cyrilzakka/clinical-trials huggingface dataset:
Impacts of Oral Irrigation in Orthodontic Patients

The present study aimed to investigate clinically the cleaning effectiveness of different treatment modalities, that is, oral irrigator or interdental brush usage addition to routine brushing and examine interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid of orthodontic patients. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who are orthodontic patients.

The aim of this study is to compare the effectiveness of oral irrigator (OI) with interdental brush (IB) clinically and biochemically in orthodontic patients.

Thirty patients were randomly divided into two equal groups; patients using OI in addition to manuel brushing (OI-group), patients using IB in addition to manual brushing (IB-group). Study was planned as randomized, single-blind, parallel-design. Periodontal indexes were recorded clinically and interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid were evaluated biochemically. After baseline examinations \[Silness-Löe plaque index(PI), Löe-Silness gingival index(GI), probing pocket depth(PPD), clinical attachment level(CAL), bleeding on probing(BOP)\], initial periodontal therapy was completed using full-mouth disinfection method. The data was collected in the baseline, 2nd, 4th and 8th weeks.

The hypothesis of our study is that oral irrigators may be effective in oral care of orthodontic patients because of the ease of use.

Eligibility Criteria:
Inclusion Criteria:

* Being over 12 years old.
* Having at least 20 permanent teeth with bands or brackets.
* Finished phase I periodontal treatment.
* Bleeding below 10% during probing.
* No pocket depth of more than 5 mm.
* Not receiving any treatment other than orthodontic treatment during the study.
* Absence of removable or fixed prosthetic restorations.
* Absence of any systemic disease (hepatic, renal, hematologic, cardiovascular).
* Agreeing not to use any non-study mouthwash throughout the study.

Exclusion Criteria:

* Performing poor cooperation.
* Having diseases associated with bacteriemia.
* Used antibiotics and anti-inflammatory drugs for any purpose for a long time.
* Having diabetes.
* Smoking habits.
* Having a physical or mental problem that affects manual dexterity.
* Using medication that could affect gingival health (such as dilantin, calcium channel blocker, cyclosporine, and anticoagulant).
Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

The prevalence of preoperative anaemia in patients undergoing major surgery is approximately 30%, and is independently associated with higher mortality, a higher rate of postoperative complications, and a greater probability of receiving a transfusion. In a prehabilitation program, the evaluation and correction of anaemia in the preoperative period is essential, as it is a risk factor for transfusions and complications. The main objectives of this study were to analyse the need for blood transfusion, post-surgical complications, hospital length of stay, ICU length of stay, hospital readmissions, and surgical wound infection in patients treated with ferric carboxymaltose (FC) before surgery. A total of 152 patients were included, of whom 96 received FC before the intervention and 56 received no treatment (control group).

It was conducted a prospective pre-post interventional study between 1 January 2019 and 31 December 2022 at Infanta Cristina University Hospital in Parla (Madrid, Spain).

Written informed consent was obtained from each participant. To ensure anonymity and confidentiality, patient data were coded and stored in secure, password-protected databases accessible only to authorized research personnel, in compliance with Spanish legislation (Organic Law 3/2018 and RD 1090/2015).

The data used in the study were anonymous and collected by impartial, unpaid, volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years; on the SWL.
* Hemoglobine \<13g/dL.
* Referred for major elective surgery requiring hospital admission (e.g., oncologic resections such as mastectomy, colon resection, nephrectomy, hysterectomy), typically involving general anesthesia and moderate to high morbidity risk, capable of understanding and consenting to the study
* Physically and mentally able to complete assessments

Exclusion Criteria:

* Patients with hypersensitivity to FC, or any of its excipients. • Patients with active bleeding
Effects of Levosimendan on Cellular Metabolic Alterations in Patients With Septic Shock

To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following levosimendan administration in patients with septic shock.

The study was designed as a prospective, double-blind, controlled, clinical trial and performed in a multidisciplinary intensive care unit. After achieving normovolemia and a mean arterial pressure of at least 65 mmHg, 20 septic shock patients were randomized to receive either levosimendan 0.2 μg/kg/min, or dobutamine 5 μg/kg/min. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis. All measurements, including data from right heart catheterization were obtained at baseline and every 6 hours for the following 72 hours after randomization.

Eligibility Criteria:
Inclusion Criteria:

* patients who fulfilled the criteria of septic shock that required norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65 mm Hg despite appropriate volume resuscitation (pulmonary arterial occlusion pressure \[PAOP\] = 12 to 18 mm Hg and central venous pressure \[CVP\] = 8 to 12 mm Hg)

Exclusion Criteria:

* pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and a limitation on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
Cardiac Injury in Patients With Influenza

This study investigate the prevalence of elevated biomarkers of cardiac injury in patients with suspected influenza infection and the prognostic implication on the composite endpoint of death of any cause, hospitalization due to myocardial infarction, unstable angina, heart failure and stroke.

The relationship between influenza and cardiovascular events was described in an early study of influenza epidemics from 1915 to 1929 including the 1918-1920 pandemic. Retrospective studies have shown increased risk for acute myocardial infarction (AMI) during the first week following an infection with influenza.

Biochemical markers of cardiac injury such as high sensitive cardiac troponins may be increased during infection with influenza. Increased levels of cardiac troponins are associated with adverse outcome in many different populations.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) presenting with influenza-like illness.
* Written informed consent.

Exclusion Criteria:

* Inability to provide informed consent.
* Age \<18 years.
* Symptoms indicating an acute coronary syndrome, acute heart failure, rapid atrial fibrillation or acute stroke.
Early Embryo Cleavage And Multiple Pregnancies After ICSI

To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.

A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study.

The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).

Eligibility Criteria:
Inclusion Criteria:

* BMI \>25 - 30 kg/m2
* Have two ovaries
* Regular cycles
* first ICSI cycle
* Long midluteal GnRH protocol.

Exclusion Criteria:

* uterine factor as a cause of female factor infertility
* pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...)
* history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...)
* azoospermia as a cause of male factor infertility
Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy

Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Intervention group received 60 minutes aquatic-based exercise in the form of warm-up for 10 mins, then strengthening exercise for 40 minutes, followed by 10 min cooling down in the form of stretching and mobility exercise, three times a week for 8 weeks, plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. The control group received 60 minutes of land base exercise, three times a week, for 8 weeks. Arm volume, shoulder flexion, abduction range of motion and pain using a visual analogue scale were assessed at baseline and after 8 weeks of treatment.

Group A: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in Group-A had been dealt with water-based exercise was conducted at a hydrotherapy pool for the Eden Health care, cairo, The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water.

Control group, Group B: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in control group had been dealt Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles .

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer with unilateral axillary lymph node excision.
* Mild-moderate degreed lymphedema (stage I and II) .
* Lymphedema with a duration of at least 1 year .

Exclusion Criteria:

* Recurrence of cancer.
* Ongoing active oncological treatment.
* Functional disorders hindering participation in exercise programs.
* Open wound at any area of the body.
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease

Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in the general population, being twice as frequent in women and with a tendency to increase incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies on the role of vitamin D supplementation in CKD population are missing. The clinical-scientific hypothesis of this study is that replacement of vitamin D (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.


Eligibility Criteria:
Inclusion Criteria

- adult patients with chronic kidney disease on dialysis, with vitamin D deficiency.

Exclusion Criteria

* current treatment for restless leg syndrome
* history of parathyroidectomy in the last 6 months
Steroid Before Thyroidectomy

We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thyroid surgery for benign disease

Exclusion Criteria:

* Depression
* Chronic pain disorder
* Insulin dependent diabetes mellitus
* History of PONV
* Pregnancy
* Age \< 18 years
* Received antiemetic therapy within 48 hours
Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer

The role of early timing of adjuvant chemotherapy was postulated to be particularly important for patients with endocrine non-responsive disease. The role of cytotoxicity during the period of breast surgery itself and immediately after (perioperative chemotherapy) remained unknown. We investigated in a randomized trial the role of perioperative chemotherapy in patients treated with a preoperative chemotherapy for locally advanced breast cancer and compare it to the preoperative chemotherapy without additional cytotoxic therapy during and immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor cells, or with absence of progesterone receptors, received up to 6 courses of primary systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60 mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF). Patients achieving a partial or complete remission were randomized to continue the infusion of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer histologically proven \> 2 cm, ER and PgR \<20% or Any ER and PgR absent (T2,T3 N0-2, M0)
* No treatment with previous chemotherapy/hormonotherapy
* Performance status 0-2 (ECOG scale, Appendix 2)
* Measurable or evaluable lesions
* Age between 18-70 years
* No significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments
* Absence of psychiatric illness
* WBC \> 4,000/mm3; PLTS \> 100,000/mm3
* AST, ALT, LDH, gamma-GT \< 2.5 x upper limit of normal and bilirubin \< 3 mg/100 ml
* Informed consent obtained
* Pregnancy test (in fertile women). An effective contraceptive method must be utilized by fertile women.
* Baseline examinations (chest X ray, CT scan, ECG etc) performed within one month prior initiation to therapy

Exclusion Criteria:

* Uncontrolled infection and metabolite disease
* Distant metastases
* Active peripheric and/or central neurological disease
* Active cardiac disease defined as CHF (NYHA III-IV) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction
* History of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

The primary objectives of this study are:

Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are experienced but capsid inhibitor (CAI) naive.

Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced but without resistance to TAF.


Eligibility Criteria:
Key Inclusion Criteria:

* Plasma HIV-1 RNA ≥ 5,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count \> 200 cells/mm\^3
* Treatment naive or experienced but CAI (for Part A only) and integrase strand transfer inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within 12 weeks of screening
* Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on Day 10
* Screening genotype report must show sensitivity to at least one agent in either non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) class to allow its use as part of standard of care oral antiretroviral treatment in the future
* Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)
* No clinically significant abnormalities in electrocardiography (ECG) at Screening
* Willing to initiate B/F/TAF on Day 10 after completion of all assessments

Key Exclusion Criteria:

* Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Alendronate to Prevent Loss of Bronchoprotection in Asthma

Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history consistent with moderate asthma for \>1 year
* Asthma is controlled with ICS, with an FP dose ≤ 1000mcg/day and \>100mcg/day (or equivalent)
* Able to perform reproducible spirometry according to ATS criteria
* Baseline FEV1 ≥ 50% of predicted and ≥1L.
* If FEV1 \<80%, a minimum 12% increase in FEV1 post-bronchodilator or a MCh PC20 ≤ 8 mg/mL
* If FEV1 ≥80%, a MCh PC20 ≤ 8 mg/mL
* Salmeterol protected MCh ≤ 16 mg/mL

Exclusion Criteria:

* Uncontrolled asthma, as suggested by an ACT score \<18 while on high-dose ICS (FP daily dose \>500mcg or equivalent)
* Non-ICS controller medication or LABA use within 4 weeks of study entry.
* Contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study
* Calculated GFR of less than 35 mL/min
* History of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or \> 10 pack-years total if ≥ 18 years of age
* Systemic corticosteroid treatment for any condition within 4 weeks of enrollment at Visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of Visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years
* History of a respiratory tract infection within 4 weeks of Visit 1
* Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects who are of non-childbearing potential.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months
A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema

The purpose of this study was to evaluate the clinical efficacy, safety, and tolerability of donidalorsen in participants with hereditary angioedema (HAE) type 1 (HAE-1), HAE type 2 (HAE-2), or HAE with normal C1-inhibitor (C1-INH) and to evaluate the effect of donidalorsen on plasma prekallikrein (PKK) and other relevant biomarkers.

This was a randomized, double-blind, placebo-controlled study in 23 participants conducted concurrently in 2 parts (Part A and Part B); participants were allocated into Part A or Part B according to type of HAE (i.e., either HAE-1/HAE-2 in Part A or HAE-nC1-INH in Part B). Part A was randomized, double-blind, and placebo-controlled; and Part B was open-label. The length of participation in the study was approximately 8 months, which included an up to 8-week screening period, a 12-week treatment period, and a 13-week post-treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of HAE-1/HAE-2 (for inclusion in Part A) or HAE-nC1-INH (for inclusion in Part B)
* Participants must have experienced a minimum of 2 HAE attacks (assessed by the Angioedema Activity Score \[AAS\] and confirmed by the investigator) during the screening period
* Access to, and the ability to use, ≥ 1 acute medication(s) to treat angioedema attacks

Exclusion Criteria:

* Anticipated use of short-term prophylaxis for angioedema attacks for a pre-planned procedure during the screening or study periods
* Concurrent diagnosis of any other type of recurrent angioedema, including acquired or idiopathic angioedema
* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C, or chronic hepatitis B
* Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
* Treatment with another investigational drug or biological agent within 1 month or 5 half-lives, whichever is longer, of screening
* Exposure to any of the following medications:

  * Angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptive or hormonal replacement therapy) within 4 weeks prior to screening
  * Chronic prophylaxis with Lanadelumab within 10 weeks prior to screening
  * Oligonucleotides (including small interfering ribonucleic acid \[RNA\]) within 4 months of screening (if single dose received) or within 12 months of screening (if multiple doses received)