cyrilzakka/clinical-trials huggingface dataset:
Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD

Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.

New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.

To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology.

The educational intervention consisted on three 60-minutes online sessions, organized as follows:

Session 1: anatomical information about pelvic floor and exercises about pelvic floor consciousness; Session 2: function and dysfunction of pelvic floor and exercises related; Session 3: risk factor for pelvic floor dysfunctions and exercises to strengthen the pelvic floor musculature.

Eligibility Criteria:
Inclusion Criteria:

* To train and compete in any of the sport modality.
* To have federative license from a regional or national sport federation in the season when study starts.

Exclusion Criteria:

* Non applicable
Lanadelumab in Bradykinin Angioedema

A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema

The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.

The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).

Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.

The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.

Eligibility Criteria:
Inclusion Criteria:

* Male/female \>18 years old
* Patient with hereditary or acquired angioedema
* Patient treated by lanadelumab
* Patient whose the biological explorations have been carried out or will be carried out at Laboratory of Immunology of CHUGA
* Informed consent is obtained from the participant

Exclusion Criteria:

* Absence of biological material at T0 and M3 (stored for routine analysis)
* Person under guardianship or curatorship
* Female who is pregnant, nursing
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fed Conditions

Objective:

Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the study were separated by a washout period of 7 days.

Study Design:

Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Brief Online Personalised Feedback Intervention for Gambling Harm

Purpose and significance A brief self-directed online personalised feedback intervention was developed for the UK context designed to prevent, reduce, and address gambling harm. The intervention, which also comes in a paper format, comprises of normative feedback and personalised information on the risk of gambling above lower-risk gambling guidelines. The content is based on recent work adapting the Canadian lower-risk gambling guidelines to the UK context. The purpose of this exploratory research is to conduct the first randomised controlled trial of this intervention. Further, given the increased prevalence of online gambling, the project will target this at-risk population.

Rationale This project will generate participant feedback on the intervention important to improve its utility. The project will also produce publishable findings on the intervention's efficacy. This evaluation provides a necessary first step towards the wide-spread implementation of this free-of-charge intervention in the UK.

Methodology First, using methods developed in our previous research, we will rapidly recruit 926 online gambling participants with moderate or problem gambling from an existing online panel of UK residents. These participants will be randomised to receive the self-directed online intervention or assigned to a no intervention control group. Participants will be followed-up up at one- and three-months to provide detailed feedback on their impressions of the intervention (and what further modifications are needed) and to assess the short-term impact of the intervention on gambling frequency and harm.

Potential implications of the proposed research The intervention can be accessed at any time of the day and allow the delivery of help without requiring face-to-face contact. Online interventions also have the potential to promote reductions in social inequalities through reducing barriers to accessible care. At present, there appears to be no UK online at-risk gambling intervention that is publicly available.


Eligibility Criteria:
Inclusion Criteria:

* Problem gambling severity index score of 3 or more
* Willingness to complete 1 and 3-month follow-up surveys

Exclusion Criteria

* Do not live in the United Kingdom
* Incorrectly answer attention check question on baseline survey
* Do not endorse that they answered all questions truthfully on the baseline survey
Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.

This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.

Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.

Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.

A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.

The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.


Eligibility Criteria:
Inclusion Criteria:

* Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding.
* Paediatrics: Older than 5 years and \<18 years when entering the study. (Belgium only) or
* Adults: ≥18 years when entering the study (Belgium and Australia).
* Subject/legally designated representative is fluent speaker in the language used for assessments.
* Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative).

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma

To investigate the effectiveness of YAG laser iridotomy in preventing peripheral anterior synechia after CO2 Laser-Assisted Sclerectomy Surgery and the long-term effect of reducing intraocular pressure

Group A: YAG laser iridotomy was performed one week before operation, followed by CO2 Laser-Assisted Sclerectomy Surgery; Group B: only CO2 Laser-Assisted Sclerectomy Surgery; The patients were followed up for 1 year to observe and compare the difference of the incidence of peripheral anterior synechia and the effect of long-term intraocular pressure control between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma patients in Ophthalmic Center;
* Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control;
* The patients were 18 to 50 years old, regardless of gender;
* Class operation was performed;
* Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
* Informed consent has been signed.

Exclusion Criteria:

* Allergic to any perioperative medication in this study;
* History of ocular trauma;
* Any previous intraocular surgery;
* Gonioscopy showed a narrow angle (Schaffer III or below);
* Secondary glaucoma was diagnosed;
* Optic atrophy caused by other reasons;
* Severe complications such as rupture of posterior capsule and choroidal hemorrhage occurred during operation;
* Patients with severe ocular complications after operation
* The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
* Women in pregnancy, lactation or planned pregnancy;
* The researchers believe that the patient's condition may put the patient at significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.
Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)

Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical, biochemical and genetical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.


Eligibility Criteria:
Inclusion Criteria:

* moderate disease

Exclusion Criteria:

* serious disease,
* biological treatment,
* pregnancy.
Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

This trial is conducted in Europe. The aim of this trial is to investigate the effect of growth hormone on left ventricle morphology and function (systolic and diastolic).


Eligibility Criteria:
Inclusion Criteria:

* Adult growth hormone deficiency
* At least 2 years without growth hormone treatment

Exclusion Criteria:

* Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic
* Pregnancy
Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure

The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.

BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public health by high morbidity and mortality rates that are associated. Studies show that changes in striated skeletal muscle of those individuals, possibly caused by progressive physical inactivity, contribute to the construction of the pathophysiology of this disease, emphasizing the importance of exercise for these patients. Exercise programs can be traced safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a set of activities that aims to ensure that patients with heart disease the best conditions, especially physical. In this context, non-invasive ventilation (NIV) is an alternative to provide an improved tolerance during exercise in patients with HF.

GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of life in patients with heart failure when compared to performing these exercises without ventilatory support.

METHODS: This is a clinical trial, controlled, randomized and blind to be developed with patients arising out of the main Recife reference centers in the care of patients with heart failure. It will be conducted assessments of functional capacity made by cardiopulmonary exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be used to Patient Global Impression of Change Scale (PGIS).

EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary adults diagnosed with heart failure of ischemic hypertensive or alcoholic etiology;
* Ejection fraction of the left ventricle smaller than 50% (LVEF \<50%) assessed by echocardiography simple;
* Recent and functional class II and III by the New York Heart Association (NYHA);
* FEV1 \<80% predicted and / or FEV1 / FVC\> 70% predicted;
* Clinical stability; Ex-smokers for more than five years;
* No change in the class of drugs within three months prior to the beginning of the study.

Exclusion Criteria:

* Patients with unstable angina;
* Myocardial infarction or heart surgery up to three months before the survey;
* FEV1 / FVC \<70% predicted characterizing obstructive respiratory disorder;
* Respiratory diseases;
* Smoking;
* Hemodynamic instability;
* Trauma of recent face;
* Nausea and vomiting;
* Orthopedic and neurological diseases;
* Psychic changes that restrict them to respond to the questionnaire.
Anesthesia Management of Retroperitoneal Adrenalectomies

This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.

Due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. Furthermore, excessive hypercarbia and an increased arterial-alveolar CO2 difference can be seen during these operations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an adrenal tumor

Exclusion Criteria:

* Age below 18 years
Assessment of Cytokine Values in Serum and by RT-PCR in HIV-1 Individuals With and Without HAART

A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment. 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (\>80% - r2\>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups.

A cross-sectional study was performed on HIV-1 infected individuals with or without antiretroviral treatment (ARV) at the AIDS Day-Hospital, Botucatu School of Medicine, Unesp. Between August 2004 and October 2005, 73 HIV-1 infected individuals were divided into three groups: G1= 15 infected individuals with or without AIDS who never received ARV; G2= 27 patients on HAART, and plasma HIV-1 RNA viral load (VL) equal or greater than 50 copies/mL and G3= 31 patients on HAART with undetectable VL for at least the past 6 months and a fourth group G4= 20 individuals chosen between blood donors without any disease sign and with negative HIV serum tests (control group). Serum cytokine levels pg/mL (ELISA) and specific mRNA expression by RT-PCR were performed on all four groups for TNF-a, IL-2, INF-g, IL-4 and IL-10. All patients were submitted to VL determination and CD4+ and CD8+T lymphocyte counts. Results analysis showed a significant comparison between groups for both methods and association between them (\>80% - r2\>0.80) with only one exception, in the individuals of control group, for IL-2 by ELISA determination. The cytokine profile for both methods and three patient groups was mature Th-0. The behavior of IL-2 and INF-g must be emphasized with the consequent expression on dominant Th profile. Both methods showed low IL-2 and elevated mean INF-g values in the three patient groups. Several authors have recently drawn attention to the substantial apoptosis of infected and non infected CD4+T cells, mainly during primary infection, persisting only in those with INF-g phenotype producer and not IL-2.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection

Exclusion Criteria:

* no HIV infection