cyrilzakka/clinical-trials huggingface dataset:
Photodynamic Treatment as Part of Oral Healthcare on Persons With Sjögren's Syndrome

This thesis study will investigate whether the regular use of antibacterial photodynamic therapy can alleviate dry mouth symptoms in patients with Sjogren's syndrome and thus be a potential addition to regular oral self-care habits that promote and maintain oral health.

Sjogren's syndrome is a chronic autoimmune disease that has a holistic impact on a patient's health. The most significant consequence in terms of oral health is the destruction of the salivary glands by the autoimmune reaction, leading to salivary gland failure and consequently dry mouth with reduced saliva secretion. Decreased saliva secretion predisposes to a number of oral health problems, and patients with Sjogren's syndrome are therefore at risk for conditions such as caries and periodontitis, an inflammatory periodontal disease. Regular visits to an oral health professional and good oral hygiene and eating habits and habits promote and maintain oral health. Treatments for dry mouth symptoms associated with Sjogren's syndrome aim to relieve oral symptoms by preserving, replacing and stimulating salivary gland secretion in ways that relieve local inflammation.

Regular home-use of specially designed antibacterial photodynamic therapy device in addition to standard oral self-care has been shown to destroy oral disease-causing bacteria in a way that bacteria cannot develop resistance to. In addition, the treatment method also stimulates saliva production through photobiomodulation. The aim of our study is therefore to investigate, by means of a clinical measurement, whether the regular use of the antibacterial photodynamic therapy device as part of oral self-care can have an effect on the amount of stimulated saliva secretion of a patient with Sjogren's syndrome during the ten-week study period. The aim is also to describe, by means of a questionnaire measuring the subjective symptoms of dry mouth, whether the treatment has an effect on the frequency of the typical symptoms of xerostomia.

Eligibility Criteria:
Inclusion Criteria:

* Adult (minimum 18 years of age) person with Sjogren's syndrome, with dry mouth symptoms but some saliva secretion.
* Otherwise perceived health good, primary Sjögren's syndrome patient.
* No need for antibiotic prophylaxis at the time of a limited oral examination.
* Signed written informed consent.
* Subject's co-operation allows participation in the study.

Exclusion Criteria:

* Pregnancy and/or breastfeeding.
* Fungal infection in the mouth
* Poor oral health, such as caries lesions or advanced periodontitis.
* Fixed dentures, or orthodontics.
* No saliva secretion.
* Bisphosphonate drugs, multiple (more than two) medications in use.
* Participation in other oral health research at the same time.
Optimal Balloon Catheter Placement During Sonohysterography

Saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. According to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. The purpose of this double blind control trial study is to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.

The proposal of study approved by the investigators institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. A total of 300 infertile women undergoing sonohysterography will be randomized to intrauterine or intracervical balloon catheter placement. The examination is scheduled in the early follicular phase of menstrual cycle, immediately after cessation of menstrual flow and before day 10. After preparation of patient, a 2 lumen 6-French flexible catheter is introduced into the cervical canal and balloon at the catheter tip is placed in the lower uterine segment or 1 cm into cervical canal and inflated with 1 mL of sterile saline solution. Under sonographic guidance, sterile normal saline solution (10-50 mL) is slowly introduced into the cavity until an adequate distention of the uterine cavity is obtained. Three-dimensional ultrasound scanned volumes are recorded. Patients are asked to assess their level of pain at the time of the balloon inflation and deflation using a 10-point visual analog pain scale. Patients are checked for the sign and symptoms of vasovagal reaction during and 30 minutes after procedure. Outcome measures will be assessed based on the intent-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients who will be referred to Royan institute for sonohysterography to evaluate the internal structure of uterine cavity (acquired \& congenital abnormalities) are included in this prospective comparative study.

Exclusion Criteria:

* Exclusion Criteria:

  * Symptoms of active pelvic infection
  * Abnormal uterine bleeding
  * Women with cervical stenosis
  * Women with each lesions which disrupts catheterization such as large myoma
GPC3-CAR-T Cells for the Hepatocellular Carcinoma

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.

GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106, 3×106, 10×106 GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma. The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB, PFS, OS and DOR.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≧18years, gender unlimited.
2. Failure or intolerance after at least first-line treatment.
3. GPC3 positive(IHC)
4. Patients must have at least one target lesion available for evaluation.
5. BCLC B or C.
6. Child-Pugh grade A or B
7. ECOG is 0 or 1 (one week before enrollment.)
8. Estimated life expectancy ≥ 3 months.
9. Functioning of major organs are normal.
10. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
11. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

Exclusion Criteria:

1. There are uncontrollable active infections that need systemic treatment.
2. HIV antibody is positive or syphilis antibody is positive.
3. Pregnant or lactating women.
4. hepatic encephalopathy.
5. patients with organ failure:

   * Heart: NYHA heart function grade IV;
   * Liver: Grade C that achieves Child-Turcotte liver function grading;
   * Kidney: kidney failure and uremia;
   * Lung: symptoms of respiratory failure;
   * Brain: a person with a disability.
6. It is undergoing systemic hormones therapy.
7. Impact results show that over 50% of the liver is occupied by tumor .
8. Patients who are still in the observation stage of other antitumor drugs 30 days before blood collection.
9. Patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion.
10. Abnormal thyroid function ≧Level 3.
11. Active autoimmune diseases require systemic treatment during the first two years of screening.
12. Patients have mental illness or history of drug abuse.
13. Patients are participating in other clinical studies.
14. The researchers found that it was unsuitable for the recipients to be enrolled.
Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age

Folic acid is a palatable and easily available drug with no serious adverse effects. L-methylfolate is its biologically activated form and is preferred because of its direct availability for certain metabolic processes. As there is no specific and safe drug available that may help in decreasing the duration of diarrhea, purging rate or consistency of stools; and having known the theoretical benefits of folic acid in this regard, it would be appropriate to assess the effectiveness of L-methylfolate among children with diarrhea.

After approval from the Institutional Review Board of King Edward Medical University, Mayo Hospital, Lahore, all children diagnosed with acute watery diarrhea as per operational definition fulfilling the inclusion criteria, presenting to the Department of Pediatrics, Mayo Hospital, will be enrolled in this study.

Informed written consent will be taken from the parents/guardians of all participants. A detailed history and examination of each subject would be done by an investigator at presentation.

Patients will be randomized in two groups - A and B by lottery method. There will be 162 patients in each group. The treatment regimen that includes breast feeding, nutritional advice, rehydration plan; ORT by low osmolar ORS or intravenous rehydration (if required) and zinc sulphate will be given according to the WHO guidelines to all patients of both groups. Children under 1 year of age in group A will receive 3 drops (90mcg) of L-methylfolate calcium) while those older than 1 year of age will be given 5 drops (150mcg). Subjects in Group B will receive equal amount of distilled water as placebo (i.e. 3 drops to \<1yr age and 5 drops to \>1 yr. Frequency and grades of loose stools in both groups will be assessed daily and written down on a predesigned proforma.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2months- 5 years
* Both genders
* Acute watery diarrhea as per operational definition
* Diarrhea of less than 7-day duration

Exclusion Criteria:

* Severely malnourished children \<3 SD
* Bloody diarrhea
* Prolonged (7-14 days duration), persistent (\>14 days duration) or chronic diarrhea (\>4weeks duration)
* Those who received folic acid within the last 14 days
* Hospital-acquired diarrhea (diarrhea occurring after 48hrs of stay in hospital)
* Antibiotic-associated diarrhea.
* Presence of other co morbid conditions like pneumonia, sepsis, meningitis, etc.
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children

A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a helpful dietary recommendation to reduce total cholesterol levels in children with identified, modifiable CVD risk factors, elevated total cholesterol and obesity. Consumption of dry bean powder and rice bran merit additional investigation to study feasibility and acceptability in children and how they influence their lipid levels or obesity.

Children will be screened prior to participation with the expectation of enrolling 40 to randomize equally to either the control arm or one of the three intervention arms. This should assure that at least 10 participants would complete each intervention. The four groups are placebo (no bean powder or rice bran included), 1/4 cup cooked navy bean powder (17.5grams powder)/day, 15 grams rice bran/day, and combination of 9 grams of bean powder/day and 8 grams rice bran/day. Participants will follow this dietary intervention by being provided a study snack, such as a banana nut muffin and strawberry-pineapple smoothie. Participants will consume one snack on a daily basis for a total of four weeks (28 days). The snack options were developed by a professional chef and research dietitian to fit a set of requirements for calorie and macronutrient content based on USDA food guide recommendations. The placebo group will be provided the same snacks without the inclusion of rice bran or bean powder.

Randomization of subjects to the dietary intervention groups will be done during the study enrollment period. Randomization will be based on sex of the subject to include equal numbers of both genders across all 4 groups.

All participants will consume the allocated foods daily for a total of four weeks (28 days) and will not be required to alter the rest of their diets in any other way. They will also complete a 3-day food and activity log each week, starting the week prior to the study intervention (Week 0) and ending the week of their final visit (Week 4).

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 8-13 years old who were screened by the Healthy Hearts Club
* Non-fasting total cholesterol greater than or equal to 180 mg/dl
* Non-fasting LDL greater than or equal to 100mg/dl
* Non-fasting HDL less than 60mg/dl
* Willing to consume study provided ingredient (cooked dry bean powder or rice bran or combination) for 28 consecutive days.

Exclusion Criteria:

* History of food allergies and/or major dietary restrictions
* Taking prescribed medication
* Ongoing medical illness
Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure

Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start.

Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation.

Study design: A nationwide non-inferiority multi-center randomized parallel active control study.

Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.

Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline.

Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total.

Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months.

Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.


Eligibility Criteria:
Inclusion Criteria:

* Indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements:
* arterial carbon dioxide \> 6.0 kPa daytime or arterial or transcutaneous carbon dioxide \> 6.0 kPa at night or orthopnea as a result of diaphragm paralysis
* Age \> 18 years
* Existence, of a sufficient network (social or professional) according to the supervising HMV center making initiation of HMV at home possible and safe.

Exclusion Criteria:

* Patients who already have had HMV due to acute respiratory failure
* Necessity for invasive ventilatory support
* Patients admitted to a nursing home
Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis

Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.

Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation) but they suffer from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time.

A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.

Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation). The PASI (Psoriasis Assessment Severity Index, minimum score 0, maximum 72) is the most widely used. It suffers from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time. This PASI score was "unavoidable" in the international clinical studies used to obtain marketing authorisation for medicines. The PGA (Physician global assessment) is simpler and less time-consuming, ranging from 0 to 4, but is not very discriminating. More recently, a "Simplified Psoriasis Index" (proSPI) health professional score has been developed, which correlates well with PASI for the severity component of psoriasis and with quality of life for the psychological component of the disease. It is less time-consuming to establish than PASI, but suffers like all clinical scores from a problem of inter- and intra-observer reproducibility.

A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient with skin psoriasis (new and untreated or being treated, flare-up or stable, possibly bleached)
* Requiring a blood sample for disease or treatment monitoring

Exclusion Criteria:

* History of invasive mucosal squamous cell carcinoma, or squamous cell carcinoma of the skin with lymph node or visceral recurrence.
* Patient under guardianship or curatorship
* Opposition to participation in the study
Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission (QUALM)

Few studies have been conducted on the quality of life of patients with stage IV melanoma. Particularly, there is no data regarding the quality of life of patients with a multimetastatic melanoma currently in remission.

Then, the main objective of this study is to evaluate the quality of life from a point of view medico-psycho-social in patients with multimetastatic melanoma in remission for more than 6 months.

The cutaneous melanoma, (9th rank of all cancers), was until recently neglected and poorly known by the general public. The metastatic stages have dramatic rates of survival: 25% at 1 year and 2% at 5 years with a median of about 6.2 months. However, in the last ten years, the treatment of metastatic forms has undergone a real revolution.

Its high metastatic potential for a very low initial tumor mass, gives evidence of a great aggressiveness. The cutaneous melanoma is resistant to the main therapeutics (chemotherapy and radiotherapy). Thanks to the emergence of immunotherapies and targeted therapies anti-RAF (Rapidly Accelerated Fibrosarcoma) and anti-MEK (Mitogen-activated Extracellular) the prognosis of patients with metastatic melanoma has considerably improved, increasing the number of "long-term survivors".

However, these treatments can cause many adverse effects that can impact patients' quality of life, despite a better tolerance compared to conventional chemotherapies. To our knowledge there are no data regarding the quality of life of patients with metastatic melanoma currently in remission.For this purpose, it is necessary to obtain solid data using validated questionnaires. Thus, we have chosen to evaluate quality of life using specific questionnaires to better understand patients' expectations, their difficulties, and then to improve the relationship between the patient and the physician.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Presenting a stage IV melanoma of the American Joint Committee on Cancer (AJCC) classification (multimetastatic) in remission for more than 6 months:
* Complete remission (defined as the complete disappearance of target lesions according to the RECIST criteria, based on a thoraco-abdomino-pelvic CT scan and a brain Magnetic resonance imaging (MRI) or
* Complete metabolic remission (defined as the complete disappearance of target lesions in PET CT (positron emission tomography computed tomograph, that is to say, disappearance of the hypermetabolic character of the anatomic structures. There may remain target lesions in conventional CT but they are not hypermetabolic in PET CT)
* Patients able to answer the questionnaires
* Patients with enough understanding of the French language

Exclusion Criteria:

* Adjuvant treatment
* Patient under tutorship or curatorship
* Refusal to participate in the study
The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer

The opioid growth factor-receptor antagonist-naltrexone hydrochloride (NTX)- has gained much reach interest for applications in ophthalmology, because of its novel mechanism of action for speeding up corneal wound healing in both diabetics and non-diabetics, effective both locally and systemically and its availability as a low molecular weight synthetic drug.

Corneal epithelial defects generally heal within 2 days without complications, in some patients with decreased corneal sensitivity, such as patients with severe dry eye, corneal neuropathy, or autoimmune diseases, the corneal epithelium shows a reduced tendency for spontaneous healing Resistant corneal ulcers may appear as epithelial defects associated to Bowman's layer disruption with associated damage and partial variable loss of superficial corneal stroma larger than 2 mm in diameter that persist more than 2 weeks even treated with conventional treatment . Noninfectious corneal ulcers have a similar clinical presentation like that of infectious ulcers but with no known infectious cause . Resistant corneal ulcer can lead to serious complications such as infection, inflammation, corneal scarring, opacification, corneal thinning, and perforation . In our study NTX accelerated healing of resistant corneal ulcers that was refractory to conventional treatment with lubricant eye drops and was safe with no complications reported in all treated eyes.

Eligibility Criteria:
Inclusion Criteria:

* refractory non infective corneal ulcer

Exclusion Criteria:

* infection