cyrilzakka/clinical-trials huggingface dataset:
Measurement-Based Care Vs. Standard Care for Major Depressive Disorder

Major depressive disorder (MDD) is one of the leading causes of disability worldwide, indicated as one of the two most disabling mental disorders by the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 (Vos et al., 2020). Despite several effective pharmacological and psychosocial interventions available globally, only about one-third of depressed patients achieve remission (Xiao et al., 2021). There is a need to establish scalable clinical management practices which utilize biopsychosocial assessments, formulate a differential diagnosis, and provide evidence-based treatments for patients with MDD (Hong et al., 2021). While significant evidence for effectiveness of Measurement Based Care (MBC) is found in clinical settings from high and middle-income countries, assessments of MBC compared with usual care for the treatment of MDD are yet to be completed in low-resource settings like LMICs. The aim of this trial is to determine the efficacy and safety of MBC in patients with MDD in comparison with standard care in Pakistan. In order to reduce the variance found in treatment-as-usual and isolate the impact of MBC, standard care for this trial will limit medication choices to either paroxetine or mirtazapine.

Hypothesis: The rates of response and remission, and time to response and remission would be significantly shorter in the MBC group, without greater dropout rates and side effect burden, compared with the standard treatment group.

Study design and setting This will be a multi-centre, with assessors blind to protocol and treatment group, parallel arm, randomized controlled trial (RCT). The study is a direct replication of a study conducted by Gou et al. (2015) in China.

Participants Participants will be recruited from psychiatric units of teaching and non-teaching hospitals in 6 centres: Karachi (population 23 million), Lahore (population 10 million), Rawalpindi (population 3 million), Hyderabad (population 2 million) and Quetta (population 1 million) and Multan (1.8 million).

Sample size The sample size of 120 participants for this exploratory trial is based on the study conducted by Guo et al.

Eligibility Criteria:
Inclusion Criteria:

1. Adult outpatients age 18-65 of age
2. Diagnosis of nonpsychotic MDD established by treating psychiatrists and confirmed by a checklist based on DSM-5 criteria at study entry
3. Currently depressed with a score \>17 on the 17-item Hamilton Depression Rating (HDRS-17)
4. Able to communicate effectively and give written informed consent
5. Resident of the trial catchment area.

Exclusion Criteria:

1. Lifetime history of drug or alcohol dependence; 2. Diagnosis of bipolar, psychotic, obsessive-compulsive, or eating disorders confirmed with DSM-5 criteria 3. History of a lack of response or intolerance to either of the two protocol antidepressants (paroxetine and mirtazapine) 4. Currently pregnancy or breastfeeding; 5. Suicide attempts in the current depressive episode; 6. Any major medical condition contraindicating the use of the protocol antidepressants.

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Effect of Nasal Steroid in the Treatment of Anosmia Due to COVID-19 Disease

Background: Anosmia is a debilitating common symptom of COVID-19. The therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. However, the effect of local steroid was not assessed before.

Objective: To estimate the efficacy of local steroid in the treatment of anosmia in COVID-19 patients.

Background: Anosmia is a debilitating common symptom of COVID-19. The therapeutic effect of systemic steroid for the treatment of anosmia has been studied with various findings of its efficacy. However, the effect of local steroid was not assessed before.

Objective: To estimate the efficacy of local steroid in the treatment of anosmia in COVID-19 patients.

Materials and Methods: A double-blinded randomized controlled trial was conducted at Al-Ramadi Teaching Hospital and Tikrit Teaching Hospital during the period from 23th August to 30th September. Proven cases by real-time polymerase chain reaction and presented with anosmia alone or with ageusia were enrolled in the study. The patients divided into 4 groups according to the treatment modalities. Group A (local steroid nasal drops), group B (local normal saline nasal drops), group C (systemic and local steroid), and group D (systemic steroid and local normal saline). Comparison between the groups concerning the fate and the recovery time of the anosmia was analyzed.

Results and Conclusion: Depends on the finding of the studied patients.

Eligibility Criteria:
Inclusion Criteria: Proven cases of COVID-19 infection by real-time polymerase chain reaction (PCR) of the nasopharyngeal and oropharyngeal swabs and presented with recent onset of anosmia alone or with ageusia or other symptoms of the disease were enrolled in the current study.

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Exclusion Criteria: Patients with pregnancy, children \<18 year, psychological disturbances, previous anosmia, severe sinonasal diseases, previous sinonasal surgery, refuse to participate in the study, and those who lost to follow-up were excluded from the study.

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Time of Permanence of Dressing Following Breast Reconstruction

This randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization.

The rates of surgical site infections (SSI) after clean operations range from 1 to 2%. However, infection rates in the breast surgical literature tend to be higher, with reported rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.

The Centers for Disease Control and Prevention has established guidelines for postoperative incision care. However, there is no recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. This remains an unresolved issue.

Eligibility Criteria:
Inclusion Criteria:

•candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy

Exclusion Criteria:

* use of antibiotics at the time of the operation
* presence of skin lesions on the surgical site
* body mass index over 35Kg/m2
* hard smoking
Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting cognition in 30 teens with autism spectrum disorder.

Given the limited options for treatments to improve the core symptoms of autism spectrum disorder (ASD), strategies that could target secondary features of the condition and improve quality of life for affected individuals are critical. Neuroplasticity-based cognitive training has been found to improve cognition in youth with attention deficit hyperactivity disorder (ADHD) and in adults with schizophrenia. In this trial, the investigators are seeking to extend the relevance of computerized cognitive training to youth with ASD. Given the literature, the investigators hypothesize that computerized cognitive training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with ASD. The investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity based cognitive tests or enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be assessed again after 15 hours of training over 6 weeks and then again at a three month follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 ASD or previously diagnosed DSM-IV autistic disorder, Asperger's disorder or pervasive developmental disorder not otherwise specified (NOS) and who continue to manifest symptoms in core domains
2. Current ASD symptomatology at time of enrollment
3. Evidence of decrements in at least one of three target cognitive domains (mental flexibility/abstraction, working memory, or attention).

Exclusion Criteria:

1. Intellectual Disability
2. A known comorbid neurodevelopmental disorder with possible association with autism (i.e., fragile X syndrome, tuberous sclerosis, Angelman syndrome, Prader-Willi syndrome, Williams syndrome, neurofibromatosis, mitochondrial disorder).
3. Nonverbal or minimal verbal ability
4. No computer/internet connection at home
5. No family member with e-mail
6. Patients likely to have a change in therapeutic treatments within the next 6 weeks
A Study of HER2 Tumor Vaccine in Patients With Her-2 Positive Gastric/GEJ Adenocarcinoma Esophagogastric

This is a single-arm, open-label, clinical study to evaluate the safety of HER2 tumor vaccine injection alone/in combination with standard of care chemotherapy in patients with HER2/neu overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of HER2 tumor vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years;
* Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection;
* HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization \[FISH\];
* ECOG score of 0 \~ 2;
* Adequate bone marrow, hepatic and renal and coagulation function;
* Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
* Voluntarily participated in this study, signed the informed；

Exclusion Criteria:

* Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease；
* Subjects who have had major surgery within 4 weeks before HER2 tumor vaccine administration
* Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 5 elimination half-life prior first dose of HER2 tumor vaccine treatment;
* Subjects with known brain metastasis and/or clinically history tumor brain of metastasis；
* Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion;
* Active infection requiring treatment. HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication
* Other conditions that the investigator assessed as ineligible for inclusion.
Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety, and Stress Levels in Dementia Caregivers

Dementia, which leads to deterioration in cognitive and behavioral functions, is a chronic progressive disease. Since the diagnosis is made, the care needs of the patients increase. In the later stages of the disease, it becomes completely dependent on the caregiver.

they are coming. Caregiving is performed by family members in developing countries such as Turkey. Family members face many difficulties in their social, work, and daily lives after they start to care. These difficulties are the burden of caregiving is called. Caregivers who perceive the burden of care also experience anxiety, stress, and depression. Jacobson progressive muscle relaxation in coping with these problems exercises can be used. This study was planned to examine the effects of progressive muscle relaxation exercises on anxiety, stress, depression, and caregiver burden in dementia caregivers.

The research is a pre-test, post-test, and cross-sectional research. After explaining the purpose of the study to the caregivers who met the inclusion criteria, the Information Form, the Depression Anxiety Stress-21 Scale (DAS-21), and the Zarit Care Burden Scale will be administered. Then, progressive muscle relaxation exercises will be applied to caregivers. During the interview, the audio recording of the exercise will be given to them. Also, contact information (caregiver and researcher) will be shared mutually.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* Being literate
* Not having difficulties in verbal communication
* Have been caring for at least 3 months
* Being able to provide care for free
* Being the primary caregiver of the patient
* Not having a psychiatric diagnosis
* Not using medication for psychiatric illness

Exclusion Criteria:

* Providing care for less than 3 months
* Providing paid care
Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing

The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged from 18 to 75 years (included).
* Scheduled for a colonoscopy as an outpatient.
* Normal renal function

Exclusion Criteria:

* Having a disease or condition as follows:

  * repeated episodes of nausea and vomiting
  * abdominal pain due to severe infection or requiring surgery
  * clinically significant abnormal electrolytes values
  * congestive heart failure, unstable angina pectoris or recent myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within previous 3 months
  * known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis,
  * inflammatory bowel disease,
  * history of gastric stapling or bypass procedure or gastric retention
* Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
* Known allergy to any of the active ingredients or excipients of the study drugs.
* History of phenylketonuria
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* active rheumatoid arthritis;
* current inadequate clinical response to methotrexate.

Exclusion Criteria:

* receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

This randomized controlled trials study aims, first, to determine the effectiveness of a nurse-led PNE program designed by a multidisciplinary team, compared with an active control group on pain intensity, fibromyalgia (FM) severity, pain catastrophizing, and cognitive performance in patients with FM. Second, to determine the mediator role of pain catastrophizing in the effects of PNE on outcomes of interest. Third, to explore PNE-induced changes to the brain circuitry using QEEG in patients with FM.

This is a parallel-group, randomized controlled trial (RCT). 98 participants who meet the 2016 American College of Rheumatology diagnostic criteria for FM will be enrolled.

Eligible participants who complete the baseline measurements will be randomly allocated to a PNE group (N = 49) and a self-management education group (N = 49).

Primary outcomes include pain severity determined using the Brief Pain Inventory-Short Form (BPI-SF) and FM severity assessed using the Fibromyalgia Impact Questionnaire-Revised (FIQR).

Secondary outcomes, including pain catastrophizing and sustained attention, will examine using the Pain Catastrophizing Scale (PCS), the Psychomotor Vigilance Test (PVT), and QEEG, respectively.

All outcomes will be measured at 3 different time points: (T0: baseline; T1: immediately after the 6-week intervention period; and T2: 3 months after the intervention period).

Implications:

This will be the first-ever RCT to examine the effectiveness of a Chinese-language PNE program and the first study to determine the brain changes after PNE using QEEG in patients with FM. Once the effectiveness of the PNE and its brain mechanisms are supported by evidence from this trial, it will become a game changer in the management of the FM population. If an evidence-based PNE platform based on the patented training course is subsequently developed, the product will have great potential for commercialization.

Eligibility Criteria:
Inclusion Criteria:

* Participants must read and understand Chinese language.
* According to the 2016 ACR diagnostic criteria, participants' PDS scores more than or equal to 13 points

Exclusion Criteria:

* Subjects who have medical history of traumatic brain injury or neurological disorder.
* Subjects who have present psychopathologic disorder.
* Subjects who are cancer.
* Subjects who are pregnancy.
An Intervention Study to Reduce the Use and Impact of Potentially Inappropriate Medications Among Older Adults

An educational intervention targeting community-dwelling older adults will lead to a reduction in potentially inappropriate prescriptions (e.g. benzodiazepines, oxybutynin).

Cessation of potentially inappropriate medications (e.g. benzodiazepines, oxybutynin)will lead to improved cognitive outcomes in older adults.

This study tests the effectiveness of a knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician

Eligibility Criteria:
Inclusion Criteria:

* 65 year old human adults
* who fill a prescription for at least 5 medications
* community dwelling
* chronic use (3 months or longer) of at least one potentially inappropriate medication (e.g. benzodiazepine, oxybutynin)

Exclusion Criteria:

* patients with severe mental illness, dementia and epilepsy
* concomitant consumption of any other antipsychotic medication (including lithium, olanzapine, clozapine, quetiapine, risperidone, haloperidol etc.)
* concomitant consumption of any antiepileptic (including carbamazepine, valproate, gabapentin, lamotrigine, topiramate, oxcarbazepine etc.)
* concomitant consumption of a cholinesterase inhibitor or memantine
Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients with Prostate Cancer

This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to enhance patient education may improve patient understanding and result in higher patient satisfaction with treatment decisions amongst men with PC.

PRIMARY OBJECTIVES:

I. To develop an adaptive virtual consultation tool for PC (AVCT):

Ia. To incorporate and integrate the inputs from a diverse group of patients (including minorities), patient advocates, nursing, physicians and education experts in the design process for the adaptive consultation tool; Ib. Employ user centered iterative design approach to develop an adaptive learning tool on mobile devices that is tailored to individuals based on symptoms, health literacy, learning style, and disease specific characteristics.

II. To assess the feasibility, acceptability and usability of AVCT:

IIa. To validate the design approach and customization rules at the completion of the participatory design process using a convenience sample of subjects through assessment of system interaction logs and qualitative feedback from users on cognition, ease-of-use, usability and customization efficacy; IIb. To utilize the feasibility study results in (2a) to refine the interface, information presentation, and adaptive customization approach.

III. To determine the efficacy of AVCT using a small-scale comparative study:

IIIa. To design and execute a three arm comparative study consisting of adaptive virtual consultation, non-adaptive virtual consultation and standard-practice information-only control intervention and assess the comparative efficacy of the tool on the main outcome variable, satisfaction with health care episode; IIIb. To measure changes in other outcome variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the mediating influence of decision self-efficacy and a number of moderating factors including preference for decision-making participation and health literacy on outcome variables.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM 1: Patients participate in an adaptive virtual consultation on trial.

ARM 2: Patients participate in a non-adaptive virtual consultation on trial.

ARM 3: Patients receive information-only on trial.

After completion of study intervention, patients are followed up at 3- and 12-months post treatment decision.

Eligibility Criteria:
Inclusion Criteria:

* The participants in this study will be community dwelling, males with prostate cancer (PC) and their healthcare advocate, if applicable
* Proficiency in English is required

Exclusion Criteria:

* Mental incompetency to participate in the study and/or no treatment option due to other health reasons