cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

This study includes screening and treatment and follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the study.
* Voluntarily participate in the study and sign the ICF.
* 18 years ≤ age ≤ 65 years, male and female.
* Willing to take effective contraceptive measures during the study period.

Exclusion Criteria:

* Plan to receive any major surgery during the study period.
* With malignant tumors within 5 years before screening.
* Positive results of alcohol breath test or urine drug abuse screening during screening period.
* Any reason that the investigator believes that will prevent the subject from participating in the study.
Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis

The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen \& Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis in participants attending the Nine Circles Community Health Centre in Winnipeg, Manitoba.

The main questions are: Does the POCT provide accurate results compared to conventional syphilis serology methods? and Can the use of POCT improve the timeline for diagnosis and treatment of syphilis?

Researchers will compare the POCT results with conventional laboratory testing to assess if the rapid test can reliably diagnose syphilis during the initial clinic visit.

Participants will: Provide a blood sample via fingerstick for POCT testing and complete a feedback survey to evaluate the POCT experience.

Key details: This study will involve approximately 600 participants aged 18 and older over the course of 12 months which includes both new and repeat visits


Eligibility Criteria:
Inclusion Criteria:

* Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care
* Be able to provide informed consent and are a minimum 18 years of age are eligible for this study
* Those who had other STIs in the past, or being suspected of having other STIs, are not excluded as long as testing for syphilis is part of the care provided to them

Exclusion Criteria:

* Those who, at the discretion of the HCP/Research Nurse, appear intoxicated and/or with extreme distress, or confused, will be excluded
* Those below the age of 18 years
* if it has been less than 90 days since their last POCT study visit and they are asymptomatic.
Aspirin and Enalapril in Microalbuminuric Type 2 Diabetes Mellitus Patients

Research design: randomized, double-blind, placebo-controlled crossover study to evaluate the putative interference of low-dose aspirin (for 8 weeks) on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients

Research design: randomized, double-blind, placebo-controlled crossover study Patients: Microalbuminuric (urinary albumin excretion \[UAE\]30-300 mg/d)type 2 diabetes mellitus patients without ischemic heart disease or peptic ulcer Aim:To evaluate the putative interference of low-dose aspirin (300 mg/d)for 8 weeks)on enalapril antiproteinuric properties in microalbuminuric type 2 diabetes mellitus patients Study protocol:Crossover randomization to 8 weeks of enalapril 10 mg/d plus aspirin (300 mg/d) or plus placebo, and a 6-week washout period. Measurement of UAE (immunoturbidimetry) and glomerular filtration rate (51Cr-EDTA), blood pressure and metabolic control at baseline and at the end of each period.

Statistical analyses: Bland\&Altman analyses for crossover trials.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus microalbuminuria

Exclusion Criteria:

* ischemic heart disease peptic disease
Time-to-Detection in Culture of Mycobacterium Tuberculosis

determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission


Eligibility Criteria:
Inclusion Criteria:

* have at least 1 contact case explored for tuberculosis
* latent tuberculosis infection

Exclusion Criteria:

-
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.

The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson Disease
* Must be experiencing sleep akinesia

Exclusion Criteria:

* Current treatment with other dopamine agonists
* Nocturnal hallucinations
* Dementia
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.

Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones.

The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic aortic valve disease in need of valve replacement
2. Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.
3. Study patient is an adult of legal consent age.
4. Study patient has provided written informed consent to participate in the study

Exclusion Criteria:

1. Life expectancy \< 12 months due to co-morbid conditions.
2. Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation
3. Preexisting bioprosthetic valve or ring in aortic valve position.
4. Pre-existing pacemaker or ICD/CRT.
5. Cardiogenic shock or hemodynamic instability.
6. History of active endocarditis
7. Contraindications for a trans-femoral access.
8. Severe left ventricular dysfunction with LVEF \<30%.
9. Severe mitral valve insufficiency.
10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
11. Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
12. Patients suffering from dementia.
13. Pregnant or nursing women
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital

The goal of this clinical trial\] is to compare the outcomes between induction to labour at home versus hospitalized. The main questions it aims to answer are:

* Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate?
* Will the induction to labour at home increase maternal satisfaction
* Will the induction to labour at home improve medical circuits and coulb it be cost effective? Participants who meet inclusion criteria will undergo randomization so as to be asignated an induction to labour at home or in the hospital.

Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.

INDOBAMHOS is a multicentric randomized clinical trial which is based in the principle that cervical rippening with intracervical probes with ballons is as safe as pharmacological induction with PGE2 and it seems to be a suitable option to develop the cervical rippening process of the induction at home rather than in the hospital.

The purpouse of the study is to demonstrate that the comfort of performing the cervical rippenning at home will benefit patients with an increase of the vaginal delivery rate and increases maternal satisfaction. And also will improve medical circuits and could be cost-effective when compared to hospitalized labour induction.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with ages \>18 y.o
* Being able to read and understand the informed consent
* Accept to join the study when signing the informed consent
* Singleton
* Cephalic presentation
* Weeks of gestation between equal or more than 37 and less than 42
* Low risk indication of labor induction: Cronologically prolonged gestation
* Intermediate risk indication of labor induction: Macrosoma, Elevated maternal age, Intrahepatic Gestacional Colestasis, Gestational Diabetes Mellitus treated with diet, Gestational Diabetes Mellitus with insulin therapy and correct metabollic controls, Small for gestacional age fetus, Stable chronic hypertension, anterior caesarean section

Exclusion Criteria:

* Premature rupture of membranes (PROM)
* Breech presentation
* Unstable presentation
* Polihydramnios
* Severe congenital fetal afection
* Fetal growth restriction
* Suspected fetal well-being loss on CTG
* Bishop score equal or higher than seven before insertion of the CRB
* High cephalic presentation
* Home further than 30min from Hospital
* Preeclampsia
* Diabetes Mellitus type 1
* Maternal Hypertension
* Other maternal pathology with severe compromise
* Vaginal delivery Exclusion:
* Oclusive and non-occlusive placenta previa (marginal or low insertion)
* Vasa previa
* Transverse / Oblique situation
* Cord prolapse
* History of previous caesarean section with uterine incission in inverted T
* History of uterine rupture
* Two or more previous Caesarean section
* Active genital herpetical infection
Growth Hormone Resistance of Beta-cells in Women and People

The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years old
* hemoglobin HbA1c ≤5.6% and fasting blood glucose \<100 mg/dl
* body mass index ≥30.0 kg/m2 and \<45.0 kg/m2

Additional, group-specific inclusion criteria:

* Family history of type 2 diabetes: first degree relative with type 2 diabetes
* Control group: no family history of type 2 diabetes

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study, or breastfeeding
* Current diagnosis or history of type 1 or type 2 diabetes
* Use of medications that can impact the study outcomes (e.g., GLP-1 receptor agonists)
* History of bariatric surgery
* Known hypothyroidism or use of thyroid medications
* History of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as Turner Syndrome, Prader-Willi Syndrome, or renal impairment
* Current cancer or cancer that has been in remission less than 5 years
* First degree relative with type 1 diabetes diagnosis
* Evidence of significant anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease)
* Alcohol use disorder, use of controlled substances, or smoking \>2 cigarettes per day
* Greater than 3% weight loss within three months of screening or engaged in regular (≥3 days per week), continuous moderate- or high-intensity exercise of ≥30 min duration
* Mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent
Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (Gyn Right) - Pilot Study

In this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. Furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Offered patient information and written informed consent
* Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour

  1. Patient Group 1: Female patients with \> 500 ml ascites in the preoperative sonographic examination
  2. Patient group 2: Female patients aged \> 70 years and at least one of the following secondary diagnoses:

     * Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction
     * existing arterial Hypertension for more than 5 years
     * chronic heart failure (New York Heart Association (NYHA) class II-III)
     * peripheral arterial disease

Exclusion Criteria:

* Patients aged less than 18 years
* Persons without the capacity to consent
* Inability of German language use
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* (Unclear) history of alcohol or substances disabuse
* Coworker of the Charité
* Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalization
* Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study
* Neurological or psychiatric disease at the beginning of hospitalization
* CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization
* American Society of Anesthesiologists (ASA) classification greater than IV
* Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization
* Pulmonary oedema in thorax x-ray at the beginning of hospitalization
* History of intracranial hemorrhage within one year before participation in the study
* Conditions following venous thrombosis within the last three years before study inclusion
* Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
* Diabetes mellitus with signs of severe neuropathy
* Known atrial fibrillation
* Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.
Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure

The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for heart failure
* \> 18 years old
* Malnutrition determined by MNA test (\< 17 points)

Exclusion Criteria:

* If is not possible to perform a nutritional assessment
* Planned PCI or CABG to correct heart failure etiology
Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics

The objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.

In total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. After surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. Within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. In this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. Recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking.

The possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. Furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint.

The goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral primary knee arthrosis indicated for total knee replacement.
* Patients able to understand the protocol and to sign the informed consent.

Exclusion Criteria:

* Patients with indications for revision surgery.
* Patients with patellectomy.
* Child-bearing female.
Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat concentration, and weight management, and has other health benefits.The purposes of this study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and diabetic patients.

The KGN diet was composed of well-cooked noodle with 2 g of KGM in a dosage of 200 g/piece twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period between alternative diets. All 33 subjects received two servings of either GMNs or PNs (400 g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. After a 2-week washout period, the subjects received the other type of noodle for 4 weeks. The body weight, BMI, waist circumference, fasting blood glucose and lipid profile, as well as serum vitamin A, E, β-carotene and high sensitivity C-reactive protein (hs-CPR) were measured by HPCL.

Eligibility Criteria:
Inclusion Criteria: Adults with metabolic syndrome

Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:

1. Abdominal obesity (waist circumference \>= 90 cm in men and \>= 80 cm in women)
2. Impaired fasting glucose ( \>= 5.6 mmol/L)
3. Hypertriglyceridemia ( \>= 1.7 mmol/L)
4. Low HDL-C (\< 1.0 mmol/L in men and \< 1.3 mmol/L in women)
5. Increased blood pressure (SBP \>= 130 mmHg and DBP \>= 85 mmHg).

Exclusion Criteria:

1. Liver and renal diseases
2. Undergoing statin therapy
3. Pregnancy women
4. Taking antioxidant vitamins supplements
Chinese PD-SNCA Registry

The purpose of the Chinese PD-SNCA Registry(CPD-SNCAR) is to develop a database of patients of Parkinson's disease with a-synuclein (SNCA) gene variants in mainland China.

Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. SNCA is the first gene implicated in monogenic parkinsonism. However, some polymorphisms of SNCA gene such as rs894278 and rs11931074 can affect the risk of sporadic PD. The investigators aim to establish a database of PD with SNCA variants and characterize the clinical manifestation of these patients in mainland China.

Method:

1. Peripheral blood from patients has been tested to have SNCA gene variants.
2. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO).
3. The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with positive SNCA variants

Exclusion Criteria:

-