cyrilzakka/clinical-trials huggingface dataset:
Understanding the Persistence of Immunity After MenC Vaccines

Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in 1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3 and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose of a MenC conjugate vaccine during the mass immunisation campaign.

Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and serum bactericidal antibody (SBA) titres following immunisation in young children. A cross-sectional review on rates of sero-protection against MenC disease in the UK has demonstrated that the majority of children who were immunised with a single dose of a MenC conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years after the immunisation campaign. As this cohort of children reaches adolescence there is a risk of increased transmission of the organism and a resurgence of meningococcal disease in children who do not have protective levels of antibody. There is thus a need to conduct a study evaluating the changes in MenC SBA titres over time in children who received a single dose of a MenC vaccine in early childhood which is the main objective of this study.


Eligibility Criteria:
Inclusion Criteria:

* Participant whose parent is willing and able to give informed consent for participation in the study.
* Participant who gives assent for participation in the study.
* Male or Female, aged 11 to 13 years.
* Known to be free from medical problems as determined by a medical history and clinical assessment
* Participated in the University of Oxford clinical trial: U01-Td5I-303/ C01.183

Exclusion Criteria:

* History of invasive meningococcal C disease
* Any vaccination against MenC disease with the exception of a single dose in 2000 during the nationwide MenC immunisation campaign
* Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
* Major congenital defects or serious chronic illness
Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care

This study evaluates the impact of optimizing drug prescriptions on re-admissions of elderly patients within 30 days after hospital discharge. It compares a group of patients receiving comprehensive care (medication reconciliation at hospital entry, multidisciplinary medication review, and medication reconciliation at discharge), versus another group that does not benefit from the program.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in the department of short geriatric stay

Exclusion Criteria:

* Patients already included in the study, and readmitted in the same service.
Description of the Ability to Learn How to Handle Inhaler Devices in Asthma

Asthma is a major public health problem. The main treatments against asthma are delivered to the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime their device, which may alter the positive effects observed in clinical trials.

The main objective of this study is to describe the handling of inhaler devices (Diskus®, Turbuhaler® and Ellipta®) in patients with asthma.

All participants will use each inhaler device (Diskus®, Turbuhaler® and Ellipta®) daily for one week:

* Two puffs per day (Diskus® and Turbuhaler®),
* One puff per day (Ellipta®). At each visit (day 1, 8, 15 and 22), patients will have a physical exam.

For each inhaler device, 4 video recordings will be performed:

* Video recording #1: Inhalation (one puff) without any instruction of use.
* Video recording #2: Inhalation (one puff) after reading the patient information leaflet.
* Video recording #3: Inhalation (one puff) after watching a standardized video demonstrating correct inhaler technique.
* Video recording #4: inhalation (one puff) after seven days of daily use. The patient will be asked to fulfill a satisfaction survey about each inhaler device.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged more than 18 years
* Written informed consent
* Diagnosis of asthma according to international guidelines (GINA 2017)
* Social security or health insurance
* Women using an effective method of birth control.

Exclusion Criteria:

* Previous treatment with Ellipta®, Diskus® or Turbuhaler®
* Asthma exacerbation within 6 weeks before inclusion
* Subject having close contacts with devices (Ellipta®, Diskus® or Turbuhaler®) users, currently or in the past
* Severe asthma
* Hypersensitivity to budesonide
* Chronic psychiatric disease
* Medical condition that may affect handling of inhaler devices
* Subject deprived of his/her liberty
* Protected adult
* Subject in exclusion period related to another protocol
* Pregnant or breastfeeding women.
OCS Heart EXPAND + CAP Continued Follow-Up

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials
Evaluation of AL Prediction for Rectal Cancer

Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-75 years
2. Adenocarcinoma confirmed by pathology
3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal edge was less than or equal to 12cm
4. Preoperative imaging diagnosis was cTxNxM0
5. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, and no invasion of adjacent organs)
6. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia
7. Voluntarily sign the informed consent form

Exclusion Criteria:

1. Previous history of malignant tumor
2. Simultaneous multiple primary colorectal cancer
3. Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions
4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery
5. Patients with familial adenomatous polyposis and active inflammatory bowel disease
6. A history of severe mental illness
7. pregnant or lactating women
8. Patients with uncontrolled infection before operation
9. The investigator did not consider the patient to be eligible for the trial
Overcoming Perfectionism: A Randomised Controlled Trial of an Online CBT Based Guided Self-help Intervention

The purpose of this study is to assess the effectiveness of CBT based online guided self-help intervention for perfectionism at reducing symptoms of perfectionism and Axis I disorders post-treatment and at six-month follow-up.

Perfectionism is elevated across, and increases risk for a range of Axis I disorders, as well as having a direct negative effect on day to day function. A growing body of evidence shows that cognitive behavioural therapy (CBT) reduces perfectionism and Axis I disorders, with medium to large effect sizes. Given the increased desire for online interventions to facilitate access to evidence-based therapy, web-based CBT self-help interventions for perfectionism have been designed. Existing interventions have not included personalised guidance which has been shown to improve outcome rates.

The purpose of this study is to assess the effectiveness of CBT based online guided self-help intervention for perfectionism at reducing symptoms of perfectionism and Axis I disorders post-treatment and at six-month follow-up.

A randomised controlled trial method is employed, comparing the treatment arm (online guided self-help) with a waiting list control group. Outcomes are examined at three time points, T1 (baseline), T2 (post-intervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media, and if eligible will be randomised using an online automatic randomiser.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 or over, with no upper age limit.
* Score one standard deviation above published norms on the 'Concern over mistakes' subscale of the Frost Multidimensional Perfectionism Scale (Frost, Marten, Lahart, \& Rosenblate, 1990), i.e. a score of ≥ 29 (Flett, Sawatzky, \& Hewitt, 1995).
* Be fluent in English.

Exclusion Criteria:

- They report suicidal thoughts or intent prior to commencement of the intervention.
Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes

Crossfit® is a training modality that consists in functional movements, constantly varied and executed at high intensity. Both training sessions and competitions involve physically demanding activities, which in addition to being performed at very high intensity also involves the aerobic metabolism pathway. These characteristics led to very high metabolic and muscular stress, as well as decrease in physical performance immediately after competitions and training sessions. The cumulative effects of the metabolic and muscular stress can be a precursor of injuries. Studies using different therapeutic modalities aiming to improve post-exercise recovery are needed in order to tackle this issue.

However, to the date there are no studies investigating the effects of different therapeutic modalities in an exercise modality such as Crossfit®. Therefore, the aim of this project is to assess the effects of different therapeutic modalities on performance and muscle recovery of Crossfit® athletes.

It will be carried out a randomized, crossover, controlled trial.

Volunteers will be allocated to four interventions, and the order of the interventions will be randomized.

The outcomes will be obtained at baseline (prior to the Workout of the Day - WOD), and in different timepoints after that.

The WOD will be consisted in finishing as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.

The investigators will analyze: the maximum number of free squats performed in 1 minute; the activity of creatine kinase (CK); the levels of Interleukin-6 (IL-6); the ratings of perceived exertion; and the volunteers satisfaction with the interventions.

All data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments.

Eligibility Criteria:
Inclusion Criteria:

* Crossfit® amateur male athletes
* Do not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study;
* Are not using pharmacological agents;
* Athletes should have been practicing the sport for at least 1 year;
* Voluntarily commit to participate in all stages of the study.

Exclusion Criteria:

* Present musculoskeletal or joint injuries during data collection.
Cleidocranial Dysplasia (CCD): From Genotype to Phenotype and Considerations for Care

Cleidocranial Dysplasia (CCD) is a rare, autosomal dominant disorder characterized by dysplasia of bones and teeth. Given the rarity of this condition (prevalence of 1 in 1,000,000), the variable phenotype and lack of correlation to specific genotypes, coordinated clinical research is needed to better understand CCD. The purpose of this project is to: investigate the genetic makeup and phenotypic expression of CCD, understand the quality of life for patients with this diagnosis, and further identify the multidimensional healthcare needs of these patients. Participation involves completion of a survey to ascertain medical history and quality of life, a physical exam and research whole exome sequencing from a blood or saliva sample. The goal of this research is to elucidate critical pathways in skeletal and dental development and improve quality of life for CCD patients through the standardization and optimization of timely diagnosis and multidisciplinary care.


Eligibility Criteria:
Inclusion Criteria:

* Patient has molecular or clinical diagnosis of CCD
* Caregiver or parent of patient with CCD.

Exclusion Criteria:

* Patient does not have CCD
* Patient over 18 but cannot consent for themselves
* Not fluent in English.
The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users

Studies have shown that Pilates exercises are one of the exercises that can improve breathing capacity, coordination, balance, flexibility, and muscular endurance. Pilates exercises improve walking and balance, reduce back pain and prevent further pain or injury. These are all common problems for people who have undergone lower extremity amputation. The aim of our study is to improve the pelvis-trunk coordination, gait symmetry, and balance on individuals who have undergone amputation and also to increase body awareness.

The patients will be randomly assigned to two groups. Clinical Pilates (CP) and Classic Physiotherapy (CF). Two groups will be Transfemoral and Transtibial amputees, one CP, and the other CF. Groups will be treated for a period of 12 weeks. The assessment will be made before the treatment and after 12 weeks. Patients will practise exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise.

In the clinical Pilates group, exercises that improve back extensor, trunk flexor, and pelvis stabilization will be applied along with breathing exercises. The classic group consists of straight leg raising, back extensors strengthening, abdominal strengthening exercises.

Gait spatiotemporal parameters, balance, fall risk and mobility, functional capacity, core muscle endurance, and strength, the pain will be evaluated. Quality of life, body image, and also prosthesis satisfaction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Be a Volunteer,
* Being at least 6 months after amputation,
* Having no problems related to prostheses,
* Using a hydraulic, pneumatic, or microprocessor knee joint type,
* According to the functional classification of amputees, individuals at the K3-K4 level,
* Individuals with unilateral transtibial, unilateral transfemoral amputation

Exclusion Criteria:

* Users using assistive devices,
* Those with bilateral amputation,
* Those having contractures,
* Those with acute low back pain,
* Spine and lower extremity involvement due to systemic inflammation (rheumatoid arthritis, spondyloarthropathy, etc.),
* Systemic neurological disease (Multiple sclerosis, Alzheimer's, etc.),
* Patients with other diseases that prevent mobilization (vertigo, cerebellar ataxia, etc.).
Novel Device for Reducing Catheter-Related Infections

This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.


Eligibility Criteria:
Inclusion Criteria:

* Admission in the ICU at time of catheter insertion
* Indication for central venous catheter placement
* De novo catheter insertion in the subclavian or internal jugular veins

Exclusion Criteria:

* Anticipated catheter duration \< 72 hours
* Planned guidewire exchange
* Documented bacteremia within 48 hours prior to catheter placement
* Extensive skin breakdown near the site of potential catheter placement
* Emergent line placement
* Screening labs with ANC \< 500 or platelets \< 50K
* Hypersensitivity to cyanoacrylates or formaldehyde
* Prior enrollment in study
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.

Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastric cancer
* Operable

Exclusion Criteria:

* Withdrew consent
* Pregnant
* Ascites
* Distant metastasis
* Liver dysfunction (serum total bilirubin \>2.0 mg/dL)
* Renal failure (serum creatinine \>1.5 mg/dL)
* A past history of small bowel obstruction.
Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient with regard to the pseudonymized documentation as well as the transfer and processing of his/her data within the study and the ADOREG \[Cancer Registry of German Working Group of Dermato-Oncology\] registry (data transfer to ADOREG registry only for patients from German sites);
* Legally capable male or female patient ≥ 18 years of age (no upper limit);
* Decision was taken to treat the patient with encorafenib plus binimetinib in accordance with the current SmPC \[Summary of Product Characteristics\] and by prescription; this decision was taken prior to and independent from the inclusion into the study;
* Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to providing written informed consent for this study or is planned to be started in the near future;
* Unresectable advanced or metastatic malignant melanoma with BRAF \[Rapidly Accelerated Fibrosarcoma isoform B\] V600 mutation;
* Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4 \[Cytotoxic T-Lymphocyte Antigen-4\] and/or anti-PD(L)1 \[Programmed cell Death protein 1\]) in the unresectable advanced or metastatic setting.

Exclusion Criteria:

* Previous treatment with a BRAF- and/or MEK \[Mitogen-Activated Protein/Extracellular-signal Regulated Kinase\]- inhibitor except for:

  -- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended \> 6 months prior start of Encorafenib/Binimetinib treatment;
* More than one prior line of checkpoint inhibitor treatment in the unresectable advanced or metastatic setting;
* Any previous chemotherapeutic treatment of the melanoma disease;
* Presence of any contraindication with regard to the encorafenib-binimetinib-treatment as specified in the corresponding SmPCs;
* Current or upcoming participation in an interventional clinical trial;
* Current or upcoming systemic treatment of any other tumor than melanoma;
* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia

Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. However long-term disease-free survival after allogeneic SCT has been reported. Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an important problem in this setting.

Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL.

Patients with relapsed or refractory CLL who are eligible for the study receive a cytoreductive therapy until SCT. Irrespective to the formal response, patients proceed to allogeneic SCT after fludarabine-based reduced-intensity conditioning. The use of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood stem cells \> 3 x 10E6 CD34 cells/kg is recommended, but bone marrow \> 1 x 10E8 MNC/kg is accepted. GVHD-prophylaxis is based on cyclosporine A adapted to blood levels (150 to 200 ng/mL) over a period of three months. In Phase I of the study, alemtuzumab has been applied as part of the conditioning regimen until day 5. In Phase II, alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 and after Amendment II in September 2006 scheduled for day 28. Furthermore methotrexate is given on days 1, 3, 6. and 11 at a projected cumulative dose of 45 mg/m2. Subsequent immunosuppressive therapy depends on the occurrence of GvHD, the development of chimerism, and residual disease. Patients with relapsing or residual disease (minimal residual disease excluded) who do not suffer from GvHD should receive donor lymphocytes in increasing dosages. The initial dose is 1 x 105/kg T-cells in unrelated donors and 1 x 106/kg in matched related donors. If no GvHD develops within 6-8 weeks, the next higher dosage is applied.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* sufficient organ function
* availability of an HLA-compatible donor (related or unrelated)
* age \< 65 years
* karnofsky index \> = 70%
* B-CLL requiring treatment after failure of at least one prior cytostatic treatment

Exclusion Criteria:

* positive HIV-serology
* pregnancy
* intolerance to study drugs
* second neoplasia
* serious infections