cyrilzakka/clinical-trials huggingface dataset:
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation

This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.

The name of the study device involved in this study is:

- THOR LX2.3 with LED Lollipop

As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful.

Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT.

The name of the study device involved in this study is:

- THOR LX2.3 with LED Lollipop

This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT.

The U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses.

The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations.

Participants will receive study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first.

It is expected that about 20 people will take part in this research study

Eligibility Criteria:
Inclusion Criteria:

* Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.
* Age ≥18 years.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.
* Participants who have a history of radiation therapy to the head and neck.
* Participants who have a history of photosensitivity or underlying disease with known photosensitivity.
* Participants who are planned to receive palifermin for OM prevention.
Surgery for Recurrent Intrahepatic Cholangiocarcinoma

The investigators retrospectively reviewed the participants suffering from recurrent intrahepatic cholangiocarcinoma after curative resection and aimed to explore the predictive factors for recurrence and clarify the potential benefit of repeat hepatectomy or/with metastasectomy.


Eligibility Criteria:
Inclusion Criteria:

* R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.

Exclusion Criteria:

* (1)Patient with R1 or R2 resection
* (2)Distant metastasis noted when laparotomy
* (3)Surgical mortality
The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis

Peri-implantitis is a plaque-associated condition occurring around dental implants, characterized by inflammation in the peri-implant mucosa and loss of supporting bone. To stop this progression, mechanical debridement of biofilm and calculus is commonly used to treat peri-implant lesions as well as the use of adjunctive measures such as titanium brushes. As observed, they improved plaque removal when compared with steel curettes alone. Therefore, it is of interest to evaluate the impact of this procedure in terms of clinical, radiographic and microbiological outcomes to assess their efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ≥18 years of age.
* Ability to understand all the study procedures and to comply with them along the entire study period. Ability and willingness to give written informed consent.
* An adequate level of oral hygiene (plaque index ≤ 25%) (O'Leary et al., 1972).
* Treated periodontal disease.
* Presence of at least one titanium implant with peri-implantitis \[i.e., presence of bleeding and/or suppuration on gentle probing with probing depth of ≥6 mm, and progressive bone loss. In the absence of initial radiographs, a bone level ≥2 mm apical to the most coronal part of the intrabony portion of the implant will be used as threshold of disease (Romandini et al., 2021)\].
* Horizontal and vertical peri-implant bone defects.
* Implant function time ≥ 1 year.
* Presence of ≥2mm of keratinized peri-implant mucosa.
* Screw-retained single and multiple restorations.

Exclusion Criteria:

* Untreated periodontitis.
* Smokers \> 10 cigarettes per day.
* Local or systemic diseases that would interfere with routine periodontal therapy (i.e., uncontrolled diabetes mellitus, cancer, HIV, chronic high-dose steroid therapy, metabolic bone disease, radiation, immunosuppressive disease, hepatic dysfunction, immunosuppressive disease, autoimmune disease).
* Pregnant or lactating women.
* Previous surgical and non-surgical treatment of affected implants at least 12 months prior to the beginning of the study.
* Radiographic peri-implant bone loss \> two-thirds.
* Mobility of the implant.
* Known allergy or intolerance to macrolides.
* Use of systemic antibiotics during the last 3 months.
* Need of endocarditis prophylaxis.
Artemisia and Green Tea Extracts for Gastric Mucosal Health

This clinical trial aims to determine whether Artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety.

The main questions are:

* Does Artemisia and green tea extracts promote gastric mucosal health in participants?
* What side effects occur when participants take Artemisia and green tea extracts?

Researchers will compare Artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health.

Participants will:

* Take Artemisia and green tea extracts or a placebo daily for 8 weeks.
* Visit the clinic every 4 weeks for checkups and tests.

Eligibility Criteria:
Inclusion Criteria:

* Rome IV-based functional dyspepsia-

Exclusion Criteria:

* Patients with gastrointestinal symptoms requiring immediate drug treatment.
* Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome.
* Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial.
* Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month.
* Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year.
* Individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (LA grade A or higher), or malignant tumors identified within the last 6 months through endoscopy.
* Patients with uncontrolled hypertension (resting BP ≥160/100 mmHg).
* Patients with uncontrolled diabetes (fasting glucose ≥160 mg/dL).
* Individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution.
* Individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution.
* Alcohol abusers.
* Individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders).
* Pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period.
* Individuals with allergies to any components of the study foods.
* Individuals who participated in or plan to participate in another drug clinical trial within the last month.
* Individuals deemed unsuitable for the study by the investigator for other reasons.
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas

Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT) activity and potentially capable of enhancing the antitumor effects of temozolomide (TMZ). Compared to the standard 5-day TMZ regimen, alternating weekly regimen that deliver more prolonged exposure of TMZ may lead to higher cumulative doses, and may deplete more O6-methylguanine DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells to TMZ.

The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent high-grade gliomas.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)
* All patients should complete radiation therapy for primary gliomas.
* MRI showed unequivocal evidence of tumor recurrence or progression.
* The time to be enrolled should be more than 90 days after the radiation therapy.
* Written informed consent
* Eastern Cooperative Oncology Group(ECOG) score: 0-2
* The patients with recurrent gliomas were treated without dose-dense TMZ therapy before enrollment.
* Surgical interventions for recurrent gliomas are permitted and patients with no residual tumor are permitted

Exclusion Criteria:

* Abnormal function of liver or renal (value more than 1.5 fold normal upper limit)
* Blood routing: Hb \< 90g/L, absolute neutrophil count≤1.5\*10\^9/L, platelet \< 100\*10\^9/L
* Pregnant or lactating women
* Allergic to administered drugs
* Radiation therapy in the previous 90 days before enrollment
* The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
* Acute infection in need of antibiotics intravenously
* Participation in other clinical trials in the 90 days before enrollment
Changing the Default for Tobacco Treatment

The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.

In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.

For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.

This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.

Eligibility Criteria:
Inclusion Criteria:

* Speak English or Spanish
* Have access to a telephone or mobile phone
* Not be currently pregnant or breast feeding
* Have no significant co-morbidity that precludes participation
* Current daily smoker
* Not in treatment for tobacco dependence
* Reside in Kansas or Missouri

Exclusion Criteria:

* Admission greater than 3 days
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms

To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Isolation of a resistant gram-negative pathogen, eg, Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection
* Resistant gram-negative organisms are defined by the likely presence of ESBL or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections

Exclusion Criteria:

* Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
* Anticipated length of antibiotic therapy \< 7 days
* Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients.

However, the effects of SZC during the perioperative period remained unknown.

This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).

Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. SHPT is characterized by elevated parathyroid hormone (PTH) synthesis and secretion accompanied by parathyroid cell hyperplasia.Elevated PTH level is considered as a risk factor for fracture, hyperphosphatemia, anemia, and cardiovascular calcification that worsens the health-related quality of life and increases mortality.

Parathyroidectomy (PTX) has been considered the first-line treatment for severe SHPT. Generally, approximately 29% of patients with end-stage renal disease undergo parathyroidectomy to control secondary hyperparathyroidism. Successful PTX may rapidly reduce serum PTH levels and alleviate clinical symptoms.

Postoperative hyperkalemia is one common complication after PTX. With an incidence of 25-80%, in previous research, hyperkalemia has been reported during and immediately after PTX, leading to devastating consequences.

SZC increases fecal potassium excretion and lowers serum potassium levels by binding potassium ions, demonstrated to reduce serum potassium to normal levels within 48 hours in hyperkalemia patients.

Nevertheless, the effects of SZC during the perioperative period remained unknown.

Sixty-two patients with secondary hyperparathyroidism (SHPT) were randomly recruited into the experimental and control groups. Patients in the experimental group were required to take SZC 10g before PTX. Laboratory chemistries, including serum potassium levels, serum calcium levels and serum PTH were obtained before and after surgery. We aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).

Eligibility Criteria:
Inclusion Criteria:

* Secondary Hyperparathyroidism (SHPT) is a common and severe manifestation of chronic kidney disease (CKD), especially in end-stage renal disease (ESRD) patients. ESRD MHD with SHPT patients were recruited into this study

Exclusion Criteria:

* Patients with severe cardiovascular disease who cannot tolerate general anesthesia surgery were not included in this study.
Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population

The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.

The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.

The aim of this study is to investigate the effects of transcranial Direct Current Stimulation (tDCS) stimulation during a verbal paired-associate learning task to determine if tDCS may be used as a way to enhance brain plasticity during an associative memory task, and to accelerate learning and to optimize associative memory performance. We hypothesize that participants who receive tDCS stimulation will improve their associative memory performance.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 55 and 75
2. Currently not using any medication contradicting with tDCS
3. Native English speaker
4. Capable of understanding and signing an informed consent

Exclusion Criteria:

1. Acquainted with the Swahili language or culture
2. Severe disease
3. Mental illness
4. Cardiac history
5. History of severe head injuries
6. History of epileptic insults
7. Any implanted devices such as pace maker, neurostimulator
8. Pregnancy
Musculoskeletal Symptoms in Post Acute Covid-19 Patients

The patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared with the patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory, chest computed tomography findings.

There is a lack of an overview of the factors associated with post acute-Covid-19 musculoskeletal symptoms. The aims are;1-to evaluate the most frequent admission symptoms and the frequency of musculoskeletal symptoms in post acute-Covid-19 patients,2-to determine the related factors with the post acute-Covid-19 musculoskeletal symptoms.

In this retrospective study; the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared wthe patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory (complete blood count, C-reactive protein, ferritin, D-dimer), chest computed tomography findings.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Having Covid-19 treatment (home quarantine / hospital / intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest CT.

Exclusion Criteria:

* Patients who did not have musculoskeletal symptom records (admission symptoms and musculoskeletal symptoms such as; fatigue, spine / joint /muscle pain/ numbness) in patients files
* Acute Covid-19 patients whose symptoms started less than 1 month
Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-Athletic Females

The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.

Menstrual function and dysfunction conversations have long been stigmatized both in the general population and in sport settings (O'Flynn, 2006). However, Discussions of menstruation in the sport context often focuses on the impact of physical menstrual symptoms and dysfunction on activities such as training and sport performance (Bruinvels et al., 2016; Knowles et al., 2019). In addition, no study had been compare between sprinters and long-marathon runners in menstrual characteristics and estradiol level. Therefore, the purpose of this study to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.

Eligibility Criteria:
Inclusion Criteria:

* Virginal females.
* Their age ranged from 16 to 19years.
* All females had the same socio-economic status.

For athletic groups only:

* They have been starting the practice of sport at least one year before the onset of menarche.

Exclusion Criteria:

* Females who had been used oral contraceptives or any hormonal treatment in the previous six months.
* Smoking.
* History of chronic disease.
* Having any psychiatric problems.

For athletic groups only:

* injured females who were absent from training for at least three months.
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea

The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen, urinary tract and pneumonia which could have come from hospitalizations.

This study was required by the Ministry of Food and Drug Safety (MFDS) of Korea's regulations.

The objective of this study is to determine any problems or questions associated with Zavicefta after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".

1. Serious adverse event/adverse drug reaction
2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
3. Known adverse drug reaction
4. Non-serious adverse drug reaction
5. Other safety and effectiveness information As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. This reserach shall begin after approval of marketing in Korea by MFDS.

Eligibility Criteria:
1. Adults and paediatric patients aged 3 months and older, who have been administered at least one dose of Zavicefta for the treatment of one of the indications as follows:

   * Complicated intra-abdominal infection (cIAI)
   * Complicated urinary tract infection (cUTI), including pyelonephritis
   * Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
   * Other aerobic Gram-negative organism infection with limited treatment options
2. Adults 19 years of age or older, who have been administered at least one dose of Zavicefta for the treatment of the indication as follows:

   •Bacteremia associated with or suspected to be associated with cIAI, cUTI or HAP including VAP.
3. Patients are treated with Zavicefta for the first time
4. Patients have signed the data privacy statement.
Therapeutic EUS Registry

The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of Therapeutic Endoscopic ultrasound (T-EUS) . The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

This study is a prospective, observational, medical chart review. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - May 2019. Those subjects will undergo no additional tests and procedures as part of this study.

In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of T-EUS procedures.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - May 2019
* Any patient who will undergo clinically indicated and/or standard of care T-EUS procedures from June 2019 - June 2027

Exclusion Criteria:

* Any patient who has not undergone endoscopic ultrasound would be excluded from the study.
* Below 18 years of age