cyrilzakka/clinical-trials huggingface dataset:
Effect of Removal of Intracanal Medication on Post Operative Pain

Recruited patients with necrotic pulp after application of Calcium hydroxide are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

The investigator will recruit patients who are found eligible to the criteria, Calcium hydroxide will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.

After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients.
* Patient's age between 20-50 years.
* Both sexes.
* Necrotic pulp as indicated by thermal or electric pulp testing.
* No history of previous endodontic treatment of the tooth.
* Enough crown structure for adequate isolation.

Exclusion Criteria:

* Pregnancy or lactation
* Medically compromised patients
* Previous endodontic therapy of the affected tooth.
* Teeth diagnosed with vital pulp.
* Teeth with periodontal pocket more than 3mm deep.
* Teeth with abnormal anatomy or calcified canals.
* Teeth with caries below the bony level (non-restorable tooth).
* Immature teeth with open apices.
Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)

Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.

Same as above

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes, Glucose \> 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.

Exclusion Criteria:

* Type 1 Diabetes
A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years old.
2. Scheduled to remove the impacted tooth.
3. Any NRS score ≥5 within 4 hours after the surgery.
4. Willing to comply with the study procedures and requirements.
5. Willing and able to provide written informed consent for this study.

Exclusion Criteria:

1. Subjects who had used other drugs that affect the analgesic effect.
2. Subjects who have infection or other complications on the planned oral surgical site.
3. Subjects with uncontrolled hypertension or hypotension.
4. Subjects with severe cardiovascular and cerebrovascular diseases.
5. Subjects with severe gastrointestinal disease.
6. Subjects with a history of drug or alcohol abuse.
7. Subjects with significant abnormal electrocardiogram.
8. Subjects with significant abnormal laboratory value.
9. Subject who were allergic to the study drug and ingredients.
10. Pregnancy, lactation or having recent pregnant plan.
11. Subjects who participated in other clinical research study 30 days before entering this study.
12. Other conditions unsuitable for participation in the study.
Intercostal Muscle Oxygenation During Exercise Tests

The aim of our study is to determine the effects of different exercise capacity tests on intercostal muscle oxygenation and to reveal the effect of changing accessory respiratory muscle oxygenation on exercise test success.

In the study, intercostal muscle oxygenation will be measured in different exercise capacity tests. A total of 32 healthy young women and men between the ages of 18-25 who meet the inclusion criteria and voluntarily agree to participate in the study will be included in the study. The cases will be randomized into 2 groups: Six minute walking test group and incremental shuttle walking test group. Heart rate, oxygen saturation, and fatigue levels will be measured with the modified Borg scale before and after the tests. During the tests, oxygen levels of the intercostal muscles will be monitored with the MOXY device. After sufficient wash out time, the groups will be crossed and different exercise tests will be applied to the cases. The result of our study will provide information about the use of intercostal muscles during different exercise tests. As a result of the study, results that can be interpreted for patient groups with circulatory system, respiratory system and physical limitations will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-35
* Body Mass Index \&lt;25 kg/m²
* Participating in the study voluntarily

Exclusion Criteria:

* Being a smoker
* Presence of any systemic, orthopedic or cardiopulmonary disease that may prevent exercise tests
* Presence of any diagnosed respiratory, vascular and heart disease
Effect of Empagliflozin on Body Composition and Ketones

The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45

Exclusion Criteria:

Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI \< 20 kg/m2 eGFR \< 45 Malignancy
Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
2. Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
3. Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
4. Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
5. Patients who give written consent to participate in the study. -

Exclusion Criteria:

1. History of current pathology or current laboratory results indicative of any severe disease.
2. Pacemaker or metallic implants that prevent MR imaging.
3. Inability to complete questionnaires.
4. Refusal to give informed consent.
5. Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
6. Positive screening test for HIV, Hepatitis B or Hepatitis C.
7. History of malignancy.
8. Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
9. Body mass index\> 40 kg/m2.
10. Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.
11. Pregnancy or lactation

    -
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma

This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy. The purpose of this study is to evaluate the safety and efficacy of AK129 (bispecific antibody targeting LAG-3 and PD-1) monotherapy or in combination with AK117 (anti-CD47 monoclonal antibody) in R/R cHL with PD-1/L1 inhibitor treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old at the time of enrolment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Expected Survival of ≥ 12 weeks.
* Diagnosed as R/R cHL according to Lugano 2014 criteria.
* Has progressed on treatment with PD-1/L1 inhibitior therapy.
* Has adequate organ function.
* All female and male subjects of reproductive potential must agree to use an effective method of contraception from the start of screening until 120 days after the last dose of study treatment.

Exclusion Criteria:

* Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zone lymphoma.
* Central nervous system (CNS) lymphoma involvement.
* Known history of human T-cell leukemia virus type 1 (HTLV-1) infection.
* Autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose of study treatment.
* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
* Previous use of any agents targeting the CD47-SIRPα pathway, LAG-3 pathway, or similar targets.
* Has other malignancies within 3 years prior to the first dose or residual lesions from other malignancies diagnosed more than 3 years ago.
* Has an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
* History of active or previously confirmed inflammatory bowel disease.
* History of interstitial lung disease requiring corticosteroid therapy, or current interstitial lung disease.
* Has known active Hepatitis B or Hepatitis C.
* Unresolved toxicity from previous anti-tumor treatment.
* Uncontrolled comorbidities.
A Brief Body-mind-spirit Intervention to Promote Positive Emotions

Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote well-being. Research has shown the positive effects of a body-mind-spirit (BMS) approach in enhancing health and well-being. We will develop and assess a pilot trial involving a holistic BMS approach to promote positive emotion change, emotion regulation and self-awareness through an ICT-supported program in a community setting.

The body-mind-spirit (BMS) approach views the three components as a connected, balanced system that interacts with one another harmoniously. With the well-established academic-community partnership between HKU and Caritas-Hong Kong, our pilot trial aims to build upon the previous experiences by Caritas-Hong Kong and investigate the feasibility and effectiveness of a BMS approach in enhancing positive emotions and well-being among community participants. This trial is an innovative attempt at conducting an ICT-supported online intervention with community participants. It would also help meet the urgent need for brief, community-based preventive mental health promotion, especially in the context of the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Chinese-speaking;
* Individuals aged 18 years and above;
* No history of diagnosed mental illness;
* Access to an internet-connected computer.

Exclusion Criteria:

* Individuals who cannot meet the inclusion criteria.
Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method

The objective of this clinical investigation is to provide the first and preliminary clinical data to study the safety and efficacy of male circumcision where the dry circumcision method is employed.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects, aged 21 years or above at the point of screening for participation.
2. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
3. Subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation co-operate with the investigational procedures and are willing to return to the clinical centre for all the required post-treatment follow-ups.
4. Subjects willing to be circumcised for cultural reasons.
5. Subjects living in the site's area.
6. Subjects who can be easily contacted by telephone.
7. Subjects who can correctly speak and correctly read English.

Exclusion Criteria:

1. Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
2. Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin).
3. Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum.
4. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
5. Subjects who have participated in a clinical study with an investigational product in the last 6 months.
6. Subjects who have an abnormal penile anatomy.
7. Subjects who are currently involved in any injury litigation claims.
8. Subjects who have penile diseases or lesions.
9. Subjects who have clinical symptoms of sexually transmitted infections.
10. Subjects with opportunistic infections.
11. Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation.
12. Subjects whose penile circumference is higher (\>3mm) or lower (\<3mm) than the available circumcision tubes.
13. Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans \> 5mm).
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)

The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect anomalies that may deserve a clinical action.

PREMS is a non-interventional, prospective, and multicenter study. The primary objective is to assess the added clinical value of periodic IEGMs, based on the rate of patients with a rhythm or sensing/pacing anomaly detected on the first IEGM transmitted by Home Monitoring (HM) and non detectable so obvious on the other parameter set offered for the remote follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with a single or dual chamber PM within the last 3 months
* Home-Monitoring activated and functional
* Periodic IEGM "ON" and programmed at 30 days intervals
* Patient willing and able to comply with the protocol and who has provided written informed consent about HM
* Patient whose medical situation is stable

Exclusion Criteria:

* Age \< 18 years
* Patient unable to handle the Cardio messenger correctly
* Participation in another clinical study
Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube

This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER.

Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.

The PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent.
* Patients who are expected for at least 12 hours to be:

  * Mechanically ventilated and sedated.
  * Requiring a nasogastric tube.
* Included are:

  * Patients who have undergone tracheostomy.
  * Patients who require use of pro-kinetic drugs and proton pump inhibitors.
  * All levels of Gastric Residual Volume (GRV)

Exclusion Criteria:

* • Patients with a contraindication for insertion of a nasogastric tube.
* Patients with a known esophageal obstruction, preventing passage of the device.
* Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients)
* Acute and severe coagulation disorders
* (INR\> 2 or platelets below 30,000)
* Diabetic patients with documented gastrointestinal neuropathy
* Pregnancy or lactation
* Allergy to Silicon
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Pilocarpine or any comparable or similar product.
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors

This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the following criteria for each indication cohort:

1. Esophageal cancer cohort, patients with histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable or with distant metastasis, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;
2. Gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with locally advanced unresectable or distant metastases, HER2-negative, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;
3. 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;
4. Colorectal cancer cohort, patients with histologically confirmed adenocarcinoma of the colon or rectum, who progressed during or after first-line 5-FU-based combination therapy;
5. Pancreatic cancer cohort, patients with histologically or cytologically confirmed locally advanced unresectable or distant metastatic pancreatic ductal adenocarcinoma, who have not received any previous systemic antitumor therapy 2 . Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy \>=12 weeks; 4. At least one measurable lesion according to RECIST 1.1; 5. Adequate organ function;

Exclusion Criteria:

1. Leptomeningeal metastases and /or active brain metastases;
2. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);
3. History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;
4. History of immunodeficiency;
5. History of serious cardiovascular and/or cerebrovascular diseases;
6. History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration
Mood Disorders Bladder Cancer

This is a cross-sectional study evaluating mood disorders in bladder cancer patients and their caregivers across the bladder cancer trajectory


Eligibility Criteria:
Inclusion Criteria:

* Patients or caregiver of patient with a histologic diagnosis of bladder cancer of the following subtypes, urothelial carcinoma, adenocarcinoma, or squamous cell carcinoma, within 24 months of survey administration and received treatment at the University of Kansas Health System
* ≥ 18 years of age
* Have a patient-designated primary informal/family caregiver
* Able to speak and read English
* Willing and able to provide informed consent
* Functioning telephone number or access to one

Exclusion Criteria:

* Patients or caregivers of patients with metastatic bladder cancer
* Patients who are unable to designate a primary caregiver
* Patients and caregivers who do not both consent to study participation
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.


Eligibility Criteria:
Inclusion Criteria:

* Exudative age-related macular degeneration
* Best-corrected visual acuity between 20/32 and 20/320 in the study eye

Exclusion Criteria:

* Near-sightedness of 8 diopters or more
* Uncontrolled glaucoma in the study eye
* Cataract surgery or Lasik within the last 3 months
* Any active ocular infection or inflammation
Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

* Elective pancreaticoduodenectomy

Exclusion Criteria:

* Concomitant chemotherapy
* Severe malnutrition (SGA score C)
* Conditions affecting gastric emptying
Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis

The goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score.

The participants will be evaluated by numeric rating scale and oxford knee score for assessment of pain relief up to 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Grade 4 knee osteoarthritis according to Kellgren-Lawrence radiological classification.
* Failure to manage pain with conservative methods.

Exclusion Criteria:

* Prior knee replacement
* Patients with cardiac pacemakers or implantable cardiac defibrillators.
* Septic knee or systemic sepsis.
* Allergy to any of the drugs used in the study.
* Coagulopathy or patients on anticoagulants.
* Patients with psychiatric illness.