cyrilzakka/clinical-trials huggingface dataset:
Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study

The purpose of this study was to construct a Stigma intervention program for college students with Irritable Bowel Syndrome (IBS) based on the Acceptance and Commitment Therapy (ACT) theory and to investigate the effectiveness in reducing stigma in IBS patients with the aim of enhancing their mental health and improving their quality of life.

Using purposive sampling method, 84 college students with irritable bowel syndrome (IBS) accompanied by a sense of shame who met the inclusion and exclusion criteria from June 2023 to January 2024 in a comprehensive university in Yangzhou City were selected for the study. Using the method of random grouping, the patients who met the inclusion and exclusion criteria were numbered and randomly divided into the control group and the intervention group by computer random number procedure. Because individual patients fell out during the study, the final sample size for inclusion in the study was 80 cases, with 40 cases in each group. The control group was given conventional health education on irritable bowel syndrome, and the intervention group was given a 6-week acceptance and commitment therapy-based intervention programme for college students with irritable bowel syndrome based on stigma, with a 6-week intervention period and a 3-month follow-up period. The ANOVA of repeated measures data was used to analyse the trends in the Stigma, Psychological flexibility (PF), Self-acceptance (SA) and Quality of Life (QOL) score trends over time to assess the effects of the intervention. A single-blind method was used in this study, and only the outcomes assessor was blinded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with IBS who meet the Rome IV diagnostic criteria;
* Duration of IBS disease≥0.5 years;
* The Perceived Stigma Scale in IBS (PSS-IBS) total score≥80;
* Patients can proficiently use WeChat and participate in remote follow-ups;
* Understand the research content, participate voluntarily and sign the informed consent.

Exclusion Criteria:

* Patients with other intestinal diseases or serious primary diseases;
* Patients with comorbid psychiatric diseases;
* Patients who engaged in psychological workers or received psychological counseling within 3 months;
* Patients who have recently participated in or are currently participating in other similar studies.
Stability Plus - Outcomes From Extended Continuum of Care

Basic Protocol

1. Identify participant(s)
2. Request patient participation/Acquire Consent
3. Register patient at www.stabilityplus.net through the LOGIN tab

   * Patient ID (Name/Initials/SSN or any combination thereof)
   * Gender
   * Age
   * Surgical Procedure
   * Date of Surgery
   * Select Basic Exercise Program that corresponds with Surgical Procedure
4. Perform Initial Assessment using Basic Exercises for the Surgical Procedure
5. Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)
6. Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient
7. Monitor patient progress through Stability Plus portal.


Eligibility Criteria:
Inclusion Criteria:

* Undergone total joint replacement
* Must be able to complete pre-operative strength assessment
* Must be able to exercise using specified resistive bands

Exclusion Criteria:

* Non-ambulatory patients
An Evaluation of the Safety and Performance of the CathVision Cube® System

The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.

Patients undergoing assessment and ablation of cardiac arrhythmias, by Electro Physiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision Cube® System in parallel with a commercial (CE marked) EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.

Eligibility Criteria:
Inclusion Criteria:

* Patient indicated by investigator for catheter ablation or diagnostic electrophysiology procedure.
* Male or non-pregnant female aged ≥18 years. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
* Able and willing to directly provide informed consent.

Exclusion Criteria:

* Patient inability to understand or refusal to sign informed consent.
* Pregnant or nursing patients and those who plan pregnancy in the period up to 1 month following the index procedure.
* Current participation in another investigational drug or device study that interferes with this study.
* Patient is a prisoner.
* Patients who in the opinion of the physician are not candidates for this study. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD
* DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.

Exclusion Criteria:

* Other significant neurological disorder
* History of dementia
* Prior history of stereotactic neurosurgery
* Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
* Pregnant women
Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation

Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent
* 18 years or older
* English speaking
* Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration

Exclusion Criteria:

* Fails to consent
* \< 18 years old
* Hypertonic therapy not indicated
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.


Eligibility Criteria:
Inclusion Criteria:

* Femoral neck fracture
* Fracture due to low energy trauma
* Ability to understand danish and give informed consent
* Ability to walk before trauma
* Indication for osteosynthesis
* ≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
* Informed consent

Exclusion Criteria:

* Drug or medical abuse
* Drug intolerance
* Pathological fractures
* Inflammatory arthritis
* Patient included in the study with the contralateral hip
Cocaine/Crack and Reduction of Compulsion With Biperiden

Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.

Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.

Eligibility Criteria:
Inclusion Criteria:

* Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

Exclusion Criteria:

* Being under treatment with psychoactive drugs
* Have been diagnosed for other Psychiatric Disorders
* Have dependence diagnosis for other drugs, except for tabacco
Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages

Subarachnoid hemorrhage (SAH) is a rare and serious form of stroke, mainly linked to the rupture of an intracranial aneurysm responsible for bleeding into the meningeal spaces.

The main late serious complication is delayed cerebral ischemia (DCI), resulting in the appearance of new neurological deficits.

Prevention of ICR involves in particular maintaining euvolemia, and early treatment of hyponatremia, itself dependent on the level of volume.

Evaluation of water status and sodium balance is therefore essential. This assessment is complicated and relies on indirect parameters, both clinical and biological.

Impedancemetry, making it possible to measure water volumes and sodium load, could be an aid in the management of blood volume and sodium intake.


Eligibility Criteria:
Inclusion Criteria:

* Adult man, woman
* Hospitalized following Subarachnoid Hemorrhage within 72 hours of bleeding
* Admitted to the neurological intensive care unit for less than 48 hours
* Being able to understand the ins and outs of the study
* Having expressed his non-opposition

Exclusion Criteria:

* Patients under legal protection
* Pregnancy
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).


Eligibility Criteria:
Inclusion Criteria:

* Status post sleeve gastrectomy or roux-en-y gastric bypass
* At 6 months after bariatric surgery, has not achieved \>= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (\>=120% of 95th%ile or BMI \>=35kg/m2 for 12-17yo; BMI \>=35kg/m2 for 18-24yo)

Exclusion Criteria:

* Absolute contraindication to phentermine or topiramate (i.e. phentermine:

history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)

* Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
* Use of anti-obesity medication within 6 months of screening
* Initiation of a new medication associated with weight loss or gain within 30 days of screening
* Type 2 diabetes mellitus
* Hypothalamic obesity
* Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety
* History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening
* History of schizophrenia
* Severe hepatic impairment (ALT \>10x upper limit of normal or known synthetic liver dysfunction)
* Moderate or severe renal impairment (GFR \<30mL/min/1.73m2)
* Dosage change to hypertension, dyslipidemia, depression, or anxiety medication \<4 weeks prior to study enrollment
* Contraception started \<7 days prior to study enrollment
* Current pregnancy/plans to become pregnant within 16 weeks from study drug start date
* Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control
Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients

There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).

Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.

Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.

The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II \& III.
* Normal respiratory functions or mild lung disease.

Exclusion Criteria:

* BMI more than 40.
* Moderate to severe obstructive pulmonary disease (FEV1 \< 80% of predicted).
* Moderate to severe restrictive pulmonary disease (TLC \< 70% of predicted).
* Severe pulmonary hypertension (mean PAP\>55).
* Previous lung surgery.
* Decompensated cardiac disease (NYHA 3 or 4).
* Patients who received invasive mechanical ventilation within the last 30 days before surgery.
The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed Analysis

To study the morphology of the peri-implant defects using cone-beam computed tomography based on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss + inflammatory clinical parameters)

Diagnosis of peri-implantitis requires:

* Presence of bleeding and/or suppuration on gentle probing.
* Increased probing depth compared to previous examinations.
* Presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling.

In the absence of previous examination data diagnosis of peri-implantitis can be based on the combination of:

* Presence of bleeding and/or suppuration on gentle probing.
* Probing depths of ≥6 mm.
* Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.

Nowadays, several radiographic techniques are available to investigate the peri-implant bone morphology by two-dimensional radiographs such as panoramic radiography and intraoral radiography, or three-dimensional techniques such as computer tomography and cone beam computer tomography (CBCT) (Harris et al. 2012). CBCT provides high-contrast 3D visualization of bone beds; however, artifacts caused by the metallic character of implants could disguise information around implants. The diagnostic outcomes of CBCT imaging of peri-implant bone loss have been related to the type of study and defect morphology (Pelekos et al., 2018). The ex vivo studies (cadaver models), considering sensitivity and specificity reported good values for both circumferential and infrabony defects but lower for dehiscences (de-Azevedo-Vaz et al., 2013, Kamburoglu et al., 2013). Contrastingly, CBCT imaging for defect analysis in animal studies showed positive correlation with histology but tend to overestimate (Fienitz et al., 2012, Golubovic et al., 2012) or underestimate (Corpas Ldos et al., 2011, Ritter et al., 2014) the size of the defect. This variability in the measurement is mainly dependent on the different configuration, location or size of the defect. and also by the scattering, beam hardening artifacts, energy settings, exposure time, field of view.

Hence, it is aimed at assessing the morphology of the peri-implant defects using CBCT

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 80 years of age
* Partial/complete edentulism missing one or more teeth and having it restored with implant-supported prosthesis
* No antibiotic in the last 2 months previous to examination
* \>3 year after prosthesis delivery

Exclusion Criteria:

* Uncontrolled systemic disease
* Cemented-retained restorations
* Patients with uncontrolled/active periodontal disease in need of periodontal treatment
* Pregnant patients
* Zygomatic implants
* Implants placed in regenerated/augmented bone
* Patients taking medications known to modify bone metabolism or known to have degenerative diseases of bone (hyperparathyroidism, osteoporosis), vitamin D, patients who had taken antibiotics, NSAIDS or corticosteroids for more than two weeks in the past 3 months before examination
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

This is an open-label, single dose study in healthy male subjects.

A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.

On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:

* greater than 90% of the administered radioactivity has been recovered, and
* less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces

Eligibility Criteria:
Inclusion Criteria

Subjects must meet criteria to be included in this study, including but not limited to the following:

1. Healthy male 18 - 55 years, inclusive, at the time of informed consent
2. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
3. Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.
4. Provide written informed consent
5. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

1. Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
2. Exposure to clinically significant radiation within 12 months prior to Day -2.
3. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
4. Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
5. Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
6. Hypersensitivity to the study drugs or any of their excipients
7. Known to be human immunodeficiency virus (HIV) positive

Restrictions will apply on prior and concomitant medications, food and beverages
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).

A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF. Data for this outcome will be examined every six months and at the end of 2 years of study. Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (UPr/Cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (GFR).

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 7-70 years old
* Renal biopsy, diagnostic for IgA nephropathy
* Must be able to take oral medication

Exclusion Criteria:

* Clinical and histologic evidence of systemic lupus erythematosus
* Well-documented history of Henoch-Schonlein purpura.
* Clinical evidence of cirrhosis or chronic liver disease
* Abnormal laboratory values at the time of study entry
* Estimated GFR outside of protocol defined limits
* History of significant gastrointestinal disorder
* Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
* Other major organ system disease or malignancy
* Current or prior treatment with MMF or azathioprine