cyrilzakka/clinical-trials huggingface dataset:
Optimal TTM Tailoring for Population Cessation

This study explored optimal tailoring strategies for population tobacco cessation in 4 treatment groups and a control group over 24 months. Transtheoretical model (TTM) tailored feedback on all 14 variables has been found to be a robust population cessation strategy across studies. This proposal sought to find a subset of these variables that is optimal for tailoring, both minimizing response burden while maximizing effectiveness. Addiction variables have been demonstrated to predict smoking outcomes across studies as well, so we will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring group. Optimally tailored feedback that both helps unmotivated smokers reduce their addiction and helps motivated smokers quit could lead to a breakthrough in population cessation.

Smoking remains one of the biggest causes of premature morbidity and mortality. Nicotine addiction continues to challenge researchers to optimize their best interventions, and these challenges increase with efforts to integrate smoking cessation into multiple behavior change research and dissemination. Tailored intervention strategies have demonstrated effectiveness, yet much research remains to be done exploring optimal tailoring strategies. Transtheoretical model (TTM) tailored feedback on all 14 variables has been demonstrated to be a robust population cessation strategy across studies, producing 22-25% quit rates at 18-24 month final timepoints. This proposal sought to find a subset of these variables that is optimal for tailoring, both minimizing response burden while maximizing effectiveness. Addiction variables have been demonstrated to predict smoking outcomes across studies as well, so we will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring group. Enhanced addiction tailored feedback that both helps unmotivated smokers reduce their addiction and helps motivated smokers quit could lead to a breakthrough in population cessation. This proposal tests four types of TTM-tailoring for smoking cessation in an additive design: assessment-only control group; Minimal tailoring (stage only); Moderate tailoring (stage, pros, cons, efficacy); Full TTM tailoring (all 14 TTM variables); and Enhanced TTM tailoring plus addiction variables. Smokers will be randomized to one of five treatment groups and evaluated at baseline, 6 months, 12 months, and 24 months. Treatment groups will receive tailored feedback at baseline, 6 months, and 12 months. Analyses will compare treatment groups on quit rates at the final timepoint to see how effectively each treatment helps smokers to quit. A series of mediation and moderation analyses will examine how each treatment works. This study has the potential to find an optimal tailoring strategy for population cessation that could accelerate future multiple behavior change research and dissemination efforts.

Eligibility Criteria:
Inclusion Criteria:

* smoker

Exclusion Criteria:

* pregnancy
Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery

This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery

High-dose opioid is associated with various side effects such as nausea, vomiting, urinary retention, and respiratory depression. The neuraxial block (intrathecal, epidural) and peripheral nerve block are regional anesthesia techniques which have the potential to reduce intraoperative opioid consumption. The deep parasternal intercostal plane block is fascial plane block which intended to block anterior cutaneous branch of intercostal nerves.

This study is a double-blind randomized controlled trial. Thirty subjects will be recruited with consecutive sampling method. Eligible subjects with signed informed consent will be randomized into two groups. The first group is the treatment group who will receive bilateral deep parasternal intercostal plane block after induction of anesthesia and the second group will be the control group who will not receive any regional anesthesia. After surgery, extubation time, adverse event (nausea, vomiting), and intensive care unit length of stay will be recorded for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* Elective open-heart surgery with median sternotomy approach

Exclusion Criteria:

* Patient who refuses to participate
* Patient with local infection in the block area
* Patient with chronic pain
* Patient with history of chronic analgesics use
* Patient who is contraindicated for local anesthetics
* Patient with cognitive disorder
* Patient with severe psychiatric disorders
The Effects of Family Clinic and Municipality

This trial is a randomized controlled trial with the aim is to assess the effectiveness of Family Clinic and Municipality (FACAM) to improve mother-child relationship, maternal health, maternal mental health, and the development and well-being of the child.

Pregnant women who struggle with psychosocial challenges during pregnancy have a higher risk of preterm birth, giving birth to a child with low birth weight and a higher risk of complications during pregnancy both for mother and child. An early and coordinated intervention to reduce inequality in health may be important for this group of vulnerable women.

The FACAM intervention is developed in Odense with the aim of reducing inequality in health by giving vulnerable pregnant women and their children the best possible start in life by offering an interdisciplinary coordinated support. The support will be offered by Odense municipality, the family clinic (Familieambulatoriet), and local voluntary organizations.

The aim of the trial is to assess the effectiveness of FACAM to improve mother-child relationship, maternal health, maternal mental health, and the development and well-being of the child.

The study is a Randomized Controlled Trial (RCT). A total of 320 pregnant women will be randomized to FACAM or Care as Usual.

Participants are pregnant women categorized as antenatal care group 3 or 4, living in Odense and with a referral to Familieambulatoriet, OUH. Participants must be able to fill out questionnaires in Danish or English.

Data will be collected at baseline (pregnancy), and when the child is 3 and 12 months old.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women admitted to the Familieambulatorium, and living in Odense municipality
* Antenatal care group 3 or 4 according to the Danish health authorities' recommendations

Exclusion Criteria:

* Life-threatening illness in parent or child
* Not able to fill out questionnaires in Danish or English
* Child in out of home care after birth
* Pregnancy with twins
* Previous participation in the FACAM project
Effects of Plyometric Training on Endurance and Explosive Strength in Cricket Players

This study will help to understand the effects of plyometric training on endurance and explosive strength in cricket players.

It will consist of combination of plyometric training with warm up and cool down including Squat to Squat Jump, Lunge to Plyo Lunge, Step Jack to Star Jumps, Plank to Plyo Spider Lunge, Plank to Frogger Frequency = 2 days per week for 2 weeks and then 4 days per week after 2nd week to 4th week, Intensity =500 jumps, Time = 30 min.

Eligibility Criteria:
Inclusion Criteria:

* Active Male cricket players, age between 18-30 years.
* Playing from last 6 months.
* Normal BMI athletes

Exclusion Criteria:

* History of trauma/injury in last 2 months.
* Playing for less than 6 months.
* Over-weighted or underweighted athletes
* Any co-morbidity
* Cardiorespiratory issues like asthma
* Hypertension or Diabetes
* Meniscus or ACL/PCL/LCL/MCL injured patient
* Ankle sprain in last 6 month
Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia

The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy
* Subject weighs ≥35 kg
* Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of SP-420 and for the duration of the study
* Serum ferritin ≥700 ng/mL and iron saturation ≥70% within 3 weeks before Baseline (Day 1)
* Cardiac T2\* score \>20 msec within 6 months before Baseline (Day 1)
* Willing to use contraception during the study

Exclusion Criteria:

* Pregnant or breast-feeding
* Serum creatinine greater than the upper limit of normal
* Platelet count \<100 × 10\^9/L
* Use of another investigational drug within the last 30 days
* Significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the Investigator, would exclude the subject
Nutrition, Growth and Development Among Very Preterm Infants

The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight below 1,500 grams
* Written consent to participate from the parents

Exclusion Criteria:

* Congenital malformations
* Clinical syndromes known to affect growth and development
* Critical illness and short life expectancy
* If participants refuse to participate
Intractable Self-harm-What Support is Effective?

The aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm.

The main questions are:

1: Is there, in individuals with intractable self-harm, a relevant improvement in daily functioning and is this improvement related to the provided interventions?

The secondary research questions are:

2. Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm?

3. Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions?

4. Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions?

5. Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata?

6. Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?

Individuals with intractable, imminent and lethal self-harm often have multifaceted psychiatric symptoms, pervasive suffering, high mortality and a reduced level of daily functioning. Severe self-harm can lead to long periods of psychiatric inpatient care which can lead to reduced autonomy and aggravated self-harm. Effects of this care remain uncertain. The Swedish National Board of Welfare has provided National specialized medical care units for severe self-harm behaviour to three Swedish hospitals.

In one of this hospitals, Region Skåne, the intervention will be consultation-based. Individuals with intractable self-harm will be offered an assessment and review of all medical records which will result in a individualized intervention plan. Interventions include further assessments and supporting the existing treatment providers, families or caregivers. Recurring network-meetings will occur every three months as well as at he end of the intervention.

Data collection will include self-report measures as well as information from charts and national och regional registries.

Eligibility Criteria:
Inclusion Criteria:

* Having tried or made serious attempt to try at least two different interventions with evidence to reduce self-harm, without sufficient reduction in suffering or self-harm

Exclusion Criteria:

* Need for translation services to complete measures or interviews
* Not able to complete measures or interviews
Supportive Coaching Intervention in PLWHA

Introduction:

Coaching is a process of self-exploration, thoughts, and feelings followed by actions within the coachee, through the relationship between the coachee and the coach. This process will help discover potencies in oneself as part of psychological and emotional support.

Objective:

To investigate the effectiveness of Transpersonal Supportive Coaching on Serotonin Levels and Quality of Life PLWHA.

Method:

This research was conducted using an intervention mixed-methods design which is the integration of quantitative and qualitative approaches to study designs, data collections, and analyses.

Alternative hypothesis:

1. There is a difference in serotonin levels before and after Transpersonal Supportive Coaching on PLWHA.
2. There is a difference in the quality of life before and after Transpersonal Supportive Coaching on PLWHA

Sampling technique: Purposive sampling

Sample Size :

The estimation of sample size was calculated using the Slovin formula:

n = N / (1 + (N x e²))

n = sample N = population e = margin error (0.05)

n = 100/(1+100 x 0.0025) = 80

The sample will be divided into 3 groups (each group = 26.67 or 27).

Detailed Intervention:

1. Intervention group: A group was given supportive coaching for 4 months with a 45-minute duration per coaching. It was given two times a month and also taking an antiretroviral (ARV) therapy.
2. Control group I: A group was given only basic support for 4 months and taking ARV therapy.
3. Control group II: A group only taking ARV therapy without any support was given.

Statistical analysis:

1. Qualitative analysis using thematic and content analysis with N-Vivo software
2. Quantitative analysis:

   1. Univariate analysis using Mean and Standard deviation and percentage with 95% Confidence interval
   2. Bivariate analysis using Anova or Kruskal Wallis tests.
   3. Multivariate analysis using logistic regression for main effect test and Process version 5.3.5. for mediation test with bootstrapping method
   4. Data will analysis using SPSS version 26

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed with HIV maximum 2 months
* Stadium I, II

Exclusion Criteria:

* Stadium III and IV
* Opportunistic infection

Drop Out (DO) criteria:

* Not participating in Supportive Coaching for consecutive 3 times
* Not taking ARV for 1 week
SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy

Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.

Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.

The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.


Eligibility Criteria:
Inclusion criteria:

* All patients undergoing lobectomy VATS
* Older \> 18 years
* Patients who meet criteria of ASA 1 to 3 class

Exclusion criteria:

* Patient's refusal to participate in the study
* Psychiatric disorder (impossibility to collect the informed consent)
* Patient under juridical protection
* On going an other study
* Non balanced epilepsy
* 3 grade auriculo-ventricular heart block without pacing
* Severe hepatocellular insufficiency
* Anti arrhythmic treatment : class III of the Vaughan William's classification
* Pregnant patient or/and breastfeeding
* History of opioid abuse
* Allergy to local anesthetic drug or opioids
Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data

The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:

* Who are receiving primary total elbow replacement surgery?
* Where and by whom is the total elbow replacement surgery is being performed?
* What the current surgical practices for total elbow replacement?

Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 to 100 years old with a primary TER on the National Joint Registry (NJR) elbow dataset from the start of data collection on the 1st of April 2012 to the 31st of December 2022 will be included.

Exclusion Criteria:

* Patients are excluded if they did not consent for their data to be used for research purposes, if it is impossible to trace them after surgery, if their ID numbers are invalid, or if the surgery was not performed in England.
* Unconfirmed procedures and procedures with inconsistent operative patterns (i.e. a sequence of operations where the primary operation is not the first operation in the sequence or where there are multiple primary operations recorded for the same joint) will be excluded from the analyses.
Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake

Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.

50 women with PCOS , diagnosed based on Rotterdam ESHRE criteria,were assigned to two groups - the probiotics one and the placebo one. Women from the probiotics group were given SanProbi® Barrier capsules. They were taking probiotics for 12 weeks. The placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. The study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). The serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. In the laboratory studies, the following hormones were measured before and after 12-week intervention: Testosterone, Androstenedione, 17-hydroxyprogesterone (17(OH)P); follicle stimulating hormone (FSH), luteinising hormone (LH); estradiol (E2), prolactin (PRL), thyroid stimulating hormone (TSH), thyroxine (T4) and sex hormone binding globulin (SHBG). The weight and height were measured before and after 12-week intervention. BMI was also calculated.

Eligibility Criteria:
Inclusion Criteria:

* women with PCOS, diagnosed based on Rotterdam ESHRE criteria

Exclusion Criteria:

* The patients with comorbidities such as diabetes mellitus type I and II, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study
Early Diagnosis of Intracranial Infection After Craniotomy

Intracranial infection are serious complications postoperatively in neurosurgical patients. Early identification of these complications is essential to minimize the mortality and moribidy. The aim of this study is observe the postoperative dynamic changes of body temperature (BT), procalcitonin (PCT), C-reactive protein (CRP), and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection.

Intracranial infection is a serious complications after neurosurgical operation. Early identification of intracranial infection is important so that, first, optimal treatment is initiated which may improves outcome, second, inappropriate antibiotic treatment and subsequent resistance are prevented, and third, it will promote shorter hospitalization and less cost. In several previous studies, the values of procalcitonin (PCT) and C-reactive protein (CRP) in predicting intracranial infection have been evaluated in neurosurgical patients. However, due to the limited number of studies, the results are not convincing enough and more investigations seems warranted to clarify their dynamic changes in neurosurgical patients without intracranial infection and their role in confirming the suspicion of intracranial infection or excluding intracranial infection from the differential diagnosis.

The aim of the investigator's study is to observe the postoperative dynamic changes of BT, PCT, CRP, and white blood cell (WBC) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy for rational decisions about antibiotic treatment.

Eligibility Criteria:
Inclusion Criteria:

1. craniotomy of brain tumor;
2. no clinical manifestations of infection before operation;
3. no other infection such as respiratory tract infection, urinary tract infection and deep vein catheter infection before the definite diagnosis of intracranial infection ;
4. the patients had informed consent to enter the study.

Exclusion Criteria:

1. blood system diseases,respiratory tract infection, urinary tract infection and deep vein catheter infection;
2. malignant tumors with neuroendocrine characteristicsr;
3. aspiration, pancreatitis, etc.
To Investigate the Use of a New Syringe "Visual Pressure Control (VPC)" for Epidural Anesthesia in Children Surgery

Pediatric epidural anesthesia has emerged as a safe and effective regional anesthesia technique for providing intraoperative and postoperative analgesia in thoracic and abdominal surgery. The loss of resistance technique is the gold standard for the placement of the epidural.

The VPC (visual pressure control) syringes developed by PAJUNK enable direct visualization of the introduction of the needle into the epidural space.

This trial is a non blinded, pilot study. A minimum of 15 children between the ages of 0 and 16 who require surgery that may benefit from epidural anesthesia will be enrolled.

The number of attempts, the complications (dural and vascular punctures, neurological complications) and the degree of satisfaction of the operator measured by a 7-point likert scale will be studied as secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* children aged from 0 to 16y
* surgical procedure that can benefit from a lumbar or low thoracic epidural anesthesia

Exclusion Criteria:

* parental refusal
* allergy to local anesthetics
* coagulation disorders
* spine abnormalities