cyrilzakka/clinical-trials huggingface dataset:
Combined Anesthesia for Labor and Maternal Temperature

Maternal intra-partum fever commonly complicates the process of labour. Its occurrence is often regarded as being synonymous with the presence of chorioamnionitis. This inevitably results in the administration of antibiotics to the affected mother. Review of the literature however suggests that this approach is not always appropriate. Non-infective causes of this condition that are often overlooked include the use of epidural analgesia for pain relief, normal thermal physiological changes in women not using any form of analgesia and delivery in an overheated room. Women with certain risk factors such as nulliparity and a long latent phase of labour are also more prone to developing maternal intra-partum fever. Irrespective of its aetiology, maternal intra-partum fever carries risks both for the mother and her unborn child. Putting more thought into the care of these patients will go a long way in reducing the maternal and neonatal morbidity associated with this complication.The combined spinal-epidural (CSE) technique has been introduced in an attempt to reduce these adverse effects. CSE is believed to during labour provide more rapid onset of analgesia than epidural analgesia, The incidence of fever is significantly lower with CSE technique.

The objective this study is determine the fever maternal incidence with CSE technique for labor analgesia.

METHODS: a randomized open clinical trial will be conducted involving Seventy healthy, term, nulliparous women in spontaneous labor were assigned to either CSE technique or non pharmacologic analgesia for labor.these patients will be randomly assigned to receive or not CSE technique for labor analgesia. Outcomes analysis wiil include maternal fever, pain intensity measured by visual analog scale, labor duration, c-section and instrumental delivery. statical analysis will performed using Mann-Whitney and Fisher" exact test 5% level of significance.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancies
* babies were presenting head first
* were expecting a vaginal delivery single fetal
* gestational age up to 37 weeks
* cervix length between 3-6 cm

Exclusion Criteria:

* Maternal fever before randomization
* Antibiotics before randomization
* haemostatic disorders during pregnancy
* severe preeclâmpsia-eclampsia
Matrix Metalloproteinase-1/Tissue Inhibitor of Metalloproteinase-1 (MMP-1/TIMP-1) Ratio and Diabetic Foot Ulcers

The primary objective of this study is to assess the sensitivity and specificity of a MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow up visit.

This monocentric, prospective, non-randomized study assesses the amount of the main metalloproteinases (MMP1, MMP9, MMP13) and their inhibitor TIMP-1 in wound fluid from diabetic foot ulcers.

It aims at demonstrating whether a MMP-1/TIMP-1 ratio equal to 0.24 at study entry can predict wound healing 12 weeks later. All patients will receive the same treatment according to our local protocol. The difference with standard care will be a sample of wound fluid at week 0 and week 4 and a numeric photograph for wound area measurement at week 0, week 4 and week 12.

The main outcome measurement is the percent change of wound area between week 0 and week 12 Secondary objectives include the evaluation of a MMP-1/TIMP-1 ratio equal to 0.4 and the search for confounding factors. A correlation between MMP-9, MMP-13 and wound healing will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Age over 40
* Chronic diabetic foot ulcer (duration over 30 days)
* Grade 1 to 3, stage A and C according to the University of Texas Wound Classification, except stage B and D
* Wound area over 0.5 cm²
* Social Security membership or benefit from Social Security
* Informed consent, with a signed and approved form
* Possibility to have clinical follow-up and compliance during 3 months

Exclusion Criteria:

* Urgent need for locoregional surgery
* Clinical criteria for infection, defined by the presence of pus or/and at least 2 local signs among the following: heat, erythema, lymphangitis, lymphadenopathy, oedema, pain
* Other pathology that could interfere with the healing process (vasculitis, connectivitis, dysimmunity, immunosuppressive treatment or corticoids, ongoing radiotherapy or chemotherapy )
* Any severe pathology that would constitute a contra-indication to the patient's inclusion
* Ongoing therapeutic research protocol
* Underage patient, major patient under guardianship or protected by the Law
* Pregnant, parturient or breastfeeding woman
* Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is a type of diabetes mellitus with normal glucose metabolism before pregnancy. Pregnant women with prepubertal diabetes have complicated clinical experiences, and the effects of severe disease or poor glycemic control on mothers and infants. The incidence of gestational diabetes mellitus is very high, and the short-term and long-term complications of the mother and the child are higher. Through the detection of blood samples, we can not only obtain the basic information related to the disease such as blood cells and blood biochemistry, but also learn the important information such as enzymes, antibodies and cell metabolites in the blood that are conducive to the diagnosis of the disease. More importantly, blood contains genetic material (such as genomic DNA) that can be used to screen for genes and break down molecules. Placenta tissue examination can provide important cellular, biochemical, immunological and other information. However, due to the complex etiology of gestational diabetes. Especially associated with genetic or immunological factors, in the short term often cannot make a definite diagnosis, and patients in hospital time is limited, some check items such as gene detection, placental tissue can't complete them in hospital, need to return the patient's blood, cord blood and placenta tissue, to facilitate later further screening and biology research. This study intended to establish gestational diabetes patient's blood, cord blood and placenta tissue samples library, screening is closely related to the disease biomarkers, such as disease-causing gene mutations, susceptible gene mutation and protein metabolism product, so as to clarify disease relationship between genotype and clinical phenotype, the pathogenesis of diseases, etc., and provide the basis for the diagnosis of disease and treatment optimization.

the registry procedures: we collected data and blood samples from pregnant women diagnosed with GDM and matched healthy pregnant women as controls on the day admitted to hospital for delivery. All of the participants recruited were Han Chinese. Placental tissue was collected immediately after delivery and saved at -20 °C for analysis.

Eligibility Criteria:
Inclusion Criteria:

1. The patient was older than 18 years old and had not been diagnosed with diabetes before pregnancy. A 75-gram glucose load examination was performed during 24-28 weeks of gestation：GDM should be diagnosed at any time in pregnancy if one or more of the listed criteria are met following a 75-gram glucose load: fasting PG ≥5.1 mmol/l; 1-hour PG ≥10.0mmol/l; 2-hour PG 8.5-11.0 mmol/l.
2. If the patient is younger than 18 years old, consent from parents or guardians is required;
3. Inclusion objects in line with the above sample sources;
4. Signed the informed consent;

Exclusion Criteria:

1. Refuse to sign the informed consent
2. Severe mental symptoms, unable to cooperate with blood collection
Surgical Treatment for Hallux Rigidus

The purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.

Hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (MTPJ). There are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. Patients with end stage arthritis are often given several surgical options for the treatment of the first MTPJ. The procedures are correlated to the patient's age, type of shoe gear, activity level, Body Mass Index, degree of arthritis, desire for joint mobility and bone density. This proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first MTPJ implants. A multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first MTPJ will be evaluated. Subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. Further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. The results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus.

Eligibility Criteria:
Inclusion Criteria:

* End stage hallux limitus/rigidus
* Status post 1 year since having the surgery
* Must have had a joint resection, fusion, or hemi-metallic implant

Exclusion Criteria:

* History of seropositive or seronegative arthritis
* Have had a primary surgery before then had one of the above surgeries performed
A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine

This an open phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.

This study is an open phase Ⅳ clinical trial to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd..A total of 600 subjects including 450 subjects in the experimental group and 150 subjects in the control group who participated in the second stage of phase Ⅲ clinical trial (PPS)will be enrolled .Based on the age at the time of enrollment in the phase Ⅲ study, there will be 150 participants in each age group (2-17 years old group, 18-60 years old group and ≥61 years old) in the experimental group and 50 participants in each age group in the control group .3.0-3.5ml of venous blood will be collected from all subjects after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated in the second stage of phase Ⅲ clinical trial (PPS);
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form);
* Proven legal identity.

Exclusion Criteria:

* Have received any pneumococcal vaccine after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine ;
* History of invasive disease caused by streptococcus pneumoniae after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
* Autoimmune disease or immunodeficiency / immunosuppression was known after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
* History of immunosuppressive therapy after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Pain Reduction Using NEurostimulation Study

This is a 4-year project to see if a small battery-powered, device attached to a headband, that sits on the skin surface and delivers what is a hardly noticeable level of electrical stimulation can reduce pain in patients who receive hemodialysis on an ongoing basis.

This is a 4-year R01 project to conduct a randomized controlled trial to evaluate the efficacy of an at-home transcranial direct current stimulation (tDCS) device to mitigate pain in persons receiving hemodialysis (HD) on account of end-stage kidney disease (ESKD). Pain is a highly common and morbid condition among persons with ESKD requiring HD. Because the current method of managing pain in this population typically involves the use of analgesic medications that confer substantial health risks, novel non-drug therapies are needed to reduce pain and lessen reliance on opioid and other drug therapies. The investigators will undertake a randomized controlled trial to determine the efficacy of an at-home neuromodulatory device to mitigate pain and improve other salient outcomes (e.g., mood, quality of life) in a stratified sample of Hispanic or Latino(a), Black or African American, and non-Hispanic White ESKD patients requiring HD. However, no individuals will be excluded based on race/ethnicity

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Age ≥ 21 years
* Diagnosis of end stage kidney disease (OCD 18.6) and receiving hemodialysis
* Montreal Cognitive Assessment (MoCA-Blind) adjusted score of≥18;
* Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during the week preceding the screening;
* Speaks English or Spanish
* Medically stable, as determined by clinician and defined as unlikely to undergo a substantial change in illness or treatment during the next 3 months
* Able to provide written informed consent.

Caregivers:

* Age ≥21 years
* Serves as primary caregiver for ESKD patient (e.g., partner, adult child, friend)
* Speaks English or Spanish

Exclusion Criteria:

* Active medical or major psychiatric illnesses that will impact pain or interfere with study procedures
* History of head trauma, seizure disorder, brain surgery, stroke, or cancer affecting head, metal implants in the head, or compromised skin integrity on the head in the area where electrodes will be placed
* Use of another neurostimulation device (such as spinal cord stimulator, cardio-stimulator implanted cardioverter-defibrillator)
* Not able to respond to brief questionnaires and rating scales that will interfere with study procedures
* Does not tolerate tDCS at a skin test (performed at training Visit 2)
* Does not provide informed consent

Exclusion criteria for all above groups:

\* Does not speak English or Spanish
A Study to Investigate the Effect of PH-797804 on QTc Interval

The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

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 time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for males.
Breath Stacking Technique Associated With Expiratory Muscle Training in Amyotrophic Lateral Sclerosis Patients

it will be conducted a randomized parallel controlled trial with patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) to compare two techniques to lung recruitment and cough augmentation, to assess their effects on pulmonary function, global functionally, swallowing and ability to speech in these population.

age over 18 years preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam; no barium allergies; without tracheostomy or invasive mechanical ventilation; no diaphragmatic pacemaker and without associated respiratory disease.Participants are excluded if they have pregnancy; previous kidney disease or other concomitant diseases; respiratory diseases and hospitalization in intensive care units (ICUs) during the study.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of neuromuscular disease confirmed by neurologists at the referral center for neuromuscular diseases at Brasília prior to screening for recruitment
* age over 18 years
* preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam;
* no barium allergies
* without tracheostomy or invasive mechanical ventilation
* no diaphragmatic pacemaker
* without associated respiratory disease

Exclusion Criteria:

* pregnancy
* previous kidney disease or other concomitant diseases .respiratory diseases and hospitalization in intensive care units (ICUs) during the study.
Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma

This is a prospective observational study , to clarity the characteristics of airway inflammation, airway reactivity and airway resistance in rhinitic children with or without asthma and to explore the possible predictors in the progression of allergic rhinitis to asthma.

Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist physician are enrolled in the department of respiratory and otorhinolaryngology and pediatrics in Guangzhou Institute of Respiratory Disease. According to presence of typical symptoms and signs, patients are divided into allergic rhinitis without asthma (AR group) , allergic rhinitis concomitant asthma (AS+AR group), asthma without rhinitis (AS group). In addition, healthy students in a school are enrolled as normal control group. History of all subjects are collected, the following measurements are performed: skin prick test (SPT), peripheral blood cells five-classification test, serum total immunoglobulin E (IgE) and specific IgE of common inhalant allergens testing, nasal lavage and induced sputum cells classification ，pulmonary function test, bronchial provocation test using methacholine，airway resistance measured by impulse oscillation technique, the levels of eosinophil（ECP），eosinophil peroxidase（EPO）.Meanwhile myeloperoxidase （MPO）and eosinophil-derived neurotoxin (EDN) are measured in induced sputum ,in nasal lavage and in serum.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of allergic rhinitis and/or asthma
* Sensitized to more than 1 common aeroallergens

Exclusion Criteria:

* Respiratory infection 2 weeks prior to initial visit
* Children with nasal polyposis
* History of immunotherapy
* Unable to complete the test or had limited understanding
* Use of systemic corticosteroids 4 weeks prior to initial visit
* Nasal and inhaled corticosteroids 2 weeks prior to initial visit
* Leukotriene receptor antagonists 2 weeks prior to initial visit
Optical Tomography With Ultrasound Guidance

The investigators propose to validate the utility of their novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators' unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the optical tomography.

As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a small group of patients who underwent biopsy have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.

The objective of this study is to validate the investigators' initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.

Specific objectives of the study are:

Objective 1: Validate the sensitivity, specificity, positive predictive value and negative predictive value of optical tomography/US for distinguishing benign and early stage malignant breast tumors. Approximately 300 patients who will undergo ultrasound-guided biopsy are being recruited to this study from the University of Connecticut Health Center and Hartford Hospital. The total hemoglobin concentration and blood oxygen saturation will be the measured indices and the biopsy results will be used as the 'gold' standard.

Objective 2: Perform pilot studies of optical tomography/US to assess chemotherapy response and evaluate treatment efficacy. Patients diagnosed with locally advanced breast cancers (size greater than 3 cm) who will undergo chemotherapy will be enrolled to this study. Approximately, 20 to 30 patients are being recruited to the study from the University of Connecticut Health Center and Hartford Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing ultrasound guided biopsy or breast cancer patients undergoing neoadjuvant thermotherapy treatment

Exclusion Criteria:

* Women under 18 years old.
Evaluation of the Efficacy and Safety of Nano-S1

This study aims to assess the efficacy of the efficacy and safety of investigational drug (NanoS) in patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including death.

We conducted a prospective randomized double-blind clinical trial over five months to determine the efficacy of NanoS compared to placebo. The effectiveness of treatment was measured by the significant decline in the number of cases of covid-19 infection and/or a decrease in the viral load determined by SARS-CoV-2 cycle threshold (Ct) value using RT-PCRs test.

Eligibility Criteria:
Inclusion Criteria:

1. Participants are hospitalized in a COVID unity or outpatient follow-up by the investigator
2. Participants who have positive SARS-CoV-2 test result and the onset of symptoms of COVID-19 ≤7 days prior to randomization, Not exceed the 7th day since the beginning of disease symptoms; and the randomization's day.
3. Present at least one of these symptoms: Participants who have one or more mild or moderate COVID-19 symptoms: Fever, general signs such as: headaches, asthenia, myalgia, arthralgia, etc... ENT signs such as: Sore throat, anosmia, agueusia, hypoacusis, deafness, etc... Digestive signs such as: diarrhea, vomiting, abdominal pain, etc... Respiratory signs such as: dyspnea, cough, etc... And cutaneous signs such as: skin rash, livedo, etc...
4. Present an oxygen saturation patients with SpO2 \&gt; 94% at room air
5. Present at least one of these risk factors:

   Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death: Age 65 years old Or -Age between 18 and 64 years old with at least one of these risk factors: Obesity (BMI\&gt; 30 kg/m2),and/or diabetes under treatment and/or cardiovascular disease (including hypertension and stable angina) high blood pressure

   and/or Chronic obstructive pulmonary disease (COPD) disease and/or asthma and/or Neoplasia (solid tumour; hematological malignancy) neoplasia, and/or a blood disease and/or heart failure and/or chronic renal failure (Cl creat\&gt; 30Mml/min) and/or unstabe angina and/or autoimmune disease.
6. Have signed the informed consent to participate in this trial.

Exclusion Criteria:

* Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.