cyrilzakka/clinical-trials huggingface dataset:
Treatment of Recurrent Urinary Tract Infection (RUTI) by Traditional Chinese Medicine

Traditional Chinese Medicine (TCM) could be used to treat Recurrent urinary tract infection (RUTI).

Antibiotics and TCM are used to treat RUTI to evaluate treatment efficiencies.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated RUTI

Exclusion Criteria:

* complicated RUTI
* other disease with urinary tract
* infection by pathogens other than bacteria
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

This is a multicenter study conducted in 2 parts:

The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region.

The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline.

The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.


Eligibility Criteria:
Key Inclusion Criteria:

* Inclusion Criteria for Part I:

  * Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).
  * Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.

Key Inclusion Criteria for Part II:

• Subjects who participated in and completed Part I per protocol.

Key Exclusion Criteria:

* Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
* Pregnant or nursing women.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia

A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study.

A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. Patients underwent standard electrocardiography (ECG) monitoring with heart rate (HR), noninvasive blood pressure (NIKB), peripheral oxygen saturation (SpO2) and Bispectral index (BIS). Baseline NIKB, SpO2 and HR were recorded before the procedure, intraoperatively and in the postoperative recovery unit. In the postoperative recovery unit, the patient's recovery time was also evaluated and recorded with the Modified Aldrete Recovery Score.

Eligibility Criteria:
Inclusion Criteria:

1. Children weighing over 10 kg and between the ages of 3-18 who will undergo angiography
2. Patients who are not allergic to the drugs used

Exclusion Criteria:

1. ASA Ⅳ patients
2. Patients with Diabetes Mellitus
3. Patients with severe lung disease
4. Patients with psychiatric disorders
5. Patients with opioid addiction -
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814

This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.


Eligibility Criteria:
Inclusion Criteria:

Subject has completed ADF103814 and continues with adefovir dipivoxil treatment via prescription without interruption prior enrolment in this extension study.

Availability and willingness of subject to provide written informed consent.

Exclusion Criteria:

Use of immunosuppressive therapy requiring use of more than 5mg of prednisolone(or equivalent) per day, immunomodulatory therapy (including interferon or thymosin) or systemic cytotoxic agents during the study.

Previous or current lamivudine or antiviral therapy Clinical signs of decompensated liver disease as indicated by the protocol Inadequate haematological function defined by the protocol - Documented evidence of active liver disease due to other causes Hepatocellular carcinoma as evidenced by the protocol Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders or cancer.

Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.

Planned for liver transplantation Therapy with nephrotoxic drugs or competitors of renal excretion can be expected during the course of the study.

History of hypersensitivity to nucleoside and/or nucleotide analogues. Inability to comply with study requirements as determined by the study investigator.
Study to Evaluate the Safety of Repatha® in Pregnancy

To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months

Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study.

Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother

Eligibility Criteria:
Inclusion Criteria:

* Females diagnosed with Familial hypercholesterolaemia (FH).
* Confirmed pregnancy during the study observation period.
* Pregnancies identified retrospectively but within the study period will be included
* Multiple pregnancies, occurring in the same woman within the study period, will all be included (as separate pregnancies)
* Provided informed consent to follow-up in this study, for subject and their infant(s) born during the study observation period

Exclusion Criteria:

There are no exclusion criteria
Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer

It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.


Eligibility Criteria:
Inclusion Criteria:

* Patients 14 years of age or older
* Diagnosed with cancer and who are or have recently received radiotherapy treatment.
* We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.

Exclusion Criteria:

* Patients with dermal lesions in grade greater than 2.
* Skin cancer invasion or distant tumor metastasis.
* Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.).
* History of hypersensitivity reaction to any of the ingredients of the studio cream.
* Participants involved in other clinical trials within that month.
Cromolyn Detection of Silent Aspiration

The overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. In the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration. In the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 mL of a 1mg/mL solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of GER (gastroesophageal reflux) with microaspiration.


Eligibility Criteria:
Inclusion Criteria:

Healthy participants

* Adult non-smokers
* Females only - negative urine pregnancy test

Lung transplant patients

* Adult patients awaiting (or recently undergone) - lung transplant
* Evidence of gastro-esophageal reflux with probable recurrent aspiration
* Females only - negative urine pregnancy test

Idiopathic pulmonary fibrosis patients

* Adult patients currently enrolled in on-going University of California, San Francisco study of prevalence of recurrent GER with aspiration in idiopathic pulmonary fibrosis
* Evidence of gastro-esophageal reflux with probable recurrent aspiration
* Females only - negative urine pregnancy test

Exclusion criteria:

Healthy participants

* History of dysphagia
* GER
* Recurrent cough
* Asthma
* Pneumonia after childhood
* Sleep impairment
* Use of drugs or alcohol impairing consciousness
* Impaired gag reflex on physical examination
* Any other significant medical illness (e.g., morbid obesity, diabetes, neurologic disease, etc.) that in the opinion of the investigator could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study
* Greater than 5 pack years lifetime smoking history
* History of intolerance or allergy to cromolyn sodium

Lung transplant patients

* History of intolerance or allergy to cromolyn sodium
* History of Nissen fundoplication

IPF patients

* History of intolerance or allergy to cromolyn sodium
* History of Nissen fundoplication
Lipids and Other Bioactive Compounds of Human Breast Milk

The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups. Increased understanding of breast milk composition, the normal variation of various bioactive compounds and their levels is required to be able to develop formulas better corresponding the breast milk, and ensure the optimal development of also the formula-fed babies.


Eligibility Criteria:
Inclusion Criteria:

* breast-fed child was born full-time and is healthy.
* age of the breast-fed child is 0-6 months

Exclusion Criteria:

* breast-fed child was born prematurely (gestation week \<37)
Low-dose Intravenous Dexamethasone at Different Times as Adjunvants for Brachial Plexus Blocks

Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.

Interscalene brachial plexus block (ISB) is regarded as the standard of care for anesthesia and analgesia for shoulder surgery by providing the superior analgesia and reducing opioid consumption. After several hours when the effects of single injection ISB wear off, the patients often suffer moderate to severe pain of the surgical insult and required strong opioid analgesia. Efforts to prolong ISB duration by adding adjuvants to local anesthetic (eg. clonidine, dexmedetomidine) have been studied with promising results. Dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect \~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. Intravenous administration of dexamethasone was reported to have similar effects as perineural route indicating the possible mechanism for prolonging analgesic duration might be due to the systemic effects of dexamethasone. We hypothesized: should that is the reason, systemic administration of dexamethasone at different time may provide similar effects on the duration of peripheral nerve block. Dexamethasone is a slow effect cortisone with long half-time, it is widely used at the beginning of surgery to prevent postoperative nausea and vomiting. A trial that demonstrates enhanced block quality and duration associated with intravenous dexamethasone at different time may allow us to achieve prolonged duration of effect if dexamethasone is used in perioperative period for different purpose. This would further identify the possible mechanism of dexamethasone to prolong the analgesia effect of local anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital.
* ASA functional status class I to II
* Age 18 to 70 years
* BMI ≤ 35 kg/m2

Exclusion Criteria:

1. Lack of patient consent
2. Allergy to dexamethasone or ropivacaine
3. BMI \> 35 kg/m2
4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
5. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume \< 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
6. Pregnant or nursing females
7. Chronic opioid use defined as \> 30mg oral morphine or equivalent per day
Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study

The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are:

* What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard?
* What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors?

Participant Will:

• Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT/CT examination and sign an informed consent form.

Patients who are clinically assessed as suspected or diagnosed with malignant solid tumors will receive an intravenous injection of 20-25mCi of 99mTc-FDPH46. Whole-body planar scintigraphy will be performed at 10, 30, 90, 150, and 240 minutes post-injection to obtain dynamic biodistribution images. Additionally, 99mTc-FDPH46 SPECT/CT imaging will be conducted 60-90 minutes after the intravenous injection to acquire both whole-body planar scintigraphy and SPECT/CT tomographic fusion images. After the scans are completed, patients will be observed in the waiting room for 1 hour before they are allowed to return.During the follow-up visit after the examination, the researchers will collect the patients' clinical information and any changes in symptoms, and record them in the medical records. All subjects will be followed up once on the same day after the SPECT/CT scan and again one week later.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are clinically suspected or diagnosed with malignant solid tumors.
2. Ages between 18 to 80 years old.
3. Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
4. Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.

Exclusion Criteria:

1. Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.
2. Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
3. Unstable vital signs, ECOG score \>2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.
Echocardiographic Evaluation of the Effects of Dexmedetomidine in Diastolic Dysfunction

Dexmedetomidine is a selective α2 adrenergic agonist that can be considered a primary anesthetic, an adjuvant to propofol or inhalational anesthetics. Dexmedetomidine mediate its cardiovascular effect through activation of receptors in central and peripheral nervous system. The classic cardiovascular response of dexmedetomidine is the biphasic with initial shorten-increase in blood pressure followed by long-lasting decrease in BP and HR. There were several reports about these hemodynamic changs of dexmedetomidine, but not the evaluation of direct cardiac function of patients who was preexisted diastolic dysfunction. The purpose of this study is to evaluate the effects of dexmedetomidine as an anesthetic adjuvant in diastolic dysfunction by using the echocardiography.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria included patients who estimated lateral e' velocity \<10 cm/s or septal e' velocity \<8 cm/s from the mitral annuli and averaged E/e' ≧ 9 in preoperative echocardiographic evaluation. For patients of old age (\> 60 yr) who did not undergo preoperative echocardiographic evaluation, written consent was obtained and TTE was performed to evaluate presence of diastolic dysfunction; patients with diastolic dysfunction, as previous defined, were included and those without were excluded

1. Above 40 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status II, III.
3. Preserved systolic function (Ejection fraction \> 50%)

Exclusion Criteria:

The exclusion criteria included patients who estimated lateral e' velocity \>10 cm/s or septal e' velocity \>8 cm/s from the mitral annuli, and averaged E/e' ≦ 8 in preoperative echocardiographic evaluation.

1. severe functional liver or kidney disease
2. diagnosed HF (LV ejection fraction \<50% , or wall motion abnormality)
3. arrhythmia or received treatment with antiarrythmic drug .
4. severe bradycardia(HR \< 45 bpm) and AV block 6. pathologic esophageal lesion (esophageal stricture or varix ) 7. pregnancy 8. severe chronic obstructive lung disease.
Implementation of the Fatty Liver Index in Primary Care

This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 14 years and older.
* Attended at the Basic Care Units (BCU) participating in the Primary Care Center Baix a Mar study.
* Intention to undergo medical follow-up at the study center.
* Body mass index ≥ 25.

Exclusion Criteria:

* Pregnant women
* Alcohol consumption habit (Standard Drink Unit (SDU); one SDU equals 10 grams of alcohol. Risky consumption is considered from 4 SDUs in men and 2 SDUs in women).
* Displaced patients not assigned to the study center.
* Patients classified as Advanced Chronic Care Model or Complex Chronic Patient.
* Participants diagnosed with any of the following pathologies: Chronic liver diseases, including hepatic steatosis; Dementia; Active oncological diseases
* Cognitive or affective pathology that limits the ability to collaborate with lifestyle interventions carried out at the center.
* Patients under the care of endocrinology specialists.
* Participation in another clinical trial involving an experimental intervention during the period of this trial.
Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.

All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges :

* Scarf or Jonhson (chevron) osteotomy
* Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.

Prospective assessmentfor all patients with an average follow up of 5 years :

* Groulier score scale (similar to AOFAS score rating)
* X-rays data
* Clinical evaluation
* Pedoscopic data.

Eligibility Criteria:
Inclusion Criteria:

* All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges.

  * Scarf or Johnson (Chevron) osteotomy,
  * Experienced surgeon : Pr MABIT, Pr ARNAUD, Pr CHARISSOUX.
* Age of Patients \> 18 years.

Exclusion Criteria:

* Hallux valgus wich wasn't operated by these surgeons.
* No consentment
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma

This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.

PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
2. Male or female aged \>= 18 years;
3. HCC diagnosed by pathology or clinical;
4. BCLC stage C or B (unresectable or/and not suitable for local therapy);
5. Child-Pugh score \<= 7;
6. ECOG performance status of 0 or 1.

Exclusion Criteria:

1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
2. Symptomatic CNS metastases, not suitable for the study assessed by investigator;
3. Evidence of major coagulopathy or other obvious risk of bleeding;
4. Unable to accept enhanced imaging examination (CT or MRI) for any reason;
5. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
6. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
8. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
9. Patients with psychiatric disorders or poor compliance;
10. Women who are pregnant or breastfeeding;
11. The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE;
12. Other conditions lead to inappropriate to participate in this study as judged by the investigator.