cyrilzakka/clinical-trials huggingface dataset:
Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease

This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.

The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.

The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.

This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed solution in middle-stage non-fluctuating Parkinson's disease (PD) patients (Hoehn\&Yahr II to III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.

The design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. The intervention includes 100 mg Coenzyme Q10 nanodispersion (Nanoquinon solution) tid or matched placebo for three months.

Participating study centers include Neurological University Outpatient Clinics and Neurological Departments of Community-based Hospitals experienced with PD patients.

The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS) Part II and III.

The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of parkinsonian symptoms in PD patients.

Main inclusion criteria:

* Parkinson's disease according to the UK Brain Bank criteria
* Hoehn \& Yahr stadium II until III
* Age 40 to 75 years
* UPDRS Part III \> 15 points
* No motor fluctuations or dyskinesias
* Stable medication for 4 weeks prior to inclusion

Main exclusion criteria:

* Atypical parkinsonian syndromes
* Dyskinesias or motor fluctuations
* Coenzyme Q10 treatment in the past
* Pregnancy

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease according to the UK Brain Bank criteria
* Hoehn \& Yahr stadium II until III
* Male or female
* Age 40 to 75 years
* UPDRS Part III \> 15 points
* No motor fluctuations or dyskinesias
* Stable parkinsonian condition for 4 weeks prior to inclusion
* Outpatients
* Patients without or with stable levodopa treatment for 4 weeks prior inclusion
* Written informed consent

Exclusion Criteria:

* Atypical or drug-induced parkinsonian syndromes
* Dyskinesias or motor fluctuations
* Coenzyme Q10 treatment in the past
* Pregnancy
* Epileptic seizures in the history
* Hypothyroidism
* Severe medical conditions with interference with study drug
* Treatment with CSE inhibitors, thyroidal hormones, antiarrhythmic drugs, warfarin, metformin
* Treatment or intake of vitamins, magnesium, vitamin E, calcium
Auriculotherapy as a Coping Strategy in Professional Nursing

This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies in 75 nursing professionals in a University Hospital.

There is consensus that psychological and social factors can lead to physical health problems of individuals and coping strategies in stressful situations may be crucial for the mental, physical and social development of people. Taking care of professionals who provide health services is a key strategy, since good results depend on the service, especially in work teams healthy and, therefore, able to promote the humanization of service.

Eligibility Criteria:
Inclusion Criteria:

* Average and high score by the List of Stress Symptoms
* Voluntary participation in the study
* Availability of time for submission to the sessions

Exclusion Criteria:

* Pregnancy
* Medical license or vacation during the period
* Low score of stress
Treatment With Benzodiazepine After Cardiac Surgery

The study deals with the prevalence of insomnia after heart surgery and the outcome of treatment with Benzodiazepine for this phenomena.

Patients after heart surgery develop sleep disorder in the form of Insomnia. This finding is known and described in the literature with respect to a large number of major operations such as the pneumonectomy, esophageal resection, pancreatic surgery, liver surgery and so on. In the general population, Insomnia is a common disorder and describe in more than 50% in adults over the age of 50. In patients with comorbidity among other things, heart disease indicates a rate of up to 85% of chronic insomnia. The reasons for insomnia after multiple heart surgery, including emotional stress that accompanies the patient after surgery, pain and prolonged hospitalization in the hospital. In this study, aim to compare the results of short-term treatment with sleep medication after heart surgery on morbidity and immediate recovery. This study will allow us to examine the effect of sleep medication therapy in patients receiving treatment compared to patients who did not receive treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older.
2. Applicants hospital for open heart surgery

Exclusion Criteria:

1. patients who came to emergency heart surgery.
2. patients who are not hemodynamically or respiratory stable
3. Patients who were taking hypnotic drugs on a daily basis before surgery.
4. Patients with low compliance that will not be able to fill out a sleep diary
5. lactose intolerance (due to components placebo)
6. Patients who can not take medication by one or more of the following:

   * pregnant.
   * nursing.
   * Patients with severe respiratory insufficiency
   * Patients with liver failure.
   * Patients who are addicted to alcohol
   * Patients without psychiatric background.
Efficacy and Safety of 14-day Concomitant Therapy for Refractory Helicobacter Pylori Infection

The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable. .

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years were recruited for this study if they had failed at least three rounds of anti- H. pylori therapies.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, vonoprazan, bismuth and antibiotics in the previous 4 weeks
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer,
* History of allergy to any of the drugs used in the study,
* Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk,
* Currently pregnant or lactating,
* Severe neurologic or psychiatric disorders,
* Alcohol abuse or drug addiction,
* Patients with compliance lower than 90% in any previous treatment,
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Metals/Vitamins Levels in NTD

Introduction: Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. The aims of this study were to determine the levels of trace elements and heavy metals, namely folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se), in the amniotic fluid of pregnant women, and to investigate their relationship with neural tube defects (NTDs).

Methods: The study will be included 70 pregnant women whose fetuses were complicated with NTDs (study group) and 70 pregnant women with unaffected healthy fetuses (control group). The samples levels of elements and vitamins will be measured using inductively coupled plasma-mass spectrometry and will be compared between the two groups.

Detailed Description:

This observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between August 2020 and March 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/167). The study strictly will be adhered to the principles of the Declaration of Helsinki. All women will be provided written informed consent before the acquisition of all samples. The study will be included 140 pregnant women who underwent amniocentesis at the investigator's perinatology department.

The study group will be included 70 pregnant women whose fetuses were found to have congenital NTDs (eg, anencephaly, spina bifida, acrania, and encephalocele) on detailed ultrasonographic examinations between 16 and 37 weeks of pregnancy. The control group included pregnant women with healthy fetuses (n = 70), who were matched for gestational weeks and maternal age and underwent amniocentesis because of age-related risk or increased risk in the triple test. Then, this study will be determined maternal plasma/urine/hair, and amniotic fluid folic acid, zinc (Zn), molybdenum (Mo), vanadium (V), strontium (Sr), aluminium (Al), tin (Sn), antimony (Sb), mercury (Hg), calcium (Ca), iron ( Fe), magnesium (Mg), phosphorus (P), barium (B) and selenium (Se) concentrations in women with NTD compared to those of volunteer healthy pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women complicated with Neural tube defects
* Healthy pregnancy
* Singleton pregnancy

Exclusion Criteria:

1. pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
2. women who have dyed their hair in the last 5 months
3. history of using any medication
4. presence of gestational hypertension or gestational diabetes
5. drug user
6. patients who had other fetal congenital abnormalities or genetic syndromes
7. multiple-gestation pregnancies
8. intrauterine fetal death
9. oligohydramnios
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.

A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases.A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone.The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively.Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel.We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.
* Age ranges from 18 to 70 years.
* Patients must not have received any prior anticancer therapy.
* Performance status of 0 to 1
* Estimated life expectancy of at least 6 months.
* Tumor can be measured according to RECIST criteria
* Signed informed consent document on file.
* Females with childbearing potential must have a negative serum pregnancy
* Adequate organ function including the following:

Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.

Exclusion Criteria:

* Carcinoma at the upper part of esophagus
* Histologic diagnosis of adenocarcinoma of esophagus.
* Prior treatment for esophageal cancer.
* Active infection.
* Pregnant or breast feeding.
* History of significant neurological or mental disorder, including seizures or dementia.
* Prior invasive malignancy in 5 years (except for carcinoma in situ).
Community Translation of the Expecting Study

The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

The aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based Expecting intervention with pregnant women with obesity in community settings. Specifically, the investigators will show effective application of the Replicating Effective Programs (REP) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. REP provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. Built into the REP framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. The investigators will randomize half to receive the community-adapted Expecting intervention (Intervention, N=30) and half to receive standard of care (Control, N=30).

Eligibility Criteria:
Inclusion Criteria:

* (a) Body Mass Index \> 30,
* (b) singleton pregnancy,
* (c) between 11-15 weeks of pregnancy (at enrollment),
* (d) sedentary (do not engage in purposeful physical activity plus have sedentary work)
* (e) cleared by physician

Exclusion Criteria:

* (a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)
* (b) illicit drug use.
Schedule Intervention to Increase Sustainable Walking Activity in Midlife Working Adults

While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. The goal of this study is to use a planning intervention to help establish and maintain a daily step regimen in working midlife adults. The investigators will ask participants to plan when, where, and how to act on a daily walking goal in conjunction with a scheduling intervention to increase the chances that they will maintain this new regimen. The effectiveness of three different scheduling interventions will be compared.

While people commonly understand that regular physical exercise conveys many health benefits, only 20% of U.S. adults take regular exercise and they have difficulty maintaining new healthy behaviors. The goal of this study is to use a planning intervention to help establish and maintain a daily step regimen in working midlife adults. The investigators will ask participants to plan when, where, and how to act on a daily walking goal in conjunction with a scheduling intervention to increase the chances that they will maintain this new regimen. Participants will be randomly assigned to one of three conditions: consistent schedule, inconsistent schedule, no schedule. All participants will be provided with an accelerometer to measure their daily activity and as a behavioral support for our intervention and they will be given a step goal. The goal given to each individual will be to increase immediately their daily steps to a level based on recommended guidelines (e.g., Hill, Wyatt, Reed, and Peters, 2003). The investigators will test which version of the scheduling intervention is most successful for increasing and maintaining step counts. It is predicted that participants in the consistent schedule condition will increase their step count more than those participants in the no schedule control condition, and that they will maintain this activity for a longer period after the intervention period is complete than those participants in the inconsistent schedule condition.

Eligibility Criteria:
Inclusion Criteria:

* currently working 3 or more days (or 24 hours or more) per week;
* physically minimally active (as determined using the International Physical Activity Questionnaire (IPAQ)

Exclusion Criteria:

* a recent (within the past 6 months) cardiovascular event, or fall.
* anyone who already exercises regularly, 3 times a week or more for at least 30 minutes, will be excluded
Evaluation of the Re-volumizing Performance of Aliaxin (New Trademark)

Aim of the study is to evaluate the re-volumizing performance and the duration effect of the product Aliaxin (new trademark) in women aged 40-65 years with midface volume defects due to aging mechanism.


Eligibility Criteria:
Inclusion Criteria:

* female sex;
* age 40-65 years;
* FVLS 2-4;
* asking for midface volume restoration;
* available and able to return to the study site for the post-procedural follow-up examinations;
* agreeing to present at each study visit without make-up;
* accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
* accepting to sign the informed consent form.

Exclusion Criteria:

* Pregnancy;
* lactation;
* smokers;
* alcohol or drug abusers;
* subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the first aesthetic procedure) and at T1 (3-4 weeks after the first injection treatment execution, before the touch-up aestetic procedure);
* Body Mass Index (BMI) variation (± 1) during the study period;
* performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;
* performing permanent filler in the past;
* change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study currently or during the previous 3 months.
* dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* recurrent facial/labial herpes;
* clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
* diabetes;
* endocrine disease;
* hepatic disorder;
* renal disorder;
* cardiac disorder;
* pulmonary disease;
* cancer;
* neurological or psychological disease;
* inflammatory/immunosuppressive disease;
* drug allergy.
* anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
* using of drugs able to influence the test results in the investigator opinion.
Profile of Chronic Musculoskeletal Pain Patients Related to Treatment Adherence and Virtual Reality

Lack of adherence is one of the main problems of chronic musculoskeletal pain treatment. To improve adherence it is essential to take into account the characteristics of the patients and their thoughts and beliefs about pain. Virtual reality can present some advantages in the face of these problems too.

The objective of this study is to evaluate the profile of chronic musculoskeletal pain patients, the barriers associated with lack of adherence to treatment, and the interest of virtual reality in rehabilitation.

* Background: Lack of adherence is one of the main problems of chronic musculoskeletal pain treatment. To improve adherence it is essential to take into account the characteristics of the patients and their thoughts and beliefs about pain. Virtual reality can present some advantages in the face of these problems too.
* Objectives: Evaluate the profile of chronic musculoskeletal pain patients, the barriers associated with lack of adherence to treatment, and the interest of virtual reality in rehabilitation.
* Methodology: Observational study. The profile of chronic musculoskeletal pain patients will be described. Patients will be recruited using the snowball method. The evaluation will be carried out via telematics through the use of videoconference and surveys. We will evaluate chronic pain and characteristics, kinesiophobia, functionality, quality of life, psychosocial aspects and other related outcomes. We will identify barriers associated to treatment adherence and we will evaluate patients' perception of rehabilitation with virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* Chronic musculoskeletal pain (≥ 3 months)
* Adults (≥ 18 years)
* Have a computer or mobile device/Basic knowledge and access to the internet
* Wish to participate in the study and sign the informed consent

Exclusion Criteria:

All those participants who present any physical pathology or of any kind that imply an inability to understand the necessary instructions to carry out the study will be excluded.