cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.


Eligibility Criteria:
Inclusion Criteria:

* male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
* Previous vaccinations against diseases which are targeted by the vaccines used in the study.
Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes

The aim of the study is to investigate the efficacy and safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin for 12 weeks in individuals with type 2 diabetes mellitus

To compare the clinical efficacy, insulin resistance and blood glucose fluctuation of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin in patients with type 2 diabetes mellitus using FGMS.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate and be able to sign informed consent prior to the trial.
* Patients with type 2 diabetes, aged 18-75 years old and BMI ≥18.0kg/m2.
* Treatment with one or two hypoglycemic drugs (in combination, the sulfonylureas dose should be less than half of the maximum dose).
* HbA1c : 7.0-9.0%.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* Recurrent urinary tract infections.
* Drug abuse and alcohol dependence in the past 5 years.
* Patients with poor compliance and irregular diet and exercise.
* Systemic hormone therapy was used in the last three months.
* Patients with infection and stress within four weeks.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Maintaining Cochlear Patency After VIIIth Nerve Surgery

Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in \~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.


Eligibility Criteria:
Inclusion Criteria:

* patients of all ages with unilateral or bilateral acoustic neuromas who face loss of hearing in 1 ear from surgical removal via a translabyrinthine approach.
* patients do not meet criteria for conventional cochlear implantation or auditory brainstem implantation.
* tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve.
* the patient must be willing to undergo preoperative S pneumococcus immunization protocol recommended by the US CDC immunization recommendations for cochlear implant patients.

Exclusion Criteria:

* inability to preserve the auditory division of the VIIIth cranial nerve during tumor removal ossification or fibrosis of the cochlea found on preoperative imaging (CT or MRI) that precludes cochlear implantation.
* active middle ear disease.
Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.

To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications.

The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 years or older on the day of enrollment
* The informed consent form has been signed and dated
* Receipt of 1 dose of Efluelda Tetra on the day of enrollment according to the approved local product label

Exclusion Criteria:

* Previous history of enrollment in this study
* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
PMC Split Preparation for Colon Cleansing

This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy

Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy.

Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if \>2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.

Eligibility Criteria:
Inclusion Criteria:

* adult outpatients
* aged 18-85 yr
* undergoing elective colonoscopy

Exclusion Criteria:

* previous colon resection,
* ileus,
* intestinal obstruction,
* toxic megacolon,
* severe heart failure (NYHA Class III or IV),
* acute cardiovascular disease,
* uncontrolled arterial hypertension (systolic pressure \>170 mmHg, diastolic pressure \>100 mmHg),
* severe liver cirrhosis (Child-Pugh score C),
* renal failure (creatinine clearance\<30 mL/minute),
* ascites,
* phenylketonuria,
* glucose-6-phosphate dehydrogenase deficiency,
* pregnant or breastfeeding women
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release

The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:

• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?

Participants will undergo:

* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection
* Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy

This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful Collagenase Clostridium Histolyticum (CCH) injection and release will receive a standardized regimen of adjuvant radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a \> 20 degree worsening of contracture in the presence of a palpable cord as compared to within 14 days from CCH injection, or the need for medical/surgical intervention to correct the new or worsening contracture.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 or greater with DC
* Extension deficit \>10 degrees
* Unable to simultaneously place the affected finger and palm flat on a table.
* Women included in the study will be post-menopausal or using contraception, and a pregnancy test will be performed as standard of care.
* For patients who are having multiple CCH injections, only the first 2 joints on given hand will be included

Exclusion Criteria:

* Unsuccessful non-surgical release (\> N/1 disease)
* They develop an open wound during CCH
* Breast feeding or pregnancy
* A chronic muscular, neurologic, or neuromuscular disorder affecting the hands.
* Less than the age of 45
* They have previously undergone radiation on the hand in which they plan to get CCH injections
* They are pregnant women, impaired adults or prisoners
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study.

This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).

This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study.

This Protocol Posting has been updated following Protocol amendment 3, September 2009.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:

  * Year 1: 22 to 36 months of age.
  * Year 3: 44 to 60 months of age.
  * Year 5: 5 years post-dose 4 +/- 8 weeks
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study
* Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

Exclusion Criteria:

Children should not have:

* received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
* had a history of H. influenzae type b, meningococcal serogroup C and Y diseases
Effect of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid-19 Syndrome.

The aim of this work is to study the incidence of diaphragmatic dysfunction after COVID 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function.


Eligibility Criteria:
Inclusion Criteria:

* Male and female above 18 years old
* history of probable or confirmed SARS-CoV-2 infection 3 months from the onset of symptoms or at least 2 months from the end of symptoms .

Exclusion Criteria:

* Subjects under 18.
* Patients known to have chronic lung disease .
* Patients known to have neuromuscular disorder.
* Patients known to have diaphragmatic hernia.
* Patients known to have malignancy.
* Patients with clinical evidence of phrenic nerve injury.
* Patients with recent abdominal or thoracic surgery,
* Patients with history of traumatic lesion possibly affecting diaphragm.
* Subjects with severe malnutrition.
* Patients with BMI more than 30
Adherence to Antimalarial Drugs in Sierra Leone

The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. This will be addressed through a mixed methods study that will provide not only a measurement of adherence ACTs and malaria test results, but will also provide contextual information in order to better understand factors that affect adherence. Data will be collected through a series of interviews with health workers and parents/caregivers and through observations of patient-provider consultations.

The first stage of the study begins with semi-structured interviews and observations of patients/caretakers' consultations with health workers and will look at how health workers diagnose and treat malaria. This will be followed by short exit interviews at the health facility with caregivers to assess patient satisfaction with services, as well as to test the consistency between the data obtained through structured observations and the exit interviews.

Follow-up surveys at the homes of patients will be used to measure and compare the adherence of participants to two different ACTs (AQAS and AL) formulations and potential factors that affect adherence. Additionally, data will be collected using in-depth interviews to collect supplementary information in order to discover, in more detail, factors that may affect behavioral choices and/or attitudes with regard to adherence.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a child between 6 to 59 months
* Visiting health facility for treatment of fever
* Do not have signs of severe disease
* Are not being referred to another health facility
* Living within a defined distance from the health facility (\<8 km/ 5 miles)
* Have not taken part in the study already or are not part of a household that has already taken part in the study
* Responsible caretakers/parents provide additional informed consent

Exclusion Criteria:

-
Web-based Cognitive-behavior Therapy (CBT) for Opioid-treated, Chronic Pain Patients With Aberrant Behavior

The purpose of this study is to develop and evaluate an innovative, web-based self-management intervention for opioid-treated chronic pain patients who display aberrant drug-related behavior.

Within the past decade, there has been increasing recognition of the limitations and risks of opioid therapy for chronic pain, spurred by the U.S.' widespread epidemic of opioid misuse. Within the clinical context, concerns about long-term opioid therapy persist due to limited evidence of efficacy and the occurrence of medication misuse/abuse (termed aberrant drug-related behavior). Psychosocial approaches, particularly self-management strategies such as cognitive-behavior therapy (CBT), have been found to be efficacious for the treatment of chronic pain. However, most chronic pain patients are not exposed to comprehensive psychosocial interventions, due to factors including pain specialty physicians' lack of familiarity with and time to provide behavioral treatments and insufficient payer coverage for these therapies. To address these public health concerns, this study developed, implemented and evaluated an innovative, web-based CBT intervention for the treatment of chronic pain tailored to the specific needs of patients who are prescribed opioids and present with aberrant behavior. The development of this interactive, web-based intervention was informed by iterative feedback from pain experts and chronic pain patients. In a randomized, controlled trial, chronic pain patients receiving opioid therapy at a pain specialty practice were assigned to receive 12 weeks of either treatment-as-usual (TAU; n=55) or treatment-as-usual plus the web-based intervention (Web-CBT; n=55). The trial evaluated the relative effectiveness of these treatments on the primary outcomes of pain severity, pain interference and aberrant opioid-taking behavior, and the secondary outcomes of pain catastrophizing and pain-related Emergency Department visits. Additional analyses explored the impact of the intervention on several supplementary outcomes, such as various categories of activities, psychiatric distress and positive affect, and examined hypothesized mediators of treatment outcome, including quality of life, social support and expectations about the future.

Eligibility Criteria:
Inclusion Criteria:

* moderate-to-severe pain for at least 3 months (score of 5 or greater on Brief Pain Inventory)
* patient at pain treatment program study site
* prescribed opioid analgesics
* aberrant drug-related behavior within the past 30 days (endorsing 4 or more items on the Current Opioid Misuse Measure)

Exclusion Criteria:

* primary headache or cancer pain
* scheduled for major surgery within the next 6 months
* described by physician as likely to die within the next year
* plans to move out of the area within the next 3 months
* insufficient ability to provide informed consent or insufficient English to participate in consent process, assessments or computer intervention
Epidemiological Study in FRONtoTemporal Dementia

An international, multicenter, epidemiological observational study aims to investigate the prevalence of genetic etiologies in patients diagnosed with FTD or clinically suspected for FTD.

Frontotemporal dementia (FTD) is a genetically and pathologically heterogeneous neurodegenerative disease caused by the loss or damage of nerve cells in the brain's frontal and temporal lobes. This leads to abnormalities in behaviour, personality, and language comprehension problems. Also, people with FTD show movement disorders like tremor, rigidity, difficulty in coordination, muscle spasms and weakness. FTD's etiology is sporadic or heritable. Sixty to 70% of FTD cases are sporadic, while 30 to 40% are inherited (familial aggregation). For this study, blood samples were collected from clinically diagnosed or suspected FTD patients and were analysed for a broad range of pathogenic variants in genes associated with FTD. The scientific insights acquired from this study will help identify novel therapeutic targets and develop/ investigate potential disease-modifying drugs.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent, which includes reference to the genetic testing, is obtained from the participant/legal guardian
* The participant is aged between 25 to 85 years
* The participant is diagnosed with Frontotemporal dementia (FTD) or has signs or symptoms of FTD
SP-420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias

The purpose of this study is to test the safety and tolerability of SP-420 and it's efficacy in terms of lowering iron in subjects with Beta-thalassemia or other rare anemias who need regular blood transfusions.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Iron-overload secondary to β-thalassemia (homozygote or compound heterozygote) or other rare anemias (e.g., aplastic anemia, pure red-cell dysplasia ) requiring chronic RBC transfusions and iron chelation therapy
* On a stable dose of iron chelation for at least 4 weeks prior to screening visit
* Weight ≥35 kg at screening
* Willing to discontinue current iron chelation therapy 7 days (± 3 days) prior to the first dose of SP-420 and for the duration of the current study
* LIC ≥5 and ≤25 mg/g dry weight on the R2-MRI obtained within 2 weeks prior to the baseline visit
* Cardiac T2\* score \> 12 msec obtained on the MRI obtained within 2 weeks prior to the baseline visit

Exclusion Criteria:

* Pregnant or breast-feeding
* Current malignancy with the exceptions of localized basal cell or squamous cell skin cancer or localized prostate cancer or is receiving immunotherapy, chemotherapy or radiation therapy for a malignancy
* Current myelodysplastic syndrome
* Alanine aminotransferase (ALT) \>4 times the upper limit of normal, decompensated cirrhosis, or ascites at screening
* Past history of clinically significant kidney disease (per the Principal Investigator)
* Serum creatinine greater than the upper limit of normal during screening
* Urine protein to creatinine ratio \> 0.5 mg/mg during screening
* Ongoing symptoms of cardiac dysfunction or failure
* Ongoing symptoms of neuropathy, including peripheral sensory neuropathy, peripheral motor neuropathy, or paresthesia at screening
* Received another investigational drug within 30 days or investigational antibody within 90 days of Day 1 of the study
* Other condition that, in the opinion of the PI, would interfere with the conduct of the study
Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections

To investigate prevalence of dry eye disease in Norwegian patients with age-related macular degeneration receiving intravitreal injections, as well as to reveal possible risk factors of DED in this population.

Questionaires (OSDI, McMonnies) and clinical investigation using the Oculus 5 Keratograph for objective ocular surface evaluation. Tear fluid samples will be collected for later biochemical analysis.

Eligibility Criteria:
Inclusion Criteria:

* AMD diagnosis
* Treated with intravitreal injection agents

Exclusion Criteria:

* Not able to cooperate