cyrilzakka/clinical-trials huggingface dataset:
Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow

The purpose of this study is to determine if blood flow to the clitoris is increased by topically applying a cream that causes increased blood flow. This will be measured with a sonogram.

On the first office visit the patient will have their baseline clitoral and uterine blood flow measured quantitatively by the same sonographer using the General electric Voluson 700 unit. Clitoral blood flow will be accessed utilizing the 12 megahertz linear probe. With light pressure, the probe will be applied sagittally and proximal to the clitoral hood with an angle less than 20 degrees. Peak clitoral artery systolic and end diastolic velocity will be measured and resistive index values will be recorded. Then utilizing the 7.5 megahertz vaginal probe baseline uterine artery flow measurements will also be obtained and recorded.

The patient will then be placed in an exam room and the same nurse practitioner will apply the GRAS cream or the placebo to the patients' clitoral hood with minimal manipulation. Ten minutes later the sonographer will repeat the two scans and record the same measurements as before. The patient will then come back another day to repeat the above process. Patients will be coded to assure that which ever cream they received the first visit they will get the opposite the second time. The creams will be blinded to the nurse practitioner, the patient, the sonographer, and the principle investigator.

GRAS cream is arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%,

Eligibility Criteria:
Inclusion Criteria:

* Healthy sexually active females ages 25-60 years

Exclusion Criteria:

* Not eligible if they are experiencing sexual pain disorders
* Psychological sexual aversion disorders
* Vaginismus
* Pregnant/nursing
* Diabetes mellitus
* Central nervous system disorders
* Psychosis
* Currently on any SSRI's, or any other condition that may effect the patient from reliably signing the informed consent.
Effect of Fluid Oral Intake During Labour

Fasting during labour is a usual conduct in many hospitals around the world (due to the theorical risk of bronchoaspiration). There is little evidence supporting this conclusion. Besides, there are several studies that suggest that food intake during labour can be associated with shorter labours and a lower cesarean rate. The aim of the investigators study is to show if the oral intake of fluids during labour can reduce the first stage of labour with minimum risk to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 37 weeks.
* Cervical dilation \< 5 cms.

Exclusion Criteria:

* Maternal pathologies (diabetes, heart disease, preeclampsia)
* Breech presentation or any other condition that is an indication of cesarean section.
* Premature rupture of membranes.
Examining the Impacts of Fidget Technology on Attention in Children With ADHD

Purpose: The purpose of this study is to investigate the usage of fidget technology and its effects on attention, working memory, and comprehension in children ages 6-13 with Attention Deficit Hyperactivity Disorder (ADHD). This study aims to examine the implications of fidget usage 2 different measures of attention; attentional control (working memory domain) and comprehension (recall, encoding, and recognition).

Participants: 6-13 year-old clients at 3-C Family Services, a private mental health clinic in Cary, NC, with a diagnosis of ADHD (Inattentive, Hyperactive, or combined types). Exclusion criteria: participants with an Intelligence Quotient (IQ) below 70 as estimated by referring 3-C clinical staff, or any history of psychosis.

Procedures (methods): This research will use a demographic and background collecting survey to gather relevant data about each participant. Parents will be asked to fill out a baseline ADHD Rating Scale-IV: Home Version (ADHD-RS), to account for their child's symptoms of ADHD over the past 6 months. Participants will be randomly assigned to one of 2 conditions, an experimental group where participants select a fidget, and a control group where participants are not provided a fidget. Fidget options will include a fidget spinner, pop-it, stress ball, and fidget cube as not all children would benefit from the same type of fidget equally. Participants in the experimental group will then be allowed to practice with and familiarize themselves with the fidget for 1 minute to decrease the attentional drain that the fidget may pose in its initial state.

After random assignment to either control or experimental group, participants in each group will then complete the same 2-back version of the N-back Attention Control Task (cognitivefun.net), and a video comprehension multiple choice test. After 3 minutes N-back scores will be recorded including visual correct ratio and visual response time scores. The video comprehension item is adapted from Lee and List, 2019. The video is a Ted Talk titled "The Survival of the Sea Turtle" ( https://www.youtube.com/watch?v=t-KmQ6pGxg4). Items in the multiple choice test will be aggregated to a score of percent correctness for each participant. Participants may request to have questions read to them by the research assistant present.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD

Exclusion Criteria:

* Psychosis
* IQ under 70
Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery

Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class effect, and Sevoflurane is the most widely used today.

In humans, the protective effects of halogenated agents have principally been studied in heart surgery and have shown encouraging clinical results. It seems that HAA induce both pre-conditioning of the myocardium (early and late) and post conditioning.

Given these protective effects of HAA, in 2007, the American Heart Association (AHA) recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients with a high cardio-vascular risk. The aim of this study is to show a decrease in rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane anaesthesia, in the post-operative period following vascular surgery with clamping


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided written consent
* patients over 18 years of age
* patients undergoing scheduled vascular surgery with high clamping for:
* Abdominal aortic aneurysm
* suprapopliteal vascular bypass (aorto-bi-femoral, femoral trifurcation, ilio-femoral or femoro-femoral, femoro-popliteal).

Exclusion Criteria:

* persons without health insurance cover
* patients younger than 18 years of age, pregnant or breast-feeding women and adults under guardianship
* patients with epilepsy
* emergency surgery
* patient presenting a contra-indication for Sevoflurane: hypersensitivity to sevoflurane or to other halogenated anaesthetic agents, myopathy, hyper-eosinophilia, immunoallergic hepatitis, known or suspected genetic predisposition to malignant hyperthermia
* patients presenting a contra-indication to the use of Propofol: known hypersensitivity to propofol or to one of the constituents of the product, allergy to peanuts or soja
* Patients presenting a contra-indication for sufentanil: hypersensitivity to sufentanil or to opioids
* Association with opioid agonists-antagonists or partial opioid antagonists
* patients presenting a CI for the use of Cisatracurium: history of allergy or hypersensitivity to cisatracurium or atracurium
* patients presenting cardiac, respiratory, renal or kidney failure, hypovolemia, poor general health
* Patients with a risl of prolongation of the QT interval
* Patients with end-stage renal failure - requiring dialysis
Fibromyalgia Syndrome on Patients With Chronic Migraine

The aim of this study to evaluate the effects of fibromyalgia syndrome accompanying women with chronic migraine on pain, quality of life, sleep, anxiety and depression, central sensitization and functionality.

Patients who applied to Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Neurology, headache outpatient clinic and were diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), after the patient's history and physical examination, will be included in the study.

Date of birth, education level, body mass index, occupation, marital status, socioeconomic status, age of onset of migraine complaints, descriptive information about migraine attacks (type (with or without aura), duration of attacks, average number of days with pain, pain severity, accompaniments) will be questioned.

In addition, if the fibromyalgia syndrome meets the diagnostic criteria, symptom duration and average body pain severity in the last 3 months will be questioned.

A total of 66 patients are planned to be included in the study. In the study, 2 groups will be formed, the first group will consist of chronic migraine patients, the second group will consist of patients with chronic migraine as well as fibromyalgia syndrome.

All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization. Relevant forms will be filled by patients.

Patients will be evaluated with the diagnostic criteria for fibromyalgia syndrome and if the patients meet the diagnostic criteria for fibromyalgia syndrome, the Fibromyalgia Impact Questionnaire will be applied. The patient will be evaluated by Alper Mengi in terms of fibromyalgia syndrome diagnostic criteria.

Eligibility Criteria:
Inclusion Criteria:

For patients with chronic migraine:

* Being diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3)
* Being literate

For patients with fibromyalgia syndrome:

* Diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3)
* Being literate
* Diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology criteria

Exclusion Criteria:

* Having another pathology that can explain their pain in the head and face region other than chronic migraine (such as sinusitis, tension-type headache, trigeminal neuralgia, drug overuse headache)
* Psychiatric disease or using psychiatric drugs
* History of serious head trauma or neurosurgical intervention
* History of infectious, chronic inflammatory disease, malignancy
* Pregnant and breastfeeding women
* History of additional neurological disease other than migraine
* Uncooperative
* Having congestive heart failure, chronic kidney failure, chronic liver disease, lung disease, uncontrolled diabetes, peripheral vascular disease
* Diagnosed with hypothyroidism or hyperthyroidism
ENHANCE - Evaluating the Implementation of Head and Neck Cancer E-health

The NHS Long Term Plan has an ambition to provide patients with digital services and tools to give them more control over their own health and care. Guy's Cancer Centre in London (UK) is offering patients with head and neck cancer (HNC) the use of a smartphone cancer support app. Few studies have evaluated the best way to implement apps to support patients with cancer, nor explored how they could help patients to self-manage. This is a hybrid implementation-effectiveness study to evaluate the implementation of a cancer-specific self-management app currently being used at Guy's Cancer Centre. The purpose of the study is to assess the following: (1) key implementation outcomes, including acceptability and usability; (2) barriers and facilitators to patients and staff using the app; (3) the effectiveness of the app to support patients to self-manage during treatment for HNC.

Eligible participants include patients being treated for HNC, and their oncology clinical team. The study will be conducted at Guy's Cancer Centre, a comprehensive cancer centre in London, UK.

The study will employ mixed methods. Data collection will involve questionnaires to measure the acceptability and usability of the app, and routinely collected patient-reported outcome measures. In addition, a sub-sample of participants will take part in semi-structured interviews to explore how the app was used and views about the implementation process. Findings from this study will identify barriers and facilitators to using the app and context about how it may help patients to self-manage their condition. These findings will help to refine ongoing development of digital cancer services. Findings will inform the development of recommendations for the integration of digital health in cancer services that can be shared with Cancer Alliances across the UK.


Eligibility Criteria:
Inclusion Criteria:

* Individuals currently undergoing treatment for head and neck cancer, under the care of an oncologist, or
* Health professionals involved in the care of patients using the app, or involved in the implementation of the app

Exclusion Criteria:

* Individuals who are not able to speak or understand English, due to no translation services available
* Patients with ECOG Performance Status Scale level 3 or 4 at baseline
Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

Investigation Device: EZVent Ventilator System is designed for respiratory support in hospitalized mechanical ventilated patients. The Ventilator is designed to be used for adults patients. It is designed to be a stationary product suitable for service in hospitals, critical care situations to provide continuous positive pressure respiratory support to the patient. The ventilator met EDA, ISO 80601-2-12 requirements on essential performance of critical care ventilator and other applicable international standards.

Study Title: Open-labeled, non-randomized, self-controlled study to evaluate the safety and performance of EZVent in hospitalized mechanically ventilated patients. Investigational Device EZVent Ventilator System.

Purpose: Evaluation of the safety and performance of EZVent in hospitalized mechanically ventilated patients.

Objectives: Evaluation of the safety and performance of EZVent through monitoring the vital signs and arterial blood gases (ABG) in comparison to a commercial ventilator.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 years or above.
* Mechanically ventilated Patients (on either VC, PC or CPAP modes).
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Considered clinically stable, with FiO2 less than 60% and PEEP no greater than 10 cm H2O

Exclusion Criteria:

* Pregnant Women
* Patients who experienced myocardial infarction within the last 6 weeks.
* Shocked patients, Hemodynamic instability requiring vasopressors, cardiac arrhythmias, terminal malignancy.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
* Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
* Clinically normal physical exams and laboratory measurements

Exclusion Criteria:

* Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
* Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.

This is a phase Ib/II study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg and 1.6mg/kg dose level, Phase II study is a multi-center, randomized, double-blind, placebo control study to evaluate the safety and efficacy of IMC-002 in active Systemic Lupus Erythematosus patients.

Eligibility Criteria:
Inclusion Criteria:

* Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
* SLEDAI total score ≥ 6 at screening
* BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
* Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
* Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

* Active or unstable neuropsychiatric SLE or lupus nephritis
* Autoimmune or rheumatic disease other than SLE
* Significant, uncontrolled medical conditions not related to SLE
* Active and/or severe viral, bacterial or fungal infection
* History of malignancy within 5 years
* Other protocol defined exclusion criteria may apply.
L-Carnitine and Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

The purpose of the study to assess the efficacy of adding L-carnitine to clomiphene citrate for increasing the ovulation and the pregnancy rate in women with PCOS.

A total of 106 women with the diagnosis of PCOS based on the European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria, 2003) will be randomly assigned using a computer-generated randomization sheet and they will be distributed into two groups:

1. Group L (53 patients):

   This group will receive oral clomiphene citrate (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle plus oral carnitine supplementation (Carnivita Forte, Eva Pharma, Egypt) (1g tablet, three times per day) from the third day of the cycle until the day of the pregnancy test.
2. Group C (53 patients):

This group will receive oral clomiphene citrate only (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle. Serum FSH, LH \& free testosterone concentrations will be measured on day 3 (basal) of the cycle. Trans-vaginal folliculometry will be performed on all women on days 7 and 9 of the cycle and then individualized according to the response. When one leading follicle attains a diameter of 17mm or more, the endometrial thickness will be measured and 10,000 IU of Human chorionic gonadotropin (hCG) will be given (im injection; Pregnyl, organon, Holland). Timed intercourse will be advised after 36-48 hours from the night of hCG administration for 2 successive days. Ovulation success will be confirmed by transvaginal ultrasound which will show that the leading follicle has collapsed, and some fluid appeared in the Douglas pouch.

Serum progesterone will be measured on day 8 post hCG injection, ovulation will be confirmed if the serum progesterone level is ≥ 5 ng/ml (Leiva et al., 2015).

Luteal-phase support will not be provided in both groups. Pregnancy test will be done in the form of testing the level of beta hCG in the blood after 14 days once the success of the ovulation process has been confirmed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 18-35 years.
2. Normal Hysterosalpingo-graphy (HSG).
3. Normal Semen analysis of the husband.
4. Diagnosed with PCOS based on the (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria 2003).

Exclusion Criteria:

1. Patient's refusal.
2. Male factors of infertility and/or abnormal HSG.
3. Hyperprolactinemia (prolactin ≥ 22 ng/dl).
4. FSH on day 3 \> 15 mIU/mL.
5. Gross ovarian pathology diagnosed by ultrasound.
Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.


Eligibility Criteria:
Inclusion Criteria:

* Primary Open Angle Glaucoma
* Progression
* Failure to reach target IOP
* Non compliant

Exclusion Criteria:

* Resurgery
* Systemic contraindication to bevacizumab
* All other forms of glaucoma
Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

* Relapsed or refractory metastatic pancreatic adenocarcinoma
* Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy)
* Measurable disease per RECIST v1.1
* Adequate organ function defined as

  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) OR ≤ 5 x ULN if liver metastases are present; total conjugated bilirubin ≤ 2 x ULN
  * Absolute neutrophil count (ANC) ≥1500 cells/mm\^3, platelet ≥100,000 cells/mm\^3, hemoglobin ≥ 9.0 g/dL
  * Creatinine clearance (CrCl) \> 50 ml/min as calculated by the Cockroft-Gault method
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Key Exclusion Criteria:

* Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma
* Major surgery within 21 days of first dose of study drug
* Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
* Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug
* Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
* Known dihydropyrimidine dehydrogenase deficiency
* Peripheral neuropathy ≥ Grade 2
* Any condition that impairs gastrointestinal absorption of drug
* Known or suspected brain or central nervous system metastases
* Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
* External biliary drain
* Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment

Note: Other protocol defined Inclusion/Exclusion criteria may apply.