cyrilzakka/clinical-trials huggingface dataset:
Deep Brain Stimulation for Patients With Dementia With Lewy Bodies

This trial aims to collect pilot data to explore whether bilateral deep brain stimulation (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking impairments among individuals with Dementia with Lewy Bodies (DLB).

We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving cognitive deficits in DLB patients. Six patients with DLB with moderate cognitive impairments (including but not restricted to deficits in attention and working memory) will have bilateral DBS electrodes implanted to ensure that superficial contacts lie in the motor Globus Pallidum interna (GPi) target, while the deepest electrical contacts lie in the NBM. We will place electrodes using our conventional image-guided, stereotactic frame-based procedure. Once the surgical wounds have healed, patients will be randomised into 2 groups in a crossover trial design to have 6 week periods of NBM stimulation switched on or switched off separated by a 2 week washout period, following which the patient will cross over to have the opposite condition for a further 6 weeks. Outcome measures collected at the 6 weeks and 14 weeks timepoints will be compared according to whether each patient was ON or OFF stimulation at that timepoint.

At the end of the crossover period, all patients will be invited for continued follow up with stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients will be given the option of receiving additional conventional stimulation to the motor GPi, through the higher contacts of each electrode, at the end of the crossover period if required for any coexisting Parkinsonian motor complications of DLB.

Eligibility Criteria:
Inclusion Criteria:

* DLB Consortium Criteria for diagnosis
* Score between 2 \& 12 on Clinician Assessment of Fluctuations scale
* MMSE score between 21 and 27
* Appropriate Surgical candidates in terms of general health
* Aged between 50 \& 80
* Able to give Informed consent
* Living at home with Carer
* Able to comply with protocol
* On stable dosage of cholinesterase inhibitor

Exclusion Criteria:

* Diagnosis of other cause for dementia
* Abnormality on brain imaging considered likely to compromise compliance with trial protocol.
* Prior intracerebral surgical intervention
Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis

Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure.

This study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated by micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the principle of the resonance frequency analysis at the 10th postoperative week during the osseointegration of dental implants (secondary stability).

The cortical alveolar bone is a recognized factor in the phase of primary stability of osseointegration. The role of trabecular bone in the secondary stability is not clearly determined.

The aim of this study is to check whether the trabecular bone with its microarchitecture plays a predictive role in osseointegration of dental implants precisely in its biological stability phase or its secondary stability phase.

If this correlation is established, a larger study must be conducted to identify a profile of patients at risk for failure of osseointegration of the dental implant.

Eligibility Criteria:
Inclusion Criteria:

* affiliated patient or entitled to a social security scheme
* requiring the installation of one or more dental implants
* partial or total loss teeth, the height and width od the alveolar bone does not require bone grafting or guides regeneration

Exclusion Criteria:

* patient who underwent pre-implant surgery (bone grafting, elevation of the maxillary sinus, guided regeneration)
* patient under corticosteroid therapy in the long term
* patient who benefited from the head and neck radiotherapy
* patient under bisphosphonates intravenously treatment
* all cases immediate implantation and extraction of all implant put into immediate expenses
Sub-dissociative Dose Ketamine Dosing Study

Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.

Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.

Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-59
* Weight 45 - 115 kg
* Acute abdominal, flank, back, musculoskeletal pain, or a headache
* Onset of pain within 7 days
* Pain score of 5 or more
* Requiring intravenous analgesia
* Hasn't been enrolled in this study previously

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Altered mental status rendering the patient unable to consent to the study
* Allergy to ketamine
* Unstable vital signs (systolic blood pressure \<90 or \>180 mm Hg, pulse rate \<50 or \>150 beats/minute, and respiration rate \<10 or \>30 breaths/minute)
* History of acute head or eye injury, seizure, intracranial hypertension
* Chronic pain
* Renal or hepatic insufficiency
* Known alcohol or drug use disorder
* Currently under influence of alcohol/opiates
* Acute psychiatric illness
Long-term Prognosis in Stroke Patients

A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.

This is a single-center cohort of consecutive patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university in Republic of Korea.

Stroke recurrence, Cardiovascular event, all cause mortality and cardiovascular mortality were collected through long-term follow up.

Eligibility Criteria:
Inclusion Criteria:

* All patients with acute ischemic stroke or transient ischemic attack

Exclusion Criteria:

* A patient who did not agree with enrollment of this study
AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male
* The subject is at least 18 years of age
* The subject has an estimated life expectancy of more than 5 years
* The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
* The subject has intrinsic sphincter deficiency due to one of the following:

post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date

* Positive Cough Stress Test (CST):
* Positive 24-hours Pad Test (PT):

A positive PT is confirmed with leakage of \>8.O g/24h and \< 400 g

* The subject has completed urodynamics, uroflow, post-void residual, and cystoscopy as per the protocol within 6 months prior to implant
* The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol
* The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics commit-tee of the respective site

Exclusion Criteria:

* Subjects who meet any of the following criteria are excluded from entry into the study
* The subject is unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements according to the study protocol
* The subject has an active urogenital infection or active skin infection in region of surgery
* The subject has serious bleeding disorders
* The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
* The subject had a previous implant to treat stress urinary incontinence
* The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
* The subject is likely to undergo radiation therapy within the next 6 months
* The subject has active urethral or bladder neck stricture disease, requiring continued treatment
* The subject has urge predominant incontinence
* The subject has an atonic bladder or a postvoid residual (PVR) ≥150mL
* The subject has a condition or disorder likely to require future transurethral procedure
* The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors'approval
* Subjects who in the opinion of the investigator are unable and/or unlikely to to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum

This study evaluates the KONTAKT social skills group training in Australian adolescents on the autism spectrum compared to an active control group which is a group cooking class

KONTAKT is a manualized Social Skills Group Training program designed for children and adolescents with ASD which aims to improve communication, social interaction skills, reduce the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting. A large randomized controlled trial in Sweden found that adolescents who participated in KONTAKT demonstrated improvements in social skills, behaviour, reduced stress and improved overall functioning as reported by parents immediately following and at three months after the program. However, social skills are at least in part influenced by social cultural contexts and there is a need to understand the feasibility, acceptability and effectiveness of KONTAKT in an Australian context. Moreover, in the previous studies, the social skills groups were compared to treatment as usual groups. Therefore, this study evaluates the KONTAKT social skills group training in Australian adolescents on the autism spectrum compared to an active control group which is a group cooking class

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 12 to 17
* Clinical consensus diagnosis of ASD as defined by DSM-5 and confirmed by the Autism Diagnostic Observation schedule-2
* IQ scores \> 70 as measured by the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)

Exclusion Criteria:

* Existing prior comorbid externalizing behaviours as assessed by the Childhood Behaviour Checklist (CBCL).
* Clinically assessed self-injurious behaviour
* Low intrinsic motivation to participate in a social skills training group
* Insufficient English language skills
Intestinal Failure in Necrotising Enterocolitis

Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis.

The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with abdominal signs suspected of NEC
* All neonates admitted to the NICU of the Maastricht University Medical Center between July 2007 and July 2008

Exclusion Criteria:

* No written informed consent of both parents
A Study of Exercise Therapy in People With Solid Tumor Cancer

The purpose of this study is to find out whether exercise therapy is an effective and safe treatment that causes few or mild side effects when done before standard surgery for solid tumor cancer. The researchers will also study whether the program is feasible (practical) by tracking how well participants follow the program.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer.
* Age ≥18 years.
* An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance.
* Measurable disease based on standard of care radiology scans or confirmation by the surgeon.
* Body weight ≤ 385 lbs (≤ 174 kg)
* Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey.
* Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist.
* Willingness to comply with all study-related procedures

Exclusion Criteria:

* Distant metastases.
* Receiving any form of antitumor therapy.
* Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes.
* Any other diagnosis of invasive cancer currently requiring active treatment.
* Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
Treatment of Hyperpyrexia and in the Pediatric Emergency Department (FEVER_ED)

Fever represents the main cause of admission to the emergency room in older people pediatric. It occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). The drugs currently indicated for the management of fever in children are: paracetamol and ibuprofen. There are no recent studies conducted in pediatric population, who have demonstrated the greater effectiveness of therapy with paracetamol or ibuprofen, The objective of our study is, therefore, to identify which therapy is most appropriate for controlling body temperature e of associated symptoms in pediatric patients arriving in the emergency room with fever.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (aged between 6 months 0 and 20 years)
* fever (T \&gt; 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
* who have expressed their consent to participate in the study.

Exclusion Criteria:

* age \&lt;6 months or \&gt;20 years;
* patients who did not express consent to participate in the study
Follow-up in Gynecological Cancer Survivors

A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment

The objective of this study is to identify physical and psychosocial problems and needs after treatment for gynecological cancer.

1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.

Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 76 Quality of Life questions, at one single time point.

Descriptive analyses will be conducted to characterize the collected data. Multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. Logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. Exploratory factor analysis will be used to explore the factor structure of the various PROMs to identify issue clustering.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven gynecological cancer (cervical, endometrial, ovarian (including fallopian tube and peritoneal primary), vulva).
* FIGO stage I-IV before completion of primary therapy.
* Disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, CA 125 (ovarian cancer), or radiological imaging techniques).
* At least 6 months but no more than 5 years since completion of primary treatment.
* Performance status 0, 1 or 2 (WHO scale).
* Age ≥ 18 years.
* Ability to understand and fill out questionnaires.
* Written informed consent according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Other cancer diagnosis in the past 5 years.
* Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
* Any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Rad-67 Repeatability and Reproducibility

The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Weight at least 110 pounds
* Subjects with the intention of being screened for eligibility to donate blood
* The subject has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects unwilling to remove nail polish or acrylic nails
* Subjects with blood cancers such as leukemia
* Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
* Subjects with self-disclosed/known pregnancy at the time of enrollment
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty

Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a femoral nerve block as part of their anesthetic care. Some centers administer the block with a single shot of local anesthetic, which wears off several hours after surgery. Other centers administer the block with a single shot followed by continuous infusion of local anesthetic, typically for 2 to 5 days after surgery. The latter method, though good for pain control, may result in decreased mobility (while the anesthetic is still active), longer hospital stays, and greater risk of falls.

This study will see if using a lower concentration of local anesthetic for the continuous femoral nerve block or only the initial single-shot dose will result in increased mobility and shorter hospital stays.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I-III
2. 18-85 years of age, inclusive
3. Able to communicate in English sufficiently to participate in the study
4. Able to walk 30 metres without stopping prior to surgery

Exclusion Criteria:

1. Intended discharge to in-patient rehabilitation facility
2. Patient refusal of FNB or spinal anesthetic or sciatic nerve block
3. Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, refusal)
4. Significant peripheral neuropathy or neurological disorder affecting the lower extremity
5. Contraindication to a component of multi-modal analgesia
6. Pregnancy
7. History of use of over 30mg oxycodone or equivalent per day (institutional threshold for acute pain service consultation pre-operatively)
8. History of significant cognitive or psychiatric condition that may affect patient assessment
9. Inability to provide informed consent
Surgical and Obstetric Outcomes in Patients with Uterine Malformations Undergoing Hysteroscopic Corrective Treatment

The goal of this observational cohort study is to learn if hysteroscopic correction can improve reproductive outcomes in women with uterine malformations. The main questions it aims to answer are:

Primary hypothesis:

-Does hysteroscopic correction significantly improve pregnancy rates at 12 months post-surgery in women with uterine malformations?

Secondary hypotheses:

* Does hysteroscopic correction significantly reduce the rate of first and second-trimester spontaneous abortions?
* Does hysteroscopic correction significantly increase the live birth rate?
* In symptomatic patients, does hysteroscopic correction significantly reduce dyspareunia and dysmenorrhea?
* Which patient, histopathological, and surgical factors are associated with improved obstetric outcomes?

Researchers will compare obstetric outcomes (pregnancy rate, spontaneous abortion rate, live birth rate, and symptom severity) before and after hysteroscopic correction to determine the effectiveness of this surgical intervention.

Participants will be women with uterine malformations who underwent hysteroscopic correction at the Digital Hysteroscopy Center of Policlinico Universitario A. Gemelli di Roma and Azienda Ospedaliera Universitaria Federico II di Napoli. Data will be retrospectively collected and analyzed to assess the impact of surgery on reproductive outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent hysteroscopy at the Class Hysteroscopy Center of Policlinico Universitario A. Gemelli di Roma or Azienda Ospedaliera Universitaria Federico II di Napoli for the correction of uterine malformations, including partial, complete, and septate bicornuate uteri, dysmorphic uteri, with or without associated cervical and/or vaginal septa (ESHRE-ESGE classification: U1a and U1c; U2a, U2b, and U3c with or without associated cervical or vaginal anomalies C1/2 or V1/2).
* Age 18 years or older.

Exclusion Criteria:

* Patients with known, concurrent causes of infertility.
* Patients who did not provide informed consent to participate in the study.
* Age younger than 18 years.