cyrilzakka/clinical-trials huggingface dataset:
Is the Direct Inferior Alveolar Nerve Block Required for Third Lower Molar Extraction?

This study is a Randomized Controlled Trial (RCT) which objective is to compare the effectiveness, efficacy and complication associated to an infiltrative anesthetic technique for the removal of lower third molars comparing it to the standard inferior alveolar nerve block using 4% articaine 1:100.000 epinephrine.

The objective is to compare the anesthetic efficacy of an infiltrative anesthetic technique placed buccally between the first and second mandibular molars plus infiltration of the third molar's lingual mucosa with the direct inferior alveolar nerve block plus buccal nerve block for the extraction of lower wisdom teeth. All using 4% articaine 1:100.000 epinephrine. The first technique is to be referred as Alternative Technique (A.T.) and the second Standard Technique (S.T.) The study is being conducted at the Hospital Odontològic Universitat de Barcelona (Campus de Bellvitge) and is being carried out by members of the Oral Surgery and Implantology Master's program of the University of Barcelona.

The sample (110 patients) consists of patients in need of lower third molar extraction. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. All patients derive from the Institut Català de la Salut-Consorci Sanitari.

The materials used are 1.8cc carpules of 4% articaine and 1:100.000 epinephrine, dental anesthetic syringe, dental anesthetic needles of 35 mm 27G and 25 mm 27G as well as all the documents necessary for data collection.

The determinations to be done are the pulpal anesthetic efficacy (in seconds, using a pulpometer), chin and tongue numbness (patient reported, measured in seconds), need for supplemental anesthesia, comfort (pain experienced during the punctions and during and after surgery), morbility (cramp sensation in the tongue or lip when performing the anesthetic technique, local and/or systemic complications).

Eligibility Criteria:
Inclusion Criteria:

* Lower third molars in any position (in accordance to Pell and Gregory and Winter classification) in need of extraction.
* Healthy patients and patients with mild systemic disease without substantive functional limitations (ASA I-II).
* Absence of acute infection in the third molar area.
* Adequate intellectual capacity for understanding the nature and purpose of the study and fill the informed consent and questionaries appropriately.

Exclusion Criteria:

* History of recent trauma in the maxillofacial area.
* Articaine or lidocaine allergy.
* Presence of a systemic pathology that contraindicates the use of local anesthetics with vasopressors.
* Acute infection in the third molar area (in the las 30 days).
* Surgeries taking more than 60 minutes (automatic dropout).
* Unwillingness to participate or continue participating in the study.
* A score equal or superior to 13 points in the Corah´s anxiety test.
* Third molars in ectopic position.
* Caries on the third molar.
Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.


Eligibility Criteria:
Inclusion Criteria:

* Participated in the previous study (ID: PRO-sIPV-MA4001-JX)
* Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination;
* There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection;
* The guardian of subjects need to agree to sign the informed consent form.

Exclusion Criteria:

* The interval between vaccination and blood collection is less than 1 month, or more than 9 months;
* Subjects were participating in other clinical studies of vaccines or drugs;
* Other conditions that make subjects unsuitable for participating in this study judged by investigator's
Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents.

Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized.

Patients affected by will be included in the study and analyzed HER2 positive breast cancer with residual invasive disease after neoadjuvant chemotherapy, treated consecutively with adjuvant T-DM1 at the various Italian oncology centers.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of HER2 positive breast cancer;
* Presence of invasive residual disease on T or N after neoadjuvant chemotherapy including anti-HER2 agents
* Treatment with T-DM1 in the adjuvant post-neoadjuvant setting, in case of positive hormone receptors in combination with adjuvant hormone therapy. Complementary radiotherapy will be allowed as per lines guide;
* Availability of adequate information regarding treatment with adjuvant T-DM1 in accordance with the objectives of the study;
* Written informed consent for the prospective part and, if possible, for the recruited patients retrospectively

Exclusion Criteria:

* Concomitant treatments with other biological agents;
* Absence of clinical data that allow the correct analysis of the primary and secondary objectives;
* Patients with a history of other malignant neoplasms;
* Contraindications to the use of T-DM
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants

This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
* Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).
* Evidence of history of orthostatic hypotension or symptomatic bradycardia.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
* Current findings or documented past history of blood pressure values \<90 mmHg systolic or \<50 mmHg diastolic.
* Any lipid panel parameter (ie, total cholesterol, triglycerides, HDL, and/or LDL) ≥1.25× ULN.
Assessment of Severity and Prognosis in Elderly Patients With COPD and Complex Chronic Comorbidities

Cigarette smoking, the major risk factor for Chronic Obstructive Pulmonary Disease (COPD), causes systemic effects, such as systemic cellular and humoral inflammation, that could substantially contribute to the development of chronic diseases, other than COPD, mainly cardiovascular diseases and metabolic disorders. Such chronic comorbidities affect health outcomes in COPD, particularly in terms of disease severity and prognosis. The aim of the project is to investigate the prevalence of chronic comorbidities associated with COPD and their impact on prognosis in elderly patients.

The investigators will recruit 100 outpatients, heavy smokers (20 pack/years), older than 65 years, diagnosed with COPD. COPD is defined by presence of fixed airflow limitation: post-bronchodilator forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) less than 70% according to spirometry classification from Global Inititiative for Obstructive Lung Disease (GOLD) guidelines. Each patient will be characterized by medical history, physical examination, and smoking history. Each patient will perform pulmonary function test, including reversibility to inhaled bronchodilator (400 mcg albuterol), and 6-minute walk test. Arterial blood gases and routine blood test, including inflammatory biomarkers, will also examined. In addition, each patient will undergo chest X-ray, thorax CT scan, echocardiography, and carotid ultrasonography.

At enrollment, all patients will be in stable condition (no changes in medication dosage or frequency, no COPD exacerbation or hospital admissions in the previous 4 weeks). Clinical and biological follow-up will be prospectively followed for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians
* Age \> 65 years
* Smoking history \> 20 pack/years (current or former smokers)
* Diagnosis of COPD according to GOLD 2010
* Stable condition

Exclusion Criteria:

* History of bronchial asthma
* Other chronic diseases such as interstitial lung disease, bronchiectasis, bronchiolitis obliterans organizing pneumonia (BOOP), pulmonary tuberculosis, cystic fibrosis
* Malignancies for which patient is being treated with radiotherapy or chemotherapy
* Acute events and/or hospitalization within 12 weeks prior to screening
Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.

This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

Exclusion Criteria:

1. Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
2. Patients with severe pulmonary fibrosis and pulmonary hypertension.
3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
5. Patients with poorly controlled malignant pleural effusion.
6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score \> 2.
8. Combined with other tumors with extensive metastasis, expected survival \< 6 months.
9. Patients with episodic psychosis.
10. Patients with implantable electronic devices (such as pacemaker or defibrillator).
11. Pregnant women, or patients who have pregnancy plans during the study.
12. Participation or ongoing participation in another clinical study within the past 30 days.
13. Other situations that the investigator deems inappropriate to participate in this study.
Xingnaojing for Mild-to-severe Acute Ischemic Stroke

The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the daily living ability of acute ischemic stroke at 90 days.

The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute ischemic stroke；
* Symptom onset within 24 hours；
* Age ≥ 18 and ≤ 80 years；
* NIHSS score ≥ 4 and ≤ 25；
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Planned or already receiving intravenous thrombolysis or endovascular treatment;
* Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
* Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
* Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
* Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
* Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
* Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
* Other conditions that render outcomes or follow-up unlikely to be assessed;
* Known to be pregnant or breastfeeding;
* Currently receiving an investigational drug;
Rituximab in Metastatic Melanoma

The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease

Exclusion Criteria:

* ECOG (Eastern Cooperative Oncology Group) performance status \> 2
* Ocular melanoma
* Immunodeficiency syndromes or hypogammaglobulinaemia
* Active autoimmune diseases
* Treatment with immunosuppressive agents other than steroids
* Depressed bone marrow function (Leukopenia \<3000, platelet count \<100.000)
* Cardiac insufficiency NYHA (New York Heart Association) IV
* active Hepatitis B,C, or HIV infection
* Pregnancy or lactation
* Interstitial pulmonary disease
* Former treatment with anti-CD20 antibody
Bioequivalence of Eye Drops and Spray Administration of Vigamox

The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cataract surgery

Exclusion Criteria:

* Allergy to Vigamox
Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis

In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* People between the ages of 20-65, who were diagnosed with RA according to ACR criteria by the PAU Rheumatology clinic and who volunteered to participate in the study, will be included.

Exclusion Criteria:

* Patients with RA who have a neurological disease that may affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident), a psychiatric disease that affects cooperation, heart failure and lung pathology that affect daily living activities, and those with other concurrent autoimmune and rheumatic diseases.
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. This study is designed to give hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the Endotoxin.

The body's immune response to injury otr infection is very complex. Immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Eligibility Criteria:
Inclusion Criteria:

* General good health as demonstrated by medical history, physical\& laboratory tests
* Age between 18 and 40 years
* Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Any medication taken in past 48 hrs (except birth control)
* Recent history of alcohol or drug abuse
* Unable to provide written informed consent
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnant or breast-feeding
Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation

60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old

60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old. All the patient was suffering from symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults who are symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients. Conservative treatment for 6weeks was failed

Exclusion Criteria:

* smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.
Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients

This study aims to evaluate the safety and feasibility of transcranial direct current stimulation (tDCS) in combination with home-based auditory training therapy in cochlear implant (CI) patients. Changes in speech perception performance will also be evaluated.

Participants will complete a 4 week web-based auditory training program while wearing a transcranial direct current stimulation device (tDCS). The customized auditory training program will be completed at home, in 20 - 30 minute sessions at least five times a week for four weeks. A customized learning and practice plan will be provided along with instructions on use of the tDCS device.

tDCS is a non-invasive brain stimulation technique that delivers low-intensity current via electrodes on the scalp to modify neuronal excitability in the underlying cortex. The tDCS system has customizable headgear with disposable, snap-in electrodes that are easy to apply at home without assistance.

Speech and hearing assessments will be completed prior to the start of auditory training, at the end of the 4 week training session, and again 6 months later.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years of age
* Patients with a Unilateral Cochlear Implant device in use for a minimum of 1 year
* Sentence recognition scores (AzBio) below 65% and/or word recognition scores (CNC) are below 75% in the implanted ear for \> one year following cochlear implantation.
* Ability to access internet to conduct computer-based auditory trainings and weekly video visits with study team weeks 2-5

Exclusion Criteria:

* Non-English speaking
* Diagnosis (documented or self-reported) of a psychiatric or neurologic condition, or any other comorbidities that may interfere with the study or increase the level of risk (such as dementia, seizures, legal blindness, brain tumor)
* Implants, other than CI, above collar bone level that may interact with delivery of tDCS
* Inability to or unwillingness to use electronic devices/computers, participate in video visits, or make required visits