cyrilzakka/clinical-trials huggingface dataset:
A Pilot Trial of Interpersonal Psychotherapy for the Treatment of Depression in Patients With Prostate, Colorectal, Lung and Pancreatic Cancer

There is now overwhelming evidence documenting the efficacy of psychotherapy in the treatment of depression in the general population. Surprisingly, however, given the high prevalence of depression in cancer patients, there are very few studies on the efficacy of psychotherapy in this population. Published studies of psychotherapy in cancer patients generally include patients with high heterogeneity of psychiatric diagnosis and frequently include patients without a psychiatric diagnosis, with the aim of preventing the appearance of a psychiatric disorder. This heterogeneity complicates the interpretation of the efficacy and specificity of these interventions. Specifically, the efficacy of psychotherapy for major depression in patients with cancer is unknown.

Interpersonal psychotherapy (IPT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) in several controlled trials. This study will test the efficacy of IPT in a group of prostate, colorectal, lung and pancreatic cancer patients with a diagnosis of major depressive disorder.

We will test the efficacy of IPT using a variety of outcome measures at different time points of the treatment. Those scales will evaluate the patient's depressive symptoms, psychosocial functioning and quality of life. Patients that are deemed eligible for the study will have IPT for twelve weeks. Patients will receive twelve 50-minute sessions over 16 weeks. To facilitate access to treatment, sessions 1,2,3,4, 8 and 12 will be in person, while all others will in be person or over the telephone according to the patient's choice. Sessions will be audiotaped and periodically reviewed by experienced supervisors to assess therapist's adherence to IPT technique. This taping will be optional and is covered in a separate consent form. This pilot study is to prove feasibility and acceptability of IPT in this population and to show preliminary efficacy.

Eligibility Criteria:
Inclusion Criteria:

* A primary psychiatric diagnosis of Major Depressive Disorder as defined by DSM-IV
* Diagnosis of prostate, colorectal, lung or pancreatic cancer (stage 1-4)
* A score of 16 or above in the 17-item HAM-D (Hamilton depression scale)
* Male or female ages 18-75.
* Ability to give consent
* English and/ or Spanish Speaking

Exclusion Criteria:

* Lifetime history of psychosis or bipolar disorder
* History of substance abuse or dependence in the three months prior to the study.
* Current suicide risk.
* Patients who have ever failed IPT in the context of cancer.
* Patients who are receiving effective medication for depression
* Patients with T3, T4 and THS abnormal values
The Impact of Performing Arts on Mental Health, Social Connection, and Creativity in University Students

The goal of this clinical trial is to investigate whether the "Movin' \& Groovin' for Wellness" (MGW) performing arts program is able to support mental, social, and emotional health in NUS students. It will also assess the program's impact on students' well-being. The main questions it aims to answer are:

1. Does participation in the program decrease depressive symptoms, stress levels and anxiety?
2. Does the program foster creative expression among participants?
3. Does the program foster social connections among participants?

Researchers compare the effects of the facilitated music and dance sessions (MGW program) to a Control group that does not participate in these activities. Participants are randomly assigned into either the Experimental (MGW) group or Control group.

Those in the Experimental group are randomly allocated to one of two subgroups, where participants either experience drumming or dancing sessions first (for 5 weeks), followed by the other activity (e.g., the only difference between subgroups is the order in which they experience the facilitated sessions). Both the drumming and dancing sessions are led by trained professionals. The sessions are held weekly for 10 weeks in dedicated performance rooms. Participants also complete questionnaires, and have the opportunity to participate in a focus group discussion to provide feedback about the program.

Control group participants complete the same questionnaires at the same time points without participating in the activities. The program aims to evaluate the effectiveness of music and dance in promoting mental health, social well-being, and creativity among university students.


Eligibility Criteria:
Inclusion Criteria:

* Be currently enrolled in NUS
* Be between the ages of 18-40 years old
* Be fluent (speak and write) in English
* Able to commit to attending the live sessions for the entire 10-week period
* Have normal or corrected-to-normal hearing and vision

Exclusion Criteria:

* Have been diagnosed with a neurological or hearing impairment, or a physical impairment that would prevent moving/dancing
* Are taking medicine to treat their mental health (as this would be a confound in the study)
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction.

Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgeries under general anesthesia.

Exclusion Criteria:

* Patients with contraindications of dexmedetomidine.
* Patients younger than 18 years old and older than 65 years old.
Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma

The purpose of this study is to develop an evidence-based educational program for scleroderma patients with hand dysfunction. The program includes a self-care handbook and multimedia video resources. The study aims to answer:

Does the intervention improve hand function in the experimental group compared to the control group? Does the intervention improve self-care knowledge of hand dysfunction? Does the intervention improve overall health?

Participants will receive an 8-week program, while the control group receives usual care. Outcome measures include hand function, overall health, and self-care knowledge.

The study will adopt a repeated measures randomized controlled trial design (parallel randomized controlled trial) using convenience sampling. Participants in the experimental group will receive an "evidence-based scleroderma hand dysfunction education program" provided by the researchers for eight weeks. The control group will receive standard medical care during the study period and will receive the same scleroderma hand dysfunction education program as the experimental group after the study concludes. Both groups will undergo pre-intervention assessments, as well as post-intervention assessments at the fourth and eighth weeks. The primary outcome measures include evaluating the effectiveness of the education program in improving hand dysfunction severity, overall health, adherence to rehabilitation exercises, and self-care knowledge related to hand dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with systemic sclerosis who meet the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) diagnostic criteria and have hand dysfunction.
2. Adults aged 18 years or older.
3. Participants who are conscious and able to communicate in Mandarin Chinese or Taiwanese Hokkien.
4. Participants who provide informed consent to participate in the study after being briefed on its purpose.

Exclusion Criteria:

1. Participants who have participated in any other hand rehabilitation program within the past three months.

2, Participants with organic brain dysfunction. 3. Participants with severe visual or hearing impairments. 4. Participants with serious illnesses that hinder communication or interfere with the normal learning process.
Functional Respiratory Imaging Study

The purpose of this study is to evaluate the stepping-up effect from a double ICS/LABA DPI therapy to a triple DPI therapy on airway geometry and lung ventilation


Eligibility Criteria:
Inclusion Criteria:

1. Subject's signed Informed Consent Form;
2. Male or female ≥ 40 years of age;
3. Current smokers or ex-smokers of at least 10 pack-years,
4. Established diagnosis of COPD
5. Post-BD Forced Expiratory Volume in one second/Forced Vital Capacity (FEV1/FVC) \< 0.7 and FEV1 ≤ 60% of predicted at V1
6. On a stable dose any non-extra fine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
7. Presence of lung hyperinflation
8. Symptomatic subjects with COPD assessment test (CAT) score ≥ 10;
9. Documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months

Exclusion Criteria:

1. Pregnant or lactating woman;
2. Exacerbations defined as a sustained and acute deterioration of subject's symptoms and signs 30 days before screening;
3. A current asthma diagnosis;
4. Respiratory disorders other than COPD:
5. Cardiovascular diseases;
6. Evidence or history of other concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease;
7. Medical history or current diagnosis of narrow-angle glaucoma;
8. History of lung transplant or lung reduction surgery;
9. ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk;
10. Laboratory abnormalities;
11. Alcohol/drug abuse;
12. Contra-indications to Investigational medical products (IMPs), based on investigator judgement;
13. Documented Covid-19 diagnosis or its complications which have not resolved within 14 days prior to screening;

15. Positive molecular Covid-19 test within the last 72 hours before the remaining of screening activities.
The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore

To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail and frail community-dwelling older adults in Singapore for the management of physical frailty. The proposed study will provide information on the benefits of FPT on physical performances of older adults and help to shape future exercise recommendations to slow or reverse the onset and severity of physical frailty.


Eligibility Criteria:
Inclusion Criteria:

* aged 55 years and above
* low muscle strength - handgrip strength less than 26kg for men and 18kg for women
* ambulate without human assistance
* able to understand basic instructions

Exclusion Criteria:

* currently enrolled in another study
* acute musculoskeletal injury
* unable to participate in the full duration of the study
* unwilling to participate if not assigned to the intervention group
* deemed not suitable to participate in exercise by a medical doctor
PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases

The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide level in children suspected and being diagnosed due to allergic diseases.

The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide (FeNO) level in children suspected and being diagnosed due to allergic diseases.

Study will be retrospective, conducted in all children diagnosed in the years of 2005-20012 in Laboratory of lung function tests of Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland. The investigators will analyse 5500 male an female children 5-18 year old suspected and being diagnosed due to allergic diseases. In these children nearly 3000 FeNO measurements, 65000 spirometry measurements, 22000 whole-body plethysmography measurements and 48000 occlusion resistance measurements were performed between the years of 2005-2012.

The investigators will retrospectively evaluate following data from medical documentation of patients:

1. FeNO levels.
2. Allergic disease diagnosis.
3. Immunoglobulin E (IgE) specific levels.
4. Treatment (drugs and dosages).
5. Lung function parameters (spirometry, whole-body plethysmography, occlusion resistance, bronchial reversibility test).

Eligibility Criteria:
Inclusion Criteria:

* Children with allergic diseases, healthy children.

Exclusion Criteria:

* Other serious diseases.
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.


Eligibility Criteria:
Inclusion Criteria:

* B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy
* Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)
* Treatment Status:

  1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
  2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT
  3. CLL subjects: relapsed to or refractory after at least two prior standard therapies
* Measurable disease defined as:

  1. NHL (including SLL): at least 1 measurable disease lesion \> 1.5 centimeters (cm)
  2. CLL: at least 1 measurable disease lesion

Exclusion Criteria:

* Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy,
* Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1.
* Prior autologous stem cell transplant (SCT) within 6 months.
Group-based Acceptance and Commitment Therapy for Family Caregivers of People with Dementia in Japan

Along with more people worldwide having dementia, the number of people with dementia and their family caregivers have increased in Japan. However, psychological support for family caregivers of people with dementia is still limited in Japan. The purpose of this pilot study is to examine feasibility and preliminary efficacy of a group-based acceptance and commitment therapy (ACT) for family caregivers of people with dementia in Japan compared to a group-based cognitive behavior therapy (CBT). This study also preliminarily examines the efficacy of combining psychological intervention for family caregivers (group-based ACT/CBT) with psychological intervention for their care recipients (group-based reminiscence therapy).

This study employs quasi-experimental design to investigate the feasibility and preliminary efficacy of the group-based ACT for family caregivers of people with dementia compared to the group-based CBT. Both interventions consist of eight sessions, each lasting about 90 minutes, through face-to-face or Zoom video conferencing over the course of four months. Family caregivers will be assigned to either the ACT or CBT interventions. Pre-, post-intervention, and 6 month follow-up measurements assess depression, anxiety, quality of life, cognitive appraisal of caregiving (i.e., subjective burden and positive aspect of caregiving), possible process factors (i.e., caregiving self-efficacy, experiential avoidance, and commitment), care recipients' behavioral and psychological symptoms of dementia (BPSD), and so on. This study also preliminarily examines the efficacy of combining psychological intervention for family caregivers (i.e., the group-based ACT/CBT) with those for their care recipients (i.e., group-based reminiscence therapy). The group-based reminiscence therapy will be held once or twice a month, each lasting about 60-90 minutes, over the course of about three months.

Eligibility Criteria:
Inclusion Criteria:

Family caregivers:

* providing care for a family member with dementia or mild cognitive impairment
* being able to speak and read Japanese
* being 20 years of age or older.

Care recipients (group-based reminiscence therapy):

* having a clear intention to participate in the intervention
* being able to speak Japanese
* being diagnosed with mild cognitive impairment or mild stage of dementia and MoCA scores ≥ 11
* obtaining consent from their family caregiver and their doctor to participate in the intervention.

Exclusion Criteria:

Family caregivers:

* having psychiatric disorder at the time of participation in the intervention.

Care recipients (group-based reminiscence therapy):

* having insufficient capacity to give consent to participate in the intervention
* being diagnosed with moderate to severe stage of dementia or MoCA scores \< 11.
Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

RATIONALE: Gathering information about changes in serotonin levels in patients undergoing chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help doctors learn more about constipation caused by chemotherapy.

PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

OBJECTIVES:

* To determine if there are any alterations in serotonin levels in patients undergoing chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer and if this is associated with increased constipation.

OUTLINE: Patients undergo blood sample collection prior to beginning of planned postoperative chemotherapy, after 3 and 6 courses of chemotherapy, and at the 3-month surveillance visit. Patients also complete a bowel function questionnaire at these time points.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
* Planned to undergo 6 courses of a taxane and platinum-containing regimen

Exclusion Criteria:

* Ovarian low malignant potential tumor
* History of constipation or irritable bowel syndrome
* History of colorectal cancer
* Prior bowel resection at time of staging/cytoreductive surgery
* Prior abdominal-pelvic radiation
* Prior bowel surgery
Can we Reduce the Number of Vaccine Injections for Children?

This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other concurrent routine vaccinations. All groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infants aged 6-12 weeks at the time of the first vaccination and who were born between 37 and 42 weeks of gestation
* Infants who are known to be free from medical problems as determined by a medical history and clinical examination
* Parents or guardians who are willing for their child to participate and who would be expected to comply with the requirements of the protocol
* Parents/guardians who have given informed consent for their child's participation in the study

Exclusion Criteria:

* History of invasive meningococcal C disease
* Previous vaccination against meningococcal serogroup C disease
* Planned administration/administration of vaccines, since birth, other than the study vaccines (with the exception of oral rotavirus vaccine, Hepatitis B vaccine and BCG).
* Receipt of investigational vaccines/drugs, other than the vaccines used in the study, within 30 days prior to receiving the first dose of the vaccines or their planned use during the study period
* Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* Receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone \>0.5mg/kg/day)
* History of allergy to any component of the vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures
* Acute disease at the time of recruitment as defined by the presence of a moderate or severe illness with or without fever (with the exception of minor illnesses such as diarrhoea, mild upper respiratory infection without fever). In such situations enrolment should be postponed until the participant has recovered.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
* Parents who plan to move out of the geographical area where the study would be conducted.