cyrilzakka/clinical-trials huggingface dataset:
Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension

The purpose of this study is observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. Outcomes will be observed for 10 months under the current (traditional) clinical blood pressure threshold for acute treatment of hypertension, which is \>= 160 millimeters of mercury (mmHg) systolic blood pressure (SBP). This will be followed by one month of education about rationale for the new SBP threshold of \>= 180 mmHg and change of clinical guidelines. Then, there will be 10 months of observation after adopting the updated clinical threshold for acute antihypertensive treatment (\>= 180 SBP).


Eligibility Criteria:
Inclusion Criteria:

* any individual \> 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with \>= 160/110 mmHg

Exclusion Criteria:

* Active seizure, stroke, Congestive Heart Failure (CHF)/pulmonary edema, acute kidney injury (AKI), or myocardial infarction (MI)
* A history of stroke, CHF, chronic kidney disease (CKD), MI
* Have Hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome or thrombocytopenia (platelets \< 100×10\^9/L)
* Persistent neurologic symptoms including headache \>8/10 one hour after analgesic or blurry vision/loss of vision
A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865

This study will see how PF-06372865, an experimental drug distributes in the brain after one dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-06372865in these subjects and will measure the level of PF-06372865 in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Known or suspected sensitivity to flumazenil and other benzodiazepines.
Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers

Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 50 years
* Broca \>= -20% and \<= + 20 %

Exclusion Criteria:

* Any finding of the medical examination (including laboratory blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
* Intake of drugs with a long half-life (\>24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smoker (\>= 10 cigarettes or \>= 3 cigars or \>= 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse
* Drug abuse
* Blood donation (\<= 1 months prior to administration)
* Excessive physical activities (\<= 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactating
Vagal-stimulation-PAVK-tcpO2-study

H-1: tcpO2U2 \> tcpO2U1 H-0: tcpO2U2 ≤ tcpO2U1


Eligibility Criteria:
Inclusion Criteria:

1. Each subject must sign an informed consent (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
2. PAVK stadium IIb due to Fontaine for at least 6 month
3. reduced systolic occlusion pressure at ankle (arteria tibialis posterior and anterior): ABI \<0,9
4. radiologic significant occlusion at arteria femoralis superficialis and/or at arteria poplitea and/or at arteria of lower legs (MRT, CT, CO2-angiography or color-coded duplex sonography)
5. expected availability during study participation over 12 weeks (via health care center)

Exclusion Criteria:

1) \<18 years 2) pregnancy and non-exclusion of pregnancy (women of child-bearing potential)

* 3)risk of incidence of pregnancy during study participation (female must fulfill one of the following criteria: menopause for more than 2 years, postmenopausal sterilisation, surgical sterilisation, hormonal contrazeption during study participation, spiral or diaphragm/condome+spermicide).

  4) lactation period 5) person of legal incapacity 6) regard, placement or appointment of an solicitor 7) military service 8) contraindication for the application of STIVAX 8a) malignant tumour (existence of a known, histologic verified, malignant tumour) 8b) hemophilia 8c) psoriasis vulgaris 8d) recent stroke 8e) superficial and deep infection of auricle and external auditory canal 9) (with the exception of STIVAX-application): foreseeable relevant stimulation of afferent contents of vagus to the ear within next 2 weeks.

  10) isolated diabetic microangiopathia 11) implantated cardiac pacemaker or defibrillator 12) transcutaneous partial pressure of oxygen (tcpO2) \> 50 mmHg 13) concomitant disease with potential to limit the significance of the investigation of the walk distance (angina pectoris, heart failure, relevant pulmonary disease, relevant orthopedic or neurologic disease) 14) concomitant disease with potential to improve or to worsen the walking or the perfusion of the extremities in a relevant way.

  15) foreseeable change of PAVK-relevant medication or of concomitant medication with the potential to improve or to worsen the walking or the perfusion of the extremities in a relevant way within next 2 weeks.

  16) foreseeable start of a structured walking training within the next 2 weeks. 17) change in PAVK relevant medication or concomitant medication with potential to improve or worsen the walking or the perfusion of the extremities in a relevant way within the last 3 months.

  18) start with structured walking training within the last 3 months. 19) change in smoking habits within the last 3 months. 20) simultaneous participation in another clinical trial with insurance-protection.

  21) use of a therapy with stimulation of the afferent parts of vagus on the ear in the past.
Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.

The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.

The most current gynecological consultations in emergency unit first lead to a pregnancy diagnostic test. The gold standard used is the diagnostic test based on determination of the β-human chorionic gonadotropin concentration. But this assay need time and expect women to wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A 62-patients study showed that results obtained with the rapid test were correlated with results obtained with the test based on determination of the β-human chorionic gonadotropin concentration.

The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic test realized in emergency room, in comparison with the blood determination of the β-human chorionic gonadotropin concentration which is only tested in medical laboratory. A little amount of total blood sample used for gold standard test will be used to assess sensibility, specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.

Eligibility Criteria:
Inclusion Criteria:

* Adult women who are in genital activity
* Women who are in emergency unit to consult for metrorrhagia and/or pelvic pains.
* Lack of intrauterine gestational sac determined using endo-vaginal ultrasound
* Women who need a diagnostic test using the β-human chorionic gonadotropin blood test.

Exclusion Criteria:

* Previous pregnancy diagnostic assessed using the β-human chorionic gonadotropin blood test.
* Patients included in an ovarian stimulation program for infertility
* Ectopic gestational sac in which there is an embryo with a cardiac activity determined with ultrasound.
* Patient objecting to participate in the study
* Minor
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
OC and ICTP in Gingival Crevicular Fluid During Piezocision Accelerated Orthodontic Treatment

The aim of this study was to evaluate the tooth movement with and without piezocision with regard to the levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen in the gingival crevicular fluid.

15 systemically healthy subjects requiring extraction of the maxillary 1. premolars with distalization of the maxillary canines were enrolled to the study. Piezocisions were performed on the distal and mesial sides of the right maxillary canines while the left maxillary canines served as controls. Canine distalization was performed via closed-coil springs applying 150 g of force per side by using miniscrews as anchorage. Gingival crevicular fluid samples were collected from both mesial and distal sides of right and left maxillary canines at 0, 1, 7, 14 and 28 days. The gingival crevicular fluid levels of osteocalcin and cross-linked C-terminal telopeptides of type I collagen were determined by using ELISA. The rate of tooth movement was measured on 14 and 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Class I, Class II or Class III malocclusion,
* Proclined incisors requiring extraction of the maxillary first premolars with subsequent retraction of the maxillary canines
* No previous orthodontic treatment
* Good oral hygiene and periodontal health (plaque and gingival indices less or equal 1, probing depth less or equal 3 mm, no radiographic bone loss).

Exclusion Criteria:

* having systemic diseases that could affect bone and tooth movement
* smoking
Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation

This study evaluates the influence of the taste sensitivity, of food preferences and of the reward system on the energetic balance before and after liver transplantation in cirrhotic patients and after kidney transplantation in renal failure patients

Background and Aims: Protein-energy malnutrition is associated to cirrhosis with a high prevalence and greatly increases the morbidity and mortality of the disease. Malnutrition results of numerous causes including intestinal malabsorption, increased energy resting expenditure, metabolism disturbances, impaired sensory taste and changes in food preferences which might participate to a reduction in food intake. The aim of this study was to determine the relationships that may exist between taste sensitivity and food preferences on the one hand, eating habits, nutritional status, energy balance and biological parameters including amino acids on the other hand in patients with end-stage cirrhosis and in patients with renal failure.

Fifteen end-stage cirrhotic patients and 15 renal failure patients will be included and matched with 30 healthy subjects. The following parameters will be evaluated during a morning testing session: gustatory sensitivity using a triangular detection threshold method for sweet, salty and umami solutions; preferences for fat- and carbohydrate-rich foods using the PrefQuest score; liking for six foods (protein-, carbohydrate- and fat-rich foods) and wanting for 18 foods (photographs); hunger sensation; energy intake (24 h ingested food); body composition (BMI and impedancemetry); resting energy expenditure (indirect calorimetry) and physical activity (questionnaire). Several plasmatic parameters (amino-acids, leptin, ghrelin, lipid profile) will be also determined.

Eligibility Criteria:
Inclusion Criteria:

* written consent
* patients in waiting renal transplant
* patients in waiting liver transplant

Exclusion Criteria:

* chronic infection
* acute infection
* cancer
* antibiotic treatments
* alcool abuse
* pregnant woman
* specific or restrictive diet
Vitreous Levels of Cysteine-rich 61 in Patients With Proliferative Diabetic Retinopathy

To determine the vitreous levels of fractalkine, cysteine-rich 61 (Cyr61), and VEGF in patients with PDR. Verifying that it is greater to that found in non-diabetic patients with different non-angiogenetic diseases.

Introduction:

Angiogenesis, the growth and proliferation of new blood vessels, is an important aspect of the vascular proliferation found in tumor growth, wound repair, inflammatory states, and ischemic sequel in the ocular angiogenetic diseases. Intraocular neovascularization, the major eventually complication of diabetic mellitus, may result in vitreous hemorrhage, tractional retinal detachment, neovascularization glaucoma and eventually blindness. The involved factors include basic fibroblast growth factor (bFGF), insulin-like growth factor-I (IGF-I), vascular endothelial cell growth factor (VEGF), and Connective tissue growth factor (CTGF)/Cysteine-rich protein (Cyr61)/Nephroblastoma overexpressed gene (CCN) family. VEGF is a primary angiogenic factor that mediates ischemic-induced retinal neovascularization. VEGF level are elevated in the vitreous fluid in patients with proliferative diabetic retinopathy (PDR). The unselective anti-VEGF antibody bevacizumab has been used for the treatment of diabetic retinopathy.

Problem:

In spite of its potent anti-VEGF property, it does not completely inhibit ischemia-induced retinal neovascularization. Several other factors which were detected to have increased vitreous levels in the PDR patients might participate in the angiogenic process of diabetic retinopathy. One of the member of the CCN family, connective tissue growth factor (CTGF), was found to be involved in the angiogenesis and fibrosis mechanism of PDR. It is unclear if the other factors in the CCN family might also control the development of retinal angiogenesis and fibrosis.We measured vitreous cysteine-rich 61 (Cyr61) levels in PDR patients, non-diabetic patients,and PDR patients pretreated with bevacizumab. We further correlated the cysteine-rich 61 levels with different stages of PDR. Concomitant VEGF level was also measured to better understand the interaction of different factors.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with type 1 or type 2 diabetes mellitus
* Not eligible for any currently approved treatments or experimental protocols
* Patients with PDR who receiving vitreoretinal surgery.

Exclusion Criteria:

* A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure
* Panretinal laser photocoagulation in the study eye
* Previous treatment with intravitreal or sub-Tenon triamcinolone
* History of submacular surgery or other surgical intervention for diabetic
Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1

Administration of 4 strain of probiotics, prebiotic, magnesium and crocus sativus extract in a sachet to people with diabetes mellitus type 1 for 6 months

Double blind placebo controlled randomized trial: A sachet of a combination of 4 strains of probiotics (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides, Magnesium and Saffron extract was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.

Eligibility Criteria:
Inclusion Criteria:

* People with diabetes mellitus type 1 (with diabetes duration over 1 year) (adults \<18 years old) wearing a continuous glucose monitoring system with or without an insulin pump

Exclusion Criteria:

* Pregnant
* People with diabetes mellitus type 2
* Breastfeeding women
* People with liver disease
* People with chronic kidney disease (over stage 3)
* People with allergy in crocus sativus
* People that consume everyday herbs or supplements
* People on anti platelet treatment not for prevention
Genetic Basis of Melanocytic Nevi

The objective of this protocol is to further elucidate the genetic mutations that drive melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole genome, whole exome, or targeted sequencing of de-identified specimens.

Herein, the investigators plan to isolate DNA from de-identified skin biopsy specimens and blood samples:

1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the tissue will be submitted for routine diagnostic dermatopathology and investigational histomorphologic and immunohistochemical analysis.
2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a normal control when analyzing sequencing data to identify somatic mutations in lesional tissue.


Eligibility Criteria:
Inclusion criteria:

* Male or female subjects that are 18 years or older
* Subjects with melanocytic nevi\\

Exclusion criteria:

* Patients less than 18 years of age
* Patients without melanocytic nevi
* Patients with a bleeding disorder or are taking anticoagulation medication
Active Living After Cancer: Implementation Within Be Well Acres Homes

The goal of this research study is to learn more about a physical activity program adapted for cancer survivors.

Primary Objectives:

Evaluate the effectiveness of ALAC adapted for delivery in Acres Homes, using a randomized wait- list-control group design. The primary outcome will be physical functioning as measured by the 30- second sit-to-stand test at 12 weeks. Secondary outcomes will include physical functioning measured by the six-minute walk, objective and self-reported physical activity, social connectedness, and quality of life. The investigators will also investigate whether program effects are maintained at 6 months. Hypothesis: Cancer survivors in the adapted ALAC program will increase their physical activity and improve their physical functioning from baseline to the end-of-intervention assessment, compared to a wait-list-control group.

Compare the reach of the ALAC program in Acres Homes to ALAC in other persistent poverty neighborhoods in Houston. Hypothesis: The Acres Homes adaptation of ALAC will have a greater reach (percent of cancer survivors enrolling in ALAC in a specific neighborhood) than in other persistent poverty neighborhoods in Houston.

Explore the moderating effects of social and environmental variables on program effectiveness. Hypothesis 3A:Participants' financial distress, experiences of discrimination, health literacy, and social connectedness will influence the effect of the ALAC intervention on participants' physical activity, physical functioning, and program engagement. Hypothesis 3B: Neighborhood characteristics, like walkability, crime rate, air quality, access to green space, and neighborhood social vulnerability, will be related to the effectiveness of the ALAC program in terms of enrollment and health outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Past diagnosis of invasive cancer, or a caregiver (family or friend) of a participating survivor.
2. No longer receiving treatment for cancer (except hormone therapy or long-term maintenance chemotherapy).
3. Over the age of 18.
4. Screen negative for contraindicating health problems on the adapted Physical Activity Readiness Questionnaire (PAR-Q),79 or screened positive but have approval from a health care provider to participate.
5. Lives in the Acres Homes neighborhood of Houston, Texas or has a home zip code of 77088 or 77091.
6. Able to provide informed consent.

Exclusion Criteria:

1. Women who are pregnant (as indicated by self-report).
2. Has participated in the ALAC program within the past year and attended more than 2 group sessions.
A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures

Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.

Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.

Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.

Eligibility Criteria:
* Inclusion Criteria:

  1. both sexes
  2. 21-60 years old, with
  3. ASA physical status -
* Exclusion Criteria:

  * severe cardiovascular or respiratory disease
  * (ASA grade ≥III)
  * pregnancy
  * allergies to the drugs being used
  * known alcohol or substance abuse
  * expected communication difficulties with the patient.