cyrilzakka/clinical-trials huggingface dataset:
Study of tDCS for Mild Cognitive Impairment

The primary objective of this study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)

Twenty-four patients were recruited and randomized to receive either real- or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. The patients were evaluated at baseline and at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a subjective memory impairment
* Subjects who have Korean version of Mini Mental Status Examination score 22 or more
* Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
* Subjects who have had other cognitive impairments besides memory
* Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
* Subjects who are not dementia of Alzheimer's type
* Subjects who are right-handed
* Subjects who are able to read and write
* Subject or legally responsible caregiver has provided informed consent

Exclusion Criteria:

* Subjects who have a history of stroke and seizures
* Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a treatment ischemic attack.
* Subjects who have neurologic problems on physical examination that cuase memory disturbances
* Subjects who have a history of DSM-IV Axis I disorders
* Subjects who have extremely sensitive skin
* Subjects who have suffered from the cancer in 3 years
* Subjects who have had a cerebrovascular neurosurgery in medical history
* Subjects who have dyspnea in sitting position
* Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack.
* Subjects who have a history of drug or alcohol abuse (in the past 5 years)
* Subjects who have a history of mental or emotional disorders (in the past 5 years)
* Subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia
* Subjects who have a history of hospitalization due to head injury
* Subjects who are unable to read even with glasses
* Subject who are unable to understand the conversation due to the hearing defect (even with the hearing aid)
Non-Invasive Assessment of Graft Fibrosis After Living Donor Liver Transplantation

The aim of this study is to compare prospectively the ability of MRE and Transient Elastography in detection and staging of allograft fibrosis in comparison to Liver biopsy in patients who underwent Living Donor Liver Transplantation for complications related to HCV.

The study included Patients transplanted for HCV related disease diagnosed by positive serum PCR (HCV RNA) and liver biopsy with elevated liver enzymes and/orhyperbilirubinemia with Normal Abdominal Doppler ultrasound and MRCP.Other aetiology for liver disease as indication for transplantation and other causes of post-transplant abnormal liver profile as Post transplant biliary stricture or vascular liver diseases (if unresolved) were excluded from the study. Patients with active CMV infection(proved by positive CMV PCR or positive inclusion bodies by histopathology) were also excluded. All patients were subjected toFull history taking and thorough clinical examination, Laboratory investigations including CBC, Liver profile tests, Albumin, Bilirubin (Total and Direct), ALP(Alkaline phosphatase), AST(Aspartate aminotransferase), ALT (Alanine aminotransferase), INR (International Normalization Ratio),HCV RNA quantitative,CMV PCR, AST/ platelet ratio, Alpha feto-protein and fibro alpha score

Eligibility Criteria:
Inclusion Criteria:

* Adult recipients who are candidate for LDLT due to HCV related ESLD and meeting the transplantation criteria of the Ain Shams Center of Organ Transplantation (Child Pugh score ≥ 7and MELD score ≥15).

Exclusion Criteria:

* Adult recipients who underwent LDLT due to other causes rather than HCV. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery Acquired immunodeficiency syndrome (AIDS) Malignancy outside of the liver not meeting oncologic criteria for cure Hepatocellular carcinoma with metastatic spread Anatomic abnormalities that preclude liver transplantation Uncontrolled sepsis Acute liver failure with a sustained intracranial pressure \>50 mmHg or a cerebral perfusion pressure \<40 mmH Persistent non adherence with medical care and Lack of adequate social support Advanced age older than 65y.
Injection Therapy for Neuropathic Pain

Shoulder, neck, back and temporal pain and herpes zoster pain are neuropathic pain. Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can relieve neuropathic pain. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.

In this study, the recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20) of bovine testicular sperm acrosomes were used to cleave macromolecular HA. Regardless of the cutting time, the HA fragment HA35, with an average molecular weight of 35 kDa, was produced (Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase is often used to improve the penetration and absorption of other injectable drugs. Hyaluronidase injection is also used off label to degrade excessive components used in cosmetic injections, such as cross-linked macromolecular HA fillers (https://www.realself.com/news/hyaluronidase-dissolve-fillers). In this study, HA35 was prepared by mixing hyaluronidase extracted from bovine testis (hyaluronidase for injection, H31022111) and HA (sodium hyaluronate for injection, H20174089) at room temperature for 20 minutes. The analgesic effect of HA35 on herpes zoster and shoulder, neck, back, and temporal pain was studied. This was a single-arm, open-label prospective clinical study in which patients were evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* The course of neck, back and temporal pain ranged from 0 to 8 months.
* The course of herpes zoster of 0-2 months.
* Adults aged 18-60 years.
* Be willing and capable of giving informed consent.
* Have a clinical diagnosis of neuropathic pain as determined by a multidisciplinary study team.
* Subject must sign the informed consent in person prior to beginning any screening procedure.

Exclusion Criteria:

* Have a persistent pain resulted from other medical conditions or unknown causes.
* Pregnant females.
* Be concomitantly participating in another clinical study.
* Have been immunocompromised.
The Effectiveness of Lay Health Advisors Strategy Intervention on Aborigines Elderly Oral Care Education

In the present study, the investigators aimed to evaluate the effectiveness of community-based oral exercise with LHA intervention on the oral health-related quality of life, oral function and oral self-care behaviors. This randomized controlled trial included LHA group (EG) and leaflet group (CG), respectively. The EG received a four-week one-on-one session by an LHA. Baseline and follow-up data collection were used to collect the data in oral Self-care behaviors, oral hygiene, oral function and quality of life.

A randomized controlled trial (RCT) was conducted. The participants recruited from aboriginal communities in Eastern Taiwan. Data collecting time was from 2019 to 2020. Participants from the identified communities were randomly assigned to EG or CG using random table. Participants who were 55 years old or above and indigenous people were recruited in the study. Participants who were disability, have had oral cancer, impaired facial appearance and impaired cognitive function were excluded. Impaired cognitive function was screening by Short Portable Mental Status Questionnaire (SPMSQ). Participants were recruited according to the predetermined minimal sample size estimated based on a type I error = 0.05, power = 0.95, and effect size (ES) f = 0.25 (medium effect in Cohen's f) . The number of samples in each group was expected 66 participants. An additional 30% drop out rate was added. The final number of samples for each group were required at least 86 participants. The total sample size was 122 and 118 in EG and CG, respectively. All participants underwent data collection at baseline and at 2-week, 3-and 6-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* 55 years old or above and indigenous people

Exclusion Criteria:

* Disability, have had oral cancer, impaired facial appearance and impaired cognitive function were excluded.

Impaired cognitive function was screening by Short Portable Mental Status Questionnaire (SPMSQ).
Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation \[SFLP\]) in patients with severe twin to twin transfusion syndrome.

We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity

Eligibility Criteria:
Inclusion Criteria:

* Both twins are alive
* TTTS diagnosed prior to 22 weeks gestation
* Monochorionic diamniotic gestation
* Like sex twins
* Single placental mass
* Thin intertwin membrane
* Oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm)
* Polyhydramnios with deepest vertical pocket of \> 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of \> 6 cm if previous amnioreduction)
* Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present
* No associated structural abnormalities
* No sonographic evidence of CNS injury at time of entry
* No preterm labor
* No maternal medical contraindication to anesthesia or surgery

Exclusion Criteria:

* Failure to meet all inclusion criteria
* TTTS presenting after 22 weeks gestation
* Randomization after 24 weeks gestation
* Cervical length \< 2.0 cm post initial
* Presence of cervical cerclage
* Uterine anomaly
* Refusal to accept randomization
* Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions
* Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution
Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

This is a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.

The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020

In the field of soft tissue sarcomas, Gastrointestinal Stromal Tumors (GIST) represents a really peculiar neoplasm for its biological and clinical properties. Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological adjuvant treatment is reserved to those with a relevant risk of recurrence/progression.

After tumor removal, clinical and radiological follow-up is of central importance to early intercept recurrence and to evaluate the most correct subsequent therapeutic approach. In particular, for the group of patients with GIST at very-low and low risk of recurrence/progression, the evidences to support a specific follow-up program and its features are poor.

On the basis of the aforementioned considerations, we propose a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.

The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020

Eligibility Criteria:
Inclusion Criteria:

* \>18 years at diagnosis
* primary GIST removed by surgery or endoscopic procedures
* availability of medical data needed for the study
* very-low and low risk GIST defined as:

  * largest size of \< 3 cm (for all sites of origin)
  * gastric GIST with ≤ 5/50 High Power Fields (HPF) mitoses and ≤ 10 cm in the largest size
  * gastric GIST with \> 5/50 HPF mitoses and ≤ 5 cm in the largest size
  * intestinal GIST with ≤ 5/50 HPF mitoses and ≤ 5 cm in the largest size

Exclusion Criteria:

* Metastases at diagnosis.
* Previous treatment with imatinib
Escalating, Constant and Reduction Energy Output in SWL for Renal Stones

Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal and ureteral calculus disease. In vitro studies suggest that progressive increase in lithotripter energy output voltage could produce the best overall stone comminution in comparison with constant or deescalating energy output. However, it is possible that the beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked any marginal benefits for energy output escalation. The Escalating SW method adds the benefit of less renal tissue injury.

Research Significance:The present study will signifies and evaluates the stone free rates of three groups of patients with renal stones treated with different SWL energy outputs (Escalating, Constant and Reduction energy output).

Research Objectives: The aim of this research project is to study the effect of dose adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and to optimize the conditions for successful Shock Wave Lithotripsy.

Research Methodology: This clinical trial will be conducted at a tertiary care university hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant dose). Parameter of the three groups will be compared to detect the treatment difference.

Escalating SW amplitude treatment protocols have been shown to be safe on long-term with less harm to kidney tissue. This clinical trial will be conducted at a tertiary care university hospital. All patients referred to the SWL unit will be evaluated for eligibility to be randomized. Randomization process "complete" or "unrestricted" randomization was used to allocate patients to the three arms of the clinical trial where one patient was randomly assigned to one of the three arms blindly.

Eligibility Criteria:
Inclusion Criteria:

* Single stone
* Radio opaque
* Less than 2cm in size
* Renal stone

Exclusion Criteria:

* bleeding disorder,
* urinary tract infection (UTI)
* distal ureteric obstruction
Fecal Microbiota Transplantation for Epilepsy

Increasing evidences showed the microbiota effects on neuropsychiatric disorders. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation for epilepsy.

Very few literatures reported the clinical use of microbiota or bacteria for brain diseases. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (FMT). This study aims to evaluate the efficacy and safety of FMT for epilepsy. Patients were diagnosed as epilepsy by electroencephalogram (EEG) and MRI and clinical data when the study began and thent received repeated FMT with fecal from healthy donors.The antiepileptic medication regimen of patients remained unchanged after FMT. The primary outcome measure was the frequency of the seizures. Secondary outcome measure were the 50% response rate.

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Eligibility Criteria:
Inclusion Criteria:

had been diagnosed with epilepsy for at least three months; experienced at least one seizure during the three months before WMT ;

Exclusion Criteria:

had other severe diseases, including other intestinal disorders (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure or serious liver or kidney disease, had undergone previous FMT or WMT, had taken antibiotics within three months before starting WMT
Exercise Videos - Perspectives of People Living With Chronic Pain

Exercise videos on the internet are used by millions worldwide to provide structure and motivation. They can guide exercise execution and play a role in helping people to maintain regular exercise.

On completion of the Pain Management Programme (PMP) at the Walton Centre, many patients are measurably more able bodied as a result (or at least part of a result) of regular engagement in exercise. Despite these positive outcomes and the patients stated intent to continue with exercise, many patients are struggling to maintain exercise in a meaningful way when re-assessed at their six month follow up appointment.

Patients have expressed that videos of the exercises would have motivated them to engage in sustained regular exercise in a more meaningful manner.

As physiotherapists, the investigators would like to ask a sample of patients on the PMP whether they anticipate exercise videos, reflecting the exercises practised on the PMP, would be beneficial for them to support maintenance/ sustainability of PMP exercises. Exercises practiced on the PMP include stretches, repeated movements in sitting, standing and lying, Pilates, yoga, normalised/functional movements and patients may like these exercises included in the videos.

The investigators plan to approach this using two focus groups followed by a qualitative analysis of recorded transcripts of the group discussions. Data would be analysed using a thematic analysis to establish key themes related to the research questions. The information gathered will inform the value of and content / format of specifically developed exercise videos.

The outcome of this project will inform the investigators of the use of exercise videos in this patient population and the value of this in encouraging people to keep up exercise over a sustained period. Other centres working with patients with chronic pain may be able to learn valuable lessons from this project in informing their own exercise promotion materials for their patients.


Eligibility Criteria:
Inclusion Criteria:

* Have attended a PMP at the Walton Centre within the last 12 months
* Aged 18+
* Able to provide written informed consent in English

Exclusion Criteria:

* Have not attended a PMP at the Walton Centre, or have attended \>12 months ago
Neuromuscular Control in Knee Osteoarthritis

Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA) the most common form. The lifetime risk of developing symptomatic KOA by the age of 85 years is 44.7%, where females are at a greater risk (1.8 times) than male counter parts. KOA is the leading cause of limitations in activities of daily living such as walking and climbing stairs particularly in the elderly. This is primarily due to pain and instability of the joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage. Patients with KOA have larger variations in muscle strength and are unable to maintain a target force combined with impaired ability to perceive joint movement and positioning suggests impaired neuromuscular control (NC) may influence KOA. NC refers to the nervous system's control over muscle activation contributing to task performance. This study aims to establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.


Eligibility Criteria:
Inclusion Criteria:

Knee osteoarthritis participants only:

* Knee Osteoarthritis confirmed by a physician using the American College of Rheumatology (ACR 1986) Criteria
* Have unilateral or bilateral knee osteoarthritis
* Aged 40 years or over.

Healthy control participants only:

* Have no history of unilateral/bilateral knee osteoarthritis
* Had no current chronic/stable knee pain in the past 3 months
* Aged 40 years or over.

Exclusion Criteria:

All participants are excluded if they:

* Have neuromuscular skeletal injury/illness (e.g.Multiple Sclerosis, Parkinson's disease, Muscular Dystrophy, Cerebral Palsy)
* Have had knee surgery, knee arthroplastic surgery and arthroscopic debridement or corrective surgery for knee osteoarthritis in the past 12 months
* Have had corticosteroid injections to or around the knee in the past 3 months.
* Have unstable heart disease
* Previously had a stroke
* Have insulin-dependent diabetes
* Have osteoporosis
* Have a history of falls and other motor deficits
* Are unable to walk up and down stairs
* Are unable to rise from a chair without the aid of another person
* Have an unstable medication schedule and medication that causes dizziness
* Have Dementia/Alzheimer's/ an inability to comprehend, follow instructions and give informed consent
* Have an inability to lie flat for 60 minutes Have mental in their body.
SonR Based Stimulation-VECtor OPTimisation in CRT Patients

The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive measurements are intended to evaluate hemodynamic differences between the different stimulation configurations using the Finapres® method.


Eligibility Criteria:
Inclusion Criteria:

* Indication for CRT-D implantation according to guidelines at the time of implantation
* Implanted CRT-D system with SonR sensor technology
* Sinus rhythm
* NYHA class II-IV
* Age ≥ 18 years
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients having received a CRT system without SonR sensor technology
* Patients with an insufficient SonR signal
* Confirmed pregnancy
* Age \< 18 years
* Life expectancy \< 1 year
* Atrial fibrillation / atrial flutter at the time of enrollment
* Unability to give informed consent
* Participation in another clinical study with active therapeutic arm
* Regular follow-up at the study site from enrolment to 12 months follow up not guaranteed