cyrilzakka/clinical-trials huggingface dataset:
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).


Eligibility Criteria:
Inclusion Criteria:

* Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
* HbA1c above or equal to 7.0%
* Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion Criteria:

* Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
* Known proliferative retinopathy or maculopathy requiring acute treatment
* Any disease or condition which the Investigator (trial physician) feels would interfere with the trial
A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations

This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor antagonist) on activating mutations of the Calcium-sensing receptor in patients with Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary depending on measured levels of ionized calcium.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit
* At least 18 years of age
* Body mass index (BMI) ≥ 18.5 to \< 39 kg/m2

Exclusion Criteria:

* Diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of NPSP795
* History of treatment with PTH 1-84 or 1-34 within the previous 6 months
* History of hypocalcemia requiring frequent IV calcium infusions
* History of hypocalcemic seizure within the past 3 months
* Blood 25-hydroxy vitamin D level \< 25 ng/mL. If subjects have a blood 25-hydroxy vitamin D level \< 25 ng/mL at the outpatient screening visit, they will be prescribed vitamin D replacement. Once the 25-hydroxy vitamin D level is \> 25 ng/mL, the subject will be eligible to continue on to the treatment phase of the study
* Estimated glomerular filtration rate (GFR) \< 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function
* 12 lead resting electrocardiogram (ECG) with clinically significant abnormalities
* Concomitant medications with the potential to interfere with NPSP795 metabolism
* History of thyroid or parathyroid surgery
Taking POSNA's OrthoKids to the People

The objective of this project is to determine the efficacy of a tablet-based educational intervention at improving orthopaedic health literacy amongst families of pediatric patients treated for fractures in an outpatient setting.

This project aims to reduce knowledge disparity amongst caregivers of patients presenting for pediatric fracture care. At our institution, many patients presenting with fractures do not have easy access to either technology or the internet, preventing caregivers from benefiting from educational tools such as POSNA's OrthoKids®. We are planning to increase access and improve health literacy through a simple intervention of providing tablet-based access to POSNA's Orthokids while families are waiting for their physician. Families will be randomized to either standard waiting room experience vs. tablet-based educational intervention to limit selection bias. A brief pre-visit questionnaire will be completed by all caregivers to assess fracture and cast care knowledge as well as the highest educational degree obtained by the caregiver.

Eligibility Criteria:
Inclusion Criteria (RCT and observational arms):

* Children with forearm fractures who presented to the CHNOLA ED. "Children" are defined as persons under the age of 18 years for this study. "Forearm fracture" is defined as a radial and or ulnar shaft fracture for this study.
* Documented radiographs must show an injury in which the fracture line is wholly located within the diaphysis of the radius or ulna.

Exclusion Criteria (RCT and observational arms):

* Fractures that require internal or external fixation
* Fractures associated with multi-system trauma
* Caregivers that do not speak English or Spanish as their first language
REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents

To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.

The general objective of the study is to test the REThink therapeutic game for improvements in clinical and subclinical mental health symptoms in children and adolescents aged 8-16 years old from multiple schools and counties. The game will be used by children and adolescents from the experimental group for a period of four weeks. Pre-test and post-test measurements will be taken.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents aged 8 to 16 years
* subclinical level on the SDQ measure, total score, or emotional symptoms
* parental consent provided

Exclusion Criteria:

* intellectual disability or physical limitations precluding the use of the online game
* does not have parental informed consent
LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


Eligibility Criteria:
Inclusion criteria:

1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
2. Unresected tumour prior to chemo-radiotherapy (CRT)
3. Concomitant CRT completed prior to randomisation
4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
4. Known pre-existing Interstitial Lung Disease (ILD)
5. Pregnancy or breast feeding
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Sleep Extension to Improve Sleep Efficiency and QoL in HF With Preserved Ejection Fraction: the SLEEP-HF Pilot Study

Nearly one-third of US adults have poor sleep quality. Sleep quality refers to sleep efficiency, sleep latency, sleep duration, wake after sleep onset, and movement during the night. Specifically, sleep efficiency (SE) measures how well an individual utilizes their time in bed for restorative sleep and it highly depends on actual sleep duration. Reduced SE is associated with a greater risk for heart failure (HF), which affects \~6.7 million adults in the US alone. HF with preserved ejection fraction (HFpEF) accounts for about half of all HF diagnoses and is associated with poor prognosis (30-50% 5-year mortality from diagnosis) and severely reduced quality of life (QoL). Long-term goal for the investigators is to identify sleep modulation as a potential therapeutic target to improve QoL in HFpEF, with poor SE being present in \~60% of patients with HFpEF. The study is aimed to see if the sleep modulation is feasible and modulating sleep can improve the QoL and functional capacity along with the reduction of inflammation among subjects with HFpEF.

The investigators plan a 2-week single-arm open-label feasibility study in 17 subjects with HFpEF with a 1-week run-in phase (3 weeks total duration) with a sleep extension intervention combined with sleep hygiene training to improve SE in patients with symptomatic HFpEF. The investigator's primary endpoint is to increase sleep duration and efficiency with this intervention.

Eligibility Criteria:
Inclusion Criteria:

* confirmed clinical diagnosis of stable HF (NYHA class II-III)
* left ventricular ejection fraction\>50% documented in the prior 12 months
* aged ≥18 years
* habitual reported sleep duration ≤7 hours
* sleep efficiency \<85% measured during the 1-week run-in phase

Exclusion Criteria:

* concomitant conditions that can limit physical activity
* severe debilitating diseases (ischemic heart disease. angina, arterial fibrillation, moderate to severe valvular disease)
* taking sleep medicine or melatonin irregularly
* pregnancy
* stage V kidney disease (with dialysis)
* shift worker
* insomnia
* hospitalization within the last 2 months
* patients with sleep and circadian disorders
* fluid overload
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Relationship Between Sleep Quality, Sleep Duration, Heart Rate, and Step Number

This study aims to evaluate the relationship among sleep duration, heart rate, number of steps, and sleep quality.

There are studies examining the relationship between sleep quality and physical activity in young adults. In these studies, weakly significant relationships were recorded between sleep quality and physical activity level. However, in these studies, the level of physical activity was evaluated with the International Physical Activity Questionnaire and the questionnaire was filled in within the framework of certain activities. In this study, physical activity will be evaluated with the number of steps taken per day. In addition, there is no study examining the relationship between sleep quality, sleep duration, and heart rate in young adults. With the current study, parameters that will affect physical activity such as sleep duration, heart rate, and the number of steps will be evaluated and their relationship with sleep quality will be determined. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, sleep duration, heart rate, and step count will be assessed by the Fitbit® Inspire 2 (Fitbit, Inc., San Francisco, California, USA), and quality of life will be assessed by the Nottingham Health Profile. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-30,
* Without any chronic disease,
* No past or present mental illness,
* Can speak, read, and write Turkish and
* Who volunteered to participate in the study

Exclusion Criteria:

* With any neurological, psychiatric or cognitive impairment,
* Who cannot speak, read or write Turkish
Black Health Identification Program (B-HIP)

Nearly 69% of African American (AA) Medicare beneficiaries have multiple chronic conditions (MCCs) such as cancer and cardiopulmonary diseases. Older age and MCCs are guideline-recommended indications for referral to early palliative care to assist with effective communication and value-solicitation surrounding treatment decision-making. Studies have shown that early palliative care participation achieves beneficial goals of care communication, quality of life (QOL), symptom burden, and mood in older adults with cancer and heart failure as well as among their family caregivers. However, older AAs with MCCs, especially those living in the Deep South, are less likely to have access to early palliative care, even though they generally experience higher symptom burden, healthcare use, and poorer communication around goals of care. This disparity in palliative care use may be, in part, to a lack of culturally-responsive care practices that effectively activate AAs with MCCs to identify their own values and priorities for end-of-life care. While efficacious communication models exist, few have been tested in culturally-diverse samples. Guided by the theory of Social Cognitive Theory and Health Behavior Model, this study's purpose is to conduct a formative evaluation of a Self-directed "My Health Priorities" Identification Program to determine cultural acceptability and feasibility of use in among AAs with MCCs in a primary care setting. The 2-phase study specific aims are to:

Aim 1. (Phase 1) Conduct a single-arm formative evaluation trial of Self-directed "My Health Priorities" Identification Program to determine acceptability and feasibility with a sample of 20 AA patients with MCCs and FCGs and adapt for future efficacy testing.

Aim 2. (Phase 2) To examine the ability of the dyads to complete pre- and post-test measures of perception of care, treatment burden, shared decision-making, and communication exchange.

The findings from the research will directly inform a small-scale pilot grant that will assess acceptability, feasibility, and potential efficacy of a values solicitation and operationalization intervention for AAs with MCCs and caregivers.


Eligibility Criteria:
Inclusion Criteria for Patients

* African American (AA)
* ≥ 65 years
* has at least two of the following chronic conditions: cancer, heart disease, kidney disease, liver disease
* English-speaking
* cognitively able to participate in decision-making discussions
* reliable internet and telephone access
* FCG willing to participate in study

Inclusion Criteria for FCG

* AA

  * 18 years
* identified by patient as his/her primary FCG
* English-speaking; and 5) reliable internet and telephone access.

Exclusion Criteria for Patients and FCG

* Axis I psychiatric disorder (schizophrenia, bipolar disorder), dementia
* active substance use disorder
* living in a nursing home or assisted living facility residence.
Intra-Pelvic Organ Motion for Cervix Cancer Patient Using Imaging

Patients with cervix cancer having radiotherapy experience side-effects because the radiotherapy fields have to be quite large to account for tumour movement in the pelvis during treatment, this irradiates a lot of normal tissues. This study aims to characterize and model the tumour motion, as well as the motion of surrounding normal tissues, during treatment. By doing this, the investigators can look at ways to minimise tumour motion and spare more normal tissues. By tailoring the radiotherapy dose more accurately, the investigators will reduce the side-effects of treatment and improve local control of the tumour. By doing multiple magnetic resonance imaging (MRI) scans of the patients during treatment, the investigators can identify where the tumour and surrounding normal tissues are at that point in time. Collecting all the information from these scans, will allow the investigators to model the motion of the tumour and these pelvic organs, and investigate the best way to target the tumour while still sparing normal tissues.

At simulation: patients will have two MRI scans in addition to the standard planning CT scan. One MRI scan will be with bladder full, the other will be with bladder empty. During treatment: patients will have two or three MRI scans per week at their convenience. MRI scans will be scheduled close to radiotherapy treatment times to minimise inconvenience for the patient. On the same day they have an MRI scan, they will also have a CBCT at the time of treatment. None of the images will be used to alter or influence the treatment the patient is receiving. If the patient feels that the imaging schedule is too inconvenient, they will be given the option to reduce the frequency of the scanning or to withdraw from the study.All the images will be loaded onto a password secure server. The MRI scans will be fused to the planning CT scan using bone-to-bone matching. Tumour and intra-pelvic organs will be contoured on the MRI scans. The contours will be used to create surface meshes of each organ and with research software, we will be able to model the motion and deformation of these organs over the course of radiotherapy. Using this data, we will be able to simulate the dose impact of the organ motion on different intensity-modulated radiotherapy plans. We will also explore the impact of bladder \& rectal filling on tumour motion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18years
* Biopsy confirmed cervix cancer
* Not suitable for surgery
* Suitable for radical radiotherapy
* ECOG 0-2
* Informed consent

Exclusion Criteria:

* Patients unwilling or unable to give informed consent
* Prior pelvic radiotherapy
* Contraindications to MRI scan
ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy

aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Current guidelines recommend biannual surveillance for hepatocellular carcinoma (HCC) in all patients with cirrhosis. However, risk of HCC incidence is not the same for different patients. The study aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Eligibility Criteria:
Inclusion Criteria:

* no history of previous HCC
* SVR after DAAs treatment

Exclusion Criteria:

* history of previous HCC
Exercise in Treatment Resistant Depression (TRD): A Feasibility Study

The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression. The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.

Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care. Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item). Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.

Eligibility Criteria:
Inclusion Criteria:

* Being sedentary (exercising less than 3 times/week for \> 20 minutes at moderate/vigorous intensity for each bout)
* Ability to come for supervised exercises up to 5 days/week.
* On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
* Being able to read, understand, and provide written informed consent.

Exclusion Criteria:

* DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
* Behavioral or personality disturbances, which may significantly interfere with study participation.
* Evidence of acute suicidal risk.
* Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
* Pregnancy.
Effect of Resistance Training in Water Combined With Land on Starting and Turning ,12-weeks Resistance Training

Resistance training has been widely used in various sports and is a common practice aimed at improving competition performance, especially in swimming. Swimming performance is highly dependent on muscle strength, especially short distances. Water or land resistance training can improve the swimming performance, especially the swimming performance of 50 meters and 100 meters. Both type of training has their own strength and weakness. Hence, combining both methods strength may enhance swimmer performance. In addition, competitive swimming consists of different stages, namely start, clean swim, turn and finish. However, there is no literature on the influence of resistance training on starting and turning.

Through experimental design and quantitative research methods. In this experiment, the resistance training method of water combined with land was used to intervene the turning and starting of young people, and the traditional strength training was compared to find out a better training method. The experiment will use 12 weeks of resistance training to improve the swimmer's turn and start intervention. The experiment consisted of four groups, 20 boys and 20 girls in the experimental group and 20 boys and 20 girls in the control group. Compare the differences between the two groups. Divided into discussion groups and general teaching groups. Two of the most significant differences, this experiment aims to provide a theoretical basis for improving the training methods of swimming, so that young swimmers can get better swimming performance, especially on the start and turn.

Experiment Group Week1-3: Drag Umbrella , Resistance Bands, Swiss Ball, Hand Resistance. Week3-6: Drag Umbrella , Resistance Bands, Swiss Ball, Hand Resistance. Week6-9: Drag Umbrella, Pulley Pull, Medicine Ball, Resistance Suit. Week9-12: Drag Umbrella Pulley Pull, Medicine Ball, Resistance Suit. Control Group Week1-3: Sit-Up, Press-Up, Deep Squat, Lift Heel Week 3-6: Sit-Up, Press-Up, Deep Squat, Lift Heel Week6-9: Dumbbell, Barbell ,Stomach Up, Squat Up Week9-12: Dumbbell, Barbell, Stomach Up, Squat Up

Eligibility Criteria:
Inclusion Criteria:

1. Swimmers participate in organized swimming training programs.
2. Participants with an average age of about 10 years.

Exclusion Criteria:

1. Untrained, novice, masters, and paraplegic swimmers.
2. Triathlon and water polo athletes.
3. Injured swimmers.