cyrilzakka/clinical-trials huggingface dataset:
The Effect Of Tafamidis Meglumine In Transthyretin Amyloid Polyneuropathy Patients

This is a single-arm, open-label, multicenter study designed to evaluate the efficacy, safety, tolerability as well as pharmacodynamics of tafamidis meglumine in ATTR-PN participants in China.

Approximately 10-15 participants are planned to be enrolled. All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily for 72 weeks (18 months).

This is a single-arm, open-label, multicenter study designed to evaluate the efficacy, safety, tolerability as well as pharmacodynamics of tafamidis meglumine in ATTR-PN participants in China.

All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily starting on Day 1. Clinical visits will be scheduled at Baseline (Day 1) and at Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60 and Week 72. At Week 36 and Week 60 site visit, assessment of adverse events, safety related lab testings, concomitant medications and investigational product compliance will be scheduled. Every 6 weeks (do not exceed 7 weeks since last confirmation) telephone contacts will be made during visits in which no investigative site visits are scheduled for assessment of adverse events, concomitant medications and investigational product compliance (between Week 12 and 24, between Week 24 and 36, between Week 36 and 48, between Week 48 and 60, and between Week 60 and 72).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants between the ages of 18 and 80 years.
2. Participants have amyloid documented by biopsy
3. Participants must have a TTR mutation that is associated with ATTR-PN.
4. Participants have peripheral and/or autonomic neuropathy
5. Stages of disease according to symptom severity-stage I.

Exclusion Criteria:

1. Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
2. Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs.
3. Use of diflunisal, tauroursodeoxycholate, doxycycline, inotersen, patisiran or any other TTR stabilizing agent, or experimental interventions for familial amyloidosis within 30 days prior to the study entry and/or during study participation. Participants who are taking or who have previously taken tafamidis.

   Prior/Concurrent Clinical Study Experience:
4. Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
5. Participant has primary (light chain) or secondary amyloidosis.
6. If female, participant is pregnant or breast feeding, or plans to be pregnant or breast feeding in the next 18 months.
7. Participant has received prior liver or any other organ except cornea transplantation.
8. Participant requires significant assistance with ambulation or is wheel chair bound.
9. Participants with cardiomyopathy specific TTR mutations.
10. Participant has other causes of sensorimotor neuropathy.
Identifying Skin Biopsy Sites

The primary objective of this study is to investigate the patient experience during skin biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and Over
* The subjects are in good health.
* The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
* Patients who have had one or multiple skin biopsies OR board-certified dermatologists.

Exclusion Criteria:

* Under 18 years of age.
* Subjects who are unable to understand the protocol or give informed consent.
A Danish Nationwide Longitudinal Study on Prevalence of Periodontitis and Its Co-morbidities

The project (PlanPerioMed) is a register-based study evaluating the associations and patterns of health care delivery between periodontitis and medical diseases using data from the Danish dental record system Dentalsuite (Plandent A/S) and national Danish health care registries with three overall hypotheses/ aims:

* Determine the extent to which periodontitis in registry data is associated with more odontological treatment services and treatment frequency.
* Determine if patients with systemic diseases attend dentists more frequently and receive more treatment services per patient than the population without these diseases.
* Determine to which extent periodontitis and received periodontal treatment affects the risk of medical diseases.

The study will focus on association and trajectories of periodontitis and its treatment with three medical diseases, namely, Type 2 Diabetes Mellitus (Type 2 DM), Cardiovascular Diseases (CVD) and Rheumatoid Arthritis (RA). The dataset consists of approximately 4,000,000 people aged between 18 and 99 years attending private practice in Denmark. The results from PlanPerioMed study are likely to have ramifications for treatment guidelines for other periodontitis comorbidities, e.g. CVD and DM, and will thereby improve the quality of life for a wide range of patients and reduce long-term societal health care expenses related to periodontitis and its comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinical registrations of DMFT, periodontal status and corresponding treatment codes
* Self-reported systemic diseases including Diabetes Mellitus Type 2, Cardiovascular Diseases and Rheumatoid Arthritis
* Subjects with Clinical Attachment Loss\>=3mm, Probing Depth \>= 3mm and bleeding on probing (as defined by World Workshop 2017- criteria for periodontitis) in clinical examination will be included in the study population.

Exclusion Criteria:

* Subjects with more than 32 teeth
* Subjects with no clinical registrations
Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-70 years of age.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Histologically confirmed recurrent or metastatic neuroendocrine carcinoma
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;
* Any other malignancy within 5 years.
* participants were deemed unsuitable for participating in the study by the investigator for any reasons.
Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation

The success rate of single-procedure atrial arrhythmia-free survival particularly ranged from 40% to 66% in persistent AF ablation. However, The surgical Cox maze III procedure has been established to be an effective curative strategy for AF with an AF-free survival rate of more than 95%. The main reason is the difficulty of creating continuous, transmural, and durable lesions by catheter ablation, especially when the procedure is performed on some complex anatomical structures in which epicardial muscular bundles may serve as components of the reentrant circuits.

The durability of the conduction block is a crucial factor for long-term effective AF ablation since previous studies reported that the reconnected Pulmonary veins contributed to the atrial tachycardia recurrence after persistent AF ablation. In addition, it is possible that the inadequate lesions accidentally produce new arrhythmogenic substrates. Therefore, new and better techniques are always chosen to minimize the reconnection of Pulmonary vein isolation (PVI) and additional ablation.

For paroxysmal AF, the ablation strategy of PVI plus superior vena cava isolation is chosen while PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus (CTI) for persistent AF. Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds was regarded as an AF recurrence after a 3-month blanking period. The primary outcome was defined as 12-month atrial arrhythmia-free survival. The secondary outcomes include the block rate of PVI, superior vena cava isolation, and all linear ablations.


Eligibility Criteria:
Inclusion Criteria:

* Radiofrequency catheter ablation for the first time
* AF rhythm recorded by ECG

Exclusion Criteria:

* Thrombosis in left atrium
* Left ventricular ejection fraction of \< 35%
* Abnormal thyroid function
* Previous history of AF radiofrequency ablation and CABG
* Left atrium diameter of \> 65 mm or the volume of \> 200 ml
Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study

5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .


Eligibility Criteria:
Inclusion Criteria:

* 28 to 34 weeks
* preterm termination of pregnancy
* singleton pregnancy
* any obstetric or medical cause for termination of pregnancy

Exclusion Criteria:

* IUFD
* multiple pregnancy
* congenital anomalies
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons

This study will prospectively evaluate the prevalence and incidence (over a two year period) of MRSA colonization and infection among HIV-infected military beneficiaries to determine predictors for the development of MRSA colonization and infection. This study will also investigate the utility of decolonization procedures for clearance of MRSA carriage and prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial sensitivities of isolates in this population will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 18 years of age) who are HIV positive by a reactive screening (ELISA, EIA) and a confirmatory test (Western blot) and who are able to attend the study visits which are every 6 months (+/- 2 months), at the minimum

Exclusion Criteria:

* Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products.
* Age less than 18 years.
* Inability to remain in the study for the two year duration.
* Pregnant or breastfeeding females.
* Females who intend to become pregnant during the two year study time period.
* Persons who are healthcare providers with direct patient contact.
Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)

A study to evaluate patient satisfaction, aesthetic and psychological impact of combined treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).


Eligibility Criteria:
Inclusion Criteria:

* Qualified to receive treatment with BOTOX® Cosmetic, a facial filler (JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA Plus XC and/or JUVÉDERM® VOLUMA® XC) and LATISSE® treatment
* Naïve to botulinum toxin therapy of any serotype for any indication
* Naïve to prescription eyelash growth products of any type
* Naïve to dermal filler treatment in the face and neck

Exclusion Criteria:

* Undergone facial plastic surgery, tissue grafting, tissue augmentation or facial dermal filler injections
* Had laser, photomodulation, intense pulsed light, radio frequency, dermabrasion or chemical peel in the face or neck
* Have received skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 3 months
* Systemic retinoid therapy within 1 year prior to study enrollment
* Presence of inflammation at the proposed injection site(s)
* Profound atrophy/excessive weakness of muscles in target areas of injection
* Known immunization or hypersensitivity to any botulinum toxin serotype
* Undergone oral surgery or dental procedures within 30 days
* No visible eyelashes
* Use of permanent eyeliner, eyelash implants, semi-permanent eyelash tint, dye or extension
* Use of prescription eyelash growth products
* Unwilling or unable to remove contact lenses prior to study medication application in the evening and keep lenses out for 30 minutes
* Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

Previous research regarding the use of phenylephrine has excluded obese subjects (BMI \>35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* ASA Physical Status I-II
* Non-laboring women
* Single gestations ≥ 36 weeks
* Obese women (Body Mass Index 35 - 55 kg/m2)
* Non-emergent CD under spinal anesthesia

Exclusion Criteria:

* Height \< 5'0"
* Antiemetic drug use in the 24 hours prior to CD
* Allergy to phenylephrine, or any other standardized medication
* Hypertensive disease of pregnancy (i.e. mild \& severe preeclampsia)
* Chronic hypertension receiving antihypertensive treatment
* Severe Cardiac disease in pregnancy with marked functional limitations
* Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
* Subject enrollment in another study involving a study medication within 30 days of CD
* Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Spread of Paravertebral Injections in the Lumbar Plexus Area

Lumbar paravertebral block (LPB) has been used for anesthesia in different settings such as in varicocelectomy and inguinal hernia repair in adults and pediatrics. Different studies considered LPB as an alternative to general and spinal anesthesia when contraindications exist, especially in elderly patients. However, the results obtained when using LPB are controversial in terms of number of injections performed and the success rates.

Patients scheduled for hernia repair who will agree to undergo different number of paravertebral injections in the thoraco-lumbar plexus area under CT guidance.

While the patient is in lateral decubitis position, LPB injections will be made using a 100 mm 22 G nerve stimulator needle (Stimuplex, B.Braun, Melsungen, Germany). The site of injection is determined by manual palpation. The number of injections ranges from one to five and the level of injections ranges from T11 to L3.

The needle is penetrated perpendicular to the skin using the following nerve stimulator settings: 5mA, 9V and 2Hz. The stimulating needle is gently manipulated into a position to allow an adequate muscular response with a stimulating current of 0.4-0.8 mA. At this point, 4-5 ml of the contrast (Telebrix 35, 350 mg/ml, Roissy CDG Cedex, France) is injected. The patients will receive the same amount of contrast, despite the different number of injections. The needles are kept in their position and afterwards followed by CT scan.

A radiologist who is blind to the study will interpret the radiological results and document the level at which the needle tip is found, the distance from the kidney and the spread of the injected contrast. In order to ensure patient's safety, different measures will be taken to keep the radiation as low as reasonably achievable.

Following the radiological practice, patients will be transferred to the operating room to undergo inguinal herniorrhaphy, and will not followed for the purpose of this study.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Scheduled for hernia repair

Exclusion Criteria:

Patients

* with coagulation disorders,
* with infection at the injection site,
* with allergy to contrast
* receiving opioids
Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention

The prevalence of tobacco smoking is high among persons with HIV (PWH). The investigators are piloting a two session computer-delivered intervention (CBI) with linkage to a community health worker (CHW) among hospitalized PWH with tobacco use 1a) To determine feasibility and acceptability of delivering this intervention and 2a) To determine intervention effect on 1) readiness to quit smoking and confidence in ability to quit smoking 2) uptake of smoking cessation therapy


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18,
* A patient admitted to the Johns Hopkins Hospital
* Smoked \>100 cigarettes in their lifetime
* Current smoker
* English speaking

Exclusion Criteria:

* Contraindication to nicotine replacement therapy including unstable angina and acute coronary syndrome
The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes

The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.


Eligibility Criteria:
Inclusion Criteria

* Female
* Having had a natural menopause and a minimum of 1 year since last menstruation
* Caucasian
* under 70 years
* Type 2 diabetics
* Those using statins (≥40 mg simvastatin or ≥10 mg atorvastatin) for at least 12 months
* Not currently taking Hormone Replacement Therapy (HRT) and not having taken HRT for a minimum of 6 months prior to commencement
* Having no significant past or present medical history of vascular disease, or cancers (specifically breast, uterine or ovarian)
* Never-smokers, and ex-smokers who have given up smoking at least 12 months before recruitment to the study

Exclusion Criteria

* Currently taking HRT or having taken this medication within 6 months of the trial
* Those prescribed to use statin therapy for less than 12 months Significant past or present medical history of vascular disease (including ECG and enzyme confirmed myocardial infarction, clinical angina, ischaemic stroke peripheral vascular disease, intermittent claudication) or cancer (especially breast, uterine or ovarian)
* Hypertensive's with a systolic BP ≥ 160 mm Hg at maximum, or hypertensive's with a systolic BP ≤160 mm Hg at maximum, but who have received antihypertensive therapy for less than 12 months or have had increases to their medication indicating poor control
* Current smokers or those having given up smoking less than 12 months before recruitment to the study
* Those prescribed aspirin for a period of less than 12 months prior to recruitment
* Those prescribed insulin for a period of less than 12 months prior to recruitment and those having had increases to their medication indicating poor control
* Regular non-prescribed use of anti-inflammatory pain relief medication (i.e. aspirin, paracetamol, cocodamol).
* Taking other counter indicative medication e.g. steroidal medication during the trial, or within 1 month of the trial beginning.
* Taking food / dietary supplements e.g. vitamins, minerals, fish oils, plant oils, isoflavones, soy products, carotenoids during the trial (unless prepared to cease intake during, and 1 month preceding the trial).
* Having vaccinations (excluding the flu vaccination) or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
* Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
* Assessed from the clinical screening: HbA1c ≥ 10%; Creatinine \>125µmol/L; ALP \> 378 IU/L; ALT \>150 IU/L; GGT \> 180 IU/L
Environmental Intervention for Weight Gain Prevention

The primary aim of this research is to evaluate the efficacy of a multicomponent worksite-based, environmental intervention in reducing weight increase and obesity over time in working adults.

This study is a randomized trial designed to evaluate the effectiveness of a multi-component worksite intervention with strong environmental components to prevent weight gain. Six worksites will be randomized to either an intervention or a no-treatment control group. The intervention will be comprised of 1) changing the availability, portion sizes, and prices of foods and beverages sold to employees in their worksites in ways that encourage healthier food choices; 2) increasing the availability of physical activity opportunities at the worksite by implementing walking programs and increasing stairwell access and attractiveness; 3) placing scales in the work environment to encourage body weight monitoring and to enable workers to set goals for their weight; and 4) to provide educational materials to all employees to make them aware of the environmental intervention and of behavioral practices likely to be effective in preventing weight gain. The intervention will be implemented for a 2-year period in each intervention site. Effectiveness will be evaluated by assessing body weight, eating behavior and physical activity in a cohort of employees in both control and intervention sites at baseline and again 2 years later. Weight trends in these populations will also be compared to data from national and state-level annual surveys of weight in representative population samples. Data will be collected on the effects of specific intervention components via aggregate measures of food choice and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* generally in good health
* part- or full-time employee in one of the participating worksites

Exclusion Criteria:

* work on site \<50% of the time
* work second or third shift
ARTiBIOME: Observational Study on the Effect of HIV and ART on Gut Microbiome

Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. However, little is known on the impact of the antiretroviral treatment on this population and very few studies have evaluated these alterations.

The aim of this study is to study microbiome on healthy patients and HIV-infected patients exposed to antiretroviral treatment with integrase strand transfer inhibitors.


Eligibility Criteria:
Inclusion criteria:

* Willing to sign consent form
* Men with an age \>18 years
* Engagement in insertive or receptive anal intercourse with another men

  \*Exclusion criteria:
* Previous history of ART exposure
* Use of antibiotics in the past 3 months
* Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.