cyrilzakka/clinical-trials huggingface dataset:
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device

A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen.
* Specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient.
* Specimens shall not contain any individually identifiable information from the patient it was obtained from.

Exclusion Criteria:

* Patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis.
* Patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer.
* Patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen.
Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial.

All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder.
* Laboratory tests for blood and urinalysis must be within normal limits.
* Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions.
* Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal.

Exclusion Criteria:

* Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days.
* Currently suicidal.
* Medical reasons not to receive drug therapy.
* Allergy or hypersensitivity to selective serotonin inhibitor antidepressants.
* Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.
* Liver function test greater than 2 times the normal level
* Require ongoing therapy with another psychoactive drug during the study period.
* Females who are pregnant or lactating.
Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia

* Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in both men and women and is caused by the action of androgens in genetically predisposed individuals.
* This clinical trial was designed to evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment of androgenetic alopecia.


Eligibility Criteria:
Inclusion Criteria:

* Androgenetic alopecia according to the following scales:
* Men: Hamilton/Norwood Scale: grades II-VI
* Women: Ludwig Scale grades I-II.
* Possibility of follow-up during the study

Exclusion Criteria:

* No androgenetic alopecia
* Telogen and anagen effluvium
* Active inflammation or infection in the intervention area
* Presence of active systemic infections.
* Background of cancerous or precancerous lesions.
* Background of connective or rheumatic diseases.
* Suffering from any serious blood disorders.
* To have undergone treatments for alopecia in the previous 6 months.
* Previous hair implants
* Intake of drugs that affect hair loss.
* Be undergoing immunosuppressive therapy and/or anticoagulants.
* Known intolerance to mesotherapy.
* Taking contraceptives containing cyproterone acetate.
* Pregnancy
* In general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables.
Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)

To evaluate children undergoing catheter ablation at pediatric centers in North America in order to provide information on the incidence rate of serious cardiac damage as a result of ablation, the incidence rate and time course of recurrence after initially successful ablation, and the incidence rate of proarrhythmia following ablation.

BACKGROUND:

Radiofrequency catheter ablation is a catheterization laboratory technique for the cure of cardiac arrhythmias, which has become common in pediatric cardiology practice. Recent analyses have suggested that ablation therapy is more cost-effective compared not only with surgery, but also with antiarrhythmic medication. Despite a good initial success rate of the technique, and a low initial complication rate, there is concern about possible long-term effects with the technique in the pediatric age group. There are reports not only of damage to cardiac valves, but also the development of new arrhythmias, including sudden death, as a result of ablations in children. Recurrences are observed frequently following initially successful procedures. Finally, there are animal data to suggest that immature myocardium is more prone to severe damage as a result of ablation procedures. Few, if any, data exist to support the long-term safety of these ablation techniques in children. Therefore, before ablation therapy becomes the standard approach in children, it is important to carefully assess the long-term risks in this patient group.

DESIGN NARRATIVE:

Multi-center, prospective, five-year study. The collection of these data was intended to provide the following information: 1) the incidence of serious cardiac damage as a result of ablation; 2) the incidence and time course of recurrence after initially successful ablation; and 3) the incidence of proarrhythmia following ablation. A total of 480 pediatric patients were enrolled prospectively and evaluated both before ablation of supraventricular tachycardia and at intervals following ablation with clinical history and examination, electrocardiogram, 24-hour Holter monitor, and echocardiogram, with non-invasive studies read by outside consultants. In addition, a complete Registry of pediatric patients undergoing ablation at the participating centers was established to allow comparisons with the study group and to provide population estimates of success and complication rates.

Eligibility Criteria:
No eligibility criteria
Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain

This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.

The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.

It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical I-II
* Scheduled for MRM
* Under general anesthesia.

Exclusion Criteria:

* Liver or kidney disease
* Patient with previous chronic pain on opioids
* Patients on antidepressants and antipsychotics.
* Allergies to study drugs
Stepwise Strategy to Improve CANcer Screening Adherence: Cervical Cancer

This study aims to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organized cervical cancer screening: step 1a - customized text message invitation; step 1b - customized automatic phone call invitation; step 2 - secretary phone call; step 3 - health professionals face-to-face appointment.

A population-based randomized controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomized (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automatic phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (invitation by written letter).

As primary objectives, we intend to test the superiority of interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, based on intention-to-treat analyses.

The secondary objectives will be the following:

1. To test the non-inferiority of interventions based on step 1a and step 1 (1a+1b), considering a non-inferiority limit of 5%;
2. To test the superiority of the specific components of the multistage intervention corresponding to step 2 and step 3;
3. To quantify the differences in adherence to cervical cancer screening, for interventions based on step 1 (1a+1b) and multistage interventions based on steps 1 and 2 and steps 1 to 3, between:

   1. Urban and rural areas;
   2. Younger and older population;
   3. Deprived and wealthy population;
   4. Never vs. ever users of screening;
   5. History of regular vs. irregular participation in screening programs.
4. To quantify the differences in adherence to cervical cancer screening when using a positive or a neutral content of text messages and automatic phone calls, in step 1;
5. To estimate the proportion of women who were performing cervical cancer screening in private health care services who started to be screened in an organized cervical cancer screening program, after a nurse face-to-face appointment at their primary care unit.

Intention-to-treat analysis will be used as primary strategy for all comparisons between interventions and control. Secondary per-protocol analysis will also be conducted. Binary logistic regression may be used to control for confounding, or in secondary analyses of the isolate effects of steps 1a, 2 and 3.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 25 and 49 years
* Medical registration at any of the primary health care units selected for this study
* Eligible for cervical cancer screening\*

  * \*Defined as all women aged between 25 and 60 years old who do not verify any of the following criteria: hysterectomized, active cervical cancer disease, currently undergoing cervical cancer treatment or did not start sexual activity.

Exclusion Criteria:

* Unavailability of mobile phone number
Pharmacokinetic Study of Testosterone Enanthate

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Exclusion Criteria:

* Normal testosterone levels
* Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study
Family Process, Adherence, and Child Asthma Outcome

To examine the role of family processes in asthma regulation in three groups of children with mild to moderate asthma.

DESIGN NARRATIVE:

The study, which was ancillary to the Childhood Asthma Management Program (CAMP), clarified the extent to which and the mechanisms whereby specific family processes might be protective or deleterious in the adherence behaviors and treatment outcome in three groups of children with mild to moderate asthma: 80 children participating in the Denver site of the CAMP, 80 children receiving asthma-related care in a large, nationally recognized health maintenance organization, and 60 children recruited by using school records to identify children with asthma receiving their care in a variety of different health care systems across the Denver metropolitan area. The study examined the extent to which family process variables were cross-sectionally associated with and longitudinally influenced adherence to asthma treatment and asthma treatment outcome as well as the consistency of this relationship across the three sites. The study also determined whether adherence with treatment mediated the relationship between specific family processes and asthma treatment outcome, as well as the consistency of this relationship across the three sites.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
* Patients must be able to adhere to the study visit schedule
* Independently mobile
* Patients must be able to give informed consent (IC) prior to any study procedures
* Surgical (1) and non-surgical (2) groups:

  1. Eligible for bariatric surgery (BMI \> 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
  2. Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program

Exclusion Criteria:

* Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
* Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
* Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
* Pregnancy or lactation, or planning to get pregnant during the study period
* Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
* Active and significant psychiatric illness including substance misuse
* Significant cognitive or communication issues
* Medications with documented effect on food intake or food preference
* Participating in another scientific study at the same time, if
Effect of Muscle Strengthening Training in Adults with Fontan Circulation

Aim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls.

Hypothesis: adults with Fontan circulation have a relatively lower effect of muscle strengthening exercise training compared to healthy controls.

10 adults with Fontan circulation will be recruited from the clinic specialised in adults with congenital heart disease at Norrlands Universitetssjukhus. In addition, 10 age- and sex matched controls will be recruited. The sample size is estimated according to a previous study with the same primary outcome. We estimate that 7 patients and 7 controls are needed in the study and plan to enrol 10 patients and 10 controls in case of any drop outs.

Muscle tests will be performed at baseline. Based on the results from the muscle tests, an individualised muscle training exercise protocol will be designed and the participants will be working out at a gym during 10 weeks. After 10 weeks the same tests will be performed to evaluate the effect of the muscle training exercise.

In addition to the muscle tests, muscle mass and aerobic exercise capacity will be evaluated with peripheral quantitative computed tomography and cardiopulmonary exercise test respectively. Physical activity will be mapped with a validated questionnaire (IPAQ) and an accelerometer attached to the participants thigh. Any impact on fatigue will be evaluated with a validated questionnaire (MFI-20). All tests and questionnaires will be performed at baseline and at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age minimum 18 years
* Patients: Congenital heart disease (Fontan circulation, univentricle heart)
* Controls: no known congenital heart disease.

Exclusion Criteria:

* Muscle strenghtening exercise training at regular basis (2 times/week or more)
* Active disease or other condition that affect exercise training (e.g. rheumatoid arthritis)
* Cognitive or psychological affection
* Other conditions that affect independent decision-making competence
Exhaled Nitric Oxide : Biomarker of Acute Respiratory Distress Syndrome

The aim of the study is to see if endogenous exhaled Nitric Oxyde (eNO) concentrations measured are significantly higher in ARDS patients admitted in ICU ; compared to control subjects in good health with no lung disease or global inflammation, operated under general anesthesia (i.e. intubated and ventilated) for thyroid or parathyroid.

The measurement of endogenous exhaled NO is monitored using a laser spectrometer machine connected to the expiratory circuit of the respirator. The measure is non-invasive and made by sampling expiratory gaz like for capnography.

In control subjects, the measurement period corresponds to the first ten minutes after induction of anesthesia (with intubation) before surgical incision.

In ARDS patients in intensive care, the measurement of eNO is made in the first twenty-four hours after intubation and ventilation of the patient with mechanical respirator.

The primary endpoint is a significantly higher eNO concentration in patients suffering from Acute Respiratory Distress Syndrome (ARDS).

Secondary endpoints will assess correlations between eNO concentrations and usual ARDS severity criteria: PaO2/FiO2; ventilator-free days; length of stay in intensive care and all-cause hospital mortality at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* For ARDS patients :

  * Patients with ARDS (according to the Berlin criteria) admitted in intensive care unit and intubated for less than 24 hours.
* For control patients :

  * Patients with no major disease (classified 1 or 2 in the classification of the American Society of Anaesthesiology)
  * Patients undergoing general anaesthesia for a thyroïd or parathyroïd surgery

Exclusion Criteria:

* Minors under the age of 18 years old
* Pregnant women
* prisoners
* patients who have withdrawn their consent.
Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity all over the world. In the last years, efforts have been made to define more effective therapeutic and preventive strategies.Periodontal diseases have been considered a probable risk factor for CVD with a great amount of evidence from observational studies. Although there are some interventional studies evaluating the systemic effects of periodontal therapy, there is little information regarding the impact of periodontal treatment on the prevention of cardiovascular events. To the best of our knowledge, there are no randomized controlled trials published to date assessing the effect of periodontal therapy in primary prevention of CVD.


Eligibility Criteria:
Inclusion Criteria:

* Individuals having at least 50% of their dentition with periodontal probing pocket depths N4 mm and
* With documented radiographic alveolar bone loss were included

Exclusion Criteria:

* Known systemic diseases
* History and/or presence of other infections
* Systemic antibiotic treatment in the preceding 3 months
* Treatment with any medication known to affect the serum level of inflammatory markers, lipids, or BP
* Pregnant or lactating females
* Allergy to tetracyclines
Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）

Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to severe chronic systolic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* aged from 18 to 75 years, males or females
* Willing to provide written informed consent
* NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for

  ≥4 weeks
* Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks
* Sinus rhythm with resting heart rate≥70 b.p.m.
* Left-ventricular systolic dysfunction, with ejection fraction≥40% documented within previous 1 month

Exclusion Criteria:

* Unstable cardiovascular condition(for example, hospital admission for worsening heart failure)
* Recent (\<2 months) myocardial infarction or recent or scheduled coronary revascularization
* Stroke or transient cerebral ischaemia within previous 4 weeks
* Severe primary valvular disease
* Scheduled surgery of valvular heart disease
* Active myocarditis
* Congenital heart diseases
* peripartum cardiomyopathy
* hyperthyroid heart disease
* On list for cardiac transplantation
* Cardiac resynchronization therapy started within previous 6 months
* Pacemaker with atrial or ventricular pacing (except biventricular pacing)˃40% of the time, or with stimulation threshold at the atrial or ventricular level˃60 b.p.m.
* Permanent atrial fibrillation or flutter
* Sick sinus syndrome, sinoatrial block, second and third degree atrio-ventricular block
* History of symptomatic or sustained (≥30 s) ventricular arrhythmia unless a cardioverter/defibrillator implanted
* Cardioverter/defibrillator shock within previous 6 months
* Family history or congenital long QT syndrome or treated with selected QT-prolonging products(except amiodarone)
* Contraindication or intolerance to ivabradine or lactulose
* Severe or uncontrolled hypertension (SBP≥180 mmHg or DBP≥110 mmHg)
* known anaemia(Hb\<100 g/L)
* Known moderate or severe liver disease(ALT/AST˃3ULN), known severe renal disease(Cr˃2ULN)
* Pregnant or lactating women and women planning to become pregnant
* Use of an investigational drug within 30 days of enrollment
* Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study
Greening the Humanitas Fertility Center: How to Build a More Sustainable Medical Daily Routine

The goal of this observational study is to redefine an everyday clinical routine at the Humanitas Fertility center calculating the effects derived from the reduction of inappropriate and avoidable tests, procedures, tools and treatments currently used.

Anonymized patients data about clinical procedures are used, taken from the internal database of the Humanitas fertility center


Eligibility Criteria:
All outpatient, surgical and laboratory procedures, considered as daily clinical routine at the Humanitas Fertility center, will be taken into account, analysed and defined as appropriate or not.