cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that sildenafil may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

The purpose of this study is to evaluate the use of sildenafil in patients with pulmonary fibrosis and PH being considered for lung transplantation. We hypothesize that not only will sildenafil improve functionality and QOL in the pre-transplant setting but it may also improve primary graft dysfunction after lung transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Idiopathic Pulmonary Fibrosis referred for lung transplantation at our medical center
* Minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization

Exclusion Criteria:

* Non ambulatory
* Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
* Any other pulmonary vasodilator within one month of enrollment
Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction

The purpose of this study was to determine whether providing patients with life expectancy (LE) information in the form of their Prostate Cancer Comorbidity Index (PCCI) scores impacted their decisional conflict or anxiety about prostate cancer or death.

Patients with newly diagnosed prostate cancer were consented and randomized to receive standard of care counseling (SOC) versus the same counseling plus provision of their specific LE (PCCI). Patients were blinded to the specific content of their counseling session. After counseling, patients completed the Decisional Conflict Scale (DCS), Death Anxiety Scale (DAS), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Patient Satisfaction Questionnaire (PSQ-18). Treatment preferences were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men 18 years and older
* Newly diagnosed prostate cancer

Exclusion Criteria:

* Non-English speaking
* Prior history of prostate cancer
Naltrexone Neuroimaging in Teens with Eating Disorders

Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).

The investigators will use a randomized, placebo-controlled, double-blind, crossover trial to evaluate the use of fMRI as a pharmacodynamic biomarker of reward system modulation. The overall goal of this work is to develop an objective tool to detect acute drug response. If validated in future, larger trials, the pharmacodynamic biomarker may facilitate early phase/quantitative pharmacology studies of novel or repurposed agents expected to modulate the reward system. The reward system will be antagonized by naltrexone in adolescents aged 13-21 years with an ED defined by binge/purge behaviors (e.g., Anorexia Nervosa-Binge Purge, Bulimia Nervosa, Binge Eating Disorder). A crossover design was chosen to quantify within-individual change in opioid reward pathway modulation following antagonism. Eligible patients will be randomly assigned to Group A or Group B. A statistician (or other non-study staff) will generate the schedule and communicate with the investigation drug service to maintain the double-blind design. A washout period of at least 14 days will exceed the 48-hour carry-over effect from naltrexone 50 mg administered orally. The two study visits will be mirrored in structure and duration to maintain blinding.

It is not the intent of this study to generate data for submission to the FDA or to support a significant change in advertising of the drug. Storage, control and dispensation of the drug will occur through collaboration with the investigational drug service (IDS) pharmacy. Use of naltrexone for this study meets criteria for investigational new drug (IND) exemption, category #1 (21 Code of Federal Regulations (CFR) 312.2(b)(1)).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults aged 13-21 years
* Eating disorder diagnosis characterized by binge eating and/or purging (eg, Anorexia Nervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding/Eating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria.
* Stable medication regimen (no dose or drug changes in the past 4 weeks)
* Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study

Exclusion Criteria:

* Pregnant (via UCG)
* Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
* Non-removable metal in the body that is magnetic resonance imaging incompatible
* Current naltrexone use
* Self-reported opioid use in the past 7 days
* A language barrier (e.g., non-English speaking) for the participant that precludes communication and/or ability to complete all study-related requirements.
Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial

In a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray versus forced coagulation, will be compared. The primary outcome of the study is time to complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain, and postoperative bleeding complications.

Intraoperative bleeding during large loop excision of the transformation zone (LLETZ)-conization can be achieved by two modes of electrocoagulation, spray coagulation and forced coagulation. Spray coagulation is a superficial coagulation mode, whereas forced coagulation is a deep tissue coagulation mode. It is unknown, whether spray or forced coagulation is superior regarding intraoperative hemostasis and other outcome Parameters such as postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, comparing the two coagulation modes, spray coagulation and forced coagulation, The primary outcome of the study is time to complete hemostasis measured in seconds, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 10 step VAS scale, and postoperative bleeding complications, defined as necessity to intervene surgically for vaginal bleeding up to 14 days postoperatively. The study Population consists of women undergoing LLETZ-conization for histologically proven cervical dysplasia. The study hypothesis states that the difference in the mean time until complete hemostais will be at least 1/3 shorter in women randomized to spray coagulation. With a study Population of 120 women, this study has a power of \>80% to detect a difference of 1/3 of the mean coagulation time until complete hemostais based on an anticipated mean time of 85 seconds.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven cervical dysplasia
* colposcopy Prior to LLETZ-conization
* informed consent
* no known hematologic disorder

Exclusion Criteria:

* significant language barrier
* a personal history of LLETZ-conization
BC-101 in Treatment of Nasolabial Fold Wrinkles

This is an open-label, single-arm, dose-escalating study to evaluate the safety and tolerability of BC-101 administered via subcutaneous/intradermal injection in the treatment of moderate to severe nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are in general good health condition.
2. Subjects who have moderate to extremely deep bilateral nasolabial fold wrinkles, as documented by a score of 3 or greater on the six-point Evaluator Wrinkle Severity Assessment scale (0-5).
3. Subjects who are dissatisfied with both nasolabial fold wrinkles based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale (-2 to +2).
4. Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period.
5. Subjects who fully understand the research nature of this study and sign the informed consent.

Exclusion Criteria:

1. Subjects who have an active cutaneous infection on the face.
2. Subjects with existing malignant neoplasm.
3. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).
4. Subjects who have active dermal diseases, inflammation, or any related disease.
5. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin).
6. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
7. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
The Evaluation of the Diagnostic Properties of Intra-operative In-situ Thyroglobin Levels of Cervical Lymph Nodes, in the Discrimination Between Benign and Malignant Lymph Nodes in Thyroid Cancer: a Prospective Multicentre Study.

Cytological examination of punctured lymph nodes is the gold standard for confirming metastatic lymph node spread of differentiated thyroid cancers. In order to increase the diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels of the aspirate could be included. Although this technique has been well proven, many uncertainties remain, especially with regards to a pathological cut-off value and its clinical utility when the thyroid is still intact. This uncertainty is mainly due to discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology, and their final histopathological analyses.

To eliminate this uncertainty, cyto-punction will be performed intra-operatively after localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The thyroid gland might be present or absent (already operated) depending on the case. Finally, the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In order to determine whether the Tg values are appropriate in cases where the thyroid is intact, a control group has been included (First operation for thyroid cancer or benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection in patients for whom it is not indicated, only lymph nodes found along the incision path for neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed and excised.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged 18 years and above, male or female, with a valid social security coverage;
* Subject willing to participate in the study with a signed informed consent;
* Subject being operated for a papillary thyroid cancer, re-operated for persistent/relapsed lymphadenopathy, or for benign thyroid pathology (Graves disease, multinodular goitre, toxic nodule);
* Subject having had a blood test for plasma Tg levels and circulating anti-Tg antibodies in the week preceding the surgical intervention.

Exclusion Criteria:

- Subjects presenting with thyroid cancers of non follicular origin
Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.


Eligibility Criteria:
Inclusion Criteria:

* A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR
* Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least moderate severity (cough or rhinitis) and at least one constitutional symptom of at least moderate severity (myalgia \[aches and pains\], headache, feverishness, or fatigue)
* Influenza symptom onset \< 48 hours. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting \> 48-hours but ≤ 72-hours

Exclusion Criteria:

* Women who plan to breast-feed for the first 48 hours after study drug administration
* Subjects requiring hospital admission to treat medical condition(s) which could represent complications of influenza.
* Recent worsening of any chronic medical condition consistent with complications of influenza
* Current evidence of a bacterial infection requiring antibiotic treatment
Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial

Despite the active development of surgical methods of treatment (endovascular embolization and microsurgical clipping) of cerebral aneurysms, determining the indications and method of surgical treatment of cerebral aneurysms still causes debate in many cases. To a greater extent, this concerns the treatment of unruptured aneurysms. While there are a number of randomized trials of surgical treatment of ruptured cerebral aneurysms, there is currently no published randomized trial comparing surgical clipping and endovascular embolization of unruptured aneurysms. The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular embolization of cerebral aneurysms (both ruptured and unruptured) in a prospective, randomized fashion.

The study is planned to include 200 patients. Before randomization, patients will be stratified according to the presence or absence of aneurysm rupture in the acute period. The stratified patients will be randomized into two groups (100 to the microsurgical clipping group and 100 to the endovascular embolization group). Each group will be divided into 2 subgroups of 50 people each: the first subgroup includes patients in the acute period of aneurysm rupture, the second subgroup includes patients with unruptured aneurysms. Patients will be followed postoperatively, outcome endpoints will be assessed at discharge, 6 and 12 months. At discharge and after 6 and 12 months, patients will be assessed clinically using a modified Rankin scale (mRS). Cerebral angiography will be performed intraoperatively (endovascular group), after surgery (microsurgical group) and 12 months after discharge (both groups). Thus, the outcome of surgical treatment, including periprocedural complications and mortality, will be assessed both clinically and angiographically.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ruptured (acute SAH) or unruptured cerebral aneurysm who require surgical treatment (clipping and / or embolization)
* Both male and female
* Age from 18 to 80 years
* Informed consent to participate in the study signed by the patient. If the patient cannot give consent, informed consent is signed by closest relatives or based on the results of a medical concilium
* The patient (legal representative) agrees to a clinical assessment (examination and / or telephone visit) within 6 months and 12 months and to an angiographic control after 12 months
* Patient has not previously been randomized to this or other ongoing study
* Aneurysm has not previously been treated with endovascular embolization or microsurgical clipping

Exclusion Criteria:

* The target aneurysm has been treated (embolization or clipping) before
* Severe clinical condition of the patient (Glasgow coma scale \<4, unstable hemodynamics)
* Lack of signed informed consent
* Severe medical or surgical comorbidity in which the patient's life expectancy is less than 2 years
* Pregnancy, breastfeeding
Psycho-educational Intervention Programme for Comprehensive Preparation for Retirement: Study Protocol

Background: The transition to retirement can be a challenging event, necessitating the adjustment of new routines, roles and expectations. Such modifications have the potential to impact the individual's quality of life and psychosocial well-being. t is of the utmost importance to develop intervention programmes that prepare people for retirement, with the objective of facilitating a positive and healthy transition.

Methods: A parallel randomised controlled clinical trial with two arms will be conducted. The study will be conducted at the Faculty of Psychology of the University of Salamanca (USAL) in Spain. The study will recruit individuals aged 60 years or older who are already retired or who will retire within the next five years. The participants will be divided into two groups: the intervention group (IG), which will undergo a comprehensive psychoeducational intervention programme, and the control group (CG), which will engage in a controlled follow-up. The programme will comprise 12 sessions over a period of three months. All participants will be assessed at the outset and conclusion of the study, as well as after three months, during which time data regarding their socio-demographic characteristics and responses to the following scales will be collected: The World Health Organization Quality of Life Measure - Brief Version (WHOQOL-BREF), the Retirement Attitudes Scale (EAJ), the Satisfaction With Life Scale (SWLS), the Questionnaire of Stereotypes towards Old Age (CENVE), the Acceptance and Action Questionnaire-II (AAQ-II), the MOS Questionnaire of Perceived Social Support (MOS), the General Health Questionnaire (GHQ), the Generalised Self-Efficacy Scale (EAG) and the Self-Regulation Scale (EAR).

Discussion: The objective of this study is to enhance the comprehension and implementation of intervention programmes in anticipation of retirement and the subsequent phase of life. To this end, a comprehensive psychoeducational intervention is proposed, with the aim of improving quality of life and attitudes towards retirement, increasing life satisfaction, psychological flexibility, perceived social support and general health, self-efficacy and self-regulation, and reducing stereotypes about ageing. The programme is designed to equip individuals with the skills and knowledge to navigate the challenges and opportunities associated with the transition to retirement.


Eligibility Criteria:
Inclusion Criteria:

* Be retired or nearing retirement (within 5 years)
* Be 60 years of age or older
* Voluntarily sign the consent form to participate
* Complete the initial assessment

Exclusion Criteria:

* No evidence of literacy difficulties or a significant deficit in language comprehension
* Not meet any of the inclusion criteria.
Pharmacokinetics of Procaterol in Elite Athletes

The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.

Doping study

Eligibility Criteria:
Inclusion Criteria:

* Doctor diagnosed asthma for the asthmatic group
* GINA 1-3 for the asthmatic group
* Use of beta2-agonist for at least 12 months for the asthmatic group
* age 18-45
* males
* informed consent

Exclusion Criteria:

* smoker or former smoker
* airway infection to weeks prior to the study or during the study
* other chronic diseaes than asthma and allergy
* Use of beta2-agonist 6 days prior to the study
* Allergy to the study medicine
Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis

The impact of continuous veno-venous haemofiltration (CVVH) on sepsis-induced multiple organ failure severity is controversial. We thus sought to assess the effect of early application of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients with severe sepsis or septic shock.

prospective, randomized, open, multicentre study was performed between 1997 and 1999 in 16 French intensive care units. Patients were enrolled within 24 hours of development of the first organ failure related to a new septic insult. They were randomized to group 1 (HF), who received haemofiltration for a 96 hr period, or group 2 (C) who were managed conventionally. The primary end-point was the number, severity and duration of organ failures at 14 days, as evaluated by the SOFA score, on an intention-to-treat analysis. Strict guidelines were provided to perform continuous haemofiltration under the same conditions and objectives in all centres.

Eligibility Criteria:
Inclusion Criteria:

* clinically identified focus of infection associated with at least 2 SIRS criteria and one or more sepsis-induced organ failures within the 24 hours prior to inclusion, plus a SAPS II score between 35-63

Exclusion Criteria:

* Patients were excluded if pregnant, younger than 18 years, in a moribund state, in chronic renal failure, or receiving immunosuppressive therapy.
Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program

The study will compare two different programs for lifestyle intervention in type 2 diabetes:

1. A brief group program, with three weekly sessions
2. A longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years.

The aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c between 48 and 75 mmol/mol

Exclusion Criteria:

* Axis I Mental Disorders
* Heart failure (NYHA Class III or IV)
* Foot ulcers or lower limb amputations