cyrilzakka/clinical-trials huggingface dataset:
Patterned Electric Dressing Effects on Open Wounds

1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization.
2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.

This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. Study participation is decided independent of clinical decision. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older
* Patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment
* The affected limb to be amputated must have at least one open wound

  * Wound(s) must be able to be covered by 3x3 dressing
* Subjects willing and able to provide informed consent

Exclusion Criteria:

* Pregnant women
* Prisoners
* Individuals lacking consent capacity
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.

PRIMARY OBJECTIVES:

I. To determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease.

II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk \[chemonaïve\] vs poor risk \[1 prior chemotherapy regimen\]).

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease
* Life expectancy \> 3 months
* Karnofsky Performance Status \> 60%
* Absence of an active infection
* Granulocyte count of \> 1,500/mm\^3
* Hemoglobin (Hgb) \>= 9 mg/dl
* Serum bilirubin =\< 1.5 mg/dl, regardless of liver involvement secondary to tumor
* Platelets \> 100,000/mm\^3
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 x the institutional upper limit of normal
* Calculated creatinine clearance of \> 60 ml/min
* Patients must have signed written informed consent
* Female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment
* Patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry
* Patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy

Exclusion Criteria:

* Diagnosis of resectable carcinoma of the stomach
* Major surgery within four weeks of study entry
* Brain metastasis or known seizure disorder
* Fertile men and women not using an acceptable method of contraception
* Pregnant or lactating patients are excluded since STI571 may be harmful to the developing fetus and child
* Patients known to be HIV positive and receiving HAART are excluded because of possibly pharmacological interactions
* Active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders
* Use of therapeutic doses of coumadin (warfarin) as anticoagulation
* Medical, social, or psychological factors which would prevent the patient from completing the treatment protocol
* Patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment
Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis

To compare the diagnostic agreement of human IL-6 chairside PoCT to ELISA in apical periodontitis undergoing endodontic therapy which could be clinically helpful to monitor the healing of periapical tissues enabling the clinician to complete the endodontic procedure, leading to a better patient care.

This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves 30 selected patients who have single rooted tooth with apical periodontitis that undergo RCT. The collection of the exudate from the canal will be on pre and post-instrumentation. The exudated will collect twice in each instrumentation for PoCT and ELISA.


Eligibility Criteria:
Inclusion Criteria:

* Patient having single root tooth with AP that is negative to the pulp sensitivity test
* Presence of periapical lesion

Exclusion Criteria:

* Pregnancy
Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine

The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).

Pain from vaso-occlusion in sickle cell disease (SCD) is persistent, and its management continues to pose a challenge to practitioners. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are recommended for acute SCD pain, however there is no clear evidence for the effectiveness of oral NSAIDs in combination with parenteral opioids in adults with SCD.Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs for combination treatment with morphine via PCA.

This is a randomised controlled trail to evaluate the effectiveness of oral ibuprofen plus intravenous Diamorphine or morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used in acute SCD pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with SCD of any phenotype

Exclusion Criteria:

* Patient has a history of allergic reaction to either diamorphine/morphine or ibuprofen
* Patient has contraindications to diamorphine/morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma
* Patient in a drug dependency programme
* Patient is on renal dialysis
* Stroke within the last 6 weeks
* Platelet count less than 50 x 10\^9/l
* Patient is pregnant or breastfeeding
* Doctor unwilling to randomise the patient for other reasons
* Previous participation in the trial
* Patient receiving drug treatment with which opioids or NSAIDs are likely to interact significantly
* Stage 1 - 5 chronic kidney disease (ref Appendix 2), including urine protein: creatinine ratio of \>50 (Because the ibuprofen dose is substantial it is felt that precautions should be taken to exclude those who have any signs of chronic kidney disease. One of the signs of kidney disease is "persistent proteinuria". Therefore, the patient who intermittently has proteinuria(which could be due to other reasons) could still participate.)
* Oxygen saturation by pulse oximetry \<94%
* Participation in another clinical trial within the last month
Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.


Eligibility Criteria:
Key Eligibility Criteria:

* Must have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
* Must not have significant pain in feet due to other causes (for example, arthritis).
* Must have intact skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks).
* Must not use topical pain medications for HIV-associated neuropathy.
* Must be able to comply with study requirements such as completing daily pain diary and attending study visits.
* Must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed.
* No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
* No history or current problem with substance abuse.
A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients

The present study seeks to examine the course of body image, social avoidance and psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.

Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.

The original protocol has been modified to include more assessment times. The original protocol was set up to assess patients after patient discharge from the inpatient burn unit and at 6 and 12-months post discharge. The present protocol has been modified to capture assessments at 2 weeks, 3 months, 6 months, 9 months, 12 months post-burn. Patients will be assessed at these time points or until they are discharged from the outpatient burn clinic. In addition, inclusion criteria have been modified to include patients who are anticipated to have a follow-up visit to the burn outpatient clinic at 3 months post-burn. The original protocol required an anticipated follow-up for 12 months post-hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
* Age 19 and older.
* Patients have the cognitive and physical capacity to answer the questionnaires.
* Patients are expected to be seen at follow-up clinic visits or if they are still in the hospital within 2 weeks and at 3 months (+ or - 4 weeks)post-burn.

Exclusion Criteria:

* Patients are unable to return for follow up visits
GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>= 18 years of age
* Female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
* Completed the last two visits of the randomized treatment period in GALLANT 6

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
* Creatinine levels of above twice the normal range
* Creatine kinase of above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
Impact of Hepatectomy on HCC Recurrence

Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.

Patients with hepatocellular carcinoma (HCC) who undergo curative hepatectomy may experience varying remnant liver volumes. The investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in HCC patients. A retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary HCC lesion measuring ≥5 cm between January 2019 and June 2022. Patients were divided into major hepatectomy (MAH) group (n=70) and minor hepatectomy (MIH) group (n=127) based on the extent of liver resection. Recurrence-free survival (RFS) was compared between the two groups. Propensity score matching was employed to mitigate potential biases in this research.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed solitary HCC with a size of ≥5 cm
* Eastern Cooperative Oncology Group score of 0 or 1
* preoperative indocyanine green retention rate at 15 minutes ≤15% and Child-Pugh A classification
* no evidence of vascular invasion or extrahepatic disease.

Exclusion Criteria:

* not diagnosed with HCC or had an HCC measuring \<5 cm
* had confirmed tumor metastases or macrovascular invasion based on radiological examinations
* died within 90 days after surgery were excluded
Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Objective: To evaluate the impact of mouthguards (MG) on acceptability, incidence of soft tissue injuries, periodontal and salivary parameters, as well as on the perception of the body in sports practice (PeCoPes) and on the quality of life of athletes, and evaluate the consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself. Methodology: This is a longitudinal study that will include children, adolescents, and adults aged 7 to 30 years who practice sports and require MGs. Sociodemographic data, medical history, dental history, dietary habits, and sports practice data will be collected. Participants will undergo a complete oral clinical examination. Data on knowledge of traumatic dental injuries (TDI) and MGs will also be collected. Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use, the following parameters will be evaluated: presence of mucosal injuries, visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count. Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use. PeCoPes and quality of life will be assessed before, 1, 3, and 6 months after MG use. The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status. The data will be tabulated and analyzed using SPSS 21.0, and appropriate statistical tests (p\<0.05) will be performed according to the study objectives.


Eligibility Criteria:
Inclusion Criteria:

* Children, adolescents, and adults aged 7 to 30 years, with no systemic health issues, of both genders;
* Engaging in sports practice at least twice a week.

Exclusion Criteria:

* Presence of cavitated dental caries and/or periodontitis;
* Angle Class III malocclusion with negative anterior overjet;
* Presence of non-removable prostheses or any other accessory in the upper or lower arch that may interfere with the adaptation of the mouthguard;
* Use of medications that may interfere with any salivary parameters;
* Children, adolescents, and adults with neurological disorders or communication difficulties.
Antioxidant Treatment of Type 2 Diabetes

This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.


Eligibility Criteria:
Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -

Exclusion Criteria: None, except known intolerance to n-acetylcysteine

-
Litfulo Capsules Special Investigation

The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.

This study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. The investigators complete the CRF based on the information extracted from the medical record created in daily medical practice.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

* Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study
* Patients who have not participated in a clinical trial (clinical study) of this drug

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

* Patients previously enrolled in this study
* Patients with a history of treatment with this drug (including investigational product)
Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis

To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.

The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.

Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.

During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.

Eligibility Criteria:
Inclusion Criteria:

* CAPD patients.
* Medically stable and receiving PD for\<1 week
* age between 18 and 80 years
* self-care or doing bag exchange by a fixed assistant Exclusion Criteria
* followed up at least every 2 months
* dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China

Exclusion Criteria:

* Pregnancy;
* undergoing APD therapy
* Intolerance to the study protocols;
* Severe and unstable condition, acute or chronic inflammation disease;
* a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
* suffering peritonitis before receiving the interventions
* cognitive or psychological dysfunction;
* communication barrier
A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors

This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
* Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
* Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
* Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data
* At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
* Able to provide pre-treatment (and optional on-treatment) tumor tissue

Exclusion Criteria:

* Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures
* Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy
* Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
* History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy
Possibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA

Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions, with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA, without addition of heparin perdialytic.

Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™ membrane and treated by long-term anticoagulation with VKA

The aim will be to study possibility of hemodialysis sessions success, without perdialytic anticoagulation but with adequate dialysis parameters (defined by the patient's Kt / V machine), in patients treated by long-term anticoagulation with VKA and dialysed with the HeprAN ™ membrane.

Eligibility Criteria:
inclusion criteria :

* 18 years old and older
* chronic hemodialysis for at least 3 months
* treated by long-term anticoagulation with VKA
* hemodialysis with the HeprAN® membrane
* per dialytic heparin therapy (UFH or LMWH)
* dialyzed at Reims University Hospital
* agreeing to participate in the study

Exclusion criteria

* chronic hemodialysis without per dialytic heparin
* Patient dialized with single lumen catheter for vascular access
* less than 18 years old
* pregnant or lactating women
* protected by law