cyrilzakka/clinical-trials huggingface dataset:
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor

OBJECTIVES:

I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.

II. Determine the objective response rate in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).

Patients receive oral carboxyamidotriazole (CAI) daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity.

Patients with stable disease are randomized to one of two treatment arms.

Arm I: Patients receive oral CAI as above.

Arm II: Patients receive a placebo.

Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed renal cell carcinoma

  * Metastatic or unresectable disease
  * Documented disease progression, even after nephrectomy
* At least 1 unidimensionally measurable lesion

  * At least 20 mm by conventional techniques
  * At least 10 mm by spiral CT scan
  * The following lesions are not considered measurable:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Abdominal masses not confirmed and followed by imaging
    * Cystic lesions
* Performance status - CTC 0-2
* WBC at least 2,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Creatinine no greater than 2.0 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No baseline neuropathy or cerebellar dysfunction greater than grade 1
* At least 4 weeks since prior immunotherapy
* No prior carboxyamidotriazole
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* Concurrent epoetin alfa allowed
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
* No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)
* At least 4 weeks since prior radiotherapy
* No concurrent palliative radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior surgery
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions

The aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
2. History of beneficial effects of antihistaminic treatment.
3. Age between 18 and 75 years.
4. Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence,vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised.
5. Voluntarily signed written informed consent.

Exclusion Criteria:

1. The presence of permanent severe diseases, especially those affecting the immune system, except ACU
2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
5. Evidence of severe renal dysfunction
6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value)
7. History of adverse reactions to DL, loratadine, or other ingredients of the IMP
8. Presence of active cancer which requires chemotherapy or radiation therapy
9. Presence of acute urticaria, angioedema, or larynx edema
10. History or presence of alcohol abuse or drug addiction
11. Participation in any clinical trial within 4 weeks prior to enrolment
12. Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG
13. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
14. Intake of oral corticosteroids within 14 days prior to the beginning of the study
15. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
16. Pregnancy or breast-feeding
Evaluation of Patient's Knowledge of Their NACO Treatment

More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant .

The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect


Eligibility Criteria:
Inclusion Criteria:

* patient with AOD treatment
* capable to answer to questionnaire
* with or without antivitamin K

Exclusion Criteria:

* dementia
* cognitive trouble
* refusing participation
Effect of Prostacyclin on Haemostasis in Abdominal Surgery

The purpose of this study is to investigate the effect of continuous perioperative infusion of prostacyclin on haemostasis and endothelial functionality in patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men and women above 18 years old
* Undergoing Whipple surgery or liver resection
* Able and willing to give informed consent

Exclusion Criteria:

1. Allergy towards the study medication
2. In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists
3. Autoimmune disease
4. Intracranial bleeding within the last 6 months
5. Acute coronary syndrome or myocardial infarction within the last 6 months
6. Congestive heart disease
7. Pregnant or breastfeeding
8. Participating in another clinical study within the last 30 days
9. Liver cirrhosis
10. Need for renal replacement therapy
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
* Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
* Are of stable weight for at least 90 days prior to screening
* Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

* Have Type 1 Diabetes (T1D)
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory
* Have a prior or planned surgical treatment for obesity
* Have New York Heart Association Functional Classification IV congestive heart failure
* Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
* Have any lifetime history of a suicide attempt
* Had chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
* Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
Tranexamic Acid for Total Knee Arthroscopy

The purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.

Tranexamic acid (TXA) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. Various regimens of TXA administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. We are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of TXA administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. All recruited patients receive the first dose of 15mg/kg of IV TXA prior to skin incision. The second dose of 15mg/kg IV TXA or identical placebo is administered prior to the release of the tourniquet.

The assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (ROTEM). A blood sample is collected in the preoperative area and after the administration of each dose of TXA. Clinical data is collected until 90 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate.

Exclusion Criteria:

* Known allergy to TXA
* History of venous or arterial thrombosis within 12 months
* History of thromboembolic event within 12 months
* Acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months
* Known congenital thrombophilia

Relative Contraindications:

* History of seizures
* Impaired kidney function (Glomerular filtration rate \< 30 ml/min)
Study in Patients With Asthma

The purpose of this study is to determine which dose of the investigational drug is the most safe and effective in the treatment of asthma compared to the control drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of asthma

Exclusion Criteria:

* Current asthma exacerbation or recent asthma exacerbation, requiring hospitalization
* History of smoking
* Debilitating systemic and/or life-threatening diseases.
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy

To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.

Oral immunotherapy consisted in the administration of increasing amounts of raw emulsion egg. The children started with 1 drop of undiluted raw egg emulsion (0.05 ml) flavored with vanilla and cacao, hidden by the parents in the child's breakfast (cow's milk, soymilk, fruit juice or other). The dose was doubled at intervals of about one month in the day hospital. The increases in dose were customized for each subject based on the frequency and severity of side effects, or when an inter-current illness or asthma worsening intervened during the SOTI.

The investigators limited the SOTI protocol to six months for all patients, irrespective of the dose reached, in order to favor the adherence of families to the study.

When objective symptoms seemed more important (grade 2, 3 and 4 reaction), medical treatment was given. Subjects were discontinued from the study in case of severe adverse reactions (grade 5 reaction). Parents were advised they could telephone investigators 24 hours a day

Eligibility Criteria:
Inclusion Criteria:

* at least 1 anaphylactic reaction (grade 3, 4 and 5 according to Sampson's grading after accidental exposure to trace amounts of egg or egg-derivative products, requiring emergency treatment, at least 1 year before enrollment
* demonstration of egg white specific IgE by the skin prick test (SPT), end-point SPT, raw egg white prick-by-prick (PP) and egg white-specific IgE determination
* positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of less than 0.9 ml of raw emulsion egg

Exclusion Criteria:

* age below 5 years
* poorly controlled asthma
* parents with a history of unreliable management of complications and treatment.
A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.

To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Background: Intravenous injection of propofol produces pain. Many factors are involved and various techniques have been tried to minimize the propofol-induce pain with variable results.

Objective: To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Design: Randomize controlled trial. Method: Two hundred and ten ASA class I - III patients undergoing elective surgery were blinded and equally allocated into 3 groups. Patients in group N, L1, and L2 received MCT/LCT propofol 10 ml mixed with 0.9% NaCl 2 ml, 1% lidocaine 2 ml, and 2% lidocaine 2 ml respectively. Pain at time of propofol injection was assessed by blinded anesthesiologist on a four point scale ; 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Results: Patient's demographic data of each group were similar. There were significant differences in the incidence of propofol injection without pain among groups (p\<0.001). The numbers of patients who had moderate and severe pain in groups L1 and L2 were significantly less than those in group N (p\<0.001). The mean blood pressure and heart rate were not significant differences in among groups. Conclusion : The amount of 20 mg, and 40 mg lidocaine to MCT/LCT propofol in our study is equally effective in decreasing pain and more effective than MCT/LCT propofol alone group significantly. They were no significant differences in hemodynamics change in among groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I - III patients
* undergoing elective surgery
* age 18-75 years

Exclusion Criteria:

* allergy to propofol and lidocaine
* abnormal liver and renal functions
* has psychological problem or drug abuse
* has recieved analgesic drug 2 weeks prior to surgery
* risk of aspiration
Substance Abuse Pre-Treatment Screening Study

The overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. A second purpose is to have a consolidated intake data base on which secondary analyses can be conducted.

Approximately 1500 candidates per year will respond to advertisements and will complete preliminary telephone screening without identifiers. Appropriate candidates will be given appointment times and on arrival will undergo the consent process for evaluation. A complete medical, social, psychiatric, and drug use history will be obtained. Subjects fulfilling general health inclusion requirements will then be offered an appropriate study for which the specific consent will be obtained. The evaluation period will be no more than one day with all results evaluated within the two following days. Acceptable candidates will then be invited to complete the study specific consent.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to participate in 3- to 6-month treatment program.
* At least 18 years of age.
* Seeking treatment for substances of abuse including (cocaine, opiates, and alcohol).
* Generally physically healthy.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Mandated by the courts/parole officers to attend treatment.
* Not seeking treatment for substances of abuse.
* Plans to move from the Houston area within the 3- to 6-month treatment period.
* Seeking treatment for a substance for which the Treatment Research Clinic (TRC) has no current trial.
AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility Criteria:
Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option
* Gender: Males and Females.
* Age: 40 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
* Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.
* Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Irregular astigmatism (e.g. keratoconus)
* Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
* Monocular status (e.g. amblyopia)
* Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
* Diabetic retinopathy
* Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
* History of retinal detachment
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo

The present study will aim to evaluate:

1. The presence of Hypoxia Inducible Factor in vitiligo patient
2. Defect of Autophagy Related Genes in vitiligo patient
3. The cross relation between Autophagy Related Genes and Hypoxia Inducible Factor in the pathogenesis of vitiligo among Egyptian patients in Sohag Governorate


Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years
* With non segmental vitiligo
* A group of participants will be included as a control group

Exclusion Criteria:

* Pregnancy
* Patient with chronic inflammatory skin disorders
* patient on anti-oxidant or anti-inflammatory drugs
* patient on topical or systemic treatment for vitiligo in last 4 weeks
* patients with other autoimmune diseases
* patients with diabetes mellitus
Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

The purpose of this study is to determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). The goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. A successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.


Eligibility Criteria:
Inclusion Criteria:

1. Return to the OR for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) Exam findings within six weeks of index operation:

   * Drainage for more than 7 days
   * Wound appearance consistent with deep infection or hematoma
   * Persistent fever or evidence of bacteremia
   * All patients currently deemed appropriate for irrigation and debridement
2. Labs

   - Rising inflammatory seromarkers
3. Aspiration with a positive culture

Exclusion Criteria:

1. Previous history of periprosthetic infection
2. Prisoners
3. Patients not willing to consent for the proposed treatment
4. Patients with altered mental status
5. Concurrent metastatic infection
6. Superficial Infection