cyrilzakka/clinical-trials huggingface dataset:
Metformin Versus Insulin in Gestational Diabetes

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with gestational diabetes who had at least twice plasma glucose at fasting \> 5.4 mmol/L and/or 1 hour postprandial value \> 7.7 mmol/L at 24 to 32 gestational weeks

Exclusion Criteria:

1. Fasting glucose \> 7.0 mmol/L or 1 hour postprandial plasma glucose \> 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) \> 7.0%
2. Renal, hepatic or cardiac failure
3. Pregestational use of metformin
4. Pregnancy with multiple fetuses
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma

This phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation
* Tumor classified as EER UT2-UT3, whatever the nodal status
* pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani.
* Age 18 years or older
* Informed and written consent

Exclusion Criteria:

* T1
* T4 (proven invasion of sphincter)
* Diffuse metastatic syndrome (no curative intent, short expected life span)
* preoperative incontinence (non due to the tumor)
How Shoes With Rocker Soles Affect Walking

The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. This study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.

The rocker sole is the most commonly prescribed external shoe modification. Use of rocker soles has been based on theoretical considerations and empirical observations with minimal scientific study and validation. With the passage of the therapeutic shoe bill (PL-100-203, section 4072) authorizing Medicare coverage of shoes and shoe modifications for diabetics, it is important to have objective data regarding the effect of rocker soles. This cross-over study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker soles. Patients will be evaluated at baseline and after 20 minutes wearing each rocker sole shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Insensate individuals

Exclusion Criteria:

* History or physical findings of any trunk, back or lower extremity orthopedic or neurologic abnormalities
* Inability to walk
* Inability to follow verbal directions
Effects and Safety of Epidural PDRN vs. Placebo

This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis.

Patients who are already planning to receive an Transforaminal epidural block from their clinician will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adults aged between 19-80 years old
* 2. Radiological confirmation of spinal stenosis on MRI
* 3. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
* 4. Follow-up possible during 3 months the clinical trial

Exclusion Criteria:

* Not able to comply fully with the protocol, including treatment, follow-up or study procedures
* pregnant or feeding women
* Alcohol/drug abuse
* Anticoagulant medication
Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry

This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.

This observational study consists of a patient and a physician survey. This survey will consist of questions developed by Bayer and submitted to the Steering Committee of the existing registry, ATHN-2. Once enrolled to participate in the ATHN-2 registry and provided consent to participate in the Bayer nested study, patients who have switched from another product to Kovaltry or Jivi within the past 50 weeks or at the time of enrollment will be prompted to answer the additional survey questions.

Conclusion of the ATHN-2 registry is scheduled for 2021. Once data is cleaned and locked by the registry, the data will be delivered to Bayer for conduct of our analyses.

Eligibility Criteria:
Hemophilia A patients who have switched treatment to treatment with Kovaltry or Jivi within the past 50 weeks, who are enrolled the ATHN 2: Factor Switching Study, and who have consented to participate in the Kovaltry or Jivi specific module will be included in this study.
Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia

The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in patients with recurrent sustained VT/VF in spite of appropriate medical therapy and cardio-version/ defibrillation after correction of underlying correctable factors with those without PSGB by prospective randomized trail. PSGB will be performed every 3 days by anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We will compare the frequency and episode number of VT/VF, procedure related complication, acute and long-term mortality.

Recurrent ventricular tachycardia(VT)/ fibrillation(VF) increases mortality, especially in patients with structural heart disease. It has been reported that cardiac sympathectomy reduces VT/VF episodes in patients with complex VT, long QT syndrome, catecholaminergic polymorphic VT, or myocarditis. However, cardiac sympathectomy operation is hard to conduct in patients with hemodynamically unstable recurrent VT/VF or electrical storm. Therefore, we hypothesized that bed-side percutaneous stellate ganglion block (PSGB) reduces VT/VF episodes and mortality in patients with repetitive VT/VF who are properly managed with optimal medical therapies.

Eligibility Criteria:
Inclusion Criteria:

* Patients agreement of consent
* AF patient age 20-85
* Patient are diagnosed Refractory Ventricular tachycardia
* Patients who have generated Refractory Ventricular tachycardia despite of defibrillation and drug therapy
* Patients with ICD have generated ICD shock or anti-tachycardia pacing despite of defibrillation and drug therapy

Exclusion Criteria:

* Patients who do not agree with study inclusion
* Patients who do not taken stellate ganglion block due to unstable hemodynamic status
* Patients have experienced major hemorrhagic complication
* Patients of the DNR status
* Patients with malignancy tumor, major neurogenic disease or gastrointestinal disease
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery

Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.

The investigators' department performs 150 gastric bypass surgeries annually. Surgeons use both harmonic scalpel and ligasure sealing device in cases. Aim is to compare both of these devices over coming each other. Benefits ease of these devices are compared.

Eligibility Criteria:
Inclusion Criteria:

* obesity
* BMI over 40 kg/m\^2

Exclusion Criteria:

* Normal BMI cases
Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung Cancers

The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators would like to determine the percentage of patients with squamous cell lung cancers who experience shrinkage of their tumors following treatment with this regimen. This combination of drugs is not a standard therapy for patients with squamous cell lung cancers. However, each of these drugs, when given alone or with other chemotherapies, is FDA-approved for the treatment of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell lung cancer
* Newly diagnosed untreated Stage IV and/or recurrent after adjuvant therapy with metastatic disease
* Patients previously treated with immune checkpoint inhibitor therapy are eligible
* Measurable disease as per RECIST 1.1
* Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy.
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception method during treatment and for three months after completing treatment
* Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
* \< Grade 2 pre-existing peripheral neuropathy (per CTCAE)
* Marrow and organ function as follows:
* ANC ≥ 1500 cells/mm3
* Platelets \> 100,000 cells/mm3
* Hemoglobin\>9g/dL
* Creatinine clearance ≥ 40mL/min
* Bilirubin ≤ 1.5 mg/dL
* AST/ALT≤2.5 x upper limit of normal range (ULN),
* alkaline phosphatase ≤ 2.5 X upper limit of normal, unless bone metastasis in present in the absence of liver metastasis

Exclusion Criteria:

* Prior treatment with albumin-bound paclitaxel or gemcitabine
* Prior systemic anticancer therapy for advanced squamous cell lung cancer
* Untreated brain metastasis. Patients with treated brain metastases who are off steroids are eligible
* Peripheral neuropathy greater than grade 1
* Malignancies within the past 5 years other than non-melanoma skin cancer or insitu cervical cancer status post treatment
* Patients with other serious medical illnesses including, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
* Class III or IV congestive heart failure by New York Heart Association
Brain Regulation of Appetite in Twins

Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to come with their twin to the University of Washington (Seattle)
* Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or
* Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m\^2
* Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m\^2

Exclusion Criteria:

* History of weight loss surgery or active participation in weight loss program
* Major medical problem (e.g., diabetes, cancer)
* Current use of weight loss medications or other medications known to alter appetite
* Pregnancy or menopause
* MRI contraindication (i.e., implanted metal, claustrophobia)
* Lifetime eating disorder
* Current smoking
* Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males)
* Self-reported weight \>330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures.
* BMI \< 18.5 or \> 45 kg/m\^2
* Allergies to study foods or inability to taste
* Twins were raised apart
* Co-twin not eligible or not willing to participate
Study to Assess Accuracy of Rapid Mood Screener in Adult Participants With Unipolar Major Depressive Disorder or Bipolar 1 Disorder in Real World Setting

Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD). The purpose of this study is to confirm Rapid Mood Screener (RMS) effectively classifies participants with BP1.

Rapid Mood Screener (RMS) is a brief 6-item clinician-administered checklist, in which a participant's endorsement of four or more questions should trigger further clinical evaluation for BP1. Approximately 404 participants (303 with confirmed unipolar MDD and 101 with confirmed BP1) will be enrolled in the United States.

Participants will be answering RMS questionnaire and accuracy will be measured against Mini-International Neuropsychiatric Interview (MINI) interview.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to provider with primary complaint of new or continuing depressive symptoms.
* May be treatment naïve even if not in their first depressive episode.
* Meets one of the following criteria:

  * Previously treated and currently off medication.
  * Currently using an antidepressant, atypical antipsychotic for mood disorder, or mood stabilizer.

Exclusion Criteria:

* Hospitalized or admitted to the emergency room due to mental health issues in the past 30 days.
* Currently experiencing a manic episode.
* History of schizophrenia or depression due to another psychotic disorder or a medical, organic, or drug-induced cause or a neurocognitive disorder (dementia/delirium) (as defined by Diagnostic and Statistical Manual of Mental Disorders \[DSM-V\] criteria).
* Participant did not provide informed consent.
Sonohysterography , 3D Ultrasonography and Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility

Prospective comparative study including 100 infertile patients with suspected uterine lesion. 2D ultrasound, sonohysterography , 3D ultrasound and hysteroscopy will be done to evaluate uterine cavity.

All patients will be examined by 2D transvaginal ultrasound using a 6.5 MHz probe (Sonoace 5000, Medison Co. Ltd, korea). Examination is performed after emptying of the bladder in dorsal lithotomy position.

Three dimensional ultrasound will be performed using Medison, Voulson 530 D-MT ultrasound machine (Medison Co. Ltd, Korea). The uterus is visualized in the longitudinal plane, the ultrasound probe is kept steady and the patient is asked to lie still on the examination bed.

Sonohysterography will be done after introduction of the catheter into the cervix, a twenty milliliter syringe which is prefilled with the distending media (saline) is then fitted to the catheter. The speculum is removed and endovaginal probe is introduced in the posterior vaginal fornix. The uterus is then visualized in the longitudinal plane to demonstrate the endometrial cavity and the catheter. Once this is possible, sterile saline is slowly injected through the catheter into the uterine cavity; up to ten milliliter of saline is usually enough for the procedure.

Hysteroscopy will be done under general anesthesia. The hysteroscopy is rigid continuous flow diagnostic hysteroscopy . It has a 30º panoramic optic which is 4 mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.

Eligibility Criteria:
Inclusion Criteria:

* Suspected uterine factor of infertility

Exclusion Criteria:

* tubal, ovarian or male factor of infertility
Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

This study intends to further reveal the effect of RIC in stroke-related insomnia and explore its potential mechanisms.

Sleep disturbance after stroke is an important factor affecting the prognosis of stroke function. At present, most studies have focused on the diagnosis and treatment of sleep disordered breathing after stroke, while stroke-related insomnia has been neglected. Therefore, it is of great significance to explore a treatment that combines stroke protection with sleep improvement.

Remote ischemic conditioning (RIC) triggers endogenous protective effect through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of autonomic nervous system, release of humoral factors, improvement of vascular endothelial function and modulation of immune/inflammatory responses, which participate in the regulation of sleep after stroke.Therefore, this study intends to conduct a randomized controlled trial to further reveal the effect of RIC in stroke-related insomnia and explore its potential mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 70 years old;
* mRS≤3;
* Meeting the DSM-IV diagnostic criteria for insomnia: in the past one month, the presence of any of the following symptoms: a. have difficulty falling asleep (sleep latency \>30 minutes); b. have trouble in maintaining sleep; c. early awakening, accompanied by impaired daytime function, with symptoms occurring more than three times a week, lasting at least 2 weeks;
* Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

* Chronic insomnia (PSQI≥8) or other sleep disorders was diagnosed 3 months before onset of stroke;
* Presence or past history of neuropsychiatric diseases such as epilepsy, brain tumors, neurodegenerative disorders, restless leg syndrome, periodic leg movement;
* Schizophrenia, significant anxiety and depression (HAMA≥14 points, HAMD≥17 points) with moderate to high suicide risk, etc;
* Serious infection, malignancy, and other serious medical conditions (acute heart, liver, renal failure and other diseases);
* Have taken any medications (antipsychotics, hypnotics, antidepressants, etc.) that interfere with sleep in the latest two weeks;
* Have work shift or jet lag experience 4 months before enrollment Infants, Pregnant or lactating women.
Antinociceptive Effect of Transauricular Electrical Vagal Nerve Stimulation

This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of muscarinic receptors. Also, this investigation will examine whether tVNS is associated with activation in brain areas, involved in processing of thermal pain stimuli and emotional and vegetative modulation of thermal pain in subjects who will respond with antinociceptive reaction to tVNS.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers aged 18-45 years old, who have given informed consent
* at least two days free from consume of recreational drugs
* no local infection at the site of tVNS and pain stimulation

Exclusion Criteria:

* psychiatric disorders
* abnormal skin conditions (infection, scars, psoriasis, eczema) at the site of tVNS
* contra-indications for MRI (e.g. claustrophobia, pregnancy, tattoos, metallic implants)
* history of coronary heart disease, cardiac arrhythmia, glaucoma, allergy to sulphates
Skeletal Muscle Dysfunction in Heart Failure

Patients suffering from congestive heart failure report reduced exercise capacity. This skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart.

We hypothesize that congestive heart failure has systemic effects that causes the skeletal muscle dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Coronary Heart Failure
* Ejection fraction \<35%
* NYHA 2-3
* Spirometry FEV1 \> 80%

Exclusion Criteria:

* Cardiomyopathy
* Transplantation candidate
* Active malignancy
* Restraining skeletal-muscular disease
* Claudication in legs
* Hospitalized last 30 days due to acute ischemic episode
* Intravenous inotrope or vasodilatating drugs last 14 days prior to inclusion
* AMI last 8 weeks prior to inclusion
* Organized training last 4 months
* Smoking on daily basis last 4 months
* Creatinin \< 150microliters/liter
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
* Patient is a non-smoker
* Patient is in good mental and physical health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast feeding
* Patient intends to move or vacation away during the study
* Patient is a current or past abuser of alcohol or illicit drugs