cyrilzakka/clinical-trials huggingface dataset:
Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles

The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.

Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.

Eligibility Criteria:
Inclusion Criteria:

* males and females age 18 or older.

Exclusion Criteria:

* Previous treatment with a neuromodulator in the last 6 months
* previous brow lift
* currently pregnant or breastfeeding
* a history of neurological disease or deficit
* an active facial skin infection
* an allergy to neuromodulators
Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation

The pilot study was performed to evaluate the usability, credibility and expectancy of an intelligent, activity-based client-centred training system (i-ACT), and the motivation towards its use in neurological rehabilitation over a short period of time.

A mixed-method study was performed in four rehabilitation centres in Belgium. An homogenous convenience sample was recruited among persons with central nervous system disorders.

Participants received 3 x 45 minutes of training with the i-ACT system during six weeks, additional to conventional care. The Canadian Occupational Performance Measure (COPM) was used to collect and evaluate patients' individual goals towards rehabilitation. These goals were discussed with the therapists before implementing movements and exercises for each patient in the i-ACT system.

The following demographic data were obtained from the medical files: age, gender, and diagnosis. Outcomes measures were collected at baseline (T0), after 2 (T1), 4 (T2) and 6 (T3) weeks of training and at 9 weeks follow-up (T4).

The primary outcome measures were the Intrinsic Motivation Inventory (IMI), the System Usability Scale (SUS), Credibility/Expectancy Questionnaire (CEQ), the Canadian Occupational Performance Measure (COPM), and Wolf Motor Function Test (WMFT). The secondary measures were the Manual Ability Measure-36 (MAM-36), Modified Fatigue Impact Scale (MFIS), Trunk Impairment Scale (TIS), and Active Range of Motion (AROM).

After final training with i-ACT, a semi-structured interview was performed to gather more information about the participants' perception towards i-ACT.

For quantitative data, within-group differences of all the assessments were analysed using Friedman's ANOVA and Wilcoxon signed-rank test. Alpha was set at 0.05; No Bonferroni correction was applied as it is not compulsory in an exploratory study and furthermore, results are regarded as hypothesis for further investigations.

The qualitative data was collected and recorded with a voice recorder. No specific analysis was used as the interview collected data to support or oppose the findings of the quantitative data.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* a medical diagnosis of central nervous system disease
* dysfunction in upper limb and/or core stability
* Persons with multiple sclerosis (MS) had to be free of treatment with corticosteroids for one month.
* Persons with stroke or spinal cord injury, had to be at least three months post injury.

Exclusion Criteria:

* severe spasticity (when spasticity impedes movement)
* severe cognitive impairment (person is not able to understand and follow instructions)
* severe communicative impairment (person is not able to answer questions)
* severe visual impairment (person is not able to see the television screen)
* persons who use an electric wheelchair
Confounding Factors of Impedance Pneumography

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.


Eligibility Criteria:
Group 1: (children referred to sleep study for clinical reasons) Inclusion criteria:

* Age 1-7 years, both sexes
* Referred to polysomnography
* Signed informed consent

Group 2: (healthy children) Inclusion criteria:

* 2-7 years, both sexes
* Healthy at the time of inclusion based on history and clinical examination according to the investigator judgement
* Lung function in the reference range
* Signed informed consent

Exclusion Criteria:

* Preterm birth with chronic respiratory disorder of prematurity
* Significant nasal congestion or adenotonsillar hypertrophy with signs and symptoms of sleep apnea or sleep disordered breathing
* Chronic rhinosinusitis, synonasal polyposis
* Personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
* Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
* Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
* Hospital-treated for bronchiolitis with residual symptoms
* Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
* Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
* Implanted or external active medical devices
* Long lasting respiratory events during the polysomnography study like continuous upper airway limitation
Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease

To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies

We aim to know the prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain and the usefulness of advanced endoscopy (chromoendoscopy) for the diagnosis and endoscopic differential diagnosis of N-IBD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC or colitis EC corroborated by clinical and histology
* involvement of at least one third of the colon in patients with CD
* involvement proximal to the rectum in patients with UC
* Duration of disease \> 10 years
* No clinical activity:
* May Score \<6
* CDEIS \<3.5

Exclusion Criteria:

* Personal history of CRC
* colectomy
* coagulopathy
* refusal to participate in the study
* known allergy to indigo carmine
* colonoscopy in the last 6 months
What Are the Clinical Factors Associated With a Significant Pain Reduction Following Physiotherapy in Patients With Temporomandibular Disorders?

RATIONALE OF THE OBSERVATION STUDY:

This study aims to observe which patients with temporomandibular disorder improve more following a physiotherapy program of four sessions. Knowing the characteristics of patients who have the most significant improvements could help clinician advise or advise against physiotherapy for the treatment of temporomandibular disorders.

STUDY PROCEDURES The study will be conducted at the Istituto Stomatologico Italiano. Patients diagnosed with Temporomandibular Disorder will be recruited in the gnathological and neuromuscular gnathological departments. The physiotherapists of the Craniomandibular Physiotherapy Service will perform physiotherapy therapy, which consists of four physiotherapy sessions \[lasting 30 minutes, about once a week\] over a month. Before starting the treatment, participants will be asked to answer some questions concerning their state of health (e.g. pain intensity) with particular reference to Temporomandibular Disorder (e.g. location and duration of pain). The intensity of pain and the level of function will then be monitored at baseline, after 4 weeks and after 8 weeks from baseline.

EXPECTED BENEFITS FROM THE STUDY AND EXPECTED BENEFITS FOR THE PATIENT The benefits are the discovery of new knowledge in the field of therapeutic choice for patients with temporomandibular disorder.

Additional information:

In this study protocol, the variables reported in the section "Other Pre-specified Outcomes" are the predictors that will be included in the prediction model.

The total "Enrollment" is 180 participants (100 for the development phase and 80 for the validation phase).

Eligibility Criteria:
Inclusion Criteria:

* (1) adults aged ≥18 years;
* (2) TMD diagnosis according to the Axis I of the Diagnostic Criteria for TMDs (DC/TMD) (Shiffman et al., 2014);
* (3) no therapeutic interventions reported (for their TMD) in the past six months (Wahlund et al., 2015);
* (4) capacity to use and understand written and verbal Italian language;
* (5) mental capacity to provide informed consent.

Exclusion Criteria:

* (1) TMD pain related to rheumatoid/inflammatory arthritis;
* (2) any physical or mental condition that could potentially influence the study;
* (3) they commence another treatment for their TMD (pharmacology, oral appliance, others) throughout the duration of the study.
The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia

The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* heart problems
* coronary artery disease
* hypertension
* respiratory problems
* musculoskeletal problems that prevent prolonged standing or sitting
* obesity
* susceptibility to fainting
Multicenter Comparison of Interictal HFO as a Predictor of Seizure Freedom

In drug-resistant focal epilepsy, interictal high frequency oscillations (HFO) recorded from intracranial EEG (iEEG) may provide clinical information for delineating epileptogenic brain tissue. The iEEG electrode contacts that contain HFO are hypothesized to delineate the epileptogenic zone; their resection should then lead to postsurgical seizure freedom.

We test whether our prospective definition of clinically relevant HFO is in agreement with postsurgical seizure outcome. The algorithm is fully automated and is equally applied to all datasets. The aim is to assess the reliability of the proposed detector and analysis approach.

We use an automated data-independent prospective definition of clinically relevant HFO that has been validated in data from two independent epilepsy centers. In this study, we combine retrospectively collected datasets from 9 independent epilepsy centers. The analysis is blinded to clinical outcome. We use iEEG recordings during NREM sleep with a minimum of 12 epochs of 5 minutes of NREM sleep. We automatically detect HFO in the ripple (80-250 Hz) and in the fast ripple (250-500 Hz) band. There is no manual rejection of events in this fully automated algorithm. The type of HFO that we consider clinically relevant is defined as the simultaneous occurrence of a fast-ripple and a ripple. We calculate the temporal consistency of each patient's HFO rates over several data epochs within and between nights. Patients with temporal consistency \< 50% are excluded from further analysis. We determine whether all electrode contacts with high HFO rate are included in the resection volume and whether seizure freedom (ILAE 1) was achieved at ≥2 y follow-up.

Applying a previously validated algorithm to a large cohort from several independent epilepsy centers may advance the clinical relevance and the generalizability of HFO analysis as essential next step for use of HFO in clinical practice.

Eligibility Criteria:
Data as provided from the participating center
Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery

This study is to evaluate whether the administration of ultrasound-guided paravertebral block (PVB) after surgery would produce better postoperative pain control and fast postoperative recovery after Robotic cardiac surgery. Half of participants will receive PVB before surgery, while the other half will receive PVB at the end of surgery.

Ultrasound-guided PVB (either before surgery, or after surgery) is the standard postoperative pain management for Robotic cardiac surgery. This technique is to inject local anesthetic (numb medication) around nerve to decrease pain. But the optimal time of PVB is unknown.

The administration of PVB before surgery can help pain control during the surgery and after surgery. But the duration of PVB could be reduced because surgery itself can last 5-6 hrs.

The PVB after surgery will not provide pain control during surgery, but may provide longer pain control after surgery, and may help participants faster recovery after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 yrs
2. ASA I-IV
3. Either gender

Exclusion Criteria:

1. Refusal to participate in the study
2. Age\< 18 yrs
3. Contraindications to regional blockage including but not limited to:

   1. Patient refusal to regional blockade
   2. Infection at the site of needle insertion
   3. Systemic infection
   4. Bleeding diathesis or coagulopathy
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting.

This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting.

The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Eligibility Criteria:
Inclusion Criteria:

All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy for their unresectable HCC.

-

Exclusion Criteria:

-
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 40 and less than 80 years
2. Clinical suspicion or history of prostate cancer reflected by one of the following:

   * PSA \> 4ng/ml
   * Abnormal DRE exam
   * Known tissue diagnosis of prostate cancer from prior workup
3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment

Exclusion Criteria:

1. Inability to undergo MRI scan
2. Inability to receive IV contrast as per institutional protocol.
High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures

Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.

Background: Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.

Patients and Methods: A retrospective study. One hundred patients with high type fistula in ano treated surgically in Al-Sader Medical city and Al-Najaf daily private clinic, Najaf city, Iraq from Feb 2018 to March 2019. Fistulography and magnetic resonance imaging have taken from all patients. After that, fistulectomy with loose, thick Seton suture placed for three months. Patients with the persistence of high fistula tract underwent a second surgery and third operation until complete healing.

Eligibility Criteria:
Inclusion Criteria:

* High type fistula in ano Recurrent high type fistula in ano Non abscess cases

Exclusion Criteria:

Low type fistula in ano below 16 years old

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Effects of Vitamin D Supplementation on Antimycobacterial Immunity

The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Hyperparathyroidism
* Sarcoidosis
* Renal failure
* HIV infection
Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes

The main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of the study is to establish normal HyperQ values in these populations and compare HyperQ values of age-matched athletic vs. non-athletic individuals of similar health status.


Eligibility Criteria:
Inclusion Criteria:

* An asymptomatic, apparently healthy patient performing a maximal exercise stress test

Exclusion Criteria:

* Contraindications for an exercise test
* Wolff-Parkinson-White (pre-excitation) syndrome
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin
* Pacemaker
* Pregnancy or suspected pregnancy
* QRS duration\>120ms or other conduction delays
Intensive Viral Dynamics Substudy of A5248

The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective. The main study will estimate the viral load decay rate in treatment-naive HIV-infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

This substudy of A5248 will similarly examine the characteristics of decrease in viral load but will focus on estimating the time at which first-phase viral decay starts, following initiation of the study drugs.

Recent data suggest that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In the main study, the viral load decay rate will be estimated in HIV-infected, treatment-naive participants receiving RAL and FTC/TDF.

The A5248 study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.

A5248 will consist of 16 study visits. These visits will occur at study entry; Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.

This substudy will enroll 10 participants from A5248. It is critical that substudy participants take their medications as directed to ensure accurate trial results. Any participant who discontinues study treatment will also be removed from the substudy and replaced. Participants will be asked about medication holds and adherence.

No medications will be provided by the substudy. Study treatment will be provided and administered as per the main study, A5248. After participants begin study medications, samples will be collected for the substudy. Participants will be required to stay overnight and in the hospital from Day 0 until Day 2. The morning study medication dose will be administered in the clinic on Days, 2, 3, 4, and 7.

Medication diaries will be provided for participants on Day 2. Participants will be instructed to record the times they take their study medications through Day 7 of the study. Participants are required to bring these diaries to their study visits on Days 3, 4, and 7 for review.

Participants may discontinue their enrollment in this substudy and still remain in the main study, A5248. Participants may not discontinue their involvement in A5248 and remain in the substudy.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in A5248
* Willing and able to provide informed consent