. Closure of loop colostomy or ileostomy
4. Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

The object of the study is to investigate whether all included patients receive treatment that is effective against all bacteria that are defined as sensitive to meropenem with the current treatment regimen. Will the investigators findings motivate routine monitoring of plasma concentrations in children receiving meropenem? Up to 50 patients will be included in the study, and all participants are children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged from 3 months to 18 years that receive treatment with meropenem. Inclusion is independent of how long the patient has been receiving treatment. Children receiving other treatment (except hemodialysis)/other medications can be included.

Exclusion Criteria:

* Children less than three months of age. Patients receiving hemodialysis. Lack of consent.
Epidural Versus Wound Infusion Plus Morphine Bolus in Open Abdominal Aortic Aneurysm Repair

The aim of the study is to determine wether continuous wound infusion with local anaesthetic plus a single dose intravenous morphine is non-inferior to postoperative analgesia provided with continuous thoracic epidural infusion of local anaesthetic plus opiate, in patients undergoing open abdominal aortic aneurism repair.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective open aortic aneurism repair

Exclusion Criteria:

* Patient refusal
* Platelet count \< 80\*10\^3/mcL
* International Normalised Ratio \> 1.5
* Other contraindications to the placement of epidural catheter, including ongoing anti platelet or anticoagulant treatment not suspended according to national guidelines
Transcranial Alternating Current Stimulation on Patients with Delirium and Critical Illness (DeliTACS)

The goal of this clinical trial is to learn if transcranial alternating current stimulation can shorten the duration of delirium in intensive care setting. The main question it aims to answer:

* Is it possible to shorten the duration of delirium with transcranial alternating current stimulation?

Researchers will compare experimental treatment to sham.

Participants will receive experimental or sham treatment on maximum of two days depending on their delirium status. Duration of delirium is recorded and reported as "days alive and free of delirium".

Delirium is an acute-onset brain dysfunction related to extensive surgery or critical illness that leads to altered mental status and cognitive deficits. Delirium is associated with an increased length of stay in the ICU, cost of care, excessive mortality, and long-term cognitive and functional impairment. Although numerous prophylactic methods have been proposed, currently, no pharmacological or non-pharmacological methods are clinically effective. Patients with delirium have altered electroencephalography (EEG) findings among which most important are general slowing of EEG frequencies and dysconnectivity. Faster EEG frequencies, especially alpha-, beta-, and gamma-bands, are correlated with higher cognitive functions, such as memory and orientation. Transcranial alternating current stimulation (TACS) is a novel, noninvasive brain stimulation technology that cab modulate EEG frequencies by entraining of endogenous brain oscillations in response to exogenous stimuli. TACS has been shown to improve episodic memory, orientation, and cholinergic dysfunction in patients with Alzheimer's disease. TACS also increases alpha and gamma frequencies in EEG, and an increase in these frequencies is associated with the improvement of clinical symptoms. TACS has been shown to target key components of delirium pathophysiology, such as slowing of EEG frequencies and cholinergic dysfunction. Thus, we hypothesized that TACS could shorten the duration of delirium and decrease cognitive decline. We aim to test this hypothesis in a double-blind randomized trial and assess the effect of TACS on duration of delirium, EEG, biomarkers and long-term cognition.

Eligibility Criteria:
Inclusion Criteria:

* Delirium in intensive care and duration of delirium for more than 24 hours. Delirium is defined as 4 or more points on ICDSC and -1 or more points on RASS.

Exclusion Criteria:

* Under 18 years of age, pregnancy, delirium tremens, epilepsy or history of seizures any time before first trial intervention, active psychotic disease, infection of central nervous system, acute intoxication, traumatic brain injury, stroke, intracranial bleeding and implanted electronic devices.
Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment

The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat psoriasis has been proven effective in our previous study. This study aims to evaluate the efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin) in treatment of various local skin signs and thickness of psoriasis plaque.

The use of indigo naturalis ointment to treat psoriasis has been proven effective in our previous clinical studies which demonstrated the efficacy and safety of topical indigo naturalis ointment, showing its ability to provide significant improvement of psoriatic skin lesions.

We developed a new formulation in which indigo naturalis powder is refined and reduces the blue discoloration of skin and clothes, making the treatment more user-friendly. We had observed an equivalent efficacy of the refined form of indigo naturalis (INEO) ointment on treating psoriasis as the crude form. However, it is necessary to determine an appropriate dosage of the refined form regarding its efficacy and safety.

This is a double-blind, 4-arm parallel study. The aim of this study is

1. To determine an appropriate dosage of indirubin in INEO ointment, regarding its efficacy and safety.
2. To evaluate the efficacy of INEO ointment in different local skin signs of plaque lesions.
3. To evaluate the efficacy of INEO in different traditional Chinese medicine clinical syndromes of psoriasis vulgaris.
4. To investigate the effects of INEO ointment on the immune system.
5. To evaluate the effects of INEO ointment in improving quality of life after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 - 65 years, men or women.
* Diagnosed as mild to moderate plaque-type psoriasis by the dermatologist, with psoriasis for a minimum of 1 year.
* Plaque psoriasis involving \<20% of BSA and with PASI \<20.
* Female patients of child-bearing age with negative pregnancy test at screening.
* Female patients of childbearing age who have agreed to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
* Willingness to comply with study protocol.
* With signed informed consent form.

Exclusion Criteria:

* With history of topically or systematically hypersensitive to indigo naturalis or its excipient in ointment.
* With history of sensitivity to Chinese herb.
* Received systematic treatment for psoriasis within 4 weeks.
* Received topical treatment for psoriasis within 2 weeks.
* With abnormal liver or renal function, clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome,psychiatric disease, cancer or AIDS.
* Patients with pustular or erythrodermic psoriasis.
The Effect of Training Given to Nurses Caring for Dying Cancer Patients and Their Families on Care and Difficulties

Nursing is a profession that is human and is based on nursing care. Humans are social creatures that need care from the moment they are born.Today's scientific developments and changing technology have affected the health system.Many dying patients want to be hospitalized in order to receive better care and treatment. Depending on this situation, the frequency of nurses giving care to dying patients and their families has increased in hospitals. In order to increase the quality of the care given to the dying patient and his family and to reduce the difficulties experienced while giving this care, the nurse who provides the care should have sufficient knowledge and skills about the care of the dying patient and his family.

This research will be conducted as a randomized controlled experimental study in order to determine the effect of education on the nursing care given and the difficulties experienced by the nurses who care for the dying cancer patients and their families.

The research was carried out to determine the effect of the training given to the nurses who care for the dying cancer patients and their families, on the nursing care and the difficulties experienced.

H1: There is a significant difference between the "Nursing Care Scale for Dying Patients and Their Families" pre- and post-test scores of the intervention and control groups.

H2: There is a significant difference between the pre-test and post-test scores of the "Nurse Difficulty Scale for Dying Patients and Their Families" of the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer
* Working in a clinic where adult cancer patients are hospitalized for at least 1 year

Exclusion Criteria:

* On leave
* Not volunteering
A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months.

Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study.

During the study, participants will visit their study clinic 6 times.

The vaccine being tested in this study is called TDV (Live, Attenuated). TDV is being tested to prevent dengue. This study will assess the safety and immunogenicity of TDV in healthy participants.

The study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TDV or placebo- which will remain undisclosed to the participant, and investigator during the study:

* Cohort 1, ≥18 to ≤60 Age Group: TDV
* Cohort 1, ≥18 to ≤60 Age Group: Placebo
* Cohort 2, ≥4 to \<18 Age Group: TDV
* Cohort 2, ≥4 to \<18 Age Group: Placebo

This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.

Eligibility Criteria:
Key Inclusion Criteria:

1. Participants who can comply with trial procedures and are available for the duration of follow-up.

Key Exclusion Criteria:

At screening and at vaccination:

1. A body mass index (BMI) ≥35 kg/m\^2.
2. Intent to participate in another clinical trial at any time during the conduct of this trial.
3. Plans to receive any of the following:

   1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
   2. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
   3. A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation.
5. Receipt of previous vaccination against dengue virus.
6. Previous participation in any clinical trial of a dengue candidate vaccine.

At Vaccination:

1. Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment.
2. Participants medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration.

NOTE: Other protocol defined Inclusion/exclusion criteria may apply.