cyrilzakka/clinical-trials huggingface dataset:
Comparison of Self and Clinician Administered Rating Scales in Patients With ADHD

The primary objective is to establish the concurrent validity of the clinician administered Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD
* Age 13-65\* \*Parental consent and patient's assent will be obtained for minors participating in this protocol (only adolescents aged 13-18 yrs old will be included in the MGH site)

Exclusion Criteria:

* Inability to reliably report ADHD symptoms at the discretion of the investigator
The Effect of a Protein Hydrolysate on Muscle Strength Recovery

Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused by the bodies' lack of ability to recover between training. In addition, during high intensity training reactive oxygen species are formed up to 20 fold compared to resting values. This causes increased muscle tissue damage after intense exercise, which slows down recovery. Improving recovery may increase an athlete's ability to reach higher training volumes resulting in establishing a higher performance plateau.

It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate may have positive effects on strength recovery.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (based on their medical history provided during a general health questionnaire)
* Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in \>6 hours of intense physical activity per week).
* Age 18 - 35
* Experience in resistance training

Exclusion Criteria:

* Use of creatine supplements and/or anabolic steroids.
* Allergy to test product/protein
* Allergy to specific protein hydrolysate
* BMI lower than 18 or higher than 30.
* Lack of technique in correctly performing a barbell squat (judged by sports physiologist).
* Recent muscle injury in legs or back less than one month before the start of the study.
* Cardiovascular complications
* Use of medication
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
* Abuse of products; alcohol (\> 20 alcoholic units per week) and drugs
Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S).

Objectives: Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S).

Design and subjects: Pragmatic, individual randomized controlled trial in 664 daily smokers proactively recruited in smoking hotspots in Hong Kong.

Interventions: Subjects in the Intervention group will receive face-to-face brief advice (including SC services referral) using AWARD model and 1-week free NRT sample (NRT-S) at baseline; and 12-week personalized behavioral support using interactive communication technologies (include regular tailored messages on abstinence, and synchronous IM Apps \[e.g. WhatsApp\] conversation with trained SC advisors and a Chatbot). Subjects in the Control group will receive the same AWARD advice without NRT-S at baseline, and regular short-message-service messages on general health and reminders to participate in follow-up.

Main outcome measures: Primary outcomes are carbon monoxide validated smoking abstinence at 6-month and 12-month. Secondary outcomes include self-reported past 7-day abstinence, smoking reduction, quit attempt, SC services use, NRT use, self-efficacy on quitting and quality of life.

Data analysis: Intention-to-treat and cost-effectiveness analyses will be conducted. Mediation analyses will explore the underlying mechanisms of Chatbot and IM Apps behavioral support to promote quitting. Individual interviews with quitters and non-quitters, and content analysis of Chatbot/IM Apps will be conducted to have in-depth understanding on the effects of intervention on various outcomes.

Expected results: The Intervention group will have statistically significant higher validated smoking abstinence rates than the Control group at 6-month and 12-month.

Eligibility Criteria:
Inclusion Criteria:

1. Adult smokers aged 18+ years who smoke cigarette(s) daily.
2. Exhaled carbon monoxide (CO) level of ≥ 4ppm.
3. Having smartphones and willing to install IM Apps and a Chatbot.
4. Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

Exclusion Criteria:

1. Smokers who have psychiatric/psychological diseases/on regular psychotropic medications.
2. Smokers who are using SC medication, NRT, other SC services or projects.
3. Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant \<6 months) or breastfeeding.
Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus (T2DM)
* Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or
* Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and \< 10.0%

Exclusion Criteria:

* Type 1 diabetes mellitus,
* Secondary diabetes mellitus, or
* Gestational diabetes mellitus
Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance

An intervention study on the effect of dietary guidance with focus on implementing recommended food texture, at the department of Eating and Swallowing difficulties, Region Midtjylland, Denmark.

Energy- and protein intake, Weightloss, Bodymass composition, Fluid balance and Activities of Daily Living (ADL), will be measured by Bioimpedance spectroscopy, interviews and a questionnaire.

It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone to weightloss due to insufficient energy- and protein intake, and a reduction in ADL.

ADL will in this project have its focus on the eating situation.

The projects research questions are:

* Will dietary guidance with texture implementation increase energy intake in patients being examined on an outpatient basis for dysphagia, based on the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) recommendation?
* Can a dietetic guidance with texture implementation increase quality of life and ADL in patients with dysphagia?

Recruitment and data collection will take place at Hammel Neurocenter, DK.

Each patient will be included for eight weeks, after their first FEES examination. The participants will be randomized to control or intervention, and strata into three groups based on Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) 1, 2-3 and 4.

Within the eight weeks, participants have to show up three times to measurements, interviews and questionnaire, in addition to this, the intervention groups will have three follow-up phone meetings.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent form
* Newly refered patients to FEES examination
* Score 1-4 on FEDSS-scale
* Consumes 50% energy or more orally
* Consumes less energy than calculated energy need (Harris-Benedict)
* Individuals of full legal capacity
* Individuals above 18 of years
* That the patient is capable of executing examinations

Exclusion Criteria:

* Individuals with known eating disorders
* Ineligible individuals
* Individual in need of translator
* Individuals participating in another trial
Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living

This single-arm pilot study will evaluate the effects of an intervention to reduce exposure to unnecessary or potentially harmful medications among residents with dementia living in an assisted living facility. The goal of the intervention is to safely deprescribe medications (defined by dose reductions and stopped medications), based on a combination of clinical criteria and resident/surrogate preferences. The investigators will evaluate the effects of the intervention on the total number of medications deprescribed from enrollment at 30, 60, and 90 days along with resident/surrogate reports of quality of life at enrollment and 90 days.

This single-arm pilot trial will evaluate an evidence-based, patient-centered deprescribing intervention with assisted living facility (ALF) residents age 65+ who have a diagnosis of dementia. This deprescribing intervention was demonstrated to be safe and effective in reducing medication burden during the Shed-MEDS randomized clinical trial that enrolled hospitalized older adults discharging to post-acute care facilities. The intervention includes a comprehensive review of a participant's medications by the study's clinician and deprescribing recommendations using evidence-based guidelines. Deprescribing recommendations will be shared with residents/surrogate decision makers (i.e., respective family member/s) to determine their willingness to stop or reduce the dose of the targeted medications. If the resident/surrogate-decision maker agrees, deprescribing recommendations will then be communicated with the routine ALF medical providers for consideration and final deprescribing decisions.

Eligibility Criteria:
Inclusion Criteria:

* Resident of assisted living facility
* Speaks English (due to interview-based assessments)
* Diagnosis of dementia
* Taking a total of 5 medications or at least one potentially inappropriate medication (defined by the Beers criteria, STOPP criteria, and the Rationalization of home medication by an Adjusted STOPP in older Patients \[RASP\])
* Able self-consent or has a proxy (surrogate)

Exclusion Criteria:

- None
Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 20 to 60 years
* Presence of mono-infection of P. falciparum or P. vivax
* Weight between 40 kg to 90 kg

Exclusion Criteria:

* Patients with signs and symptoms of severe/complicated malaria
* Mixed Plasmodium infection
* Presence of other serious or chronic clinical condition requiring hospitalization.
* Severe malnutrition
* Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Other protocol-defined inclusion/exclusion criteria may apply.
Frontosubthalamic Networks in Parkinson's Disease.

The goal of this experimental study with is to understand the underlying mechanisms behind the increase in impulsivity seen in some patients that undergo deep brain stimulation of the subthalamic nucleus for Parkinson's Disease. The main questions it aims to answer are:

What are the distributed network effects of deep brain stimulation to the subthalamic nucleus? How does this correlate with increased impulsivity? Can alternative stimulation settings be used to minimize these?

Participants will complete decision-making tasks whilst their deep brain stimulation devices are turned on and off with simultaneous magnetoencephalography recordings (a type of non-invasive brain scan that measures brain activity in real-time)


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with Parkinson's disease who have required implanted STN electrodes for DBS in addition to their dopamine replacement therapy.
* Diagnosed with or without (control group) impulse control disorders since the diagnosis of Parkinson's Disease.
* Participant willing and able to sit in the MEG scanner and follow instructions.
* Participant willing and able to delay their morning dose of dopamine replacement therapy for up to four hours (180 minutes experimental time + journey time).

Exclusion Criteria:

* Patients with extreme language barrier that cannot understand the purpose or instructions of the study despite the use of an interpreter.
* Other implanted medical devices that may cause artefacts during MEG recordings.
* Participants with a history of co-morbid neurological disorders.
* Participant enrolled onto another clinical trial related to a neurological disorder (including Parkinson's disease) that may interfere with the results of this study.
* Participants who are unable to sit still in a MEG scanner for the duration of this experiment e.g. patients with chronic pain or osteoarthritis. This will be assessed with their primary clinician
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation

The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.


Eligibility Criteria:
Inclusion Criteria:

* Patients 17 years old and younger
* ASA status I, II, or III.
* Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic).

Exclusion Criteria:

* Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit.
* Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions).
* Subjects who are developmentally delayed.
* Subjects deemed not suitable for study at the discretion of the investigator.
Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning

The study included boys and girls with neurodevelopmental disorders between the ages of 3 and 16 years, belonging to two educational centers in Madrid, attended by children with this type of disorder. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them. The study will be randomized, so that probiotics will be administered to some children and placebos to others; and blinded, so that neither the patient nor his family will know whether probiotic or placebo is administered.

The aim of this project is to study the results obtained on microbiota, intestinal permeability, language, behavior and learning of a probiotic combination that will be administered to children in several educational centers that care for children with neurodevelopmental disorders for 5 months.

The trial was conducted in 4 stages:

* Probiotic development, which will be randomized, so that some children will receive the probiotic and others placebos, and blinded, so that neither the children nor their relatives will know whether they take placebo or probiotic.
* Initial survey to rule out digestive symptoms and resolve possible doubts. Data will be collected on type of housing, location, number of family members, and others. Collection of fecal samples prior to the administration of the probiotic, to carry out a microbiota and intestinal permeability study.
* Administration of the probiotic preparation or placebo to the subjects for 5 months. Monitoring will be done within each center and in the middle of the treatment the doctors will make a face-to-face visit to see the children.
* In the last phase a new online visit is made where a complete clinical history and a survey to rule out digestive symptomatology are evaluated. A neurocognitive evaluation is also done using the SENA behavioral test. New fecal samples are collected for a microbiota and intestinal permeability study following the same procedure as in the second stage.

Eligibility Criteria:
Inclusion Criteria:

* Children with neurodevelopmental disorders between 3 and 16 years old
* Similar characteristics in terms of type of food

Exclusion Criteria:

* Digestive symptomatology: gastroesophageal reflux, abdominal pain, flatulence, dysphagia, abdominal distension or constipation
Evaluation of Valvular Heart Disease Using Cardiac CT

The EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis.

1. Assessing the accuracy of cardiac CT in evaluating cardiac structure, volume, function, and myocardium in VHD patients.
2. Comparing the severity, classification, and etiology (primary vs. functional) of VHD.
3. Monitoring serial changes in VHD severity via echocardiography.
4. Investigating the relationship between echocardiographic and CT-derived parameters.
5. Examining the correlation between imaging findings, VHD interventions, and patient prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with VHD (mitral and/or tricuspid regurgitations) by echocardiography and be considered for surgical or interventional treatment. All patients undergo cardiac CT before these treatments.

Key inclusion criteria include patients who had a cardiac CT with 64 or more rows and are 18 years of age or older. All patients must clinically indicate cardiac CT.

Exclusion Criteria:

* Less than 18 years old, acute VHD, infectious endocarditis, patients with post-VHD intervention, and poor CT image quality for analyzing CT data.
Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.


Eligibility Criteria:
Eligibility criteria:

Inclusion Criteria:

* Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy and any other cured treatment.
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* No serious concurrent medical illness
* Unresectable BCLC stage A-B disease
* No cirrhosis or cirrhotic status of Child-Pugh class A
* No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
* No current infections requiring antibiotic therapy
* Not on anticoagulation or suffering from a known bleeding disorder
* No unstable coronary artery disease or recent MI
* The following laboratory parameters:

  * Platelet count ≥ 60,000/µL
  * Hemoglobin ≥ 8.5 g/dL
  * Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
  * ASL and AST ≤ 5 x upper limit of normal
  * Serum creatinine ≤ 1.5 x upper limit of normal
  * INR ≤ 1.5 or PT/APTT within normal limits
  * Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Known history of HIV
* History of organ allograft
* Pregnant or breast-feeding patients
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Known central nervous system tumors including metastatic brain disease
* severe Arterioportal Shunts or Arteriavein Shunts
The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer

The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection in patients with unresectable rectal cancer.

Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. The preoperative treatment in the control arm is conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks simultaneously with 5-Fu, leucovorin and oxaliplatin. Experimental group receive 25 Gy in 5 fractions of 5 Gy over 5 days and after one week interval - consolidating chemotherapy of 3 courses of FOLFOX4. Surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil or radiation. The study hypothesis is that the short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10% increase of the rate of R0 resection compared to preoperative chemoradiation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.
* WHO performance status ≤ 2.
* Lower border of tumour ≤ 15 cm from anal verge.

Exclusion Criteria:

* cardiac coronary arterial disease,
* arrhythmias,
* stroke even if they have occurred in the past and are controlled with medication