cyrilzakka/clinical-trials huggingface dataset:
Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

Evaluation of the clinical effect of hyperbaric oxygen therapy (HBOT) adjunctively to scaling and root planing (SRP) in the treatment of severe case of chronic periodontitis.

Materials and Methods: In 20 patients diagnosed with severe generalized chronic periodontitis (pockets\>7mm) with bleeding on probing, SRP was rendered in all pockets. Additionally, five consecutive hyperbaric sessions were administered in 10 patients after random allocation (SRP+HBOT). Clinical parameters were assessed at baseline up to 6 months: plaque index (PI), bleeding on probing, probing depth, clinical attachment level and BANA test.

Results: SRP+HBOT resulted in greater probing reduction and attachment gain than SRP alone 3 months after treatment (p\<0.001). The BANA test was negative after 1 week only for sites in the SRP+HBOT group (p\<0.05). However SRP+HBOT failed to show a significant difference from SRP group after 3 months were all BANA sites became negative (p\>0.05).

Conclusion: These preliminary data suggest that hyperbaric oxygen therapy had a short-term beneficial effect on pocket reduction and bacterial elimination, and may be considered a potential therapy option to improve the clinical outcomes of scaling in severe cases of chronic periodontitis.

Eligibility Criteria:
Inclusion criteria:

* This preliminary (pilot) study was designed with twenty subjects (12 men, 8 women, mean age 37.3 years) selected from a pool of 360 patients referred to the Periodontal Clinic of the School of Dentistry at Bahian Science Foundation (FBDC, Bahia, Brazil).
* The patients had an initial diagnosis of severe generalized chronic periodontitis (AAP 1999).

Exclusion criteria:

* Patients were excluded according to the following criteria:

  * smoking
  * pregnancy or lactation
  * antibiotics or periodontal treatment within the last 6 months
  * a diagnosis of aggressive periodontitis
  * trauma from occlusion or endodontic lesions
* According to an accurate clinical examination performed by a hyperbaric medical doctor (MD), the HBOT contra-indications (Iazzeti \& Mantovani 1998) served as exclusion criteria.
* The only absolute contraindication to hyperbaric oxygen therapy was from patients with untreated pneumothorax
* Relative contraindications were considered:

  * upper respiratory infections
  * high fevers
  * emphysema with CO2 retention
  * historic of thoracic surgery
  * malignant disease and middle ear barotrauma
* Patients taking or have recently taken the following drugs:

  * doxorubicin (Adriamycin®)
  * disulfiram (Antabuse®)
  * Cis-platinum and mafenide acetate (Sulfamylon®).
Envarsus XL Immunosuppression Following Liver Transplantation

The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or older
4. Recipients of a first-time liver transplant
5. Serum Creatinine level less than 2.0 on Post-Operative Day 3-7
6. Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen
7. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

1. Any prior use of tacrolimus or cyclosporine
2. Recipients of prior organ transplant
3. Need for hemodialysis in the week preceding or following liver transplantation
4. Recipients of living donor liver or split deceased donor liver allografts
5. Recipients of combined liver/kidney transplants
6. Pregnancy or lactation
7. Recipients of ABO incompatible liver allografts
A Predictive Score for the Ischemic Etiology of a Transient Diplopia (VASCO-DIP)

The transient diplopias (TD) is defined by a short diplopia. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.

The difficulty is to recognize an ischemic mechanism which imposes emergency cares.

A clinical score could help the clinician to recognize the etiology of the TD .


Eligibility Criteria:
Inclusion Criteria:

* Transient diplopia (i.e. less than 24 hours) during the last 8 days

Exclusion Criteria:

-
Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18-64 years of age (extremes included) (Part 1) and between 45-64 years of age (extremes included) (Part 2), on the date of signing the informed consent form.
* A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
* Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).

Exclusion Criteria:

* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, cannot participate in the study.
Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations

The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on the elasticity of blood vessels and the immune system.

The purpose of this study is to determine how olive leaf is absorbed and metabolised and also whether it has any effect on vascular function and cytokine concentrations.

Eligibility Criteria:
Inclusion Criteria:

* 19-40 years, non-smokers, able to swallow capsules, have a Body Mass Index (BMI) of 18.5-30, have a normal liver function and haematology and a max alcohol intake of \<21 units/week

Exclusion Criteria:

* Those who suffer from any form of disease, including endocrine disease, liver disease, diabetes mellitus, myocardial infarction, blood clotting disorder, reproductive disorder, gastrointestinal disease or a chronic gastrointestinal disorder.
* Individuals who are vegetarian, have dietary restrictions or on a weight reducing diet will not be recruited.
* Subjects who have been taking antibiotics in previous 3 months before study will not be included in the study
* Females who may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions will be excluded.
* Blood pressure \> 150/90 mmHg
* Haemoglobin \< 125 g/l for male, \< 110 g/l for female
* Gamma GT (liver enzymes) \> 80 IU/l
* Cholesterol \> 6.5 mmol/l
* Had suffered a myocardial infarction or stroke in the previous 12 months
* On any lipid-modifying medication
* On any medication affecting blood clotting
* Individuals taking vitamin and/or fish oil supplements
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma

Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates.

This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage Multiple Myeloma

OUTLINE: This is a multi-center study.

* Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months or to be observed.

Performance status: ECOG performance status 0-3 (KPS 30 - 100)

Life expectancy: 12 months

Hematopoietic:

* Hb \>10 g/dl within 14 days prior to registration

Hepatic:

* Not specified

Renal:

* Serum creatinine \< 2 mg/dl within 14 days prior to registration

Cardiovascular:

* Not specified

Pulmonary:

* Not specified

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:
* Presence of bone marrow clonal plasma cells (more than 10%)
* Presence of an M-protein in serum and/or urine (no concentration specified)
* Serum calcium \< 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey
* No symptoms of hyperviscosity, amyloidosis or recurrent infection
* Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration
* Negative pregnancy test

Exclusion Criteria:

* No previous treatment with bisphosphonates
* No disorders of the parathyroid or thyroid glands
* No current breastfeeding
* No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason \< grade 7 prostate cancers
Effectiveness of a Supervised Multicomponent Exercise-Based Telerehabilitation Intervention on Physical Performance in Older Patients with Multiple Chronic Conditions in Colombia

Currently, the older adult population faces an increase in the prevalence of cardiopulmonary diseases, which negatively impact their quality of life by limiting their ability to perform daily activities and affecting their physical and emotional well-being. In particular, cardiovascular and respiratory diseases are among the leading causes of morbidity and mortality among older adults in Colombia. Despite advances in pharmacological treatment and medical care, physical rehabilitation remains an essential component in the management of these diseases, with physical exercise serving as one of its fundamental pillars. However, access to physical rehabilitation programs for the older adult population, particularly in rural or hard-to-reach areas, continues to pose a significant challenge. Telemedicine and Information and Communication Technologies (ICT) have emerged as viable solutions to overcome this barrier, enabling the remote prescription and monitoring of physical exercises, facilitating the inclusion of more patients in rehabilitation programs, and improving their quality of life. Therefore, this study aims to evaluate the effectiveness of a multicomponent ICT-mediated intervention in terms of improving physical condition, reducing frailty, adherence, satisfaction, and quality of life in older adults with cardiopulmonary diseases.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of a non-communicable disease.
* Ability to communicate verbally or in writing.
* Stable disease status confirmed by clinical history.
* Condition present for at least three months to qualify as chronic.
* For patients with type II diabetes mellitus: glucose levels below 200 mg/dL during tele-rehabilitation sessions.

Exclusion Criteria

* Requirement for assistance with walking.
* History of disease exacerbation within the past six months.
Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. An understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. This is not an intervention study. The study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. Psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.


Eligibility Criteria:
Inclusion Criteria:

* Female and Male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis.
* Must be able to give informed consent
* All skin types on Fitzpatrick Scale (Type I-VI)
* Able to provide medical history and list of medications for psoriasis and control subjects

Exclusion Criteria:

* Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
* Tanning bed use within last 2 months
* Photodynamic Therapy or UVB treatments in past 2 months
* Female Subjects: pregnant or nursing
* History of abnormal scarring (i.e., keloids)
* Family history of psoriasis in first-degree relatives for control subjects
Turkish Validity and Reliability of the Social Frailty Index

The aim was to examine the validity and reliability of the Social Frailty Index in Turkish among older adults. 65 years and above older adults will be included included in the study. Older adults who agree to participate in the study will first be administered the Hodkinson Mental Test. Those who score 6 points and above will be included in the study. To evaluate the validity of the \&#34;Social Frailty Index\&#34;, Social Inclusion Scale, Older people\&#39;s quality of life-brief (OPQOL-brief) and Lubben Social Network Scale will be applied to the participants. To determine the reliability of the \&#34;Social Frailty Index\&#34;, older adults who do not receive any treatment will be tested and re-tested at one-week intervals.


Eligibility Criteria:
Inclusion Criteria:

* Getting a score of 6 or above on the Hodkinson Mental Test

Exclusion Criteria:

* -Having another chronic disease that can cause pain
* Having a neurological disease
* Being blind
* Having an orthopedic, neurological or mental disability
A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups.

1. To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS;
2. To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL

Exclusion Criteria:

1. Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L) thyroid dysfunction and hyperprolactinemia.
2. Type I diabetes or not well controlled type II diabetes
3. Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
4. Psychiatric diagnoses or using psychiatric medications including antidepressants
5. Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis

This is a multicenter randomized, placebo-controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.

176 eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized into two groups, including the intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day. All participants will be followed for 24 months, or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first. The primary outcome is the occurrence of subsequent peritonitis. The study aims to identify whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable and receiving peritoneal dialysis for \> 1 month
* Older than 18 years old
* Serum 25(OH)D \< 30ng/ml
* Adequate dialysis on evaluation with weekly Kt/V ≥ 1.5, or (revised time: 2023-7-11) without clinical uremic symptoms

Exclusion Criteria:

* Receive Vitamin D2/D3 during the previous 1 month (revised time: 2023-7-11) ;
* History of allergic reaction to Cholecalciferol;
* Current or past malignant disease, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating disorder, HIV/AIDS;
* Acute systemic infection, cardiovascular disease, surgery, or trauma in the last month;
* A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 6 months;
* History of kidney transplant;
* Hemodialysis combined with peritoneal dialysis currently;
* Pregnant or breastfeeding;
* Not suitable enrolled assessed by researchers, including patients who could not regular follow-up
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

The purpose of this study is to investigate the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with gastric ulcer.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have endoscopically confirmed gastric ulcers (mucosal defect with white coating) At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1)
2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
2. Participants with an Acute Gastric Mucosal Lesion (AGML) on endoscopy at baseline (Visit 1)
3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
5. Participants with a duodenal ulcer on endoscopy at baseline (Visit 1)
6. Participants with an ulcer for which medical treatment is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Population Pharmacokinetics of Metronidazole in Neonates

The objective of NEOPOPI is to conduct a population pharmacokinetic study of metronidazole in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

* Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
* Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
* Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
* Population pharmacokinetic analysis

Eligibility Criteria:
Inclusion Criteria:

* In case of birth at gestational age ≥ 37 weeks of amenorrhea (SA): inclusion of children of postnatal age \<28 days
* In case of birth at a gestational age \<37 SA: inclusion of post-menstrual age children (ie gestational age + post-natal age) \<44 SA 2. Benefiting from metronidazole antibiotic therapy, as part of their routine independent clinical management of the study, whether the targeted infection is suspected or proven 3. Social Security Affiliates 4. No opposition of parents to participation in the study

Non-Inclusion Critéria Treatment with metronidazole initiated before arrival in the investigative center (\> 1 dose).

Exclusion Criteria:

* None
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes

The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
* HbA1c between 7.0 and 9.5%
* On stable dose metformin monotherapy
* Stable body weight

Exclusion Criteria:

* Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
* Acute infections prior to dosing
* Patients with type 1 diabetes (insulin-dependent diabetes)
* Taking diabetes medication (other than metformin)

Other protocol-defined inclusion/exclusion criteria may apply