cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

This is a study about the dynamics and effects of ultrasound guided maxillary nerve block in trigeminal neuralgia

Standard pharmacological treatment for trigeminal neuralgia is often insufficient. In this setting, patients often suffer trough everyday activities and quality of life is disturbed substantially.

In this prospective clinical study, analgesic effect of ultrasound (US) guided maxillary nerve block will be investigated, in order to prolong pain-free time, reduce the use of standard analgesics, as well as atypical ones (e.g. antiepileptic drugs and antidepressants).

Characteristics of US guided maxillary nerve block will pain investigated: reduction of pain (decrease of VAS score), duration of pain-free period, pain level during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* patients with trigeminal neuralgia

Exclusion Criteria:

* allergy to local anesthetics
* local infection at the site of needle puncture
* parotitis
* serious liver disease
* use of antiarrhythmics group III (eg amiodarone)
* anticoagulant or antithrombotic drugs
* lactation
Tezspire Cardiac Events PASS

The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.

Tezepelumab (brand name: TEZSPIRE®), a human monoclonal antibody specific for the epithelial cell-derived cytokine thymic stromal lymphopoietin (TSLP), was recently launched as a first-in-class biologic add on treatment for patients with severe asthma. Results from DESTINATION, a long-term extension, phase 3 trial, showed a numeric imbalance in the occurrence of cardiac disorder system organ class serious adverse events (SAEs) in participants receiving tezepelumab compared to placebo. The observed imbalance resulted in the inclusion of serious cardiovascular events as an important potential risk to be addressed in the European Union (EU) risk management plan (RMP). AstraZeneca proposed to evaluate the risk of serious cardiovascular events with long-term tezepelumab treatment to meet regulatory requirements under a category 3 Post-Authorisation Safety Study (PASS).

This study is a non-interventional, longitudinal, population-based cohort study, using secondary data derived from multiple data sources. The study will consist of descriptive and a prevalent new-user design for comparative analyses of serious cardiovascular events outcomes in adolescent and adult patients with severe asthma exposed and unexposed to tezepelumab.

The study will be conducted using data sources from Denmark, France, Germany, and the United States of America (USA). The start of the study period will correspond to tezepelumab market launch date in each country of interest (i.e. between Q1 2022 - Q3 2023). An approximately five-year study period is planned in each country, with an anticipated last date of study period on 28 February 2029.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.

Exclusion Criteria for both exposed and unexposed groups include:

* \<12 months of data availability prior to index date,
* age \<12 years at index date,
* history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date
* for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic
* matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \[PS\] matching) will be applied to ensure exposed and unexposed patients' comparability
Obesity Intervention Program for University Students

The aim of this study is to determine the effect of preventive nursing interventions, which consist of education / practices including of healthy eating and physical activity and motivational messages which sent through social media to reduce obesity risk in university students who in the risk group for obesity.

This study has been conducted with University students in Turkey. The selected 70 students were associated with obesity risk factors about obesity (owerveight or normal weight and they were in the risk group in terms of obesity according to the risk rating scales, and between 19-24 years old) and randomly assigned to the experimental (35 students) and control group (35 students). Applications for the experimental group for 11 weeks about nutritional habits, practices for physical activity, and motivational messages sent via social media.

Primary Outcome Measure: Nutrition-Exercise Attitude Score, Nutrition-Exercise Behavior Score, Exercise Benefit / Obstacle Score. We used some scales for evaluate the primary outcomes (The Scale of Nutrition-Exercise Attitude-Behavior, The Scale of Exercise Benefit / Obstacle).

Bady Mass Index, Waist / Hip Ratio and Body fat percentage are secondary outcomes.

The data was calculated with SPSS package program.

Eligibility Criteria:
Inclusion Criteria:

* Preobezes between 25.0-29.9 BMI
* The BMI is 18.5-24.9 and who get above the average score (24-36 points high risk) from the "Risky Behavior Scale University Form: the subscale of nutritional habits
* The BMI is 18.5-24.9 and who get below the mean score (8-20 points high risk) from the Healthy Lifestyle Behavior Scale's subscale of Exercise

Exclusion Criteria:

* BMI below 18.5 and above 29.9
* Constantly regular drug users
* Those who have any health problems (who have had a heart attack, angioplasty or any surgical operation within 3 months, those with heart failure, those with metabolic disease, those with eating disorder, those with cancer, those with any psychological disease, Physically disabled)
* Those who are pregnant
* Those who have participated in any weight management program at least 2 months in advance and are still involved in the nutrition or physical activity program
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture

The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.


Eligibility Criteria:
Inclusion Criteria:

* athropic nonunion fracture of the long bone

Exclusion Criteria:

* immunocompromise,
* active infection,
* pathological fracture,
* ongoing hormonal therapy
Compare Smokers' Appraisal of Proposed Plain Packs and Existing Cigarette Packs

2 Objectives

1. To explore the noticeability of pictorial health warnings and perceptions of attractiveness and harmfulness towards plain cigarette packets and existing cigarette packets with 85% pictorial warnings in current smokers;
2. to compare the differences in perceptions of packaging in current smokers with different characteristics (i.e. by sex, age, the consumption level of cigarettes, nicotine dependence levels, and types of tobacco used for polytobacco product users);
3. to evaluate the effectiveness in reducing smoking consumption and promoting quit attempts; and
4. to assess the support for the legislation of plain packaging.

The present study will recruit at least 1,280 current smokers at smoking hotspots in Hong Kong Island, Kowloon, and the New Territories. Land-based, non-institutionalized Hong Kong residents aged 18 years and over who speak Cantonese or Putonghua are eligible to participate.

Subjects will be shown dummies of branded and plain packets that differ in brand names and plain colours. Subjects will discuss their perceptions of attractiveness and harmfulness, noticeability of warnings and effectiveness in reducing smoking consumption and promoting quit attempts. Their opinions on the legislation of plain packaging will also be asked.

After each interview, interviewers will debrief each interviewee on the harms of smoking and distribute a card providing a quitline and quitting methods.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18 years and over
* Able to speak Cantonese or Putonghua
* Smokers who have tobacco use behaviour of holding a cigarette in the hand or mouth

Exclusion Criteria:

* Foreign domestic helpers
* Non-smokers
Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.

To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.

Surgery is a common and effective treatment for localized prostate cancer. The main objective of surgical treatment is to remove the tumor completely in order to achieve the goal of cure. Intrafascial nerve-sparing radical prostatectomy is a radical resection of prostate cancer with minimal damage to the nerves and blood vessels.

There are nerves around the prostate that affect sexual function, and damage to these nerves can lead to complications like sexual dysfunction and incontinence. Therefore, how to completely remove the tumor, as far as possible to preserve these nerves, become an important issue in the surgical treatment.

This study is aim to evaluate the different among nerve-sparing strategies, including unilateral intrafascial resection, bilateral intrafascial resection and bilateral extrafascial resection, on oncological outcome and functional recovery, so as to provide clinical evidence for nerve-sparing surgery of prostate cancer via robot-assisted posterior approach.

Eligibility Criteria:
Inclusion Criteria:

* Men aged ≥18 years and ≤80 years;
* Histologically proven prostate adenocarcinoma with clinical stage \< T3(no capsule break)
* Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
* Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
* Life expectancy greater than 10 years;
* Patients who are willing to accept robot-assisted radical prostatectomy after informed existing treatment plan, must sign the informed consent form.

Exclusion Criteria:

* Surgeon thinks that the patient has an unresectable disease;
* patients who have already applied androgen deprivation therapy(ADT);
* Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
* Any contraindication;
* Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
* Patients with a history of transurethral resection or enucleation of the prostate;
* Severe systemic disease that may interfere with the data, assessment, or compliance;
* Patients who are participating in other clinical trials;
* Refusing to sign the informed consent
* Patients that are considered to be not suitable to be included by the researchers.
Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children

The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings.


Eligibility Criteria:
Centers Inclusion Criteria:

1. Centers must have \>30 children ages 2-to-5
2. Center must serve low income families
3. Centers must reflect the ethnic diversity of the Miami Dade County Public School System (60% Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White).

Participants Inclusion Criteria:

1. Participants must speak English or Spanish or Creole
2. Parents must have a child enrolled in the childcare center that is participating in the study.
3. Children ages 2-5: Parent reported data (name, Date of Birth, behaviors)

Exclusion Criteria:

1. any participants who do not speak English or Spanish or Creole.
Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.

The Korean National Immunization Program (NIP) first introduced quadrivalent influenza immunization for all pregnant women in the 2020-2021 season. This nationwide cohort study is proposed to assess the risks of adverse maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy. We will use the national health insurance database from the National Health Insurance Service (NHIS) linked with the national immunization program registry data from the Korea Centers for Diseases Control \& Prevention (KCDC).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between September 22, 2020, and April 30, 2021.

Exclusion Criteria:

* Women aged \<20 or \>45 years
* Pregnancies with a chromosomal abnormality
* Pregnancies with exposure to a known teratogenic medication
Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.

This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study.

All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group:

Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia.

Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block .

Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 40 to 65 years old
* Both sexes.
* ASA I-II.
* Undergo hip replacement surgery.
* Body mass index (BMI) from 18 to 35 kg/m2.

Exclusion Criteria:

* Patient refusal.
* Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
* BMI \> 35.
* Known allergy to local anesthetics.
* ASA III-IV.
* Patients with difficulty in evaluating their level of pain.
Gabapentin for the Treatment of Hot Flashes in Menopausal Women

The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial.

For women who fear developing breast cancer, those who have contraindications to hormone replacement therapy and those who prefer an alternative treatment, there is presently no standard treatment for hot flashes. Women and health care providers have few options other than hormone replacement therapy as evidenced-based trials of alternatives have not shown many effective options. Many non-hormonal agents have been studied including antidepressants, antihypertensives, vitamin E, soy products, black cohosh, acupuncture, and belladonna and ergotamine combinations. Preliminary studies using the antiseizure medication, gabapentin (Neurontin), has demonstrated a substantial reduction in hot flashes. This agent may provide an effective treatment for hot flashes in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Women with substantial hot flashes defined as reporting at least 14 hot flashes per week.
* Postmenopausal women as defined by the natural cessation of menses for 1 year.
* Aged 45 - 65 years.

Exclusion Criteria:

* Women on hormone replacement therapy.
* Women with a surgically induced menopause (oophorectomy).
* Women on tamoxifen or receiving chemotherapy/radiation therapy or planned antineoplastic chemotherapy/radiation therapy.
* Renal function impairment (serum creatinine greater than the laboratory normal range; or creatinine clearance \<30ml/min).
* Use of antidepressants with serotonin reuptake mechanisms and antiseizure medications within the past month.
* Neurologic conditions: seizures, vertigo, and syncope.
* Known hypersensitivity to gabapentin and its components.
* Inability to complete questionnaires for any reason including psychiatric disorders.
* History of a hypothalamic dysfunction.
* Life expectancy less than 6 months.
Magnesium Sulfate Effects on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy

This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 or 2.
* BMI of 25-34.9 kg/m2.
* Patients scheduled for laparoscopic cholecystectomy.

Exclusion Criteria:

* Severe respiratory or cardiac disease.
* Hepatic or renal function impairment.
* Neuromuscular disease.
* Patients on medications affecting neuromuscular function.
* Patients with known allergy to the drugs.
Diagnostic Value and Biological Significant of cd71 in Lymphoid Disorders

CD71 is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues. , reflecting the requirement for iron in hemoglobin. , CD71 expression is upregulated on immature proliferating cells and low levels on resting mature lymphocytes. In addition to this general function, CD71 appears to play a costimulatory role in T cell activation and receptor for IgA1 antibodies So it is growth receptor that may help in diagnosis of lymphoid disorder and in differentiation of malignant and benign that will be studied investigate CD71 expression in lymphoid disorders and its diagnostic value ,we from collect data patient and do rotune examination

1. Routine investigations for diagnosis:

   * CBC.
   * Bone marrow aspiration morphology.
   * Cytochemistry.
   * Flow cytometry immunophenotyping.
   * Bone marrow biopsy when indicated.
2. Special investigation is flow cytometry examination of CD71 expression.

sample size calculation ; sample size cases 39 sample size controls 39 total sample size 79 sample will be collected from patient in hospital university ,Data will be analysed by SPSS program

Eligibility Criteria:
Inclusion Criteria:

* all patients wiil be diagnosed lymphoid disorders

Exclusion Criteria:

* not present
Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study

To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).

To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).

Patients - methods: In this pilot study, 61 patients with Diabetes Mellitus Type 2 (DMT2, 31 women), with mean duration of DM 17.5 years and mean age 63 years were randomly assigned, either to receive the combination of ten elements (2 tablets/24h) in the active group, (n=30), or the placebo (n=31) for 6 months. We used Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured vibration perception threshold (VPT) and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check \[sural nerve conduction velocity (SNCV) and amplitude (SNAP)\]. Sudomotor function was assessed with SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF). Pain (PS) questionnaire was administered, also. All patients received metformin for at least 4 years.

Eligibility Criteria:
Inclusion Criteria:

* on metformin therapy for at least 4 years
* diabetes mellitus type 2 with diabetic neuropathy
* painful neuropathy

Exclusion Criteria:

* healthy
* without diabetic neuropathy
* pregant
Xience/Promus for Long Coronary Lesion Registry

The utilization of everolimus-eluting coronary stents in a coronary artery diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of multiple everolimus-eluting coronary stent implantation in long (\>30mm) coronary lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥20 years and are able to undergo CABG
2. Females who are not pregnant
3. Patients who present with angina symptoms or myocardial ischemia
4. Patients available for post-procedural observation and coronary angiography at 24 months
5. Patients who have signed patient informed consent
6. Lesion length is more than 30mm
7. De novo lesion or non-stented restenosed lesion

Exclusion Criteria:

1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy
2. Patients with significant allergic reaction to contrast medium
3. Chronic total occlusion
4. Lesion with TIMI0
5. Patients with chronic renal failure (SCr\>3.0mg/dl) -
Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity

High-potency benzodiazepines have strong anxiolytic effects accompanied by significant adverse effects including impaired cognitive function, drowsiness, dizziness and impaired motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence and withdrawal. Therefore, there is considerable scientific and public interest in identifying new anxiolytic agents.

The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants and patients with anxiety disorders by decreasing fear-associated amygdala activity. However, so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a homogenous structure but rather consists of several subdivisions with structural and functional differences.

Therefore, the rationale of the present project is to determine the effects of intranasal OXT and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar subregions.


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers
* right-handed

Exclusion Criteria:

* Current or past psychiatric illness
* Current or past physical illness
* Psychoactive medication
* Sedative medication
* MRI contraindication (e.g. metal in body, claustrophobia)