cyrilzakka/clinical-trials huggingface dataset:
Three-dimensional Virtual Reality and Hands-on Aromatherapy

A quasi-experimental trial was designed to evaluate the effectiveness of this combination in promoting happiness, perceived stress, sleep quality, experience on meditation, and life satisfaction among institutionalized older adults in Taiwan.

Background: In Taiwan, which has one of the most rapidly aging populations in the world, it is becoming increasingly critical to promote successful aging strategies that are effective, easily usable, and acceptable to institutionalized older adults. Although many practitioners and professionals have explored aromatherapy and identified its positive psychological benefits, the effectiveness of a combination of 3D virtual reality and hands-on aromatherapy remains unknown.

Objectives: A quasi-experimental trial was designed to evaluate the effectiveness of this combination in promoting happiness, perceived stress, sleep quality, experience on meditation, and life satisfaction among institutionalized older adults in Taiwan.

Methods: Sixty institutionalized elderly participants underwent the combination program or were in a control group. Weekly two-hour sessions were implemented for 9 weeks. The outcome variables were happiness perceived, stress, sleep quality, experience on meditation, and life satisfaction, which were assessed at baseline, and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* An ability to understand verbal instructions
* An ability to provide simple responses
* An ability to operate a joystick freely with at least one hand

Exclusion Criteria:

* A history of severe psychiatric conditions;
* Dementia
* Significant visual or hearing impairment;
* Marked upper motor difficulties that could affect the participants' ability to participate in the study
* Currently suffering from severe illnesses, e.g., stroke and Parkinson disease.
Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis and Staging of Lung Malignancies

Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging \& diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination. The present research aims to compare the diagnostic and staging accuracies of (EBUS-TBNA) versus FDG-PET /CT as two diagnostic modalities in patients with suspected lung malignancies. However as a secondary outcome this study aims at monitoring the possible complications arising post EBUS-TBNA procedure.

Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging \& diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination.

Objective: To compare the diagnostic and staging accuracy of convex probe EBUS-TBNA versus FDG - PET/CT as two diagnostic modalities in diagnosis of suspected lung cancer \& staging of concurrent mediastinal lymphadenopathy Patients and Methods: This prospective, interventional cohort research was performed on 40 cases with suspected lung malignancies. All cases were examined via FDG-PET/CT followed by convex probe EBUS-TBNA for diagnosis of suspected lung cancer \& staging of concurrent mediastinal lymphadenopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or more.
* Patients presented with centrally located suspiciously malignant lung masses with or without lymphadenopathy.
* patients with mediastinal lymphadenopathy only as evident by contrast - enhanced CT scan of the chest.
* patients with peripheral lung malignancy and mediastinal lymphadenopathy who were referred for MLN staging were also recruited to the research

Exclusion Criteria:

* All patients who were who were unfit for bronchoscopy as per international guidelines for practice.
* Cases are diagnosed with stage IV (metastatic) lung cancer.
* Patients with histopathological diagnosis other than malignancy (as Sarcoidosis, Tuberculosis).
* patients unfit for FDG-PET G-PET/CT examination (uncontrolled Hyperglycemia, renal impairment).
* Patients who refused to participate to the study.
Understanding of Psychotic Disorders in Children With 22q11.2DS

The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of 22q11.2 deletion syndrome or no developmental disease
* Aged from 4 to 13 years old
* French language

Exclusion Criteria:

* Diagnosis of intellectual deficiency according to DSM 5 criteria
* Drug prescribed for somatic condition that could influence cerebral functioning
Capecitabine in Women With Operable Breast Cancer

The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.

* Prior to the start of treatment, patients will have a small metal clip inserted into the tumor bed to identify the tumor site to the surgeon. At that time, a needle biopsy of the breast tumor or a sentinel (underarm) lymph node biopsy will also be performed.
* Patients will take capecitabine orally twice daily for 14 days. This treatment will repeat every 21 days (1 cycle). Patients will receive 4 cycles of this treatment.
* A physical exam and blood work will be done every three weeks after starting therapy to monitor side effects.
* After two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine.
* After completing 4 cycles (12 weeks) of capecitabine, patients will then undergo surgery to remove any remaining breast cancer (lumpectomy or mastectomy). Post-surgical treatment (radiation, chemotherapy, and hormonal therapy) is at the discretion of the patients physician.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of primary invasive breast cancer
* Stage I-III operable breast cancer.
* Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
* Women greater than 18 years of age
* ECOG performance status 0-1
* WBC \> 4000/mm3
* Platelet count \> 100,000/mm3
* SGOT \< 2x ULN
* Calculated creatinine clearance \> 50ml/min

Exclusion Criteria:

* Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.
* Pregnant or breast-feeding women
* Inflammatory breast cancer
* HER2 positive disease
* History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency
* Uncontrolled intercurrent illness
* Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
* Excisional biopsy performed prior to enrollment
* Uncontrolled coagulopathy
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer

This pilot clinical trial studies how well the "JeffQuit" group therapy program works in enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group therapy to provide psychological support and address the mental need for smoking, the habit or routine it creates, and the physical need for nicotine. It is not yet known how well the JeffQuit program will work in helping patients with a history of cancer to stop smoking.

PRIMARY OBJECTIVES:

I. To assess the initial effectiveness of the JeffQuit program on smoking cessation in cancer patients.

II. To assess the quality of life improvements related to the JeffQuit smoking cessation program in cancer patients.

OUTLINE:

Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.

After completion of study, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. History of cancer
2. Current smoker
3. Willing to provide consent and participate in the JeffQuit program
4. Referral by a Kimmel Cancer Center provider

Exclusion Criteria:

1. Any significant active medical disorder or physical condition that could reasonably be expected to interfere with the ability of the patient to quit smoking as determined by the Principal Investigator (PI)
2. Currently participating in another smoking cessation program
3. Currently receiving chemotherapy or radiation therapy that would interfere with their ability to participate in the JeffQuit program
4. Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
5. Patients with current alcohol or drug abuse
6. Enrollment in active clinical trial/ experimental therapy within the prior 30 days
7. Are in the terminal stages of illness
Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)

This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.

This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery. The study will be randomized across two groups, one group will evaluate laparoscopic lens cleaning with D-HELP during laparoscopic surgery and the second group will evaluate laparoscopic lens cleaning using the FloShield Air System during laparoscopic surgery. Each surgery will be captured on video. Study parameters will be evaluated through review of each video by an independent evaluator.

Eligibility Criteria:
Inclusion Criteria:

* Female or Male;
* 18 years of age or older;
* Patient scheduled for gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery under the care of the study investigator;
* Suitable candidate for surgery

Exclusion Criteria:

* Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator);
* Use of Surgiquest AirSeal®;
* Use of humidified insufflation
5 Year Radiological and Clinical Results From Patients Operated for Hallux Valgus Deformity.

Retrospective study of patients operated for hallux valgus deformity at our hospital (ostfold hospital trust) 5 years ago. Patients will be clinically examined, a weighted radiograph of the foot (traditional and newer parameters will be evaluated) and patient reported outcome measures (PROM) scores will be collected.


Eligibility Criteria:
Inclusion Criteria:

* All patients (18-80 years at time of surgery) operated for hallux valgus deformity at ostfold hospital trust 2016-2018

Exclusion Criteria:

* Not able to speak/write/read norwegian language
EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES

To compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries.

Objective was to compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries. After approval from the ethical committee, 62 patients fulfilling the inclusion criteria were enrolled in this study from outpatient department. All participants were examined physically in person by the primary investigator. After which the patients were divided randomly into two groups A and B, 31 patients in each group. Group A patients were undergone bowel preparation while group B patients were not undergone bowel preparation. All patients were operated by a single consultant pediatric surgeon with more than 10 years of experience. Patients were called for follow up weekly till 6 weeks. Hospital stay was noted at the time of discharge. Wound infection rate was assessed till 30th post-operative day while anastomotic leak was ruled out on clinical and radiologic exam if symptoms were present. All the data of this study were analyzed in SPSS version 26. We concluded that that there is no significant difference in surgical outcomes between the group receiving the bowel preparation versus the group not receiving the bowel preparation in terms of surgical site infection rate, anastomotic leak and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital condition such as Hirschsprung disease, anorectal malformation requiring pull through with or without covering colostomy.
* Patients with anorectal malformation requiring anorectoplasty with or without covering colostomy.
* Ileostomy/colostomy acquired due to intestinal perforation, intestinal obstruction, and trauma admitted for reversal.
* Age up to 12 years.
* Patients of both genders.

Exclusion Criteria:

* Any associated congenital morbid anomaly having Meningomyelocoele, Muscular dystrophy (were assessed on clinical examination)
* Patients with behavior disorders such as autism (were assessed during psychiatric history and clinical examination)
* Patients with behavioral disorder are difficult to counsel and follow up
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile.

Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection (CDI).

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Men or women 18 years of age or older
* Current diagnosis of a recurrence of non-severe, non-complicated CDI
* Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode

Exclusion Criteria:

* Pregnant, breast-feeding, or considering becoming pregnant during the study
* Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
* Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
* Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
* Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
* Major intra-abdominal surgery within the past 60 days prior to Screening
* History of total colectomy/ileostomy or bariatric surgery
* Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
* Planned hospitalization or invasive surgery during the study
* Severe acute illness unrelated to CDI
Intravitreal Injections-related Anxiety

Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is the anxiety and discomfort which patients often experience due to the idea of "getting a needle in the eye". In addition, a recent case study indicated the importance of patient education in achieving positive outcomes from intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis.

The use of intravitreal injections of Ranibizumab (Lucentis, Genentech) is becoming increasing common for the management of age-related macular degeneration (AMD). It is therefore important to acknowledge and address patients' anxiety due to anticipated discomfort from the idea of "getting a needle in the eye". In addition, visual provision of information at diagnosis concerning long-term treatment expectation may enhance the informed consent process. The use of visual aids may also accommodate patients of different educational background when presented with new and complex treatment information. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis. Although this tool will be developed in the context of injection-requiring retinal diseases, it has applications in the care of disease requiring long-term treatments.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* AMD patients requiring intravitreal injections

Exclusion Criteria:

* Unable to read or comprehend English
* Any contraindications to intravitreal injections, such as IOP elevations
Patient Perception of Video Advance Care Planning

Rates of advance directive completion among Americans, even those suffering from serious chronic illness, are notoriously poor. Moreover, the contents of completed advance directives are often difficult to interpret in the face of a medical crisis. The study aims to examine patient perceptions of electronic, interactive versions of advance care planning documentation.

The investigators are studying the video platform of a commercially available advance directive application, Honor My Decisions. This application was generated with funding from patient advocacy groups. The application allows a person to create a legally valid advance directive on his or her own tablet or smart phone and share that directive (either by printing or emailing a secure link to family and/or health care providers). Additionally, the app includes a feature by which individuals may record several 2-4 minute videos to memorialize their health preferences, and also to leave a more personal message for loved ones (a video legacy).

The research team has compiled a list of question prompts for these advance care planning videos with the assistance of a panel of experts on communication, palliative care, critical care, ethics and the law. The investigators collected prompt suggestions from these 9 experts with a modified Delphi technique, using iterative surveys to generate consensus. The experts were instructed to consider both contents and phrasing of question prompts, to promote usability and also later utility (if the patient later became unable to speak for him- or herself). These question prompts will form the basis of this pilot study.

The investigators aim to assess the experiences of patients completing electronic advance directives and documenting their care preferences and personal legacy via video. Renal dialysis patients have been selected as a patient population with frequent hospitalizations and low rates of advance directive completion. Patients will be given the opportunity to interact with the application and record their own videos. They will then provide immediate and long-term feedback about the video question prompts via interview.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing dialysis treatment
* 18 years of age or older

Exclusion Criteria:

-
Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease

This study is designed to address the feasibility of a randomized, double masked, cross-over study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

The Primary Hypothesis is that such a study will be feasible as defined by subject adherence to study medication and study procedures and avoidance of other cannabinoid containing substances during the trial period as well as by ability to mask subjects and investigators to treatment assignment

Secondary hypotheses are:

Dronabinol will:

Reduce patient-reported pain interference Reduce patient-reported pain scores and change patient-reported pain quality. Reduce use of opioid pain medications. Improve patient-reported stiffness, nausea and vomiting, sleep, mood, anxiety, and social functioning.

Reduce markers of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥18 years, able to understand and sign the informed consent form
* Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
* Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
* Willing to abstain from marijuana, medical and illicit, during study weeks 1 through 6.
* For patients currently receiving hydroxyurea and/or L-glutamine, on a stable dose(s) for at least 3 months
* For patients currently on a chronic red blood cell transfusion program, on such a program for at least 3 months

Exclusion Criteria:

* Known intolerance to dronabinol, sesame oil, or marijuana
* Patients with a diagnosis or medical history of any psychiatric disorder with psychosis
* Presence of any concomitant medical condition, or use of concomitant medication, that, in the Investigator's opinion, may place the subject at increased risk of side effects of dronabinol.
* Pregnant or nursing women
* If a woman capable of becoming pregnant, unwilling to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception or vaginal ring, medroxyprogesterone, contraceptive implants, intrauterine device, or patch, surgical sterilization, total abstinence. We have not included a similar restriction for men as the current FDA approval includes no such restriction.