cyrilzakka/clinical-trials huggingface dataset:
Assessing the Usability and Reliability of the Prototype Prosthesis Devices

The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years;
* Lower limb amputation at the transfemoral or transtibial level;
* Functional medical classification: Level K3-K4 \[25\];
* Subjects wearing a prosthesis for at least 1 year (experienced wearers);
* Maximum body weight 100 kg.

Exclusion Criteria:

* Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
* Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
* Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
* Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
* Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
* Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.
Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient

Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.

* Registered subjects are 1:1 randomized using a random sequencing generator (www.random.org). Experimental group with 30 patients and Control group with 30 patinets.
* In the case of the experimental group, LACUDY 2mL is inserted twice a week for a month before going to bed for 4 weeks.

  * Unpack the product and take it out.
  * Remove the cap by turning it.
  * Fit the nozzle to the end of the syringe and turn it to combine.
  * Hold the syringe with the nozzle facing the vulva, insert it about 5-6 cm into the vagina, and then slowly press the tip of the push rod with patient's thumb to inject all the liquid in the syringe into the vagina.
  * Slowly remove the syringe as the nozzle opens.
  * It is recommended to wear a pad as the injected solution may flow out.
* In the case of the control group, they go about their daily lives without any treatment.
* Both the experimental group and the control group are instructed not to administer intravaginal suppositories or other drugs related to vaginal atrophy and sexual function improvement.
* A total of 2 questionnaires were conducted before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Aged 20 to 60 years diagnosed with breast cancer
3. Receiving anti-hormonal therapy
4. Patients who subjectively complain of vaginal dryness
5. Patients without current psychiatric problems
6. Patients who can understand and respond to the contents of the questionnaire
7. Ability to provide informed consent

Exclusion Criteria:

1. Women under 19 and over 61
2. Pregnant woman
3. In case of recurrence or disease progression
4. Patients without sexual experience
5. Unable to provide informed consent
A Randomized Double Blinded Placebo Controlled Study on the Effects of Dietary Supplementation With a Probiotic on Stroke Patients

The aim of this study is to determine the effects of an intervention using a commercially available probiotic in a cohort of acute stroke patients. In order to determine this, a double blinded, randomised and placebo-controlled study design was chosen.

Patients are recruited from the Stroke Unit of the Ludwig Maximilians University Munich within seven days of stroke onset. Recruited patients are then randomly assigned to either the Control or Treatment group and subsequently take the commercially available probiotic, or the placebo, twice a day for 3 months. At this point, study participants present themselves for routine clinical examination at the outpatient clinic of the Institute for Stroke and Dementia Research (ISD). During these examinations, blood and stool samples are collected for metabolomic and metagenomic analysis. Additionally, questionnaires concerning cognitive function (MOCA), depression (BDI) and general gastrointestinal status (GSRS-IBS) are completed.

Clinical data from both acute admission and three month follow-up are also collected for the purposes of this study.

Furthermore, members of the same household as the study participants are asked to donate a stool sample. These samples will be used to create a reference cohort for a paired matching approach with the Treatment and Control groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic stroke with onset in past 7 days
* Treatment received in the Stroke Unit of the LMU University Hospital, location Großhadern

Exclusion Criteria:

* Chronic immunological disease
* Severe gastrointestinal disease
* Colectomy
* Artificial intestinal outlet (ostomy)
* Liver cirrhosis, pancreatitis, gastritis, cholecystitis (or other acute gastrointestinal diseases)
* Chronic alcohol abuse
* Terminal prognosis
Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.

Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject meets the DSM-IV criterion for current alcohol dependence.
* Subject is currently not engaged in, and does not want, treatment for alcohol related problems.

Exclusion Criteria:

* Subject meets criteria for current DSM-IV diagnosis for any other psychoactive substance abuse or dependence disorder, excluding nicotine and caffeine.
* Specialized inpatient or outpatient alcoholism or other addiction treatment (except nicotine) within the past 12 months.
The Effects of Dry Needling on the Superficial Neck Musculature

The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena.

To address the treatment of myofascial trigger points, conservative and invasive techniques have been proposed. Dry needling is one of the invasive techniques that have been shown to be effective in improving pain and function in patients with myofascial trigger points.

This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck pain.

The main objective of the study is to analyze the effects of dry needling on the superficial neck musculature in patients with chronic myofascial neck pain in terms of pain, functional capacity, mobility, psychosocial variables and motor control compared with both sham dry needling group and control group.

In addition, a secondary objective is to analyze the relationships between the psychosocial variables and the results obtained in the variables analyzed in the patients belonging to the three groups.

For this purpose the investigators conduct a randomized controlled trial double-blind. Patients included are randomized into 3 groups. One receives dry needling, another one receives sham dry needling, and the last one is a control group.

The hypothesis of this study is that patients in the real dry needling group will improve more compared to patients in the sham dry needling group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with myofascial neck pain
* Presence of at least one active myofascial trigger point on the superficial neck musculature
* Neck pain of at least 3 months
* Age 18-70
* Pain intensity between 20 and 100 mm in the Analog Visual Scale
* Neck disability index (NDI) greater than or equal to 15 points
* Spanish speakers
* Patients who do not present contraindications for the use of dry needling (anticoagulants, nickel allergy or belenophobia)
* Patients who have not received physiotherapy or pharmacological treatment for neck pain for the last three months

Exclusion Criteria:

* History of cervical trauma
* Cervical spine surgery
* Vertebral fracture
* Cervical pain associated with whiplash
* Red flags (tumor, metabolic disorders or rheumatoid arthritis)
* Inflammatory lesion in the neck region
* Pregnancy
* Fibromyalgia diagnosis
* Neck pain associated with radiculopathy
* Patients pending legal litigation
* Psychiatric pathology diagnosis
How Stress Alters Opioid Drug Effects

The main objective of the study is to test the hypothesis that opioid drug effects vary as a function of pre-drug affective state. Specifically, it is hypothesized that social stress induction enhances opioid drug wanting compared a non-stress control condition.

Healthy participants complete four experiment sessions in a placebo-controlled, double-blind, randomized repeated-measures psychopharmacological study. Participants completed four combinations of pre-drug state induction (social stress or no-stress) and drug (intravenous oxycodone or saline).

Temporary and reversible social stress is induced using the Repeatable Social Stress Test (ReSST) which enables repeated administrations of stress-inductions. Across four sessions participants experience two carefully tailored tasks to provoke the experience of social evaluative threat and two non-stressful control tasks.

After each state inductions, participants receive an injection of opioid drug or saline. After a drug absorption phase and viewing of a state reinstatement video designed to evoke a mild form of social evaluative threat participants perform a drug-self-administration test to determine the potency of a second dose.

Self-reported affect, mental and physiological state and drug effects are assessed throughout the session.

Eligibility Criteria:
Inclusion Criteria:

* Mentally and physically healthy
* Body mass index (BMI) in the healthy range (18.5 \< BMI \< 30)
* Normal or corrected vision
* Had received an opioid drug at least once in their lifetime (to ensure no severe adverse or allergic reactions).

Exclusion Criteria:

* Any significant physical health problem (e.g., heart, lung, kidney, liver, and other conditions)
* Current or past substance use problems
* Current mental health problems
* Past mental health problems beyond mild episodic anxiety or depression
* Social anxiety or fear of public speaking
* Past or current chronic pain
* Pregnancy or breastfeeding
* Recent use of any contraindicating medications
* Prior difficulty in providing blood samples.

All exclusion criteria required a 'yes' or 'no' response from participants. Participants were also asked to report any illnesses or medical conditions that were not covered by the questions in the clinical interview. Mental health and substance use were assessed during the clinical interview using the Mini-International Neuropsychiatric Interview (MINI). The interview required binary responses to questions regarding a wide range of psychological symptoms relevant for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and ICD-10 (International Classification of Diseases) psychiatric disorders. Interviewers then used the pre-defined cut offs relevant to the severity of symptoms for each psychiatric disorder to assist the clinical judgement.
Effects of Pulmonary Rehabilitation on Clinical Outcomes in Children With Asthma

Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. However, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (PADL) and activities of daily living (ADLs) have not yet been investigated in depth. Therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on PADL, ADL, and other clinical outcomes of children with asthma. For this, a randomized clinical trial will be carried out that will have 2 groups: the control group (CG), which will receive only educational sessions, and the intervention group (IG) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. The total duration of interventions in both groups will be 12 weeks. The primary outcomes of this study are PADL (assessed using a physical activity monitor - Actigraph) and ADL; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. We hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in ADL and PADL, and better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 12 years old;
* Clinical diagnosis of asthma, established according to the criteria of the Global Initiative for Asthma (GINA);
* Absence of other lung diseases or signs and symptoms of other lung diseases;
* Absence of cognitive changes;
* Absence of signs and symptoms of gastroesophageal reflux disease and dysphagia;
* Clinical stability according to the criteria of the Global Initiative for Asthma (GINA);

Exclusion Criteria:

* Desire of the patient and/or the patient's family to discontinue participation in the study for any reason;
* Present some new limitations that may interfere with functionality;
* Comorbidities that prevent or contraindicate the performance of the proposed interventions.
Nicotinic Receptors and Schizophrenia

The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: males and females who are incapable of pregnancy

Exclusion Criteria:

* Medical illnesses requiring acute treatment
* History of seizures
* Substance abuse including nicotine
A Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX

This is a retrospective, non-interventional study. Investigators from infectious diseases and gastroenterology departments will participate this study.

Patients data will be collected from hospital medical records.

Pangenotypic Sofosbuvir/Velpatasvir/Voxilaprevir for 8-12 weeks has been shown highly effective, safe, and well-tolerated in treating patients with chronic HCV infection in clinical trial settings, however, there are no real-world setting data are available.This is the first opportunity from all over the world to demonstrate SOF/VEL/VOXs efficacy and safety in Real World setting especially for the naive patients.

SOF/VEL/VOX is often positioned in retreatment by international guidelines. Previously the reimbursement guideline in Turkey did not allow patients to be re-treated after the failure of DAA treatments. With current guideline Vosevi is approved as the only option for failures of DAA treatments. In the past years in Turkey, SOF+RBV in GT2, SOF+PEF+RBV in GT3, LDV/SOF in GT1.4-6 patients and Viekirax/Exviera in GT1,4 patients have been used and unfortunately, some patients did not benefit from these suboptimal treatments. The efficacy and safety of SOF/VEL/VOX in patients who have experienced treatment failure in real life will be another objective of the research.

This research will support

1. Efficacy and safety of 8-week Pangenotypic SOF/VEL/VOX for treatment naive non-cirrhotics
2. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for treatment naive compensate cirrhotics
3. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for retreatment of NS5A or NS3A4 and non-NS5A treatment-experienced patients (incl. noncirrhotics and cirrhotics)

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as chronic hepatitis C and aged 18 and older
* Patients received SOF/VEL/VOX treatment

Exclusion Criteria:

* Decompensated cirrhotic HCV patients
* Having HCC
* eGFR\<30 ml/min
Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction

The purpose of this study is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients.

The Caloric test and Video Head Impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to Clinic with complaints of vertigo, dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. In order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was done with timed balance tests and quality of life assessment was performed with Dizziness Handicap Inventory.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-70 years of age with bilateral vestibular hypofunction and peripheral vestibulopathy

Exclusion Criteria:

* Patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.
Metabolism of Ornithine Phenylacetate

Intravenous infusion of stable tracers of ornithine, glutamine, glutamate, and glycine will be performed, and collect blood samples, urine samples, and muscle biopsies to evaluate the effect of a continuous oral intake of phenylacetate salt of ornithine (OP) on its metabolic fate.

The study involves 1 screening visit of approximately 1 hour and 4 study days of approximately 10 hours. The subject will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight and height will be measured and Dual-energy X-ray absorptiometry (DXA) will be performed to measure body composition. After 4 hours subjects received a continuous intravenous infusion with OP in a dosage of 1 g /h. Next to the stable tracers provided to determine OP metabolism, stable tracers of phenylalanine (PHE) and tyrosine (TYR) may be provided to determine the effect of OP on protein metabolism at plasma and muscle tissue level. This required 2 muscle biopsies and on 2 study days 1 set of stable tracer pulses.

Eligibility Criteria:
Inclusion criteria healthy subjects:

* Healthy male \& female according to the investigator's or appointed staff's judgment
* Age 40-70 years (to be comparable with patients with liver cirrhosis: average 54.1 +/- 9.4 years)

Exclusion Criteria

* Metabolic diseases including diabetes and hepatic or renal disorders
* Presence of acute illness or metabolically unstable chronic illness
* Failure to give informed consent
* (Possible) pregnancy
* Any other condition according to the PI or nurse that would interfere with the study or safety of the patient or influence the results
* Unwilling to stop taking nutritional protein supplements within 5 days before test day
* History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime
* Currently taking anti-thrombotics (i.e. medical indication) and cannot stop for 3-7 days prior to test days
* Allergy to local anesthetic
Influence of Pomegranate Juice Consumption on the Level of Antioxidants in Breast Milk

Many medicinal effects of Pomegranate juices are already known. Mainly known for its anti-viral, anti-bacterial and anti-oxide tendency of pomegranate juice.

Many studies which have demonstrated antioxidant activity of pomegranate juice in the blood and blood cells were published.

In addition, published studies have demonstrated the anti-oxidant activity which inhibit the development of atherosclerosis and stroke, even in patients with diabetes, and its effect of decreasing systolic blood pressure in patients with systemic hypertension.

The purpose of the work is to examine the effect of drinking pomegranate juice on the level of anti-oxidants in human breast milk.

the effect of pomegranate juice consumption on breast milk anti oxidants level.

Eligibility Criteria:
Inclusion Criteria:

* lactating woman

Exclusion Criteria:

* pomegranate allergy
* diabetes mellitus
* use of other Dietary Supplement
The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis

This is a single-center, prospective, randomized (1:1), open-label study with two parallel groups. This study is planned to investigate the efficacy and safety of dabigatran etexilate comparing with warfarin for the treatment of cerebral venous thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Cerebral Venous thrombosis (CVT), with or without intracranial haemorrhage.
* Patients in the acute or sub-acute phase of CVT.
* Completion of anticoagulation therapy for 5-15 days which has been administered until randomization; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin.
* Eligibility for treatment with an oral anticoagulant.
* Written informed consent.

Exclusion Criteria:

* Cerebral Venous thrombosis (CVT) associated with central nervous system infection or due to head trauma.
* Thrombosed venous sinuses showed completely recanalized by MRV before randomisation.
* Planned endovascular treatment for CVT or surgical treatment for other diseases.
* Conditions associated with increased risk of bleeding.
* History of symptomatic non-traumatic intracranial haemorrhage with increased risk of recurrence according to investigator's judgment.
* Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis.
* Severe renal impairment(CrCL\<30mL/min).
* Active liver disease (ALT≥ twice the upper limit of normal).
* Preganancy, nursing or planning to become pregnant during the trial.