cyrilzakka/clinical-trials huggingface dataset:
Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women

The purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to attempt sexual intercourse and/ or masturbation at least two times per week
* Ongoing relationship for at least 3 months
* Female subjects aging 40 years and more, Male subjects must be older than 18
* The participation in this study should be of free choice to male partners
* Willingness to perform a pregnancy test every month (for pre-menopausal subjects)
* Willingness to use contraception during the study period (for pre-menopausal subjects)
* Normal findings in the urogenital tract unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Primary sexual dysfunction
* sexual abuse
* severe psychiatric diseases
* untreated conditions and medication intake with associated reduction of sexual function.
* In male partners: any severe andrological or related medical problem.
Effects of L-citrulline Supplementation on Vascular Function in Metabolic Syndrome

The objective of this project is to provide evidence that L-Citrulline (CIT) supplementation can improve vascular function in the fasted and acute hyperglycemia conditions in middle-aged and older women with metabolic syndrome.

Using a double-blind, randomized, placebo-controlled, and parallel design, middle-aged and older women with metabolic syndrome will be randomized into receiving either CIT supplementation (10g/day) or placebo (Microcrystalline Cellulose) for 4 weeks.

The first visit will be approximately 1hr and 30 minutes. The 2nd and 3rd visits will each be approximately 2hrs and 30 minutes, separated by 4 weeks in between each visit. During visits 2 and 3, vascular measurements will be assessed in the fasted state and 30, 60, and 90 minutes after acute glucose ingestion (75g).

Eligibility Criteria:
Inclusion Criteria:

Must present at least 3 of the following 5 cardiometabolic risk factors

* Waist circumference ≥88 cm
* Fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%.
* Blood pressure ≥130 mm Hg
* Triglyceride ≥ 150 mg/dL
* HDL \<50 mg/dL

The following are also inclusion criteria's:

* Women aged 45-79 years old
* Body mass index ≤ 39.9 kg/m2
* Sedentary (defined as \< 120 min/week of exercise)
* Abstain from any dietary supplements with vascular effects for one month prior to the beginning of the study and until participation in study has terminated.

Exclusion Criteria:

* \< 45 and \> 79 years of age
* Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, biguanides, insulin, beta blockers, statins, verapamil)
* Systolic blood pressure ≥ 160 mmHg
* BMI \> 40 kg/m2
* Recent changes in medication (3 months)
* Current smoking any tobacco use
* Cardiovascular disease, diabetes (Type 1 or 2), and other metabolic or chronic diseases
* More than 7 alcoholic drinks/week of consumption
Stress Management Intervention in Women's Heart Clinic, Heart SMART Program

Will the intervention (Heart SMART program) be feasible in moderate or high stress patients, who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?

The Heart SMART Program is designed to offer a practical and efficacious stress management and resiliency intervention. It involves making participants aware of practices to enhance present moment awareness and engagement. It teaches learners to train their attention, and refine interpretation; utilizing principles of gratitude, compassion, acceptance, higher meaning and forgiveness. Participants will choose to use one of two delivery methods (either the face to face method or the on-line method) of the Heart SMART program.

Eligibility Criteria:
Inclusion Criteria:

1. Women age 25-75 years.
2. Able to speak English and complete questionnaire.
3. Self-reported Stress Scale 6 - 10 (visual analog scale of 1 to 10 with 1 being lowest stress and 10 being highest stress)
4. Women in face to face session will have to be able to attend the SMART session.
5. Women in the online group will be required to have the ability to use internet to access the online training material.

Exclusion Criteria:

1. Self-reported Stress Index \<6
2. Pregnant women will be excluded from participation in the study. Pregnancy test is not required because the intervention in this study poses no risk
3. Unable to give written consent
4. Inability or refusal to cooperate with study procedures
ST250 as a Therapeutic Option for Head & Neck Reconstruction

To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

After tonsillectomy procedures, the wound is usually left bare to heal. This causes severe pain postoperatively and postoperative hemorrhage. SupraTHEL 250 is a synthetic biodegradable PLA membrane which is proven as a skin membrane in burn wounds with excellent result. We therefore hypothesize that the use opf SupraTHEL 250 after tonsillectomy procedures will allow for faster , less painful healing of the wound bed which allows for a better quality of life for the patients.

Eligibility Criteria:
Inclusion Criteria:

* recurrent episodes of tonsillar infection

Exclusion Criteria:

* children
* pregnant/ breastfeeding women
* patients undergoing chemo / radiotherapy
Evaluation of Anxiety in Surgery Preoperative Area (ASDT)

Anxiety is associated with discomfort but also with an increased risk of pain and/or analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic consultation but without considering the real anxiety level of the patients. The objective of this premedication is mainly to improve patient comfort, to reduce patient anxiety and to improve patient cooperation.

According to a study conducted in the 1990s, 40 to 80% of patients are anxious before surgery.

Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and postoperative pain.

Preoperative area is a place of convergence for patients who need surgery or an interventional procedure.

Staying in the preoperative area may be a source of anxiety and may affect the patient management.

The investigators will interview patients undergoing surgery or interventional procedure to assess their level of anxiety, pain and their experiences during their stay in preoperative area. The objective is to analyse the level of anxiety and / or pain and their clinical consequences, and then to assess the relationship with any potential premedication.


Eligibility Criteria:
Inclusion Criteria:

* Patient in preoperative area before surgery or interventional procedure
* Patient to receive general anesthesia, local, locoregional, sedation,
* Agreeing to participate in the study after receiving information note,
* ≥ 18 years of age.

Exclusion Criteria:

* \< 18 years
Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects

The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues: the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique (DIPRF) These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration.

Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF); group 2 (control group) will be augmented by the conventional subepithelial connective tissue graft technique. Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes, including pain and satisfaction after the procedure will be recorded for both techniques. For each site, an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensions(tissue volumetric changes) will be recorded. These measurements will be obtained before the surgical procedure, 2 weeks, and 3 and 6 months post-surgical. CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects, and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Adults above the age of 18 to 50 years.
2. Males and females as confirmed by asking the female patients about whether they are pregnant or not
3. Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth.
4. Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft.
5. Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
6. Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue.
7. Good oral hygiene.
8. Patient accepts to sign an informed consent.
9. ASA I or ASA II Patient.

Exclusion Criteria:

1. Patients with ridge defects due to bone defect
2. Smoker patients who smoke more than 10 cigarettes per day
3. Pregnant females
Ultrasound Guided Femoral Nerve Block

The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of parenteral injection of opioid pain medication in patients presenting to the emergency department (ED) with hip fracture.

In this proposed protocol the investigators will conduct a prospective, randomized control trial comparing the efficacy of Ultrasound Guided Femoral Nerve Blockade (USFNB) versus the standard of care pain management by parenteral injection of opioid pain medication of patients presenting with hip fracture at the BIDMC ED. We hypothesize that USNFB approach will be non-inferior in achieving pain control (efficacy) and superior in the total dose of opioids (lower amount) as compared to the standard protocol. The enrolled population will be randomized 1:1 using a simple balanced randomization scheme.

Participants will be surveyed six times 6 times on a Visual Analog Scale (VAS)\* on their pain intensity reduction over 4 hours.

Physicians performing the block will be surveyed promptly following the procedure regarding difficulty performing the block and its efficacy.

Specific Aim #1: The investigators hypothesize that in patients presenting to the ED with hip fracture, USFNB will demonstrate equal efficacy in pain relief with fewer side effects when compared to conventional parenteral opioid therapy. The investigators evaluate this hypothesis by monitoring Visual Analogue Scales (VAS) in patients receiving either USGFNB or opioid therapy over the first 4 hours of observation. The side effects will be noted during the same interval of time.

Specific Aim #2: The investigators hypothesize that in patients presenting to the ED with hip fracture, USFNB will reduce the amount of narcotic used to control pain. The investigators will evaluate this by studying narcotic use over the first 4 hours of evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age presenting to the ED with radiographically established intra-, extracapsular hip fracture, able to consent and participate in the study and who have moderate to severe pain (numerical pain score \>= 31) at the time of enrollment.

Exclusion Criteria:

* Patients with a previous history of hypersensitivity to local anesthetics,
* Patients who have signs of a local infection at the site of planned needle placement.
* INR \> 1.4NOAC use within 48 hours
* Prophylactic Low-Molecular Weight Heparin (LMWH) within 12 hours
* Therapeutic LMWH within 24 hours
* Prophylactic Unfractionated Heparin (5000 Units BID or TID) within 6 hours
Effect of Proprioceptive Neuromuscular Facilitation Techniques on Elderly People with Scapular Disposition

Proprioceptive neuromuscular facilitation (PNF) has been defined as a comprehensive rehabilitation approach focusing on a motor learning effect, especially in the elderly. Therefore, PNF can be an effective treatment method for our purpose which is to analyze if PNF techniques improve balance and gait characteristics in elderly with scapular disposition and to determine the difference when used with the gait education

Participants will be randomly divided into 2 groups. Scapular PNF techniques in addition to gait training will be applied to the 1st group for 8 weeks, and only gait training exercises will be applied to the 2nd group for 8 weeks. Individuals will be evaluated in detail at the beginning, and end of the study, and after 3 months as a follow-up evaluation. For the assessment of scapular disposition, the Visual Scapular Disposition Test and Lateral Scapular Slide Test will be applied. Walking Speed will be evaluated with a dedicated area by measuring the distance. The Modified Dynamic Gait Index will be used for measuring the ability of the participant to maintain walking balance while responding to different task demands. For fall risks and functional mobility Timed Up and Go Test and Falls Efficacy Scale will be used. For balance assessment Berg Balance Scale and Functional Reach Test. For assessment of the quality of life, SF-36 will be used. Posture will be assessed with a dedicated application called PostureCo

Eligibility Criteria:
Inclusion Criteria:

* Having scapular disposition (Patients will be determined after the visual scapular disposition test and lateral scapular slide test)
* With no injuries
* Able to walk without any assistive devices
* To be able to read and write in Turkish

Exclusion Criteria:

* Having a musculoskeletal or neurological problem that causes issues with applying the intervention.
* Any orthopedic, neurological, cardiac, vestibular, visual, or psychiatric impairment which would not allow them to perform
* Had physiotherapy during the past 3 months
Immune Response to Hepatitis C Virus

This study will identify and characterize immune factors involved in hepatitis C infection and elimination of the virus. Individual responses to hepatitis C infection vary; some people are able to eliminate the virus, whereas others remain chronically infected. This study may identify factors important in preventing infection that may be of help in developing a vaccine or more effective treatments.

People over 18 years old who have been exposed to hepatitis C virus may participate in this study. Subjects will be recruited from the National Institutes of Health, Inova Fairfax Hospital, Occupational Medical Services-IDP P.C., Washington Hospital Center and Holy Cross Hospital, all in the Washington, D.C. metropolitan area. Individual patients from other centers will also be recruited on a case by case basis.

Participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. The first collection will be as soon as possible after exposure to hepatitis C virus and then again at 2, 4, 6, 12, 24, and 48 weeks after exposure. The white blood cells will be studied for their response to the virus, and markers for infection will be followed. If infection develops, additional samples of blood may be requested, and patients will be offered evaluation for treatment. Test results will be kept confidential and will not be entered into any medical records.

The course and outcome of hepatitis C virus (HCV) infection is determined by both host and viral factors, none of which have been well defined. In this study, we will follow and assess patients who are occupationally exposed to HCV for viral and immunologic factors that may relate to disease outcome. This protocol is mostly a sample acquisition protocol to support laboratory research. Patients will be interviewed and have blood (and lymphocytes) taken as soon as possible after exposure and again after 2, 4, 6, 12, 24 and 48 weeks. Virological markers, serum antibodies and both CD4 and CD8 T cell responses to HCV will be monitored. Persons who develop hepatitis C will be referred for therapy or enrolled in therapeutic trials currently in place at the National Institutes of Health. These studies will help define the relative roles of virological and immunological factors in determining the course and outcome of HCV infection.

Eligibility Criteria:
* INCLUSION CRITERIA:

Male or female;

All ethnic groups;

Age above 18 years;

Defined exposure to hepatitis C.

EXCLUSION CRITERIA:

Subjects with a Hct of less than 30.
Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy

The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.


Eligibility Criteria:
Inclusion Criteria:

* Is an acute ischemic stroke patients with evidence of intracranial vascular occlusion
* Is enrolled in principle within 8 hours of symptom onset
* Has treatment plan that includes stent retriever
* Has protocol-defined scores on several scales

Exclusion Criteria:

* Has treatment plan that includes fibrinolysis or fibinolysis
* Has identified intracranial hemorrhage or subarachnoid hemorrhage
* Has active bleeding like gastrointestinal hemorrhage
* Has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
* Has severe hepatic or renal impairment
* Has been a participant in other clinical trial within 30 days prior to treatment
* Is pregnant, lactating, or planning on becoming pregnant during treatment period
* Has any condition or history that might, per protocol or in the opinion of the investigator, compromise:

  1. safety or well-being of the participant or their offspring
  2. safety of the study staff
  3. analysis of results
Surface Electromyography in Stratifying Chronic Low Back Pain.

Surface Electromyography can be utilised to detect normal muscle electrical activity during maximum forward flexion termed Flexion Relaxation Response (FRR)

In this study, our primary objective is to assess FRR and disability (ODI) correlation protocol as an objective tool in stratifying Chronic LBP. We also would like to evaluate the relationship between FRR with pain intensity and lumbar range of motion as our secondary objective.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged between 20 - 70 years old
* Mechanical LBP \> 6 weeks (not acute LBP)
* Not received any specific exercise spinal manipulation or surgery to improve LBP within the last 3 months.

Exclusion Criteria:

* Pregnancy
* Radicular LBP patients or specific-spinal pathology / "red-flags".
* Surgical intervention for the current LBP complaint (includes traumatic causes of LBP with surgical intervention)
* Cognitive or communication difficulty preventing active participation in exercises or communicating pain scores
Influence of Vitamin C on Post-operative Atrial Fibrillation

Post-operative atrial fibrillation (POAF) is the most common arrhythmia which typically develops 2-3 days after cardiac surgery. The incidence of POAF variates between 10% and 65% depending on the type of cardiac surgery and is especially high in patients which underwent Coronary Artery Bypass Grafting (CABG) and heart valve surgery. POAF is associated with increased morbidity and mortality and has a major impact on hospital resources.

The precise pathogenesis of POAF is very complex, but several studies have demonstrated an association between inflammation, oxidative stress and POAF. Since this oxidative stress may be reduced by dietary anti-oxidantia such as vitamin C, the aim of this study is to evaluate the effect of oral vitamin C administration of the incidence of POAF.

After obtaining informed consent, patients which are planned for CABG or heart valve surgery are randomly assigned into the Vitamin C group or Placebo Group.

Each patient will receive 1 g Vitamin C or Placebo twice a day from 5 days before until 10 days after surgery. The medication will be given orally and both patient and surgeon are blinded for the administrated medication.

Patients receive standard of care in the post-operative period, which includes close monitoring for possible arrhythmias. If such an arrhythmia develops, this is treated according to the normal procedures. All information such as the used medication, the hospitalization / ICU length of stay and the ventilation time is automatically registered in the patient records.

From each patient, three additional blood samples (peri-operative, post-operative Day 0, post-operative Day 1) will be obtained for analysis of Neutrophil gelatinase-associated lipocalin (NGAL), a possible marker of subclinical kidney damage. These samples will be analysed in batch once all samples are collected.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* eligible for elective cardiac surgery
* preoperative sinus rhythm

Exclusion Criteria:

* patients who do not want to participate
Study in ICU Patients Regarding Protein Intake and CT-derived Body Composition

The purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients.

Optimal protein and energy intake have been shown to be relevant for reducing mortality in prospective observational studies in mechanically ventilated patients admitted to the intensive care unit. However, nutritional status (protein mass, muscle mass) of patients at admission and possible consequences for clinical outcome are largely unknown. Computerized tomography scans can be used to assess muscle mass as a proxy for body protein mass.

The investigators are especially interested in the effect of protein intake on clinical outcome in intensive care patients with different body protein mass at admission. This is relevant for appropriate formulation of clinical (protein) nutrition in this patient group. Therefore, the relationship between protein intake and patient outcome is evaluated in intensive care patients with low muscle and normal muscle area, using muscle area from computed tomography scans as a proxy of body protein mass.

Additionally, data from computed tomography scans regarding muscle quality and muscle- and fat quantity are used to evaluate the prognostic value of body composition at intensive care admission. Finally, abdominal computed tomography scans are compared with thoracic computed tomography scans.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal computed tomography scan made 1 day before up to 4 days after admission to the intensive care unit
* Length of intensive care stay of at least 4 days
* Mechanical ventilation during intensive care stay

Exclusion Criteria:

* Computed tomography scan not eligible for analysis
* Missing data