cyrilzakka/clinical-trials huggingface dataset:
Fiber Mix and Glycemic Response

This study determines the acute effect of a dietary fiber mix on blood glucose levels. Participants will consume the fiber mix as a drink and we will monitor changes in blood glucose levels. All participants will consume white bread as the control food.

There is some evidence for increased dietary fiber intake to positively impact on metabolic outcomes in patients with type 2 diabetes, potentially via modulating gut microbial composition and functions. We have developed a dietary fiber mix that is consisted of fiber of various physicochemical properties to maximize the fermentability of the supplement and thus its effects on the gut microbiota. Since the fiber mix also contains nutrients that will raise blood glucose levels, we need to characterize the glycemic response to the fiber mix itself, before we can use it in an upcoming trial to determine the effect of dietary fiber supplementation on the gut microbiota and glycemic control.

Enrolled participants will be assigned to a subject group based on their diagnosis of type 2 diabetes and fasting blood glucose concentrations. Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes will be assigned to the Prediabetes/Diabetes group. For the other participants, those with fasting blood glucose \< 100 mg/dL will be assigned to the Non-Diabetes group, and those with fasting blood glucose \> 100 mg/dL will be assigned to the Prediabetes/Diabetes group.

Participants will attend 8 food testing visits over 2 weeks. For each visit, participants will attend the research facility in the morning after an overnight fast. They will consume either white bread (with 50 g of available carbohydrates as a control food) or 60 g of the fiber mix (as a drink).

Postprandial glycemic response will be assessed by changes in blood glucose levels, to be monitored using a continuous glucose monitoring system (FreeStyle Pro). A sensor will be placed on the participant's arm and will stay on until the end of the study.

Participants will provide photos of all the food and drink and a brief description of what they have consumed throughout the 2-week study.

Eligibility Criteria:
Inclusion Criteria

* Aged between 18 and 65 years
* Understand and be able to follow written and oral instructions in English
* Provide written informed consent

Exclusion Criteria

* Receiving insulin for diabetes treatment
* Receiving injectable prescription medicine
* Self-reported allergy or intolerance to any ingredients in the test food
* Any conditions deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research that may interfere with study outcomes, at the discretion of the investigators
* Any conditions deemed by the investigators that would compromise the individual's ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators
Evaluation of Gingival Biotypes of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations

The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in the anterior region of adults with abnormal skeletal jaw relations.

This study will include consecutive adult patients seeking orthodontic treatment with skeletal Class II and Class III jaw relations based on clinical and cephalometric values. Each group will be further divided according to their vertical skeletal pattern. Gingival biotype will be determined -using the probe transparency method- into either thick or thin biotype for all anterior teeth in both jaws. Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm. Statistical analysis will be applied to see the correlation between gingival biotypes , width of keratinized gingiva , and abnormal skeletal jaw relations.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients having an age range of 18 -30 years.
2. Adults with skeletal Class II and Class III jaw relation
3. Fair oral hygiene with absence of any active periodontal disease.
4. Patients with full permanent dentition (with the exception of third molars) with acceptable alignment of teeth.
5. Absence of systemic disease (medically free patients).

Exclusion Criteria:

1. Patients with extensive restorations on the anterior teeth.
2. Subjects taking medication affecting the periodontal tissues
3. History of previous periodontal surgery or orthodontic treatment.
4. Pregnant or lactating female patients
5. Syndromic patients
Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma

Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.


Eligibility Criteria:
Inclusion Criteria:1. Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI.

2. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia.

3. Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer. Exclusion Criteria:No other patients except those listed above will be recruited. Additionally, patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.
Immunogenicity of COVID-19 Vaccine Co-administration with Influenza Vaccine in Healthy Volunteers

This study, a pilot randomized controlled trial, single-blind (outcome assessor), evaluating the immune response (both humoral and cell-mediated) against SARS-CoV-2 and the safety of three different vaccine administration approaches: the SARS-CoV-2 mRNA vaccine alone, the influenza vaccine alone, and the co-administration of both vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Thai adults aged 18-60 years, who have vaccinated COVID-19 and influenza vaccine more than 6 months.
* The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 1-month follow-up of the study.
* Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization.
* The subject can provide with informed consent and sign informed consent form (ICF).

Exclusion Criteria:

* Have history of influenza or COVID-19 infection within 6 months.
* Have the medical history or family history of convulsion, epilepsy, encephalopathy, and psychosis.
* Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
* History of Guillain-Barré syndrome.
* Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months of after baseline period.
* Have infectious diseases, including HIV and SARS-CoV-2 infection or any symptom of common cold.
* Have history of SARS-CoV-2 infection less than 6 months.
* Having severe chronic diseases or condition in progress cannot be controlled. For example, poor controlled DM and uncontrolled HT.
* Have the history of urticaria 1 year before receiving the investigational vaccine.
* Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
* Having needle sickness.
* Have the history of immunosuppressive therapy, cytotoxic therapy, or systemic corticosteroids.
* Have received blood products within 4 months before injection of investigational vaccines.
* Under anti-tuberculosis treatment.
* Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social, or other conditions.
Prevention Recurrent Otitis Media in the Young Children

The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.

Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.

In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 otitis media episodes during the last half year
* address near (\< 50 km) the university hospital of Oulu

Exclusion Criteria:

* otitis media effusion lasting longer than two months without acute exacerbations
* prior adenoidectomy or tympanostomy
* head or neck malformation
* retarded child
* serious disease
* chemoprophylaxis for another disease
Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery

Influence of the platysma suture on postoperative pain and wound healing.

Does a running platysma suture after primary thyroid resection alter direct postoperative pain, wound healing and long term cosmetic results.

Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain (detected by the visual pain score 0-10) and reduces the pain medication (detected by the cumulative NSAID and opioid treatment per patient). The second Question to be answered is if the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.

Eligibility Criteria:
Inclusion Criteria:

* primary thyroid surgery

Exclusion Criteria:

* previous neck surgery
* application of wound drainages
* preoperative diagnosed malignancy
* surgical extension beyond thyroid resection (e.g. lymphadenectomy)
* preexisting coagulopathy
* preexisting chronic pain syndromes
* preexisting dependency on pain reliefs
* preexisting disorders in wound healing (e.g. diabetes mellitus)
* intolerance to any study medication
The Effect of Sensory Motor Training on Postural Stability in Post-menopausal Women With Non-specific Low Back Pain

The study will be conducted to determine the effect of sensory-motor training on postural stability in post-menopausal women with non-specific low back pain.

Low back pain (LBP) primarily affects postmenopausal women between the ages of 45-60, and it causes distress on social and economic levels Postmenopausal women with non-specific low back pain (NSLBP) and decreased function often feel anxious and sad, which affects their work, sexual and social lives Neuromuscular rehabilitation techniques addressing sensory deficiencies have emerged in recent years and have received increasing therapeutic attention. These techniques could broadly be summarized as sensorimotor training (SMT) methods aiming at increased proprioceptive input to improve motor response in dynamic environments. This might lead to improved quality of postural control, which in turn may alleviate postural specific musculoskeletal pain.

As it promotes proximal stability and distal mobility, Core muscles Stabilization Exercises (CSE) are becoming a more significant part of the treatments. The use of CSE is promoted as a general physical therapy approach for NSLBP. Overtime, CES have improved, focusing more and more on maintaining spinal stability. Theoretical ideas for the treatment of spinal ailments that aid in reducing pain and enhancing function in patients with LBP significantly support the use of CSE. CSE trains muscle activity patterns without unnecessarily overloading the tissue, enhances aerobic fitness, spinal mobility, muscle strength, motor co-ordination and can help to stabilize the spine at a quite cost affordable price and reduce low back pain.

Eligibility Criteria:
Inclusion Criteria:

* All women suffering from non-specific low back pain for at least 3 months.
* Their ages will be ranged from 50-65 years.
* They will be at least 3 years post menopause.
* Their body mass index (BMI) will be less than 30 kg/m2.

Exclusion Criteria:

* Musculoskeletal injuries.
* Cardiovascular, respiratory or neurological disorders or psychiatric problem.
* Spinal deformity, bone fracture.
* Back surgery experience.
* Hormone replacement therapy and females with cancer.
* Sensory neuropathy and nervous system problems.
* Middle ear or vestibular problems.
Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder

The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with COPD, 40 - 75 years of age
* All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of \>/= 30% and \<= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</= 70%
* Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years
* Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
* Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening

Exclusion Criteria:

* Subjects with a significant respiratory disease other than COPD.
* Exacerbation within 8 weeks prior to screening
* Subjects with more than 1 COPD exacerbation within 12 months prior to screening
* Subjects must have an FEV1 of at least one Liter
* Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count \>/= 0.6 x 10\^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
* Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder
* Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
* Subjects with a history of cystic fibrosis
* Subjects with clinically evident bronchiectasis
* Subjects taking any:

  * Oral beta-adrenergic drugs or non cardioselective beta blockers,
  * Oral glucocorticoids,
  * Antihistamines or antileukotrienes prescribed for asthma,
  * Oral cromolyn sodium or oral nedocromil sodium,
  * Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
Cognitive and Hormonal Treatment of Sex Offenders

The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

The aim of this study is to determine if Cognitive treatment and hormone treatment can change the relapse rate of sexual offenders.

In the first part of study we are studying changes in the offenders cognitive distortions and in the second part we are studying changes in sexual activities and sexual thoughts after treatment with Leuprorelin. The study is an open pre and post study.

Eligibility Criteria:
Inclusion Criteria:

Men sentenced for paraphilia

Exclusion Criteria:

Men above 70 years and men that does not speak english
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)

The purpose of the Post-Market Surveillance study is to evaluate safety.

Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is skeletally mature (21-85 years old).
* Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
* Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
* Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.

Exclusion Criteria:

* The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
* Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
* Acute or chronic systemic, spinal or localized infections.
* Active, severe systemic and metabolic diseases.
* Obesity defined as Body Mass Index \> 35.
* Subject is pregnant or interested in becoming pregnant in the next 36 months.
* Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
* Lack of patient cooperation.
* Foreign body sensitivity to the implant material.
* Degenerative scoliosis greater than 25 degrees.
* Grade 4 degenerative spondylolisthesis (\>75% slip).
* Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required\*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
* Soft tissue deficit not allowing wound closure.
* Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
* Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
* Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
* Pars defect.
* Clinically compromised vertebral bodies at affected level due to current or past trauma.
* Prisoner or ward of the state.
* Currently in litigation regarding a spinal condition.
* Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
* Is currently involved in a study of another investigational product for similar purpose.
Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers.

Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer

Patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period.

The intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). Quality of life (FACT-G) and spiritual well-being (FACIT-SP12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview).

This pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse
* More than 17 years old
* French language
* Having signed informed consent

Exclusion Criteria:

* Patients requiring palliative care
* Important psychic vulnerability or severe psychiatric disorders
Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma

This study focuses on advanced lung and head and neck SCC tumours, with adjacent normal lung tissues. Biopsies will be performed in National University Health System, Singapore (NUHS) as part of participants' standard care. Patient blood was also required for extraction of cell free DNA (cfDNA) and genomic DNA (gDNA). Patients' medical records will also be reviewed for the purpose of this study.

Primary objective:

To investigate the prevalence of MET and TP53 mutations, as well as HER2 and MET amplification, in lung and head and neck tumours, through prospective collection of tumour specimens in newly recruited patients.

Secondary objectives:

1. To distinguish the presence of somatic/germline MET and TP53 mutation in lung and head and neck tumours.
2. To detect for amplifications of MET and/or HER2 genes in SCC samples.
3. To investigate the association and interaction of cMet and HER2 in SCC tumours.
4. To establish a prospective documation of clinical, histopathological, treatment and follow-up (clinic pathological) data of newly recruited patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Histologic or cytologic confirmation of metastatic squamous cell carcinoma of the lung or head and neck region
3. No other active malignancy within the past 24 months
4. Refractory disease

Exclusion Criteria:

1. Patient with other active malignancy within the past 24 months
2. Unable or unwilling to provide signed informed consent