cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Vitamin K2 Status of Calcium-based Stone Formers

This is an observation, single site-study with one study visit during which all data and samples will be collected. Study participants will be asked to provide blood, urine, and fecal samples so that the investigators may study the differences in the gut microbiota, vitamin K2 levels, and other parameters between participants who form kidney stones and those who do not.

It is hypothesized that calcium-based stone formers will have an altered fecal gut microbiota compared to non-stone former controls. This altered microbiota will have a lower abundance of bacteria that produce menaquinones (vitamin K2), thus stone formers will also have a different blood menaquinone profile compared to controls. Ultimately, the different levels of menaquinones will result in increased inactive Matrix Gla protein (dp-ucMGP), which is a key protein that sequesters free calcium. To test this hypothesis, calcium-based stone former and non-stone forming controls will be recruited to a single site, observation study to collect urine, blood, and fecal samples. These samples will be used to determine dp-ucMGP levels, menaquinone profiles, the composition of the gut microbiota, and other parameters of interest.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female, 18 - 65 years old
* No self-reported kidney stones during their lifetime (controls)
* Ultrasound examination confirming absence of kidney stones (controls)
* Have had at least 1 incidence of a clinically confirmed calcium-based kidney stone in the last 12 months (stone formers)
* Ability to collect a clean catch urine sample
* Prescription and over-the-counter drugs unchanged for ≥30 days
* Willingness to provide medical information, blood, urine, and fecal samples

Exclusion Criteria:

* Current, or within 30 days, use of antibiotics or antifungals
* Current, or within 30 days, use of vitamin K antagonists
* Current probiotic use or any use within 14 days of screening sample collection should be recorded
* A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy 2021-06-29 1.0 Page 4 of 6
* Fecal incontinence
* History of disorder with abnormal calcium regulation such as hyperparathyroidism, active malignancy, or osteoporosis.
Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges

The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.

This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
2. The age of patients ranges from 50 to 80 years old.
3. Patients with a resorbed mandibular ridge.
4. Patients with a Class I maxillo-mandibular relationship
5. Patients with adequate inter-arch space.
6. Patients with good neuromuscular control.
7. Patients without any tempo-mandibular disorder.

Exclusion Criteria:

1. Patients with any oral diseases that may affect complete denture construction
2. Patients with bad oral hygiene.
3. Patients with oral parafunctional habits.
4. Hysterical patients.
5. Patients will undergo or have previously received chemotherapy or radiotherapy.
6. Drug-addicted patients.
Contrast ICE for Myocardial Scar in VT Ablations

There is a high correlation between scar areas identified by contrast-enhanced ICE and scar areas identified by conventional electroanatomic mapping. Therefore, the investigators will assess the utility of contrast-enhanced ICE to identify and localize myocardial scar real-time during VT ablation procedures.

Ventricular tachycardia (VT) is a life-threatening arrhythmia which occurs frequently in the setting of structural heart disease, most often as result of myocardial fibrosis or scar. Catheter ablation is often performed to treat recurrent VT, but is predicated on precise localization of myocardial scar, as scar is often the source of VT. Currently during VT ablation procedures the identification of scar is based on electroanatomic mapping where bipolar voltage criteria have been established (i.e., bipolar electrogram voltage \< 1.5 mV is considered scar). However this definition is purely based on electrical signal information and so has significant limitations: 1) there has not been definitive establishment of the sensitivity and specificity of this threshold for defining scar in comparison with tissue; 2) a detailed 3-D map created by time-consuming movement of the mapping catheter must be obtained in order to assess the existence and location of the scar; 3) only scar on the surface in contact with the mapping catheter (most often endocardial) may be definitively identified, whereas there may be intramyocardial or epicardial scar that would not be identified unless the mapping catheter makes direct contact with those areas which may involve additional risky access (epicardial) or even impossible (intramyocardial). For these reasons it would be very helpful to have another method to identify and localize myocardial scar during a VT ablation procedure. Cardiac MRI has been validated for identifying and localizing scar, but would not be recommended for many patients due to presence of ICD (implantable cardioverter-defibrillator) devices in these patients. Contrast-enhanced echocardiography has been validated to identify myocardial scar (Montant 2010), and intracardiac echocardiography (ICE) is standardly used in VT ablation procedures. Therefore, the investigators will assess the utility of contrast enhanced ICE by identifying and localizing myocardial scar real-time during VT ablation procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Subject is undergoing catheter ablation of likely reentrant VT
* Planned use of intracardiac echocardiography (ICE)
* Subject is willing to sign and date the study informed consent form

Exclusion Criteria:

* Contraindication to Perflutren (Optison) echo contrast
* Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
* Known hypersensitivity to Perflutren, blood, blood products or albumin
* Subject has medical condition that would limit study participation (as per MD discretion)
* Subject is pregnant
* Inability to give informed consent
Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris

The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of patients with pemphigus vulagaris (PV).

This was a non-confirmatory, randomized, partial-blind, placebo-controlled trial evaluating the efficacy, safety and pharmacokinetics (PK) of VAY736 in the treatment of PV patients.

A total of 13 patients were enrolled and randomized into the study. Of these 13 patients,seven were randomized to the 3 mg/kg VAY736 group, two were randomized to the 10 mg/kg VAY736 group and four were randomized to the placebo group.In the placebo group, three out of the four patients consented to open-label VAY736 treatment and received 10 mg/kg VAY736 after Week 24 onwards. Thus, a total of 12 patients received VAY736, 7 patients received 3 mg/kg and 5 patients 10 mg/kg.

The Screening period consisted of a Screening Visit performed within 28 days prior to randomization to assess patient eligibility. Following Screening, patients underwent pre-dose procedures which included assessment of their PV by Pemphigus Disease Area Index (PDAI), Autoimmune Bullous Skin disease Intensity Score (ABSIS) and Investigator Global Assessment (IGA), and blood sampling for PK endpoints. Patients then received the study drug, which was administered over approximately a 2 hour period. The patients remained in the study center overnight post-infusion for observation and for measurement of safety parameters and PK samples approximately 24 h post-infusion (start of infusion: ±2 h). Patients were then discharged from the study site and returned as per the schedule. Patients were evaluated at Week 1, Week 2 and Week 3, then every 3 weeks through to Week 12, and every 4 weeks through to Week 24. At Week 24, the blind was broken to confirm treatment allocation. If a patient was on placebo, such patient completing the Week 24 visit and after unblinding had the option of receiving open label VAY736 10mg/kg.

Recruitment was paused in Mar-2015 and at the time 13 patients were enrolled. The study recruitment was then terminated in Dec-2015 for strategic reasons related to the development of the compound.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 20 to 70 years of age
* Confirmed diagnosis of pemphigus vulgaris
* Presence of mild to moderate pemphigus vulgaris
* Patients must weight between 40 kg and 150 kg inclusive
* on a stable dose of oral corticosteriod therapy (with or without azathioprine or mycophenolate)

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they are using a highly effective method of birth control during dosing and for 4 months following study treatment
* Recent previous treatment with photo therapy, biological therapy, steroids, immunosuppresive agents (unless washout period applied)
* Active or recent history of clinically significant infection
* use of rituximab within 1 year Other protocol-defined inclusion/exclusion criteria may apply.
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
* No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.

Exclusion Criteria:

* Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
* In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
* Withdrawal, at any time, from the preceding gefitinib study.
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
Validation of AI Models to Measure Physical Activity After a Stroke

The research team are developing algorithms using artificial intelligence that use information collected by accelerometers to detect a person's position, such as whether an individual is lying, sitting, or standing, and the individual's movements, such as whether they are taking steps or standing up.

Sensor location will affect the accuracy of the model and acceptability of the method. The research team are therefore developing algorithms for four different locations.

The purpose of the research is for the development of the algorithms and check whether they accurately recognise different positions and movements in people whose movement is affected by a stroke, and by being in a hospital environment (e.g. using a profiling bed).

The research team plan to recruit between 34 and 50 participants who are admitted hospital due to having a stroke. After providing informed consent, participants will be asked to complete a one-off assessment with a member of the research team and a ward physiotherapist. Participants will be asked to wear the four sensors, and move through a series of postures, walk for up to six minutes, and stand as many times as they feel able in one minute.


Eligibility Criteria:
Inclusion Criteria:

* admitted to hospital with a diagnosis of an acute stroke.

Exclusion Criteria:

* unable to provide informed consent;
* receiving end-of-life care;
* the consultant in charge of their care disagrees with their inclusion
Effect of VPro5 Therapy on Clear Aligner Therapy

The investigators hypothesize that brief, daily application of HFA will increase the efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or discomfort. The investigators will divide subjects into 5 groups changing clear aligners at different time intervals with or without HFA application for 5 minutes/day to assess the effect on: time intervals between aligners, cytokine activity, and pain perception.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 - 45 years of age
2. Subject is willing and able to comply with all study procedures and sign Informed consent/HIPAA forms
3. Subject must have complete adult dentition (excluding third molars)
4. Subjects must have class I malocclusion or mild class II/III malocclusions
5. Subject is at least one month into aligner treatment.
6. Subject has history of and current healthy oral hygiene (PD is\<4mm, GI\<1, and PI=1)

Exclusion Criteria:

1. Subjects who have received periodontal treatment in the previous 6 months
2. Subjects who are taking medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporin, ant-inflammatory drugs, systemic corticosteroids, or calcium channel blockers.
3. Subjects missing adult teeth (except the 3rd molars) or with severe class II or class III malocclusion.
4. Subjects with skeletal class I but extreme dental malocclusion
5. Severe crowding that require extraction
6. More than 4 mm positive overjet and more than 2 mm negative overjet
7. Extreme deep bite (more than 90%);
8. Severe openbite (more than 2 mm)
9. Pregnant women
10. Subjects do not have any systemic diseases effecting bone metabolism
11. Smoking
12. Vulnerable subjects per IRB definitions
13. Subjects with current caries
14. Subjects that require interproximal reduction or attachments during the study period
15. Subjects who are non-compliant regarding aligner wear or VPro5 recommended daily usage
Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (\>80gm).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from LUTS secondary to infravesical obstruction from BPH
* failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 80 gm

Exclusion Criteria:

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP
Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.

Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP.

Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause.

aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 1. All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months.

  2. For acute ITP, patients will be newly diagnosed (about one month within the diagnosis).

  3. For chronic (12-24 months) and persistent (3-12 months) ITP patients.

Exclusion Criteria:

1. Patients' platelet count more than 40 x 109/L.; or above 18 years
2. Patients with secondary cause for thrombocytopenia.
3. Patients with any there associated chronic illness affecting oxidant status
The Adrenal Contribution to Androgen Production in Girls During Puberty

In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.

Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.

Eligibility Criteria:
Inclusion Criteria:

* Normal CBC (Hemoglobin must be at least 11mg/dl)
* Normal renal and liver function tests (AST\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
* direct bili \<0.2 mg/dL;
* total bili \<1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)

Exclusion Criteria:

* Pregnancy
* On oral contraceptives
* On insulin lowering drugs
* On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
* On medications that will influence androgen metabolism or clearance
* On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
* Subjects with morning cortisol\<5 ug/dL will be excluded and asked to see their primary care physician.
* Subjects with 17-OHP\>250 ng/dL) will be excluded and asked to see their primary care physician.
* Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded
Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.

After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).

Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.

Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.

Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.

The pain level of the patients was evaluated using a numerical rating scale;

* before the femoral sheath extraction (PAS1),
* during the femoral sheathing (SDQ2),
* immediately after the femoral sheathing (SDQ3),
* 30 minutes after the femoral sheathing (SDQ4) and
* 1 hour after the femoral sheathing (SDQ4). SDÖ5) was evaluated and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Intervention in the femoral region,
* Femoral sheath size is 6-7 fr,
* Presence of only one sheath in the femoral region,
* No analgesics were administered before femoral sheath removal,
* Absence of serious bleeding and major hematoma in the femoral region,
* Being over 18 years of age,
* No communication problems,
* Having a place and time orientation,
* No dizziness,
* Not having any psychiatric disease,
* No visual, auditory or mental problems,
* No previously identified cold allergy,
* Being willing and willing to participate in the study,

Exclusion Criteria:

* Serious bleeding and major hematoma development in the femoral region,
* Not applying intracoronary stent or coronary angioplasty after coronary angiography,
* Vital signs are abnormal enough to prevent intervention,
* Having visual, auditory and mental disabilities,
* Having a communication problem,
* Not being willing and able to participate in the study,
* It is defined as wanting to withdraw from the study at any stage of the study or being excluded from the study by the researcher.