cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial.
* Subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial.
* Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"
* Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy
* Subjects demonstrating drug efficacy:

  * Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)

Exclusion Criteria:

* Subjects presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:

  * Delirium, dementia, amnestic disorder, or other cognitive disorders
  * Schizophrenia or other psychotic disorder
  * Personality disorder
* Subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance
* Subjects who represent a significant risk of committing suicide
* Subjects known to have a complication of allergy to aripiprazole or other quinolinone-skeleton compounds
* Subjects with a complication of neuroleptic malignant syndrome
* Subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
* Subjects with a complication of paralytic ileus
* Subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy
* Subjects with a complication of diabetes
The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus

The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.

Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children up to 16 years old with type 1 diabetes

Exclusion Criteria:

* Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.
Continuous Glucose Monitoring for Colorectal Cancer

Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications.

The primary aim of our project is to assess the feasibility of the use of continuous glucose monitoring in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. However, glucose levels measured in patients before surgery are taken infrequently, and there remains controversy regarding optimal management. Usually, a blood glucose meter is used to measure non-fasted blood glucose concentrations, and a single-point measurement can easily misrepresent the actual glycemic control. Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control and is providing insights into glucose regulation in patients, demonstrating significant periods of clinically silent hypoglycemia and hyperglycemia.

The primary aim of our project is to assess the feasibility of the use of CGM in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* confirmed colorectal cancer qualified for surgery

Exclusion Criteria:

* patients who will be unable or will refuse to express informed concern
* pregnant women
* people undergoing dialysis treatment
Low-Intensity CBT for Gynaecological Cancer Survivors

There are 21,500 gynaecological cancers diagnosed in the UK each year. These are often diagnosed later than common cancers, which is predictive of low survival and high psychological distress. There are few studies published which accurately map the profile of distress and supportive care needs in gynaecological cancer patients, nor which test psychological interventions to support this group.

This study will use a non-randomised controlled trial design to explore the potential benefits of taking part in a psychological intervention designed in this group of women. The intervention is group-delivered and runs for eight weeks. It is delivered by psychologists, psychological wellbeing practitioners, and cancer nurse specialists. The investigators will use validated self-report questionnaires to assess how helpful this intervention is at reducing distress and improving quality of life in the participants. This will be done in comparison with a treatment-as-usual control group recruited from a second clinical site. This second group of participants will not receive the psychological intervention, but they will complete the same assessments, at the same time points. To ensure participants are well supported, data collection in control control group participants will be done by telephone interview rather than self-report questionnaires. Both groups of participants will undertake a three-month follow-up assessment to check the longer-term effectiveness of the psychological intervention.


Eligibility Criteria:
Inclusion Criteria:

* Must be over the age of 16.
* Must have received a gynecological cancer diagnosis.
* Must have completed first line treatment within four months of the study start date (not restricted to any specific modality of treatment).
* Must be able to speak English.
* Must be able to provide consent.

Exclusion Criteria:

* Any patients that are unlikely to survive for the full five-month duration of the study.
* Any patient who does not have sufficient English language ability to complete data collection.
* Any patients who are notable to provide consent will not be included as this group would be unlikely to be able to complete data collection even if adjustments to the consent procedure were made.
Coronal and Radicular Caries Prevalence and Related Risk Factor in Diabetic Patient

This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in this population. The study examines the relationship between glycemic control (e.g., HbA1c levels) and the severity of caries, as well as the impact of diabetes-related changes in oral health, such as gum recession and dry mouth, on the development of both coronal and radicular caries. The findings could inform preventive strategies and dental care guidelines tailored for diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient whose age between 30-65
2. Diabetic patients
3. Patient consulting in the outpatient clinic
4. Co-operative patient
5. Males \& Females
6. Egyptian

Exclusion Criteria:

1. Patients under or over this age group
2. Lack of compliance
3. Disabilities
4. Pregnant women
Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

The goal of this study is to evaluate a series of cases of penetrating cerebrovascular injury managed without upfront operation. Investigators focus on patient characteristics, injury details, treatment modalities, serial imaging studies, patient outcomes, and complications. Investigators will compare this patient population to patients managed with upfront operation for context.

Penetrating cerebrovascular injuries (PCVIs) are uncommon, with little data to guide management when emergent operative repair is not performed. Investigators hypothesized that PCVIs may be managed with antithrombotic therapy and directed use of endovascular interventions, but that PCVIs may require enhanced surveillance due to a risk of delayed complications. To perform this study, investigators will review patients with penetrating carotid and vertebral artery injuries managed at an urban Level I trauma center from 2016 to 2022. Patients will be included if they underwent initial nonoperative management (NOM). Patient characteristics, injury details, treatments, serial imaging, outcomes, and complications will be assessed in a retrospective manner using chart abstraction. Investigators will briefly compare these patients to those managed with upfront operations for context.

Eligibility Criteria:
Inclusion Criteria:

* Penetrating neck trauma
* Carotid or vertebral artery injury
Oral Iron Substitution for Orthopedic Surgery

The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of Patient Blood Management in preparation for orthopedic surgery.

Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic tolerance.

In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006. Since then patients for elective orthopedic surgery (knee an hip replacement) are screened for iron deficiency anaemia and if needed treated with the more effective intravenous iron.

Oral iron medications are not as efficient (low bioavailability, more side effects) as the intravenous iron infusion. Although there is risk of anaphylactoid reactions.

In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist tested on its effectivity for treatment of iron deficiency in the course of PBM.

It has a much more higher bioavailability without the typically side effects of the routinely used oral iron medications.

Within this study the investigators want to examine the feasibility of this iron substitution concept OLEOvital and its efficacy. Also the investigators want to get pilot data for a further randomized controlled trial.

The increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and monitored.

For comparison of the new oral substitution concept OLEOvital with the standard intravenous iron substitution an historic control group is going to be used.

Eligibility Criteria:
Inclusion Criteria:

* age over 55 years
* indication for patient blood management for elective orthopedic surgery
* listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin of patient blood management
* Haemoglobin male \< 12-13g/dl, female \<11-12g/dl
* written informed consent after written and verbal information

Exclusion Criteria:

* indication for treatment with erythropoietin
* pregnancy
* nursing period
* diarrhea or tendency to diarrhea
* fructose intolerance
* pre - menopause
* permanent or expected blood loss
* participation in other study
* expected compliance problems
* legal incapacity
Exploring the Effects of a Baduanjin Program on the Symptoms of Constipation in Patients With Schizophrenia Spectrum

Patients with schizophrenia spectrum have been suffering from constipation due to long-term use of psychotropic medications and changes in physical activity and eating habits caused by diseases.

Aim this study was to examine the effectiveness of Baduanjin program in improving the symptoms of intestinal peristalsis and constipation in patients with psychosis.

Method:A randomized controlled trial was conducted in tow psychiatric centers in northern Taiwan.The experimental group was provided with an 8- session Baduanjin program for 24 weeks (1 hour, thrice times per week), while the control group received routine care.

This study was conducted in two psychiatric center. Residents in one of psychiatric center were allowed to walk for 20 min after dinner every day, and each unit residents rare active. In this study, patients on the schizophrenia spectrum were invited to receive screening for constipation syndrome. A total of 275 patients agreed to undergo the screening. In total of 112 patients satisfied the inclusion criteria, and 58 patients consented to participate in the experiment.

Each participant was assigned one number from 1 to 112 by the first author. The second author enrolled participants. They were randomized to either Baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 3. Patients in the experimental group (EG) participated in the Baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 hour after dinner between 6 and 7 pm; the entire program continued for 24 weeks. The control group (CG) received routine care. The outcome indicators for this intervention program involved the risk factors for constipation, constipation symptoms, and Intestinal Peristalsis.

Eligibility Criteria:
Inclusion Criteria:

* Comply with the diagnosis of the spectrum.
* Have the willingness to participate in the study and could read, communicate and cooperate with the completion of the consent form and questionnaire.
* The age is 20 to 64 years old.
* No need for any assistance in walking, and the gait is stable.
* Appeared more than 2 times in the past month for more than 3 consecutive days without resolving or routine use of laxatives

Exclusion Criteria:

* Diagnosis is organic brain disease, alcohol and substance abuse.
* There have been problems with gastrointestinal bleeding or lesions.
* Have a history of extensive abdominal surgery or gastrointestinal surgery.
* There are medical considerations and medical expenses reduction activities.
Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods

Infants and children under two years are the group with the highest rates of iron deficiency anemia. Provision of sufficient dietary iron to this age group is a challenge, and in-home iron fortification of complementary foods using micronutrient powders can be an effective approach. However, WHO has recently cautioned against untargeted use of in-home micronutrient powders that contain the entire iron RDA for a child in a single dose in areas with high rates of infections from malaria and diarrheal disease. Therefore, in this study, we will investigate the effect on the infant gut microbiota of a low dose (ca. 25% of the RDA) of highly bioavailable iron, provided by a micronutrient powder added to a complementary food.

The study aim is to determine if in-home fortification using an iron-containing micronutrient powder in Kenyan infants will improve iron status and/or modify the composition and metabolic activity of the gut microbiota. Active surveillance will be done weekly to monitor the health of the infants.

Our study will be done in a subgroup (n=160) of a larger double-blind controlled feeding trial in which 330 infants will be randomized to receive a micronutrient powder containing either 2.5 mg iron or no iron for 1 year. In our substudy, the infants will be studied only over the first 6 months of the 1 year intervention. Blood samples, taken at baseline and after 6 months will be used to define the iron status and the anemia level of the infants. Stool samples (2 at baseline before intervention, 6 throughout the study and additional samples in case of diarrhea) will be obtained for analysis of the gut microbiota. In the entire study (n=330), we will measure changes in iron status over 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Mother at least ≥15 years of age, infants 5.5- 6.5 months
* Willingness to provide informed consent
* Apparent good health
* Long-term residence in study site and anticipating residing in the area for at least 3 years
* Speak a Mjikenda language or Kiswahili in the home
* Willingness to provide blood samples during clinic visits

Exclusion Criteria:

* Hemoglobin \<70 g/L for infants; these infants will be referred for treatment at the local health clinic/hospital.
* Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition or any other finding that in the opinion of the PI or co-researchers that would increase risk of participating in the study.
* Other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)

The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients.

The main questions this study aims to answer are:

* Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention?
* What is the usability, user experience and user acceptance of the aktivplan digital intervention?

Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation.

Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions.

Patients in the control group will receive the usual standard of care without the aktivplan digital intervention.

Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors
* Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection
* Agreement to attend the study follow-up visit
* Written informed consent to take part in the study

Exclusion Criteria:

* Existing use of a digital intervention for regular heart-healthy physical activity
* Medical contraindications for incremental cycle ergometry test
* Medical contraindications for regular heart-healthy physical activity and sports
* Medical contraindications for use of a smartphone
* Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions)
* Participation in another clinical study within the past 6 months
* Addiction or other medical conditions causing reduced decisional capacity
* Pregnant women in the third trimester
* Pregnant women in the first and second trimester with medical contraindication for physical activity and sports
* Breastfeeding women with medical contraindication for physical activity and sports
* Indication that patient is unlikely to follow study procedures (limited cooperation)
Equitable Access to COVID-19 Vaccines

This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations and address vaccine hesitancy to improve access by using a proactive organized population-based outreach leveraging health information technology with tailored navigation support to address mistrust and social barriers.

This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations through a proactive organized population-based outreach approach. It will leverage health information technology with tailored navigation support to address mistrust and social barriers. Study key objectives are to:

1. conduct a survey of patients to assess and track barriers, intent, and sources of information on COVID vaccine over time.
2. Determine whether a primary care physician (PCP) endorsement with or without interactive digital communication plus navigation is more effective in promoting uptake of COVID-19 vaccine than general messages from the clinic. Patients will be randomized to one of three arms:

   1. Arm 1: Message about vaccine availability delivered by SMS advising patients to make an appointment.
   2. Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP.
   3. Arm 3: Same as Arm 2 plus a interactive 2-way SMS options.

Eligibility Criteria:
Inclusion Criteria: 18 years and older, receiving care at Adelante Healthcare and not vaccinated or already scheduled for vaccination through the health center's appointment system Exclusion Criteria: Patient younger than 18 or who have been previously or are selected for vaccination during or prior to the week of study enrollment