cyrilzakka/clinical-trials huggingface dataset:
Early Albumin Resuscitation During Septic Shock

Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.

Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.

Setting: 27 Intensive Care Units (ICU) in France

Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris

Patients: 800 patients could be included during the first 6 hours of their septic shock.

The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.

The albuminemia of all patients is requested before the treatment until Day 4 post treatment.

The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.

The first patient will be in July 2006, the last patient expected is on July 2009.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Septic shock \< 6 hours
* Agreement of patients

Exclusion Criteria:

* Allergy to albumin
* Weight \> 120 kg
* Non septic shock
* Burned
* Cirrhosis
* Albumin perfusion 48 hours before randomization
* Pregnant women
* Cardiac dysfunction New York Heart Association (NYHA) 3 or 4
* Patients with therapeutic limitation
Minimum Current for Train-of-four Monitoring

Neuromuscular monitoring during general anesthesia is important to make sure adequate muscle relaxation during operation and adequate recovery of muscle power and spontaneous breathing during emergence from general anesthesia. The neuromuscular monitoring is usually using electrical stimulants and the method called train-of-four (TOF) is representative. Because it uses electrical stimulants, the patients could be uncomfortable and feel pain during the monitoring when the patients are conscious. Lowering the current of the stimulants would be helpful in reducing the pain, but there is a concern that the TOF results performed in lower current would be underestimated or inaccurate. Therefore, the investigators want to find the minimal current for TOF monitoring that shows adequate TOF results.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-65
* Scheduled for an elective surgery
* ASA physical status 1 or 2

Exclusion Criteria:

* BMI \> 25 kg/m2
* Neuromuscular disease
* Decreased renal function
* Neurologic disorder
* Impossible to cooperate or communicate
Pain Management After Elective Shoulder Surgery

Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing elective shoulder surgery with a single-shot interscalene plexus brachialis block in addition to general anesthesia
* patients aged 18-99 years
* patients being capable of giving an informed consent to participation in this study

Exclusion Criteria:

* patients aged below 18 years
* patients with decompensated liver, heart or renal insufficiency
* patients with any kind of lung disease
* patients with a chronic pain syndrome
* patients with a previous pain medication with more than 3 drugs over more than 3 months
Menstrual Complaints in Adolescents and Adults

The aim of this study is to investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents.

This study was an online prospective cohort study and consisted of using the Menstruatie Educatie Kalender (Menstruation Education Calendar) application (MEK app) daily for at least one cycle with a questionnaire before and after the use of this application. Participants consisted of postmenarchal adolescents and adults with a menstrual cycle with monthly bleeding. The study involved minimal effort for participants: a baseline questionnaire at the start of the study, requiring approximately 10 minutes; daily app use for at least one cycle, taking around 20 seconds each day; and a final questionnaire at the end of the study, lasting about 10 minutes. Participants received no compensation for participating and the use of the MEK app was free.

Previous research on menstrual complaints in adolescents has considered sample sizes of approximately 1,000 participants to be representative of the population. Since this prospective cohort study about adolescent's menstrual complaints involved repeated measurements, and the literature suggested that repeated measurements of outcome variables increase study power and reduce the required sample size, this study aimed to include a total of 900 adolescents and 900 adults.

The study results were reported using descriptive statistical analyses. To compare dichotomous outcomes the chi-square test or the Fishers' exact test was used. Depending on the data distribution, the Student's t-test or Mann-Whitney U test was used to compare continuous outcomes. Mixed effects logistic regression was used for the association between menstrual complaints and the impact on daily life activities. The statistical analysis was performed in IBM SPSS Statistics version 28 using a two-sided p-values. P-values under 0.05 were considered statistically significant.

Eligibility Criteria:
The inclusion criteria were

* post-menarcheal adolescents and adults aged 12-60 years,
* having a menstrual cycle with monthly bleeding (also with an intra-uterine device or use of contraceptive pills),
* speaking Dutch (MEK-app is available in Dutch only);
* having a smartphone with the operating system Android or iOS and
* obtaining informed consent from the participant and the parents of the participants aged 12-16 years.

The exclusion criteria were

* amenorrhea
* incompleted questionnaires
* not using the MEK-app for at least one period
Pain and Perceptual Distortion of Face

Post-traumatic trigeminal neuropathic pain (PTNP) is "a unilateral or bilateral facial or oral pain following and caused by trauma to the trigeminal nerve(s), with other symptoms and/or clinical signs of trigeminal nerve dysfunction, and persisting or recurring for more than 3 months". PTNP may result from a major craniofacial/oral trauma or may be subsequent to relatively minor dental treatments such as teeth extractions, surgeries, root canal treatment. Patients suffering from this condition have a significantly reduced quality of life. Unfortunately, the currently available management modalities are associated with limited success and side effects.

Repetitive transcranial magnetic stimulation (rTMS), which is a safe, non-invasive brain stimulation technique has emerged as a potential treatment for chronic pain. In this study, the purpose is to explore the potential of rTMS in treating the persistent neuropathic pain by providing individualized treatment for the sufferers.

In addition to pain, a curious observation in people with PTNP is that they report that the painful facial area is "swollen" or "feels differently". There are often no clinical signs or physical differences present, hence such self-reported "illusions" may represent a kind of disrupted body image or a "perceptual distortion" of the face and can be speculated to contribute to the maintenance of facial pain. rTMS paradigms are being widely applied in both therapeutic and investigative studies.In this project, the aim is to employ continuous theta-burst stimulation (cTBS), an inhibitory rTMS paradigm, to evaluate its effect on pain perception and PD in people with PTNP.

In this project, people with PTNP (N=9) received a rTMS (50 Hz, 600 pulses for 40s) session/week as intervention for four consecutive weeks at the primary somatosensory cortex (face area) in a "n-of-1" single-blinded randomized controlled cross-over design: (A) active-sham-active-sham or (B) sham-active-sham-active. That is the same participant received both active and sham either in the (A) order or (B). Pain intensity and perceptual distortion (PD) as perceived size changes of the affected face area were measured at baseline, immediately, 60 mins after rTMS in each session and end of the session (a week after rTMS), one and three months after rTMS. Questionnaires on quality of life, jaw function, sleep quality were also assessed. Changes in pain and PD after each intervention were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Persistent Post-traumatic trigeminal neuropathic pain patients for 6 months or longer
* Stable on analgesic medication

Exclusion Criteria:

* past history of TMS therapy or TMS-related contraindications (pacemaker, epilepsy etc.).
* Major stroke
* Pregnancy
* Severe organic brain damage
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.


Eligibility Criteria:
Key Inclusion Criteria:

* A clinical diagnosis of hereditary angioedema Type 1 or Type 2, defined as having a C1-INH functional level and a C4 level below the lower limit of the normal (LLN) reference range, as assessed during the Screening period.
* Subject weight of ≥ 40 kg
* Access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of HAE
* Subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their HAE during the study.
* Subjects must have a specified number of investigator-confirmed attacks during the run-in period of a maximum of 56 days from the Screening visit.
* Acceptable effective contraception
* Written informed consent

Key Exclusion Criteria:

* Pregnancy or breast-feeding
* Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
* Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
* Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
* Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these drugs during the study
* Current participation in any other investigational drug study or received another investigational drug within 30 days of the Screening visit
* Prior enrollment in a BCX7353 study
Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders

The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,
* age between 8 and 12 years,
* ability to read and write Swedish and
* with access to a computer and use of internet.

Exclusion Criteria:

* Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.
Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients

The purpose of this study is to assess the ability of regular gargling to eliminate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the throat and nasopharynx. This 4 arms interventional study compares the effect of gargling using povidone-iodine, essential oils- based, tap water with control (no intervention) among Stage 1 coronavirus disease-2019 (COVID-19) patients.

Findings from this study will provide new insight into the importance of gargling in the treatment and prevention of COVID-19.

Experimental plan

After consent is taken, all groups will be briefed regarding the study protocol separately.

* Group A will be briefed on the correct procedures of gargling with Betadine®. The participants will be instructed to take 10ml of povidone-iodine (PVP-I), tilt their heads backward and gargle for 30 seconds, three times per day for 7 days
* Group B will be briefed on the correct technique of gargling with Listerine®. The participants will be instructed to take 20ml of essential oils, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days
* Group C will be briefed on the correct technique of gargling with hydrogen peroxide. The participants will be instructed to take 10ml of hydrogen peroxide, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days
* Group D will be briefed about the involvement in this study. They will be managed according to the standard protocol of the hospital with no additional intervention.

Monitoring

1. Oropharyngeal and nasopharyngeal swabs will be taken on day 4, 6 of intervention, and day 12 post-intervention. The swabs will be subjected to detection of SARS-CoV-2 by real-time reverse transcriptase-polymerase chain reaction (rt RT-PCR).
2. Patients will be given a chart for them to record their gargling practice and symptoms (if any) during the intervention period ( 7 days)
3. Clinical data collection sheet will be provided to attending clinicians. The required information includes demographic data, daily vital signs, serial absolute lymphocytic count, LDH, chest radiograph, and symptoms. Clinical monitoring will be done until day 14 of the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. adult aged 18 years and above
2. able to understand instructions
3. Stage 1 COVID-19
4. \< 5 days of illness or diagnosis

Exclusion Criteria:

1. Less than 18 years old
2. Unable to understand instructions
3. Stage 2 \& 3 COVID-19
4. Respiratory symptoms or fever on admission
5. Abnormal chest radiograph or computed tomography (CT) findings on admission
Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

The purpose of this study is to determine if cardizem is effective in the treatment of nitric oxide non-responder pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants
* Confirmed WHO class I pulmonary arterial hypertension
* Nitric Oxide Non-Responders on right heart catheterization
* Experience dyspnea, NYHA III-IV with poor oxygenation and quality of life despite standard treatments
* Must be able to swallow medications

Exclusion Criteria:

* Pulmonary hypertension secondary to 1) elevations in pulmonary venous pressures (i.e. left heart disease), 2) chronic hypoxemic states from lung diseases such as COPD, sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to high altitude and developmental abnormalities 3) chronic thromboembolic disease, 4) sarcoidosis, 5) Lymphangiomyomatosis, 5) Pulmonary Langerhans Cell Histiocytosis
* Already on a calcium channel blocker
* Systolic blood pressure less than 90
* Heart rate less than 55
* Pregnant
* Cannot sign informed consent
* Right heart failure
* Pulmonary Veno-occlusive disease
SynCardia Companion 2 Driver System Post Approval Study Protocol With INTERMACS™-Based Data Collection

Study Purpose

The purpose of this PAS is to confirm that patients implanted with the temporary Total Artificial Heart (TAH-t) and supported with the Companion 2 Driver System have outcomes similar to those patients implanted with the TAH-t and supported with the CSS Console. The data collection mechanism for this study is the INTERMACS Registry.

Study Objectives

Primary Objective 1:

To confirm that patients implanted with the TAH-t and supported by the Companion 2 Driver System have outcomes similar to those patients implanted with the TAH-t and supported by the CSS Console.

Primary Objective 2:

To compare positive outcome rates for all TAH-t patients entered in the Intermacs Registry initially supported with the Companion 2 Driver System to positive outcome rates for all TAH-t patients initially supported by the CSS Console.

Primary Objective 3:

To review additional data (patient survival, adverse event rates and bridge to transplant rates) to support the conclusion that the use of an artificial heart is reasonable and necessary for the treatment of irreversible biventricular failure in Medicare/Medicaid patients.

Secondary Objective:

* To evaluate the incidence of adverse events (AEs). The AEs will follow the definitions in the INTERMACS Registry.

Study Hypothesis: Primary Objective 1 The primary hypothesis is that the positive outcome rate (defined as transplant , transfer to the Freedom Driver System support, or continuing on implant driver support, whichever occurs first; assessed at three and six months post-implant) for patients supported with the Companion 2 Driver System is non-inferior to the survival rate for patients supported with the Circulatory Support System (CSS) Console.

Data Collection The data will be collected as defined in the INTERMACS Protocol and the patients will be followed at one week, one month, three months and six months or until their study endpoint is reached.

Data Analysis

Primary Objective 1:

Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes for TAH-t patients who were implanted while supported with the Companion 2 Driver System compared to TAH-t patients who were implanted while supported with the CSS Console.

Primary Objective 2:

Data analysis will provide descriptive statistics on enrollment, adverse events, and outcomes for all TAH-t patients enrolled in the INTERMACS Registry.

Phase I as described above was completed; Phase II of Study design is under review by FDA with anticipated initiation in early 2021.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with the TAH-t
* Patient or their legal representative has signed an informed consent (ICF) form for INTERMACS Registry participation or waiver of consent has been approved at the implanting institution.

Exclusion Criteria:

* Patient or legal guardian has not signed an ICF for INTERMACS Registry participation, if required at the institution.
* Patient is incarcerated.
Transversus Abdominis Plane Block From Abdominal Approach

Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.

Potential advantages compared to percutaneous approach are decrease in risk of visceral injury as it is under direct visual and tactile guidance, ease of approach in obese patients, short theatre time for administration, easy to administer.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* Age 18 or above
* Scheduled to undergo TAH+/- salpingoophorectomy.
* Scheduled to receive general anaesthesia under standardized anaesthetic regime.
* Comprehends how to use intravenous patient controlled analgesia (IV PCA).
* Is willing to complete the postoperative assessment.
* Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.

Exclusion Criteria:

* Known allergy to drugs involved in this study
* Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
* Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
* With co-existing pathology resulting in persistent pain requiring analgesics.
* Wound incision extending to supra-umbilical level.
Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders

Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved.

The management of mental disorders has long followed the traditional categorical approach of developing a treatment for a given disorder. However, researchers have recently pointed out the limits of this approach in the field of mental health. They highlight the large number of co-morbidities, the existence of aspecific disorders and the intra-diagnostic heterogeneity of patients. These factors have led them to develop a transdiagnostic approach, which focuses on the mechanisms common to the various disorders in order to treat them at the same time and thus reduce the cost of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Have at least one diagnosis of a psychiatric disorder
* Be able to carry out psychotherapy sessions
* Have been on stable psychiatric medication for 30 days
* Written informed consent obtained from the participant
* Be affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Cognitive deficits marked by a score above the 10th percentile for one or more tests in the assessment history.
* Persons deprived of liberty by judicial or administrative decision; Persons under legal protection: guardianship or curatorship
* Presence of a severe depressive episode
* Be engaged in psychotherapeutic work elsewhere
* Presence of a state of excessive deficit, making psychotherapy impossible
* Presence of psychic decompensation (e.g. delusions) making psychotherapy impossible
Evaluation of Motor Imagery, Cognitive Function and Reaction Time in Children With Bronchiectasis

The aim of this study was to evaluate motor imagery ability, reaction time and cognitive function parameters in children with CF and non-CF bronchiectasis compared to healthy peers.

The main causes affecting exercise capacity in patients with bronchiectasis are restriction of tidal expiratory flow, dyspnea secondary to dynamic hyperinflation, changes in pulmonary mechanics, inadequate gas exchange and decreased skeletal muscle mass. Due to all these symptoms, exercise capacity decreases in patients with bronchiectasis and the importance of physical activity increases. . In addition to decreased exercise capacity in individuals with bronchiectasis, studies on the effect of motor imagery ability, which is considered as a mental exercise, have not been found. Inadequate blood supply to the brain and muscle dysfunction have been reported to cause cognitive damage and decreased reaction time in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cystic or non-cystic bronchiectasis
* Being clinically stable
* Not having an exacerbation or infection
* Being between the ages of 7-18
* To be able to read and understand Turkish

Exclusion Criteria:

* Unstable concomitant cardiac, orthopedic or neurologic disease
* History of previous lung or liver transplantation
* History of acute exacerbation and/or hospitalization in the last 1 month
* Changes in medical treatment during the study period.