cyrilzakka/clinical-trials huggingface dataset:
Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study

The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin).

This study is proposed as a prospective interventional cohort safety study for biweekly intermittent fasting.

In the effort to improve compliance of lifetime dietary change, the version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.

On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.

Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.

Eligibility Criteria:
\*\*Subjects must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and female Active Duty members and DoD beneficiaries ages 18-69
* Diagnosed with Type 2 Diabetes or pre-diabetic
* Prescribed/taking Metformin 500mg to 2000mg daily

Exclusion Criteria:

* History of recurrent hypoglycemic events on present medication regimen
* Drugs/medication with known increase in hypoglycemic events \[Include basal insulin, rapid acting insulin, sulfonylureas, etc.). Metformin is not known to cause hypoglycemia.
* Pregnant
* Medication-induced or secondary diabetes
* Known abnormal hematocrit
Promoting Inclusive Educational Environments for Children with Autism and Other Social-communication Challenges: Preschool Class and Primary School

This study evaluates the effect of using the Autism Program Environment Rating Scale (APERS) as the foundation for providing feedback, in-service training and coaching to teachers, to improve program quality for autistic (ASD) students and students with related social-communication challenges (SCC) in Swedish primary school classrooms. In the current study half of the participating classrooms will receive the APERS-based model for program quality improvement, while the other half will receive services as usual.

It is hypothesized that the APERS-based model will improve primary school program quality for children with ASD and SCC, as well as improve functioning for students with ASD/SCC and self-perceived self-efficacy among participating teachers, compared to the study's comparison group.


Eligibility Criteria:
Inclusion Criteria:

* autism diagnosis
* socio-communicative challenges identified by parents and/or school staff
* attending a primary school classroom (i.e., from pre-school class to third grade)
Efficacy and Safety of Wuling San on Breast Cancer-related Lymphedema

The purpose of this study is to assess the efficacy and safety of Wuling San, a traditional Chinese medicine, in reducing arm volume excess in women with stage I-II breast cancer related unilateral lymphedema.

The investigators will aim to enroll 200 female adult patients (aged between 20 and 40 years) of all ethnicities/races, who have been referred to the Fourth Affiliated Hospital of Guangxi Medical University for breast cancer related unilateral lymphedema. The investigators will be using a standardized data collection form in this study, where standard of care will be practiced and the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent.

Eligibility Criteria:
Inclusion Criteria:

* Women completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy)
* age 20-40 with unilateral BCRL, stage I or II, BMI of 18-25
* Volume difference ≥300 mL between the normal and lymphedematous upper extremity based on perometry evaluation
* No evidence of breast cancer recurrence
* At least 6 months postoperative from axillary lymph node dissection

Exclusion Criteria:

* Bilateral lymphedema or stage III lymphedema
* History of bilateral axillary lymph node dissection
* Recent history of cellulitis in the affected extremity (within last 3 months)
* Recurrent breast cancer or other malignancy
* Current (within last month) use of chemotherapy for breast or other malignancy
* Current (within last 3 months) use of radiation for breast or other malignancy
* Recent (within last month) or current intensive MLD and/or short stretch bandage use
* Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
* Pregnant or nursing (lactating) women
* Patients that take drugs like diosmin at the time of enrollment, or within 30 days.
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Unable to comply with the protocol, measurement and follow-up schedule.
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome

Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the decade that followed, it was found RPNI surgery not only provided amputees with neuroma (a growth made up nerve tissue) pain relief but could help prevent neuroma from developing as well.

This single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory nerves with a small piece of the patient's pectoralis muscle, performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent and/or reduce the risk for long-term nerve pain after breast cancer surgery (also called neuroma-related post-breast surgery pain syndrome (PBSPS)) versus the standard surgery alone (Control group). Symptoms of PBSPS include discomfort, numbness, tingling, and shooting pain in the chest and breast area. It is relatively common and may have many causes.

About 200 adult females (18-65 years old) who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study. Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Study participants will complete self-reported surveys (pre-surgery and at Months 1, 3, 6, and 12 post-surgery) designed to measure pain levels, quality of life, and function before and after surgery. Study participation will last approximately 12 months. Subjects will remain blinded to their assigned study arm until their study participation has concluded.


Eligibility Criteria:
Inclusion Criteria:

1. Adult female 18 to 65 years of age.
2. Undergoing breast mastectomy with immediate reconstruction.
3. Able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. History of chronic pain syndrome unrelated to breast surgery.
2. Unwillingness or inability to comply with the study's follow-up requirements.
3. Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.
4. Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.
5. Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI.
Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

This study aimed to record diaphragm electrical activity (Edi) during the preextubation (weaning) and postextubation periods and to analyze whether Edi monitoring could predict extubation success.

This prospective observational study included 25 pediatric patients who were intubated due to respiratory failure in the pediatric intensive care unit of the tertiary university-affiliated Marmara University Hospital between August 2014 and July 2015. To conduct the study, we obtained informed consent from the patient's parents and ethical approval from the Marmara University Faculty of Medicine Scientific Research Ethics Committee Board on 06.09.2014. Pediatric patients included which had indication for the insertion of a nasogastric tube (Edi catheter), independent of the study. So Edi catheter had been used instead of nasogastric tube.

When the patients were ready for clinical weaning in accordance with the clinician, the Edi catheter was appropriately inserted into the patients. Then, a spontaneous breathing trial (SBT) was performed and diaphragm activity monitoring was recorded during this process. The patients who met the inclusion criteria switched in a spontaneous breath trial with pressure support ventilation (PSV) or NAVA (Neurally Adjusted Ventilatory Assist) on a Maquet (Solna, Sweden) Servo-i mechanical ventilator for both ventilation modes The patients' demographic and clinical characteristics, mortality scoring, vital parameters (HR, TA, SpO2, RR) and ventilatory parameters (Edi peak, Edi min, FiO2, expiratory Vt), as well as follow-up period were recorded. Arterial/capillary blood gases were taken within the last four hours before extubation and within the first, sixth, 12th, 18th and 24th hours after extubation. If arterial blood gas monitoring was initiated in the patient, arterial monitoring was continued. If capillary blood gas monitoring was initiated, capillary monitoring was continued. Edi data were recorded for at least 24 hours before and after extubation. Edi values were obtained retrospectively from the trend diagram, which provides 24-hour continuous records on the ventilator screen.

Eligibility Criteria:
Inclusion Criteria:

* • Aged between one month and 18 years old

  * Intubated for more than 48 hours due to respiratory failure
  * Indication for the insertion of a nasogastric tube (Edi catheter), independent of the study
  * Ready for weaning:

    * Normal vital signs for age (fever, heart rate (HR), respiratory rate (RR), tension arterial (TA)
    * No catecholamines or sedation drugs
    * pH of 7.35 to 7.45
    * Positive end expiratory pressure (PEEP) ≤6 mmHg
    * Fractionated oxygen (FiO2) ≤0.5
    * Oxygen saturation (SpO2) ≥92%
    * Vt≥ 5 ml/kg

Exclusion Criteria:

* • Contraindication for the insertion of the nasogastric tube (Edi catheter)

  * Patients treated with muscle relaxants
  * Absence of consent given by the patient's family
  * Cases whose Edi levels could not be taken from ventilator's trend diagram due to missing values.
Use of Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency

This study will seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20).

The treatment of gingival recessions associated with interproximal bone and gingival tissue deficiency, and also the absence of interdental papilla, are major challenges within the periodontics due to lacking predictability. However, an intervention in these cases is extremely important, since the presence of these defects is associated with aesthetic, phonetic, hypersensitivity and may be associated with other dental damages. This study will seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20). A split-mouth design will be used with both procedures performed at the same surgical time.

Eligibility Criteria:
Inclusion Criteria:

* Presenting at least two single-rooted teeth with Miller's Class III and IV recessions with Norland \& Tarnow class I, II or III papilla deficiency

Exclusion Criteria:

* History of periodontal surgery at the area on the last 12 months
* Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
* Pregnant
* Smokers
* Diabetics
* History of head and neck radiotherapy
* Teeth without adjacent mesial and distal contact
* Teeth with mobility
* Malpositioned teeth
* Teeth with endodontic treatment
* Teeth without a visible cementoenamel junction
Post Approval Study of the TS Feature With the 530G Pump System Supplemented With Commercial Patient Data

The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.

Multi-center trial is initiated to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump (Medtronic MiniMed® 530G insulin pump) in patients 16 and older with insulin requiring diabetes over a period of one year.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is age 16 or older at time of screening
2. Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
3. Subject is currently on pump therapy.
4. Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
5. Subject is willing to complete all study related activities
6. Subject is willing to upload data every 21 days from the study pump
7. Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access.
8. Subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.

Exclusion Criteria:

1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks.
2. Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study
3. Subject is being treated for hyperthyroidism at time of screening
4. Subject has an abnormality (\>1.8mg/dL) in creatinine at time of screening visit
5. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.
6. Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
7. Subject is currently abusing illicit drugs
8. Subject is currently abusing prescription drugs
9. Subject is currently abusing alcohol
10. Subject has sickle cell disease or hemoglobinopathy
11. Subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation
12. Subject diagnosed with current eating disorder such as anorexia or bulimia
13. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
14. Subject is on dialysis
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism.

Patients participating in Part One will receive a single open-label dose of memantine. Blood samples for pharmacokinetic analysis will be collected.

Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study evaluating change in all core domains (social interactions, communication, and restricted interests and repetitive behaviors) of autism.

In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in these studies were as follows:

* Group A: ≥ 60 kg; max 15 mg/day
* Group B: 40-59 kg; max 9 mg/day
* Group C: 20-39 kg; max 6 mg/day
* Group D: \< 20 kg; max 3 mg/day

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 6 to 12 years
* Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 \& 3).
* A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
* Patients over age 12, only if they completed Study MEM-PK-21

Exclusion Criteria:

* Medical history of active epilepsy/seizure disorder except simple febrile seizures
* Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study
Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases

This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.

The incidence of Acute Epidural Hematoma (AEDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%.

Most people with EDH are generally expected to have a good clinical outcome with the prompt and correct treatment. However, AEDH still represents a potentially life-threatening condition when a local mass effect exists due to rapidly elevated intracranial pressure (ICP) resulted from the rapid build-up of blood. Brain hernia and cerebral infarction might occur and lead to a terrible clinical outcome. In addition, there is a set of patients who experience clinical deterioration after an initial hematoma-evacuation craniotomy because of secondary brain injuries, including massive cerebral infarction (MCI), additional decompressive craniectomy is recommended as soon as possible.

Although DC can reduce the morbidity and mortality in critically ill patients with a sTBI, the removal of the bone flap is not necessary for the majority of patients with AEDH, because of the relatively low incidence of MCI secondary to AEDH. Recommendations indicated an epidural hematoma greater than 30 ml should be surgically evacuated regardless of the patient's GCS score. Although craniotomy provides a complete evacuation to remove the clot of the hematoma, there are insufficient data to support a specific surgical treatment method. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. Therefore, there is a clinical rationale for investigating the current status of surgical treatments and prognosis for AEDH, thereby providing a reliable reference for the optimization of therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Clear medical history of traumatic brain injury;
2. within 12 hours after injury;
3. Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
4. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
5. With informed consent to surgery and trial participation.

Exclusion Criteria:

1. Previous intracranial surgery prior to trauma;
2. Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or an injury that was deemed to be unsurvivable;
3. CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
4. Patients who had injury of the oculomotor nerve;
5. Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI;
6. Pregnant female.
Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain

The investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. The experiment incorporates three tasks in which participants experience and rate 1) somatic pain, 2) vicarious pain, and 3) cognitive effort. In the somatic pain task, participants receive a brief thermal stimulus administered to a site on their arm; in the vicarious pain task, participants watch a short video clip of a patient with back/shoulder pain; in the cognitive effort task, participants perform a cognitively demanding "mental rotation" task that requires them to indicate whether two 3D objects are the same or different when rotated along the y-axis. Each trial follows a sequence that begins with a fixation, followed by a social influence cue, then an expectation rating, followed by a condition-specific stimulus, and then, an actual rating of the outcome experience.

There are four events of interest: 1) cue perception, 2) expectation rating, 3) stimulus experience, and 4) outcome rating.

First, participants are presented with a cue that depicts how other participants responded to the upcoming stimulus ("cue perception"). Although the participant is told these are real ratings, they are in fact, fabricated data points that vary in intensity (low, high). Then, based on the provided cues, participants are prompted to report their expectation of the upcoming stimulus intensity ("expectation rating") After providing an expectation rating, participants are presented with a condition-specific stimulus (somatic pain, vicarious pain, or cognitive effort) that also varies in three levels of low, medium, high stimulus intensity ("stimulus experience"). Once the stimulus presentation has concluded, participants are prompted to provide an actual rating of their experience ("outcome rating"). For the somatic pain condition, participants rate their expectations and actual experience of how painful the stimulus was; for the vicarious pain condition, they rate their expectations and actual perception of how much pain the patient was in; and for the cognitive condition, the participant provides expectation and actual ratings of task difficulty.


Eligibility Criteria:
Inclusion Criteria:

* Capable of performing experimental tasks (e.g., are able to read, can tolerate the maximum level of thermal pain stimuli).
* Fluent or native speakers of English

Exclusion Criteria:

* Contraindications to magnetic resonance scanning (e.g., metal in body, claustrophobia, pregnancy)
* Substance abuse within the last six months
* Current or recent history of pathological pain
* Current or recent history of neurological disorders
* Currently or recent history of chronic pain
* Left-handed only