cyrilzakka/clinical-trials huggingface dataset:
Affective Learning in Disabled Health Training

This study was conducted to determine the effect of the learning method based on transformative learning theory to improve sensitivity towards the disabled on the empathic tendency, attitude and alexithymia levels of nursing students.

This randomized, controlled and experimental study was conducted between October and December 2019. The sample of the study consisted of 70 2nd grade nursing students (34 people in the experimental group and 36 in the control group). The learning method based on transformative learning theory was applied to the experimental group. The data were collected using a demographic information form, the Empathic Tendency Scale, Attitudes Towards Disabled Person Scale, and Toronto Alexithymia Scale. The Mann-Whitney U Test, Wilcoxon Signed Ranks Test, Paired Sample Test, and Pearson's Chi-Squared Test were used to determine the differences between the groups.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years old or above,
* to study in the second year,
* taking the theoretical course of Disabled Health

Exclusion Criteria:

* having attended any training for disabled people before
* to have any disabled person in the family members with whom they live.
Evaluation of the Effect of Pramlintide on Satiety and Food Intake

This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.


Eligibility Criteria:
For Healthy Volunteers:

•BMI \>=20 to \<=25kg/m2 or \>=30 to \<=40 kg/m2

For Subjects with Type 1 or Type 2 Diabetes:

* Treated with insulin for at least 6 months prior to screening
* HbA1c value between 6.5-10% inclusive
* BMI between 20-40kg/m2
Glycemic Response After Palaeolithic-type Meals

The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as compared to a meal constructed along the lines of the WHO dietary recommendations.

The effects of this set of meals will be assessed with respect to blood

* blood glucose
* plasma insulin
* satiety scores
* plasma gut hormones It is hypothesised that lower post prandial blood glucose concentration, a lower insulin response and increased satiety will be seen after the Palaeolithic meals compared with a reference meal

Eligibility Criteria:
Inclusion Criteria:

* male
* ≥ 18 and ≤ 60 years old
* Body mass index (BMI) ≥ 18 and ≤ 27.0 kg/m2
* Apparently healthy
* Not smoking
* A fasting blood glucose value within the normal reference value

Exclusion Criteria:

- No prescribed medication
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers

The study will evaluate the treatment effect of MDI-1228-mesylate Gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). In addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.

The study is targeted to enroll approximately sixty subjects with diabetic foot ulcers. All subjects will be randomized at baseline visits at a 2:1 ratio to either receive the study treatment plus standard of care or standard of care alone.

All subjects who meet inclusion/exclusion criteria will have all ulcers treated; however, only one ulcer, the largest, will be selected as the target ulcer.

Before performing any study procedures, all potential subjects will sign an informed consent form (ICF).

The total study duration is anticipated to be up to 18 weeks, including:

* Up to a 14-day screening period
* Up to 12 weeks study treatment
* Up to 4 weeks of follow-up
* End-of-treatment visit will be performed on the last day of treatment (D84)
* End-of-Study visit will be performed at the follow-up visit (D112)

Wound photography should be dedicated to one study site personnel to control variance.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures;
2. Male or female 18-75 years;
3. Meet diagnostic criteria for a diabetic ulcer with the presence of at least one target ulcer that meets the characteristics:

   * Located on dorsal or plantar surface of foot or below the knee.
   * Wagner grade 2, ulcerated lesion at or below the knee, without systemic infection.
   * The target ulcer should be the largest, and all each individual ulcers size should be less than 25cm2. All ulcers will be treated the same as the target ulcer.
   * Target ulcers persisted for at least 12 weeks prior to enrollment and have been on standard of care for at least 4 weeks prior to enrollment.
   * There is a minimum 3cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post-debridement).

Exclusion Criteria:

1. Allergy to the main components or excipients of MDI-1228_mesylate gel, allergy to JAK inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution.
2. Skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc.
3. The target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment.
4. Those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.
A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients

This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients

In this retrospective study, the investigators will collect and analyze data from reviewing medical history files of larger and long-term follow-up cohorts with Wilson's disease in Taiwan to assess the efficacy and safety of Trientine in Taiwanese Wilson's Disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Wilson's disease.
* Male or female patients, aged 3 years to 75 years

Exclusion Criteria:

* Patients with comorbidity which is not related to Wilson's disease.
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants

The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.


Eligibility Criteria:
Inclusion Criteria:

* Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
* Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.

Exclusion Criteria:

* Patient is less than 18 years of age
* Patient is not being treated in the U.S.
Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible.

This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with severe symptomatic aortic stenosis
* Accepted for transfemoral TAVI by a Heart Team decision
* Evaluation of platelet reactivity assessed by VerifyNow® assay prior TAVI

Exclusion Criteria:

* Contraindication to TAVI
* TAVI performed by a different access route than transfemoral
* Ned for oral anticoagulation therapy
* History of intracranial hemorrhage
* Ischemic stroke the 14 days before TAVI
* Active pathological bleeding or diathesis
* Moderate to severe hepatic impairment
* Use of strong CYP34A inhibitors or inducers
* Contraindications to DAPT for 3 months
* Contraindication to clopidogrel or ticagrelor
* Platelet count \<50,000
* Pregnancy or breastfeeding
Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

To observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis.

The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was used to image the superficial and deep retinal vascular plexuses before ICL implantation surgery and at 3 months follow-up. OCTA images were corrected for magnification, skeletonized, separated the large vessels and partitioned. Retinal microvascular density was measured by using fractal dimension analysis. The aim of this study was to uncover potential retinal vascular network alterations induced by ICL implantation surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old;
* Binocular myopia, with a refraction of greater than -3 diopters (D);
* anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) \> 2.8 mm;
* corneal endothelial cell count (cECC) ≥ 2000 cells/mm2;
* stable refraction at least 1 year before surgery;
* unsatisfactory vision with contact lenses or spectacles.

Exclusion Criteria:

* history of intraocular surgery
* other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.)
* other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).
The Effect of Web-based Education Given to Parents on Children's Internet Gaming Disorder

Internet Gaming Disorder (IOB) is an important problem that is increasingly prevalent all over the world and can be prevented before it develops. This research is a single-blind, randomized controlled experimental study to evaluate the effect of Internet-based education given to parents on children's Internet gaming disorder. 96 children and their parents studying in the central districts of a province and at risk for the development of IOBB were divided into intervention (48) and control groups (48) according to the randomization list. The "I know digital games" training consisting of three modules and 10 videos was given to the intervention group via the website prepared by the researchers, and no intervention was made to the control group. The research data were collected at three different times using the "Internet Gaming Disorder Scale Short Form" (İOOBÖ9-SF) and the forms developed by the researchers. In the analysis of data; descriptive statistics, Chi-square, Mann Whitney U test, and repeated measures ANOVA were used. Before the analysis, eight missing data in the control group were estimated with regression estimation models from intent to treat protocols. Statistical significance level p ≤0.05 was taken in all analyzes. Parents and children in the intervention and control groups were similar in terms of sociodemographic characteristics and playing characteristics (p\>0.05). It would be beneficial to involve parents in the interventions that nurses will make for primary school children in order to prevent IOB.


Eligibility Criteria:
Inclusion Criteria:

* For kids

  * To have a score between 25-36 from IOOBÖ9-SF \[69\]
  * Willingness to participate in the study,
  * No communication barrier,
  * Being educated in high socioeconomic level schools,
  * Not having a psychiatric diagnosis and/or not using psychiatric medication
* for parents

  * Your child's score between 25-36 on IOOBÖ9-SF,
  * Willingness to participate in the study,
  * No communication barrier,
  * Having at least one tablet/smartphone/computer and being able to use these devices,
  * Having mobile or home internet,
  * Being literate,
  * The parent who will participate in the study does not have a psychiatric diagnosis and/or uses psychiatric medication.

Exclusion Criteria:

* For kids

  * Having received 25 points below or 36 points above IOOBÖ9-SF
  * Not being willing to participate in the study,
  * Having a communication barrier (not being able to speak or understand Turkish...),
  * Having a psychiatric diagnosis and/or using psychiatric medication
* for parents

  * Your child's score below 25 or above 36 on OOOBÖ9-SF
  * Not being willing to participate in the study,
  * Having a communication barrier (not being able to speak or understand Turkish...)
  * Not having at least one tablet/smartphone/computer,
  * Not having mobile or home internet,
  * Being illiterate,
  * The parent who will participate in the study does not have a psychiatric diagnosis and/or uses psychiatric medication.
Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy

The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy.

* Development of a home-based remote upper limb function evaluation program using heterogeneous (multimodal) sensors.
* Development of a home-based remote upper limb function improvement treatment program using heterogeneous sensors.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 12 years
* MACS level 1-4
* Diagnosed with CP due to central nervous system lesions

Exclusion Criteria:

* Individuals with a Manual Ability Classification System (MACS) level V, indicating an inability to use both hands in daily life activities.
* Individuals who fall within levels 0 to 4 of the House Functional Classification System.
* Individuals with severe intellectual disabilities, characterized by difficulties in understanding or following instructions.
* Individuals with vision impairment that could affect participation in the therapy.
* Individuals who have received a botulinum toxin injection in the upper extremity within the past 6 months.
Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants

The correct timing and technique of neural tube defect (NTD) repairs significantly decreases the morbidity and mortality of NTD cases. However, infections related to the surgery are still common. We investigated the effects of topical rifampicin (RIF) combined with routine prophylaxis in newborns with open NTD.

The study will be conducted in the Yuzuncu Yil University neonatal intensive care unit, Van, Turkey. The data of 60 neonates diagnosed with open NTD, who will be underwent surgical intervention between August 2016 and December 2017, will be prospectively evaluated. These cases will be randomised.These neonates are going to divide into two groups: the experimental group and the control group. The experimental group will be consisted of 30 newborns diagnosed with open NTDs, administered topical RIF (10 mg/kg/day, 24 h infusion) and cefotaxime (50 mg/kg/day, two doses, iv), and the control group will be consisted of 30 newborns diagnosed with open NTDs, administered cefotaxime (50 mg/kg/day, two doses).

In this study, researchers will be investigated whether prophylactic topical RIF applied on a pre-operative mesh in newborns with open NTD reduce the rate of SSIs and meningitis/ VP shunt infections after surgery. For deep incisional primary SSIs will be evaluated according to the diagnostic criteria of the United States (U.S.) Centers for Disease Control and Prevention (CDC) (1). The diagnosis of VP shunt infections will be made after extensive clinical and laboratory evaluations. the diagnosis of to make shunt infections, criteria of the Hydrocephalus Clinical Research Network (HCRN) will be taken into consideration (2).

Topical RIF Application Procedure The NTD site will be covered with a sterile gauze dressing in the first hours of life after birth in all babies with open NTDs. Then, 10 mg/kg/day RIF will be added to 24 ml of saline (0,9% NaCl), and this will be applied to the mesh as an infusion at a 1cc/h speed . Every day, the same dose of RIF will be delivered to the mesh,changed daily, as a 24-hour infusion until the patient could be operated. After the patient is operated, the RIF infusion delivered to the mesh will be stopped. The cefotaxime treatment will be continued until 72 hours post-op (3).

Eligibility Criteria:
Inclusion Criteria:

* Newborns who have open NTDs

Exclusion Criteria:

* Healthy newborns
Increase Understanding and Safety of Treatment

Purpose: The purpose of this study is to use a randomized controlled trial to explore whether the patients with cancers on clinical trials can use the Health Insurance APP-My Health Bank to increase understanding and safety of treatment. It is of hope that the results of this study can help confirm whether cancer patients participate in clinical trials, learn to use the " Health Insurance APP-My Health Bank ", can increase the safety of treatment, including the understanding of the disease , the understanding of the lab data, and the communication about contraindications and concurrent use of medications. The results of this research will help clinical healthcare professionals promote the use of My Health Bank, and improve the safety of clinical trials, as well as to increase the communications between patients, doctors and nurses.

Methods: In this study, cancer patients (hematology-oncology patients are the priority invitations) were invited to participate in clinical trials in the outpatient and inpatient units. After explaining that they agreed to participate in the study, they were randomlyassigned to the experimental group and the control group. Intervention includes teach the subjects one-on-one to use the "My Health Bank" for 30 minutes (such as download, register, test, find information, etc.), and provide pre-recorded 1-minute instructional videos for viewing when needed at home. The intervention group also accepts to follow the use of My Health Bank app at home every two weeks for a period of two months. Both groups will receive pre- and post-evaluations, including knowledge of the disease, understanding of lab data, and knowledge of medication safety (prohibited medicines and concomitant medications). Post-intervention, the intervention group will also be evaluated on the "Satisfaction and Quality of Technology Use" of My Health Bank APP. Data analysis is expected to adopt Intention-to-treat analysis (ITT) method to compare the differences before and after intervention between the two groups to verify teach patients the clinical feasibility of using a My Health Bank and the effect of assisting patient care.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 20, the subject voluntarily accepts this study and signs the consent form
* Participants in clinical trials of hematological tumor-related diseases (have been or are participating in it)
* Need to be literate and can communicate in Chinese and Taiwanese
* Have a mobile phone or electronic device to download the my health bank APP and be willing to cooperate with it for at least two months of continuous use

Exclusion Criteria:

* I have downloaded the "my health bank APP" and use well
* Cognitive impairment diseases (e.g. dementia)
* The clinical trial protocol that originally participated in that it is not allowed to articipate in other interventional studies.
Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery

The investigators propose to compare two different treatments, continuous positive airway pressure (CPAP) versus breathing of atmospheric pressure, in subjects with obstructive sleep apnea (OSA)recovering from weight loss surgery in the post anesthesia care unit (PACU). WE hypothesize that subjects with OSA will have a higher Apnea-Hypopnea Index (AHI) with desaturation and the investigators expect that post-operative CPAP treatment in the PACU will significantly improve the AHI and therefore improve patient safety in the PACU. The investigators also hypothesize that subjects with OSA have a greater decrease in oxygen saturation in response to opioid administration by patient-controlled opioid analgesia (PCA).

Patients with morbid obesity have an approximately 60-80 percent incidence of OSA depending on the criteria used for making diagnosis, and they are suggested to be at increased risk to develop serious perioperative complications, especially during the postoperative period. Weight loss might be considered as an appropriate treatment of OSA but in turn it has recently been reported that OSA is an independent risk factor for development of perioperative complications, importantly oxygen desaturation, in patients undergoing weight loss surgery. It seems logical to evaluate if these patients would benefit from post-operative CPAP treatment in the PACU. The results of this multidisciplinary study will have an impact on PACU treatment of patients with OSA and will further optimize patient care at MGH.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for weight loss surgery at Massachusetts General Hospital
* Male and female subjects
* age ≥ 18 years

Exclusion Criteria:

* CNS disease with impairment of cognitive function and/or muscle paresis such as stroke, or dementia
* age \< 18 years
* missing or insufficient PSG data to make diagnosis OSA
* impaired decision making capacity