cyrilzakka/clinical-trials huggingface dataset:
A Nutrition-Focused QIP in Outpatient Clinics

A nutrition-focused QIP will be implemented with a primary assessment of QIP feasibility, patient health and economic outcomes as well as patient and provider experience data. A 2-phased QIP study group will be prospectively enrolled from outpatient clinics affiliated with the USC health system and compared with historical and concurrent control groups.


Eligibility Criteria:
QIP Group

Inclusion Criteria:

* Poor nutritional status
* 2 or more chronic conditions (other than those listed as exclusions)
* Estimated life expectancy of 90 days or greater
* Able to consume foods and beverages orally
* Literate and willing to sign informed consent form

Exclusion Criteria:

* Pregnant
* Normal nutritional status
* Unable to consume foods and beverages orally
* Estimated life expectancy of less than 90 days
* Severe dementia or delirium and no dedicated caregiver to assure compliance with QIP study requirements
* Uncontrolled eating disorder, significant neurological or psychiatric disorder (including substance abuse), or other conditions that may interfere with study product consumption or compliance
* Known allergy or intolerance to any ingredient found in ONS products recommended in QIP

Retrospective and Concurrent groups eligibility are reflective of the QIP eligibility criteria however, the timeframe differs.
A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers

Trial Objective: To investigate the safety, tolerability, PK, and PD following single ascending doses of HBM9161 in healthy Chinese subjects.

HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases. This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24 healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group).

This study will also provide guidance on doses to be used in future studies involving patients with autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Han Chinese male or female subjects, and his/her biological parents and grandparents are of Han Chinese ethnicity.
2. Body weight ≥ 50kg with BMI ≥19.0 and \<=24.0 kg/m2 at screening and baseline visit.
3. Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.

Exclusion Criteria:

1. Subject has a total IgG level of \< 700mg/dL at screening.
2. Subject has an active infection or has had a serious infection within 6 weeks prior to Day -1 or infection requiring oral anti-infective agents within 2 weeks prior to Day-1, or subject had a febrile illness or symptomatic, viral, bacterial, or fungal infection within 1 week prior to admission (Day -1).
3. History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).
4. Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.
5. Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula at screening.
6. Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:
7. Positive HIV test result at screening.
8. Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
9. Subject has a positive T-cell interferon-γ release assay (TIGRA) result
10. Subjects who had immunization within 4 weeks before screening; or subjects who plan to have immunization during the study and within 12 weeks after dosing of the study drug.
11. For female subjects, positive pregnancy test at screening or Day -1, or planning to become pregnant from screening until 90 days after the dosing of the study drug.
12. Lactating female subjects.
NT-3 Levels and Function in Individuals With CMT

This study will assess the serum NT-3 levels in individuals with the diagnosis of peripheral neuropathy or any type of Charcot-Marie-Tooth Neuropathy (CMT) and correlate this with function.

This study will assess the serum NT-3 levels in those with a peripheral neuropathy diagnosis which will help to determine the therapeutic levels of NT-3 in subjects that will receive AAV1.NT-3 gene therapy in a future study. This study also aims to define the natural history of any type of Charcot-Marie Tooth Disease (CMT), better define the rate of disease progression and skeletal muscle involvement. Another aim is to generate a registry of well-characterized CMT patients who may be candidates for future trials.

Eligibility Criteria:
Inclusion Criteria:

* Males or females from 7 years of age or older
* Diagnosis of acquired peripheral neuropathy (PN) such as due to diabetes, chemo-induced, autoimmune chronic inflammatory demyelinating polyneuropathy (CIDP) established by a report of electrical studies or with a known genetic CMT diagnosis. Definitive diagnosis of PN is established with a report of electrical studies, EMG/nerve conduction studies.2
* Perform assessments to the best of their ability with reliable results as deemed by the evaluator.
* Ability to attend scheduled appointments
* Ability to provide informed consent (or assent for ages 9-18)

Exclusion Criteria:

* Current pregnancy per medical history
* Has a medical condition or extenuating circumstances that, in the opinion of the investigator, might compromise the subject's wellbeing, safety, or clinical interpretability
ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)

Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries.

Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.

The precise frequency of ALK in Latin American population has not been determined. Studies isolated in some Latin American countries like Brazil report a frequency of 3.2%, Argentina of 4.2% and Mexico of 9.0% of ALK fusion in a small number with lung cancer. Reliable information about ALK frequencies and disparities among ethnic groups is critical. Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC. Discusses the difficulty of having a single diagnostic test for this chromosome abnormality.

The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. Currently, the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization (FISH) for selecting patients for ALK-tyrosine kinase inhibitors (TKI) therapy according to the United States Food and Drug Administration (FDA). But, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. Recent evidence suggests that ALK Immunohistochemistry (IHC) instruments globally protocols, can be very effective in the detection of ALK rearrangement in NSCLC (ALK+) tumors expressing the fusion ALK protein.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed lung cancer and tissue availability for ALK analysis.

Exclusion Criteria:

* Not lung cancer
Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy

This study looks at the effects of a protocolized music therapy intervention on state anxiety for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an imaging and diagnostic procedure, has been identified as producing significantly high levels of anxiety in many cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with breast cancer, and newly diagnosed patients with head and neck cancer.
* 18 or over.
* Fluent in English.

Exclusion Criteria:

* Under 18 years.
* Pre-existing anxiety disorders.
DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM).

The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Documented T1D for at least 1 year prior to study enrolment
2. Subjects aged 18 - 65 years old
3. A1c at inclusion ≤ 10%
4. Subjects using basal-bolus MDI therapy:

   1. Basal insulin: Glargine, Degludec, or Determir
   2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues
5. Subjects using CGM or SMBG that are compatible with data transmission to the study DMS.
6. BMI \< 28 kg/m2
7. Subjects willing to follow study instructions:

   1. For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile (optional). Document blood glucose level, insulin delivery, meals and daily activities. Wear blinded CGM.
   2. For CGM users: Use CGM according to manufacture instructions, Document insulin delivery, meals and daily activities.
8. Subjects have connection to the internet at home.
9. Subjects have a smartphone compatible with study requirements
10. Subjects willing and able to sign a written informed consent form.

Exclusion Criteria:

1. An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
2. Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety
3. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:

   * Subject has unstable or rapidly progressive renal disease or is receiving dialysis
   * Subject has active proliferative retinopathy
   * Active gastroparesis
4. Participation in any other interventional study
5. Female subject who is pregnant or planning to become pregnant within the planned study duration
6. Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
7. Drug or alcohol abuse.
Epidrum for Thoracic Epidural Analgesia

The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Elective major thoracic surgery requiring thoracic epidural analgesia

Exclusion Criteria:

* Contraindication to epidural anesthesia
* Marked spinal deformities or a history of spinal instrumentation
ALS and Airway Clearance (ALSAC) Therapy

Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE. The study period will be six months and include three clinic visits, baseline and follow-up visits at 3 and 6 months, and 6 monthly home visits by the respiratory therapist.

The proposed project includes both the HFCWO and MIE and will capitalize on the specific goals of each therapy and address the problem as a whole rather than piece-meal. The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many patients diagnosed with ALS are unable to expel the secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows to pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. The MIE, a noninvasive therapy, removes secretions in patients who have an ineffective cough because the peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions. Logically, the two mechanisms of action of these devices should work synergistically to produce effective airway clearance to keep the lungs clear, healthy and reduce the risk of infections from stagnant secretions. Respiratory infections are especially serious for patients with ALS because the patient is not able to recuperate from infections as quickly as a person without ALS. The objective is to determine if changing the use of existing respiratory therapy devices can improve the physical and psychosocial health and quality of life for patients diagnosed with ALS and caregivers.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 and above,
2. Probable or definite ALS diagnosis,
3. Peak Cough Flow of \<160L/min or complain of issues clearing airway secretions
4. Caregiver must also consent to participate

Exclusion Criteria:

1. Current use of HFCWO or MIE
2. Tracheostomy
3. Congestive heart failure
4. All contraindications for the HFCWO
5. Head and/or neck injury that has not been stabilized;
6. Active hemorrhage with hemodynamic instability;
7. Uncontrolled hypertension;
8. Active or recent gross hemoptysis; and
9. All contraindications for the MIE
10. History of bullous emphysema;
11. Known susceptibility to pneumothorax;
12. Pneumomediastinum; and
13. Recent barotrauma
14. Frontal Temporal Dementia (FTD) - suspected or diagnosed . FTD is a form of dementia found in about 20% of Familial ALS. This dementia interferes with the ability to follow commands and follow through with therapies due to forgetfulness.
15. Patients not able to provide informed consent.
Comparison of Dietetics Support with and Without Continuous Glucose Monitoring in Individuals with Type 2 Diabetes.

A parallel, single-blinded, randomised clinical trial conducted remotely across Australia from the Mary MacKillop Institute for Health Research (MMIHR, Australian Catholic University) for individuals with type 2 diabetes, by researchers from Australian Catholic University, University of Adelaide, University of Queensland, University of Wollongong, Monash University, Monash Partners, Deakin University, La Trobe University and Melbourne University.

In a parallel groups design, a total of 156 individuals will be recruited. After baseline pathology (HbA1c), blinded (Libre Pro iQ) continuous glucose monitoring (CGM) data and questionnaires (via REDCap) have been collected, participants will be randomised into one of two groups (DIET, dietetic support only; CGMD, CGM plus dietetic support). All participants will receive four (4) dietetic consults via telehealth at weeks 2, 6, 10 and 16, the content of which will be related to the randomised condition. Measurements will be repeated at 3 and 6 months from baseline to assess the changes in primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+ years
* Reside anywhere in Australia and have a postal address
* Confirmed T2D diagnosis by a GP/endocrinologist
* Current HbA1c of ≥7.0%
* Have a smartphone and able to independently use it

Exclusion Criteria:

* Under the age of 18 years
* Use of insulin therapy (within the last three months) or medications which interfere with blood glucose levels (i.e. steroids)
* Use of CGM within the last six months
* Eating Disorder Examination Questionnaire (EDE-Q) global score \>2.8 OR global score \> or equal to 1.52, with sum of Q14-18 \> or equal to 4
* Currently having ongoing consultations with an APD or have had a consult with an APD (within last three months)
* Not weight stable (\>5 kg change over last three months)
* Severe hypoglycaemic event (i.e. requiring assistance) within last six months
* Change of antihyperglcyaemic medications within last three months
* Women who are pregnant or breastfeeding (within 24 weeks)
* History of psychotic disorder, or current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder)
* History of blood disorders (including but, not limited to, anemia and thalassemia) that impact the primary outcome (HbA1c)
Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty

The therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. This choice for patients aged between 45 and 64 years old remains a controversial subject.

The aim of our work was to describe the current situation in the management of femoral neck fractures in these patients and to evaluate the results of the two options

Our study was retrospective descriptive including patients aged between 45 and 64 years operated between January 2015 and December 2022 for femoral neck fracture. The patients will be divided into two groups: The internal fixation group and the arthroplasty group . Epidemiological, clinical and radiological data as well as therapeutic results and postoperative complications will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Femoral neck fracture between 45 and 64 years
Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT

Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all youth by the age of 16. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by youth, parents and health care providers. Even if anxiety disorders are discovered, youth may not get the right therapy. Anxious youth can become sick if their anxiety is not treated properly.

The investigative team will carry out research to test Breathe, their new Internet-based treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe includes information materials and personalized homework assignments to help anxious youth learn ways to manage anxiety.

This study is a pilot randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives:

1. To evaluate the change in youths' anxiety (primary outcome) from pre- to post- intervention.
2. To estimate recruitment and retention rates for a full-scale RCT.
3. To estimate a sample size for a full-scale RCT.
4. To define the minimal clinically important difference (MCID) for the primary outcome measure.
5. To measure intervention acceptability.
6. To determine the use of co-interventions during the trial.
7. To conduct a preliminary economic analysis.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV social anxiety, generalized anxiety, anxiety not otherwise specified, or adjustment disorder as the primary clinical problem
* ability to read and write English
* regular access to a telephone and a computer system with high speed Internet service
* ability to use a computer to interact with web material
* youth aged 13-14 must have a consenting parent

Exclusion Criteria:

* youth with an anxiety problem that is not included above
* youth who receive cognitive behavioural therapy
* youth who cannot provide consent
Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia

Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ICs, relatives either have no time or opportunity to leave the PwD alone or there are no support groups in the vicinity. The Talking Time project therefore aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown resulting benefits for ICs.

Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled trial. The effects of the 3-months Talking Time intervention will be compared to a normal care group. Outcomes will be measured at two different times (baseline = T0, after 3 months =T1). The control group will receive the Talking Time intervention after T1.

ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on four days per week in the last six months. Exclusion criteria are psychiatric disorders of the IC.

Primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the SF-12. Secondary outcomes are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.


Eligibility Criteria:
Inclusion Criteria:

* medical ICD-10 dementia diagnosis available for the patient (F00.-\*: Alzheimer disease or related disorders, F01.-: Vascular dementia, F03.-:Unspecified dementia)
* living with or sharing cooking facilities with the care recipient or providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours on at least 4 days of a week for at least the past 6 months, respectively
* access to a telephone connection to be able to participate in the talking Time Intervention and the telephone- based interviews for the evaluation

Exclusion Criteria:

* lack of knowledge of German Language of informal caregiver
* risk of suicide in the informal caregiver
* actual psychiatric diagnosis of mental illness of the caregiver
* ICD-10-diagnosis of Dementia in other diseases classified elsewhere (F02.-\*), except Dementia in Primary Parkinson disease (F02.3\*) and Lewy Body disease (F02.8/G31.82)