cyrilzakka/clinical-trials huggingface dataset:
Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands

Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To confirm these retrospective analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF patients with reduced or mid-range ejection fractions (LVEF \<50%).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18year
2. Outpatients with chronic HF, New York Heart Association \[NYHA\] class II - ambulatory IV
3. LVEF\<50%
4. Serum NT-proBNP concentrations:

   Previous HF hospitalization ≤ 1 year before randomisation ≥400pg/mL if sinus rhythm; ≥800pg/mL if AF Previous HF hospitalization \> 1 year before randomisation or in the absence of HF hospitalizations ≥ 600pg/mL if sinus rhythm; ≥1000 pg/mL if AF

   BNP concentrations:

   Previous HF hospitalization ≤ 1 year before randomisation ≥100pg/mL if sinus rhythm; ≥200pg/mL if AF Previous HF hospitalization \> 1 year before randomisation or in absence of HF hospitalization ≥150pg/mL if sinus rhythm; ≥250pg/mL if AF.
5. ≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)

Exclusion Criteria:

1. Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF)
2. History of HF hospitalization ≤7days
3. History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days
4. Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2
5. The presence of a mechanical assist device
6. Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
7. Scheduled for mechanical assist device or heart transplant
8. Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
9. Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
10. Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)
11. (Intermittent) complete heart block or second-degree AV block type Mobitz without pace maker or ICD
12. Severe (grade III/III) aortic valve disease
13. Complex congenital heart disease
14. Proven hypersensitivity to digoxin (prior side effects)
15. Concomitant medication that interacts with digoxin
16. Use of digoxin ≤6 months prior to inclusion
17. Participation in another (intervention) clinical trial (registry studies not included)
18. Women who are pregnant, breastfeeding or may be considering pregnancy during the study period
Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)

Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.

Not Provided

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 60 years, hospitalised in cardiology wards of the Centre Hospitalier Universitaire of Poitiers
* Left ventricle hypertrophy on echocardiography
* Patient able to comply with study procedures
* Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
* Patient having signed an informed consent after clear and fair information on the study

Exclusion Criteria:

* CardiacTransplant
* Complex congenital cardiopathies
* Know diagnosis of amylosis
* Contra-indication to bony scintigraphy : hypersensitivity to sodium oxidronate or one of its excipients, or to one of the components of radiopharmaceutic marked product ;
* Subject not able to comply with study procedures
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, patients staying in a health or social establishment, adults under legal protection, and patients in emergency situation.
* Women not menopausal
Acupuncture for Chemotherapy-Induced Nausea and Vomiting

The purpose of this study is to clarify whether the matching acupoints is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .

Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed as cancer and need to accept chemotherapy.
2. The score of Karnofsky ≥70
3. Patients of either gender and older than 18 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. Patients receiving chemotherapy either he first or multiple cycle, but the patient will be taken in only one time
6. To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
7. Life expectancy≥ 6 months
8. Willing to participate in the study and be randomized into one of the four study groups.

Exclusion Criteria:

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
4. Presence of cardiac pacemaker
5. Active skin infection
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction)
9. Brain metastases
10. Women in pregnant and lactating period
Rosiglitazone on Microalbuminuria in Type 2 Diabetics

Following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a 1:1 ratio to receive 32 weeks of double-blind study medication: Rosiglitazone (starting dose 4mg od) or Glyburide (starting dose 5mg od), both in combination with open-label Metformin \> or = (1g/day). Subjects were stratified for use of ACEI, nondihydropyridine calcium channel blockers (NDP CCB), or angiotensin II receptor blockers (ARB) to provide equal representation of these subjects in each treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 40-80 with T2DM and Microalbuminuria previously treated by diet and exercise alone, a single oral antidiabetic agent, or combination oral antidiabetic therapy.

Exclusion Criteria:

* Pregnancy or lactation, use of any TZD (pioglitazone or Rosiglitazone) or insulin, renal disease or renal dysfunction , any degree of congestive heart failure, clinically significant hepatic disease or anemia, presence of unstable or severe angina or coronary insufficiency, high blood pressure
Veteran Stress and Learning Study

This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.


Eligibility Criteria:
Inclusion Criteria:

* Veterans and civilians with an age range of 18 to 65 years
* Participants must be physically healthy volunteers

Exclusion Criteria:

* Individuals who fall outside the age range
* Individuals with medical conditions that would interfere with participation
* Other criteria
Oxytocin, Alcohol Craving, and Intimate Partner Aggression

Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria indicate that participants must
* aged 18 or over
* fluent in English
* endorse at least one instance of mild or moderate physical IPA with their partner in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2)
* both partners must be willing to participate
* one or both partners must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for an alcohol use disorder (AUD). Concurrent substance use disorders (e.g., marijuana) is acceptable provided alcohol is the participant's primary substance of choice.

Exclusion Criteria:

* Exclusion criteria include
* pregnancy or breastfeeding
* current or history of psychiatric or medical condition that could interfere with neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease; synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating disorders)
* Body Max Index (BMI) ≥ 39
* current suicidal ideation and intent
* severe physical or sexual IPA in the past six months as defined by the Conflict Tactics Scale (CTS-2)
* initiation of psychotropic medication in the past 4 weeks
* acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).
Effect of Interactive Virtual Reality Device on Cervical Proprioception and Range of Motion in Forward Head Posture

Forward head posture (FHP) is one of the most common postural deformities, which affects 66% of the patient population and this study will be designed to investigate the effect of interactive virtual reality device on cervical proprioception and range of motion in symptomatic forward head posture.

Thirty subjects of both sex with ages ranging from 20-24 years and BMI ranging from 18-25 kg/m² with symptomatic forward head posture will be participated in this study. They will be assigned randomly to two groups. Group A will receive traditional treatment (chin tuck exercise for posture correction); 3 min each day for 4 weeks, three sets of 10 repetitions (each repetition was held for 5 sec) were performed. Group B will receive the same as group "A" and received VR training by Xbox Kinect 360 (15 min per session 3 times per week) for 4 weeks. Cervical joint position error (JPE) (CROM device) and cervical range of motion will be measured pre and post treatment.

Eligibility Criteria:
Inclusion Criteria :

1. Subject's age range from 18-24 years old distance of ≥ 2 cm between the acromion and the earlobe when they were positioned perpendicular to the ground.( Kim et al 2018).
2. Prolonged neck pain for more than three months; and the Neck Disability

Exclusion Criteria:1- Existing vestibular pathology.

2- Cervical fracture/dislocation. 3- Sys- temic diseases. 4- Neurological/cardiovascular/respiratory disorders affecting physical performance.

5- History of traumatic head injury. 6- Pregnancy.

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The Choice of Treatment Methods and Efficacy of LABC

The goal of this clinical trial is to compare the therapeutic effects of chemotherapy followed by surgery and surgery followed by chemotherapy in patients with locally advanced breast cancer（LABC). Patients with LABC will be randomly divided into two groups, each receiving chemotherapy followed by surgery or surgery followed by chemotherapy. The main comparison was between the disease-free survival (DFS) of two groups of patients, with the secondary study endpoint being overall survival (OS); Five year survival; Local recurrence or distant metastasis rate.

Local advanced breast cancer was enrolled in the Department of Breast Surgery of Peking Union Medical College Hospital and Beijing Cooperation Hospital according to the criteria for patient inclusion. It is estimated that 50 patients will be enrolled. Randomly divide patients into two groups. The plan for Group A (experimental group, 25 cases) is "surgery+systematic treatment"; The plan for Group B (control group, 25 cases) is "neoadjuvant therapy+surgery+systematic treatment". Based on the previously obtained patient personal information, treatment related information, tumor tissue/blood sample test results, statistical analysis was conducted to explore the impact of different treatment strategies for locally advanced breast cancer on the survival and prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18-70 year old female
2. Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed;
3. Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer;
4. After evaluation by experienced clinical physicians, the patient's tumor has the possibility of surgical resection. Specific evaluation indicators include ultrasound assessment of the tumor not surrounding the axillary vein;
5. Accept treatment plans including surgery, radiotherapy, and chemotherapy;
6. Volunteer to participate in clinical research and sign an informed consent form;
7. Willing to undergo follow-up and complete quality of life (EQ-5D series scale and FACT-B scale) and postoperative psychological status (Anxiety/Depression Self Rating Scale) assessments;

Exclusion Criteria:

1. Patients under 18 years old or over 70 years old;
2. Those who have received breast cancer related surgery, radiotherapy or chemotherapy;
3. Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer
4. History of other malignant tumors;
5. Pregnant or lactating women;
6. Accompanying active infection and fever;
7. Other serious diseases that may significantly affect clinical trial compliance, such as severe cardiopulmonary dysfunction, liver and kidney dysfunction, poorly controlled diabetes and mental illness.
Effect of Low Amplitude Vibration Therapy on Flexibility of Hamstring Muscle in Athletes of Pakistan

Whole body vibration therapy is rapidly becoming a topic of interest for the researchers around the world. Evidence suggests that Whole body vibration has an effect on improving flexibility of hamstring muscle and balance in athletes. The purpose was to examine the effect of low amplitude Whole body vibration on the flexibility of hamstring muscle and improving balance in athletes of Pakistan

A total 60 number of athletes were analyzed and out of these 40 were included in the study who full fill the inclusion criteria, selected athletes were randomly assigned into two groups (control \& experimental). After a total 2 drop outs from control group and 3 drop outs from experimental group, there were 18 athletes in control group and 17 in experimental group who continued till the analysis. Experimental group was given five sessions of low amplitude whole body vibration therapy for almost duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles for 5 minutes and the control group was given only the static hamstring muscle stretches for five minutes, and same five sessions alike on alternative days. Static stretching protocol had 10 stretches in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle. All participants were assessed using Biodex Whole body vibration plate, Biodex balance system , Goniometer and a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* National athletes of Pakistan.
* Age between 18-30 years

Exclusion Criteria:

* Athletes having history of any acute injury within last 6 weeks.
* Athletes who have had any surgical procedure previously or Patients who were medically unstable.
Quality of Life in Middle-aged and Older Patients With Congenital Ichthyosis

The goal of this observational study is to learn about the quality of life in patients with congenital ichthyosis.

The main question it aims to answer are:

• What is the impact of ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with inherited ichthyosis ?

Participants will take part in individual interviews in which the investigators will explore if and how ichthyosis impacts their quality of life. Examples of such questions are whether participants experience pain, experience struggles in their personal or professional lives, with sports activities or if participants experience a financial burden.

There is limited knowledge on factors affecting the quality of life in patients with ichthyosis, especially in middle-aged and elderly patients. With this study the investigators aim to study the impact of inherited ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with ichthyosis.

Secondary research questions include:

1. What is the impact of ichthyosis on the biological quality of life; by analysing physical complaints, adverse events and drug management in patients with long-term medication use of both topical and systemic treatments, and discussing the sexual health and reproductive challenges?
2. What is the impact of ichthyosis on the psychological quality of life; by examining patients' self-esteem and any clinical symptoms of body dysmorphic disorder, and mental and emotional complaints such as concerns about their future care?
3. What is the impact of ichthyosis on the social quality of life; by analysing interpersonal relationships, social support dynamics, societal costs and awareness, and career opportunities?

Furthermore the investigators aim to discover knowledge gaps in current patient management and possible areas of improvement in patient care towards health professionals.

Eligibility Criteria:
Inclusion Criteria:

* 30 years of age and older
* Clinical or genetic confirmed variant of congenital ichthyosis

Exclusion Criteria:

* \<30 years of age
* ichthyosis vulgaris
* another primary chronic skin condition besides ichthyosis
* patients who are not able to read/speak Dutch
Somatic Stem Cells in Leiomyomas?

The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method.

The organ of interest in our study is the myometrium, a muscle layer of the uterus located between the perimetry and the endometrium.

The investigators try to identify, locate and characterize the myometrial stem cell population in the uterine fibroids by isolation of "Side Population" by flow cytometry. Once the investigators achieve the purposes to set out, the investigators would try to maintain "in vitro" stem cell population isolated from myometrial fibroids, for further endocrine characterization. Finally, the investigators would try to induce the formation of fibroids in murine models as a first step to demonstrate that the origin of these formations is due to the abnormal proliferation of myometrial adult stem cells. The results of this study will allow the identification of the cell population in the fibroids. The investigators also can being able to compare with the myometrium in order to establish a relationship that helps us to understand more about the pathophysiology of this disease, using these stem cells as targets therapy in the treatment of this myometrium condition.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis for subserosal, intramural and submucosal fibroids.
* Aged between 20 and 40 years
* Signing of informed consent for collection and storage of biological samples.

Exclusion criteria:

* Contraindications for surgery.
* Failure to sign informed consent for collection and storage of biological samples.
Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic inflammatory disease affecting 10% of women. The objective of this study is to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis: the levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog (GnRHa) leuprolide acetate.

Hypothesis:

H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There is alteration in hemostatic system with the use of GnRHa or LNG-IUS

Materials and Methods: In this randomized open-label controlled trial, 44 women with endometriosis will be randomly allocated to one of two groups: 22 women will be assigned to use LNG-IUS and 22 to use GnRHa. The assessed variables will be D-dimers, fibrinogen, prothrombin time, activated partial thromboplastin time, coagulation factors (F) II, V, VII, VIII, IX, X, and XI, antithrombin (AT), protein C, free protein S, tissue plasminogen activator (t-PA), α2-antiplasmin, thrombin-antithrombin complex, and prothrombin fragment 1+2. All variables will be assessed before treatment and six months after treatment onset.

Eligibility Criteria:
Inclusion Criteria:

* to have endometriosis
* aged 18 to 40 years
* Being without contraceptives for at least 3 months or with depot medroxyprogesterone acetate or GnRHa for at least 6 months at the time of randomization.

Exclusion Criteria:

* obese patients with a body mass index (BMI) ≥30 kg/m2
* smokers
* diabetics
* alcohol or drug users
* patients currently wishing to conceive
* patients with chronic diseases (except endometriosis)
* patients with infectious processes
* patients with a personal and/or family history of thromboembolic events
* patients taking medications known to interfere with inflammation markers (such as hormonal and nonhormonal anti-inflammatory agents) within the 15 days before the study.