cyrilzakka/clinical-trials huggingface dataset:
Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.

Vagus nerve stimulation group Group:

1. Each participant signed a consent form after receiving a detailed explanation about the procedure.
2. Patients rested on their sides in a sitting position.
3. Disinfection of the stimulation locations.
4. Ear clips were placed in the ear region (auricular concha) at the stimulation site.
5. Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
6. Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again.

Circuit training group Group:

1. Each participant will signed a consent form after receiving a detailed explanation about the procedure.
2. The training regimen included ten different forms of resistance and aerobic exercises.
3. Emotional eating was assessed by Emotional Eating Scale.
4. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).

5 Cortisol was assessed in lab. 6. After one month all the assessment procedure will be repeated again.

Eligibility Criteria:
Inclusion Criteria:

having two or more than one of the following:

* Type 2 diabetes Miletus
* Hypertensive.
* Abnormal Cholesterol or Triglyceride level.
* BMI more than 30 kg/m
* Waist circumference more than 94 cm.

Exclusion Criteria:

* Vagotomy.
* Diathermy.
* Wallowing difficulties.
* Dyspnea.
* Cardiac arrhythmia.
* Seizure.
* Previous brain injury or surgery.
* Dysautonomia.
Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment

The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.


Eligibility Criteria:
Inclusion Criteria

* Subjects aged 35 to 50 years old
* Subjects with the intention to undergo facial aesthetic treatment and who are likely to benefit from a combination of injection treatments and the benefit can be shown by improvements in their global facial aesthetic appearance and satisfaction.
* Subjects with nasolabial folds assessed as mild or moderate.
* Subjects with upper facial lines to be treated (at least two of glabellar lines, crow´s feet and/or forehead lines) assessed as moderate or severe, when the severity of the lines has an important psychological impact on the subject.
* Subjects with signed informed consent.

Exclusion Criteria:

* Obvious facial sagging (major loss of facial fat/volume).
* Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.
* Heavily scarred or sun-damaged facial skin.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.
* Cancerous or pre-cancerous lesions in the areas to be treated.
* Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.
* Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.
* Any aesthetic surgery of the face.
* Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face.
* History of severe keloids and/or hypertrophic scars.
* Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration.
* Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics.
* History of autoimmune diseases.
* Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs \[NSAIDs\]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
* Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.
* Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.
iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men

This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.

PRIMARY OBJECTIVES:

I. Plan and develop a PPCD iCCaRE ViRA model that will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research.

II: Establish the acceptance and usability of the iCCaRE ViRA at a urology clinic among 50 Black men (BM).

OUTLINE: This is an observational study. Participants are assigned to 1 of 5 cohorts.

COHORT I: Consumer advocates attend a focus group on study.

COHORT II: Clinicians complete interviews on study.

COHORT III: iCCaRE project representatives test the virtual health intervention, complete a survey, and attend a focus group on study.

COHORT IV: Non iCCaRE affiliated member tests the virtual health intervention, complete a survey, and attends a focus group on study.

COHORT V: Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1: iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research \& Clinical Intervention Services core, and non-iCCaRE affiliated member.
* AIM 2 ALPHA TESTING: 1 representative from each of the other iCCaRE five projects and six cores/services and 1 non iCCaRE affiliated member
* AIM 2 BETA TESTING-PATIENTS:

  * A Black male
  * A patient who has been diagnosed with prostate cancer in Florida
  * Have an abnormal PSA and/or DRE lab value within the previous 6 months
  * Minimum age of 30 yrs
  * Consent to participating in the intervention

Exclusion Criteria:

* AIM 2 BETA TESTING-PATIENTS:

  * Patients who are not Black males
  * Not patients at a urology clinic
  * Have normal PSA and/or DRE lab values within the previous 6 months
  * Older than 80 yrs
  * Are not willing to consent
Losartan in Hypertensive Men and Women With Sleep Apnea Before and on Continuous Positive Airway Pressure (CPAP) Treatment

Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup.

OSA is a highly prevalent condition in hypertensive patients and the prevalence is even higher in patients with drug-resistant hypertension. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, has an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup. The investigators will include 90 otherwise healthy, untreated hypertensive men and women(age 50-69 yrs, Body-Mass-Index \<35 kg/m2; 60 patients with OSA, 30 non-OSA) as described above. Before start of treatment, fasting blood samples will be drawn regarding the neuroendocrine hormones (adrenaline, noradrenaline, plasma renin activity, angiotensin II,aldosterone, pro-BNP) and cardiovascular biomarkers (CRP,interleukines, cytokines). All subjects will start with Losartan 50 mg and 24 h- blood-pressure response and blood sample analysis will be compared between OSA and non-OSA subjects after 6 weeks of treatment. In the second 6-week period, all subjects will continue with Losartan while the half of the OSA group (n=30) will be randomized to CPAP and the other 30 patients will continue with Losartan only.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \<35 kg/m2
* Systolic Blood Pressure \>=140 mmHg and/or Diastolic Blood Pressure \>=95 mmHg
* No known clinical disease except hypertension
* No cardiovascular medication
* Apnea-Hypopnea Index \< 5/h (no OSA), or Apnea Hypopnea Index \>=15/h (OSA)

Exclusion Criteria:

* Manifest diabetes, liver- or kidney disease Signs of atrial fibrillation or former myocardial infarction at electrocardiogram
Endometrial Injury in Women With Unexplained Infertility

Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.

A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath.

The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure.

Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 39 years old.
2. Normal HSG and/or diagnostic laparoscopy.
3. Normal seminal profile.
4. Regular ovulation confirmed by mid-luteal progesterone.
5. Normal TVS criteria.

Exclusion Criteria:

1. Uterine fibroid.
2. Pelvic endometriosis.
3. Irregular menstruation.
4. Ovarian cysts.
Efficacy of Diclofenac on Pain During Endometrial Sampling

Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number of patients, the diagnosis of its cause is performed via fractional curettage under local anesthesia such as paracervical nerve block or intravenous meperidine.

Pain is one of a common adverse effect of this procedure and this topic should be concerned by a responsible doctor.

NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain control and is as effective as coxib in acute pain management. Because of its cost, easy accessible and easy administration, Diclofenac Potassium was selected to be used in this study. Its onset of action is about 1 hour and only one dose of this drug do not cause any serious side effects.

The hypothesis of this study is that "Diclofenac Potassium has an additional effectiveness for acute pain control in patients undergoing fractional curettage under paracervical nerve block due to abnormal uterine bleeding" Double blind randomised controlled trial was performed in this study with 45 patients included in each group.


Eligibility Criteria:
Inclusion Criteria:

* Thai women at the age over 35 years old
* Presenting with abnormal uterine bleeding and have a plan of performing fractional curettage

Exclusion Criteria:

* uterine anomalies
* pregnancy
* Pelvic inflammatory disease
* Uncontrolled medical conditions
* Known cases of gynecological diseases such as gynecological malignancy, abnormal pap smear
* NSAIDs allergy
* contraindicate to NSAIDs use
A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers

The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that renal clearance of metformin is affected in Caucasian with the known single nucleotide polymorphisms A270S in OCT2.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written consent
* rs316019 genotyped
* Age 18-65 years old

Exclusion Criteria:

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding
Dysfunctional Hemoglobin Pulse Oximetry

The purpose of the study is to assess device performance in the presence of carbon monoxide.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female.
* The subject is of any racial or ethnic group.
* The subject is between 18 years and 50 years of age (self-reported).
* The subject does not have significant medical problems (self-reported).
* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
* Exclusion Criteria:
* Has a BMI greater than 30.0 (calculated from self-reported weight and height).
* Has had any relevant injury at the sensor location site (self-reported).
* Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
* Has a known respiratory condition (self-reported).
* Is currently a smoker (self-reported).
* Has a known heart or cardiovascular condition (self-reported).
* Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).
* Is female and actively trying to get pregnant (self-reported).
* Has a clotting disorder (self-reported).
* Has Raynaud's Disease (self-reported).
* Is known to have anemia (hemoglobin value below lower range of normal for gender)
* Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).
* Is known to have a inherited or congenital methemoglobinemia (self-reported).
* Has unacceptable collateral circulation from the ulnar artery (based on exam).
* Is unwilling or unable to provide written informed consent to participate in the study.
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Trial Regarding the Acceptability of Audiotape Intimate Partner Violence (IPV) Screening

The purpose of this study is to compare the safety, acceptability and ease of the administration of two screening methods, a pen and paper questionnaire and an audiotape with headsets, for screening for intimate partner violence in a pediatric emergency department (ED).

Intimate partner violence (IPV) is a significant health problem, affecting 2 - 4 million women each year. Over half of the homes in which women are abused contain children, with 3.3 - 10 million children witnessing IPV each year. In 1998, the American Academy of Pediatrics (AAP) issued guidelines stating that "identifying and intervening on behalf of battered women may be one of the most effective means of preventing child abuse," and recommending that pediatricians perform routine IPV screening. Because of the substantial number of families seen in the emergency department (ED), this setting could provide an important site in which to implement universal screening. Exactly how to implement screening in this busy environment is unclear. One possible approach involves the use of an audiotape with a headset with a prerecorded screening questionnaire that prompts the respondent to circle "yes" or "no" answers on an otherwise blank sheet of paper. This method of screening has the potential benefits of:

* Providing a more private method of screening;
* Improving screening of women who cannot read well;
* Enhancing the rate of screening by removing the burden of screening from providers.

Comparison: Female caregivers in a pediatric ED will be randomized to answering domestic violence (DV) screening questions either via pen and paper or via audiotape. After answering these screening questions, all women will be asked standardized questions about the acceptability, safety and ease of use of the method to which they are randomized.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 or an emancipated minor

Exclusion Criteria:

* Child undergoing acute resuscitation
* Other adults in the room
A Multicentre, Retrospective Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors

The primary endpoint of the study was the acute GvHD incidence, the secondary endpoints were chronic GvHD incidence, overall survival (OS), transplant related mortality (TRM) incidence, relapse incidence (RI) and neutrophil and platelets engraftment after GvHD prophylaxis with ATG-CSA-MTX or PTCy-MMF-FK506


Eligibility Criteria:
Inclusion Criteria:

* children and adults)
* HSCT from a one-antigen mismatch unrelated donors
* Treated at the Centro Trapianti Metropolitano di Torino between 2012 to 2017

Exclusion Criteria: none
Haemodynamic Effect of Dexmedetomidine

Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients.

The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure and heart rate variability during drug infusion) depend on pre-drug autonomic system activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement before drug injection and during drug infusion. Heart rate and blood pressure measured before and during drug infusion will be analysed.

HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug injection and during its infusion. 5 minutes intervals will be analysed , using Frequency Domain Measures of HRV. Surgical procedure will start after measurement have been taken.


Eligibility Criteria:
Inclusion Criteria:

* patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
* planned eye surgery under sedation

Exclusion Criteria:

* patient's refusal
* contraindications to dexmedetomidine
* diseases/drugs that influence on autonomic nervous system activity
Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)

This is a study of ABT-126 in the treatment of cognitive impairment associated with schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).


Eligibility Criteria:
Inclusion Criteria:

* The subject was randomized into Study M10-855 and completed through Week 26 in that study.
* The subject is receiving one or more antipsychotic medications.

Exclusion Criteria:

* Additional history collected during participation in Study M10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia.
* The subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ECG) measurements in Study M10-855 that indicates the subject is likely to become medically unstable during the current study.
* The subject is currently taking or is expected to be prescribed any excluded medication without the approval of AbbVie medical monitor.
* The subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial.
A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes

This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.


Eligibility Criteria:
Inclusion Criteria:

* female patients between 18 and 65 years old
* patients with metastatic breast cancer previousely treated with A/T
* able and willing to give consent to participate in the study

Exclusion Criteria:

* pregnant or lactating females
* other tumor history
* instable complication (e.g., myocardial infarction within 6 months,arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
* concurrent disease or condition that would make the patient inappropriate for study participation
* resist to participate in the study