cyrilzakka/clinical-trials huggingface dataset:
RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.

This study evaluates the difference of imaging diagnostic quality and fertility promoting effect in the diagnosis and treatment of infertility by hysterosalpingography between using ethiodized poppyseed oil and the second-generation non-ionic monomer contrast. Half of participants will receive ethiodized poppyseed oil for hysterosalpingography, while the other half will receive the second-generation non-ionic monomer contrast for hysterosalpingography.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 21 to 39 years, Female;
* Had spontaneous menstrual cycle;
* Had been trying to conceive for at least 1 year;
* There was an indication for evaluation of tubal patency by means of hysterosalpingography.
* Understand and sign informed consent.

Exclusion Criteria:

* Known endocrine disorders(e.g., the polycystic ovary syndrome, diabetes, hyperthyroidism, and hyperprolactinemia);
* Less than eight menstrual cycles per year;
* A high risk of tubal disease (as indicated by a history of pelvic inflammatory disease, previous chlamydia infection, or known endometriosis);
* Hyperthyroidism;
* Vaginitis, acute or subacute pelvic inflammatory active phase, uterus or fallopian tube tuberculosis;
* Uterine or cervical bleeding;
* Menelipsis without excluding pregnancy;
* Severe heart disease and lung disease;
* Body temperature beyond 37.5 ℃ within 3 days before hysterosalpingography;
* A total motile sperm count of \<1 million sperm per milliliter;
* Complications or social environment that can cause patients to fail to follow the study plan and even endanger the patient's safety.
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

The main aim of this study is to compare the HAE attacks (both total and those requiring on-demand treatment) in the 12 months before and up to 24 months after initiation of treatment with lanadelumab.

This study is conducted in the United Kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. Data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. Participants will be contacted every 3 months during study participation (via phone).


Eligibility Criteria:
Inclusion:

* Documented diagnosis of HAE type I or II (confirmed through laboratory testing)
* Documented initiation of treatment with lanadelumab or due to be initiated within next 4 weeks
* Greater than or equal to (≥)12 years of age at initiation of treatment with lanadelumab
* ≥12 months of continuous medical record data before initiation of treatment with lanadelumab

Exclusion:

• Exposure to lanadelumab administered as an investigation product in a clinical trial setting at any point in time
Riluzole Augmentation Pilot in Depression (RAPID) Trial

The investigators are doing a research study to find out if riluzole, when taken along with a standard antidepressant (sertraline) can help people with major depression.

This research study will compare riluzole + sertraline to placebo + sertraline. The investigators hypothesize that adding riluzole will lead to a better antidepressant response, in less time, then sertraline alone.

Recent attention has focused on the glutamatergic system as a new, distinct target for depression treatment. Riluzole (Rilutek, Sanofi), an oral modulator of glutamate activity with neuroprotective and anticonvulsant properties, is currently approved by the United States Food and Drug Administration for treatment of amyotrophic lateral sclerosis (ALS). Preliminary studies using riluzole to treat depression in humans are promising, though larger, double-blinded controlled trials are needed.

Overall study population:

Adult outpatients with a current, untreated major depressive episode.

Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 18-75) who meet DSM-IV criteria for a major depressive episode,
* Hamilton Depression Rating Scale (HDRS) \>22, and
* No antidepressant treatment for at least three weeks

Exclusion Criteria:

* Active drug or alcohol disorder in the past 3 months
* History of psychosis, history of mania or hypomania
* Epilepsy or history of seizures
* Hypothyroidism
* Congenital QTc prolongation
* Liver disease
* Lung disease
* Acute suicide or homicide risk
* Pregnant women, breastfeeding women, women of childbearing age not using contraception
* Unstable medical illness
* Elevated thyroid-stimulating hormone (TSH\>5.0mlU/L), or
* Abnormal liver function tests (ALT\>50 U/L or AST\>50 U/L)
* ADD / ADHD (Attention deficit hyperactivity disorder)

Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients

There is a decline in androgen concentration with ovarian aging. Also, ovarian response to COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian androgen concentration. A physiological way to induce androgen synthesis within the ovary is to stimulate theca cells androgen production by hCG stimulation. By doing this in the previous cycle we might expect a better response to COH.


Eligibility Criteria:
Inclusion Criteria:

* previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved

Exclusion Criteria:

* 42 years or older
* BMI \<18 or \>30
Weight Loss in Pre-diabetic, Obese Women

This is a six (6) month, single center, randomized, double-blind, parallel, controlled-feeding weight-loss study comparing two dietary groups (triglyceride and olestra) in pre-diabetic obese women.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* BMI 30-45 kg/meter squared
* waist circumference greater than 88 cm
* blood glucose level 5.8-6.9 mmol/l

Exclusion Criteria:

* Pre-diabetic
* pregnant
* nursing
* food preferences not compatible with the study diet
* allergies or food sensitivities with any of the study diet
Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.


Eligibility Criteria:
TBI patients

Inclusion Criteria:

* Isolated and non opened traumatic brain injury
* 18 - 65 years old
* Intubated and mechanically ventilated
* Glasgow score \< or = 9 or
* Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
* Medical insurance

Exclusion Criteria:

* Treated major cardiovascular risks factors
* cardiovascular past medical history (acute cardiovascular event)
* Cardio thoracic surgery
* Brain dead status
* Inotrope drugs
* Severe polytraumatism
* Acute haemorrhage
* Non echogenic patient
* High level athlete
* Incapacitated person by law and pregnant women
* Discovery during echocardiography of underlying cardiomyopathy
* Urgent neurosurgery required

Control patients

Inclusion Criteria:

* Isolated and non opened traumatic brain injury
* 18 - 65 years old
* Intubated and mechanically ventilated
* Paired with TBI patient on age, BMI and sex
* Undergoing urgent non severe surgery
* Medical insurance

Exclusion Criteria:

* Traumatic brain injury
* Treated major cardiovascular risks factors
* cardiovascular past medical history (acute cardiovascular event)
* Cardio thoracic surgery
* Inotrope and vasopressive drugs
* Circulatory failure
* Non echogenic patient
* High level athlete
* Incapacitated person by law and pregnant women
* Discovery during echocardiography of underlying cardiomyopathy
* Urgent neurosurgery required
Central Auditory Processing and the Use of Hearing Aids

The purpose of this study is to evaluate the central auditory processing in patients with bilateral sensorineural hearing loss and to observe the change of the central auditory processing ability after using hearing aids.

Screening for recruiting

* Among patients who are visiting for hearing disturbance, patients with bilateral sensorineural hearing loss will be included after audiologic tests, history taking and physical examination.
* audiologic tests: pure tone audiometry, speech audiometry, impedence audiometry, distortion product otoacoustic emission, auditory brainstem response.

Dividing into "Hearing aids" group and "No hearing aids" group

* The use of hearing aids will be recommended to all included patients.
* Hearing aids group: patients who want to be prescribed hearing aids (28 subjects)
* No hearing aids group: patients who do not want to be prescribed hearing aids (28 subjects)

Audiologic test

* Hearing in noise test (HINT), central auditory processing disorder test
* at screening, 1, 3, 6, 9 and 12 months after starting hearing aids use

Eligibility Criteria:
Inclusion Criteria:

* Adults of age 45 years of older
* Bilateral sensorineural hearing loss
* Average pure tone audiometry threshold \>= 40dB
* Speech discrimination \>= 60% in both ears

Exclusion Criteria:

* Refusing the study
* Medical history of any brain damage or intracranial surgery
* Showing signs of central lesion in MRI or neurologic exams
* Speech discrimination \< 60% in any ear
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease

The objective of this study is to further the understanding and application of 60Hz subthalamic deep brain stimulation (STN-DBS) in Parkinson's patients with gait disorder. The investigators will achieve this through 2 study aims:

1. Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors
2. Develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors

Gait disorder, which manifests as shuffling, reduction in speed, multistep turning, and/or freezing of gait (FOG), can arise later in the Parkinson's disease (PD) course and cause significant disability. Ultimately, patients are at risk for falls and can become socially isolated due to their mobility limitations. These symptoms tend not to respond to high frequency STN-DBS. However, lower frequency stimulation (60-80Hz) of the STN in treating gait disorder and/or freezing of gait has demonstrated benefit. This study potentially can expand knowledge of 60hz DBS while improving its utilization in combination with PD medications-enabling sustainable and possibly predictable therapeutic benefit.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 21-80
2. Patients diagnosed with Parkinson's disease (PD)
3. PD subjects who have bilateral STN-DBS (greater than 3 months) or in the preoperative stage of being implanted with bilateral STN-DBS
4. Have underlying gait disorder
5. Currently treated with oral levodopa therapy
6. Willingness to comply with all study procedures

Exclusion Criteria:

1. Cognitive deficits based on historical record that limit participant compliance with study protocol
2. Vestibular disorder or musculoskeletal problems affecting gait or balance
Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)

This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.

This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.

Eligibility Criteria:
Inclusion Criteria:

* Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months.
* LVEF \< 35% by trans-thoracic echocardiogram assessment
* Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities\*
* Normal sinus rhythm at enrollment
* RBBB with QRS duration \>120 msec on 12 lead surface EKG.
* PR interval \<250 msec on 12 lead surface EKG

  * Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion)

Exclusion Criteria:

* Age younger than 18 years old
* Pregnancy
* Acute Myocardial infarction within 6 months of entry into the study
* Inotrope dependent heart failure condition
* Left ventricular assist device or heart transplantation
* Any other known conditions other than heart failure that could limit survival to \< 6 months.
* Atrial fibrillation or flutter burden \>10% of the time within the last 6 months
* Atrioventricular node disease that requires ventricular pacemaker support \>10% of the time
Tranexamic Acid (TXA) in Hip Arthroscopy

The primary goal of this study will be to determine if perioperative IV Tranexamic Acid (TXA) administration will reduce intra-operative bleeding and subsequently improve visual clarity during surgery and reduce operative traction time in patients undergoing hip arthroscopy. Additionally, this study aims to determine whether IV TXA injections will reduce post-operative pain and affect hip-specific patient-reported outcomes in patients undergoing hip arthroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Scheduled to undergo primary hip arthroscopy for any intra-articular procedure
* Able to complete and understand study materials in English

Exclusion Criteria:

* Age under 18 years
* Cannot complete and understand study materials in English
* Patients undergoing revision surgery
* Patients who have had previous surgery to the study joint
* Patients on drugs that interfere with coagulation or TXA clearance
* Patients with a known allergy to TXA
* Patients with any of the following comorbidities
* Bleeding and/or coagulative disorders
* Renal impairment
* Sickle cell disease
* Thrombotic diseases
* Comorbidities preventing surgery (including pregnancy)
Minocycline for Bipolar Depression

The purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is approved for the treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.

Bipolar depression remains the great unmet need in the treatment of bipolar disorder. Only two treatments have been FDA-approved for the management of acute bipolar depression (the combination of olanzapine and fluoxetine and quetiapine). Early pilot data suggests the drug minocycline has potent antidepressant effects. Minocycline is approved by the Food and Drug Administration (FDA) (for acne and bacterial infections), is inexpensive and readily available in generic formulation, and is generally well-tolerated. This study will examine whether administering the drug minocycline to individuals with bipolar depression over 8 weeks will improve their depressive symptoms. This study will also offer an option to participate in proton magnetic resonance spectroscopy (1H-MRS) to measure N-Acetylaspartate (NAA) levels in the brain, which are thought to be decreased in bipolar disorder.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for Bipolar I Disorder or Bipolar II disorder, depressed phase
* A baseline score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Participants on mood stabilizer medication for at least two weeks prior to starting the study, and must remain on the treatment during the study
* Able to understand English

Exclusion Criteria:

* DSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type
* Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
* Serious suicide or homicide risk
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
* Clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before visit 1
* Drug/alcohol dependence within past 30 days, or current substance use disorder that requires detoxification
* Current use of minocycline or history of anaphylactic reaction or intolerance to minocycline
* Primary clinical diagnosis of antisocial or borderline personality disorder
* Patients with metallic foreign bodies or claustrophobia will be excluded from the MRS component
A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice

Hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.

Fractional flow reserve (FFR) is defined as the ratio of mean distal pressure (distal to the target lesion, Pd）to mean proximal pressure (aortic pressure, Pa) in the coronary artery(Pd/Pa) while the maximal hyperemic flow is achieved. Nowadays, FFR-guided PCI is highly recommended for the assessment of physiologic ischemia in intermediate coronary lesions. However, hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Based on the clinical and physiologic outcome study, a lot of non-hyperemic indexes had been proposed, and adenosine injection could be waived. Whereas, these novel physiologic indexes are limited to the proprietary software of each vendor, curtailing clinical application. Intracoronary nitroglycerin injection was needed before each FFR assessment. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for FFR examination

Exclusion Criteria:

* Hypersensitivity to adenosine or nitroglycerine
* Severe Valvular aortic stenosis
* Resting heart rate less than 50 beats per minutes
* Systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 40 mmHg
* exposure to PDE-5 inhibitors within 48 hours.
* Recent intracranial hemorrhage or brain injury
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program

The purpose of this study is to determine whether different types of online health tools can aid overweight individuals in reducing their weight and managing their cardiovascular risk factors in the context of an employee wellness program.


Eligibility Criteria:
Inclusion Criteria:

* Vanderbilt University employee
* Completion of the 2009 Go For the Gold Health Risk Assessment (HRA)
* Obesity defined by BMI \> 30
* Identification of an additional risk factor on the HRA by either (a) a personal history of diabetes, high blood pressure, or high cholesterol or (b) a reported cholesterol \>= 240 mg/dl, blood glucose \>= 126 mg/dl, a systolic blood pressure \>= 140 mm Hg, or a diastolic blood pressure \>= 90 mm Hg
* Permission to be contacted regarding health on the HRA

Exclusion Criteria:

* Pregnant females and those who become pregnant prior to completion of the study
* Age younger than 18 years or older than 65 years
* Non English speaking individuals
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion Criteria:

* Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months
* Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Subject is pregnant or lactating female.