cyrilzakka/clinical-trials huggingface dataset:
The Immune Response After Periodontal Treatment

Primary Objective:

To identify changes in systemic markers of inflammation following periodontal treatment, comparing two standard treatment modalities (hands scaling and ultrasonic scaling)

Secondary Objectives:

To investigate bacteraemia, composition and function of oral bacteria, treatment outcomes following periodontal treatment, patient and operator preferences, and treatment time comparing hand scaling and ultrasonic scaling.

Effective root surface debridement (RSD) is essential for successful periodontal treatment. Myriad studies demonstrate that RSD may be carried out using hand or ulstrasonic instruments with equal efficacy. Locally, effective debridement results in reduced inflammation in the gingival tissues, ultimately preserving the dentition. Systemically, RSD results in an immediate inflammatory response with elevated C-reactive protein (CRP), and cytokines (e.g. interleukin-6 and Tumor Necrosis Factor) detectable in the serum. This systemic inflammation may relate to systemic dissemination of bacteria from the periodontal pockets into the circulation, during instrumentation. Bacteria are detectable in serum immediately after instrumentation. The incidence of the bacteraemia varies considerably between different studies, ranging from 13% of patients to 43% to 55%. These studies used different methods of instrumentation; Kinane et al used full mouth ultrasonic scale, Zhang et al used a mixture of hand and ultrasonic instruments, and Heimdahl et al used curettes only. Whilst tempting to speculate that ultrasonic instrumentation induces less bacteraemia than hand instrumentation, there is no direct comparison of the effect of ultrasonic instrumentation with hand instrumentation on post treatment systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written, informed consent to participate
* Men or women aged 18 years to 70 years inclusive
* Periodontal disease requiring treatment at Glasgow Dental Hospital

Exclusion Criteria:

* Known or suspected high risk for tuberculosis, hepatitis B or HIV infections
* Require interpreter/non English language written material to understand and provide, or any other reason for being unable to provide written, informed consent
* History of bleeding diathesis
* Females using contraceptive methods.
* Pregnant or lactacting females.
* Reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases.
* Any pharmacological treatment within 3 months before the beginning of periodontal treatment.
* Specialist Periodontal treatment in the previous 6 months.
* Patients who will not tolerate Ultrasonic instrumentation even with local anaesthesia.
Induced Sputum Study (0000-065)

The primary goals of this study will be to implement innovative processing and detection assays to qualify induced sputum measurements of markers of allergen-induced airway inflammation. The results of this study are intended to form a platform to be used in the clinical development of novel asthma therapeutics.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of mild to moderate persistent allergic asthma for at least 6 months with typical symptoms, including cough, wheezing, and shortness of breath, is clinically stable and has no history of recent respiratory tract infection within 3 weeks of the start of the study
* Patient, aside history of asthma, is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
* Patient is able to perform reproducible pulmonary function test.
* Patient has an allergic response to house dust mite allergen, demonstrates a positive early and late phase response to an inhaled allergen challenge (as defined by a bronchoconstrictive response)
* Patient is a nonsmoker for at least 12 months. Patients must have less than or equal to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10 years.) Patients who have discontinued smoking for at least 10 months may be enrolled at the discretion of the investigator
* Patient is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each visit when laboratory safety tests are obtained and 48 hours prior to allergen challenge

Exclusion Criteria:

* Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the patient by their participation in the study
* Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 4 weeks of screening and/or during the study
* Patient has a history of stroke, chronic seizures, or major neurological disorder
* Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic disease
* Patient is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study, including prescription and non-prescription drugs or herbal remedies prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit
* Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages per day or \>21 drink equivalents per week.
* Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup

To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult (men or women), age 18 to 55 years inclusive;
* Body mass index 18.5 to 30.0 kg/m\*2 inclusive;
* Able to read and understand the written informed consent for study-related information and instruction;
* Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol;
* Agree not to donate whole blood or components of blood (e.g. plasma, thrombocytes) starting from signing the informed consent form through 30 days after the last study procedure, except for the blood samples collected for this study;
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera), or a double barrier and have a negative pregnancy test at Screening and prior to study drug administration on Day 0 of Dosing Periods 1 and 2. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy;

Exclusion Criteria:

* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal;
* Known hypersensitivity to any medication (active substances or excipients of the preparations) to be used in the study;
* Known galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Known severe allergies (e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids);
* Use of, within 1 month before the first study drug administration, systemic or topical medicines or substances which might affect the study objectives, e.g

  * any drug known to induce cytochrome P3A4/5 or P Glycoprotein (e.g. rifampin, carbamazepine, St. John's wort);
  * any drug known to inhibit cytochrome P3A4/5 or P Glycoprotein (e.g. erythromycin, clarithromycin, chloramphenicol, ketoconazole);
  * any drug known to induce cytochrome P2D6 (e.g. rifampin, dexamethasone);
  * any drug known to inhibit cytochrome P2D6 (e.g. cimetidine, desipramine, fluoxetine, metoclopramide);
* Positive urine pregnancy, urine drug test or Hepatitis B, hepatitis C or HIV tests;
* Clinically relevant findings in the physical examination, e.g., signs of bleeding diathesis, signs of heart failure, evidence of peripheral circulatory disturbances, and skin abnormalities;
Clinical Trials for the Effects of Polygoni Multiflori Radix Complex Extract on Memory Improvement

The aim of this study is to identify the effect of Polygoni Multiflori Radix complex extract on memory improvement using Rey-Kim scale for healthy people.


Eligibility Criteria:
Inclusion Criteria:

* A person who is more than 50 years and lesser than 70 years of age
* A person who's MQ(Memory Quotient) score is within more than 70 and lesser than 120

Exclusion Criteria:

* The patient who has past history related to memory
* The patient who has Diabetes Mellitus
* The person whose fasting blood sugar is more than 126mg/dL
* The patients who has uncontrolled hypertension
* The patient who has liver disorders
* The patient whose AST(aspartate aminotransferase) or ALT(alanine aminotransferase) level is more than 60 IU/L(international units per liter)
* The patients who has heart disorders (Angina pectoris, Myocardial infarction)
* The patient who has past history related to excision of G-I tract excluding cecum
* The patient who took drug or heal functional food within 4 weeks before screening
* The patient who took decoction of herb within 4 weeks before screening
* The patient who can't write or communicate
* pregnant woman
Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia

It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 25 to 35 kg/m².
* American Society of Anesthesiologist (ASA) physical status I or II.

Exclusion Criteria:

* patient's refusal
* Altered mental status
* Known allergy to study drugs (bupivacaine or morphine)
* Local infection at site of puncture.
* Known case with any pulmonary disease
* Known case with Obstructive sleep apnea (OSA)
* Coagulopathy and /or thrombocytopenia
* Severe hepatic or kidney impairment
Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration

This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration.


Eligibility Criteria:
Inclusion Criteria:

* • Inclusion criteria: i- complete maxillary and mandibular edentulous arches ii- residual alveolar ridges covered with healthy firmly attached mucosa. iii- Angel's class I maxillo-mandibular relationship and iv- Adequate bone height and width for placement of standard diameter implants.

Exclusion Criteria:

* History of drug administration that interfere with bone quality ii- Surgical contraindication (patients under anticoagulant ,immunosuppressive drugs, chemotherapy and irradiation therapy) iv- tempromandibular or myoneurological disorders.
Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.

Eligibility Criteria:
Inclusion Criteria:

* carpal tunnel release surgery candidates,
* distal radius fracture surgery candidates

Exclusion Criteria:

* under 18 years of age,
* pregnant women,
* prisoners
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia

In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.

The primary hypothesis for this trial is that montelukast adds efficacy to hydroxyurea therapy for improving vaso-occlusion when compared to hydroxyurea alone. The following specific aims will be tested in adolescents and adults with sickle cell disease (SCD):

Aim 1. To determine whether montelukast versus placebo added to hydroxyurea will improve markers of vaso-occlusion-associated tissue injury in adolescents and adults with sickle cell disease.

Aim 2. To evaluate physiologic effects of montelukast versus placebo added to hydroxyurea in adolescents and adults with sickle cell disease.

Subaim 2A. To determine if montelukast versus placebo added to hydroxyurea will improve lung function in adolescents and adults with sickle cell disease.

Subaim 2B. To determine if montelukast versus placebo added to hydroxyurea will improve forearm microvascular blood flow in adolescents and adults with sickle cell disease, respectively.

Funding Source - FDA OOPD

Eligibility Criteria:
Inclusion Criteria:

* 1)Diagnosis of HbSS, or HbSβ-thalassemia0, confirmed by hemoglobin analysis
* 2)Males and females age 16 years to 70 years old
* 3)Greater than 2 episodes of pain in the last 12 months
* 4)On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin

Exclusion Criteria:

1. Judged not likely to be study compliant by his/her hematologist
2. History of adverse reaction to montelukast or any of the components of montelukast
3. Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment
4. Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days
5. Chronic blood transfusion therapy defined as regularly scheduled transfusions.
6. Hemoglobin A greater than15% on hemoglobin analysis
7. Individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate).
8. Current participation in another therapeutic trial for SCD
9. Known current pregnancy
10. Known history of HIV
11. Serum creatinine greater than 3 times the site's upper limit of normal
Patient Preferences in Making Treatment Decisions in Patients With Stage I-IVA Oropharyngeal Cancer

This pilot research trial studies patient preferences in making treatment decisions in patients with stage I-IVA oropharyngeal cancer. Questionnaires that measure patient priorities before and after treatment may improve the ability to plan for better quality of life in patients with oropharyngeal cancer.

PRIMARY OBJECTIVES:

I. Determine the stability of Head and Neck Priorities Scale (HNPS) ranking between pre- and post-treatment assessments.

SECONDARY OBJECTIVES:

I. Use patient-interviews to refine and modify the HNPS for use in a larger scale trial.

II. Pilot the Head and Neck Patient Outcomes Survey (HNPOS) as a potential tool to identify priorities most important to quality-of-life outcomes.

III. Use the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H\&N) and EurolQoL-5D to determine the validity of the HNPOS.

OUTLINE:

Patients participate in a 45-minute interview comprising assessment of priorities and quality of life at baseline, 1, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve American Joint Committee on Cancer (AJCC) stage I-IVa squamous cell carcinoma of the head and neck with no definitive evidence of metastatic disease
* Sufficient vision, writing, and communication ability to complete the interviews and assessment tool
* Signed informed consent

Exclusion Criteria:

* Patients who are enrolled in other head and neck cancer treatment protocols are permitted to participate in this study if a) the other protocol permits this and b) the other protocol does not utilize the HNPS
* Patients who have previously undergone cancer treatment or are presently undergoing additional cancer treatments
* Patients who have already undergone unsuccessful curative-intent surgery on their head and neck cancer
* Patients, who have had a major surgery (defined as requiring general anesthesia but not including tonsillectomy, neck dissection, or panendoscopy \[triple endoscopy or examination under general anesthesia\]), or significant traumatic injury within 4 weeks of the study; patients who have not recovered from the side effects of any of the above surgeries
* Patients unwilling to or unable to comply with the protocol
* Patients unable to communicate with the interviewer
Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone

We will investigate if testosterone is preferentially given to patients at higher risk of cardiovascular events. If this is the case, then observational studies may be prone to selection bias resulting in overestimation of the cardiovascular risk associated with testosterone when compared to a healthier population not taking testosterone


Eligibility Criteria:
Inclusion Criteria:

- All male individuals in the source population with a first testosterone use during the study period will be included as cases. The date of the GP consultation associated with the first testosterone prescription will be designated as the index day.

Exclusion Criteria:

- Patients of less than 18 years on the index day, with less than 2-year contribution to the CPRD-HES link before the index day, or with use of testosterone before the study period will be excluded from the group of cases.
A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
* Histologically confirmed lymphoma belonging to one of the following subtypes:

  1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
  2. follicular lymphoma grade 3B
  3. T-cell/histiocyte-rich LBCL
  4. primary cutaneous DLBCL, leg type
  5. EBV-positive DLBCL, NOS
  6. primary mediastinal LBCL
  7. high grade B-cell lymphoma with MYC/BCL2 rearrangement
* Stage II-IV disease
* At least 1 measurable site of disease (\>1.5 cm long axis)
* No previous treatment for lymphoma
* WHO performance status 0 - 3 (Grade 3 if related to DLBCL)
* Written informed consent

Exclusion Criteria:

* Severe cardiac disease: NYHA grade 3-4
* CNS involvement at diagnosis
* Uncontrolled serious infection
* Impaired liver (transaminases \> 3x normal upper limit or bilirubin \> 1.5 x normal upper limit, unless due to Gilbert´s syndrome) , renal (GFR\<30ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment.
* Absolute neutrophil count (ANC) \<1000 cells/µL or platelets \<100,000 cells/µL, unless due to lymphoma
* Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment
* Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
* Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or HACA against rituximab
* Peripheral neuropathy grade ≥ 2
Detection and Enumeration of Circulating Tumor Cells in Rectal Cancer

Rectal cancer is one of the most common malignant tumors in the world. However, there's also no reliable and sensitive method to monitor diseases and evaluate therapy responses till now. Circulating tumor cells, which could reflect tumor's status correctly and reliably, may be a promising method in this field. This study is to investigate the role of circulating tumor cells in evaluating and predicting the responses of chemoradiotherapy in rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified rectal carcinoma
* Locally advanced tumor (cT3-4 and/or N+ by transrectal ultrasound and/or pelvic magnetic resonance imaging)
* the distance from anal verge \<= 12cm
* with or without metastasis
* Age 18-75 years old
* ECOG PS 0-2
* No previous chemotherapy or radiotherapy for rectal carcinoma
* Written informed consent

Exclusion Criteria:

* no histologically verified rectal carcinoma
* rectal cancer with stage I
* distance from verge \>12cm
* age \<=18 or \>=75 years old
* performed previously chemotherapy or radiotherapy
* infection diseases within three months
* serious other diseases
* no written informed consent