cyrilzakka/clinical-trials huggingface dataset:
Treatment of Depression and/or Anxiety - the Tree Theme Method® (TTM) as an Intervention

Depression and anxiety are among our most common diseases and the prevalence is increasing. When suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. The Tree Theme Method® (TTM) is a treatment method. The purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. The method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. The TTM is a short-term therapy with five sessions. The treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions.

The aim of the project is to investigate the effects of the TTM compared to a control group for people with depression and anxiety diagnosis. The intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. The study has been approved by the Regional Ethical Review Board.

The project is a randomized multicenter study with an intervention group and a control group. A total of 130 patients will be included. Inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. Exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires.

The project implies that doctors will refer appropriate patients to the occupational therapist. After informed consent each patient will be drawn to the TTM or control. Before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health.

The study is a collaborative project involving the Region Skåne, Kronoberg County Council, and Jönköping County Council. Doctors will recruit patients and occupational therapists will perform the treatment. The research team comprise of researchers from Kronoberg County Council (B Gunnarsson and K Hedin), Lund University (C Håkansson) and School of Health Sciences in Jönköping (P Wagman).


Eligibility Criteria:
Inclusion Criteria:

* Depression and/or anxiety in age of 18-65 years and problems with everyday occupations.

Exclusion Criteria:

* Severe somatic illness or psychosis and/or difficulties to understand and fill out self-rating questionnaires
BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours

* To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);
* To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed diagnosis of malignancy that is advanced and for which standard therapies do not exist or are no longer effective.
* Life expectancy at least 12 weeks
* Eastern Cooperative Oncology Group Performance Status 0 or 1
* Adequate hepatic, renal, haematologic and other organ function
* Written informed consent

Exclusion criteria:

* Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks
* Prior treatment with afatinib and or vinorelbine
* Clinically significant active infectious disease
Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules

This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor


Eligibility Criteria:
Inclusion Criteria:

* 1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.

  2. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.

  4. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.

  6.Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .

  4. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.

  5. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.

  9. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.

  12. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.

  13. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.

  14. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Doxazosin and Ramipril in Hypertension

Randomized double-blind parallel group study in patients with mild-to-moderate hypertension to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.

This study aims to answer the following questions: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension? 2) Are the potential antithrombotic effects of doxazosin different to the effects of an ACE inhibitor? 3) Is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents?

The co-primary outcomes are changes in endothelial function assessed by flow mediated vasodilatation, and in haemostatic function measured by the generation of thrombin-antithrombin complex.

Eligibility Criteria:
Inclusion Criteria:

* Primary mild-to-moderate hypertension

Exclusion Criteria:

* Pregnancy and lactation
* Recent (6 months) malignant disease or ongoing treatment for malignancy
* No absolute indication or contraindication for any of the study drugs
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID:HPV-PRO-006-2, Identifiers: NCT02562508) and received at least one dose;
2. The legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization;
3. Participants under the age 18, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18 and older agree to sign the written informed consent;
4. Able to comply with the requests of the study;

Exclusion Criteria:

1. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;
2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes

A single center, prospective, one arm clinical study to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML( acute myeloid leukemia) and myelodysplastic syndromes.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 60 years.
2. Patient is a candidate for allogeneic hematopoietic cell transplantation due to acute myeloid leukemia(intermediate or high risk acute myeloid leukemia in complete remission, low risk with positive Minimal residual disease) or high risk myelodysplastic syndrome.
3. Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
4. Patient signed informed consent form prior to any study related screening procedures are performed.
5. Patient has Eastern Cooperative Oncology Group performance status score of 0 or 1.
6. Patient is a candidate for allogeneic hematopoietic cell transplantation from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.

Exclusion Criteria:

1. Has received more than 1 allogeneic hematopoietic cell transplantation.
2. Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
3. Known active human immunodeficiency virus, hepatitis B virus or hepatitis C virus infection (positive polymerase chain reaction test) or risk of hepatitis B virus reactivation (Hepatitis B surface antigen positive).
4. Presence of active disease in acute myeloid leukemia patients.
5. History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
6. Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration \> 3.0 upper limit of normal
7. Currently pregnancy or breast feeding.
8. Treatment of any other investigational agent in the same time as this study.
9. Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
10. Women of childbearing potential who do not agree to use two effective methods of contraception.
Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults

Older adults develop modifications in the execution of movement that lead to impairments in activities of daily living performance. Accordingly, there is a need for technological advances in devices that assist older adults targeting improvements in parameters of movement performance that have the highest impact on the skills of daily living. Therefore, to gather the parameters of movement impacting daily living activities, the main goal of this study is to perform a comparative analysis of the biomechanical movement parameters between older adults with and without disability, performing the tasks: gait, sit-to-stand, timed up and go, quiet standing and climb and descend stairs.

This work was supported by theFundação para a Ciência e Tecnologia (FCT), \[grant number 2020.05356.BD\] and through R\&D Units funding \[UIDB/05210/2020\], Fundação para a Ciência e Tecnologia (FCT), Portugal and the European Union.


Eligibility Criteria:
Inclusion Criteria:

* older adults, 60 years or over;
* community-dwelling;
* able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;

Exclusion Criteria:

* older adults who are institutionalized;
* older adults who have established diagnosis of malignancy or terminal diseases with an anticipated survival of less than 1 year;
* older adults who have stroke history, cerebral hemorrhage, head trauma, or Parkinson's disease;
* older adults who have cognitive impairment, specifically Mini Mental State Examination (Portuguese version) score of 22 for 0 to 2 years of literacy, 24 for 3 to 6 years of literacy and 27 for more than 6 years of literacy (Morgado et al., 2009);
* older adults who have rheumatic pathologies that interfere with the tasks performance;
* older adults who have diabetic foot, lower limb fracture less than 6 weeks, or other related conditions;
* older adults who have unstable cardiovascular disease, liver or renal function failure;
* older adults who have a body mass index greater than or equal to 30 kg/m2;
* older adults who vestibular and/or audition or vision impairments non corrected that influence the performance of tasks;
* older adults who presence of symptoms at the time of evaluation that influences the participant performance of tasks.
Can a Rapid 2 Day Followup After Discharge From the ED Reduce Readmissions and Death for Patients 75 Years and Older?

Our hypothesis is that a rapid follow up for elderly patients in a Geriatric Clinic discharged from the Emergency Department (ED) will have fewer unplanned return ED visits and fewer unplanned hospital admissions with no attendant increase in mortality.

Patients 75 years of age and older will be randomized following discharge from the ED into two groups. The first will receive standard post ED care. The second will receive an appointment to our Geriatric Clinic within 2-3 days for stabilization, further treatment and contact with the patient's primary physician to communicate the course of the patient's illness and to schedule subsequent follow-up with the patients regular medical provider.

There will be two primary outcomes: The first will be a composite of morality and/or return to the ED at 30 days, and the secondary primary outcome will be mortality. Economic data regarding resource utilization by patients will also be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* All patients 75 years of age and older discharged from the ED

Exclusion Criteria:

* Younger than 75.
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease

The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Crohn's disease involving predominantly the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
* Harvey Bradshaw Index of at least 7
* The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
* Written informed consent

Exclusion Criteria:

* Concomitant corticosteroids, including budesonide
* Corticosteroids within the previous 2 months
* Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
* Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
* Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
* If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months
* Current experimental drugs or experimental drugs within the last 3 months
* If the severity of the flare has started to decrease spontaneously
* Coexisting diagnosis of primary sclerosing cholangitis,
* Infectious diarrhea,
* Signs of intestinal obstruction or perforation or abscess,
* New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare,
* Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare
* Allergy or sensitivity to salicylates
* Pregnancy or breast-feeding
* Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active
* Severe renal or hepatic disease
Expression of S100A2 and Trefoil Factor Family Members in Epstein-Barr Virus Related Gastric Cancer

The investigators hypothesize that aberrant hypermethylation of tumour suppressor genes is an important mechanism for Epstein-Barr Virus (EBV) - related gastric carcinogenesis, the promoter hypermethylation status and the expression of S100A2 and TFF1 might be different between EBV-associated gastric cancer (GC) and non EBV-associated GC.


Eligibility Criteria:
Inclusion Criteria:

* Nil

Exclusion Criteria:

* Nil
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent;
* Provide written assent (of study subject);
* Adolescent ≥12 and \<18 years of age;
* Have a BMI ≥ the 95th percentile of BMI for age and gender;
* Female subjects must be using adequate contraception;
* Willing and able to comply with all study requirements

Exclusion Criteria:

* Condition or disease interfering with metabolism;
* Any medical treatment with insulin;
* Hyperthyroidism, or clinically significant hypothyroidism;
* Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
* Use of chronic systemic glucocorticoid or steroid therapy;
* History of any eating disorders;
* Any history of laxative abuse;
* Prior bariatric surgery;
* Any history of nephrolithiasis;
* Any history of epilepsy, or treatment with anti-seizure medications;
* Positive urine drug screen;
* Current smoker or smoking cessation within the previous 3 months of screening;
* Obesity of a known genetic or endocrine origin;
* Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
* Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
* Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
* Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.
Maternal Vitamin D for Acute Respiratory Infections in Infancy

There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.

In this study, an acute respiratory infection (URTI and/or LRTI) has been clinically defined as:

A) Upper respiratory tract infection (URTI)

A new-onset illness consisting of at least two of the following clinical criteria at any time during a surveillance week:

* Caregiver-reported cough;
* Caregiver-reported rhinorrhea;
* Caregiver-reported nasal congestion; and,
* Measured axillary temperature greater than or equal to 37.5°C.

B) Lower respiratory tract infection (LRTI)

1. New onset clinically-diagnosed LRTI:

   * Caregiver-reported cough AND/OR difficulty breathing during a surveillance week; AND,
   * Observed lower chest wall indrawing AND/OR elevated respiratory rate (60 breaths per minute or greater for infant up to 59 days of age, or 50 breaths per minute or greater for infant 60 days of age or older)
2. Hospitalized LRTI

   * Hospitalization with physician diagnosis of pneumonia or bronchiolitis

Eligibility Criteria:
Inclusion Criteria:

* Infants born to women enrolled in the MDIG trial (NCT01924013).
* Maternal inclusion criteria (at time of enrolment) will be:
* At least 18 years of age
* 17 to 24 completed weeks of gestation
* Intends to permanently reside in the trial catchment area for at least 18 months
* Family plans to reside in catchment area for the first 6 months postnatal
* Provides written informed consent for participation

Exclusion Criteria:

* Mother withdrawn from MDIG trial prior to delivery
* Failure to provide consent for participation in sub-study
Psycho-Social Outcomes Following Emergency Laparotomy

An emergency laparotomy (EmLap) is a life-saving operation; but the aftermath for those that do survive can be lifechanging. Each year, in excess of 25,000 EmLaps are performed in UK. A national effort, through the National Emergency Laparotomy Audit (NELA), has managed to improve peri-operative care, and reduce 30 day mortality from 1 in 4 to less than 1 in 10. Whilst this reduction should be commended, it also means that more patients are surviving with some form of new infirmity.

This infirmity may be short-lived and reversible in some, and yet others may transition into a permanent chronic disease state. The impact of EmLap on those individuals that "do not fully recover" is far-reaching and often interlinked, covering biological, social and psychological domains. This makes it difficult to describe the true problem, i.e. holistic morbidity and suggest an intervention to improve it.

The primary aim of this work is to describe the holistic morbidity of EmLap throughout the first year of a patient's recovery.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or above
* Able to communicate in English
* Cognitively able to complete the questionnaire
* Able to provide informed voluntary consent
* Undergone an EmLap during admission
* Clinical team anticipate to be "medically fit for discharge" within 48 hours (of consent)

Exclusion Criteria:

* Any terminal diagnosis in which the clinical team do not anticipate life expectancy to exceed 6 months from the time of surgery
* Acutely unwell at the time of recruitment. These patients may still be eligible and can be re-screened and recruited at a later date, should their condition improve.