cyrilzakka/clinical-trials huggingface dataset:
Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Phase 1b, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction

Eligibility Criteria:
Inclusion Criteria:

Patients are eligible to be included in the study only if they meet at least all the following criteria:

1. Male or female, \>18 years of age.
2. CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
3. Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
4. New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
5. BMI ≥ 30 kg/m2.
6. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. Decompensated heart failure.
2. Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
3. Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
4. Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
5. History of heart transplant or on heart transplant list.
6. Uncontrolled systemic hypertension.
7. Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
8. Patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.
Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain

Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Male and female sexes.
* ASA I-II.,III
* Cancer patients undergoing thoracotomy incisions
* Body mass index (BMI) from 18.5 to 30 kg/m2

Exclusion Criteria:

* Patient refusal
* Known allergy to any of the used drugs
* Low platelet count, any coagulation defect
Dietary Protein and Resistance Exercise in Elderly

The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of resistance training (2x/week for 8 weeks) with and without different goals of protein intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons.

Participants (n = 137) will be community-dwelling older adults. After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 groups (low protein + strength training, high protein + strength training, low protein and no strength training(=control)). Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.

Primary outcome measure is the change in the Chair Stand Test. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, microbiota, metabolomics, proteomics and the nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the age of 65 and 85 years of age
* Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State \>23)
* Independently mobile

Exclusion Criteria:

* Chronic diseases, which contraindicate a training participation
* Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
* Diabetic retinopathy
* Manifest osteoporosis
* Regular use of cortisone-containing drugs
* Regular strength training (\> 1x / week) in the last 6 months before inclusion
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein

The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The second most common cause is a refluxing or incompetent Small Saphenous Vein (SSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the SSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the SSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic chronic venous insufficiency.
* Patients in whom endovenous thermal ablation is clinically indicated.
* Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
* Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow in the saphenous vein \>0.5 seconds after calf compression or while standing.

Exclusion Criteria:

* Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).
* Have a history of Deep Venous Thrombosis (DVT).
* Have a history of hypercoaguability disorder.
* Are pregnant or breastfeeding.
* Are nonambulatory.
Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:

The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Male or post-menopausal female (no menses in the last year)
* Plasma phylloquinone \<1.0 nmol/L
* Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had pain, aching, or stiffness in or around your knee(s) on most days for at least one month?"
* Kellgren-Lawrence (KL) grade 2-3 in at least one knee
* Ability to understand study procedures and to comply with them for the entire length of the study
* Ability to answer questions by phone
* Ability to swallow capsules

Exclusion Criteria:

* KL grade 4 in at least one knee
* Inability to walk
* Cognitive impairment (based on a Montreal Cognitive Assessment Test score ≤ 17)
* Widespread pain
* Malabsorption disorders (e.g. advance liver disease, stage 4 or 5 chronic renal disease, Crohn's disease, celiac sprue)
* Serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation
* Plan to permanently relocate from the greater Boston, MA or Chapel Hill NC areas during the trial period
* Planned knee or hip arthroplasty during the study period
* Undergoing cancer treatment
* \< 50 years old
* Circulating phylloquinone ≥ 1.0 nmol/L
* Warfarin (Jantoven) use
* Use of other investigational drugs
* Use of herbal, botanical or vitamin K supplements
* Use of assistive walking devices
Cough Suppressive Therapy in Patients With Chronic Cough

In this randomized, placebo-controlled, interventional study on chronic cough a non-pharmacological cough suppressive therapy is the intervention to be studied, with a control group receiving treatment consisting of general healthy lifestyle advice. The following data will be collected before, after and up to six months after treatment: Standardized questionnaires for diagnosis of background factors, Leicester Cough Questionnaire (LCQ), Work Ability Index (WAI), and cough frequency as well as lung function and biomarkers.

The primary treatment effect measurement will be changes in chronic cough-related quality of life, measured by the Leicester Cough Questionnaire (LCQ).

The study will be carried out in collaboration between respiratory physicians, clinical physiologists, physiotherapists, speech- and language therapists and gastroenterologists.

The primary hypothesis of the planned study is:

The cough suppressive therapy improves chronic cough-related quality of life and work ability, and is sustained over six months after treatment.

The secondary hypotheses of the planned study are:

Treatment of chronic cough by the cough suppressive therapy can reduce cough frequency (measured by an automated cough detector), airway inflammation and airway resistance.

Baseline differences in clinical findings, biomarkers and physiologic measurements predict different treatment effects.

The following data will be collected before and after treatment:

* Standardized questionnaires for diagnosis of background factors and cough duration, LCQ, WAI, questions on sick leave days, voice disturbance questionnaire.
* Physiological measurements: Spirometry with reversibility test, impulse oscillometry before and after provocation with hypertonic saline inhalation. 24 hours cough frequency analysis, voice analysis.
* Biomarkers: Fractional exhaled nitric oxide (FeNO), blood-eosinophils and eosinophil cationic protein in serum, proteomics in particles in exhaled air (PExA)

Eligibility Criteria:
Inclusion Criteria:

* Chronic cough (duration \>2 months) without a structural lung disease and a normal chest X-ray, which have failed pharmacological treatment.
* Being able to understand the swedish language.

Exclusion Criteria:

* Pulmonary abnormalities on a chest X-ray, structural lung disease, or chronic obstructive pulmonary disease (COPD) of spirometry stage Global Initiative for Obstructive Lung Disease (GOLD) 2 or higher.
* Smoking under the last three months.
* Ongoing or recent treatment with angiotensin-converting enzyme (ACE) inhibitor
* Active aspiration, vocal cord nodules or upper respiratory tract infection in the previous 4 weeks.
Probiotics Use in the Chronic Peritoneal Dialysis Patients

The purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.

Peritoneal dialysis was one of therapies for uremia patient. However, peritoneal dialysis related peritonitis was a major complication for these patients. Severe and prolong peritonitis may led to membrane failure and drop out of peritoneal dialysis. Among the pathogens, G(+) bacteria came from skin surface and G(-) bacteria came from gastrointestinal tract. The later might be related to the pathogens in the gastrointestinal tract, and led to peritonitis if constipation or diarrhea developed. In addition, intestinal pathogens may be related to chronic inflammation in uremia patients. There was a MIA syndrome (malnutrition, inflammation and atherosclerosis) noted before, and chronic inflammation may be related to malnutrition. Today, we know that nutrition status and inflammation marker (CRP) may be associated with patients' outcome. Many gastrointestinal syndromes such as constipation suffer our patients. The dialysate in the abdominal cavity may further exacerbate the appetite. The probiotics was though to improve the pathogens in intestinal tract, improve gastrointestinal function. We want to decrease the incidence of peritonitis by using the probiotics. In addition, the improvement in gastrointestinal function can increase the nutrition status.

Eligibility Criteria:
Inclusion Criteria:

* 1. uremia patient under chronic peritoneal dialysis ≧ 3 months
* 2. Age between 16 and 75 years

Exclusion Criteria:

* 1. uremia patient with advanced malignance disease
* 2. uremia patient had more than 2 episode of G(+) peritonitis within the last one year
* 3. uremia patient with expected life ≦ 1 years
* 4. uremia patient with the history of drug or alcohol abuse
* 5. uremia patient with poor drug compliance
* 6. uremia patient with active infection disease
* 7. uremia patient with uncontrolled autoimmune disease such as SLE
Naturalistic Monitoring and Treatment of Chronic Insomnia

90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. The purpose of the study is to examine if the SleepScore max provides a accurate measurement of sleep relative to a validated, wrist-worn sleep monitor and if a integrated coaching feature within the SleepScore Max facilitates improvement in sleep relative to other gold standard treatment methods.

90 chronic insomniacs, carefully screened using the criteria of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders 3 (ICSD-3), will be studied. Additionally, 30 healthy normal sleepers will be included as controls. The duration of study participation will be 10 weeks. All subjects will wear an actigraph during week 1 to record baseline sleep patterns, followed by 8 weeks of recording with the SleepScore Max. During week 10, the subjects will wear the actigraph again to measure post intervention sleep. The healthy subjects will be used as a control to test if the SleepScore Max can track sleep well as compared to actigraphy. The subjects with chronic insomnia will be randomized into one of three groups (30 subjects in each). One of these groups is the test intervention group, in which subjects will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. The other two groups will serve as passive and active controls. The passive control group will track their sleep using the SleepScore Max device, but without any feedback or coaching. The active control group will also be tracking their sleep with the device, without feedback or coaching, but they will also undergo online CBTi which is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Physically and psychologically healthy (except for chronic insomnia for the insomnia participants) as assessed by questionnaires and history
* No sleep disorders other than chronic insomnia (for insomnia participants only) as assessed by questionnaires and history
* Has daily access to an iPhone

Exclusion Criteria:

* Non-English speaking
Empowering Families Project

This RCT will test the marginal benefit of adding economic-focused services to traditional relationship education (RE) interventions. 344 couples will be randomly assigned to the RE only or RE plus economic-services condition. All couples will be assessed at baseline, 6-weeks, 6-months, and 12-months. This project will examine whether couples in the RE plus condition have better relationship and economic outcomes than couples in the RE only condition.


Eligibility Criteria:
Inclusion Criteria:

* couples involved in a romantic relationship

Exclusion Criteria:

* current domestic violence or child maltreatment
Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more dangerous LA, especially in patients with increased cardiovascular risk. There is scarce clinical data about the safety of the use of hyaluronidase in dental procedures.

This study aimed to compare hemodynamic and electrocardiographic variables during a dental surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in healthy subjects.

This double-blind crossover "split-mouth" trial evaluated the cardiovascular effects induced by 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine, concomitantly with 75 TRU/mL hyaluronidase or placebo in inferior alveolar nerve block, for the performance of bilateral and symmetrical third molar surgery in 20 outpatients. Cardiovascular parameters, including systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR), were monitored using oscillometric and photoplethysmographic methods in 10 clinical stages. Electrocardiographic records (ECG) of 12 leads were obtained in four steps. Hyaluronidase injected concomitantly with LA did not induce changes in SBP, DBP and HR compared to placebo. There were no instances of ST segment depression, ST segment elevation, wide QRS complex extrasystoles, or narrow QRS complex extrasystoles.

To date, few studies in dentistry have investigated the effects of local anaesthetic efficacy in hyaluronidase, and even fewer have studied the relation to systemic effects induced by this interaction.

The use of LA injected concomitantly with 75 TRU/mL of hyaluronidase is safe when using this dose and route of administration.

Clinical Relevance: In dentistry, few studies have investigated the effects of hyaluronidase on local anaesthetic efficacy, and even fewer have examined the possible systemic effects induced by this interaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients should present bilateral lower third molars (teeth 38 and 48) for extraction and identical anatomical arrangement;
* Absence of significant clinical morbidities, ASA I (American Society of Anesthesiologists, 1963);
* Aged over 18 years.

Exclusion Criteria:

* Women during pregnancy or lactation;
* Smokers;
* History of sensitivity to any drug used in the research;
* Presence or history of cancer or an infectious lesion;
* Individuals who used any medication in the last 15 days (except oral contraceptives);
* Presence of abscess or pericoronitis in the region to be operated;
* Patients who required supplemental anaesthesia upon anaesthetic block of the inferior alveolar nerve (post-randomisation exclusion).
Kneipp Water Applications for Insomnia

The purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 18 years
* Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month)

Exclusion Criteria:

* secundary sleeping disease
* Mental diseases which require therapy
* Medication: benzodiazepine,Z-drugs, barbiturat, antihistaminika, melatonin
* Severe comorbidity
* Gravidity
* Shift work
* Voyages (\>3 times during the study)
* regulary application of Kneipp
* Participation on other studies to therapy sleeping diseases or stress
Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter

The Midline catheter is a peripherally-inserted catheter, with the distal tip being placed at or below the level of the axilla. It is a relevant alternative to other catheters in case of limited venous access and long-run perfusions. Moreover, another significant advantage may be the reduction of the risk of infection.

However, the Midline catheter is poorly described in scientific literature, essentially through retrospective and meta analyses including multiple types of catheters (Piccline, CVC, PAC). Therefore, the TIM-GHM study aims to prospectively assess the rate of infections in case of the Midline catheter.

The results of this study could bring a collective benefit in terms of knowledge and reliability of these intravascular devices.

Depending on these results, a randomized, controlled study will be considered, in order to compare the Midline catheter to its main alternative : the Piccline.


Eligibility Criteria:
Inclusion Criteria:

* Age superior or equal to 18 years old
* Intravascular treatment planned for more than 6 days

Exclusion Criteria:

* Medical history of mastectomy with bilateral lymphadenectomy
* Peripheral neuropathy
* Upper-Extremity Deep Vein Thrombosis
* Arteriovenous fistula
* Poor condition of the skin of the upper limbs
* Patient in palliative care
* Patient in emergency care
* Patient under guardianship/curatorship
* Pregnant or breastfeeding women