cyrilzakka/clinical-trials huggingface dataset:
Dietary Phosphorus Load and Postprandial Serum Phosphate in HD Patients

This study is to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients

Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives.

Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were directly observed eating a standard low phosphorous diet and on the other day, a modified low phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals for the four hours after the meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age;
* on dialysis for \> 3 months;
* pre-dialysis serum phosphate \< 2.5 mmol/L and
* serum potassium \< 6.3 mmol/L on most recent routine monthly blood test;
* urinary outputs of \< 200 ml/day by self-report;
* being in their usual state of health

Exclusion Criteria:

* history of diabetes mellitus
* history of parathyroidectomy
* history of calciphylaxis
Evaluation of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite in Pulpectomy of Nonvital Primary Molars

This randomized clinical trial aims to compare the clinical and radiographic success of Moringa Oleifera leaf extract with Sodium Hypochlorite as intracanal irrigants in pulpectomy of nonvital primary molars in children aged 3-7 years. The study evaluates both clinical parameters (pain, swelling, mobility) and radiographic healing (periapical changes, root resorption) over 12 months.

Effective disinfection during pulpectomy of primary molars is essential for treatment success. Sodium hypochlorite is the gold standard intracanal irrigant but presents concerns regarding cytotoxicity and taste. Moringa Oleifera, a natural agent with antimicrobial, antioxidant, and anti-inflammatory properties, may offer a biocompatible alternative. This study is a parallel-design, randomized clinical trial evaluating 50 teeth in children aged 3-7 years. Patients will be randomly allocated to either 1% Sodium Hypochlorite or Moringa Oleifera leaf extract for intracanal irrigation. Clinical and radiographic outcomes will be assessed at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative children aged between 3-7 years
* Males/Females.
* Primary molars necessitating pulpectomy diagnosed with deep dental caries with pulp necrosis and periapical pathosis or both.
* Systemically healthy children

Exclusion Criteria:

* Medically compromised and uncooperative children
* Tooth indicated for extraction due to root resorption more than two thirds of the root, teeth near exfoliation, deep subgingival caries hindering proper coronal seal.
* Mobile teeth (Miller's Grade 2 or more)
* Previous pulp therapy
Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest

After a mild traumatic brain injury (mTBI) people often report balance problems. At Parkwood hospital we have noticed that balance is improved when patients with mTBI wear a weighted compression vest. This follow up pilot study looks at the immediate effects of weighted compression vests on participants with altered balance after mTBI. Participants will be recruited from the Ministry of Health Outpatient Acquired Brain Injury (ABI) Program wait list. Then each participant will perform a series of balance and walking tests under 2 conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression vest. It will be randomized whether participants wear the vest on the first or second testing day. Participants will also be asked how confident they are about their balance and how anxious they felt performing the assessments after each testing session. We hypothesize that the weighted compression vest will improve fatigue and anxiety immediately and 24 hours after performing a complex task, and will improve static and dynamic balance, gait variability, and walking speed in patients with mTBI, during the tasks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed concussion. Symptoms persistent for more than 3 months. Self-reported balance deficits. Participants have been referred by a physician to the Outpatient ABI team at Parkwood. Participants have been screened by the ABI team and are currently awaiting treatment. No other diagnosed orthopedic injuries or significant health conditions. Able to follow instructions

Exclusion Criteria:

* Other pre-existing vestibular problems. Other diagnosed orthopedic injuries or significant health conditions that impair balance or mobility.
Clinical Efficacy of Nail Brace for Treatment of Ingrown Toenails

Background: Ingrown toenails are one of the most frequent nail disorders and can be treated with conservative or surgical approaches. Although discovered a long time ago, the available data are still very limited on the potential effectiveness of nail braces for ingrown toenail treatment.

Objective: This study aimed to evaluate the efficacy of nail brace (combiped and podofix) for treatment of ingrown toenails.

Method: Participants with ingrown toenail and \>= 12 years old with total 40 ingrown toenails were included. Investigators divide patients to 3 group: (1) combiped group: Participants with non-infected or mild infected ingrown nail, combiped nail brace was applied instantly.20 patients(2) combine combiped and podofix group: Participants with severe paronychia with pyogenic granuloma, oral analgesics and antibiotics were prescribed first and nail brace was applied 1 week later. Depends on disease condition, investigators applied 1-2 combiped nail brace. If the pyogenic granuloma is not resolved after 1 week, investigators applied podofix first for 2-4 weeks and then combiped nail brace. After the nail brace applied, participants must come back between 2-4 weeks depends on disease condition.10 patients (3) podofix group: participants who are afraid of combiped implantation, or with mild recurrence will be applied with podofix.

Participants come back every month for evaluation and photography. Physician global assessment (0-6),Patient global assessment (VAS 0-10), Treatment satisfaction (VAS 0-10), and questionnaire were evaluated 1 month, 3 months and 6 months after the device applied. Participants need to be followed for recurrence at 3rd month and 6th month after removed the nail brace.

Eligibility Criteria:
Inclusion Criteria:

* more or equal to 12 years old patient with ingrown toenail

Exclusion Criteria:

* \< 12 years old
* under other nail bracing use
* received partial nail resection within recent 2 months
* psoriatic nail
* target therapy related paronychia
* received combiped or podofix previously and removed within recent 6 months
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention

This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age ≥18,
* 2) Scheduled to undergo unilateral total knee or hip arthroplasty

Exclusion Criteria:

* 1) Cognitive impairment preventing completion of study procedures.
* 2) Current cancer diagnosis,
* 3) Contralateral knee or hip replaced in the previous 3 months,
* 4) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,
* 5) Intent to add new pain treatments during the study period (except for what is part of the study),
* 6) Other unstable illness judged by medical staff to interfere with study treatment.
Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain

The study consists in recruiting patients with ankle sprains who visit the emergency department (ED).

Each patient will be tested by an osteopath who we will measure pain, swelling and/or edema, and mobility of the ankle. Patients will be asked to reproduce exercises such as to hold on one foot, to stand on tiptoes...

Then, patients will be divided into two groups. The first group will undergo medical treatment during the ED visit, while the second group will undergo osteopathic treatment.

Three time points will be planned. The first one will be the patient's consultation in the ED where treatment will be carried out according to its assignment, as well as the clinical measures previously described. The second time point will be seven days later (plus or minus three days), where only clinical measurements will be performed. The third time point will be three weeks later (plus or minus three days), when the ankle sprain has consolidated, in order to carry out the clinical measurements again.

These clinical measurements will allow to evaluate the effectiveness of a single osteopathic consultation in the ED. The investigators expect a reduction in immediate pain, and thereafter, a reduction in swelling, and an improved mobility and stability of the ankle.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Unilateral sprain
* Stage 1 or 2 sprain
* Recent sprain \< 72 hours
* With or without the presence of edema and/or hematoma
* Receiving prior consultation from an ED physician
* Understanding French
* Agreeing to participate in the study and having signed the consent form
* Apyretic
* Patient affiliated to a social security schem

Exclusion Criteria:

* Fractured foot, tibia, fibula
* Stage 3 ankle sprain
* Operated sprain
* Current use of drugs/alcohol
* Altered mental state
* Chronic ankle injury on the contralateral side
* Person deprived of liberty by a judicial or administrative decision
* Neoplasia
* Any contraindication to osteopathy
Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .

Comparison between ultrasound guided transmuscular QL block and Fascia iliaca block in pediatric patients undergoing DDH surgery regarding the quality of pain control in the perioperative period..


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-12 years
* Of both sexes
* American society of anesthesiologist (ASA) physical status classification class I
* Undergoing general anaesthesia for DDH surgery

Exclusion Criteria:

* Parents' refusal of regional block
* Duration of surgery over 120 min.
* History of allergy to local anesthetics
* Bleeding disorders (INR \>1.4, Platelet count\< 75000)
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
* Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
* Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.

Exclusion Criteria:

* A subject who experienced any of the following during prior study:

  * Advanced or poorly controlled diabetes
  * Joint surgery (joint evaluated in this study)
* A subject who has been prescribed excluded medications during prior study.
* History of following during prior study:

  * Clinically significant drug or alcohol abuse
  * Intravenous (iv) drug abuse
  * Active infection with listeria or tuberculosis (TB)
  * Lymphoma, leukemia
  * And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
* A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index \[BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m\^2)\] with a participant in the control group.


Eligibility Criteria:
Key Inclusion Criteria:

* All Individuals:

  * Must have a calculated BMI from 18 to 40 kg/m\^2, inclusive, at screening
* Individuals with impaired renal function

  * Chronic stable renal impairment without recent clinical change

    * Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min
    * Moderate: CrCl = 30 - 59 mL/min
    * Severe: CrCl = 15 - 29 mL/min
* Healthy individuals

  * CrCl ≥ 90 mL/min

Key Exclusion Criteria:

* All Individuals:

  * Pregnant or lactating females
  * HIV positive or chronic hepatitis B infected
* Individuals with impaired renal function

  * Chronic liver disease
  * Dialysis or anticipated use of dialysis
  * Renal transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Magnesium Versus High Dose Fentanyl in Endotracheal Intubation

this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation

to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in attenuating stress response in cancer patients undergoing surgeries under general anesthesia requiring endotracheal intubation

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients undergoing surgery under general anesthesia requiring endotracheal intubation
* ASA I II
* 18 to 60

Exclusion Criteria:

* allergy to any of the used drugs
* renal or hepatic impairment
* hypertensive patients, patients with cardiovascular or cerebrovascular diseases
Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy

There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13 released by the tumor cells. B cells release lymphotoxin which drives malignant cell proliferation through the NFkB pathway. This is a pilot trial in 18 patients to determine whether depletion of B cells by rituximab will result in a decrease in the extent of B cell infiltration of the prostatic cancer. The extent of infiltration in the diagnostic biopsy will be compared to that in the prostatectomy samples following administration of 4 weekly doses of rituximab.

This is an open label, single institution, pilot study of rituximab neoadjuvant therapy in patients with high risk prostate cancer scheduled to undergo radical prostatectomy. Prior to prostatectomy, patients will receive one treatment cycle (28 days) of rituximab 375 mg/m2 intravenously once weekly. Patients will be scheduled to undergo radical prostatectomy within two weeks of completing study treatment. Tissue from prostatectomy will be used for immunohistochemistry (IHC) staining of pharmacodynamic markers.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and provide written informed consent.
* Patient has EITHER:

  * A Kattan nomogram predicted probability of being disease free 5 years after surgery of \< 60%, OR
  * A Gleason sum ≥ 8.
* Indicated for radical prostatectomy.

Note: candidates for radical prostatectomy are still eligible even if they have a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation.

* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix A).
* Males aged ≥ 18 years.
* Adequate organ function as defined below measured within 21 days of study entry:
* Hematology:

  * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
  * Platelet count ≥ 100 x 109/L
  * Hemoglobin ≥ 9.0 g/dL
  * White blood cell (WBC) count ≥ 3.0 x 109/L
* Biochemistry:

  * Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2 x institution's upper limit of normal (ULN)
  * Total bilirubin \<1.5 times ULN
  * Serum creatinine and blood urea nitrogen (BUN)\<1.5 times ULN
  * Na, K Cl, carbon dioxide (CO2), Ca, phosphate (PO4) within institutional limits
* Available prostate biopsy specimen which is evaluable for B lymphocyte count.

Exclusion Criteria:

* Received prior treatment for prostatic adenocarcinoma including prior surgery (excluding TURP), radiation therapy, or chemotherapy.
* Current or past use of investigational agents within 4 weeks of study enrollment.
* Evidence of metastatic disease on cross sectional imaging or bone scan.
* History of hepatitis B or C, hepatitis immunodeficiency virus (HIV), tuberculosis or a chronic infection of any type.
* Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology).
* Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing).
Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.


Eligibility Criteria:
Inclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:

* Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
* Subject provides written assent to the study according to age and capacity of understanding;
* Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;
* Blood was drawn after the first booster vaccination in precursor Study 700401;
* Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).

Exclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:

* Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;
* Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;
* Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);
* Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);
* Subject has a known or suspected problem with drug or alcohol abuse (\> 4 liters of wine/week or equivalent level of other alcoholic beverages);
* Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.
Immediate Implants With Customized Abutments

Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.

Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.

The following groups will be randomly assigned:

Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.

Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.

Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.

The primary objective is:

- The implant success

The Secondary objectives are:

* The Changes in mid-facial mucosal recession
* The changes in papilla height
* The changes in soft tissue ridge width
* The aesthetic evaluation
* The implant stability

Eligibility Criteria:
Inclusion Criteria:•

* The patient is ≥ 18 years old
* Extraction of single rooted tooth with healthy adjacent teeth (PD\<5mm, no BOP)
* Patient must be able to understand the purpose of the study and to sign the consent form

Exclusion Criteria:

* Smoking status of more than 10 cigarettes/day
* History of uncontrolled metabolic disorders (e.g. diabetes mellitus)
* History of malignancy, radiotherapy, or chemotherapy
* Pregnant or breast feeding
* History of immunodeficiences
* existence of metabolic bone disease or disease affecting bone healing
* untreated or active periodontitis (BOP and PD\>5mm)
* absence or defects of the buccal bone plate