cyrilzakka/clinical-trials huggingface dataset:
D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

This study seeks to examine the effects of D-cycloserine augmentation on cognitive remediation for patients diagnosed with schizophrenia. We will test the hypotheses that D-cycloserine will significantly improve cognitive performance, negative symptoms, and measures of functioning compared to placebo when combined with eight weeks of cognitive remediation. We expect that these effects will persist when assessed at six-month follow up.

D-cycloserine has been shown to enhance learning in animal models and, in a previous trial, once-weekly D-cycloserine improved negative symptoms in schizophrenia subjects. We set out to test whether DCS combined with cognitive remediation would improve learning of a practiced auditory discrimination task and whether gains would generalize to unpracticed cognitive tasks.

The proposed study consists of an 8-week, placebo-controlled, double-blind, parallel-group trial of D-cycloserine augmentation of cognitive remediation in schizophrenia outpatients. The primary outcome measure is change in performance on the MATRICS cognitive battery composite score after 8 weeks. Secondary outcome measures include a measure of processing speed assessed after weeks 1, 2, 4 \& 8, and changes in negative symptoms and measures of functioning after 4 and 8 weeks. In addition, all outcome measures will be repeated at 6 months to assess persistence of benefit.

Hypotheses:

1. D-cycloserine will significantly improve cognitive performance as measured by the composite score on the MATRICS battery compared to placebo after 8 weeks of cognitive remediation.
2. D-cycloserine will significantly improve negative symptoms as measured by the SANS compared to placebo after 8 weeks when combined with cognitive remediation.
3. D-cycloserine will significantly improve measures of functioning (GAS, QoL and CGI) at 8 weeks compared to placebo when combined with cognitive remediation.
4. D-cycloserine effects on cognition, negative symptoms and functioning will persist compared to placebo when assessed at 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-65 years
* Diagnosis of schizophrenia or schizoaffective disorder, depressed type
* Stable dose of antipsychotic for at least 4 weeks
* Able to provide informed consent
* Able to complete a cognitive battery
* Able to perform the cognitive remediation exercises

Exclusion Criteria:

* Current treatment with clozapine
* Dementia
* Seizure disorder
* Unstable medical illness
* Renal insufficiency measured as eGFR \>60mg/dL/min
* Active substance abuse: positive urine toxic screen
* Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.

Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be between 13 and 65 years of age, inclusive
* Must have unresectable primary tumor or metastases
* Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan.
* Creatinine clearance \>70ml/min/1.73m2
* ANC \>500/mm3
* Platelets \>50,000/mm3
* Life expectancy \> 8 weeks
* Karnofsky performance status \>50%
* Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry.

Exclusion Criteria:

* Patient may not be pregnant or breastfeeding.
* Patients who have received prior radiotherapy to all areas of current active disease are not eligible.
Two Daily Disposable Contact Lenses in Symptomatic Patients

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and must sign an IRB-approved informed consent form;
* Soft contact lens wearers in both eyes during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
* Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria:

* Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
* Intolerance, hypersensitivity, or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Monocular (only one eye with functional vision).
A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes

This RCT will test a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module incorporates effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely (CW) guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin. The implementation of the module is triggered by patient scheduling and medication prescribing in EPIC. The BE principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior.


Eligibility Criteria:
Inclusion Criteria:

* Patient at NYULH primary care or endocrinology practice
* Practices that have patients aged 75 or older
* Practices that have a diagnosis of diabetes in the EHR chart

Exclusion Criteria:

• Under age 75
Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents

Vitamin D deficiency is common in older persons, in particular in residents of nursing homes. This is mainly explained by the fact that older persons do not often go outside in the sunshine. On top of that the capacity of the skin to synthesize provitamin D is decreased and dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis, falls and fractures. To prevent morbidity and mortality due to falls and fractures it seems logical to supplement vit D in order to correct the deficiency. The advised daily dose of vit D supplementation is 800 IU. Several studies showed that with this dose the required serum 25(OH)D levels will not be reached.

primary objective of this study is:

* to investigate whether with a loading dose based on body weight and baseline serum 25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a day.
* to determine the best consolidation treatment.

Secondary objective

* is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in residents of nursing homes.
* is there a relation between the increase in serum 25(OH)D level and muscle strength (handgrip strength).
* is there a relation between the increase in serum 25(OH)D level and mobility (2 minute walk test).

Study design:

Randomised trial with 3 study groups:

* Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy.
* Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy.
* Group 2. 800 IU vit D3/ dag.

Study population:

Vitamine D deficient residents of nursing homes, 65 years or older.


Eligibility Criteria:
Inclusion Criteria:

* Long term indication for living in a residential home for the elderly
* Age \> 65 years
* Vitamin D deficiency (serum 25- hydroxycholecholecalciferol (25(OH)D3 \< 50 nmol/l)
* Informed Consent

Exclusion Criteria:

* Hypercalcemia (serum CA \> 2.60 mmol/l)
* Life expectancy \< 1/2 year
* Multivitamin use including \> 400 IE vit D
* Non-functional dominant arm
Effect of Cupping Therapy on Microcirculation in Healthy Volunteers

Twenty healthy volunteers were included in the study. The NIRS was placed on the thenar region of the hand. The vascular occlusion protocol had been done before and after cupping therapy (CT). Regional oxygen saturation (rSO2), the times to the lowest and highest values were recorded. The occlusion slope, the recovery slope and the first 10 second recovery slope were calculated.

Participants rested in a seated position at standard temperature for at least 10 minutes. A blood pressure cuff was applied to the upper arm, and the NIRS device (Covidien INVOS™ 5100C Cerebral/Somatic Oximeter, Dublin) was used to monitor regional oxygen levels in the thenar region of the hand throughout the protocol. After a 3-minute stabilization period, the vascular occlusion protocol commenced: the blood pressure cuff was inflated rapidly within 3-4 seconds to 50 mmHg above the baseline systolic blood pressure and maintained for 3 minutes, then deflated within 1 second. The participant rested for another 10 minutes before a certified cupping therapist placed a plastic therapy cup on the forearm, 5 cm from the medial and lateral epicondyles. The size of the cup was based on the participant's forearm, covering 50% of the area. The cup was vacuumed twice using a manual hand pump and left in place for 5 minutes before the air was released through the valve. Following a 3-minute stabilization period, the vascular occlusion protocol was repeated. During the test, rSO2 values and the time to reach the lowest and highest values were recorded. Using this data, the occlusion slope, recovery slope, and 10-second recovery slope were calculated. The occlusion slope was determined by the formula \[(baseline rSO2 - minimum rSO2) / time to lowest rSO2\], in %/minute. The recovery slope was calculated as \[(minimum rSO2 - maximum rSO2) / time to reach the highest rSO2\], in %/second. The 10-second recovery slope was calculated as \[(minimum rSO2 - rSO2 at 10 seconds) / 10 seconds\].

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Healthy

Exclusion Criteria:

* Smoking or using tobacco products
* Taking alcohol or other substances, or any medication
* Have conditions affecting microcirculation
* Have acute or chronic pain
* Anemia
* Obesity
* Reynaud's phenomenon
* Baseline blood pressure being 140-90mmHg or above
* sPO2 value being below 96%
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians \& patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female in age ≥18 at Visit 1
2. Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
3. HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
4. With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin

Key Exclusion Criteria:

1. Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 X the upper limit of normal at Visit 1
2. Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
3. Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
4. Pregnant women or breastfeeding women at the time of enrolment
5. Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment
Nudging Handwashing: a Cluster-randomized Trial in Bangladesh

The study will collect and analyze quantitative data regarding handwashing behaviors among school-aged children to determine the impact of nudges compared to handwashing and hygiene education programs.

Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates of handwashing than traditional handwashing and hygiene education programs.

This study will utilize a cluster-randomized trial design to collect quantitative data and analyze the handwashing behaviors of school-aged children.

The primary purpose of this protocol is to assess nudges as a viable method of promoting handwashing among school-aged children.

The specific objectives of this quantitative exploration are to:

1. Determine if nudges can prompt significant behavior change and result in higher rates of handwashing among school-aged children in Bangladesh
2. Determine if behavior change resulting from nudging is sustainable over time

Eligibility Criteria:
Inclusion Criteria:

* schools in Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division that that meet the following inclusion criteria:

  1. No hygiene education programs in the last two years
  2. No handwashing stations or facilities on school grounds
  3. Improved sanitation/toilets facilities (latrines)
  4. Water supply on site or within 3-6 meters of the school
  5. A school population between 125-450 students, and
  6. A government primary school (all co-ed)
  7. Willingness of the school principle / head teacher and a representative of the School Management Committee (SMC) to participate in the proposed research

Exclusion Criteria:

1. Located outside of Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division
2. Have had a hygiene education program in the last two years
3. Already has handwashing stations or facilities on school grounds
4. Does not have improved sanitation/toilets facilities (latrines)
5. Does not have water supply on site or within 3-6 meters of the school
6. Has a school population under 125 or over 450 students
7. Is not a government primary school or is not co-ed
8. School principle / head teacher or representative of the School Management Committee (SMC) is not willing to participate in the proposed research
Reliability of the Gyko Inertial Sensor System in Evaluating Jumping and Postural Stability Parameters in Healthy Adults

The aim of the study is to examine the Gyko inertial sensor system in healthy adults. In the study, jump and postural control parameters are assessed with a one-week interval. To evaluate intra-rater reliability, ICC, SEM, and MDC values will be calculated.

The Gyko inertial sensor system is a lightweight and portable device that applies protocols for assessing and monitoring joint function, muscle strength, jump, and postural stability parameters during the rehabilitation of a specific musculoskeletal region. Previous studies have evaluated the validity of Gyko in assessing vertical jump height in female sub-elite soccer players and its reliability in evaluating postural stability in healthy, non-athletic adults. However, the findings regarding both the validity and reliability of the device have been limited.

Our aim in this study is to evaluate the reliability of the Gyko inertial sensor system, an affordable and accessible tool that facilitates the assessment and monitoring of jump and postural stability parameters in healthy adults. If the study confirms the reliability of the Gyko device in evaluating these parameters, it could be used by clinicians, therapists, researchers, and/or coaches as a targeted alternative to gold standard methods for assessing jump and postural stability parameters in healthy adults.

Hypotheses:

H0: The use of the Gyko inertial sensor system is not reliable for assessing jump and postural control parameters in healthy adults.

H1: The use of the Gyko inertial sensor system is reliable for assessing jump performance in healthy adults.

H2: The use of the Gyko inertial sensor system is reliable for assessing postural control in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18 and 35
* having no balance issues (such as vertigo) that could affect assessments
* having no health problems that would interfere with understanding the assessments.

Exclusion Criteria:

* Having known neurological, rheumatological, or musculoskeletal system problems.
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders

The purpose of this study is to try to treat bowel movement (BM) accidents differently with children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC) medications to evoke predictable bowel movements. This will make it possible for investigators to use certain strategies to reward BMs in the toilet. Independence will be increased by fading out the use of medications. The investigators will also train caregivers to implement the procedures.

A large percentage of individuals with autism spectrum disorder (ASD) are delayed in achieving continence with bowel movements or never achieve it at all (i.e., they meet criteria for encopresis). This problem has tremendous ramifications for these individuals and their families because encopresis restricts them from integration with peers, limits access to educational opportunities, and carries significant social stigma. Previous interventions for encopresis in this population have either been unsuccessful or required implementation over very long periods.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-21
* Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII)
* Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna
* Caregiver willing to give consent/assent

Exclusion Criteria:

* Age under 5 year or over 21 years
* Does not present a diagnosis of autistic spectrum disorder
* Previous intestinal surgeries or concurrent enuresis
* Caregiver unwilling to give consent/assent
SHARE Study 4: Financial Incentives for Weight Loss

The purpose of this study is to examine different types of monetary incentive paradigms for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>=25kg/m2
* English speaking
* Age 18-70

Exclusion Criteria:

* Health problems that make weight loss or unsupervised exercise unsafe
* Current pregnancy or plan to become pregnant int he next 12 months
* Planned relocation
* Current participation in weight loss research study
Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures

It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery.

We will conduct a clinical study aiming to compare two treatment strategies; Deep neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will offer better stillness. We will also descriptively examine if patients would be safely discharged from a recovery room.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 60 years; ASA I-III.
* Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis carcinoma)

Exclusion Criteria:

* Any renal impairment (CrCL \< 80 ml/ min)
* Any hepatic impairment; Child Pugh A, B or C
* BMI \> 30 kg m2
* Known or suspected generalized neuromuscular disorders
* Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during general anesthesia
* Hypersensitivity to the active substance or to any of the excipients
* Female patient who are pregnant and breastfeeding.
* Patient with poor Glasgow Coma Score and mental derangement who is unable to give informed consent.
* Patient with Tracheostomy tube.
Mnemonic Strategy Versus Spaced Retrieval Training in Those With Mild Cognitive Impairment

This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Participants returned 1 month after treatment to see how well they remembered the learned information. Brain scans (functional MRI) were collected before and after the interventions to see if training changed the way brain regions were functioning.

Individuals with MCI were randomized to 3 sessions of mnemonic strategy or spaced retrieval training that focused on object location associations. Across these training sessions, each group received 9 training trials for each of the 45 trained stimuli. Task-fMRI was acquired before and after training. Memory was again evaluated 1 month after the last training session. The primary outcome measure was memory for the "trained" stimuli while secondary outcome was accuracy for novel stimuli acquired outside of the MRI environment.

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of MCI according to Petersen (2004) criteria, right handed

Exclusion Criteria:

* Diagnosis of other neurological condition,
* active drug/alcohol abuse/dependence,
* moderate-severe depression or other Axis I diagnoses.
The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial

The incidence of peristomy skin complication ranges from 15% to 65%. It is a serious issue and problem for patients care.The type of skin barrier is associated with peristomy skin complication. How to choose suitable skin barrier is important.


Eligibility Criteria:
Inclusion Criteria:

* Age\>20
* Receive colostomy or ileostomy
* Agree to join the trial and sign the informed consent form

Exclusion Criteria:

* Liver cirrhosis
* Renal insufficiency
* Severe malnutrition
* Unstable vital sign
* Not suitable after evaluation by Principal Investigator