cyrilzakka/clinical-trials huggingface dataset:
Haemodynamic Effects of Oxytocin and Carbetocin

The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.

As there is a trend toward childbearing in later life, pre-existing maternal cardiovascular problems may become more frequent during pregnancy and at delivery. In addition the increasing number of women with congenital or acquired cardiac diseases may not tolerate the induced haemodynamic changes as well as healthy patients. Therefore uterotonic drugs must be safe for the cardiovascular system.

Currently oxytocin is used as a common uterotonic agent in obstetrics. The use of this drug in uterotonic reasons can cause serious haemodynamic side effects which has been shown by several investigators.

Preliminary clinical observations of maternal heart rate and blood pressure suggest that that the use of carbetocin causes less hemodynamic changes than oxytocin.

Primary objective(s):

To evaluate the effect of carbetocin on maternal hemodynamic parameters (heart rate, blood pressure, systemic vascular resistance, cardiac output, stroke volume, heart rate variability, and blood pressure variability) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.

To compare the haemodynamic changes of carbetocin versus oxytocin.

Secondary objective(s) To evaluate the need of additional drugs and methods to control uterine tone.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women undergoing elective caesarean section with regional anesthesia

Exclusion Criteria:

---Women with

* placenta praevia
* placental abruption
* multiple gestation
* pregnancy related complications and disorders (i.e. preeclampsia, gestational diabetes)
* pre-existing diseases (e.g. insulin-dependent diabetes, cardiovascular or renal diseases, thyroid disease
* taking medication with known impact on the cardiovascular system
* undergoing caesarean section with general anesthesia
* secondary caesarean section
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis

Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising intervention methods to improve motor function in individuals with severe spinal cord injury. In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve spasticity and residual motor control in the same subject population. The present study explores whether single sessions of noninvasive SCS would improve walking performance and ameliorate spasticity in individuals with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive MS
* lower-limb spasticity

Exclusion Criteria:

* acute relapse of MS
* other neuromuscular diseases
* active and passive implants at vertebral level T9 or caudally
* dermatological issues at stimulation site
* pregnancy
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone

Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality.

The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs.

The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

Official Title: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Azathioprine in New Cases of Pemphigus Vulgaris Receiving Prednisolone

Randomized Double Blind Controlled Trial of Azathioprine versus Placebo in new cases of Pemphigus Vulgaris treated with Prednisolone

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Controlled, Parallel Assignment, Safety/Efficacy Study

Condition Intervention Phase Pemphigus Vulgaris Drug: Azathioprine Drug: Prednisolone Other: Placebo Phase II

Eligibility Criteria:
Inclusion Criteria:

* Lesions clinically consistent with pemphigus vulgaris
* Diagnosis confirmed by histology in terms of acantholysis within past month
* Positive DIF

Exclusion Criteria:

* Any nursing or pregnant woman
* Any history of chronic diseases including liver disease, Chronic Renal Failure, Chronic Heart Failure or Ischemic Heart Disease
* Present diagnosis of hepatitis confirmed by serology or elevated hepatic enzymes;
* Clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following:
* Hepatobiliary AST or ALT ≥ 1.5 × upper limit of normal (ULN);alkaline phosphatase ≥ 1.5 × ULN; or, total bilirubin \> 90% of the ULN;
* Renal serum creatinine \> 1.5 mg/dL; or, significant proteinuria \> 2+ on urinary dip test;
* Hematologic hemoglobin \< 11 mg/dL; leukocytes \< 3.5 × 109/L; neutrophils \< 1.5 × 109/L; or, platelets \< 100 × 109/L; Presence of anemia, leukopenia or thrombocytopenia
* Any sign of patient's non-compliance
* Known hypersensitivity to study drugs, prednisone or azathioprine
* Participating in another clinical trial at the time of screening and enrollment
Pharmacokinetic Study of ABT-126 in Healthy Volunteers

This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 and 50 years of age
* If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
* If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration

Exclusion Criteria:

* Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
* History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
* Presence of any uncontrolled medical illness
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.

The study will be conducted at two sites and will include a minimum of 4 visits. The overall study duration for participants will be approximately 8 weeks. Study participants will undergo acute respiratory disease evaluation that will include a throat swab and a blood draw. Each participant will also be contacted in six months for follow-up information.

Eligibility Criteria:
Inclusion Criteria:

* Military recruit in training
* Male or female; if female, must be of non-childbearing potential or with a documented negative pregnancy test \</= 72 hours prior to study medication administration and agree not to become pregnant

Exclusion Criteria:

* Female nursing an infant or planning on nursing during the study
* Immunosuppressed for any reason, including past (within last 6 months) or current treatment with immunosuppressive therapy
* Known allergy to any component of the vaccines and/or placebo tablets
* Immunocompromised sexual partner or immunocompromised individuals in home
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18 and older
* Planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth

Exclusion Criteria:

* Documented antiphospholipd antibodies
* Uterine malformation or parental chromosomal abnormality
* Known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol
* Any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy
Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children

The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction of Havrix™ into the Expanded Program of Immunization.

This is an observational, prospective, multi-centre, sentinel based study in 3 hospitals in Panama. Hospitals are selected based on population density or hepatitis A disease burden.

The Pan American Health Organization (PAHO) definition for a possible case of acute hepatitis A are used for subjects aged between \>1 month and \<15 years.

Data regarding clinical and epidemiologic information are collected and serum samples are collected to test hepatitis A markers and determine if infection with hepatitis A virus has recently occurred.

Surveillance will be for a period of approximately 2.5 years from the date of study initiation.

Eligibility Criteria:
Inclusion Criteria:

* A male or female between \>1 month and \<15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.
* Subjects with clinical diagnosis of possible acute hepatitis A.
* Written informed consent obtained from the parent or guardian of the subject.
* Subjects for whom a blood sample is collected.

Exclusion Criteria:

* Subjects with confirmed diagnosis of non-viral hepatitis
A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan

The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.

Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.

This study is seeking for patients with:

* sepsis (A very serious infection in your blood caused by germ (a bacteria)) or
* renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.

Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received Zavicefta for the first time after the launch of Zavicefta
2. Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
3. Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
4. Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use

Exclusion Criteria:

There are no exclusion criteria for this study.
The Influence of Axial Length on Visual Quality Following SMILE Surgery in Patients with High Myopia

This retrospective study aimed to investigate the subjective and objective visual outcomes following Small Incision Lenticule Extraction (SMILE) surgery in high myopic patients with varying axial lengths (AL).

The study enrolled 113 highly myopic patients (202 eyes) who underwent SMILE surgery at Shanghai's Tenth People's Hospital. Patients were classified into three groups based on the axial length before surgery: Group A (AL \< 26 mm, 62 eyes), Group B (26 mm ≤ AL \< 27 mm, 88 eyes), and Group C (AL ≥ 27 mm, 52 eyes). Preoperative and postoperative evaluations included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), equivalent spherical error(SE), and corneal high order aberration. Subjective visual quality was assessed using the Quality of Vision (QoV) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* manifest refraction spherical equivalent refraction exceeding -6.00D;
* stable myopia for a duration of at least 2 years;
* corrected distance visual acuity of at least 20/25;
* annual myopic spherical equivalent increment less than - 0.50 D.

Exclusion Criteria:

* a history of moderate to severe dry eye as well as any ocular or systemic disease.
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.

This is a randomised, single-center, open-label, single-dose, two-period crossover pharmacokinetics study of donepezil HCl tablets 3 mg in subjects receiving haemodialysis. Subjects will be or will not be receiving haemodialysis. After intervals of over 15 days, the subjects will be receiving the other treatment.

Eligibility Criteria:
Inclusion criteria:

Subjects with end-stage renal disease who were receiving haemodialysis. Subject who are able and willing to give written informed consent.

Exclusion criteria:

Subjects with known hypersensitivity to drugs or foods. Subjects with a corrected QT interval greater than 450 msec at Screening period.
The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.

When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction instead of clinical operation. ERCP has many advantages like less injury or faster recovery. However, according to literature, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis, which often requires emergency intervention, therefore, it is necessary to know if the gallbladder status(chronic disease) is one of the important risk factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or calculus.

.

Eligibility Criteria:
Inclusion Criteria:

* Routine ERCP for CBD stone patients with gallbladder in situ

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Unstable vital signs Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
* Any Prior surgery for CBD including ERCP
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock
* Biliary- duodenal fistula confirmed during ERCP
* Pregnant women or breastfeeding
Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)

This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75 years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a moderate or severe unipolar depressive episode and suicidal tendencies who agree to participate in a prospective study (cohort 2); and moderate or severe unipolar depressive episodes validated by research interviews and and suicidal tendencies that persist for at least 48 hours after admission who are followed up for 6 months (cohort 3).

Epidemiological cross-sectional study in over 3000 inpatients with a clinical diagnosis of major depressive disorder, validation of the clinical diagnosis in 520 patients, and prospective naturalistic 6-month follow-up study of 260 adults with a research interview-confirmed major depressive disorder, with data collection at the following points: at T0 = time of hospitalization (epidemiological study population 1 with data from clinical routine practice), at time T1 of baseline survey in patients with persistent suicidal tendencies, i.e. at least 48 hours after T0 (study population 2 as a subgroup of study population 1, with study information and consent), and in study population 3 (subgroup of study population 2, with study information and consent) at the time of discharge (T2), 3 months after admission to hospital (T3/ by telephone) and 6 months after inpatient admission (T4).

The aim of the study is to characterize the remission or recurrence of suicidal symptoms in the context of a depressive episode. It is expected that the results will help to improve the understanding of the disease process and the further development of effective intervention options.

Eligibility Criteria:
Inclusion Criteria:

For Population 1

1.any form of unipolar depressive episode

For Population 2

1. clinical diagnosis of a moderate or severe unipolar depressive episode
2. clinically diagnosed suicidal tendencies that persist for at least 48 hours after admission to hospital
3. Written consent to participate in the study

For Population 3

1. Diagnosis of a moderate or severe unipolar depressive disorder through the structured research interview "Mini International Neuropsychiatric Interview" (M.I.N.I.)
2. Suicidality with a value \> / = 1 for item 2 (passive suicidality) OR item 3 (active suicidality) based on the research interview "Sheehan Suicidality Tracking Scale" (S-STS)
3. Written consent to participate in the study

Exclusion Criteria:

* Patients younger than 18 years or older than 75 years
* No clinical diagnosis of a depressive episode
* Depressive episode in the context of a bipolar disorder- secondary depression as a result of physical illness or substance use
* severe physical symptoms of disease that make participation in the study impossible
* Pregnancy
* not being able to understand the study processes
* incapable of giving informed consent
* no authorization to give consent due to (limited) incapacity
Pain and Anxiety During Local Block

INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.

OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.

METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.

Result: after the completion of the study CONCLUSIONS: After the completion of the study


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age
* Both sexes
* Participants must present nail pathology that requires surgical intervention.

Exclusion Criteria:

* Systemic degenerative
* Neuromuscular diseases
* Pregnant or likely to be pregnant
Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients

This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Background: There are still two major problems in the treatment of SLE: flare and long-term organ damage. BLISS-52 showed there was some reduction of flare (80% vs 71%) in belimumab , but the difference was not significant. Another study tested the efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe SLE in which analysis of atacicept 150 mg suggested benefit.

Telitacicept , a BAFF/APRIL dual-target-inhibitor, which has been proved to be effective in treatment of SLE. But there is no study to show its effectiveness for prevention of flares in SLE patients with low disease activity. In this study, we take telitacicept as maintain treatment in stable SLE patients to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years;
2. SLE patients with low disease activity (SELENA-SLEDAI score\< 8 at screening ); disease duration more than 3 months；no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
3. A stable treatment regimen with fixed doses of prednisone (≤ 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months;
4. Sign the informed consent.

Exclusion Criteria:

1. Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min;
2. Exposure to cyclophosphamide within past 6 months before screening;
3. Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening;
4. Pregnant women, lactating women;
5. History of Malignancy within the last 5 years, excluding adequately treated skin tumors (basal cell or squamous cell carcinoma) or carcinoma in situ of cervix;
6. Active hepatitis or a history of severe liver disease;
7. Current infections (HIV/tuberculosis/COVID-19, etc.) at screening;
8. A significant decrease in immunoglobulin level, IgG\<5g/L;
9. Not suitable for the study in the opinion of the investigator.