cyrilzakka/clinical-trials huggingface dataset:
Progression Delaying Effect of Escitalopram in Alzheimer's Disease

This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.

* Study institutions: Four university hospitals in Korea
* Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial
* Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)

Eligibility Criteria:
Inclusion Criteria:

* Age:40\~90 years
* Education:not illiterate
* Clinical Dementia Rating (CDR):0.5\~2
* Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4
* Dementia according to DSM-IV criteria
* Probable Alzheimer's disease according to NINCDS-ADRDA criteria
* Current ongoing donepezil medication at stable doses (5 \~ 10 mg/day) for at least 2 months

Exclusion criteria:

* Evidence of delirium, confusion or altered consciousness
* Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus
* Evidence of infectious or inflammatory brain disease
* Evidence of serious cerebrovascular diseases
* Current major depressive disorder or other major psychiatric illnesses
* Evidence of serious or unstable medical illnesses which can significantly change cognitive state
* History of alcohol or other substance dependence
* Any antidepressant medications within the previous 4 weeks
* Absence of a reliable and cooperative collateral informant
* Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia
* Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale
The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Aged 25 to 49 years inclusive
* Males and females
* Self-report of good health

Exclusion Criteria:

* English is not first language (some of the cognitive tasks have only been validated in native English speakers)
* Habitual consumption of oily fish exceeds one fish meal per week
* Habitual consumption of omega-3 dietary supplements in the previous 6 months
* Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
* Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)
* Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
* Pregnant, trying to get pregnant or breast feeding
* Body Mass Index outside of the range 18-35 kg/m2
* High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Currently taking blood pressure medication
* Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
* Have frequent migraines that require medication (more than or equal to 1 per month)
* History or current diagnosis of drug/alcohol abuse
* History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
* History of neurological or psychiatric illness (excluding depressive illness and anxiety)
* History of head trauma
* Sleep disturbances and/or are taking sleep aid medication
* Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
* Diagnosis of type I or type II diabetes
* Heart disorder, or vascular illness
* Current diagnosis of depression and/or anxiety
* Over- or under-active thyroid
* Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
* Any known active infections
* Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
* Current or past breast cancer diagnosis and/or a mastectomy
* Health condition that would prevent fulfilment of the study requirements
* Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder

This study will examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder.

The major aim of this proposal is to examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder.

The specific aims are to create a research and supervisory team and to identify potential moderators of treatment response and mediators of outcome over the course of treatment.

Members of the team will meet weekly to begin a treatment development process for enhancing Interpersonal Social Rhythm Therapy (IPSRT) for these patients. Additional assessment measures will be utilized to examine the proposed mediators and moderators of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar I Disorder with Comorbid Borderline Personality Disorder, currently manic or depressed

Exclusion Criteria:

* Unstable Medical illness
TST001 in Patients With CLDN18.2 Positive Previously Treated Advanced Biliary Tract Cancer

TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer.

TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. Claudin18.2 (CLDN18.2) protein is one of the family of tetraspanning proteins expressed at epithelial tight junctions and primarily expressed only in normal gastric tissues . CLDN18.2 protein is a pancancer target expressed in primary lesions and metastases of variouscancer types, including gastric cancer, biliary tract cancer and others. Current available information indicates that CLDN18.2 is a promising therapeutic target for the treatment of solid tumors.

This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer. Eligible patients will be treated with TST001 until disease progression or other discontinuation criteria met. If there is ≥ one objective response among the first 15 enrolled patients, then the trial continues to enroll a total of 40 patients; if not, then the trial discontinues.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, unresectable advanced or metastatic biliary tract cancer.
* Patients failed at least one prior line of systemic medications; if patients had disease progression during or within 6 months after the completion of adjuvant therapy or neoadjuvant therapy, the adjuvant therapy or neoadjuvant therapy could be regarded as one line of therapy.
* CLDN18.2 expression positive confirmed through tumor tissue.
* Patients with at least one measurable disease according to RECISTv1.1.
* ECOG PS of 0 or 1.
* Patients have predicted life expectancy ≥ 12 weeks.
* Paitients with adequate cardica, liver, renal function, etc.

Exclusion Criteria:

* • History of another concurrent primary malignancy.

  * Untreated or symptomatic CNS metastases.
  * Prior treatment targeting CLDN18.2.
  * Major surgical procedure, prior locoregional therapy such as radioembolization within 28 days prior to the first dose of study drug.
  * Prior serious hypersensitivity to monoclonal antibody or any component of the investigational drug.
  * Patients had any of the following within 6 months prior to first dose of study treatment: cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris, heart failure NYHA III or IV degree, or uncontolled uarrhythmia requiring intervention.
  * Patients who are pregnant or lactating.
Telerehabilitation in Patients With Osteoarthritis

Randomized controlled study on the effectiveness of Telerehabilitation intervention on subjects with knee osteoarthritis. Subjects will be randomized into two groups. The experimental group perform 3 sessions a week for 4 weeks of TR, the control group 3 sessions a week for 4 weeks of conventional rehabilitation c/o IOR rehabilitation gym. Follow-up at 3 months.

Inclusion criteria

1. Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more indications, OARSI criteria.
2. Male or Female, aged \&gt; 18 years
3. Participant is willing and able to provide informed consent for participation in the study.
4. Subjects must be able to use an electronic device (pc, tablet, smartphone). Exclusion criteria

1. Participation in another clinical study with any investigational agent within 30 days prior of the study screening.

2. Inability to use an electronic device (pc, tablet, smartphone) 4. Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal.

5. Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological.

6. Children under the age of 18 8. NPRS value \<3 7. BMI \>25


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more articulations, OARSI criteria.
* Male or Female, aged \&gt; 18 years
* Participant is willing and able to provide informed consent for participation in the
* study.
* Subjects must be able to use

Exclusion Criteria:

* Participation in another clinical study with any investigational agent within 30 days prior
* of the study screening.
* Inability to use an electronic device (pc, tablet, smartphone)
* Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal.
* Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological.
* hildren under the age of 18
* Numeric Pain Rating Scale(NPRS) value \<3
* BMI \>25
A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the treatment of attention deficit and emotional, executive function and social function dysregulation due to attention deficit disorder (ADHD).

Participations will be randomly assigned to 3 groups which are CBT with booster sessions group, CBT only group and waiting group.With the comparison of first tow groups we will explore the effect of booster sessions, and the last two groups the effect of CBT programme.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients from Peking University Sixth Hospital
* Diagnosis of adult ADHD based on Diagnostic and statistical manual of mental disorders, Fourth Edition (DSM-IV)
* Stable on medications for adult ADHD for at least 2 months

Exclusion Criteria:

* Severe major depression, clinically significant panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
* Intelligence Quotient (IQ) less than 90
* Suicide risk
* Unstable physical condition
* Prior participation in cognitive behavioral therapy for ADHD or other psychological therapy
Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy

This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches.

PRIMARY OBJECTIVE:

I. To evaluate immune profile of AML patients receiving venetoclax plus azacitidine induction chemotherapy.

SECONDARY OBJECTIVE:

I. To determine clinical responses based on immune infiltrated vs immune depleted subtypes of AML receiving azacitidine and venetoclax chemotherapy.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy
* Treatment naive adult acute myeloid leukemia patients

Exclusion Criteria:

* Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded
* Patients who are pregnant or breast-feeding
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).

All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.

Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration \<7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA)
* be in preadolescence (Tanner stage 1) and have a CA \> 3 years
* have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV.
* receive no prior GH treatment.
* sign informed consent

Exclusion Criteria:

* 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
* 2.Known hypersensitivity to Somatropin or any other components of the study product.
* 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
* 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
* 5. Subjects took part in other clinical trial study during 3 months.
* 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease
2. treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027.
3. availability of inpatient and/or outpatient medical records for clinical data collection

Exclusion Criteria:

1. histological diagnosis other than adenocarcinoma
2. patients who have received multiple lines of ADT for mCSPC
3. patients who have received docetaxel or ARTA for metastatic castration-resistant disease
Relationship of Cervical Region Tension With Vagal Function

The increase in the tension of the soft tissues around a nerve restricts the movement, affects the function of the nerve, and makes the nerve vulnerable to entrapment. Even a mild nerve compression can cause entrapment and lead to neuroinflammation. It is known that inflammatory mediators amplify axonal sensitivity. Although the spontaneous discharge potential of visceral afferents is quite low under normal conditions, neuroinflammation increases the excitability of these fibers. With this mechanism, hyperalgesia may develop in sensory fibers in neuroinflammation. This may cause pathologies in the organs innervated by the relevant nerve.

The fascia and muscles of the cervical region surround the vagus nerve. There are two main fascial compartments in the cervical region. The SCM and trapezius muscle fascias join to the most superficial fascia of the deep cervical fascia and they together form these compartments. These fasciae superiorly attach to the cranium and inferiorly to the pectoral region. The vagus nerve emerges from the jugular foramen together with the 9th and 11th cranial nerves. It then continues through the carotid sheath in the cervical region. The carotid sheath is in contact with the SCM muscle. For this reason, it can be thought that SCM muscle tension or thickness may affect the carotid sheath and thus the function of the vagus nerve passing through it.

In summary, deterioration in vagus nerve activity plays a role in pathologies of the organs innervated by the vagus. Although the relationship between vagal dysfunction and gastrointestinal system symptoms is clear, the mechanisms affecting vagus nerve function have not yet been clarified. It has been reported in the literature that some maneuvers from the cervical region are also effective on the vagus nerve. Also, according to investigators' clinical experience, gastrointestinal symptoms are frequently observed in patients with increased cervical soft tissue tension. However, there are not enough studies investigating whether the cervical region soft tissue tension can affect the gastrointestinal system via the vagus nerve. Therefore, this study was planned to examine the relationship of cervical soft tissue tension with vagus nerve function and gastrointestinal symptoms in asymptomatic individuals and individuals with neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Being 18-50 of age,
* Having less than 30 body mass index,
* Being a volunteer

Exclusion Criteria:

* Having any type of malign disease,
* Being diagnosed with a systemic disease (cardiologic, gastrointestinal, rheumatological, neurological, etc.),
* Having any type of surgery within the last 6 months,
* Being diagnosed with Whiplash syndrome
* Having an unhealed fracture
* Pregnancy
* Using prescribed medicine for the gastrointestinal system
Testing the Influence of Different Sugary Drink Warning Label Designs

The aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. Parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic sugar warning labels; or 4) graphic health warning. This study will provide data comparing the influence of sugary drink text warning labels and two kinds of graphic warning labels.


Eligibility Criteria:
Inclusion Criteria:

1. a primary caregiver of a child 6-to-11 years old;
2. ≥18 years old; and
3. can read and speak English

Exclusion Criteria:

1. not a primary caregiver of a child 6-to-11 years old;
2. \<18 years old; and
3. cannot read and/or speak English