cyrilzakka/clinical-trials huggingface dataset:
Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.

Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.

Primary Hypothesis: The primary hypotheses are that Bipolar Disease Program (BDP) intervention will significantly improve (1) manic and (2) depressive symptom scores, as well as Total Treatment Costs as compared to usual care of bipolar patients.

Secondary Hypothesis: Secondary hypotheses include significant improvement in BDP patients as compared to usual bipolar treatment care with respect to functional outcome, quality of life, intensity of somatotherapy, patient satisfaction, and provider attitudes.

Intervention: Usual (psychiatric) Care vs Bipolar Disorder Program

Primary Outcomes: The primary outcomes are: (1) Manic Symptom Score; (2) Depressive Symptom Score; and (3) Total Treatment Costs.

Study Abstract: Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.

Patients with bipolar disorder will be randomly assigned to either standard care or the high intensity ambulatory program for three years. Outcome variables will cover three distinct domains: disease-specific outcome (number, length, and severity of manic and depressive episodes), functional outcome (social and occupational role function and subjective quality of life), and total treatment costs (direct treatment costs and indirect costs of illness). Preliminary data indicate that these domains are related but not redundant. Each of these is relevant to patient well-being and to VHA management.

Eligibility Criteria:
Inclusion Criteria:

Patients with bipolar disorder. Index episode of manic, major depression or both requiring hospitalization on acute unit. At lease two hospitalizations, three or more months apart within the past 5 years.

Exclusion Criteria:
Feasibility and Acceptability of the Clinical Frailty Scale in a Swedish Emergency Department Setting

The purpose of this study is to evaluate the feasibility and acceptability of the Clinical Frailty Scale (CFS).

The scale can potentially be adopted for daily use in the Emergency Department (ED) and have been evaluated with regard to feasibility to a certain extent, but have so far not been evaluated in the Swedish emergency care context.

The CFS is introduced and tested as part of a quality-improvement process regarding elderly people within the three Emergency departments (ED) of Region Östergötland.

CFS is a 9-point scale developed within the Canadian Study of Health and Aging, a pictograph and a clinical description aids to assign scores from very fit to terminally ill. The scale enable clinicians to stratify elderly people's degree of frailty with the help of questions and clinical assessment. However, even excellent tools will not be used if they are too difficult or time consuming. The amount of papers addressing issues regarding feasibility and acceptability of the CFS in a clinical ED-setting is still limited, and for Swedish EDs non-existent.

This study is part of a larger research project, data will be collected in three ways:

A. All eligible patients who visit the ED for a period of six weeks will be enrolled, and subsequently assessed with CFS by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). The number of screened patients divided by the total number of eligible patients will yield the screening rate. Patient- and organisational related characteristics will be collected from the electronic health record.

B. 100 patients will be assessed when someone from the research team is present to enrol patients and clock the assessments. These work shifts will be selected using the online application Research Randomizer, to randomly include all hours of the day as well as eligible health-care professionals. The research-team member will document the time to complete the assessment using CFS, which will give us the screening time.

C. To assess acceptability, health-care professionals will be sent a questionnaire per email, including two reminders. The questionnaire will consist of Likert scales, multiple-choice questions and open textboxes with the aim to explore facilitators and barriers for screening completion.

Primary aim: To explore the feasibility and acceptability of the CFS in a Swedish Emergency care context.

Eligibility Criteria:
Inclusion Criteria:

* Has been in clinical work at the ED for the period of the current study

Exclusion Criteria:

* Unwilling to provide informed consent
A Safety and Efficacy Study of LYS-GM101 Gene Therapy in Patients With GM1 Gangliosidosis

LYS-GM101 is a gene therapy for GM1 gangliosidosis intended to deliver a functional copy of the GLB1 gene to the central nervous system. This study will assess, in a 2-stage adaptive-design, the safety and efficacy of treatment in subjects with infantile GM1 gangliosidosis.

GM1 gangliosidosis is a fatal autosomal recessive disease caused by mutations in the GLB1 gene leading to accumulation of GM1 ganglioside in neurons and progressive neurodegeneration. There are three pediatric subtypes: early infantile, late infantile and juvenile. This is an interventional, multicenter, single-arm, 2-stage adaptive design study of LYS-GM101 for which the first stage (Stage 1) is for safety evaluation (FIH) and the second stage (Stage 2) will establish efficacy as compared to the natural history of the disease. The participants with infantile GM1 gangliosidosis will receive a single dose of LYS-GM101 by intracisternal injection. After a two-year evaluation period (main part of the study), each participant will be followed for an additional three-year long-term follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Documented GM1 gangliosidosis diagnosis based on genotyping confirming the β-gal gene mutations and/or documented deficiency of β-gal enzyme by laboratory testing
* Children with early infantile GM1 gangliosidosis less than 12 months of age with ability to swallow
* Children with late infantile GM1 gangliosidosis less than 3 years of age with ability to sit

Exclusion Criteria:

* Uncontrolled seizure disorder. Patients who are stable on anti-convulsive medications may be included
* More than 40% brain atrophy as measured by MRI total brain volume at screening
* Current participation in a clinical trial of another investigational medicinal product
* Past participation in a gene therapy trial
* History of hematopoietic stem cell transplantation
* Any condition that would contraindicate treatment with immunosuppressant therapy
* Presence of concomitant medical condition or anatomical abnormality precluding lumbar puncture or intracisternal injection
* Presence of any permanent items (e.g., metal braces) precluding undergoing MRI
* History of non-GM1 gangliosidosis medical condition that would confound scientific rigor or interpretation of results
* Rare and unrelated serious comorbidities, e.g., Down syndrome, intraventricular hemorrhage in the new-born period, extreme low birth weight (\<1500 grams) or known bleeding disorders
* Any vaccination 1 month prior to the planned immunosuppressant treatment
* Serology consistent with HIV exposure or consistent with active hepatitis B or C infection
* Grade 2 or higher lab abnormalities for Liver function tests (LFT), bilirubin, creatinine, hemoglobin, white blood cell (WBC) count, platelet count, prothrombin time (PT), and partial thromboplastin time (PTT), according to CTCAE v5.0
Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.

The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as moderate acne vulgaris
* Able to read and speak in Indonesia
* Indonesian Citizen
* Sign the consent form

Exclusion Criteria:

* Pregnant of breastfeeding women
* Acne vulgaris lesion located only outside of face
* Experiencing COVID-19 symptoms
* Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks
* Consume any oral antibiotics in the last 1 month
* Injected with intralesional steroid or having acne lesions extracted in the last 2 weeks
* Having laser or chemical peeling in the last 1 month
A Local Register Study For Major Depression Of Paroxetine Controlled Release

The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to Paroxetine Immediate Release, as well as the drug tolerability profile when treated on patients with Major Depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale\>18).

Exclusion criteria:

* patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.
mHealth Intervention to Promote Cancer Survivors' Physical Activity

The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.


Eligibility Criteria:
Inclusion Criteria:

* in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital
* ≥1-year post-cancer therapy
* ambulatory without any known medical contraindications to participation
* able to complete surveys in English
* agree to install and share data from the FitBit smart phone app with the investigators

Exclusion Criteria:

* currently or previously used a wearable physical activity sensing device to improve physical activity
Outpatient Rehabilitation Intervention for Young Children With SMA

An outpatient rehabilitation program for children (6 months to less than 6 years old) with Spinal Muscular Atrophy (SMA) treated with genetic based therapies is being studied. Participants will participate in a 12-week therapy program where they receive 45 minutes each of occupational therapy and physical therapy each week. Home exercises will also be prescribed to be completed 5 days per week. At the end of the therapy program, there will be a 12-week period of no therapy where only home exercises will be completed. Assessments and program evaluation will occur at the beginning (Week 0) and end of the rehabilitation program (Week 24), then at the end of the no therapy block (week 24).

The standard of care for SMA has historically been physical therapy (PT) and occupational therapy (OT) often focused on strategies that reduce the risk of secondary side effects such as joint tightness. Recently, three genetic based therapies: nusinersen, onasemnogene abeparvovec and risdiplam, have been approved as treatment by Health Canada. Genetic based therapies have provided improvements in physical function for children with SMA. Currently, there is no evidence-based guidance regarding rehabilitation to increase function for children with SMA that have received genetic based therapies. Additionally, there is a lack of published evidence regarding the type of rehabilitation programs and the impact that rehabilitation has on physical function.

An outpatient rehabilitation program for children (6 months to less than 6 years old) with Spinal Muscular Atrophy (SMA) treated with genetic based therapies is being proposed and its feasibility being evaluated. Participants will participate in a 12-week therapy program where they receive 45 minutes each of occupational therapy and physical therapy each week. Home exercises will also be prescribed to be completed 5 days per week. At the end of the therapy program, there will be a 12-week period of no therapy where only home exercises will be completed. Assessments and program evaluation will occur at the beginning (Week 0) and end of the rehabilitation program (Week 24), then at the end of the no therapy block (week 24).

Eligibility Criteria:
Inclusion Criteria:

* SMA (Type I, II or III) diagnosis;
* Receives genetic based therapy;
* Aged 6 months to less than 6 years old;
* Able to participate in weekly therapy at Holland Bloorview (i.e., can attend in-person sessions);
* Able to bring appropriate respiratory equipment to weekly therapy sessions, if required;
* Substitute decision makers (SDMs) must be able to speak and read English;
* Child participant must be able to understand/follow directions in English, as age appropriate;
* SDMs must consent to participate on behalf of their child.

Exclusion Criteria:

* Live outside of Ontario;
* Tracheostomy or use of daytime ventilation (excluding ventilation used during naps).
Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

The study aims to reduce the PTV (Planning Target Volume) safety margins to 1-2 mm in stereotactic prostate radiotherapy for low- and medium-risk prostate cancers while maintaining a dose of 36.25 Gy in 5 fractions per day. By reducing the hems, the investigators expect a reduction of acute and late toxicity on the organs at risk, dominantly the urethra, bladder, penile bulb, and rectum, and an improvement in the quality of life.

In this prospective study, a total of 100 patients will be treated over 2 years. Patients will be implanted with 4 contrast markers (fiducials) in the prostate - in the base, apex, and right and left lobes of the prostate. Subsequently, 3 planning examinations will be performed: 1. CT with a urinary catheter immediately after the implantation of fiducials (gold contrast markers), with a distance from implantation 2. planning CT and MR without a urinary catheter. The CTV (Clinical Target Volume) will be defined by the prostate, and the border on the PTV will be reduced from 3-5 mm to 1-2 mm isometrically to maximize the reduction of doses to the organs at risk (rectum, bladder, and urethra, penile bulb, testes), the organs at risk (OAR) will be marked in the radiation plan as OAR. Subsequently, the patients will be irradiated with a dose of 36.25 Gy in 5 fractions per day. Acute toxicity will be evaluated in the 1st and 3rd month after radiotherapy, and late toxicity after 4-6 months according to CTCAE criteria (Common Terminology Criteria for Adverse Events).

Eligibility Criteria:
Inclusion Criteria:

* histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases
* low or intermediate risk - favorable risk
* staging according to NCCN recommendations:
* low risk: no staging required
* intermediate risk- favorable risk: CT abdomen and pelvis
* PSA up to 15
* age over 18 years
* signed informed consent form
* suitable position of fiducials (to be determined by the physicist)

Exclusion Criteria:

* a histological type other than acinar adenocarcinoma
* the presence of local lymphadenopathy or distant metastases
* a dominant lesion in the periphery that is in contact with the capsule or grows through it
* PSA over 15
* unsatisfactory position of fiducials (to be determined by the physicist)
* previous treatment with radiotherapy to the pelvic area
Effect of Different SARS-CoV-2 Vaccine Schedules and Vaccination Intervals on Reactogenicity and Humoral Immunogenicity

Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination

The basic immunizations (first and second vaccination) were performed from January to June 2021 using the m-RNA vaccine BNT162b2 (BioNTech/Pfizer, B)9 and the vector-based vaccine ChAdOx1-S (AstraZeneca, A). BNT162b2 was used to boost vaccine all study population. The time interval between the basic immunisation and the boost vaccination varied.

Four vaccine-groups could be distinguished:

Group 1 received BNT162b2 with the second vaccination 3 weeks after the first vaccination.

Vaccinees of groups 2 and 3 received AZD1222/ChAdOx1-S as first vaccination and could choose after 12 weeks whether second vaccination with BNT162b2 or AZD1222/ChAdOx1-S should be carried out. This results in homologous (first: AZD1222/ChAdOx1-S, second: AZD1222/ChAdOx1-S) and heterologous (first: AZD1222/ChAdOx1-S, second: BNT162b2) vaccine combinations.

Group 4 received BNT162b2 with the second vaccination 6 weeks after first vaccination.

Blood samples were collected at six time points: four weeks, three and six months after completion of the basic immunization, immediately before boost vaccination, four weeks and three months after boost vaccination.

Reactogenicity after first, second, and boost vaccination was assessed using questionnaires to determine vaccine-induced adverse drug reactions (ADR) within seven days after the respective vaccinations.

In addition, demographic data (age, gender, occupational group, allergies) were collected, local and systemic vaccination reactions are differentiated and the need for medication and inability to work as a result of vaccination reactions are prospectively recorded.

Eligibility Criteria:
Inclusion Criteria:

* hospital staff who received COVID-19 vaccination

Exclusion Criteria:

* lack of a written informed consent
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy

This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.

Enrolled patients will be subjected to a pre-operative gastroscopy, 48-Hour Bravo pH study and EndoFlip. In addition, each patient will complete a GERD-related quality of life questionnaire (GERD-HRQL scale). One year after surgery, patients will undergo a follow up a gastroscopy, pH study, EndoFlip and the same quality of life questionnaire to predict the incidence of postoperative GERD and determine the effect of sleeve gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old

Exclusion Criteria:

* Hiatal hernia \> 2 cm at preoperative gastroscopy
* Erosive esophagitis at preoperative gastroscopy
* Barrett's metaplasia/dysplasia at preoperative gastroscopy
* Revision surgery before the end of the study
* Pregnancy during the study period
* Actively bleeding esophageal varices
Endoscopy With Short Fasting

Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. In recent studies, surgical cholecystectomy has been described to be safe after two hours of fasting on liquids. The aim of this study is to assess safety, quality and comfort of upper GI endoscopy after two hours of fasting.


Eligibility Criteria:
Inclusion Criteria:

* elective endoscopy

Exclusion Criteria:

* poor clinical condition