cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.

When one receives a local anesthetic, such as novocaine for a dental procedure, there is a burning painful sensation experienced upon injection of the local anesthetic. We are trying to understand the role of pH (how acidic a solution is) in the production of pain during local anesthetic administration. We hypothesize that less acidic solutions produce less burning. We also want to determine whether or not the pH of the solution affects the rate of onset of the local anesthesia. We will recruit subjects from patients who have a clinical indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve blocks are administered at adjacent spinal levels, typically using either lidocaine or bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part of the research procedure and then provide lidocaine at the control location before continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to compare the effects of the three solutions. There will be almost no deviation from the standard clinical procedure. After the injection of each solution, the pain score on administration of the medication will be recorded immediately. We will also provide a continuous stimulation (pin taps) after the local anesthetic injection and record when the patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation). Finally, we will record the pain score upon reinsertion of a needle to mark the precise location (part of the clinical procedure) one minute after the local anesthetic injection. All data will be collected during the a single clinical visit.

The study will conclude when 60 subjects have successfully been tested. Data will be reviewed annually.


Eligibility Criteria:
Inclusion Criteria:

* patients at MGH Center for Pain Medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints.

Exclusion Criteria:

* contraindication to the clinical procedure
* do not speak English
The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study

Diet can influence the body's healing and repair mechanisms. A dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. However, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues.

Nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. In particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. The aim of our controlled study is to understand whether a vegetarian/vegan diet can be considered as protective for periodontal health compared to an omnivorous diet. For this purpose, we used a test group of 22 omnivorous subjects and a control group of 22 vegetarian/vegan patients in which experimental gingivitis was induced.


Eligibility Criteria:
Inclusion Criteria:

* Optimal systemic health conditions
* Non-Smoking
* Absence of cardio-vascular pathologies
* Absence of pulmonary pathologies
* Non-diabetic
* Not pregnant
* FMPS \<20%
* FMBS \<20%
* Omnivorous or vegan/vegetarian diet for at least a year
* Absence of periodontitis

Exclusion Criteria:

* Smokers
* Presence of systemic pathologies
* Presence of cardio-vascular disease
* Presence of periodontitis
* FMPS\>20%
* FMBS\>20%
* Pregnant women
* Presence of blood pathologies
* Taking medicines (hydantoins, nifedipine or cyclosporine)
* Taking oral contraceptives
* Bacterial, viral or fungal infections
* Idiopathic gingival fibromatosis
* Mucocutaneous disorders
* Allergic reactions to toothpastes and mouthwashes
Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.

Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.

Exclusion Criteria:

* Female gender
* current GH use or GH use within three months of the study
* diabetes
* hypoglycemia
* liver or kidney disease
* use of drugs that could increase GH secretion (i.e. L-dopa)
* alcohol or substance abuse
* use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.
Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.

This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).

Eligibility Criteria:
Inclusion Criteria:

* Adult asthmatics
* History of or current use of oral steroids to control symptoms

Exclusion Criteria:

* Pregnant women
Effects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke

To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients

The effects of different exercise regimes and PNF techniques on balance and plantar pressure had been studied. This study focuses on determining the effects of CSE and PNF techniques on developing static standing balance and plantar pressure in stroke patients using PoData

Eligibility Criteria:
Inclusion Criteria:

* • Age 45-60

  * Score of 9 or higher on the static component of Berg Balance Scale
  * Both genders will be recruited.
  * First ever episode of stroke
  * Duration of stroke greater than 6 months.
  * Having a score of equal to or less than 2 on the Modified Ashworth Scale
  * Having a score of greater than or equal to 24 on the Mini-mental state examination in order to understand the commands.

Exclusion Criteria:

* • Concurrent orthopedic (for e.g. amputation ) that may hamper standing

  * Relevant psychiatric disorders that may prevent from following instructions.
  * Other medical drugs that may influence our intervention
  * Condition contraindicating physical activity
  * Use of cardiac pacemakers.
High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy

To observe the clinical effect and safety of transcranial electrical stimulation on patients with refractory epilepsy before and after treatment and analyze its therapeutic mechanism.

All participants underwent a medical evaluation that included physical examination and routine laboratory studies before and after high definition transcranial direct current stimulation (HD-tDCS) treatment.Upon meeting the inclusion criteria and providing informed consent, each participant will complete clinical assessments by a trained investigator and HD-tDCS treatment at Anhui mental health centre.

At least 90 participants were randomized (1:1:1) to receive "bilateral active" ,"Unilateral active" or "Sham" treatment protocol. The left electrical stimulation cathode was placed over CP5 with return electrodes placed at FT7, C1, P03 and P9 . The right electrical stimulation cathode was placed over CP6 with return electrodes placed at FT8, C2, PO4 and P10 .

In the bilateral treatment group, HD-tDCS treatment was placed on the left and right sides of the brain, at least eight hours apart. Twenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 30 minutes,twice a day over 10 consecutive workdays. In the unilateral treatment group, HD-tDCS treatment based on Epileptic discharge is placed on either the left or right side of the brain.Ten 2-mA sessions were applied for 30 minutes,once a day over 10 consecutive workdays.Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Before and after the tDCS treatment, the patients had receiving a battery measure of neuropsychological tests, Magnetic resonance imaging scan in multimodalities, VEEG and Resting motor threshold.

The clinical symptom of participants were followed 4 weeks and 12 weeks after the last treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of refractory epilepsy
* Right-handed and aged 18-50 years old and primary school education or above;
* No major neurological or mental illness, no head injury, alcohol dependence or drug dependence;
* During the experiment, the subjects did not smoke, drink, get sick and take psychotropic drugs, and there were no major life events that caused mood changes.

Exclusion Criteria:

* organic brain injury, neurological diseases or serious physical diseases;
* Have a history of substance abuse and drug dependence, or have used antipsychotic drugs in the past three months, and have serious suicidal tendencies;
* There are contraindications for MRI or EEG or transcranial magnetic stimulation.
Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment

The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis.

The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale.
* Patients with history of allergic conjunctivitis.
* Patients who accept no to wear contact lens during the duration of the trial.
* Patients who accept no to use any other medication by any delivery route.
* Patients with intraocular pressure controlled (less than 18 mmhg)

Exclusion Criteria:

* Patients who have undergone refractive surgery within the 6 months prior to the start of the study
* Patient with ocular or systemic active diseases
* Patients who are participating in another trial
* Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous.
* Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 / 32.
* Women who are breastfeeding and pregnant.
A Prospective Cohort of Pulmonary Ground Glass Nodules Patients With Family History.

The aim of the present prospective cohort study (GGN-F) is to study the family aggregation of pulmonary ground glass nodules via the questionnaire survey and to investigate the underlying genetic mechanism via the biobank.

In recent years, with the development of low-dose chest CT screening, more and more ground glass nodules have been found. Meanwhile, presenting as Ground-glass nodule (GGN), the early-stage lung adenocarcinoma patients with lung cancer family history have been emerging increasing in recent years in East Asian.

This prospective cohort study, with both a cross-sectional and a longitudinal part, will include patients with pulmonary ground glass nodule, which were proven malignant disease.

All participants will be asked to complete questionnaire to build the clinical database of GGN patients with detailed family history. Furthermore, blood and surgical tumor samples will be collected as a specific biobank. And the blood samples of other family members of participants will be collected, with their consent and knowledge.

Eligibility Criteria:
Inclusion Criteria:

1. patients with informed consent;
2. patients with pulmonary ground glass nodule.
3. pathological proved early stage lung cancer.

Exclusion Criteria:

1.not included in the inclusion criteria
Novel Stretching Versus Post Isometric Relaxation Techniques On Shoulder Disability In Athletes

It was a randomized control trial in which thirty (30) participants having GRID, age between 20-40 years were randomly allocated into two groups i-e NS (Novel stretching) Group (30) and PIR (posterior isometric relaxation techniques) Group (30), February 2022 to March 2022.PIR group received the posterior isometric relaxation techniques (three times a week for one month) and NS group received the Novel stretching (three times a week for one month). IR ROM was measured with a goniometer while pain was measured with Numeric Pain Rating Scale intervention and disability of arm, shoulder and hand was measured with DASH score before, immediately, and at week 4 post intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Between the ages of 18 and 40
* Athletes with glenohumeral internal deficit
* Basketball, tennis, javelin, squash, swimmers, volleyball, and weightlifter
* participated in local and regional sporting events
* showed a 10° or higher variation in Internal rotation range of motion between shoulders (dominant versus non-dominant)

Exclusion Criteria:

* Footballer, cricketer, and hockey player
* Recovering from extensive shoulder and elbow surgery that was performed three months ago.
* presently undergoing medical intervention for the shoulder
* Suffer from a life-threatening illness
Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors

SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.


Eligibility Criteria:
Inclusion Criteria:

1. Be male and ≥18 years of age;
2. Have clinically severe hemophilia A, defined as:

   1. \<1% (\<1 IU/dL) endogenous FVIII activity levels as historically documented by a certified laboratory or screening data results; OR
   2. 1-2% (1-2 IU/dL) endogenous FVIII activity levels and \> 10 bleeding events per year (in the last 52 weeks prior to screening); OR
   3. 1-2% (1-2 IU/dL) endogenous FVIII activity levels and on prophylaxis;
3. Have had \>150 exposure days (EDs) to any recombinant and/or plasma-derived FVIII concentrates or cryoprecipitates
4. Have no prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
5. Have no measurable inhibitor against FVIII as assessed by central laboratory, have no confirmed history of clinically significant FVIII inhibitor, and no clinical signs or symptoms of decreased response to FVIII administration (Note: family history of inhibitors will not exclude study participation)
6. Agree to use reliable barrier contraception after the administration of SPK-8016 until notified by the Investigator.

Exclusion Criteria:

1. Have active hepatitis B or C
2. Have significant underlying liver disease.
3. Have serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm3. Participants who are HIV-positive and stable, with an adequate CD4 count (\>200/mm3) and undetectable viral load, and are on an antiretroviral drug regimen are eligible to enroll
4. Have detectable antibodies reactive with AAV-Spark capsid
5. Have history of chronic infection or other chronic disease
6. Have been dosed in a previous gene therapy research trial within the last 52 weeks or with an investigational drug within the last 12 weeks
7. Any concurrent clinically significant major disease (such as liver abnormalities or type I diabetes) or other condition that, in the opinion of the Investigator and/or Sponsor, makes the subject unsuitable for participation in the study;
8. Unable or unwilling to comply with the schedule of visits and study assessments described in the clinical protocol.
Effectiveness of Parenting Intervention for Improving Child Mental Health

In this study, effectiveness of a group parenting intervention was assessed in a community setting, for its impact on child behaviour problems and parental mental health.


Eligibility Criteria:
Inclusion Criteria:

* Parents who consented to join the trial
* Children aged 2-8 years
* Mean score on the Eyberg Intensity Scale for clinical issues

Exclusion Criteria:

* Any comorbid psychiatric condition in parents or children
* Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention
The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients

The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status class I
* Planned for multiple dental treatments in the maxilla and mandible bilaterally

Exclusion Criteria:

* Patients \<18 years old
* Pregnant ladies
* Smokers and alcoholics
* Patients on medications
* Drug abusers
* Never received dental treatment under local anesthesia before
* Patients with an acute infection with or without fever
* Patients with preoperative pain
Multiple Ascending Dose Study for LCB01-0371

Primary

* To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
* To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
* To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects

* To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
* To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

Eligibility Criteria:
Inclusion Criteria:

1. Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
2. Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
3. Able to donate blood during study period and follow visit.
4. Agree to continue to use a reliable method of birth control until 60 days after study completion.
5. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
2. History of gastrointestinal problem which is affect to absorption within 6 months from screening
3. History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
4. History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters

It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion criteria are medical history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI\> 30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or fluid without nicotine for 10 minutes. The study protocol involves random allocation to groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary endpoint is the maximum change in heart rate compared to mean values prior to exposure. Secondary end points is the maximum change in the measured parameters (hemodynamic and autonomic values) compared to the average values before exposure. The measurements will be performed using the Task Force Monitor system for non-invasive measurement of hemodynamic parameters and the assessment of autonomic function. Adrenergic activity will be tested with microneurography. A periodic analysis is planned after examining 15 and 35 patients.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers aged 18 - 60 years
* 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required

Exclusion Criteria:

* history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI\> 30 kg/m2), the current active disease (eg. viral infection).