cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.

The present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (TTNS) in improving bladder emptying in multiple sclerosis (MS) patients.

Patients presenting with MS and performing clean intermittent self-catheterization (CISC) to empty the bladder in the context of voiding dysfunction, will be eligible.

Included patients will be randomly assigned to two distinct arms

* PTNS de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks.
* PTNS placebo : Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group).

Efficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of multiple sclerosis
* Patient with bladder-sphincter dyssinergia
* Patient using clean intermittent self-catheterization as exclusive bladder management
* Patient who has given written consent
* Socially insured patient
* Patient willing to comply with all study procedures and study duration

Exclusion Criteria:

* Patient with other associated neurological pathology
* Patient with an Expanded Disability Status Scale (EDSS) score ≥ 6
* Patient with recurrent urinary tract infections (\> 3 episodes / year)
* Patient with uncontrolled overactive bladder
* Patient with uncontrolled detrusor hyperactivity
* Patient with a bladder compliance disorder
* Patient with tibial neuro-stimulation in the last 3 months
* Patient treated with a sacral neuro-modulation
* Patient who has received an intradermal injection of botulinum toxin A within the last 9 -months Patient who received alpha-blocker treatment within the last month Patient with benign prostatic hypertrophy (prostate volume \> 40 cc) - Last ultrasound scan \< 6 months.

Patient with one or more bladder diverticulum(s) Patient with unilateral or bilateral renal Patient with unilateral or bilateral vesico-ureteral reflux Patient with impaired renal function (GFR according to CKD-EPI \< 60 ml/min/1.73m2) Patient with a metallic prosthesis on the lower limb Patient with a Pacemaker Pregnant patient
Investigation of the Effects of Temporal Adaptation Approach in Post-Discharge Stroke Individuals

Abstract Introduction: Stroke is a disease that makes it difficult to participate in daily life activities by creating functional losses. Healthy temporal adaptation can increase and support engagement in meaningful activities. This study aims to analyze the effect of the temporal adaptation approach on the post-discharge occupational engagement of individuals with stroke.

Methods: This study is a randomized controlled trial with 1 month follow-up. While the TAA approach was applied to the first group, the general condition of the second group was followed during the study. Canadian Occupational Performance Measue was administered to assess occupational performance and satisfaction, and Occupational Balance Questionnaire was for occupational balance.

Kewords: Time, stroke, rehabilitation, human activities, participation


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria used for this study are as follows: being in the chronic phase of the stroke disease (˃6 months) and score of ˃26 on the Montreal Cognitive Assessment (MoCA).

Exclusion Criteria:

* Exclusion criteria used are as follows: diagnosis of a psychiatric illness strongly affects the participation to daily life activities according to medical reports (such as schizophrenia or bipolar disorder), a physical condition other than stroke that requires medical follow-up (fracture, osteoporosis, etc.) and aphasia that would affect the intervention via interview
A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness.
* History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
* Body mass index is 18 and 40 kg/m\^2, inclusive.
* If currently taking an antipsychotic, is able to discontinue it's use at least 5 days prior to study start and the duration of the study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
* Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
* History of cancer (malignancy).
* Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
* History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
* Substance-induced psychotic disorder or behavioral disturbance.
* DSM-5 TR defined substance use disorder within 3 months of screening.
* History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
* Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
* Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
* Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention.
Bilateral Dual TAP Block: Description of a Novel Four-point Approach

A prospective study of 30 patients with severe postoperative pain following abdominal surgery, in which the dual TAP block technique has been used successfully to achieve pain relief. A description of ultrasound technique, effectiveness, duration and potential side effects of the pain treatment, with possible recommendations for future use.

This prospective cohort study is designed to describe a novel ultrasound-guided bilateral dual transversus abdominis plane (BD-TAP) block and to evaluate the postoperative analgesic efficacy in a selection of patients having undergone major abdominal surgery under general anaesthesia where neuraxial anaesthesia and/or intravenous administration of analgesics had failed or was unwanted by the patient, or if the placement of an epidural catheter was deemed impossible by the anaesthetist in charge. 30 consecutive patients planned for the study. BD-TAP to be performed bilaterally with a high frequency linear ultrasound probe, with bupivacaine. Success rate, decline in VAS score, postoperative demand of opioids and block performance time to be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pain VAS \>5 following abdominal surgery, in which conventional pain treatment or epidural block is either ineffective or contraindicated

Exclusion Criteria:

* Hypersensitivity to local anaesthetics
Immediate Implant Placement With or Without Buccal Bone Dehiscence

Immediate implant placement has been advantageous in terms of reduced treatment time and fewer surgical interventions. Given the fact that the level of buccal bone acts as a major prognostic factor for IIP, the indications for immediate implant placement were suggested to be limited to intact alveolar sockets.In recent years, many attempts have been performed to compensate for the alveolar ridge resorption in immediate implant placement in compromised sockets. The clinical outcomes of IIP with guided tissue regeneration and connective tissue grafting using papilla preservation technique in compromised extraction sockets has not been previously reported.


Eligibility Criteria:
Inclusion Criteria:

* patients with anterior failing teeth (from cainine to cainine) with the presence of neighbouring teeth
* sufficient bone volume to achieve primary stability at implant insertion

Exclusion Criteria:

* with uncontrolled periodontitis
* heavy smoker (\>10 cigarettes/day)
* unwilling to sign the informed consent
Pediatric Continuity Care Intensivist

This study will implement and evaluate the effects of a pediatric continuity care intensivist program. This study will determine the impact of an additional pediatric intensive care unit (PICU) intensivist on outcomes at the patient and family level. It will also evaluate the training program to prepare the continuity care intensivist (CCI).

This randomized controlled trial will implement and evaluate the effects of a pediatric continuity care intensivist (CCI) program. The study will evaluate how effective the modified communication training for providers is to perform this new role. The primary outcome for the study is whether a CCI will affect several patient level outcomes for patients who have been admitted to the PICU longer than 7 days. Patient length of stay, hospital acquired conditions, time to limitations of interventions and new medical technology will be assessed comparing the intervention and usual care arms. The study will also determine the impact of the CCI program on parent/family satisfaction with provider communication and decision-making for their child.

Eligibility Criteria:
Inclusion Criteria:

CCI Provider

1. Pediatric Intensive Care Unit Attending Physician who volunteers to serve in the role of CCI.

Usual Care (UC) Provider

1. Any Pediatric Intensive Care Unit Attending Physician who is not enrolled as a CCI.

Parent-Patient Dyads

1. Parent/guardian of a child who has been admitted to the Children's Hospital of Philadelphia (CHOP) PICU for ≥7 days after onset of the study
2. Parent/guardian ≥ 18 years old
3. Parent/guardian is English-speaking
4. Child \<18 years old at time of enrollment
5. Child has been admitted to the PICU at CHOP for ≥7 days
6. Medical team believed that patient will remain in the PICU for at least another seven days

Exclusion Criteria:

CCI Provider

1. Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)

UC Provider

1. Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)
2. Attending physician who is enrolled in the study as a CCI

Parent-Patient Dyads

1. Parent or guardian who has previously participated in the CCI study in a previous hospitalization (in either usual care or intervention arm)
2. Parent or guardian of a child who has already been hospitalized in the PICU \>7 days at the onset of the study.
3. Child ≥18 years of age at time of enrollment
4. Child has previously participated in the CCI study in a previous PICU stay (in either usual care or intervention arm)
5. Child has been hospitalized in the PICU \>7 days at the onset of the study
6. Child already has a "primary" attending
7. Child has a sibling that has already been enrolled in the study. This child will be ineligible for the study but will be assigned to the same care as the child who is or was enrolled in the study.
8. If contact was not established for enrollment by 14 days after admission, then the patient was no longer considered eligible for enrollment to maintain comparability of length of stay at enrollment.
Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia

This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.

To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia

Eligibility Criteria:
Inclusion Criteria:

* Each subject must:

  1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
  2. Be able and willing to follow all instructions and attend all study visits;
  3. Be 45-75 years of age of either sex and any race or ethnicity;
  4. Be presbyopic in both eyes;

Exclusion Criteria:

* Each subject must not:

  1. Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;
  2. Have any active systemic or ocular disorder other than refractive disorder;
  3. Have prior, current or anticipated use of any contact lenses during study participation;
  4. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;
  5. Have anticipated inability to stay confined on required study days;
Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy

The goal of this study is to investigate the effect of telerehabilitation in patients with rotator cuff tendinopathy. The main questions it aims to answer are:

* Is telerehabilitation effective in improving the functional status of patients with rotator cuff tendinopathy?
* Is telerehabilitation effective in reducing the pain of rotator cuff patients?

Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be included in the study. Patients will be divided into two groups. Patients in group 1 will be given a home exercise program. Then, the patients will be called 3 times a week and it will be evaluated whether they do their exercises regularly and whether they do it correctly. At the end of the first month, the patients will be evaluated again for functionality and pain.

The patients in group 2 will be given a home exercise program and at the end of the first month, the patients will be evaluated again in terms of functionality and pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rotator cuff tendinopathy
* Being able to do the prescribed exercises
* Having an access to internet and having a computer or smart phone for telerehabilitation

Exclusion Criteria:

* Patients with a neurological disease that may affect the effectiveness of exercise
* History of fracture in shoulder region
* History of surgery in shoulder region
* Patients with a psychiatric disorder
Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious

Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.

Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<32 weeks and \<1500 g
* Echocardiographic evidence of hemodynamically significant patent ductus arterious

Exclusion Criteria:

* Major congenital anomalies
* Intraventricular hemorrhage of grade 3 within the previous 24 hours
* Serum creatinine level 1.5 mg%,serum urea nitrogen concentration \>50 mg%,
* Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites)
* Hyperbilirubinemia necessitating exchange transfusion
Frailty in the Perioperative Period

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. In this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 100 patients are being included for 3 months. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery in our hospital and its association with postoperative mortality.

The presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. This is a prospective observational study in which an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery, including 100 patients for 3 months. The main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery and its association with postoperative mortality. The secondary objectives were the following: to assess the association between frailty and increased days of hospital stay, hospital readmission, and unexpected admission to ICU areas; to assess whether patients with greater frailty suffer a greater loss of postoperative functional independence; to evaluate type and frequency of complications; and to evaluate which scale is most useful to implement in the perioperative setting (Edmonton frailty test, Barthel Index, Mini-mental test, Charlson Index).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old undergoing urgent or scheduled surgery for three months.

Exclusion Criteria:

* Language barrier
* Cognitive impairment or inability to assist in clinical assessment during the study
* Refusal to participate in the study
COVID-19 and Lactating Mothers

The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.


Eligibility Criteria:
Inclusion Criteria:

* Currently lactating mother:

  * English-speaking
  * greater than or equal to 18 years of age
  * Assigned female at birth (AFAB)
  * Having a positive COVID-19 test within 14 days
* Child:

  * Infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. Infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included

Exclusion Criteria:

* Non-English speaking
Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery

To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)

The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or Older
* Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.

Exclusion Criteria:

* Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months
* Previous Corneal surgery or pathology
* Active or history of chronic or recurrent inflammatory eye disease in either eye
* Ocular Pain in either eye
* Proliferative diabetic retinopathy in either eye
* Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye.
* Laser or incisional ocular surgery during the study period and 6 months prior in either eye
* Systemic concomitant pain medication management with the pharmacology class of Oxycodone
* Systemic NSAIDS use \>/=750 mg daily
* Clinically significant macular edema
* History of cystoid macular edema in either eye
Homeopathic Treatment of Premenstrual Syndrome

The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire.

The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.

Premenstrual syndrome (PMS) is a set of physical, emotional and behavioral symptoms that occur during the week preceding menstruation and which alleviate when the menstrual flow begins. PMS affects millions of women during their reproductive years. Mild symptoms, which usually do not interfere with daily activities, are experienced occasionally by almost all ovulatory women. Between 8-30% of ovulatory women suffer from moderate to severe PMS symptoms, which may even require treatment. The more severe form of PMS, premenstrual dysphoric disorder is considered to affect up to 8% of ovulatory women. This severe form is associated with severe disruptions in work function, family, or social relationships. To date, therapeutic interventions are insufficient and ranges from stress reduction and lifestyle changing to hormonal therapies and the use of psychotropic medications. While traditional medications do not necessarily offer satisfactory alleviation of PMS symptoms homeopathy can offer a significant alleviation of PMS symptoms for an extended period of time.

The proposed study will focus on PMS symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire.

Five Homeopathic remedies (Natrum muriaticum, Lachesis, Sepia, Nux vomica and Pulsatilla ) will be used, in five different therapy groups. The women will be allocated to the groups according to their matching to the remedy according to Homeopathic principles. In each group the women will either be treated with the appropriate remedy or with a placebo remedy. Women who do not match any of these five groups will be allocated to a sixth group receiving either Folliculinum that is given as general indication for PMS in homeopathy or placebo.

The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire at (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years.
* Suffers from the PMS, confirmed by the DRSP questionnaire, for at least one year
* Read and write in
* Signing the informed consent form

Exclusion Criteria:

* Comorbidity.
* Use of medications.
* Menstruation complains which do not correlate to the menstruation cycle.
* Inability to be in a daily contact with the experiment center (e.g., by phone, electronically).
* Participating in another clinical trial in the last 30 days.