cyrilzakka/clinical-trials huggingface dataset:
NST-SPARK: Preliminary Study of an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia

This study evaluates the feasibility and acceptability of a prototype for NST-SPARK (version 1.5). This is an augmented reality (AR) mobile phone application that uses Recovery-oriented Cognitive Therapy (CT-R) to target negative symptoms of schizophrenia.

NST-SPARK uses a game AR activity to recapitulate the beginning activation and engagement phase of each CT-R session as per standardized practices for this therapeutic modality.

The specific beliefs targeted during each module are queried before engaging in the AR activity to obtain participant buy in. A self-assessment is taken before and then subsequent prompts challenge these beliefs over the course of the activity. After completion of the AR activity the self-assessment is performed again and the results are compared against the pre-activity responses.

The responses received pre- and then post- activity determine the responses SPARK provides to the participant.

Example: Question: How ambitious or motivated do you feel now?

If the post activity response shows a higher level of motivation compared to the pre-activity assessment the participant will receive the following: So you felt more motivated and more energized! And you did more work not less! Like the more you do the better you feel.

The prototype NST-SPARK v.1.5 has 2 modules: 1) SPARK ENERGY and 2) SPARK MOTIVATION, and is an abbreviated experience following the general framework for NST-SPARK.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-5 criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychotic disorder.
* Presence of negative symptoms - SANS rating of 2 or higher on either Avolition/Apathy or Anhedonia/Asociality subscale.
* Capacity to understand the study procedures and provide informed consent.
* Has dependable access to a device with videoconferencing capability and stable wifi connection which can be accessed by the study iPhone.
* Proficient in English.

Exclusion Criteria:

* Recent change in level of care: antipsychotic medication changes in the last 4 weeks OR hospitalization or emergency room/crisis visits in the last 12 weeks.
* Acute safety risk - any indication of ongoing risk to themselves or others.
* Substance induced psychotic disorder or primary mood disorder with psychosis.
* Severe cognitive or physical limitations preventing the participant from being able to independently use NST-SPARK.
Psychological and Postural Effects of Exposure to Both Types of Virtual Environments

The main aim of this study is to compare the fear of falling induced by each type of virtual scene (rocking and translation). Fear of falling will be assessed by a numerical fear of falling scale.

The benefits for the participants would be the discovery of Virtuel Reality, the awareness of their fear of falling and its repercussions on posture and, if necessary, referral to specialized rehabilitation centers. This study will provide evidence on the context of the emergence of the fear of falling in order to propose, in perspective, appropriate rehabilitation management procedures.

This bicentric study will proceed as follows:

* Complete clinical examination, carried out as part of your consultation in a day hospital.
* Perform a virtual reality session of about 2 hours. This session will take place as follows:

  * Wear a virtual reality headset. The helmet is compatible with the wearing of glasses.
  * View a virtual scene for two minutes in order to familiarize yourself with the device. This first viewing will be followed by a 10 minute break.
  * Then the patient will be placed on a rectangular platform (Wii Balance Board - WBB)
  * Give the virtual reality headset again to the patient, who will view a 2-minute series of a series of 2 minutes in a standing position comprising a moving virtual environment (one tilting forward and another in forward translation).
  * After a 10 minute break, the session will continue with 4 other sets of 5 minutes duration (5 times 1 minute of a forward tilt or forward translation scene). These 4 series will be separated by 10 min break
  * During each break, the patient participating in the study will complete a questionnaire on the possible side effects of virtual reality (cybermalaise).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years old
* Declaring to be able to maintain the upright station without technical assistance for at least 5 minutes
* Being afraid of falling with a score greater than or equal to 23 on the Falls Efficacy Scale-International questionnaire (Yardley et al., 2005)
* Good understanding of the French language
* Benefiting from a social security system
* Have read the information notice and have consented to participate in the study by signing a written consent

Exclusion Criteria:

* Severe cognitive impairment according to DMS-5 criteria
* Medical diagnosis of neurological disease
* Trauma dating less than 6 months to the lower limb
* Symptoms of vestibular or cerebellar involvement
* Major visual disorder defined by visual acuity of one or both eyes less than or equal to 3 / 10th without correction
* History of epileptic seizure: this is a total contraindication due to proximity to a screen (Virtual Reality Ethics Committee, 2019)
* Psychiatric disorders (Schizophrenia, dissociative disorders, borderline state, paranoia)
Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 yrs or older
2. Patients who have undergone a segmental colectomy
3. Must be receiving opioids via IV.

Exclusion Criteria:

1. Patients who received any experimental drug in the last 30 days
2. Patients receiving spinal medication for post-operative pain relief
3. Patients who have undergone operations for complications related to inflammatory bowel disease
4. Patients with recent history of abdominal radiation therapy.
Effectiveness of a Mobile Application in Improving Employees' Social Well-being.

The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are:

Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees?

Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms).

Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.

Participants will be recruited from workplaces that use the Frendie PRO mobile application. After collecting baseline data, each workplace will be randomly assigned to treatment or control conditions. The unit of randomization is a workplace (or a team or department in bigger organizations).

The intervention group will be encouraged to download and start using the Frendie PRO mobile application. The control group will be informed of the date when they will have access to it (six months after the baseline).

Both groups are asked to participate in two follow-ups - a 3-month follow-up and a 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All employees working at the company/team/department participating in the study and starting to use the Frendie PRO mobile application within the study period.
* Ability to fill the questionnaires online in Finnish

Exclusion Criteria:

* incapable of using questionnaire online
* does not know Finnish well enough to answer the questions
The Effects of Immersion in Dead Sea Water on Glucose Levels in Type 2 Diabetes Mellitus Patients

BACKGROUND: Bathing in sweet or mineral water can induce significant physiological changes in several body systems including the endocrine system. To date, there have only been a small number of reports that balneology can reduce blood sugar Levels in patients with type 2 diabetes mellitus (DM\].

OBJECTIVE: To compare the effects of a immersion in sweet or mineral water on blood glucose levels in patients with type 2 DM.

METHODS: Forty patients with type 2 DM will immerse in either sweet or mineral water twice daily. In both cases the water will be warmed to a temperature of 35 degrees C and the bath continue for 20 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled type 2 diabetes mellitus patients(HbA1c levels between 7.5-10)
* Ages 18-65
* Signed Informed Consent

Exclusion Criteria:

* Peripheral neuropathy
* Diabetic ulcers or damaged skin
* PVD
* Diabetes diagnosis for over 20 years
* Orthostatic Hypotension
Gemcitabine + Carboplatin in Breast Cancer

The rational for this trial is given by the knowledge that gemcitabine acts as a potent inhibitor of DNA repair and therefore may prevent adequate repair of platin-induced DNA damage. Gemcitabine is an excellent choice for combination therapy by its unique mechanism of action and favourable toxicity profile. The combination of gemcitabine and cisplatin was shown to be effective in several trials, producing response rates of 30-52 % in patients with pretreated metastatic breast cancer. To improve on tolerability and handling of the regime carboplatin may be the more appropriate choice for treatment. The mechanism of action of carboplatin is very similar to that of cisplatin. The rational for combining gemcitabine and carboplatin is based on their single-agent activities in metastatic breast cancer, the activity of this combination in other malignancies and on the fact that carboplatin has demonstrated efficacy comparable with cisplatin in several tumor types.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* All patients were required to give written informed consent.
* Prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
* Patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
* Age ≥ 18 years
* Karnofsky Performance status ≥ 70 %
* Minimal life expectancy of 12 weeks
* Adequate haematological, renal, cardiac and hepatic function:

  1. Leukocyte count ≥ 3.0 x 109/l
  2. Absolute neutrophil count ≥ 2.0 x 109/l
  3. Platelet count ≥ 100 x 109/l
  4. Haemoglobin ≥ 8 g/dl
  5. Total serum bilirubin ≤ 1.25 x upper limit of normal (ULN) In presence of liver metastasis ≤ 3 x ULN
  6. Transaminase (ALT,AST) level ≤ 3 x ULN In presence of liver metastasis ≤ 5 x ULN
  7. Alkaline phosphatase level ≤ 2.5 x ULN
  8. Creatinine clearance was required to exceed 60 ml/min.

Exclusion Criteria:

* Prior treatment with gemcitabine or platinum agents
* Inadequate creatinine clearance (\< 60 ml/min)
* Only bone metastases
* Symptomatic brain metastases
* Women who are pregnant, lactating or refuse effective contraception
* Secondary malignancy
* History of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
* Active infection
* Any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema

Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management

Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)

Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema

Exclusion Criteria:

* other causes of macular edema
* other macular diseases
TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.

This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.


Eligibility Criteria:
Inclusion Criteria:

Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.

* Female.
* Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
* Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
* Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
* Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
* Age greater than or equal to 18 years at A/MBC diagnosis.

Exclusion Criteria:

-There are no exclusion criteria for this study.
Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation

The objective of this study is to address the anti-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation.

It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects.

A double-blind, randomized, placebo-controlled, parallel study comparing the effect of tocotrienols vs. placebo will be conducted in subjects with moderately elevated inflammation. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily or placebo for 6 months. Fasting blood samples will be collected at baseline, 3 months, 6 months. A post-study fasting blood sample will be collected at 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-60
* Elevated plasma hs-CRP level of \> 1 mg/L \< 10 mg/L

Exclusion Criteria:

* Subjects with very high LDL-cholesterol ≥ 4.9 mmol/L
* Subjects with very high hs-CRP level ≥ 10 mg/L
* Pregnancy or lactation
* Current use of vitamin E or corticosteroids
* Significant hepatic and renal impairment
* Fever, cold or infection during bleeding day
Atrial Fibrillation General Registry

Given the advances in Atrial Fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in the member ESC countries. It is now nearly 10 years since the last European registry of AF management was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was needed.

Given the advances in Atrial Fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in the member ESC countries. It is now nearly 10 years since the last European registry of AF management was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was needed.

New guidelines on the management of AF have recently been published by the ESC, but it remains unclear how often clinicians adhere to them. Since the last Euro Heart survey, a change in management strategy has necessitated an update on prevalent management practices in AF. This is influenced by clinical availability of catheter ablation as a routine procedure and new antiarrhythmic drugs, and also by developments in stroke thromboprophylaxis and medical therapy options. Under the EURObservational Research Programme (EORP), an AF ablation sentinel pilot registry was launched in 2010.

A survey of AF management under the EORP programme will enable a timely assessment of the uptake of the new ESC guidelines, allow monitoring of implementation and uptake of catheter ablation, new antithrombotic drugs and new antiarrhythmic agents, and will inform about outcomes related to guideline-adherent management of AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be officially enrolled in the study only if ECG diagnosis of AF has been made.
* The qualifying episode of AF should have occurred within one year before the date of baseline.
* AF is the primary or secondary diagnosis, i.e. the current admission / visit may be due to other reasons.
* Patients need not be in AF at the time of enrolment.
* Signed Patient Inform Consent if applicable.

Exclusion Criteria:

* No ECG/Holter with AF recorded.
* Only atrial flutter recorded.
* The qualifying episode of AF occurred more than one year before the date of baseline.
* Age \<18 years.
* Patients are already included in the ESC Atrial Fibrillation Long-Term registry if your centre was enrolled in the Pilot phase.
* Patients who are currently or are planned to be taking part in a cardiac clinical trial.
A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in Japanese participants with advanced gastric/gastrooesophageal junction cancer who have not received chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* A histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible.
* Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after \>6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
* Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
* The participant has adequate organ function.
* Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version \[v\]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer.
* Female participants of childbearing potential must have a negative serum or urinary pregnancy. Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria:

* A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment.
* Uncontrolled arterial hypertension, despite standard medical management.
* A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.
* Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment.
* Radiation therapy within 14 days prior to enrollment.
* Received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.
* Cirrhosis at a level of Child-Pugh B (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
* A serious illness or medical condition(s).
* Pregnant or breastfeeding.
* Dysphagia for oral medication.
* Known allergy or hypersensitivity to any study treatment.
* Human epidermal growth factor receptor (HER) 2 status of positive.
* Received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.
Internet-delivered Postpartum Anxiety Prevention

Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. Up to 16% of mothers experience postpartum anxiety or related disorders, such as OCD. With respect to the investigator's own community, this means that up to 3,313 women in West Virginia may struggle with postpartum anxiety or OCD. Left untreated, perinatal anxiety and OCD are associated with numerous adverse outcomes, such as maternal depression, preterm birth, impaired fetal development, low birthweight, difficulty breastfeeding, anxiety in children, and interference with parent-infant bonding. Critically, anxiety is a risk factor for cardiovascular disease and substance use disorders, both significant West Virginia health disparities. Thus, there is a critical need to develop effective and scalable prevention programs to address postpartum anxiety and OCD. The purpose of this proposed community-engaged study is to develop and test the feasibility, usability, and acceptability of an Internet-delivered postpartum anxiety and OCD prevention program, called "Preventing Postpartum Onset Distress", or P-POD.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 or older
* Pregnant with first child
* Married or living with a partner
* State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139

Exclusion Criteria:

* past or current anxiety disorders
* past or current OCD
* past or current psychotic disorders
* past or current bipolar disorders
* past or current substance use disorders.
Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET

Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing oocyte pick up for IVF treatment

Exclusion Criteria:

* endometriosis
* low responders
* uterine malformations