cyrilzakka/clinical-trials huggingface dataset:
Primary Dysmenorrhea and Osteopathic Treatment

This study is adressed to women with primary dysmenorrhea, it´s a gynecological disorder that is defined as colicky pain associated with menstruation and is located in the lower abdomen and in the lumbo-pelvic area. It appears between the first 8-72 hours and four days of the menstrual cycle and affects almost 85% of women, 30% of them severely. This study aims to demonstrate that osteopathic manual therapy is an effective therapeutic option in patients with primary dysmenorrhea. Another objective is to verify that osteopathic manual treatment provides an improvement in the intensity of pain, quality of life and a reduction in the consumption of medicines in these patients.

It will be a prospective study, a double-blind randomized controlled clinical trial. The sample group will include 60 patients, between 18 and 30 years old divided into two experimental groups. The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manupulation (GPM) and a specific internal technique for mobility of the cervix, and the control group (n = 30) will only carry out a bilateral GPM. A measurement will be made before the first treatment, another after each session, and the last one two weeks after the last intervention (anthropometric measurements, quality of life questionnaire, sexual health, osteopathic tests, pressure point with algometer, pain and medicines consumption). The established outcome measures are: pain intensity according to the visual analog scale (VAS), depression points measured with an algometer, a health-related quality of life questionnaire, questionnaire sexual health and sexual dysfunctions, and the measurement of drug consumption.

Eligibility Criteria:
Inclusion Criteria:

* Crampy pain in the lower abdomen or lumbo-pelvic area between 8 hours and 4 days after menstrual bleeding.
* Clinical evolution of at least three menstrual cycles with said pathology.
* Moderate menstrual pain or severe intensity, minimum 5 VAS scale.
* Regular menstrual cycle, between 21 and 35 days.
* Accept informed consent.

Exclusion Criteria:

* Being receiving any other physiotherapeutic or pharmacological treatment for primary dysmenorrhea during the 3 weeks prior to the beginning of the intervention.
* Suffering from cardiovascular diseases, prolapse, amenorrhea, hemophilia, tumor or infectious processes, use of IUDs, consumption of oral contraceptives or suffering from any injury that affects the sensory-motor function.
Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer

The purpose of this study is to investigate thiol-disulfide balance in early stage endometrium cancer patients.

To date various oxidative stress paramaters were studied in patients with endometrial cancer, however dynamic thiol disulfide hemostasis has not been previously investigated.

The thiol-disulfide balance in the circulation will be measured by the automated system created by Erel \& Neselioglu(1).

References

1- Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem 2014;47:326-32. doi:10.1016/j.clinbiochem.2014.09.026.

Eligibility Criteria:
Inclusion Criteria:

• Histopathologically confirmed diagnosis of stage I endometrium cancer

Exclusion Criteria:

* pulmonary disease
* pulmonary hypertension
* cardiac dysfunction
* renal dysfunction
* liver disease
* chronic ishemia
* systemic inflammation
* concomitant malignancy
* patients who use vitamin A,C or E (antioxidant vitamins)
* patients who use smoke
* patients who use drink alcohol
* patients who use addictive for any drug
Healthy vs Unhealthy Obesity: Mehanistic Insights and Effects of Time-Restricted Eating

Obesity-related cardiometabolic diseases are now a leading cause of death worldwide. These diseases result from a dysfunctional adipose tissue (AT) that induces inflammation, insulin resistance and altered endocrine function. However, not all obese people develop metabolic complications, which has given rise to the concept of "metabolically healthy obesity" (MHO). Recent evidence suggests that intermittent fasting methods, in particular time-restricted eating (TRE) may be effective in improving cardiometabolic health, independently of weight loss, and this could be particularly effective in MUO subjects. The investigators hypothesize that in young male adults TRE is a more effective/beneficial approach in MUO than in MHO due to the weight loss-independent improvement in their inflammatory and metabolic derangements. To this aim, a 16-week 8h TRE intervention study will be performed in MHO and MUO subjects, assessing anthropometric, endocrine, and other outcomes.

Although clinical differences between metabolically healthy and unhealthy obesity (MHO and MUO, respectively) have been extensively described, cellular mechanisms involved in these different phenotypes are largely unknown. This evidence is crucial for proposing preventive and therapeutic approaches. Recently, intermittent fasting methods, in particular time-restricted eating (TRE, a self-selected daily limited eating window protocol), have shown to be effective in improving cardiometabolic health, independently of weight loss, which could be particularly relevant in MUO.

The investigators will recruit young (20-22y-old) males with obesity (Body Mass Index≥30) and classify them as MHO or MUO (≤1 or ≥3 metabolic syndrome risk factors, respectively). A 16-week, 8h TRE intervention will be conducted in MHO vs. MUO subgroups, to assess and compare the anthropometric, metabolic, endocrine, inflammatory and peripheral blood mononuclear cell (PBMC) mechanistic/signaling response.

The investigators expect to advance the understanding of cellular mechanisms implicated in MHO and MUO, including potential therapeutic targets. Ultimately, the investigators expect to find relevant opportunities for intervention to prevent the serious cardiometabolic consequences of obesity.

Eligibility Criteria:
Inclusion Criteria:

* Belong to the GOCS cohort at INTA
* BMI≥30
* Own and use a Smartphone with Apple iOS or Android OS
* Baseline eating period ≥ 13 h per day.

Exclusion Criteria:

* Medications for any metabolic syndrome disorder
* Shift workers
* Known inflammatory and/or rheumatologic disease
* History of cardiovascular event
* Thyroid or adrenal disease, malignancy or diabetes
* History of eating disorder.
* Special diet (e.g., celiac disease),or any other disease or treatment that may interfere with the study.
Clinical Evaluation of Lithium Disilicate and Hybrid Nano-ceramic Anterior Endocrowns (Randomized Clinical Trial)

the aim of this study was to evaluate the clinical performance of two CAD/CAM materials, hybrid nano-ceramic and lithium disilicate ceramic, in the fabrication of anterior endocrowns in patients with anterior endodontically treated teeth. While the postulated null hypothesis of this study was that there will be no significant difference between the performance of hybrid nanoceramic and lithium disilicate anterior endocrowns in patients with endodontically treated teeth.


Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene
* Patients having one or more endodontically treated molars that need prosthetic restoration.
* Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
* Fully erupted molars
* Molars free of developmental defect
* Healthy periodontium
* Absence of periapical pathosis
* Acceptable endodontic treatment and proper bone support

Exclusion Criteria:

* Patients with bad oral hygiene
* Patients with active periodontal disease
* Patients with missing teeth opposing to the area intended for restoration
* Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
Cycloergometer and Rotator Cuff Tear

The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine.

However, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.

To evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness RCT.

Since cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of RCT patients.

Eligibility Criteria:
Inclusion Criteria:

* positive imaging diagnosis of full-thickness RCT
* surgery not considered as the first treatment of choice
* willingness to sign the informed consent form.

Exclusion Criteria:

* inflammatory rheumatic diseases
* history of fracture or operations around the shoulder region
* neurological diseases
* infections or tumours
* diabetes
* coagulation diseases
* intra-articular injections of the involved shoulder within the last 12 months.
A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients

This is a two-part multiple dose study in healthy male and female (of non-child bearing potential) elderly volunteers, and in Alzheimer's disease patients, to assess the safety, effects on the body, and blood, CSF, and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients

Eligibility Criteria:
Inclusion Criteria:

* Part 1: Healthy elderly male and female (of non-childbearing potential) subjects.
* Part 2: Male and non-fertile female AD patients.
* Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Part 2: Clinical diagnosis of probable AD according to the NINCDS-ADRDA criteria.
* Part 2: Manifestation of AD symptoms at least 6 months before randomization.

Exclusion Criteria:

* Part 1: History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders.
* Part 2: Significant disease affecting the CNS other than Alzheimer's disease, including but not limited to other dementias, other significant neurological or major psychiatric disease.
* History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
* Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
* History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
NYC Heart Follow-Up Study 2010

This surveillance project will assess NYC population sodium intake using the gold standard measurement of 24-hour urine collection. This surveillance project is a critical component of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary industry reductions in processed food sodium content. The project will assess current population sodium intake, against which population intake changes at three years can be assessed


Eligibility Criteria:
Inclusion Criteria:

* \> 18 Years

Exclusion Criteria:

* Pregnant, breastfeeding or lactating; past or current dialysis
Acute Optimization of Cardiac Resynchronization Therapy (CRT)Using Echocardiography and SonR

The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.

A cardiac resynchronization therapy defibrillator (CRT-D) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. The CRT-D device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. A CRT-D device has three leads (wires that go to the heart). One lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. The top chambers are stimulated first, either by the natural heartbeat or by the CRT-D device if the heartbeat is too slow. Shortly after that, the bottom chambers are stimulated. By pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. The purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.

Based on the CRT implant, special measurements will be made to optimize the placements of the device leads. Based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups.

Group 1: Patients with no response

Patients with a successful response will be randomized to:

Group 2: Lead placement based on study measurements

OR

Group 3: Standard lead placement

Eligibility Criteria:
Inclusion Criteria:

* Must have been indicated for implantation or upgrade to a CRT-D system in the last 3 months
* Indicated for CRT according to current guidelines
* QRS Duration between 120 ms and 150 ms
* Able and willing to provide consent and Authorization of Use of PHI

Exclusion Criteria:

* Myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant
* Planned, or recent heart surgery or revascularization within the last three months
* Already enrolled in other study that precludes enrollment in this study per Principal Investigator
* Known Pregnancy at the time of enrollment
* Age less than 18 at the time of enrollment
* Unable to comply with follow-up requirements
* Chronic Atrial Fibrillation
* Recent history of medical non-compliance as determined by the investigator
* Unable or unwilling to provide consent and Authorization of Use of PHI
The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure

To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive was recorded.

To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.The diaphragm electromyogram (EMGdi) represents the neural drive to the diaphragm.A multi-pair esophageal electrode catheter was used to record the EMGdi.The PEEPi was assessed by the by the balloon-catheter in the multi-pair esophageal electrode catheter. In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive( EMGdi) was obtained from the a multi-pair esophageal electrode catheter All the signal recorded in the computer. The relation the nreural drive assessed by EMGdi and intrinsic positive end-expiratory pressure(PEEPi) would be analysed.

Eligibility Criteria:
Inclusion Criteria:

chronic obstructive pulmonary disease patients with respiratory failure

Exclusion Criteria:

1. Heart failure
2. cardiac dysrhythmia
3. Loss of consciousness
Clinical Performance Evaluation of Two Different Dental Implants

In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate to the present investigation
* Psychological appropriateness and good compliance to dentist instructions
* Patient who have been selected for implant therapy by an experienced surgeon.
Emergency Room Evaluation and Recommendations for Older Users of Emergency Departments

The study evaluates if the Emergency Room Evaluation and Recommendation Tool (ER2) reduces the hospital admission rate and the length of stay in Emergency.

Regardless of the reason for ED visit and its care plan, there are simple interventions, which may be continued to prevent short-term ED adverse outcomes. Delirium, motor deconditioning, adverse drug reactions due to polypharmacy, and inappropriate home support are the main conditions to target when taking care of older ER users.

Evidence based medicine showed that simple and early intervention in the process of care may prevent delirium (e.g., hydration, avoid restraint, mobilize and satisfy basic needs, time and place reorientation) and motor deconditioning (e.g., encourage mobility, up to chair at meal time during day light hours, provide appropriate walking aid) in older patients. The medication reconciliation is also an efficient intervention for the prevention of adverse drug reactions. Furthermore, an early assessment of home support is a crucial step to adjust home services for an early discharge to home.

Eligibility Criteria:
Inclusion Criteria:

* Being 75 years old and over
* Being brought at Emergency on medical stretcher

Exclusion Criteria:

* Being less than 75 years old
* Never come at Emergency
A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis

The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.

TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia)
* At least 18 years of age.
* ECOG PS 0, 1, or 2.

Exclusion Criteria:

* Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
* Major surgery or radiation therapy within 28 days prior to initiation of study drug.
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
* For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
* Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s).

Exclusion Criteria:

* Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months.
* Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
* Subjects with a known hypersensitivity to study drugs or their components.
* Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
* Uncontrolled diabetes mellitus.
* Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
* Current diagnosis of immunocompromising conditions.
* Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
* Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
* Extremely severe tinea pedis (incapacitating).
* Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.