cyrilzakka/clinical-trials huggingface dataset:
Comparison of Four Different Smoking Cessation Programmes

The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.

Smoking remains the most important threat to public health. The majority of smokers wish to quit smoking and every year a substantial part of smokers makes a quit attempt. However, the majority of smokers tries to quit unassisted and existing smoking cessation interventions are underused. In this study we test the effectiveness of four different smoking cessation interventions in a randomized controlled trial. The study provides knowledge on factors important for recruitment and gives indication on potential reach of interventions among the general population. This knowledge can help us in designing interventions that is both effective but also have a high reach in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 and older
* Current smoker: Willing to quit smoking within the next 12 weeks
* Having a regular access to Internet
* Having a personal e-mail address
* Having a personal mobile cell phone with a Danish number
* Given informed consent
* Can read and understand Danish

Exclusion Criteria:

* Less than 16 years of age
* No personal e-mail address
* No personal mobile cell phone
* Not able to give informed consent
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)

The purpose of this study is to determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. This study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility.

* Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase.
* Completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed.
* Useability: all therapists and subjects must rate useability as good or better.
* Success of blind: subject accuracy at guessing group membership must be at or near 50%.


Eligibility Criteria:
Inclusion Criteria:

1. Veteran or Servicemember
2. 18 to 50 years old
3. Sustained one or more mild traumatic brain injury (mTBI)s
4. Demonstration of balance deficits on the Sensory Organization Test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample))
5. Available for the duration of the study

Exclusion Criteria:

1. History of traumatic brain injury (TBI) of any severity other than mild TBI
2. Presence of active substance abuse condition
3. Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
4. Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
5. Orthostatic hypotension as defined by:

   1. A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg
   2. A diastolic blood pressure decrease of at least 10 mmHg, or
   3. A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion
6. An implanted medical device
7. Pregnancy
8. Oral infection
9. Known transmissible disease (HIV, hepatitis, influenza, TB)
10. Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
PostPlacental IUD Insertion

The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size


Eligibility Criteria:
Inclusion Criteria:

* Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section

Exclusion Criteria:

* refusal to participate in the study
* desiring other methods of contraception
* will not use any method of contraception
* has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.
Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma

Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* Patient with squamous cells carcinoma of oropharynx
* Age Superior to 10 years old
* Male or Female
* measurable target according RECIST criteria

Exclusion Criteria:

* -Other histologic cancer than squamous cells carcinoma of oropharynx
* No measurable target
* Presence of metastasis
Use of Vasopressin Following the Fontan Operation

The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.

A pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.

Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients will be enrolled with five patients as control group and five receiving Vasopressin. Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours later in the pilot study. Safety and effect size will be evaluated after this pilot study.

Drug administration protocol:

Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug drip will infuse for 48 hours after which will be discontinued.

The placebo group will be receiving normal saline at the same rate of the vasopressin group. The treating physician will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 1.5-7 years old undergoing Fontan operation.

Exclusion Criteria:

* Patients with a planned fenestrated Fontan.
* Patients undergoing revision surgery for failing Fontan.
* Evidence of renal insufficiency prior to surgery defined by creatinine \>1 mg/dl.
* Planned arch reconstruction at the time of the Fontan procedure
Pathogenetic Basis of Aortopathy and Aortic Valve Disease

The main purpose of this study is to define the complex genetic and pathogenic basis of thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by identifying novel disease-causing genes and by identifying important genetic modifiers for aortic and aortic valve disease severity.

Thoracic aortic aneurysm (TAA) is a type of aortopathy describing dilation of the proximal aortic dimensions including the aortic root, which is a risk factor for aortic dissection and sudden cardiac death. TAA and other forms of aortopathy (e.g. aortic tortuosity or aortic hypoplasia/stenosis) develop in the presence or absence of additional cardiovascular malformations including bicuspid aortic valve. TAA is associated with connective tissue disorders (e.g. Marfan syndrome), and familial clustering has been identified in a significant proportion of nonsyndromic cases, establishing high heritability. Pedigree analysis of TAA kindreds clearly identifies complex inheritance; however, progress towards understanding the genetic basis of TAA and other forms of aortopathy and, ultimately, the susceptibility to aortic dissection remains incomplete. There is a clinical need to develop novel methods for predicting disease risk based on genotype and phenotype, to further elucidate the genetic and pathogenic mechanisms of aortopathy, and to improve medical and surgical therapies. The overarching hypothesis of this study is that individual genetic variation modulates susceptibility to disease severity and progression. The goals of this study are 1) to ascertain a cohort of subjects who have aortopathy and/or aortic valve disease including TAA or who have genetic risk for the development of aortopathy and/or aortic valve disease, 2) to collect paired blood and tissue samples from well-characterized subjects, family members of subjects, and controls to perform genome-wide DNA sequence, histopathologic, transcriptional, and proteomic analyses, and 3) to establish a tissue biorepository with detailed phenotype information to facilitate a broad spectrum of current and future studies.

Eligibility Criteria:
Inclusion Criteria:

* Open to external enrollment:

  * Subjects with a genetic diagnosis of Marfan Syndrome (MDS), Loeys-Dietz Syndrome (LDS), or Vascular Ehlers-Danlos Syndrome (EDS); (Positive genetic testing or a previous cardiac study required to be eligible)
  * Family members of eligible subjects (Only family members of subjects with syndromic diagnoses are eligible for external enrollment at this time)
* Closed to external enrollment:

  * Subjects with aortic disease including TAA\* or dissection, aortic tortuosity, or aortic hypoplasia/stenosis (based on any cardiac imaging modality including echocardiography, CT, MRI, or angiography)
  * Subjects with aortic valve disease (bicuspid, unicuspid, or tricuspid disease)
  * Control subjects having tissue removed during a surgical procedure (e.g. coronary artery bypass graft surgery (CABG), cardiac transplant, etc.)

Exclusion Criteria:

• Inability or unwillingness to provide consent (assent when indicated)
Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition

The goal of this study is to test the hypothesis that immediate elbow motion is safe after anterior submuscular ulnar nerve transposition, and will not result in disruption of the repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate elbow motion after submuscular ulnar nerve transposition for performing activities of daily living and self-care are evident, however theoretical advantages include early "gliding" of the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve function.

A group of 44 consecutive patients that are determined to be candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing will be prospectively randomized to either immediate motion or long arm cast immobilization after surgery. All patients will be counseled about the two postoperative treatment options (immobilization followed by protected range of motion versus immediate range of motion), risks involved with each treatment protocol, postoperative follow-up and need for radiographs. If they choose not to participate, they will be treated by the same postoperative protocol currently used by the principal investigator: arm sling at rest for six weeks with intermittent active assisted range of motion exercises.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona

Exclusion criteria:

* Pregnancy
* Patients who have had prior ulnar nerve surgery
* Patients with other documented neurogenic processes identified on electrodiagnostic studies (ie: peripheral neuropathy, cervical radiculopathy, carpal tunnel syndrome)
* Workman's compensation patients
* Subluxing ulnar nerve
* Elbow contracture or stiffness
* Negative electrodiagnostic studies
Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer

The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.


Eligibility Criteria:
Inclusion Criteria:

* locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases
* no contraindications for PET/MRI
* no contraindications for radiochemotherapy
* informed consent
* ECOG PS 0/2

Exclusion Criteria:

* Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC
* previous PET/CT
* induction therapy
* pregnancy or breastfeeding
Short Course Regimens for Treatment of PKDL (Sudan)

This is an open label, randomized non comparative phase II clinical trial conducted on parallel groups, to assess the safety and efficacy of the combination of Paromomycin (20 mg/kg/d) IM for 14 days and Miltefosine (allometric dosing) oral for 42 days, and a combination of AmBisome® (20 mg/kg total dose) IV over 7 days and Miltefosine oral for 28 days (allometric dosing) for the treatment of PKDL patients in Sudan.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed PKDL case by clinical presentation and demonstration of parasites by microscopy in a skin smear or by PCR, with documented stable or progressive disease for at least 6 months or grade 3 PKDL
* Male or Female patients aged 6 to 60 years
* Written voluntarily informed consent is obtained from the patient, or his guardian if the patient is \< 18 years old. In the case of minors aged \>12 to \<18, assent from the children is also needed in addition to the guardian's consent.

Exclusion Criteria:

* Patients who had prior treatment of PKDL within the last 1 year
* Pregnant and lactating women and women of childbearing age (12 to 55 years) who do not accept to have a pregnancy test and who do not agree to use contraception during treatment period and for 5 months after the end of treatment.
* Patients with signs and symptoms of severe diseases: defined as suffering from a concomitant severe infection such as TB or any other serious known underlying disease (cardiac, renal, hepatic),
* Severe malnutrition defined by BMI for age WHO reference curves for gender, Z score \< -3 for subjects 6 to \< 19 years; BMI \< 16 for subjects \> 19 years old
* Patients with haemoglobin \< 5g/dL
* Patients with known skin disease
* Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
* Patients with total bilirubin levels \>1.5 times the upper normal range
* Patients with serum creatinine above the upper limit of normal range
* Patients with serum potassium \< 3.5 mmol/L
* Patients with pre-existing clinical hearing loss based on audiometry at baseline
* Patients with a positive HIV test as applicable
* Patients / guardian not willing to participate
* Patients with history of allergy or hypersensitivity to the relevant study drug
* Patients on immunomodulators therapy
Gastric Ultrasound for Preoperative Assessment of Gastric Content in Diabetic Patients

ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. This prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.

ASA fasting guidelines are only applicable to healthy elective surgery patients. Measuring gastric volume now is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance.

Using gastric ultrasound measure gastric antrum cross-sectional area to determine whether patients are empty stomach, help anesthesiologists in preoperative evaluation of diabetic patients with the risk of aspiration, so as to guide the anesthesiologist take effective interventions, this prospective observational study aim to explore the gastric emptying of type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Ages \>18 years old
2. Diabetes (I or II)
3. Following American Society of Anesthesiologists (ASA) fasting guidelines before surgery
4. Undergoing general anesthesia

Exclusion Criteria:

1. Pregnant
2. Gastric Intestinal Tract (GIT) diseases or surgeries affect gastric emptying
3. Diagnosed with liver dysfunction or renal insufficiency
4. Patients who are unable to cooperate or understand the process
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.

Observational Objectives:

To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
* Participant is aged ≥ 1 year to ≤ 12 years
* Body temperature ≤ 37.0℃
* Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster

Exclusion Criteria:

* Known allergy to any constituent of the vaccine
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Known bleeding disorder
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Participation in any other interventional clinical trial
* An acute illness with or without fever (temperature \> 37.0℃) in the latest week preceding enrollment in the trial
* Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
* Reported clearly the infection of the upper respiratory tract with 6 months
* Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma

Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. Surgery for esophageal cancer; 3. Complete medical records;

Exclusion Criteria:

* Patients with a previous history of malignant tumor
Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors \[Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)\], Caffeine and Digoxin


Eligibility Criteria:
Inclusion Criteria:

* Be informed of the nature of the study and have provided written informed voluntary consent.
* Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
* Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
* Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.

Exclusion Criteria:

* Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
* History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed.
* Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
* History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
* History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
* Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine tablets.
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
* If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea

The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.

This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.

Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Eligibility Criteria:
Inclusion Criteria:

* Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy

Exclusion Criteria:

1. Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).
2. Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).
3. Participants with a history of hypersensitivity to any ingredient of Nesina.