cyrilzakka/clinical-trials huggingface dataset:
Dose Comparison Study of Menactra® in US Children

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.

Primary Objective:

To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Eligibility Criteria:
Inclusion Criteria :

* Aged 2 to \< 11 years on the day of inclusion.
* Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
* Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
* Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Receipt of blood or blood-derived products in the past 3 months.
* Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
* Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
* History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
* Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
* Personal or family history of Guillain-Barré Syndrome (GBS).
* Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Co-infections in Children Hospitalised for Bronchiolitis

Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.

Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical impact of co-infections in this group.

Eligibility Criteria:
Inclusion Criteria:

* younger than 2 years admitted for bronchiolitis

Exclusion Criteria:

* chronic lung disease congenital heart defect down syndrome
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population

The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant, non-lactating females aged 40 or older.
2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
4. Post-salbutamol FEV1/FVC \< 70% at screening visit.
5. Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
6. Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
7. Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.

Exclusion Criteria:

1. History or current diagnosis of asthma.
2. A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
4. Clinically significant respiratory conditions other than COPD condition.
5. Clinically significant cardiovascular conditions.
6. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
7. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
8. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314

A Double-blind, Multi-center, Multi-regional, Randomized controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19

To evaluate the efficacy and safety of CKD-314 by comparing the study group and control group in hospitalized adult patients diagnosed with COVID-19 pneumonia

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years
2. Patients diagnosed with COVID-19 infection and pneumonia
3. Patients who have voluntarily decided to participate in the study and signed the informed consent form If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained.

Exclusion Criteria:

1. Patients with history of hypersensitivity to the study drug
2. Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study
3. Patients who are deemed to ineligible to participate in the study for other reasons by the investigator
Misoprostol for Non-Viable Pregnancies

The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.

Patients presenting to the OB/GYN clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. Ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of Madigan Army Medical Center. Patients consenting will be directed to the OB/GYN clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. Patients will be randomized into two groups: study group receiving Misoprostol per vagina and the control group receiving a placebo per vagina. Subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. They will also be given Motrin and Phenergan to help alleviate undesired side effects. Four 200 ug tablets of Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. Patients will return in 24 hours for re-examination. If no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative BHCG. All patients will be followed until the quantitative BHCG has fallen zero to ensure resolution of the pregnancy event.

Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a D\&C if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. Again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. Surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with nonviable pregnancy document by ultrasound
* Gestation at or less than 13 weeks by ultrasound measurements
* Clinically stable as determined by provider
* Afebrile
* Hematocrit \> 30
* Over 18 years of age

Exclusion Criteria:

* History of allergy to, or intolerance of, misoprostol
* Refusal to abstain from intercourse for 72 hours
* Significant vaginal bleeding (\> 2 pad/hr)
* History of inflammatory bowel disease
Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation

Generic plerixafor use at reduced-dose for mobilization on HSCT transplant

The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
* Patients \> 18 years old who signed our informed consent
* Normal CBC count (Hb \> 10, WBC 4.0-11.00, plt \> 100,000)

Exclusion Criteria:

* Patients with HIV, Hepatitis C, Hepatitis B diagnosis
* Pregnant women
Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream

This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene.

Skin reactions are a common and undesirable result of radiation treatment. Preventative measures are often used although there are few controlled trials. Commonly employed agents for established reactions have included sorbolene (10% Glycerine), silver sulphadiazine, hydrocolloid dressings, topical steroids, salt water or bicarbonate of soda water solution bathing and hydrogen peroxide. One trial found that Cavilon No-Sting Barrier film reduced Grade 3 skin reaction compared to sorbolene, although this film did not contain any moisturising agents.

General Hypothesis: That in a paired double blind randomised study peak and overall skin reactions experienced by post mastectomy breast cancer patients receiving radiotherapy may be reduced by Cavilon Durable Barrier Cream (CDBC) compared to Sorbolene.

Alternative Hypothesis of primary outcome: the frequency of grade 3 or more skin reaction will be reduced from 35% to 25% for skin care using sorbolene or CDBC respectively.

Alternative Hypothesis of secondary outcome: the mean area under the curve (AUC) of total skin reaction will be reduced from 9 to 8 for skin care using sorbolene or CDBC respectively.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or more years
* Post total mastectomy
* Planned dose at least 45 Gy in 25 fractions
* ECOG 0-2
* Able to attend weekly during treatment for review and photo and for up to 6 weeks after radiotherapy
* Patients capable of childbearing using adequate contraception
* Written informed consent

Exclusion Criteria:

* Previous radiotherapy to the chest wall to be treated
* Macroscopic cutaneous involvement by malignancy at time of radiotherapy
* Known allergy to product contents
* Patients who are pregnant or lactating.
ECG Belt vs. Echocardiographic Optimization of CRT

Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.

This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd \> 150 ms or those previously RV paced.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent for participation in the study
* Age ≥18 years
* Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing \< 10%)
* Adequate echocardiographic images for EF \& LVESV determination

Exclusion Criteria:

* Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
* Enrollment in a concurrent study that could confound the results of this study
* Pregnant or could become pregnant within the 6 month follow-up period
* Non-ischemic cardiomyopathy, LBBB morphology, and QRSd \> 150 ms
* Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing \< 90% over the 6 month follow-up period
Long-Covid: Treatment of Cognitive Difficulties

The purpose of the study is to explore the potential effectiveness of two common low-dose interventions, one targeting cognitive difficulties and the other targeting affective difficulties on quality of life and cognition in people suffering from long-COVID with cognitive complaints.


Eligibility Criteria:
Inclusion Criteria:

* Subjects able to understand the information and consent forms;
* Medically stable and at least 3 months after positive PCR for Covid-19;
* Self-reported sufficiently good physical condition to attend the appointment;
* No major hearing or vision disorders;
* Cognitive complaints that place the person in the top 20% of dissatisfied functioning on the BRIEF or MMQ questionnaires;
* Poor objective performance supported by a score below the 20th percentile on one task of the cognitive battery.

Exclusion Criteria:

* Any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
* Cognitive impairment (minor or major neurocognitive disorder; intellectual disability) preexisting to the Covid-19 episode;
* Acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
* Documented preexisting history of psychiatric illness, including substance abuse; Open-heart cardiac surgery or cardiac arrest during the last 6 months;
* Current hospitalization;
* Current revalidation care with cognitive treatment
iCaReMe Global Registry

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world

Eligibility Criteria:
Inclusion Criteria:

1. Being 18 years or older
2. Having type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
3. Providing written informed consent to participate in the registry

Exclusion Criteria:

1. Having a life-threatening co-morbidity with life expectancy below 1 year
2. Participating in an interventional trial requiring informed consent
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.

Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.

Exclusion Criteria:

* synchonous metastatis
* previous malignant tumour
* previous radiotherapy/ chemotherapy
* performance status WHO\>2
* contraindication to 5 FU
Internet-Delivered Positive Affect Program in Managing Emotion in Young Adult Cancer Survivors

This pilot clinical trial studies how well an internet-delivered positive affect (PA) intervention works in managing emotion in young adult cancer survivors. An internet-delivered PA intervention may teach younger cancer survivors healthy coping skills and help doctors to learn more about what effects mood may have on the health and well-being of young adults with cancer.

PRIMARY OBJECTIVES:

I. To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors.

II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability.

SECONDARY OBJECTIVES:

I. To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors.

OUTLINE:

Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.

After completion of study, patients are followed up at 1 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand English
* Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
* 18 to 39 years of age at diagnosis
* Within 0-5 years post-active treatment
* Wireless internet connection or a home computer that is connected to the internet

Exclusion Criteria:

* Evidence of a cancer recurrence
* History of multiple primary cancers
* Currently receiving palliative or hospice care
* Significant psychiatric history
A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 2)

The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion)


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer, excluding cancer in the blood
* Availability of 10 tumor tissue slides

Exclusion Criteria:

* Known brain metastases
* Severe nerve damage
* Significant cardiovascular disease
* Inadequate blood counts
* Inadequate liver or kidney function
* Inadequate thyroid function or uncontrolled thyroid disease
Falciformopexy for Treatment Perforated Peptic Ulcer.

Use the falciform ligament flap for the treatment of perforated peptic ulcer

Peptic ulcer perforation (PUP) is one in all the foremost common critical surgical emergencies. The omentum flap is usually wont to cover a PUP. However, the omentum can not be utilized in cases of severe peritonitis or previous surgical removal. this is often the primary study conducted in Vietnam that was designed to analyse the outcomes of patients with PUPs who were treated using the ligament.

In the population, the prevalence of ulcer disease supported physician diagnosis ranges from 0.12% to 1.50%, and hospitalization rates range from 0.10% to 0.19%. ulceration perforation (PUP) is one of the foremost common surgical emergencies worldwide, which is necessitate emergent surgical intervention.

the death rate of PUPs is between 1.3% and 20%, and mortality thanks to a perforation of a gastric ulcer is over mortality because of a perforation of a duodenal ulcer (40% vs 10%) . Some studies have shown that having comorbidities, being over 70 years old, undergoing surgical procedure after 36 h, PUP diameter greater than 1 cm2 and postoperative com- plications are associated with mortality. The technique of using the omental patch for repair PUP is commonest now thanks to mobility and vascularity but is also using the falciform ligament in some cases due to highly vascularity.

The technique of using the falciform ligament for the treatment of PUPs was reported in 1978 by Fry . The purpose of the study was to explain the technique and therefore the results of using the falciform ligament for the treat- ment of PUPs during a large volume surgical centre in Assuit university hospital found the falciform patch to be a successful technique in repair PUP and is assumed to be as effective as omental patch but more advantage because of highly vascular.

Eligibility Criteria:
Inclusion Criteria:

- Any cases presented with PPU within age from 18 till 70 years.

Exclusion Criteria:

* malignancy.
* Previous GIT and liver surgery.
* nonoperative treatment.