cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer.

This study aims to evaluate the effectiveness of Aquatic Therapeutic Exercise by providing a set of exercises in the reduction and / or control the volume of secondary lymphedema treatment of breast cancer in patients who are in the maintenance phase of conventional treatment. It is an experimental, randomized, unifactorial, and intersubjective study. The intervention group will be treated by guided underwater exercises while the control group will receive the same set of exercises out-of-water. The research will be based on comparing the difference on the volume of lymphedema obtained by the exercises provided aquatic environment and out-of-water exercises. The study population will be obtained from rehabilitation service Bellvitge Hospital. The goal is to evaluate the volume of lymphedema and the quality of life related to the health of patients will be evaluated before starting the treatment, at the end of the 20 sessions, when the treatment reaches 3 months and when patient is discharged.

A randomized controlled experimental study has been carried out where two work groups were compared, experimental N: 43 that carried out an exercise regimen designed in the aquatic environment and control N: 47 that carried out the same regimen of exercises in a physiotherapy room. Both groups did 20 treatment sessions of 45 minutes duration with a frequency of 2 or 3 days per week. Lymphedema changes, quality of life and adherence to treatment were evaluated. The evaluations were 3 days prior to the start of the program, at the end of the 20 sessions, and at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Female gender.
* Age between 18 and 75 years.
* Diagnosis of lymphedema in the upper limb secondary to breast cancer treatment.
* Present mild lymphedema or moderate (types I and II respectively according to the volumetric classification of the types of edema according to severity).

Exclusion Criteria:

* Primary lymphedema or secondary to other surgery.
* Bilateral lymphedema.
* Presence of hydrophobia.
* Severe cardiovascular and respiratory diseases.
* Urinary and fecal incontinence.
Extension Safety and Immunogenicity Study of GPNV-001

A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.

A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of study GPNV-001 as per protocol with no significant deviations.
2. Has provided written informed consent.

Exclusion Criteria:

1. Potential participants will be excluded if they have received a pneumococcal vaccine since the end of study visit for study GPNV-001
2. A potential participant has had an episode of pneumonia since completing Study GPNV-001
Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga

The long-term goal is to identify and establish effective mind-body interventions (as an aspect of complementary and alternative medicine) to improve health and Quality of Life (QoL) for people with disabilities. Preliminary data suggest that engagement in yoga is feasible and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. The central hypothesis is that individuals who complete yoga will have significantly better balance, mobility, and QoL after 8 weeks of yoga.

assessments completed before and after yoga. yoga was delivered twice a week for 8 weeks for one hour each session. Yoga included sitting, standing, and floor postures, breath work, and meditation

Eligibility Criteria:
Inclusion Criteria:

* Anyone age 18 and over with DPN from Diabetes Mellitus and a balance impairment. and be able and willing to attend twice weekly sessions for 8 weeks.

Exclusion Criteria:

* not have consistently engaged in yoga for greater than a year.
Efficacy Study for Surgery After Previous Failed Catheter Ablation

Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.

Primary Objectives:

1. Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF
2. Record and evaluate all complications associated with the surgical procedure.

Secondary Objectives:

1. Evaluate usage of anticoagulants at 6, and 12 months.
2. Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of atrial fibrillation
* Has undergone one or more catheter based ablation procedures for AF and the procedure failed
* Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF
Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent

In real-world practice, the investigators plan to evaluate the effectiveness and safety of using the GENOSS (GENOSS DES II) stent, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

This study will enroll patients who underwent percutaneous coronary intervention using the GENOSS DES stent.

This study is a single-arm, registry, observational study, so it is not necessary to calculate the number of subjects, but the investigators plan to enroll approximately 1,000 patients at 7 institutions during the registration period.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years of age
2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
3. Severe coronary artery stenosis suitable for Genoss stent insertion
4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution.

Exclusion Criteria:

1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
2. Patients who also received other drug-eluting stents
3. If you have a disease with a remaining life expectancy of less than 1 year
4. Pregnant or lactating women or women who may be pregnant
5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low.
6. Patients judged by researchers to be unsuitable for research
The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status

The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated.

A total of 45 of consecutive patients attending the periodontology outpatient clinic will be examined using standard periodontal clinical parameters including; Plaque index (PI), Gingival index (GI), Probing depth (PD), Clinical attachment level (CAL), and standardized periapical radiograph, to identify patients with gingivitis, periodontitis, or healthy periodontium , these 45 patients will be clustered into 3 clusters consisting of 15 patients each to represent each category. The same patients will be examined using an infrared thermal camera (Fluke PTi120 Pocket Thermal Imager), the settings will be all according to the standards of infrared medical diagnosis then the acquired images will be analyzed with (Fluke SmartView IR Analysis Reporting Software and Mobile Application). The images will be interpreted to detect the temperature changes in each mm in tissues in order to determine the patients with gingivitis, periodontitis, or healthy periodontium by an investigator blinded to clinical diagnosis. Then the diagnostic sensitivity and specificity of thermographic images for diagnosis of periodontal diseases will be calculated

Eligibility Criteria:
Inclusion Criteria:

* The patients will be enrolled into the study based on the following inclusion criteria:

  1. Patients with generalized gingivitis
  2. patient with generalized periodontitis .
  3. patient with healthy periodontium .
  4. Both genders above 18 y to 60 y .

Exclusion Criteria:

* The patients will not be enrolled into this study based on the following exclusion criteria:

  1. pregnant women .
  2. smokers .
  3. Patients on medications that cause xerostomia as diuretics , antidepressants

     ,bronchodilators ,antihistaminics , antiepileptic ( etc ..)
  4. Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the during the study .
  5. molars according to camera specifications
  6. handicapped patients
  7. para functional habits as mouth breathing and tongue thrusting
Effects of Different Birthing Balls Used at the First Stage of Childbirth

The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.

The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.

IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some non-pharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.

What the results of this study add? There is no studies using the peanut ball and the spherical birth ball together. In our study, it was found that both balls are effective, but the spherical birth ball is more significant.

What the implications are of these findings for clinical practice and/or further research? Our study suggested that the spherical birth ball had effective on birth outcomes. Future studies should be performed to investigate the effects of birth balls in the postpartum period, breastfeeding or prenatal period.

Eligibility Criteria:
Inclusion Criteria:

* primiparous
* admitted to the delivery room for vaginal delivery
* 38-40 week
* being in the latent phase of labor
* having no obstetric risks

Exclusion Criteria:

* undergo caesarean sections for various reasons
* having obstetric risks
Non-Interventional Study PREVENT

This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.

This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.

No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

It is planned to enrol 200 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 6 - 10; there are no restrictions on minimum and maximum number of subjects per site in this study.

Eligibility Criteria:
Inclusion Criteria:

1. The voluntarily given informed consent, confirmed by the Informed Consent Form, properly signed by both the subject and the investigator.
2. Locally advanced stage of PCa (stage T3-T4, Nx-N0, M0: prostate adenocarcinoma with extracapsular invasion (T3a) or invasion to the seminal vesicles (T3b), invasion to adjacent structures (T4) but without lymphatic invasion (N0) nor metastasis (M0))
3. Prostatectomy or radiotherapy completed within 3 months prior to the study enrolment
4. High (T3a or Gleason score = 8-10 or PCA \>20 ng/ml) and very high (T3b-T4) risk of recurrence
5. Histologically confirmed diagnosis of prostate adenocarcinoma

Exclusion Criteria:

1. Patients participating in clinical trials
2. Any medical condition which on the opinion of the investigator may interfere with the patient's participation in the study, e.g. severe non-malignant concomitant disease which can affect life expectancy
3. Evidence of metastatic disease on imaging studies
Fluoride Delivery to Prevent White Spots During Orthodontic Treatment

The aim of this 2-armed, parallel, randomised, controlled trial is to assess the effect of different ways of applying fluoride to teeth on the formation of white spots (enamel demineralisation), during orthodontic treatment with fixed metal braces, in children and adolescents.

One of the most common side-effects and risks of orthodontic treatment with fixed (metal) braces is damage to the outer surface (enamel) of the teeth. This damage can take the form of white or brown spots on the teeth (white spot lesions; WSLs) or if severe, holes in the teeth that need a filling.

The aims of this study are to find out the best way of preventing damage to the teeth of children and adolescents who are under going orthodontic treatment with fixed (metal) braces.

The participants will be 130 children, aged 11-16 years old, inclusive. The participants will be split into two groups using a process called randomisation. The treatments will be standard fluoride toothpaste (Colgate) and either:

1. Fluoride mouth wash (Fluorigard) or
2. Tooth Mousse Plus

The participants' teeth will be checked at every visit and the brace adjusted. Photographs of the participants' teeth will be taken very 3 months to see if any of the teeth have been damaged. The participants will be asked about the impact of their teeth on their life. Participants and parents will be asked about the impact of any white spots that form on the participants' teeth during the treatment with fixed (metal) braces.

The study will follow the participants through the whole length of treatment which will take about 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Planned to receive orthodontic treatment with upper and lower fixed orthodontic appliances (braces) either alone or following a period of functional appliance treatment.
* 11-16 years of age inclusive at the start of the fixed orthodontic appliance treatment.
* All genders.
* Fit and well with no chronic disease necessitating regular hospital follow-up at hospital.
* Willing to participate

Exclusion Criteria:

* Significant disabilities that may affect manual dexterity;
* Any medical complication that would contraindicate the use of the fluoride treatments or milk products;
* Previous orthodontic treatment except Phase I functional appliance treatment;
* From areas that have fluoridated water supply\*;
* Full coronal coverage restorations;
* More than 2 missing anterior teeth;
* Showing signs of systemic illness e.g. fever, cough, loss of taste/smell;
* Any abnormality of face, lips e.g. cleft lip and/or palate or craniofacial abnormality or soft tissues of the mouth e.g. aphthous ulcers or connective tissue disorder.
Music for Anxiety in Critically Ill Patients

Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation and strive for wakefulness. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation, but especially sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimized. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill, next to other physiological signs such as pain. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients.

Objective: The primary objective is to assess the effect of music intervention on the level of anxiety.

Study design: A randomized controlled trial. Study population: Adult patients admitted to the intensive care unit, with whom communication is possible (Richmond Agitation Sedation Scale of -2 or higher).

Intervention (if applicable): The music group will be offered to listen to music two times per day for three days after inclusion, during 30-60 minutes per session. Chosen music will be based on the preference of the patient. The control group will receive standard of care during the entire study.

Main study parameters/endpoints: The primary outcome is the effect of music on the Visual Analogue Scale for anxiety (VAS-A). Secondary outcomes include effect of music on sedation and agitation level, medication requirement, pain, sleep, delirium, heart rate, mean arterial pressure, and ICU memory and experience.


Eligibility Criteria:
Inclusion Criteria:

* Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice).
* Expected ICU stay upon randomisation of at least another 48 hours.
* Written informed consent acquired from the patient or legal representative.

Exclusion Criteria:

* Patients with severe hearing impairment, defined as no verbal communication possible.
* Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included).
* Insufficient knowledge of the Dutch or English language for informed consent.
* Participation in another study that may possibly intervene with the primary outcome measure
Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes

To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute genital Herpes simplex virus (HSV) outbreaks in HIV subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide signed informed consent
* Documented HIV infection
* In general good health, without other serious medical conditions as deemed by the investigator
* Male or female over 18 years of age
* Diagnosed genital HSV (clinical or laboratory)
* Life expectancy of 12 months or longer per investigator's judgment
* Stable on Famvir 500 mg bd for at least 30 days at time of screening

Exclusion Criteria:

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5)mIU/mL).
* Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study.
* History of hypersensitivity to Famvir, its constituents or penciclovir
* Current use of another antiherpetic medication
* Recent history of alcohol or drug abuse, which in the opinion of the investigator may interfere with their compliance with study requirements, or who have any other conditions which in the opinion of the investigator would interfere with the successful completion of study procedures
* Disorder or condition that could interfere with drug absorption, distribution, metabolism or excretion
* Known or suspected to have or past history of renal dysfunction requiring a dosage modification of Famvir 500 bd
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study

MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.

This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.

This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.

The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men 45 - 75 years old undergoing RALP
* Patient has biopsy-proven prostate adenocarcinoma
* Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings
* Written informed consent

Exclusion Criteria:

* Severe atherosclerosis
* Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries
* Tumor stage \> cT2 assessed by clinical and MRI findings
* Allergy to intravenous contrast media
* Contraindication for MRI imaging
* Renal failure (GFR\<60ml/min)
* History of pelvic irradiation or radical pelvic surgery