cyrilzakka/clinical-trials huggingface dataset:
Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability

Damage to the ligaments of the wrist occurs frequently, however, it is not well publicized or understood. Our previous and current biomechanical studies have shown that damage to certain wrist ligaments is the likely cause of wrist instability and pain. Based on our three dimensional models and animations of actual cadaver motions with various ligaments intact or sectioned, we have identified several changes in how the carpal bones move and are positioned relative to the radius with various levels of instability. Using this information, we have developed a mathematical model that can predict in cadaver wrists which groups of ligaments have been injured. We started, under IRB approval, a prospective clinical study to evaluate the reliability of this mathematical model. During the past 5 years we have studied 13 patients with suspected wrist ligament injuries who were previously scheduled for surgical treatment. CT scans have been performed of the injured wrist and for comparison purposes, the contralateral, uninjured wrist. During these 5 years, there were no problems with the conduct of the study. During these 5 years the only changes to the original study application were

* a) to include a CT scan of the contralateral wrist for comparison purposes
* b) a paper handout given to potential subjects
* c) to add additional people to the study team.

The principal investigator, blinded to the results of the CT scan, surgically explores and treats these patients in the same manner that he would for any patient with suspected wrist ligament injuries. During the surgery, the investigator determines the integrity of the various wrist ligaments. The prediction of which ligaments are damaged, based upon the CT scan information and mathematical model is compared to the actual surgical findings. The importance of this study is to develop a tool that will allow one to rapidly and non invasively diagnose wrist instability and initiate treatment before further damage is done.


Eligibility Criteria:
Inclusion Criteria:

* patients who have suffered ligamentous injuries to their wrists and have been referred to the principal investigator
* subject selected to undergo surgery
* The ethnicity and racial makeup of the group is similar to the demographics of the surrounding referral base
* There will be no exclusion of any gender, racial or ethnic group

Exclusion Criteria:

* Pregnant women will not be included because of increased anesthetic risks at surgery.
Single vs. Two Implants for Mandibular Overdentures

This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. The null hypothesis was that there was no statistically significant difference in clinical evaluation, marginal bone loss, and masticatory efficiency among single symphyseal implants, single parasymphyseal implants, and two-implant-assisted complete mandibular overdentures.

This randomized, controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures. Fifteen completely edentulous male patients (50-65 years) were chosen and randomly grouped into three equal groups (five patients in each) according to the position and number of the received implants to assist mandibular complete overdentures. Group I: single median implant. Group II: single parasymphyseal implant. Group III: two implants were inserted in the canine area bilaterally. After three months of osseointegration, the lower denture was transformed into an implant-assisted complete mandibular overdenture. Clinical observations were documented on the day of loading, three, six, and nine months later for each implant. Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading, six and twelve months later. The masticatory efficiency evaluation was conducted one month and three months after loading.

Eligibility Criteria:
Inclusion Criteria:

* patients with a class I Maxillo-mandibular jaw relationship
* patients with residual ridges had normal morphology, were free from severe bony undercuts or flabby tissue, and were covered by firm mucoperiosteum.
* A cone beam CT of the lower arch was made to detect the presence of pathological lesions, remaining roots, or impacted teeth in the arch and evaluate both bone quality and quantity, especially in the area of interest

Exclusion Criteria:

* patients with current chemotherapy or radiotherapy, bleeding disorders, uncontrolled diabetes
* patients with a history of drug therapy that interferes with bone resorption or deposition (e.g., the prolonged use of glucocorticoids, antiresorptive medications, selective serotonin reuptake inhibitors, and proton-pump inhibitors),
* Those with any physical reasons that could affect follow-up, psychiatric problems, heavy smokers, drug or alcohol addicts, immunocompromised patients, abnormal jaw relationship, inadequate inter arch space.
* patients with temporomandibular disorders and para-functional habits (e.g., bruxing and clenching).
Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension

Prospective, randomized trial to assess the effectiveness of different renal sympathetic denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a cohort of patients with therapy refractory arterial hypertension and large renal arteries

The aim of this trial is a prospective, randomized comparison of three different techniques for catheter based renal sympathetic denervation. Patients with larger (\>5.5 mm) renal arteries are randomized to a treatment with a radiofrequency based catheter of the main renal artery, the main renal artery, its side-branches and accessories or an ultrasound-based denervation of the main renal artery only. The primary endpoint is the change in daytime blood pressure acquired in ambulatory blood pressure measurement at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resistant hypertension (≥3 antihypertensive drugs including at least one diuretic, without any dosage change in the preceding 4 weeks) and a systolic office blood pressure of \>160 mmHg, ≥1 main renal artery diameter \>5.5 mm

Exclusion Criteria:

* pregnancy, known renal artery stenosis, average systolic daytime RR \<135 mmHg in 24h ambulatory blood pressure measurement (ABPM), ≥1 renal artery diameter \<4.0 mm, life-expectancy \<6 months, participation in any other clinical trial.
Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)

The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

This is an exploratory Phase 0 study in participants who previously participated in studies (54861911ALZ2002 \[NCT02260674\], 54861911ALZ2003 \[NCT02569398\], or 54861911ALZ2004 \[NCT02406027\]) with atabecestat. In this study, participants will only have blood drawn. The primary hypotheses for this study is that adverse event of elevated liver enzymes observed in some participants is caused by a T-cell dependent inflammatory response. Participants will be monitored for adverse events and will be called 1 day after the blood draw to assess for any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Participant who received and discontinued atabecestat in one of the following prior trials (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Willing and able to adhere to the prohibitions and restrictions specified for this study

Exclusion Criteria:

* Anemic based on the last blood draw in the prior atabecestat trial
* Donated more than (\>) 450 milliliter (mL) of blood in the past 3 months
* Currently participating in an atabecestat study (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)
Characterizing ASD Adult Population Asking for a Diagnosis

The investigators aim at offering to about 80 patients a diagnostic assessment for Autism Spectrum Disorder (ASD), and at testing the feasibility of this protocol to detect and diagnose ASD in adults without intellectual disability.

About 80 adults asked for an ASD diagnosis a Donald-T unit, now closed.The investigators will offer to these patients a diagnostic assessment, with questionnaires, ADOS-II, Vineland Adaptative Behavior Scale and psychiatric examination. Patients who will show negative scores at the detecting questionnaires will not be further assessed, except for 10 out of them, who will be drawn by lot. Then the investigators will be able to discuss the feasibility of such a procedure with these tools, as well as to describe the clinical profile of adult people asking for ans ASD diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* to be on Donald-T's waiting list
* be at least 18 years old

Exclusion Criteria:

* Any participant who does not meet the inclusion criteria will not be included in the study.
Anterior and Posterior Approaches of Suprascapular Nerve Block

Suprascapular nerve is a mixed motor and sensory peripheral nerve arising from the superior trunk of brachial plexus.The suprascapular nerve runs through the posterior triangle of the neck, anterior of the trapezius muscle and dorsal of the omohyoid muscle, in direction of the scapula. Suprascapular nerve block is performed by anterior and posterior approach. Posterior approach of the suprascapular nerve block has been shown for many years to provide effective analgesia in the shoulder region for the chronic and acute pain. There are studies showing that suprascapular block with anterior approach provides effective analgesia in shoulder arthroscopy.

The aim of our study was to compare anterior and posterior approaches of suprascapular nerve block in terms of analgesic efficacy and patient safety.

This study is a prospective randomized clinical trial will be conducted between March 2022 and March 2023.Participant will divide into two groups as participant who underwent suprascapular nerve block with the anterior approach and participant who underwent suprascapular nerve block with the posterior approach. Bupivacaine 5 ml %0.5 will be injected both group. Diaphragmatic thickness fraction will be evaluated with ultrasound left and right 7.-8. subcostal anterior axillary border with the participant with the semi-sitting position. Diaphragmatic thickness fraction will measure before the block and after 30 minutes the surgery. Participants will administered intravenous morphine patient controlled analgesia for 24 hours stay. The amount of opioid analgesics given in both groups will be determined (in mg). Postoperative 4th, 6th, 12th, 24th hour Visual Analogue Scale scores of the participants and opioid consumptions until that hours will be evaluated. An addition participant will be determined according to the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient who accepts to study protocol
* Scheduled for shoulder surgery
* Between the ages of 18 and 80

Exclusion Criteria:

* Patients with coagulopathy
* Patients with a history of local anesthetic drug allergy and toxicity
* Patients with advanced organ failure
* Patients with mental retardation
* Patients with infection present at the injection site
* Patients with diaphragm paralysis
* Pregnant patients
Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

The goal of this prospective study is to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda.

ADUNU is a non-randomized experiment, testing a strategy for implementing an evidence-based practice, decentralized RHD preventive services.

The objectives of the study are to:

Objective 1: Demonstrate the impact of ADUNU, using the RE-AIM framework to assess program Reach, Effectiveness, Adoption, Implementation and Maintenance.

Objective 2: Estimate the cost-effectiveness and budget impact of ADUNU.

ADUNU is a public health initiative that will be deployed the Uganda ministry of health in partnership with the District Health Offices (DHO) in two districts. The program will be overseen by the Technical and Quality Assurance (TAQA). ADUNU's main components will include a RHD testing program which consists of community and facility based echocardiographic screening of children and young adults and a registry based secondary prophylaxis injections of Benzathine penicillin G (BPG) at local health centers III and IVs in both districts.

Eligibility Criteria:
Inclusion Criteria:

* residing in one of two involved districts in Uganda
* providers at HCIIIs and HCIVs located in one of two involved Ugandan districts

Exclusion Criteria:

* None
Phase I Combination w/ Epirubicin

Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years
* Histologically or cytologically confirmed diagnosis of metastatic breast cancer
* Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)

Exclusion Criteria:

* Number of prior chemotherapy lines of treatment in the metastatic setting ≥2
Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study

The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.

Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.

The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.

Methods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).

Eligibility Criteria:
Inclusion Criteria:

* All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.

Exclusion Criteria:

* umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.
Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.

Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.

The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age


Eligibility Criteria:
Inclusion Criteria:

* All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development

Exclusion Criteria:

* Preterm neonates
* Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
* Full term neonates with impaired renal functions.
The Relationship Between Oxygen Reserve Index and PaO2

Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve using oximetry sensor. In this study, the investigators evaluate the correlation between ORI and the partial pressure of arterial blood oxygen (PaO2) in children.


Eligibility Criteria:
Inclusion Criteria:

* Age below 7 years
* Written informed consent
* Undergoing cardiac surgery

Exclusion Criteria:

* Presence of cyanotic heart disease
Herpes Simplex Meningo Encephalitis Recurrence

study of risk factors and prognosis of herpes simplex encephalitis recurrence.


Eligibility Criteria:
Inclusion Criteria:

* documented herpes simplex recurrence

Exclusion Criteria:

* other cause
Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis

The investigators performed open-labeled pilot study which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.

After informed consent, causal allergen was injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. Initial dose of allergen was 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and 1:1/10 weight/volume for dog hair/dander, HollisterStier, New Orleans, USA) in volume of 0.1ml. After the first dose, allergen concentration was escalated 3-fold at second dose, and 10-fold at third dose if there was no or mild local or systemic hypersensitivity reaction. The allergen concentration did not change at second or third dose if there was moderate local or systemic reaction. The allergen concentration was decreased by 10 or 100-fold from previous concentration if there was severe local or systemic reaction.

The investigators evaluated parameters regarding allergic rhinitis within a week before the first injection and 4 months after the first injection. These parameters included Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20), and Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life. Skin prick test, intradermal test, blood sampling for serum allergen-specific IgE, exhaled nitric oxide, and nasal lavage for Th1, Th2, and Treg cytokines were also included. Adverse events were recorded and graded according to Muller's classification and Ring and Messmer's classification.

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis to house dust mite (Df, Dp), cat or dog
* More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST)

Exclusion Criteria:

* Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline
* FEV1 less than 50% of predicted value if there is comorbid asthma
* Subject rejects the enrollment into study
* Low compliance
* Pregnancy or lactation
* Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
* Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks
* Prior history of allergen-specific immunotherapy
* Allergic rhinitis caused by other perennial or seasonal allergen
* Vulnerable volunteer
Lifestyle in Pregnancy and Offspring

Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.


Eligibility Criteria:
Inclusion Criteria:

* children born to women who were part of the preceding LiP study and who completed the LiP study until birth. Inclusion criteria for the LiP study:
* singleton pregnant
* BMI \>/= 30 and \</= 45 E xclusion Criteria for preceding LiP study:
* Chronic diseases
* Not Danish speaking
* Abuse of alcohol or drugs
* Preterm delivery in earlier pregnancies
Neuro-modulation of the Depressed Brain Using Working Memory Training and Transcranial Direct Current Stimulation (tDCS)

The goal of this project is to train currently major depressed patients on fundamental aspects of working memory while the investigators administer transcranial Direct Current Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training sessions. This working memory training would be performed using adaptive Paced Auditory Serial Addition Tasks (PASAT). The effects after two weeks of working memory training combined with tDCS or sham placebo (10 sessions) will be measured on different variables, each measured at the start and at the end of the two weeks of training. The investigators expect the greatest anti depressant results and cognitive enhancements in the group of depressed patients that received tDCS combined with working memory training.


Eligibility Criteria:
Inclusion Criteria:

* Depressive Disorder, Major (SCID)
* HDRS-24 \> 21

Exclusion Criteria:

-Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.

Any axis II disorders.

* Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
* Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.