cyrilzakka/clinical-trials huggingface dataset:
Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder

This study evaluates the effects of selective 8th cervical nerve root block during interscalene brachial plexus block on the relief of pain intensity upon the introduction of a posterior portal during arthroscopic shoulder surgery. The 5th to 7th cervical nerve roots will be blocked in half of participants, while the 5th to 8th cervical nerve roots will be blocked in the other half.

By blocking only the 5th to 7th cervical nerve blocks, conventional interscalene brachial plexus block spares the 8th cervical and 1st thoracic dermatomes which innervate the posterior aspect of the shoulder. To visualize the shoulder joint space during shoulder arthroscopic surgery, the introduction of a posterior portal is essential. However, conventional interscalene brachial plexus block cannot effectively relieve the pain caused by its insertion due to sparing of the 8th cervical and 1st thoracic dermatomes. The addition of the 8th cervical nerve root block to conventional interscalene brachial plexus block decreases pain intensity upon the introduction of a posterior portal.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 and 2
* Arthroscopic shoulder surgery under interscalene brachial plexus block

Exclusion Criteria:

* Patient refusal
* Contralateral hemidiaphragmatic paralysis or paresis
* Contralateral vocal cord palsy
* Severe pulmonary restrictive disease
* Coagulopathy
* Allergy to local anesthetics or history of allergic shock
* Difficulty communicating with medical personnel
* Peripheral neuropathy or neurologic sequelae on the operative limb
Chronic Malnutrition and Oral Health Status in Children Aged One to Five Years

Malnutrition is a public health problem that can exert a negative impact on the general and oral health of children. The aim of the present study was to evaluate the effect of chronic malnutrition on the oral health of children aged one to five years. An observational, analytical, cross-sectional study was conducted at the Nutritional Recovery Center and involved 82 children between 12 and 71 months of age. Nutritional status was evaluated using anthropometric indicators and oral health status was measured using the dmft index. Non-stimulated saliva was collected. Flow rate and buffering capacity was then measured with the aid of a pH meter.

Malnutrition is a public health problem that can exert a negative impact on the general and oral health of children. The aim of the present study was to evaluate the effect of chronic malnutrition on the oral health of children aged one to five years. An observational, analytical, cross-sectional study was conducted at the Nutritional Recovery Center and involved 82 children between 12 and 71 months of age. Nutritional status was evaluated using anthropometric indicators. The children were weighed on a previously calibrated electronic scale (capacity: 150 kg; precision: 100 g) barefoot and wearing light clothing in the presence of the mother or caregiver. Height was determined using a non-flexible metric tape (maximum length: 2 m; precision: 0.1 cm). Each measurement was made twice and the mean was used for the calculation height for age, weight for height and weight for age. The guidelines of the World Health Organization, were the reference for the evaluation of nutritional status. Oral health status was measured using the dmft index. The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition - described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. Non-stimulated saliva was collected and Flow rate and buffering capacity was then measured with the aid of a pH meter. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: \< 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and \> 2.0 ml/min = high flow. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.

Eligibility Criteria:
Inclusion Criteria:

Children aged one to five years enrolled at the Center for Educational and Nutrition Recovery.

Statement of informed consent signed by parents/guardians. Clinical diagnosis of malnutrition.

Exclusion Criteria:

Children aged one to five years not enrolled at the Center for Educational and Nutrition Recovery.

Children whose Parents/guardians did not sign a statement of informed consent.
Foot Assessment in People With Diabetes: A Quantitative Diagnostic Approach

This observational cohort study aims to develop a novel risk stratification system implementing biomechanics to aid in the prevention of diabetic foot ulcers.

The purpose of this research observational cohort study is to investigate the applicability of using biomechanical assessment in predicting the ulceration incidence in patients with diabetic neuropathic feet. The proposed study will lead to the development of further stratification of high-risk patients into subcategories indicating the vulnerability of tissue to mechanical trauma, which deemed to be the leading cause of ulceration in people with diabetic neuropathy.

As it stands, the current systems used to evaluate the risk of diabetic foot rely on global parameters such as duration of diabetes and glycated hemoglobin to predict the likelihood and risk of diabetic foot ulceration. As ulceration happens as a result of repeat mechanical trauma to the foot that doesn't heal quickly enough due to other complications of diabetes, it is important to include mechanical measurements in predicting the ulceration incident in diabetic neuropathic patients. Despite this, the currently used risk stratification systems do not include biomechanics so by introducing biomechanics it will potentially be possible to predict the ulceration risk by using more local measurements.

The primary objective is to employ the measures of neuropathy, micro/macro-perfusion, and biomechanics of the foot mainly tissue stiffness and plantar pressure to determine the vulnerability of foot to mechanical trauma and ulceration. From the data collected it is proposed that a prognostic risk stratification system will be developed based on the range of parameters collected to identify those that are at highest risk of ulceration incident. Those that are classed as high risk are to be sub-stratified to increase the accuracy of the system in predicting ulceration. This will allow a patient-specific approach to be taken in the prevention of ulcers by providing adequate information to predict ulceration incident. This then can be used to determine the likelihood of an ulcer forming. Furthermore, the possibility of identifying the ulceration site will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 OR 2 diabetes
* Over 18
* English speaking
* Ability to walk unaided over 5m
* Diabetic neuropathy as defined by a 10g monofilament test

Exclusion Criteria:

* Lower limb surgery (amputation)
* Active ulcers
* History of neurological disorders (apart from neuropathy)
* Orthopaedic problems
* Systemic disease affecting mobility or leading to chronic inflammation of any lower limb joint.
* Visual impairment leading to difficulties in walking
* Charcot foot
* Unable to walk unaided for 5m
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women

The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women ages ≥ 50 years.
2. Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).
3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria:

1. History of malignancy.
2. Menopause due to simple hysterectomy.
3. Subjects with poor blood pressure control.
4. Subjects with positive tests for infectious diseases.
5. Have a history of diseases related to bone metabolism.
6. Use of drugs that may affect bone metabolism before administration.
7. Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening.
8. Female who are pregnant or breastfeeding.
9. Unable to tolerate venipunctures or have a history of fainting needles and blood.
10. Other reasons that the investigator consider it inappropriate to participate in the trial.
Effects of Strength and Balance Training to Reduce the Fall Risk in Knee Osteoarthritis Patients

This study will address the scarcity of research and the variations in recommendations regarding the effects of strength and balance training to reduce the fall risk in knee osteoarthritis patients.

This Study will be conducted in Alkhidmat Raazi Hospital. Written informed consent for inclusion in the study was taken. Patients of experimental group will receive balance training with conventional along with TENS, heating pad for one hour 3 times weekly. Assessment will be performed pre and post of intervention. Intervention will be given 3 days a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age from 55 and 80 year
* Both male and female patients.
* Participants will need to have had knee pain for at least 6 months and experience current average pain of at least 3 (on an 11-point Numerical Pain Rating Scale (NRS)
* Patients having no other physical and mental illness.
* Osteoarthritis of knee (Stage-II) by kallgren and lawrence scale

Exclusion Criteria:

* Patients with lab results abnormal (malignancy)
* Nonmusculoskeletal conditions
* Patient's undergone surgery of knee.
* Other than osteoarthritis
COVID-19 Vaccine Text Outreach

This project aims to evaluate different approaches to increase COVID-19 vaccine uptake among at-risk patients at Penn Medicine in an equitable and systematic manner through a centralized outreach program. The investigators will evaluate different text-based scheduling and messaging approaches informed by behavioral science to increase uptake among eligible patients, including the use of clinician endorsement, opt-out framing, and scarcity.

This project will evaluate a centralized approach to increasing COVID through direct outreach to eligible patients via text messaging. This pragmatic randomized controlled trial has the following aims:

Aim 1: To conduct systematic large scale text message outreach for vaccine delivery among a defined group of Penn Medicine in a way that advances equity.

Aim 2: To offer different scheduling workflows through text messaging that might increase uptake and reduce disparities.

Aim 3: To compare the equity and efficiency of different messages informed by behavioral science, including PCP endorsement, opt-out framing, and scarcity.

Eligibility Criteria:
Inclusion Criteria:

* patients of Penn Medicine aged 18+ who reside in Philadelphia and who have had at least 1 visit in the past 5 years with a Penn Medicine primary care provider (PCP)

Exclusion Criteria:

* Patients who have completed any dose of the vaccine at Penn Medicine, are currently scheduled to receive the vaccine, have externally documented vaccination records, or have previously received text-message based vaccine outreach.
Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus Using Tinnitogram

This study will be conducted on patients with otosclerosis attending Assiut University Hospital and undergo stapedectomy operation Evaluation of each patient will conducted preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus handicap questionnaire before and after the operation to measure improvement in hearing and tinnitus

Otosclerosis is an abnormal bone remodeling in the middle ear The normal dense endochondral layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone leading to the fixation of the stapes.

* Clinical otosclerosis is more prevalent in females than in males, giving rise to the hypothesis that sex hormones may contribute to the development of disease
* The age of onset is variable, although hearing loss typically begins in the third decade, with a range from first decade to the sixth decade.

In most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing initially in one ear before progressing to the other.

Positive family history of otosclerosis has been previously reported in between 30-70% of cases.

The diagnosis is usually made clinically by

* History
* Physical examination,
* Audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most frequent presentation of patients with clinical otosclerosis is bilateral hearing loss and tinnitus Between 65 and 87% of patient with otosclerosis experience tinnitus. most of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus.

patients with tinnitus often report that their tinnitus is associated with feelings of sadness, worry, frustration, and anger.

These feelings can lead to difficulties sleeping, relaxing, and concentrating and may negatively impact relationships at work and impair participation in social settings .

Stapedotomy through sufficient air-bone gap closure Data collection

1. full history taking
2. tinnitus handicap questionnaire arabic version
3. Vital signs and general examination
4. Full ENT examination including ear canal and tympanic membrane examination
5. Routine audiologic testing which provide an assessment of patient hearing
6. Investigation
7. Preoperative fitness
8. Tinnitogra

Tinnitogram :

Tinnitus pitch match : we will start at 1000 Hz and move up and down in frequency.

Tinnitus loudness match : patient threshold was determined at frequency of pitch matching, sound level will increase in small steps(1or 2 dB ) until patient repoted that specific tone will just equal in loudeness to his tinnitus Tinnitus handicap questionnaire arabic version

Eligibility Criteria:
Inclusion Criteria:

* patient with otosclerosis undergo stapes surgery in otorhinology department in Assiut university hospital
* All patient have tinnitus and conductive hearing loss or mixed hearing loss.

Exclusion Criteria:

* patient with otosclerosis who don't undergo stapes surgery patient have tinnitus due to causes other than otosclerosis.
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression

The main goal of this study is to help answer the following research question(s) and not to treat the child's illness.

* Can this study drug make children with bipolar depression feel better?
* Does this study drug work better than a placebo (sugar pill)?
* Does this study drug cause side effects in children who take it?
* Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)


Eligibility Criteria:
Inclusion Criteria:

* Male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20 kilograms (kg) at screening.
* Must meet diagnostic criteria for current major depressive episode of Bipolar I Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Version (DSM-IV-TR) and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL)
* Patients entering the study will also be scored by the Children's Depression Rating Scale-Revised (CDRS-R) (entry score of greater than or equal to 40) as well as the adolescent-structured Young Mania Rating Scale (YMRS) (entry score of less than or equal to 15 with YMRS Item 1 \[elevated mood\] score less than equal to 2).

Exclusion Criteria:

* Patients will be excluded if they are, in the opinion of the investigator, actively suicidal
* Have an acute, serious or unstable medical condition
* Have clinically significant laboratory abnormalities
* Have had one or more seizures of unclear etiology
* Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was misdiagnosed
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

The purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration.

The trial was terminated early on April 12, 2013 due to an organizational decision, which was not based on safety or efficacy concerns. Subjects who were already enrolled into the study were followed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 60 and 90 years.
* Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration.
* Best Corrected Visual Acuity (BCVA) of 20/80 or better in the study eye

Exclusion Criteria:

* Evidence of ocular disease other than geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration in the study eye.
* History or diagnosis of exudative (wet) Age-Related Macular Degeneration, with subretinal or choroidal neovascular lesions in the study eye.
* Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal system
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.

Eligibility Criteria:
Chronic renal failure patients with hyperphosphataemia receiving hemodialysis
The Long-term Evaluation of Glucosamine Sulphate Study

The primary aim of this study is to determine if the dietary supplements, glucosamine sulphate and/or chondroitin can limit or reduce structural disease progression whilst providing symptomatic benefit in people with osteoarthritis (OA) of the knee.

The specific hypotheses to be tested in the proposed double blind, placebo-controlled, randomised clinical trial are that, compared to participants allocated to placebo, participants allocated to either or both of these dietary supplements will demonstrate:

* reduced medial tibio-femoral joint space narrowing at 2 years AND;
* reduced knee pain over 1 year

These benefits will be achieved by participants allocated to glucosamine sulphate and/or chondroitin (the study treatments) without concomitant:

* increased use of analgesics
* reduced health-related quality of life
* reduced participation in leisure-time physical activity

The LEGS study is a double blind, placebo-controlled randomised clinical trial using a 2 x 2 factorial design. Participant will be randomly allocated to one of the four possible treatment combinations:

* Glucosamine and Chondroitin (double active)
* Placebo Glucosamine and Chondroitin
* Glucosamine and Placebo Chondroitin
* Placebo Glucosamine and Placebo Chondroitin (double placebo)

Each allocation involves taking 4 study treatment capsules once a day for two years.

A total of 600 participants with symptomatic knee OA will be recruited by general media advertising and by General Practitioners through the New South Wales Divisions of general practice.

Eligibility Criteria:
Inclusion Criteria:

* Knee pain, or taking NSAIDs/ analgesia for knee pain on most days past month
* Knee pain 4-10 on 10cm VAS
* Medial tibio-femoral compartment joint space narrowing in symptomatic knee

Exclusion Criteria:

* Unstable diabetes
* \<2mm medial tibio-femoral compartment joint space width
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.

Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 3 years.

Prospective observational confirmation study of previous retrospective cohort study.

As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

see summary

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of pancreatic cancer, adenocarcinoma, UICC stage II-IV
* Age between 18 (Austria: 19) and 85 years
* No previous malign tumor
* ECOG 0-2
* Estimated life expectancy \> 3 months
* Surgical resection of the tumor (R0, R1) or determination of interoperability
* Conventional oncological therapy and measurements, or passive after-care ("best care")
* Follow-up for several years feasible
* Patient gives written consent to use the anonymized date for evaluation

Exclusion Criteria:

* Other Iscador® sorts than Qu in the test group
* Other mistletoe preparations in the test group
* Any mistletoe preparation in the control group
* Non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. Echinacea, interferons, Polyerga®, BCG, azathioprine). Allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines
* HIV infection, Aids, organ transplantation
* Contraindications for Iscador® Qu (allergy against mistletoe, acute inflammatory disease or fever \> 38.5°C, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases)
* Patients participating in another clinical study with non-approved substances