cyrilzakka/clinical-trials huggingface dataset:
The Assessment of Nutritional Status of Patients With IPF

The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.

A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. Also quality of life were assessed by SGRQ. Tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

Idiopathic pulmonary fibrosis (IPF) is an irreversible interstitial lung disease of unknown etiology, characterized by progressive loss of lung function. IPF is a disease of advanced age. Preliminary studies of IPF indicate that nutritional status may affect quality of life and prognosis, but the clinical significance of nutritional status has not been investigated. Weight loss is recognized as a common complication of IPF. There is no study that comprehensively evaluates the nutritional status of IPF patients in Turkey. The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated. A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, dynamometer, pulmonary function, and several questionnaires. so quality of life were assessed by SGRQ. All measurements were taken at the baseline. Then, tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with IPF

Exclusion Criteria:

* Not giving written consent
Diagnosing Extremity Fractures and/or Dislocations Using Ultrasound Presenting to the Emergency Department

The purpose of this study is to determine the efficacy of ultrasound in diagnosing the presence or absence of extremity fractures or dislocations.

Hypothesis: Can ultrasound be used as an accurate and effective method for determining the presence or absence of extremity fractures or dislocations? Is there a difference in amount of pain experienced prior to and after the ultrasound?

This prospective, multicenter cohort study. The sampling method will be a convenience sample of all adult patients presenting to the ED with symptoms concerning a fracture and/or dislocation of an extremity. Once a patient has been deemed an appropriate candidate for the study, written consent will be obtained from one of the Associate Investigators. Once consent has been obtained, a resident physician will perform the ultrasound examination on the affected extremity(s) and note their findings.

Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion of a fracture and/or dislocation of an extremity
* Age Greater than 18 years
* English speaking
* able to give consent

Exclusion Criteria:

* Age less than 18 years, including emancipated minors
* Unstable patients with B/P below 90mmHg systolic
* Open, unstable, or suspected compound fracture
* Physician has reviewed X-Rays and made diagnosis before ultrasound could be done
* X-Rays will not be ordered
* Patient is pregnant
* Patient cannot give own consent
* English is not the patient's primary language
Physical Activity of Asthmatic Children

Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. There no scientific argument to advice a reduction of physical activity in asthmatic children, but previous studies showed that physical activity is reduced in asthmatic children.

The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.

Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the behaviour of children and its family with a significant reduction of exercise and practice of sports.

There no scientific argument to advice such a reduction of physical activity in asthmatic children.

The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.

To evaluate the factors explaining this behaviour the investigator design an observational study, based on a questionnaire.

The evaluation of the number of sujets to complete this study is 50 asthmatic children. The whole population will be considered as the same group. This study may be further completed by a comparative and new study including asthmatic and non-asthmatic children.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic children coming for regular follow-up
* Good control of asthma

Exclusion Criteria:

* Previous pathologies with significant impact on physical activity
Effects of Oral Nutrition Supplement in Thai Malnourished Patients

A retrospective study based on Thai data from Nutrition Day study (nD). Comparing clinical outcome between malnourished patients who were prescribed oral nutrition supplement along with hospital diet and those without oral nutrition supplement.

Prevalence of malnutrition in hospitalized patients varies from 30-70% depend on category of patients recruited. Adverse effects of malnutrition include increase of infection complication, increase hospital length of stay, and increase mortality. Prescription of oral nutrition supplement (ONS) have been proved to provide patients more calorie and protein intake and can improve patients' outcome.

Despite the proved benefits of oral nutrition supplement(ONS), prescription of it in Thai hospitalized patients are far less than it should. The main reason of this under-practice is the limitation of health policies which considered ONS as an optional from main meals. Additional cost for ONS has to be paid by patients themselves, therefore the patients who have no willing to pay usually refuse to receive ONS. Unawareness of physician regarding its benefits is also a problem. In order to convince Thai authorities to allow for reimbursement of ONS and encourage prescription of ONS among physicians, an evidence based benefits of ONS in large Thai population is needed.

The nD study was a single-day, population-based, standardized, multinational, cross-sectional audit and was performed worldwide, includes Thailand, in hospitals, nursing homes and intensive care units performing since 2006 to present. Every year, registered hospitals survey their patients regarding nutritional status, nutritional support. A follow-up for clinical outcome are perform at 30 days after the first survey, include mortality, readmission. This study will based on data of Thai patients collected from nD study during 2006-2016.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old and above
* identified as malnourished or at risk

Exclusion Criteria:

* terminally ill patients
* receiving concomitant enteral tube feeding and/or supplemental parenteral nutrition
Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns

The objectives of this project are to determine if the bioavailability and release pattern of bupropion HCl products differ and if the genotype of the metabolic enzymes affects the saturation of intestinal enzymes with different dose strengths within one product line. Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER) Office of Generic Drugs improve policy development and review practice in the future for similar products, e.g. extended release oral drug products being metabolized in the gut wall and having multiple strengths.

Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy individuals when they ingest different strengths of bupropion (75-300 mg) with variable release profiles (IR vs XL vs SR) in GI tract.

Working hypothesis: Variation in release rate and mechanism of bupropion formulations in gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract, which will generate different concentration of bupropion and its metabolites in plasma.

Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and pharmacokinetics of bupropion

Working hypothesis: The gain of function of CYP2B6 variants (allele \*4 and \*22) in patients will increase the metabolism of bupropion in the GI tract and liver, reduce both local concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when bupropion is released earlier in GI tract


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers 25 to 55 years old.
* Volunteers have a Body Mass Index (BMI), calculated from the ratio of height and weight, within a range of 18.5 to 35.
* Willing to be medication and supplement free 2 weeks prior to beginning study, and throughout the study. All forms of birth control are okay.

Exclusion Criteria:

* Individuals unwilling or unable to comply with the study protocol (e.g. unable to remain medication or supplement free during the study).
* Individuals unwilling or unable to take bupropion or have an allergy to bupropion
* Any medical or surgical conditions which might significantly alter bupropion absorption (e.g., history of malabsorption, liver disease, gastric bypass surgery )
* Individuals with a history of psychiatric or neurological illness, including seizure disorders
* Nicotine dependence
* Alcohol dependence
* Pregnant or nursing women
Rehabilitation of Early Stroke Patients Using an AFO: an RCT

Stroke is a major cause of disabilities worldwide. Stroke survivors commonly exhibit walking defects which lead to an altered, slow speed and asymmetric gait pattern. The main aims of rehabilitation are to enhance recovery of movement control and regain walking ability. Ankle-foot orthoses (AFOs), braces which encompass the foot and ankle joint extending to a point below the knee, are commonly prescribed to address ambulation impairments in stroke patients. Their main function is to support the foot and allow a subject to walk safely with a gait approaching normality. This project will aim to evaluate the early provision of AFOs as an adjunct to standard physiotherapy on the walking ability of stroke survivors. Usual rehabilitation practice will be the control condition. Participants will be recruited from the stroke unit of Stobhill Hospital in Glasgow. They will be randomised into two groups. Participants allocated in the control group will receive usual clinical practice as per routine for stroke patients. The intervention group will receive custom made solid AFOs as an adjunct. They will be provided with three AFOs, one for use during rehabilitation and two which will be used only during the outcome assessment sessions for research purposes. The intervention phase will last 24 weeks. Gait analysis will be performed three times for each participant (at baseline, 12 and 24 weeks after enrolment) in the biomechanical laboratory of Strathclyde University. During these sessions force and movement data of patients walking will be recorded. Fortnightly time and distance factors of gait will be measured and a battery of functional tasks will be performed in the physiotherapy gym of the hospital using a simple video camera and a grid lino-mat. During all assessments participants with an AFO will be asked to walk with and without the AFO provided.


Eligibility Criteria:
Inclusion Criteria:

* 7 days to 8 weeks after ischemic or haemorrhagic stroke, medically stable, age range between 18 and 90 years, gastrocnemius shortening with plantarflexion contracture (5 degrees of plantarflexion or greater), capable of full correction of subtalar joint, no loss of skin integrity over the lower limb, no severe cognitive impairments, sufficient communication to follow the instructions in the trial data collection procedures (follow a single one step command).

Exclusion Criteria:

* Inability to follow simple instructions or to give informed consent, unstable angina, cardiac risks, pain related to walking, severe spasticity, the need for two assistants while walking, severe proprioceptive sensory impairment, soleus contracture which prevents casting for the AFO at 90 degrees , flexion contracture of hip musculature (greater than 10 degrees hip flexion).
A Study of TAS-116 in Patients With Solid Tumors

A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Male or females with an age ≥ 18 years (≥ 20 years in Japan)
2. Patients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.

   a. Part C: Only the following subtype of tumors with the molecular/genetic alterations will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after progression on osimertinib Advanced NSCLC, harboring ALK translocations after treatment with alectinib or at least 2 ALK inhibitors
3. Has At least one measurable lesion as defined by RECIST criteria
4. Is able to take medications orally (e.g., no feeding tube).
5. Is able to agree to and sign informed consent and to comply with the protocol
6. Has adequate organ function

Exclusion Criteria:

1. Has a serious illness or medical condition(s)
2. Has received treatment with any prescribed treatments within specified time frames prior to study drug administration
3. Significant ophthalmologic abnormality,
4. Impaired cardiac function or clinically significant cardiac disease
Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.

Attention Deficit Disorder With Hyperactivity is associated with deficits in cognition and sleep. In healthy adults, memory consolidation processes are related to sleep spindle activity in the sleep electroencephalogram. This association is poorly characterized in adults with attention deficit hyperactivity. In this study, the purpose is to characterize sleep microarchitecture disorders through the analysis of different stage of sleep EEG activity during a polysomnographic examination in adult with mixed Attention Deficit Disorder With Hyperactivity presentation compared to healthy.


Eligibility Criteria:
Inclusion Criteria for all participants:

* Age from 18 to 45 years old
* Affiliated to the French health care system

Inclusion Criteria for attention deficit hyperactivity disorder patients:

* meeting Diagnostic and Statistical Manual (DSM)-5 criteria for mixed attention deficit hyperactivity disorder presentation without drug treatment for attention deficit hyperactivity disorder.

Exclusion Criteria for all participant:

* People not able to give consent, neurological disease (other than neurodevelopmental disorders; or any other serious disease (cancer, addiction, systemic disease)), untreated sleep apnea, major depression (Beck inventory \> 15), untreated restless leg syndrome; pregnancy in progress or wish to become pregnant during the study or breastfeeding woman, drug treatment including benzodiazepine, neuroleptic or antidepressant before inclusion.

Exclusion Criteria for healthy volunteers:

* Subjective cognitive and/or sleep complaint.
NUMITOR Study: Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting

The NUMITOR study is an analytical observational study with an multicenter ambisective (retrospective and prospective) cohort design.

This study aims to create a multicenter registry that will increase the knowledge of nummular headache and assess which treatments are more effective and better tolerated. The study population will be patients with nummular headache who, under the opinion of their responsible neurologists, have required or require preventive treatment, in any of its modalities, oral or injectable.

Eligibility Criteria:
Inclusion Criteria:

1. Nummular headache according to the criteria of the International Classification of Headache Disorders, third version (ICHD-3).
2. Nummular headache duration of more than three months.
3. Treatment with a medication with possible preventive drug according to the Clinical Practice Guidelines of the Spanish Society of Neurology21.
4. Age over 18 years.
5. Informed consent signature.

Exclusion Criteria:

1. Diagnosis is better accounted for by any other entity included in the International Classification of Headache Disorders, 3rd version.
2. Serious systemic or psychiatric pathology that makes it difficult to assess the patient.
3. Secondary nummular headache
4. Use of preventive treatment with another indication (e.g., epilepsy, other painful conditions, aesthetic).
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor

This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
2. Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
3. Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
4. ECOG physical condition: 0 or 1 point.
5. Expected survival period exceeds 12 weeks.

Exclusion Criteria:

1. Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
2. Total bilirubin is more than 1.5 ×ULN.
3. Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
4. Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance \<50 mL/min(according to Cockcroft-Gault).
5. International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
6. Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m2.
7. Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).
8. Known a history with brain metastasis.
9. Have a history of liver disease of clinical significance.
10. Known to be human immunodeficiency virus (HIV) positive.
Evaluating a Personalized Trans-Diagnostic Group Therapy for Anxiety

This study is examining the impact of a therapy group for all anxiety disorders provided by the Stanford Department of Psychiatry and Behavioral Sciences's Psychosocial Treatment Clinic on anxiety symptoms, impairment, and access to quality mental health care.

Anxiety disorders are prevalent, impairing, and often precede other psychiatric and medical comorbidity (Kessler et al, 2005). Cognitive Behavior Therapy (CBT) and Acceptance and Commitment Therapy (ACT) are effective, evidence-based treatments for anxiety disorders that can be delivered in either a group or individual format (Deacon \& Abramowitz, 2004; Arch et al 2012). Traditionally, group therapy has been delivered a single diagnosis at a time. This presents challenges to care delivery, however, because a sufficient number of patients with the same diagnosis and the same availability in their schedule must be assembled in order to start a group. Fortunately, CBT and ACT can be used to target key trans-diagnostic constructs such as excessive worry, avoidance, and fear of negative evaluation that may occur in many anxiety diagnoses. Indeed, emerging research suggests these constructs may be closer to the etiological dysfunction in anxiety disorders than the diagnoses themselves and may therefore be the best treatment targets (Craske, 2012). Because of this, there is now movement towards trans-diagnostic approaches that flexibly apply core principles of CBT and ACT to any anxiety disorder.

Group therapy is a cost-efficient and effective care delivery model that is also generally acceptable to patients with anxiety disorders. However, individual therapy is often preferred (Sharp et al, 2004), perhaps due to greater personalization of care relative to standard group therapy. To address this concern the investigators aim to use a pre-treatment assessment to develop a personalized plan for each patient entering a trans-diagnostic anxiety group.

In order to evaluate the effectiveness of this approach, patients enrolled in the group who consent to participate in research will complete assessments of anxiety and related symptoms, quality of life, and cognitive function before and after therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Enrolled in a trans-diagnostic group therapy for anxiety disorders in the Stanford Psychiatry \& Behavioral Sciences' Psychosocial Treatment Clinic.
* English fluency

Exclusion Criteria:

* Unable to provide informed consent
* Acute safety concerns (e.g., suicidality requiring a higher level of care)