cyrilzakka/clinical-trials huggingface dataset:
Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).

The goal of the MRT is to optimize the ViraBrite intervention by randomly assigning participants to various combination of notification timing (e.g., morning, midday, evening). Participants will download the ViraBrite suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress). The MRT will last for 4 weeks for each participant. Each day, participants will receive prompts ("nudges") according to a micro-randomized pattern that encourage them to access the ViraBrite app and utilize suicide safety planning skills. One decision point will occur per day. At each decision point, participants will have a seventy-five percent chance of receiving a nudge. Given that they are randomized to receive a nudge, participants have a 33.3% chance of receiving a notification at one of three time points: morning, midday or evening. The MRT will also investigate the impact of estimated emotional distress as a moderator of responding to the nudge. Specifically, measures of distress including 1. Self-report of daily mood, 2. Linguistic markers of distress (i.e., first person pronoun use) and 3. Geolocation will be explored as moderators of engagement with nudges.

Eligibility Criteria:
Inclusion Criteria:

* Recent suicide attempt or ideation with a plan
* English fluency and literacy
* Parent or legal guardian willing and able to legally provide informed consent

Exclusion Criteria:

* Unable to read/understand English
* Current manic or psychotic episode
* Development disability precluding comprehension of study procedures
* No routine access to a mobile phone, assessed by EHR review and during phone screen
* No eligible parent or legal guardian to provide informed consent
Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Patients from 4 local communities in northern Norway referred (either new or follow up) to orthopaedic department, University hospital of Northern Norway for outpatient consultation, are randomly assigned to either remote consultation by use of telemedicine (camera and screen), or standard consultation at the hospital. There are x-ray facilities also at the remote site. The patients randomized to telemedicine consultation meet special trained nurses at the remote site, but doctor only by video conference. The patients will be followed for up to one year. The primary endpoint is quality of care achieved with the telemedicine consultation as compared to standard outpatient consultation (assessed by questionnaires filled out by the doctor involved). Secondary end points are patient satisfaction assessed by questionnaires and economic analyses. The study hypothesis is non-inferiority of telemedicine consultation vs. conventional, outpatient consultation.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given
* New referred patients to orthopaedic department (outpatient), UNN, for conditions suitable for telemedicine consultation
* Follow up consultation of trauma patients (operated/not operated)
* Follow up consultation after elective orthopaedic surgery (e.g hip prothesis)
* Follow up of other orthopaedic patients

Exclusion Criteria:

* Senile dementia
* Soldiers, prisoners
* Patients not talking Norwegian, dependent on translator
* If specialized procedures are required during follow up (e.g. cat-scan, ultrasound etc)
* Patients requiring a specific doctor
Minimum Anaesthesia Concentration of Lidocaine Required for Sciatic Popliteal Block

using a biased-coin design up-down sequential method, different concentration of lidocaine will be used for popliteal block After 45 successful block (positive response), the data will be used to calculate the minimum lidocaine concentration that can result in successful popliteal block in 90% of patients

The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response, the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response, the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11).

Eligibility Criteria:
Inclusion Criteria:

* orthopedic foot or ankle surgery
* day case surgery

Exclusion Criteria: patients

* \<18y,
* ASA class greater \>III,
* obese (BMI \>30),
* patients with low body weight, who required lidocaine dose is of more than 4.5mg.kg-1
* peripheral neuropathy,
* motor weakness,
* infection at the injection site
* any contraindications for medications in the study.
The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms

To assess the relationship between ovarian endometrioma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms. In addition, the investigators also assess the impact of surgeries for ovarian endometrioma on lower urinary tract symptoms, sexual function and gastrointestinal symptoms.

All patients were found to have ovarian endometrioma were invited to participate in this study. The size and location of ovarian endometrioma should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function, female sexual function, and bowel incontinence assessment questionnaires and CA125 level. In addition, patients who underwent surgeries for ovarian endometrioma will be requested to complete the above questionnaires and CA125 check-up at 3 \& 6 months after surgery. At least 30 women with age and body mass index matched and without ovarian endometrioma will be invited to participate in this study as the control group.

Eligibility Criteria:
Inclusion Criteria:

1. \>20 years old.
2. Ovarian endometrioma: women having a frosted glass content in ovarian cyst

Exclusion Criteria:

1. The patient is acute lower urinary tract infection or intestinal inflammation.
2. Had received surgery bladder or urethra.
3. Patients with a history of urinary tract stones or tumors.
Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients

Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.

Cancer patients who have developed blood clot in the arm that has the central venous catheter will be treated with standard of care blood thinning injection of low molecular weight heparin for 1 week and then for apixaban 5 mg twice daily for the rest of 11 weeks. Data will be collected to see if the central venous catheter "survived" or remained in place and did not have to be taken out because of the clot.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female \> 18 years of age.
2. Symptomatic acute upper limb thrombosis in the axillary, subclavian or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or Computerized Tomography (CT) scan.
3. Diagnosis of active malignancy, as defined by patients who are either receiving active treatment, or have metastatic disease or who have been diagnosed within the past two years.
4. Willing to provide written informed consent.

Exclusion Criteria:

1. Presence of dialysis catheters
2. Active bleeding or high risk for major bleeding
3. Platelet Count \< 75 x 109/L
4. Creatinine Clearance \< 30 mL/min
5. Currently on other anticoagulant with therapeutic intent for another indication
6. Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement
7. Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (2 mg tPA).
8. Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months
9. Treatment for current episode \> 7 days with any acceptable anticoagulant therapy
10. Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics)
11. Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid \[ASA\] and Plavix)
12. If female of childbearing potential: pregnancy and/or breastfeeding
Treatment for Depressed Preadolescent Girls

This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.

Depressive disorders during childhood are virulent, long-lasting disorders that are a risk factor for the development of future depressive episodes and other psychiatric difficulties. A dysfunctional family environment is a possible pathway to the development of depression in adolescents. The family environment is an especially salient context for the development of depression in preadolescent girls.

Depression is expressed differently between male and female adolescents; girls may not benefit as much as boys from treatments such as cognitive behavioral therapy (CBT) because the treatments may not target disturbances and skills that are specific to preadolescent girls. This study will identify effective treatments for depression in preadolescent girls.

Depressed participants are randomly assigned to receive CBT, CBT plus parent training (PT), or a minimal contact control (MCC). The CBT group receives treatment twice a week for 10 weeks. Participants in the CBT plus PT group receive therapy sessions and group treatment for 10 weeks. Participants in the MCC group meet with a research associate once a week for 10 weeks. During the control visits, the child's depressive symptoms are assessed, but no advice or treatment is given. Participants are assessed at baseline, post-treatment, and at yearly follow-up visits for up to 4 years. School performance, home environment, and the impact of the interventions on parent adjustment are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Depressive Disorder

Exclusion Criteria:

* Learning disability or limited intellectual ability
* Health-related illness that would prevent the patient from completing the research study
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.

OBJECTIVES:

* Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone.
* Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms.

* Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
* Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
* Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer and receiving one of the following combination therapy regimens:

  * Doxorubicin and cyclophosphamide with or without fluorouracil
  * Doxorubicin with paclitaxel or docetaxel
  * Fluorouracil, epirubicin, and cyclophosphamide
* Must be beginning second or third course of chemotherapy
* Nausea intensity with prior chemotherapy of at least 3 (moderate) on the intensity scale of the Morrow Assessment of Nausea and Emesis
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Adult

Sex

* Female

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Concurrent antiemetics allowed
tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity

The purpose of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to reduce impulsivity in individuals with obesity, and to evaluate weight change with these individuals. The long-term goal of this research is to develop new treatment approaches for individuals with obesity.

Two-hundred forty individuals will be screened with the goal of consenting and enrolling 124 patients and 88 patients completing the study. Participants completing the study will concurrently complete a structured weight loss program. The investigators' study protocol will consist of 13 study visits including four testing days, one before (V1), one on the day of the tenth session of tDCS (V11), another test visit (V12) 6 weeks later, and a final test visit approximately 4 months after beginning stimulation (V13).

Eligibility Criteria:
Inclusion Criteria:

* Veteran enrolled in a MOVE! Weight Management Program (group or individual) at the Minneapolis VA Health Care System
* Obese (BMI\>30 or BMI\>27 plus at least one weight-related comorbidity)
* Adults, ages 18 years or older (up to age 80)
* Able to understand English, self-consent and follow study-related procedures
* Willing to use a reliable form of birth control if they are of females of child-bearing potential

Exclusion Criteria:

* History of any of the following: seizures, severe or moderate head injury, head surgery, significant neurological disorder (significance based on Principal Investigator's judgment)
* Frequent severe headaches
* History of scalp conditions such as eczema or seborrheic dermatitis
* Metal in head (other than in mouth) including shrapnel/surgical clips/welding fragments
* Implanted medical devices (including pumps and cardiac pacemakers)
* Pregnancy
* Acute substance dependence or withdrawal that would affect ability to complete cognitive training
* Moderately severe to severe depression (as identified on PHQ-9 scale during baseline screening)
* Other psychological or medical disorders requiring inpatient treatment (as identified during chart review)
* Presence of a known metabolic or hormonal disorder (such as Cushing's, untreated thyroid dysfunction, or uncontrolled diabetes mellitus defined as a hemoglobin A1c \> 8.0), or significant edema/volume overload - all of which would affect weight
* Uncontrolled hypothyroidism that would affect weight
Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Objective: To determine efficacy of dexamethasone in treatment of meconium aspiration syndrome.

Study design: Randomized control trial. Place and duration: Services hospital, Neonatal unit, Lahore. During time span of 1st January to 30th June 2021.

Material and methods Total 100 neonates were randomly divided in two groups. Group A (n=50) was treated with dexamethasone (Cases) and Group B (n=50) served as control. Dexamethasone was given in dose of 0.2mg/kg, 12 hourly for 7 days after confirmation of diagnosis. Infants present in clinical trial were evaluated by ventilation duration (invasive and non-invasive), oxygen therapy and hospital stay.

Data was analyzed in statistical analysis SPSS version 23. Means and Standard deviation were calculated for duration of non-invasive and invasive ventilation, hospital stay and oxygen therapy. Independent sample T test was applied and value \< 0.05 was taken as significant. Whereas frequency and percentages were taken for gender, gestation, mode of delivery and outcome of MAS and Chi-square test was applied, and p value \< 0.05 was taken as significant.

Eligibility Criteria:
Inclusion Criteria:

1. Term and Post-Term babies who met the operational definition of MAS (inborn)
2. Presenting within 24 hours of life

Exclusion Criteria:

1. Preterm babies or babies with congenital malformations
2. Preterm babies or babies with dysmorphism
3. Preterm babies or babies with hypoxic-ischemic encephalopathy
Comparison of Tramadol and Dexmedetomidine in the Prevention of Urinary Catheter Discomfort in Urinary Surgery

The investigators aimed to compare the effects of tramadol and dexmedetomidine, which are commonly used in anesthesia, on preventing catheter-related bladder discomfort.

Urinary catheterization is an attempt frequently used in many surgeries, emergency services or intensive care units, especially urinary surgeries to facilitate urine output or evaluate urine output. However, as a result of urinary catheter application, most patients may develop some symptoms like pain, burning sensation and the urge to urinate constantly in the suprapubic region that the investigators call this catheter-related bladder discomfort (CRBD).

The incidence of CRBD can increase 47 to 90% in the postoperative period. The main reason of CRBD is involuntary contractions caused by muscarinic receptors, especially type 3 (M3) receptors. Therefore, antimuscarinic drugs are used to prevent and treat CRBD. Studies have shown that many drugs such as ketamine, tolterodine, oxybutynin, gabapentin, pregabalin, butylscopolamine, tramadol, dexmedetomidine are effective in preventing CRBD. Their common feature is antimuscarinic effects. However, no definitive conclusion could be reached for routine use, due to the low number of samples in the studies, surgical differences or some anticholinergic and sedative side effects. Additionally, oxybutynin, tolterodine, gabapentin, and pregabalin are only preoperatively administered orally. So more research is needed to find the ideal agent to prevent CRBD.

Tramadol is frequently used for moderate pain in surgeries. It is a centrally acting synthetic opioid analgesic that has an inhibitory effect on M1 and M3 muscarinic receptors. Tramadol has proven to be effective in reducing the severity and frequency of ICBR in intraoperative use. However, like other opioids, it can have side effects such as nausea-vomiting and sedation.

Dexmedetomidine is a selective alpha-2 adrenoceptor agonist that has analgesic, sympatholytic and sedative properties. In recent studies, it has been reported that dexmedetomidine is associated with the pathophysiology of CRBD by inhibiting type-3 (M3) muscarinic receptor which has beneficial effects in preventing CRBD in intraoperative use. Dexmedetomidine decreases the frequency of CRBD by 30%.

The first purpose of the study is to compare the effects of dexmedetomidine and tramadol on CRBD. Secondarily, the investigators aimed to compare them for their side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 70 years
* American Society of Anesthesiologists I or II
* Scheduled to undergo retrograde intrarenal surgery
* Scheduled to apply urinary catheter intraoperatively

Exclusion Criteria:

* History of bladder outlet obstruction (Bening prostatic hypertrophy)
* History of neurogenic bladder
* History of psychiatric illness
* Obese patient
* Patients whose urinary catheter cannot be inserted
* Patients who had previously urinary catheters
Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).

The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven classical HL
* First diagnosis, no previous treatment
* Age: 18-60 years
* Stage I, IIA with risk factors a-d, IIB with RF c-d:

  1. large mediastinal mass
  2. extranodal lesions
  3. elevated ESR
  4. ≥ 3 nodal areas confirmed by central review.

Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* History of other malignancy ≤ 5 years
* Prior chemotherapy or radiation therapy
* Concurrent disease precluding protocol treatment
* Pregnancy, lactation
* Non-compliance
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion Criteria:

* Evidence of other forms of inflammatory bowel disease
* Infectious disease (including human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\])
* Disease limited to proctitis \<15 cm
* Short bowel syndrome
* Prior colon resection surgery
* History of severe/fulminant UC
* Intolerant or allergic to aspirin or salicylate derivatives
* Use of rectal formulations (5-aminosalicylic acid \[5-ASA\], steroids) within ≤7 days
* Women who are pregnant or nursing
* History of known malignancy
* History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/ emotional disorders, that would interfere with their participation in the trial