cyrilzakka/clinical-trials huggingface dataset:
Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Twin pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

* Singleton or higher order than twins multiple gestation
* Monoamniotic twins
* Twin twin transfusion syndrome
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Cerclage in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina
* Painful regular uterine contractions
* Labor
* Placenta previa
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)

The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.

This was an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS who showed evidence of inflammatory activity after the cold challenge performed during screening.

The study included a screening period, a treatment period and a follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any study-specific assessment is performed
* Body mass index within the range of 18-35 kg/m2
* Patients with a genetic diagnosis of FCAS
* Patients with a clinical history and investigations consistent with FCAS

Exclusion Criteria:

* Anti-rejection and/or immunomodulatory drugs must be discontinued (please, see protocol for further details)
* Clinically significant, suspected active or chronic bacterial (including Mycobacterium tuberculosis), viral or fungal infection within 30 days prior to Day 1.
* Patients with innate (e.g. TLR immunodeficiencies, defects in IFN-γ signaling) or acquired immune deficiencies (e.g. AIDS).
* Presence of human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc), or hepatitis C antibodies at screening.
* Live vaccines within 4 weeks of Day 1
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential unless they are using highly effective methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 65 years old
* Able to give informed consent

Exclusion Criteria:

* History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease
* Subjects with medical conditions such as Severe Dementia
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males

The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.


Eligibility Criteria:
Inclusion Criteria:

healthy males

Exclusion Criteria:

use of anabolic steroids, use of narcotics,
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment

The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.

Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority of these illnesses occur as a result of endemic exposure in Arizona and California. The benefits of antifungal therapy for uncomplicated disease are not currently established. Current therapies for serious and complicated forms of coccidioidomycosis are only partially effective and in themselves are unable to eradicate the fungus from sites of infection, commonly resulting in breakthrough infection and/or relapse. Nikkomycin Z is effective in the mouse model and results in improved microbiological response over fluconazole.

The goals of this study include: 1) Evaluating the safety and tolerance of nikkomycin Z following administration of multiple doses (50 mg Q 12 h to 750 mg Q 8 h) for two week and 2) Evaluating the pharmacokinetics of nikkomycin Z after single and multiple doses in relationship to dose. The study will include patients with uncomplicated Coccidioides pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response based on biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years and \<= 50 years
* Male or Female (if female, must have a negative pregnancy test and agree to use an acceptable contraception method)
* Able to understand study and give written informed consent
* Have a respiratory illness with at least one of the following: Cough, chest pain dyspnea or tachypnea, sputum production, or fever/chills/night sweats
* Have a new or suspected new pulmonary infiltrate on Chest X-ray
* Have a positive coccidioidal serology by EIA or immunodiffusion

Exclusion Criteria:

* Patients under the age of 18 years or over 50 years
* Patients with a prior history of confirmed coccidioidal infection
* Laboratory diagnosis of another etiology for the inclusion-defining illness
* Inability to comprehend study and provide informed consent
* History of or current evidence of major organ disease
* Concomitant use of prednisone and other corticosteroids not permitted
* Concomitant immunosuppressive therapy is not permitted
* Concomitant antibacterial therapy is not permitted
Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 from Patients Who Wants to Have Children

1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and phosphate concentrations in the blood by stimulating intestinal absorption and renal reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an excess of 1.25 (OH) 2D3.

The physiological institute of the University Tübinge has succeeded in preventing vascular calcification in Klotho-deficient mice by inhibiting osteogenic signal transduction. The animals reach an almost normal life span despite increased 1.25 (OH) 2D3, Ca2 + and phosphate plasma concentrations. The male animals are again fertilized, but not the female animals. However, if the plasma concentrations of 1.25 (OH) 2D3 are normalized by administration of a vitamin-poor diet, the female animals are fertilized within two weeks. Further investigations revealed an inhibitory effect of 1.25 (OH) 2D3 on the implantation of the embryo. In the meantime the 1,25 (OH) 2D3-dependent signal transduction could be revealed, which prevents the implantation of the embryo. The vitamin D receptor and the elements of signal transduction are also expressed in the human endometrium. It is therefore possible that increased 1.25 (OH) 2D3 plasma concentrations also prevent embryo implantation in humans.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Known systemic diseases, e.g. Autoimmune disease, scleroderma, malignant disease
Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia

Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. The latest research shows that the anesthesia depth guided by EEG does not reduce the incidence of postoperative delirium. The purpose of this study was to explore the relationship between anesthesia exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD), and to observe the characteristics of EEG.

More and more studies have focused on the relationship between EEG inhibition and postoperative delirium in general anesthesia. At present, there are two kinds of commonly processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral index (BIS) and the other is patient state index (PSI). The relationship between intraoperative anesthetic exposure and postoperative delirium is unclear, or whether potential patient characteristics increase the risk of EEG suppression and postoperative delirium.

Gastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely regulate brain function through the gut brain axis. We speculated that the abnormal composition of intestinal flora before abdominal operation might be the influencing factor of POD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastrointestinal diseases
* Patients were aged 60 to 90 years
* American Society of Anesthesiologists (ASA) risk classification II-IV
* Patients were scheduled to undergo elective major abdominal operation(with a anticipated time of 2-6 h)

Exclusion Criteria:

* Preoperative dementia or cognitive impairment
* Mental instability or mental illness
* Patients with any factors affecting cognitive assessment, such as language, vision and hearing impairment
* Any cerebrovascular accident occurred within 3 months, such as stroke etc
* Previous history of delirium
* Known hypersensitivity to sevoflurane or history of malignant hyperthermia
* Abuse of narcotic sedative and analgesic drugs
* Those who have reoperation within 7 days after operation
Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight

This study aimed to evaluate the effect of weight loss with diet combined coconut flour consumption improvement weight loss and reduction in glucose, cholesterol in obese women.

This is a clinical trial with two groups, one receiving hipoenergetic diet for 180 days and another group with hipoenergetic diet for 90 days, a washout period for another 90 days and another period for another 90 days diet meal plus hipoenergética coconut. In order to assess body mass, waist circumference and neck, assess the lipid profile, glucose and uric acid.

Eligibility Criteria:
Inclusion Criteria:

women \> 20 years old BMI \>25 Kg/m²

Exclusion Criteria:

Performing diets and / or making use of drugs for the reduction of body weight; Supplements of any kind; Pregnant and lactating women; In use of statins; With voluntary water restriction. -
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)

BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure.

AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory.

PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep.

EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.


Eligibility Criteria:
Inclusion Criteria:

* Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines.

Exclusion Criteria:

* Decompensated respiratory failure attested by a pH \<7.35,
* Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection,
* Respiratory frequency \>30/min.
Effect of Dapagliflozine on Systemic and Renal Endothelial Function

This is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function.

Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.


Eligibility Criteria:
Inclusion Criteria:

1. Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
2. Treated with diet and exercise alone for recent 3 months
3. Aged 20-80 years
4. HbA1c 7\~9%
5. This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.

   * Are not breastfeeding.
   * Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
   * Intend not to become pregnant during the study.

Exclusion Criteria:

1. Previous history of IHD or brain infarct
2. Having typical anginal pain or atypical chest pain with dyspnea
3. Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.

Eligibility Criteria:
Inclusion Criteria:

* Must be within 20% ideal body weight and must weigh at least 45 kg.
* Must understand the study procedures and provide written informed consent.
* Must meet DSM-4 criteria and are non-treatment seeking at time of study.

Exclusion Criteria:

* Please contact study site for more information
Echography to Predict Radial Artery Catheterization Failure (EPRAC)

In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.

The Arterial Catheter (KTA) enables continuous measurement of invasive blood pressure in patients with accurate and reliable hemodynamic monitoring. Radial Artery Catheterization is the currently recommended placement site.

In patients undergoing cardiac or aortic surgery, placement of a radial KTA is sometimes difficult, with a failure rate of around 15%. It is also a source of local complications and prolongation of the anesthetic duration.

There is no predictive diagnostic test for failed radial KTA placement in anesthesia.

Accurately predicting the failure of radial catheterization by echography will, in the future, make it possible to offer "at risk" patients an immediate catheterization in an other site as for example brachial site.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 years old
* Be operated for a scheduled cardiac or aortic surgery
* Be able to complete all the visits and follow the study procedures
* Subjects must be covered by public health insurance

Exclusion Criteria:

* Patients protected by law or Absence of signed informed consent
* Emergency Surgery Patient
* Patient already with an arterial catheter
* Patient with Radial Arterial Catheter Contraindication
* Radial arterial catheter placed by an anesthesiologist nurse student
Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.

To determine the efficacy of bright white light exposure compared to dim red light exposure in reducing post-TBI fatigue, an 8-week, randomized parallel-group clinical trial will be performed. Outcome assessment will be blinded. Participants will complete a baseline battery (T1) including 72 hours of actigraphy. Participants will then be randomized to either the Bright White Light (BWL) or the Dim Red Light (DRL) group. After 4 weeks of daily, 30-minute light treatments, the baseline battery will be re-administered (T2) along with 3 more days of Actigraphy. A follow-up assessment involving the same measures will be administered 1 month-post cessation of light therapy (T3). Participant treatment allocations will be masked for research team members conducting outcome measures. Secondary outcome measures will be administered to explore the effects of light therapy on mood, daytime sleepiness, sleep quality, circadian rhythms, anxiety, cognition and life satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Documented TBI of any severity
* At least 6 months post injury
* Presence of clinically significant fatigue, operationalized as a score of 22 or more on the Multidimensional Assessment of Fatigue
* Age 18 or older
* English speaking

Exclusion Criteria:

* Neurological disease other than TBI
* Pregnancy (because of pregnancy fatigue)
* Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure, cirrhosis or cancer treatment in the past year
* Current major depressive episode or substance abuse
* Diagnosed sleep disorder or high risk for sleep apnea
* History of bipolar disorder or manic or hypomanic episodes
* Current chronic, severe headaches
* Sensitivity to bright light
* History of retinal damage or disease
Impact of Combined Oral Contraceptive Pills on Migraine

The investigators will assess the effect of combined oral contraceptive pills (COCs) on migraine features and treatment response to allow better interpretation of the exact consequence of hormonal contraceptive use on migraineurs.

The investigators will use a questionnaire to detect the migraineur demographic and clinical features (disease duration, attack frequency and duration, pain intensity assessed by visual analogic scale, HIT score in female patients on regular COCs

* Special emphasis was put on clinical phenotype (for example, the character of pain, location, associated symptoms, etc.); vascular risk factors (hypertension, diabetes, smoking); history of cerebrovascular events and other conditions (collagen disorders, hepatic disorders, blood diseases, heart, kidneys), and family history.
* All the patients will undergo clinical neurological and general physical examinations, and migraine history and associated phenotypic features will be established.

Eligibility Criteria:
Inclusion Criteria:

* female migraine patients on COCs or mechanical contraceptive methods, according to the International Classification of Headache Disorders 3rd edition, aged 18-55 years

Exclusion Criteria:

1. Patients with major neurological conditions such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, and brain tumors).
2. pregnant, lactating, and menopausal patients.
3. Patients with any contraindications to ibuprofen or propranolol.
Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial

The study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site

Patients referred for coronary angiography will be randomized to either left radial, right radial or femoral arterial access sites, and the coronary angiogram will be performed in a standard fashion, including left ventriculography. Radiation exposure parameters including Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be recorded. Operator experience as well as demographic data will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing diagnostic coronary angiography

Exclusion Criteria:

* non-availability of one or more of the three access sites History of coronary artery bypass graft surgery Need for percutaneous coronary intervention.