cyrilzakka/clinical-trials huggingface dataset:
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or

   Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:
   * Obesity (BMI ≥30 kg/m2)
   * Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
   * ALT \>1.5× upper limit of normal (ULN).
3. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
4. Stable body weight.

Exclusion Criteria:

1. Model for End-stage Liver Disease (MELD) score \>12
2. ALT ≥10× ULN
3. HbA1c \>9.5%
4. Total bilirubin \>1.5 mg/dL
5. Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
6. History of liver transplant, or current placement on a liver transplant list
7. Current or history of significant alcohol consumption
8. Prior or planned ileal resection, or prior or planned bariatric surgery
9. Histological presence of cirrhosis
10. History of biliary diversion
11. Known positivity for human immunodeficiency virus infection.
12. Acute cholecystitis or acute biliary obstruction.
13. BMI \>45 kg/m2
Effectiveness of a Digital Health Application for Primary Hypertension (Liebria)

This clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension.

This clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension. Inclusion criteria are: age ≥ 18; presence of primary hypertension (confirmed by medical certificate or equivalent); unmedicated or with existing antihypertensive drug therapy (with stable dose in the past 6 weeks prior to study enrolment); last reported office-based systolic blood pressure (SBP) ≥ 140 mmHg followed by home-based SBP ≥ 135 mmHg; consent to participate. Exclusion criteria are: home-based SBP \> 180 mmHg; \> triple combination of antihypertensive medication; history of secondary hypertension (e.g., thyroid disease, kidney disease); pregnancy.

Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to liebria in addition to treatment as usual (TAU, n = 164), or to a control group, in which they will receive a relevant brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU (n = 164). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e. g. cardiologist).

The primary endpoint will be home-based SBP, with 6 months post-allocation being the primary time point for assessment of effectiveness. Three months post-allocation will be used as an additional endpoint. Secondary endpoints will be patient activation, social and work-related functioning, medication adherence, home-based diastolic blood pressure (DBP), and pulse pressure.

Analysis of effectiveness of the intervention will be performed by ANCOVA of the primary endpoint and all secondary endpoints, in which the posttreatment scores will be compared between treatment groups (intervention group vs. control group), using the baseline scores of the respective outcome as a covariate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Presence of primary hypertension, confirmed by submission of a medical certificate or equivalent (e.g., informal letter signed by primary care physician); relevant ICD-10-GM diagnoses:

  * I10.00 (Benign essential hypertension: Without indication of hypertensive crisis)
  * I10.90 (Essential hypertension, unspecified: Without indication of hypertensive crisis)
* Unmedicated or with existing antihypertensive drug therapy (with stable dose in the past 6 weeks prior to study enrolment)
* Last reported office-based systolic blood pressure (SBP) ≥ 140 mmHg followed by home-based SBP ≥ 135 mmHg
* Consent to participate

Exclusion Criteria:

* Home-based SBP \> 180 mmHg
* \> Triple combination of antihypertensive medication
* History of secondary hypertension (e.g., thyroid disease, kidney disease)
* Pregnancy
Changes in Nasal Patency With Changes in Posture, Temperature, Humidity and Nasal Patency Seen by Acoustic Rhinometry

To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal patency with acoustic rhinometry.

The purpose of this study was to utilize acoustic rhinometry to assess changes in nasal patency after alterations in posture, unilateral mechanical obstruction, temperature, and humidity.

Eight healthy adult volunteer subjects underwent acoustic rhinometry under the following conditions: 1) upright, sitting position (control), 2) supine position, 3) left lateral recumbent position, 4) one nostril mechanically blocked, 5) icepack on neck, 6) drinking cold water, 7) drinking hot water, 8) nasal nebulizer, 9)oxymetazoline decongestant.

Changes in nasal cavity volumes were detected by acoustic rhinometry after alterations in posture, unilateral mechanical obstruction, temperature, and humidity. Nebulizer treatment and hot water ingestion caused a significant decrease in nasal volume. The nose was able to adapt to environmental and physiological changes in order to maintain a consistent total nasal volume.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18-58 years old

Exclusion Criteria:

* Any nasal symptoms in the last 3 weeks
* Marked septal deviation/polyposis/infection
* Any history of allergy, asthma or immunodeficiency
* Any systemic condition or infection (e.g., hypertension/diabetes/heart, liver, thyroid or kidney disease
* Any spine or neck condition that would not allow normal postures
* Pregnancy
Exergames on Shoulder Pain and Motor Function

This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke.

Background and Purpose: Stroke is a major cerebrovascular disorder causing various symptoms in the world. A substantial portion of those surviving from stroke typically experience neurological sequelae and stroke-related complications. Post stroke shoulder pain is a sensory disturbance is one of a common complication in patients with chronic stroke and may adversely affect patients' quality of life. Nowadays, exergame has been explored as an adjunct therapy for the management of pain for a number of conditions. This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke. Method: This is a randomized controlled trail. Sixty subjects with poststroke shoulder pain will be recruited and randomized into either the exergame (experimental) group or conventional (control) group. The intervention is one hour per day, four or five days per week for three weeks. The primary outcomes are Visual Analogue Scale, and Brief Pain Inventory - Short Form. The secondary outcomes are Fugl-Meyer Assessment for Upper Limb Extremity, Wolf motor function test and Shoulder Pain and Disability Index.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral hemiplegia caused by stroke
2. Modified Ashworth Scale ≤2。
3. Mini-Mental State Examination ≥24。
4. Age ≥20。
5. Shoulder pain 。

Exclusion Criteria:

1. Shoulder joint contructure
2. Forzen shoulder
3. Dizzness, lesion of auditory and vision.
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.

Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.

Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.

Patients referred for suspected chronic compartment syndrome causing will be included.

After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.

Eligibility Criteria:
Inclusion Criteria:

* Affiliation to the French National healthcare system
* French speaking patients
* Referred for investigation of compartment syndrome causing

Exclusion Criteria:

* Pregnancy
* Inability to understand the study goal
* Patients protected by decision of law
* Extended dermatosis
* Coagulation disorder
Prospective Bladder Cancer Infrastructure (ProBCI)

Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands


Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer
* Any stage except Ta
* 18 years or older
* Written informed consent

Exclusion Criteria:

* No exclusion criteria

Note: participation in ProBCI does not exclude the patient from participation in other studies.
Ultrasound Guided Octreotide LAR Injection in Acromegaly

Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of active acromegaly based on evidence of a pituitary tumor
* Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) \< 1 ng/mL during an oral glucose tolerance test
* Previous treatment with a stable dose of octreotide LAR for at least 3 months
* No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity

Exclusion Criteria:

* Uncontrolled diabetes mellitus
* Pregnant or breast feeding
* Current gallstones
* History of hepatic disease, except patients with \< 3 X ULN LFTs indicative of hepatic steatosis
* Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
* History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy
* History of investigational drugs administered or received within 30 days of study entry
* Known hypersensitivity to octreotide LAR
* Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor
Introduction Seminar About Patient Participation and Treatment Options for Psychiatric Patients on Waiting List

Patient participation is a central concept in Norwegian health policy. It is mandatory in hospitals and emphasised as one of the most prioritised areas by the Government. Studies from Norway have repeatedly found that patients who seek help in community mental health centres ("DPS") are dissatisfied with the information they receive and about their possibility for real influence in their treatment.

One way to improve individual patient participation might be to give patients information before they start their treatment. This can be done as group based patient education to reduce the resources needed. Furthermore, as there are waiting lists for treatment, such introduction seminars could be held while patients are waiting to use this time in a meaningful way.

The present study therefore aims at testing the effect of an introduction seminar for patients on waiting list in a community mental health centre.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years referred for out patient treatment who get a guarantee of starting treatment between 2 and 6 months will be included.

Exclusion Criteria:

* patients with a guarantee of starting treatment in less than two months and
* patients who do not understand the consequences of taking part in the study
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder

The purpose of this study is to determine if evening amber glasses combined with stable wake times will show an increase in total sleep time (TST) and an advance in sleep onset times (shift earlier) compared to the control group.

We propose a 3-week field study that examines the efficacy, acceptance, and compliance of using evening amber glasses to block evening light combined with a stable wake time in adolescents (14-17 years) with DSWPD (International Classification of Sleep Disorders \[ICSD-3\] criteria).3 After 1 week of baseline measurements, subjects will be instructed to wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before individually calculated midsleep time measured during the preceding week. This corresponds to the time when adolescents are most sensitive to phase delaying light according to Co-I Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22 This "amber glasses + stable wake time" group will be compared to a control group: adolescent DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach the eyes, otherwise identical in appearance) in the evening at the same times as the alternate group, but without scheduled wake times. Outcome measures will include TST and sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO, and assessments of acceptance and compliance.

Eligibility Criteria:
Inclusion Criteria

* Regular school attendance in the setting of a fixed start time.
* Adherence to ICSD-3 DSWPD diagnostic criteria.
* Average spontaneous weekend wake time ≥1 hour than school day wake time.
* Initiation of school-night sleep at 12 a.m. or later, ≥50% of the time, during a 14-day period (items 3-4 to be determined by sleep logs and actigraphy). As there are no discrete clock times associated with the ICSD-3 DSWPD description, this cutoff is based on data obtained from the 2006 Sleep in America Poll and experiences gleaned from prior recruitment.

Exclusion Criteria

* A positive urine drug abuse screen will disqualify the individual from further participation.
* Subjects will be withdrawn from the study if the sleep log and wrist monitor activity does not correspond with the sleep schedule identified with the pre-study sleep log.
* Alcohol and nicotine use will also be screened to qualify for the study. We will also screen for alcohol immediately before each DLMO assessment because alcohol acutely suppresses melatonin.
* Patients receiving medications that might contribute to sleep disturbances and/or affect treatment responses will be considered ineligible (e.g., hypnotics, antidepressants, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs), beta blockers).
* All subjects will be asked to refrain from caffeine use on the days of phase assessments, and to cease ingestion at least 6 hours prior to nightly bedtime.
* The Ishihara Color Blindness Test will be done and patients who are color blind/deficient will be disqualified from participating in the study.
Oxytocin's Effects on Face Attentional Processing

To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on attentional processing of emotional faces.

In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate the effect of oxytocin treatment on attentional processing of emotional faces. Subjects complete questionnaires in Chinese versions before treatment administration, including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory, Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search Task. In the first task, subjects need to make a response to judge the position of target after a cue-target is presented. In the second task, subjects are asked to search the target "U" or inverted "U" placed on the nose of emotional/neutral faces and make an choices based on their oorientation. During these phases, subjects' response accuracy, response time and electrophysiological activity (ERP) are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.


Eligibility Criteria:
Inclusion Criteria:

Stage I-III Criteria-

* Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
* Absence of metastatic disease evident from:

  * physical examination
  * the most recent chest X-ray
  * abdominal CT or ultrasound scan
* Life expectancy of at least 3 months
* WHO performance status of 0 to 1
* Written informed consent given

Stage IV Criteria-

* Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
* Life expectancy of at least 3 months
* WHO performance status of 0 to 2
* Written informed consent given

Exclusion Criteria:

* History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
* Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
* Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
* Females who were pregnant, planning to become pregnant or lactating
* Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
* Previous G17DT treatment
* Haematological indicators:

  * Haemoglobin \<10.0g/dl
  * White blood cell count \<4.0 x 109/l
  * Platelets \<100 x 109/l
The Effects of LY2409021 on the Liver

This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study will image the liver using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus, when they take LY2409021 to see if liver changes happen at the same time as changes in blood tests. This study is approximately 11 weeks long, not including screening. A screening appointment is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
* Must have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m\^2) if a healthy participant, or a BMI of 18.5 to 35.0 kg/m\^2 if diabetic

For participants with type 2 diabetes mellitus (T2DM):

- On diet and exercise treatment, or taking metformin

Exclusion Criteria:

For all participants:

* Have signs or symptoms of liver disease
* Are infected with hepatitis B or hepatitis C
* Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
* Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
* Have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (MRI) scan

For participants with T2DM:

- Are using insulin
Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults

Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. The intervention was implemented in two universities in the United Arab Emirates

Poor eating habits and sedentary lifestyle are common among young adults and increase risk for chronic diseases in subsequent years of life. Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students. The study intervention was guided by Social Cognitive Theory. The study involved the development of a website, integrating educational material and mobile applications for monitoring diet and physical activity and a16-week feasibility trial to promote weight loss, improve food choices and increase physical activity levels. The trial consisted of two arms: Rashakaty Basic (R-Basic) and Rashakaty Enhanced (R-Enhanced).

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese (BMI ≥25.0
* Adults: Female
* Age: 18-35 years
* Current user of a smart phone
* Student in one of the two target universities in the United Arab Emirates
* Living in or off the university campus

Exclusion Criteria:

* Past or planned weight loss surgery
* Pregnant or breastfeeding
* Lost 7 kg in the past 3 months
* Following any weight loss program for 3 months or more
* Taking any steroid or thyroid hormones treatment or any other medication that may affect body weight
* Enrolled in medical and nutrition programs since one of the program components was nutrition knowledge assessments