cyrilzakka/clinical-trials huggingface dataset:
Training and Energy Management Education to Improve Quality of Life in Persons With Multiple Sclerosis

Persons with Multiple Sclerosis (PwMS) often suffer from impaired mobility and reduced aerobic capacity. Moreover, 65% of PwMS recognize fatigue as their most disabling symptom that quickly impacts patients' health-related quality of life (QoL). Systematic reviews that evaluate therapeutic options for MS-neurorehabilitation show good evidence for exercise and energy management/conservation programs to improve fatigue or its impact on daily life. Guidelines recommend a multidisciplinary approach but to date only unimodal interventions are investigated. This study aims to investigate the influence of the combination of two different therapeutic concepts: inpatient energy management education (IEME) + High-intensity interval training (HIIT). This intervention is compared with a control group that undergoes progressive muscle relaxation (PMR) + low-intensity training (ST). IEME or PMR is performed on two days (tue-thur) and HIIT or ST on three days (mo-wed-fr) / week. The primary outcome is the effect on the quality of life after three weeks rehabilitation and after returning home (at 4 and 6 months follow-up) in PwMS.


Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis (revised McDonald criteria, 2018).
* Age \>18y
* Expanded Disability Status Scale (EDSS) score ≤ 6.5
* Fatigue Scale of Motor and Cognitive function (FSMC) total score \> 43
* Literacy and understanding German
* Informed Consent

Exclusion Criteria:

* Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Cognitive impairment Mini-Mental State Examination (MMSE) \< 21
* Major Depression or Hospital Anxiety and Depression Scale (HADS) \>11 at baseline
* Stem cell treatment in the last 6 months
* Participation in a previous high-intensity interval training (HIIT) or inpatient energy management education (IEME) study
Interactive Patient's Assistant - LUCY

Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient.

Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.


Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* Chronic heart failure (NYHA class I to III)
* Implanted ICD or CRT (at least 30 days before inclusion)
Transcranial Direct Current Stimulation (tDCS) Combined With Computerized Cognitive Addiction Therapy(CCAT) and, Electronic Follow-up for Methamphetamine(MA) Dependent Patients

Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Electronic medical systems were applied for drug related knowledge education, self-evaluation and outpatient follow-up reminder after intervention in order to reduce relapse behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Methamphetamine dependent patients with normal eyesight and hearing.

Exclusion Criteria:

* any diagnosis of DSM-IV axis I diseases.
* any physical diseases which might influence cognitive function such as epilepsy, cerebrovascular disease or brain injury.
* negative behaviors or harm to others.
* cognitive enhance drug use history in last 6 months.
* other drug dependence(except nicotine).
SHARE-D: a Decision Tool to Help Patients Make Informed Lifestyle Choices

More information is needed about effective ways to help people begin to change their lifestyle behaviours, particularly physical activity and diet. The investigators propose to test a 'tool' that can be used to guide discussions between people and health professionals about their physical activity and diet habits, so that people may be supported better in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines and make long-term changes. The investigators will explore the feasibility of using this tool in general practice, reviewing behaviours after 1 and 3 months. Patients' and healthcare professionals' views of its use and how it influenced decisions will inform development of the tool's design and a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles.

Healthier lifestyles, relating to physical activity and diet, reduce the risk of heart disease and stroke. However, making and sustaining lifestyle changes is difficult. More information is needed about effective ways to help people begin to change their lifestyle behaviours. The investigators propose to test the feasibility of using a 'tool' (the SHARED-D questionnaire) in guiding discussions between people and health professionals about physical activity and diet, and support people in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines. The 'tool' (SHARE-D) consists of questions to help people think about their personal circumstances and their motivation, opportunities, capabilities and priorities, and includes information about heart disease and stroke.

The investigators will explore the use of this tool in general practice, assessing patients' physical activity and diet behaviour after 1 and 3 months. Patients' and healthcare professionals' views of its use and how it influenced decisions will help to improve the tool's design. Participants' opinions regarding its format and method of delivery will inform future plans for its use and the design of a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles, hoping to lead to improved quality of life for people with heart disease and stroke.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* With or at high risk of coronary heart disease
* Overweight or physically inactive

Exclusion Criteria:

* Unable to complete questionnaires
* Unable to make independent changes to physical activity or diet habits
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine

This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.

This study is set up:

* to evaluate the efficacy (headache response at two hours) of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation,
* to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including: headache response, proportion of participants pain-free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication, patient global impression and vomiting
* to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ECGs
* to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response

Eligibility Criteria:
Inclusion Criteria:

* Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
* History of migraine of at least 1 year
* Migraine onset before the age of 50 years
* History of 1 - 8 migraine attacks per month
* Male or female subjects aged 18 to 65 years
* Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner)
* Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache
* Able and willing to give written informed consent

Exclusion Criteria:

* History of life threatening or intolerable adverse reaction to any triptan
* Use of prescription migraine prophylactic drugs
* Pregnant or breast-feeding women
* Women of child-bearing potential not using highly effective contraception
* History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
* History of hypertension (controlled or uncontrolled)
* Sitting BP \>160mmHg systolic or \>90mmHg diastolic on 2 repeated measurements at screening
* Current use of hemodynamically active cardiovascular drugs
* History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
* Significant renal impairment
* Previous participation in this clinical trial
* Participation in any clinical trial of an experimental drug or device in the previous 30 days
* Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
* Relatives of, or staff directly reporting to, the investigator
* Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144
Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.


Eligibility Criteria:
Inclusion Criteria:

* pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises
* ages 18 to 50
* con provide informed consent in English

Exclusion Criteria:

* Age under 18 or above 50
* gestational ages before 16 weeks 0 days or after 20 weeks 0 days
* unable to provide written consent in English
* hypertensive disorder
* uncontrolled hypertension or known hypersensitivity to ergot derivatives
* History of cardiac valvular disorders
* history of pulmonary fibrosis
* documented bipolar schizophrenia
* documented allergy to medication, including lactose intolerance (placebo pill involves lactose)
Vitamin D3 in Sensory Recovery After Digital NERVe Suture (D3NERV).

Digital nerve injuries are frequent in a FESUM center (Federation Européenne des Services d'Urgences Mains), and they need to be repaired in order to reduce the risk of hypoesthesia and to prevent painful neuroma. Several animal studies have shown that Cholecalciferol improves axonal nerve regeneration and myelination. No study has ever been done on human subjects to evaluate the nerve regeneration after Cholecalciferol supplementation.

Our hypothesis is that Cholecalciferol supplementation could improve axonal nerve regeneration and myelination after traumatic digital nerve injuries treated by microsurgical sutures and reduce the risk of hypoesthesia and neuroma.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated to social security scheme,
* Wound of the palmar hand with isolated digital nerve section, requiring digital nerve microsurgical suture in the operating room by a senior surgeon,
* Signing a free and informed consent and well-informed of the study and procedure.

Exclusion Criteria:

* Ischemia,
* Multiple lesion of the same nerve,
* Pregnant or nursing women,
* Contraindication of Cholecalciferol : known hypersensitivity, any history of hypercalcemia, hypercalciuria or renal lithiasis,
* Cholecalciferol supplementation in the past 6 months,
* Lesion of the same controlateral finger,
* History of nerve lesion or hypoesthesia on the same finger,
* History of previous neurological disorders with upper limb sensitivity disorder,
* Impossibility to undergo the medical follow-up because of geographical, social or psychological reason,
* Participation in another clinical trial that does not allow simultaneous participation in several clinical trials,
* Orlistat® Treatment,
* History of celiac disease.
Fevarin® Effectiveness in Treatment of Depression in Patients With Neurological Disorder

Prospective, multicenter, non-comparative, observational program to describe prevalence of depressive symptoms in a variety of neurological disorders and effects of Fevarin® on the severity of anxiety and depression, sleep state, and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with neurological disorders and mild or moderate symptoms of depression with Hospital Anxiety Depression Scale (HADS) depression scale score of 8 and higher. Fevarin® prescribed not earlier than 7 days before Visit 1.

Exclusion Criteria:

* Labeled contraindications to Fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.
Oral Glucocorticoids Effect on Post Endodontic Pain

The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain and medication intake in patients with symptomatic, irreversible pulpitis in mandibular molars.

Patients receive 40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); and group B (Control), where patients received two placebo tablets. All patients receive the assigned premedication 30 minutes before the administration of local anesthesia

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients, aged between 18-35 years, with mandibular molars with symptomatic irreversible pulpitis, radiographically-normal periapical area and no pain on biting or percussion.

Exclusion Criteria:

* Pregnant patients, patients with any known sensitivity or adverse reactions to any of the medications or materials used in this study, those who had used any analgesic medication during the preceding 6 hours before the treatment, those with unrestorable teeth or teeth with severe periodontal disease. Patients with active sites of pathosis in the area of injection were, also, excluded.
Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis

To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. Numerous studies deal with the aetiology of the disease, X-ray morphology and classification of curvatures and how the disorder disrupts the spinal biomechanical balance, however the disorder is a complex three-dimensional deformity that affects the body as a whole, and these effects must not be overlooked. No cross-section studies were found assessing the connection between sagittal or coronal balance and the biomechanical parameters of the lower extremity.

HYPOTHESES:

Null hypothesis There are no statistically significant relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents.

RESEARCH QUESTION:

What are the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents?

PURPOSE: To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with age 10-18 years
* complaining of dorsolumbar scoliosis
* curves (apex lies between D10 and L4)
* curve magnitudes greater than 15 degrees and less than 90
* using or not using brace
* all maturity levels (Risser = 0-5)

Exclusion Criteria:

* Other types of scoliosis ; congenital or neuromuscular
* Current physical therapy or medical treatment for scoliosis,
* Contracture or surgery affecting the lumbar spine or lower limbs
* Pathologies such as inflammatory diseases
* congenital anomalies
* Neurological disorders like cerebral palsy or ataxia
* dislocations
* visual or auditory problems
COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A

The aim of this study is to assess the efficacy and efficiency of a nutraceutical from sea urchin eggs with Echinochrome A in the inflammation of tissues in subjects with long Corona Virus (COVID) syndome

This is a double-blind placebo-controlled study in approximately 60 subjects with long COVID syndrome. After being informed about the study and potential risks, all subjects giving written informed consent will be screened to assess initial respiratory, cardiological inflammatory, neurological and emotional conditions. Prior to the first administration of the treatment, subjetcs will be randomized to receive three vials of the Dietary Supplement with sea urchin eggs extract with presence of the antioxidant Echinochrome A or placebo. According with the ACRO suggestions this study is focus on the patients. Subjects will be monitor by a Telemedicine platform called SkyMed developed for this study to assess their health daily and will have a weekly virtual meeting with a counselors to assess emotional state. Subjects will attend tp the Hospital, at the beggining of the study, and after finishing the vials of the Dietary Supplement (30, 60 and 90 days). Clinical, cardiological, neumonological and neurological studies will carried out to asses the systemic health as well as the quality of life indicators. Inflammation, trombolotic and inmune indicators will be assess in blood samples (basal, 30, 60 and 90 days).

The main objetivec behind this clinical trial is to diminish ROS in the cells, enhance gluthation pathways and diminish cellular inflammation. Echinochrome A is a powerfull marine poliphenol with known antioxidant activity found in the eggs, shells and spines of sea urchins, that had been use in eastern medicien for a long time. Powder of sea urchin eggs are mention in Materia Medica back far 1647 as a powerfull anti inflamation agent.

Eligibility Criteria:
Inclusion Criteria:

1. Positive diagnosis of COVID-19 in at least the last 12 weeks
2. Diagnosis of COVID Persistent, COVID sequalea, Long COVID
3. Adult men or non-pregnant adult women between the ages of 18 and 60.
4. The patient (or legally authorized representative) provides your informed consent before initiating any study procedure.
5. The patient (or legally authorized representative) understands and agrees comply with the planned study procedures. 6. Agreement not to participate in another trial ofintervention for the treatment of COVID-19 until day 60 after the start of the trial.

Exclusion Criteria:

* 1. Patients without persistent COVID symptoms. 2. Patients unable to give informed consent. 3. Patients without a positive result for COVID-19. 4. Pregnancy or lactation. 5. In the doctor's opinion, the patient with advanced organ dysfunction that would not make participation appropriate.
A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)

This first-in-human study is intended to evaluate the safety and preliminary effectiveness of AAV (Adeno-associated virus)-based liver-directed gene therapy in the treatment of adults with Homozygous Familial Hypercholesterolemia (HoFH).

Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic metabolic disorder characterized by absent or severely reduced capacity to catabolize circulating LDL (Low density lipoprotein) particles by the hepatic LDL receptor. As a consequence, HoFH subjects present abnormal total plasma cholesterol (LDL-C) levels, resulting in severe atherosclerosis often leading to early onset of cardiovascular disease. Early initiation of aggressive treatment for these patients is therefore essential. Unfortunately, despite existing therapies, treated LDL-C (Low density lipoprotein cholesterol) levels could remain well above acceptable levels. Thus, the functional replacement of the defective LDLR via AAV-based liver-directed gene therapy may be a viable approach to treat this disease and improve response to current lipid-lowering treatments. This first-in-human study is intended to evaluate the safety of this gene therapy investigational product and assess preliminary evidence of efficacy using plasma LDL-C levels as a surrogate biomarker for human LDLR transgene expression.

Subjects may be asked to participate in an optional kinetics study to assess the metabolic mechanism by which LDL-C is reduced.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Untreated and/or treated LDL-C levels and clinical presentation consistent with the diagnosis of homozygous FH (Familial hypercholesterolemia)
* Molecularly defined LDLR mutations at both LDLR alleles.
* A baseline serum AAV8 NAb (Neutralizing antibody) titer ≤ 1:10.

Exclusion Criteria

* Unwilling to wash out of the following lipid lowering therapies for the pre-specified time period:

  1. niacin \> 250 mg/day: within 6 weeks of baseline
  2. fibrates: within 4 weeks of baseline
  3. lomitapide: within 8 weeks of baseline
  4. mipomersen: within 24 weeks of baseline
* History of cirrhosis or chronic liver disease based on documented histological evaluation or non-invasive imaging or testing.
* Abnormal liver function tests (LFTs) at screening (AST (Aspartate aminotransferase) or ALT (Alanine aminotransferase) \> 2 × upper limit of normal (ULN) and/or Total Bilirubin of \> 1.5 × ULN