cyrilzakka/clinical-trials huggingface dataset:
Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis

These studies are designed to assess the synergistic efficacy of topical 0.1% triamcinolone cream paired with 40,000 IU of oral vitamin D3 daily in treating mild to moderate psoriasis. The study is designed to have all subjects treated with triamcinolone cream (TAC) for 4 weeks, then will be randomized 1:1 into vitamin D3 or placebo for an additional 12 weeks. At that time, the study will become open-label and all subjects will be placed on (or continue) vitamin D3 for an additional 12 weeks. The study will take place over 28 weeks total.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Mild to severe plaque psoriasis (2% or greater Body Surface Area; Psoriasis Area and Severity Score of 2 or greater; Investigator Grade Assessment of mild-severe)

Exclusion Criteria:

* Currently taking medication that alters the normal ion balance of low-dose in blood.
* No calcium supplements 1 month prior to baseline (not including multivitamins).
* Unstable or uncontrolled illness, including but not limited to cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disease at screening.
* Abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety or data integrity.
* Not on systemic non-biologic therapy (including, but not limited to, oral psoralen plus ultraviolet A \[photochemotherapy (PUVA)\] light therapy; cyclosporine; corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus; azathioprine; leflunomide; fumaric acid derivatives; or 1, 25 dihydroxy vitamin D3 and analogues) within 28 days prior to baseline.
* No phototherapy (including either oral and topical PUVA light therapy, ultraviolet B, excimer laser, or self-treatment with tanning beds or therapeutic sunbathing) within 28 days prior to baseline.
* No topical treatment (including, but not limited to, corticosteroids \[upper mid strength or lower potency topical steroids are permitted on the intertriginous areas and face\], crisaborole, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus, emollients and other nonprescription topical products containing urea, \>3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos \[for example those that contain \>3% salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues\]) within 14 days prior to baseline.
* No biologic agents within 8 weeks or three half-lives, whichever is greater prior to baseline.
* History of renal impairment.
* History of renal stones.
* History of parathyroid abnormalities
* Osteoporosis
* History of severe arthritis
* Ongoing use of tanning bed or other UV device or excessive sunlight
* Unable to understand/complete informed consent.
The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

To study the diagnostic specificity and sensitivity of various modalities used for the assessment of anastomotic leak in esophagogastric surgery and to identify the most sensitive technique. Secondarily, to propose a clinical algorithm to guide clinicians in the diagnosis of anastomotic leaks esophagogastric surgeries.

Anastomotic leak in esophagogastric surgery remains a diagnostic challenge despite advances in imaging techniques. All available modalities appear to have limited sensitivities and have significant false negatives. A high index of clinical suspicion continues to be the key element in the early diagnosis of esophagogastric anastomotic leaks. The incidence of anastomotic leak in esophagogastric surgeries is reported to range from 7-20% in various studies, and it is a major complication that increases hospital stay and mortality. It is important to identify these complications early to optimize the outcomes of these patients. There has been no study till date that examines the incidence of false negative results for anastomotic leak in esophagogastric surgeries. False negative findings may give surgeons a false sense of assurance in the patient's postoperative recovery, and escalation of oral intake may result in catastrophic complications and outcomes in these patients. This study seeks to identify the most sensitive modality in the diagnosis of esophagogastric anastomotic leaks in a retrospective series of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing any of the following surgeries at National University Hospital, Singapore between January 2001 and March 2019:
* Distal gastrectomies
* Total gastrectomies
* Bariatric gastric bypasses
* Subtotal esophagectomies
* Proximal gastrectomies
* Palliative bypasses
* Total esophagectomies

Exclusion Criteria:

* Under 21 years of age
Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema

The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (BCVA), ophthalmologic investigation, SD-OCT, FAG and anamnesis
* BCVA between 0.05 and 0.6 or retinal thickness \> 300 µm determined by SD-OCT
* The informed consent form must be signed before any study specific tests or procedures are done
* Confirmation of the subject's health insurance coverage prior to the first screening visit
* Age at least 18 years (inclusive) at the first screening visit
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* Severe ischemic maculopathy of the study eye
* Active neovascularization of iris or retina in the study eye
* History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
* Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
* Advanced glaucoma with central defects of the visual field in study eye
* Retinal pathologies with reduced visus (e.g. central scars, age related macular degeneration) in study eye
* Retinal vascular occlusion in medical history of study eye
* Active or suspected ocular or periocular infections
* Active intraocular inflammation in study eye
* Intraocular surgery of study eye within the last 6 months
* Laser therapy of study eye within the last 6 months
* Systemic steroid therapy within the last 3 month
* HbA1c \>10%
* Systolic blood pressure above 170 mmHg and diastolic blood pressure above 110 mmHg (after at least 3 min in supine position)
* Pregnant or breast-feeding woman and woman without adequate method of contraception.
* Known hypersensitivity to the active substance or to any of the excipients
Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery

The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.


Eligibility Criteria:
Inclusion Criteria:

* Aged more than 28 days and less than 14 years old；
* Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.

Exclusion Criteria:

* Emergency surgery;
* Combined with severe hepatic and renal dysfunction (with a diagnosis of acute or chronic renal insufficiency or requiring renal replacement therapy; with a diagnosis of acute or chronic hepatic insufficiency or requiring artificial liver treatment);
* Combined with non-cardiac malformations (adenoidal hypertrophy, tracheobronchial stenosis and ocular disorders);
* History of preoperative cerebral ischemia or haemorrhage;
* Refuse to sign the informed consent form or the child has poor compliance.
Subcutaneous Pharmacokinetics of Belatacept

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 65 years old
* Subjects must weigh less than or equal to 100 kg

Exclusion Criteria:

* Inability to tolerate injections or IV infusions
* autoimmune disorders
* TB
* herpes
* HCV
* HBV
* HIV
* bacterial or viral infection
* history of cancer
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh

The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.

Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem.

The surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short.

Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years
* Indication for laparoscopic parastomal hernia repair in general anaesthesia.
* Danish speaking
* ASA group I-III
* No remaining malignancy after former primary radical operation for colorectal cancer

Exclusion Criteria:

* Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation
* Incarcerated hernia (acute operation)
* History of abuse or permanent morphine use
* Expected bad compliance
* Current systemic steroid use or other immuno-suppressive treatment
* HIV-positive, pregnant or breast feeding
* Medical conditions contraindicating general anaesthesia
* Simultaneous operation for other ventral, inguinal or umbilical hernia
* Epidural or spinal anaesthesia
* Conversion to open procedure
Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* definite or probable neuropathic pain
* diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
* pain duration \> 3 months
* pain rating at baseline \>= 4 point NRS
* Informed consent

Exclusion Criteria:

* other non-neuropathic pain condition
* allergy to oxcarbazepine
* renal or hepatic impairment
* epilepsy
* depression and other serious psychiatric disorders
* serious medical condition
* previous treatment for neuropathic that cannot be stopped
* pregnancy
* patients expected not to be able to comply with study protocol
* treatment with anticonvulsants, antidepressant or opioids
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Physiological stimulation therapy effectiveness will be proved with contractility sensor or CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from neuromediated syncope. Furthermore, not only will be investigated if this system eradicates syncopes, but also if the number of presyncopal episodes is reduced.


Eligibility Criteria:
Inclusion Criteria:

* Patients that fulfill the requirements of the study:

  * Patients with 5 previous neuromediated syncopes
  * Positive Tilt test, Cardioinhibitory response, heart rate \< 40 bpm for at least 10'' or pauses \> 3''
  * Patient ≥ 40 years
  * No cardiopathy present
* Patients without the following contraindications:

  * Drug treatment with β-blockers
  * Chronic Polyneuropathy
  * All contraindications for DDD or DDDR pacing (as per clinical guidelines SEC, 2002)
* Geographically stable patients and able to attend all follow ups
* Patients that have signed the informed consent

Exclusion Criteria:

* Patients that do NOT fulfill the inclusion criteria mentioned above
* Patients with the contraindications indicated above
* Patients with syncopes due to Carotid Sinus Hypersensitivity
* Other syncope causes different to the CNS
* Patients involved in other clinical studies
* Pregnant women or in age bearing that are not using at least 2 contraception methods
Probiotics for Clostridium Difficile Infection in Older Adults

The purpose of this study is to determine whether a probiotic, when used together with standard treatment, is effective in reducing duration of symptoms and preventing recurrence of infection in older adults with a first episode of C. difficile infection.

Probiotics are live microorganisms that are available over the counter, widely used as dietary supplements or nutritional foods, and represent a low-cost, well tolerated, safe, non-antibiotic based strategy that may have efficacy as adjunctive treatment of infections without the attendant risks of promoting antimicrobial resistance. Certain probiotics have demonstrated inhibition of adherence of pathogenic bacteria and stimulation of systemic immune functions, possibly enhancing the body's ability to eradicate C. difficile in the gastrointestinal tract. However, limited data is available on the efficacy of probiotics for ameliorating C. difficile symptoms and reducing recurrence of C. difficile infection (CDI). The investigators propose a pilot randomized, double-blind, placebo-controlled clinical trial in older adult inpatients with a first episode of CDI to evaluate the efficacy of a probiotic combination, in conjunction with standard treatment, for reducing duration of diarrhea and recurrence of CDI.

Eligibility Criteria:
Inclusion Criteria:

* Adult of either gender, 18 years or older with a first episode of C. difficile infection
* Meets the case definition of C. difficile infection-diarrhea associated with a positive stool test for C. difficile toxin(s) in the 2 days prior to enrollment treated with metronidazole or vancomycin

Exclusion Criteria:

* Severe disease defined as any of the following: WBC \> 30,000 or \< 1000 cells/mm\^3, elevated creatinine \> 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed
* Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
* Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)
* Has a presence of toxic megacolon or ileus
* Has a presence of colostomy or nasogastric tube
* Has a history of abdominal surgery within the previous 3 months (from time of enrollment)
* Is enrolled in another investigational drug trial
* Is unavailable for follow-up visits
* History of multiple C. difficile infection
* Willing not to take other probiotics for duration of study
* Is severely immunocompromised.
Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients

A total of 50 patients \>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.

A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects\>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 40 years of age.
* Pt with expected stay in hospital 6 days or \>, with expectation to be bedridden for \> 4 days.
* Pts admitted to the MICU, Regional Heart Units of LV-MHC

Exclusion Criteria:

* Surgical primary admission diagnosis
* Recent surgery within the past 12 weeks
* Planned surgery on the current admission
* Pregnancy
* Vent-dependent respiratory failure requiring intubation for \>24 hours.
* Known current DVT or PE prior to enrollment in study.
* Creatinine clearance \< 30 mL/min (calculated by the Cockcroft-Gault method) in a well-hydrated patient.
* Hx of prior or current lower upper or lower GI bleed.
* Platelet count \< 100,000 per cubic millimeter
* Current or prior anticoagulation within the prior 48 hours, excluding a single dose \&lor 24 hour period of prophylactic agent
* Bacterial endocarditis.
* Hemophilia
* Hypersensitivity to aspirin.
* Hypersensitivity to Arixtra or Lovenox
* Hx of hemorrhagic or ischemic stroke \< 3 months prior to enrolling
* Hematocrit \< 28%.
* SBP \>200 mmHg or DBP \>120 mmHg
* Positive for occult blood in stool.
* Admission to hospital for \> 48 hours prior to randomization
* Documented congenital or acquired bleeding disorder
* Indwelling intrathecal or epidural catheter
* Life expectancy \< 30 days
* Inability to have a flu assessment post-discharge from the hospital
Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)

Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

Aim two is based on preliminary results of Aim one interviews, and in collaboration with the Patient Advisory Panel, the investigators developed a brief questionnaire to be administered to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and peritoneal dialysis (PD).


Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years of age or older.
* Currently consented in the Dialysis Outcomes and Practice Patterns Study - (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals unable to provide informed consent.
A Multiple Ascending Doses (MAD) Study of PMG1015 in Idiopathic Pulmonary Fibrosis Subjects

This is a phase 1b randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study of PMG1015 in idiopathic pulmonary fibrosis (IPF) subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after MAD.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of IPF as defined by current American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Clinical Practice Guidelines for IPF (2022) (Pathological examination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lung biopsy);
2. Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
3. Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
4. Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons

Key Exclusion Criteria:

1. Patients with instable condition of IPF as assessed by the investigator at screening, and those with acute exacerbation of IPF during screening or within 3 months prior to randomization;
2. Patients who are likely to be lung transplant recipients within 6 months or expected to survive less than 1 year as assessed by the investigator at screening;
3. Patients accompanying with an interstitial lung disease other than IPF;
4. Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator;
5. Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening;
6. Patients accompanying with other uncontrolled underlying diseases, for which the patient is not considered suitable for the study as assessed by the investigator;
7. Patients who had active tuberculosis within 12 months prior to screening, or clinical symptoms of bacterial, viral, fungal or microbial infections requiring intervention within 4 weeks prior to randomization;
8. Patients who have known allergic reaction to the investigational product or its active pharmaceutical ingredients (APIs), or history of allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies or any substances contained in the excipients;
9. Pregnant or lactating women; female subjects who plan to become pregnant during the study, or patients who are not willing to take contraceptive measures as required by the protocol during the study;
10. Other conditions that preclude the patient from participating in the study as assessed by the investigator.