cyrilzakka/clinical-trials huggingface dataset:
Mobile-assisted Case Management for Panic Disorder

A panic attack (PA) is an intense form of anxiety accompanied by multiple somatic presentations, leading to frequent emergency department visits and impairing quality of life. A prediction model for PAs could help clinicians and patients monitor, control, and do early intervention for recurrent panic attacks, enabling more personalized treatment for panic disorder. This study aimed to provide a seven-day PA prediction model and determine the relationship between a future PA and various features, including physiological factors, anxiety and depressive factors, and air quality index. We will enroll 200 participants (150 participants join case management with wearables study, 50 participants join TAU group) with PD (DMS-5 and MINI interview). Participants used smartwatches (Garmin vivosmart 4) and mobile applications to collect their sleep, heart rate, activity level, anxiety, and depression scores (BDI, BAI, STAI-S, STAI-T, and PDSS-SR) in their real-life for a duration of one year. We also included air quality indexes from open data. To analyze these data, our team used six machine learning methods: random forests, decision trees, LDA, AdaBoost, XGBoost, and regularized greedy forests, or other deep learning methods.

Participants enrollment Through primary psychiatrists' invitations, we will recruit 150 En Chu Kong Hospital psychiatric clinic PD participants and 50 patients from Mackay Memorial Hospital.

Inclusion criteria The inclusion criteria were 1) a primary diagnosis of PD by DSM-5, 2) more than 20 years old, and 3) an essential ability to navigate smartwatches and mobile phone applications. If participants did not fulfill criteria 3), we will invite them as the control group (i.e. TAU)

Exclusion criteria The exclusion criteria were 1) current substance abuse, 2) cardiopulmonary incapacity, 3) incapacity or limited mental capacity, and 4) acute suicidal ideation. This study required sufficient mental capacity on the part of participants to cooperate by wearing smartwatches continuously, properly maintaining the smartwatches, and completing regular, valid online questionnaires. Limited mental capacity implies that the participants have difficulties understanding, remembering, or using the information to make or communicate a decision. Our team evaluated participants' mental capacity during the diagnostic interview (DI), Mini International Neuropsychiatric Interview (MINI), and the informed consent process by certified psychiatrists and nurse practitioners. The information on acute suicidal ideation was from diagnostic interviews and questions from MINI part A and pre-assessment BDI.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of panic disorder by DSM5
2. More than 18 years old
3. An essential ability to navigate smartwatch and mobile phone applications

Exclusion Criteria:

1. Current substance abuse
2. Cardiopulmonary incapacity
3. Incapacity or limited mental capacity
4. Acute suicidal ideation
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT

In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).

Reduced response rates are observed in thicker skin lesions, which may be due to insufficient PpIX accumulation within the target tissue.

To enhance PpIX production,several physical and chemical pretreatments have been suggested. One of the chemical substances proposed to stimulate PpIX production is vitamin D because of its ability of being a keratinocyte pro-differentiating hormone.

Based on in vitro and in animal model studies, we propose to study the potential impact of patient vitamin D pre-treatment in AK response to MAL-PDT.

A randomized, controlled Split -scalp study with Calcipotriol Assisted MAL-PDT versus conventional MAL-PDT for actinic keratosis (AK) is proposed.

Twenty patients ( male gender only) with symmetrically distributed multiple AK lesions on the scalp will be included. Patients must have at least five AKs per field to be eligible.

After simple randomization, one half of the scalp will be treated with Calcipotriol ointment 50 mcg/g (Daivonex, Leo Pharma, Denmark) for 15 consecutive days.

After this period, the entire scalp will be submitted to topical PDT with Methylaminolevulinate 16% (Metvix, Galderma France) under occlusion for 90 minutes and then, illuminated with a light source consisting of a Light Emitting Diode device (LED) at 635 nm ( Aktilite - Photocure, Norway). The total light dose will be 37J/cm2.

Immediately before and after illumination with LED, measurements of the fluorescence intensity will be taken in 3 isolated spots in both sides of the scalp with a spectroscopy deviceUSB 2000+ ( Ocean Optics ® - Dunedin, Fl, USA).

AK lesions will be counted and mapped by a dermatologist not involved in the study before and after 3 months.

All patients will be advised to apply sunscreens 50 + 3x/day for the following 7 days after the procedure.

A 0-10 Visual Analogue Scale (VAS) will be used to measure the pain intensity during the illumination.

Records will be taken after 90 days and compared between sides: side effects, AK lesion response and pain level intensity. Also, a long term follow up will be provided at 6 and 12 months after.

Eligibility Criteria:
Inclusion Criteria:

* male gender
* at least six AKs per field

Exclusion Criteria:

* history of photosensitivity related disorders
* active infectious disease,
* immunosuppression
* laser or any cosmetic treatment in the previous 6 months
* other topical agents in the treatment area such as retinoids, 5-fluorouracil,imiquimod or diclofenac sodium in the previous 3 months
* allergy to MAL or excipients of the cream
* poor patient compliance.
Endotoxin Activity Assay and Microcirculation in Severe Sepsis

Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response syndrome induced by gram-negative bacteria infection. The endotoxin related inflammatory response and hypercoagulation can result in microcirculatory dysfunction. When microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and death. This is a prospective observational study, and it will not influence the sepsis treatment decision of the medical care team. The critically ill severe sepsis patients will be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and sign the consent form after explanation of the aim and process of the trial by the primary investigator or research personnel. After enrollment, the patient will receive serum assay of endotoxin activity (EAA) and endocan level. The patient will also receive examination of sublingual microcirculation by using the incident dark field video microscope. After 24 hours, the patient will receive assay of endocan level and examination of sublingual microcirculation. This study will record the vital signs, laboratory data, dose of vasopressors and inotropic agents, and severity of organ dysfunction. After 28 days, this study will check the survival, stay of intensive care, stay of hospital, ventilator day, and the results of culture of pathogens. The patients will be assign to the following three groups by the EAA level: low EAA group (\< 0.40 EAA units); intermediate EAA group (0.40-0.59 EAA units); and high EAA group (≧ 0.60 EAA units). This grouping will be used for statistical analysis and comparison. The primary goal of this study is to investigate the difference of the prevalence of gram-negative bacteria infection, pathogen, infection source, microcirculation, the severity of disease, and the prognosis among these three groups.


Eligibility Criteria:
Inclusion Criteria:

* patients with the following infections: intraabdominal infection, pneumonia, urinary tract infection, blood stream infection, or wound infection
* patients must also meet any one of the following criteria for severe sepsis

  * SBP \< 90 mm Hg, MAP \< 65 mm Hg, or requirement of vasopressors or inotropics
  * PaO2/FiO2 \< 300
  * Creatinine level \> 2 mg/dL or increase \> 0.5 mg/dL; or urine output \< 0.5 mL/kg/h more than 2 hours
  * Bilirubin level \> 4 mg/dL
  * Platelet count \< 100 k/uL or decrease more than 50%
  * INR \> 1.5 or aPTT \> 60 sec
  * GCS \< 13 or 9T
  * Lactate \> 2 mmol/L (with pH \< 7.3 or base excess \< -5 mmol/L)

Exclusion Criteria:

* younger than 20 yeras old or greater than 99 years old
* the onset of severe sepsis before enrollment is greater than 24 hours
* pregnant
* have received plymyxin-B hemoperfusion within 24 hours before enrollment
* non-native speaker
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).


Eligibility Criteria:
Inclusion Criteria:

* HS disease duration of at least 3 months before screening.
* Willingness to avoid pregnancy or fathering children.
* Active HS in at least 2 distinct anatomical areas.
* Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period

Exclusion Criteria:

* Draining fistula count of \> 20 at screening or baseline.
* Women who are pregnant (or who are considering pregnancy) or lactating.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* History of failure to treatment of inflammatory diseases with JAK inhibitors.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
* Laboratory values outside of the protocol-defined ranges.
IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.

These factors can be of different types:

* Environmental factors (sodium or alcohol intake);
* Morphological (height, weight, body mass index, body surface area);
* Initial blood pressure;
* Electrocardiogram (ECG) parameters of left ventricular hypertrophy;
* Biological parameters as the activity level of the renin angiotensin aldosterone system;
* Genetic polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

* Participants have to be 25 to 60 years of age
* Both genders
* Systolic blood pressure of 140 mmHg or above; diastolic blood pressure of 90 mmHg or above.
* Cardiovascular risk must not be high, to allow for two periods of 4 weeks of placebo without ethical concern.
Iron Dosing Pilot Study Using Model Predictive Control

This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease
* anemia
* receiving intravenous iron

Exclusion Criteria:

* none
Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial acne scars.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, between 18 years and 65 years of age.
2. Investigator assessment of the acne scarring on each cheek of moderate to severe.
3. A history of acne scarring for more than 3 years.
4. Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

Exclusion Criteria:

1. Significant active acne.
2. Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
3. Presence of hypertrophic scars on the cheeks.
4. More than 20% of treatment area comprised of ice pick scars or sinus tracts
5. Treatment area per cheek is less than 9 cm x cm
6. Unilateral or unbalanced acne scar distribution.
7. Physical attributes which prevent the assessment or treatment of the acne scars.
8. Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
9. Previous treatment with Isolagen TherapyTM.
10. Use of Isotretinoin within one year of enrollment into study.
11. Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
12. Disorders or drugs that increase bleeding or clotting.
13. Pregnant or lactating women or women trying to become pregnant during the study.
14. Excessive exposure to sun.
15. Smoking more than ½ pack of cigarettes per day.
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria

The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique.

This was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 years and above
* Diagnosed with uncomplicated senile cataract
* Visual acuity of \<3/60

Exclusion Criteria:

* Impaired mental status
* Difficulty in speaking
* Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase
* Previous surgery in the same eye
* Glaucoma
* Impaired ocular motility
* Eyelid abnormalities
* Patients with only one eye
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Patients are randomized in a 1:1 ratio to periprocedural intravenous hydration matched to urine output using the RenalGuard system and to standard hydration. The purpose of the study is to test, wether the controlled intravenous hydration with the RenalGuard system is superior to standard hydration to prevent acute kidney injury after TAVI.

Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is associated with worse outcome. The RenalGuard system was developed to prevent AKI by a controlled furosemide-induced diuresis with matched isotonic intravenous hydration. It is based on the theory, that a high urinary output prevents contrast media-induced nephropathy (CIN).

The present study is a prospective, randomized trial to investigate wether a matched intravenous hydration using the RenalGuard system is superior to standard pre- and postprocedural intravenous hydration in patients with severe aortic valve stenosis and chronic kidney disease undergoing TAVI. Primary endpoint is the occurrence of AKI after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation
* Chronic kidney disease (baseline glomerular filtration rate ≤ 60 ml/min)
* Written informed consent

Exclusion Criteria:

* Hemodynamic instability
* Dialysis-dependent chronic kidney injury
* Emergency transcatheter aortic valve stenosis
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support

The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion, whatever the pre-test probability. The main question it aims to answer is :

Are the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off? Participants will be diagnosed and treated in accordance with routine standard of care.

Establish the diagnostic performance of the Clinical Decision Support tool on fresh plasma, in PE and in DVT, in comparison with that on frozen plasma, and in comparison with the current diagnostic strategy, on the entire population and on the following different subpopulations:

* Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age)
* Patients with high clinical probability, compared to the reference diagnosis (imaging)
* Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events
* Patients with known and active cancer
* Patients with COVID-19. The assays will be conducted on a fresh and frozen plasma aliquots.

Eligibility Criteria:
Inclusion Criteria:

* PE and/or DVT suspicion
* No opposition after informing the patient for his participation in research and processing of their data for this purpose,
* Benefiting from the social security system

Exclusion Criteria:

* Preventive or curative anticoagulant treatment, or fibrinolytic treatment,
* Legal protection (e.g. guardianship or curatorship),
* Pregnant or breastfeeding women.
Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer

RATIONALE: The use of nutritional supplements, such as selenium, may stop prostate cancer from growing. Internal radiation, such as brachytherapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving selenium before brachytherapy may be an effective treatment for prostate cancer.

PURPOSE: This randomized phase I trial is studying selenium to see how well it works compared to placebo in treating patients who are undergoing brachytherapy for stage I or stage II prostate cancer.

OBJECTIVES:

Primary

* Compare the effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility, using tissue samples from biopsies before and after treatment, in patients undergoing brachytherapy for stage I or II prostate cancer.

Secondary

* Determine the effects of selenium on antioxidant enzyme activities in these patients.
* Determine, preliminarily, whether there is a threshold effect among patients with low baseline levels of selenium treated with this drug.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral selenium for 3-6 weeks. Patients then undergo brachytherapy.
* Arm II: Patients receive oral placebo for 3-6 weeks. Patients then undergo brachytherapy.

After completion of study treatment, patients are followed at 1 and 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Must have undergone ≥ a sextant biopsy
  * Clinical stage T1a-T2a disease
* Gleason score \< 8
* Prostate-specific antigen \< 20 ng/mL

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Not specified

Life expectancy

* More than 5 years

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* No prior hormonal therapy

Radiotherapy

* No prior radiotherapy

Surgery

* Not specified

Other

* More than 30 days since prior and no concurrent participation in another clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
* No selenium at doses \> 50 mcg/day as a dietary supplement, including multivitamin supplements
Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)

Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent
* Willing to take COCs and follow all study requirements
* Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
* Last menstrual period (LMP) \<35 days before study entry
* Has body mass index of 18-30
* Negative urine pregnancy test as enrollment
* Documented HIV-1 infection
* On nevirapine-containing ART for at least three months (ART group only)
* CD4 cell count of greater than or equal to 350 (for non-ARV group only)
* Currently sexually active and plans to stay sexually active for the next 6 months

Exclusion Criteria:

* Medical contraindications to COC use
* Recent pregnancy (within 3 months)
* Has breastfed in last 3 months
* Last pregnancy was ectpoic
* Has been sterilized
* Has had any of the following conditions since last pregnancy, or since menarche if never pregnant:

Pelvic Inflammatory disease Diagnosis of infertility

* Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has had no menses since last injection regardless of its timing)
* has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin implants or intrauterine systems, progestin-only contraceptive pills, medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study entry
* Has an acute infection or other opportunistic diseases requiring therapy within 14 days before enrollment
* Has active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
* Has taken any prohibited medication within 30 days before study entry
* Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake
* Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation