cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.

A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* all proven to have locoregional recurrence after curative treatment and unsuitability for further local treatment, distant metastases at presentation or acquired metastases after curative treatment. the presence of at least one measurable disease, which was defined as lesion that could be measured at least 20 mm in one dimension by conventional computed tomography (CT) or at least 10 mm by spiral CT scan; KPS≥70, and a life expectancy of at least 6 months.

Exclusion Criteria:

* other malignancy prior to study entry; bone-only metastasis;previous radiotherapy within 4 weeks; previous exposure to gemcitabine;patients with any active, non-controlled infection or other severe systemic diseases, such as congestive heart failure, angina pectoris, respiratory insufficiency and arrhythmia were all rejected at enrollment. Other exclusion criteria included concurrent treatment with other investigational drugs, hypersensitivity to platinum compounds,and current pregnancy or breastfeeding.
Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease with or without fluctuations
2. Indication for treatment with pramipexole (Mirapexin®)
3. Presence of at least mild tremor symptoms (as judged by the treating physician)

Exclusion Criteria:

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with pramipexole (Mirapexin®)
Building an Optimal Hand Hygiene Bundle

Hand hygiene is the single most effective practice in preventing the spread of hospital-acquired infections. Despite the strength of the evidence, hospital staff continue to sanitize their hands less than half of the time required by guidelines. Effective interventions are needed to improve hand hygiene compliance rates among hospital staff, but most are of poor quality and do not examine the specific effects of individual interventions. This study will build a "bundle" of three hand hygiene interventions using a research design that allows for the effectiveness of each intervention to be measured individually and combined.

The two specific aims and associated hypotheses of CREATE Project 2 include:

1. Identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene compliance and that could form an evidence-based hand-hygiene bundle for Veterans Health Administration (VHA) implementation.

   Hypothesis 1: Combinations of interventions will increase compliance rates more than single interventions.

   Aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder signs to serve as an environmental cue to action, individual hand sanitizers, and health care worker hand cultures - to identify an optimal combination of interventions to increase hand-hygiene compliance. The trial will be conducted in 59 hospital units in 10 VA hospitals in order to test the efficacy of individual and then sequentially added interventions to determine their incremental impact on hand-hygiene compliance.

   The focus for this clinical trial will be on Aim 1--Single Hand Hygiene Sign changes.
2. Identify institutional, organizational, ward/ICU, and individual level facilitators and barriers to implementing hand-hygiene interventions.

Hypothesis 2: Facilitators and barriers will pattern around contextual factors such as level of leadership support and organization of infection control programs.

Aim 2 will entail a qualitative process evaluation that includes site visits to purposefully selected sites, semi-structured interviews, and observations to examine barriers and facilitators to the interventions and develop contextual insight for implementing and scaling-up the intervention at additional sites as a national initiative.

Eligibility Criteria:
Inclusion Criteria:

* Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units

Exclusion Criteria:

None
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers

This study explores the safety, pharmacodynamics and pharmacokinetics of THN201 a combination of donepezil and mefloquine to improve cognitive function in healthy male volunteers after impairment by a scopolamine challenge.

This is a double-blind, 3-arm, parallel group study of 15 days duration including a scopolamine challenge at D15. Healthy male subjects will receive daily doses of THN201 (donepezil 5 mg and mefloquine), donepezil 5 mg or placebo and one subcutaneous injection of scopolamine 0.5 mg on D15. Cognitive function, EEG and P300 will be assessed at baseline and before and after scopolamine challenge at D15. A final safety evaluation will be performed 2 weeks after the end of the treatment period. Pharmacokinetic assessments will be performed to obtain a time/concentration profile of donepezil and mefloquine.

Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI), calculated as weight in kg/(height in m)², from 18 to 30 kg/m², inclusive
* Healthy as determined by the investigator after a comprehensive clinical assessment based on medical history, physical examination, clinical laboratory test results, vital sign measurements, blood pressure (BP), heart rate (HR) and digital 12-lead ECG readings (all results should be normal or, if out of range, they should be non-clinically significant as determined by the investigator)

Exclusion Criteria:

* Any significant cardiovascular (e.g. heart failure), pulmonary (including asthma), hepatic, renal, respiratory (e.g. asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidaemia), immunologic, dermatological, haematological, neurologic, psychiatric disease, history of any clinically important drug allergy, systemic or presence of infectious disease.
* Current suicide risk or history of suicide risk (C-SSRS baseline: "yes" answer to items 4 and/or 5).
* Brain imaging (MRI) at screening showing anatomical or vascular abnormality of any type.
* EEG examination at screening showing abnormal (epileptiform) activities.
* Symptomatic hypotension,
* Participants with, or with a history of cardiac arrhythmia or cardiac disease or a personal or family history of long QT syndrome or a family history of sudden death.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* Antimalarial medicine intake or returning from a malaria-endemic area within the 12 last months before the first IMP administration.
* Planning to visit a country requiring antimalarial chemoprophylaxis during the study period.
* History of adverse reaction after a previous mefloquine intake.
* Contraindication for the use of Aricept® or for one of its excipients.
* Contraindication for the use of piperidine derivative compounds or for other cholinesterase inhibitors.
* Contraindication for the use of Lariam® or for one of its excipients.
* Contraindication for the use of scopolamine S.C. injection.
* History or presence of drug or alcohol abuse (alcohol consumption \> 21 units / week).
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery

We aimed to assess the influence of progressive muscle relaxation exercise on kinesiophobia and pain during after lumbar disc surgery using the Visual Analog Scale (VAS) and the Tampa Kinesiophobia Scale in a prospective, randomized fashion.

Lumbar disc herniation (LDH) is a common disease that is common in the society and limits the activities of individuals in daily life. Pain, which is an undesirable but expected result of surgical interventions, which are used in the treatment of diseases and play an important role in increasing the health level of people, is one of the most common postoperative complaints. The pain is sometimes severe enough to impede movement and causes paravertebral muscle spasm. Pain can also cause kinesiophobia, which is a factor that limits the person's physical activities. This study was conducted to determine the effect of progressive muscle relaxation exercises on kinesiophobia, which can be seen in parallel with pain in the postoperative period, on the pain level of patients after LDH surgery and on the kinesiophobia experienced in parallel.

The following hypotheses (H) were tested in this study:

H1. Progressive muscle relaxation exercise has an effect on reducing pain after LDH surgery.

H2. Progressive muscle relaxation exercise has an effect on reducing kinesiophobia after LDH surgery.

Eligibility Criteria:
Inclusion Criteria:

* • The patients included in the study had lumbar microdiscectomy surgery,

  * Patients aged 18 and over
  * Patients should not have any problems that would prevent them from expressing their pain level correctly and from understanding the information given,
  * The patients do not have any psychological disorders,
  * The patients do not have any other acute disease that will cause pain.

Exclusion Criteria:

* • Being diagnosed with a psychiatric disorder,

  * A complication (bleeding, hospital infection, etc.) developed in the patients before, during and after the operation within three days,
  * Not knowing Turkish.
Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program

Purpose: The investigators wish to determine if a rehabilitation program for subjects with new, trans-tibial amputations that has the balance portion of the program augmented by the use of the Nintendo Wii fit ™ balance board improves their performance.

Hypothesis: The investigators hypothesize that subjects will benefit from the use of the device and that this will manifest as an improvement on outcome measures.

All subjects will be trained by the same specialist physiotherapist. Subjects will use the Wii Fit balance platform for a period of twenty minutes or greater per day (at the discretion of the specialist physiotherapist) during their standard rehabilitation program. These balance training exercises will be in addition to those already used in the standard rehabilitation program, but will not add to the total therapy session time. Activities on the device will be chosen by the therapist based on the subjects' current abilities and their phase of training. More complicated tasks will be given as the subject progresses. The therapist will intervene and provide instruction / correction if the subject is using unsafe technique or poor technique (postures, positioning strategies that would not be condoned in the regular training program).

The device is a stable, level platform 5.5 cm from the floor. Subjects stand on the device and may use gait aids if indicated.

Standard practice involves intensive training of the subject by the same specialist physiotherapist but without the use of the Wii Fit platform.

Eligibility Criteria:
Inclusion Criteria:

* Consented subjects with new, unilateral, transtibial amputations who are greater than 19 years of age

Exclusion Criteria:

* Subjects who have an open wound that limits their wearing of the prosthesis
The Influence of Oxytocin on Pair-bonding and Emotion Regulation

The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. In the present study, the investigators examine the effect of intranasal OXT on behavioral ratings of and neural responses to the male partner in female participants. In a second experiment, the modulatory effect of OXT on emotion regulation is investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* In a heterosexual relationship

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Pregnant or lactating
Observational Study on the Patient's Ability to Use a Digital Platform in Heart Failure

Heart Failure has a global prevalence of 1 to 3% in the adult population with an incidence of 1 to 20 cases per 1,000 people. Furthermore, HF is often associated with a number of comorbidities (anaemia, arrhythmias, depression, hyperuricemia, coronary heart disease etc.), which greatly deteriorates the patient's quality of life.

Despite the development of specific drugs, HF has a very high mortality rate, and it is the first cause of unscheduled income. An increase of 50% of these incomes is expected in the next 25 years.

In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.

This study focuses on studying the ability of heart failure patients with reduced ejection fraction (EF≤40%) to use a digital platform through an application installed on the patient's smartphone.

This is an observational, prospective, single-center study. The protocol and informed consent document have been reviewed and approved by the Ethical Committee and the study will be performed in accordance with the Declaration of Helsinki

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Informed Consent is obtained from the patient
* Patients diagnosed with heart failure with reduced ejection fraction (EF≤40%)
* Patients who extensively use a smartphone.

Exclusion Criteria:

* Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills.
* Patients with inability to give adequately the informed consent.
Validation of a New Device to Measure Neuromuscular Disease Progression

There is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in human subjects more efficiently. If we could more precisely measure whether an experimental drug slows the progression of ALS or other neuromuscular diseases, this would allow more drugs to be tested quicker and at less expense. We have developed a new device that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength (ATLIS). This device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data. This study will enable us to test the reliability and validity of ATLIS.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be at least 18 years old and able to provide informed consent
* All subjects have no health conditions that limit their ability to safely exert maximal force using the muscles in their arms and legs.
* Subjects with a diagnosis of laboratory supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial, as determined by their referring neurologist at MGH.
* All subjects must be able to speak and understand English.

Exclusion Criteria:

* Presence of significant arthritis, orthopedic conditions, or cardio-pulmonary conditions or other medical conditions that may limit the ability to maximally exert force safely.
Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration

this study compares 2 techniques in guided bone regeneration for horizontal ridge augmentation in aesthetic zone

Guided bone regeneration is a technique for ridge augmentation using membranes The membrane of GBR is an essential component of treatment as it has some important characteristics manageability, space-making ability, and adequate mechanical, physical properties, and biocompatibility Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects and achieve better wound healing and bone regeneration.

on the other hand, a Vascularized inter-positional periosteal connective tissue flap is a flap that has been used as a substitute for the collagen membrane with promising results. Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability.

So Evaluation of effect of vascularized interpositional periosteal connective tissue flap on horizontal ridge augmentation grafting of the anterior maxilla in comaprison with the collagen membranes

Eligibility Criteria:
Inclusion Criteria:

* Patients with a horizontal defect in anterior and premolar areas of the maxilla (aesthetic zone).

Exclusion Criteria:

* poor oral hygiene
* radiation therapy of head and neck cancer
* intraoral soft and hard tissue lesions
* Heavy smoking
* Bone pathology
Indocyanine Green and Portal Pressure in Viral and Alcoholic Cirrhotic Patients With Hepatocarcinoma

The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy.

The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.


Eligibility Criteria:
Inclusion Criteria:

* resectable or amenable to resection HCC in cirrhotic child A patients of alcoholic or viral etiology

Exclusion Criteria:

* cirrhosis Child-Pugh B
* absence of patient consent
* psychiatric pathology
Study to Evaluate the 'eNutri' Online Personalised Nutrition App in the United Kingdom (UK)

The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12.

The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Both groups will receive two prompts to remind them of their diet advice at weeks 4 and 8. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12. 98 participants will be recruited per study arm and will be randomly allocated to an intervention arm using a minimisation technique integrated with the eNutri app.

Eligibility Criteria:
Inclusion Criteria:

* Living in the UK
* Can understand written English

Exclusion Criteria:

* Food allergies or food intolerances (diagnosed or self-diagnosed)
* Receiving professional nutritional advice from a dietitian, nutritionist or medical professional
* Following a specialised diet (e.g. vegan, calorie-controlled/weight-loss diet)
* Athletes or those following a or sports nutrition regimen
* Pregnant, lactating or planning a pregnancy within the next 3 months
* Diagnosed medical conditions that require specific dietary guidance (e.g. diabetes, Crohn's disease or eating disorders), those who are currently undergoing rigorous medical treatment (e.g. chemotherapy for cancer) or conditions that affect memory (e.g. dementia)
* Medications that impact on diet (e.g. weight-loss medication) or involve dietary restrictions
* Those who eat less than 2 meals per day
* Excessive use of herbal or dietary supplements (e.g. 3 or more per day)
* Taking part in another nutrition study
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants

The primary purpose of this study is to demonstrate the bioequivalence (BE) of a single subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking, male or female, age greater than or equal to (\>=) 18 years and less than or equal to (\<=) 65 years at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
2. Body Mass Index \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening

Exclusion Criteria:

1. Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing
2. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
3. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent
4. Prior exposure to lecanemab, or any other anti-amyloid therapies
5. Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body \[mAb\]) treatment
Erector Spina Plane Block for Multilevel Major Spinal Surgery

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation

Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* Agreed to participate in the study

Exclusion Criteria:

* Patients with infection at the injection site
* Coagulopathy Allergy to amide-type local anesthetics
* History of peripheral neuropathy
* Hepatic and/or renal failure
* Refusing the procedure
* Patients with heart disease
* Patients who have previously undergone surgery from the same area