cyrilzakka/clinical-trials huggingface dataset:
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer

The purpose of this study is to evaluate the efficacy, tolerability and safety of a multi-targeted therapy in patients with hormone-refractory prostate cancer.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration).
* Patients must have increasing PSA levels (within 3 months prior to enrollment) with at least two consecutively increasing PSA levels.
* PSA value before inclusion must be at least 5 ng/ml
* At least 18 years of age.
* At least capable of self care and up of at least 50% of waking hours (ECOG performance status 0 - 2), adequate bone marrow function and lab results.

Exclusion criteria:

* Change of hormone therapy within 6 weeks prior inclusion
* Prior chemotherapy
* Therapy with Imatinib, or therapy with other inhibitors of tyrosinkinase.
* Second neoplasm diagnosed within 5 years before study start.
* Patients who require therapy with warfarin
* Known diagnosis of HIV, hepatitis B, or hepatitis C infection.
* Severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency
* Surgical therapy within 4 weeks before inclusion.
* Prior therapy with isotopes strontium or rhenium.
* Radiation therapy to \> 25% of bone marrow within 4 weeks before inclusion.
* Treatment with other experimental substances within 30 days before study start.

Other protocol-defined inclusion/exclusion criteria may apply
A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects

The objective of this study is to evaluate the safety and effectiveness of topical KIO-201 in patients with persistent corneal epithelial defects (PED). KIO-201 will be administered six (6) times per day while awake for 4 weeks.

The primary exploratory effectiveness outcome for this study is the percentage of patients achieving corneal healing as determined by corneal fluorescein staining and photos. The effectiveness endpoint will be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.

This is a prospective, exploratory study in which up to 10 patients (up to 20 eyes \[minimum of 10 eyes\]) diagnosed with Stage 1 and Stage 2 PED (as defined by fluorescein staining of the cornea and refractory to one or more conventional non-surgical treatments of at least 2 weeks) will receive KIO-201 with a dosing regimen of six (6) times per day over 4 weeks.

Both eyes are to be included if both eyes meet inclusion criteria and both eyes will be treated with KIO-201.

Patients will followed for a 4 week study.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older.
* Patients with persistent corneal epithelial defects (PED) (Stage 1 and Stage 2 PED).
* Patients with PED in one or both eyes, at least one eye meeting all study criteria.
* Have PED of at least 2 weeks' duration refractory to one or more conventional non-surgical treatments for Stage 1 and Stage 2 PED (i.e., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops).

Exclusion Criteria:

* Have any active ocular infection (bacterial, viral, fungal or protozoal) in the affected eye(s).
* Schirmer's test without anesthesia ≤ 3 mm/ 5 minutes in the affected eye(s).
* Patients who have received amniotic membrane transplantation and have not healed.
* Patients treated with a bandage contact lens but have not healed.
* Prior surgical procedure(s) for the treatment of PED in the affected eye(s).
* Patients with lid abnormalities.
* Corneal disease that may affect outcomes.
* Stage 3 PED.
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adults 18-70 years of age;
* HBeAg-negative chronic hepatitis B for \>/=6 months;
* liver disease consistent with chronic hepatitis B.

Exclusion Criteria:

* interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy \</=12 months before first dose of study drug;
* non-responders to previous interferon therapy;
* co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
* hepatocellular cancer;
* compensated (Child A, score 6) or decompensated liver disease (Child B or C).
Role of Magnesium in Pediatric Cochlear Implant

To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery. Also its effects on the intraoperative evoked stapedial reflex thresholds (ESRT) and the intraoperative anesthetic requirements were evaluated.

Sixty-six ASA I and II children (1-6 years) undergoing cochlear implantation under general anesthesia were enrolled in this double blind, randomized study. Children were randomly allocated into two equal groups. Children in Group M (magnesium sulphate group) received an iv bolus dose of magnesium sulfate 40 mg Kg-1 over 5 minutes before induction of anesthesia followed by 15mg Kg-1 h-1 infusion until the start of skin closure. Children in Group C (Control group) received equivalent volumes of isotonic saline solution over the same period instead of magnesium sulphate. Haemodynamic variables, quality of surgical field, ESRT and the intraoperative anesthetic requirements were recorded

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II children

Exclusion Criteria:

* uncontrolled hypertension,
* diabetes mellitus,
* liver disease,
* kidney disease,
* heart disease,
* allergy to magnesium sulphate,
DePuy Synthes Variable Angle LCP Patella Plating System Study

The Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System is an FDA approved device. The purpose of this study is to see how well the Depuy Synthes LCP Variable Plating System work in fixing a broken kneecap (patella). Depuy says that the device will improve healing when compared to traditional ways of repairing a broken patella.

The goal of this randomized control trial is to learn how well the LCP Variable Plating System works to fix a broken patella (kneecap) compared to traditional fixation methods, in male and females, age 18 to 74, with a patellar fracture, and being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital. The main question it aims to answer are:

* To understand if the Depuy Synthes LCP Variable Angle Plating System will provide a better way to help patients recover from a broken patella.

Participants will evaluated at specific time points: post-op day 1, 6 weeks, 3 months, 6 months, and 12 month post-surgery. Participants will be asked to:

* Complete surveys at all evaluation timepoints.
* Have x-rays(radiographs) taken at the 6 week, 3 month, 6 month, 9 month, and 1 year timepoints.
* Participants will have a passive range of motion tests done at 6 week, 3 month, 6 month, 9 month, and 1 year timepoints.
* Participants would have strength and balance tests done at the 3 month, 6 month, 9 month, and 1 year timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age between 18 and 74 years old (inclusive)
* Patellar fracture
* Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital

Exclusion Criteria:

* Age greater than or equal to 75 or less than 18
* Patients that are non-ambulatory/limited ambulation prior to their injury
* Previous patellar fracture
* Pre-existing osteoarthritis of the knee
* Ipsilateral femoral or tibia fractures
A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive

Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.

Eligibility Criteria:
Inclusion Criteria:

* Must be a female between 13-45 years of age
* Must have a history of seizures
* Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill

Exclusion Criteria:

* Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill
A Research Study Looking at the Safety of Single Doses of ZP9830 and How it Works in the Body of Healthy Participants

The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.

Part A: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c), and safety and PK will be assessed.

Part B: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.) and safety, PK and PD will be assessed.

Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed.

Eligibility Criteria:
Inclusion Criteria:

Healthy male subject.

18-45 years of age (inclusive).

Body weight ≥50 kg.

Part B only: Fitzpatrick skin type I-III (Caucasian).

C-reactive protein ≤10 mg/L.

Further inclusion criteria apply.

Exclusion Criteria:

Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of it might interfere with, the conduct or the interpretation of the results of the trial, or that would pose an unacceptable risk to the subject in the opinion of the Investigator \[following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead ECG\].

Any disease associated with immune system impairment, including immune mediated diseases and transplantation patients.

Any confirmed significant allergic reactions (urticaria or anaphylaxis) to insect bites.

History of neurological disorders including neuropathy, as judged by the investigator.

Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food (in particular any level of severity of allergy to shellfish), or multiple drug allergies (non-active hay fever is acceptable).

Further exclusion criteria apply.
Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function

Assess the values of train-of-four ratios with the TetraGraph and thoses obtained with the TOFscan during recovery of neuromusculat function in surgical patients who have been administred rocuronium.

Primary outcome : value of TOFratio with the TetraGraph when TOFratio of TOFscan is greater than or equal to 90% Pilot study : no hypothesis


Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 18 years old
* patients willing to participate and provide an informed consent
* elective surgical procedures, without emergency, administration of rocuronium for neuromuscular blockade, and recovery of complete neuromuscular function at the end of the surgery

Exclusion Criteria:

* patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or similar wrist injury
* patients with systemic neuromuscular diseases such as myasthenia gravis
* renal insufficiency or renal failure
* significant liver disease
* patients having surgery that would involve prepping the arm into the sterile field
* allergy to rocuronium
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).

The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.

The study is looking at several other research questions, including:

* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
2. Tumor biopsy is required during screening period as described in the protocol
3. Participant is willing to undergo delayed surgery
4. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

1. Stage I or II CSCC
2. Anogenital, penile, vermilion lip CSCC
3. CSCC bone invasion
4. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
5. Prior radiation therapy for CSCC
6. Myocardial infarction within 6 months of enrollment, or history of myocarditis.
7. Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion Criteria apply
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Be able to handle the bags themselves or with help from caregiver
* Have an ileostomy with a diameter between 15 and 45 mm
* Have had their ostomy for at least three months
* Currently use a 1-piece flat standard care product with open bag
* Negative result of a pregnancy test for women of childbearing age
* Custom-cut product user
* Be suitable for participation in the investigation

Exclusion Criteria:

* Use irrigation during the study (flush the stoma with water)
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
* Are pregnant or breastfeeding
* Participating in other interventional clinical investigations or have previously participated in this investigation
* Max three days wear time
* Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.

Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes at week 12.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 years of age
* Smoke ≥ 5 cigarettes per day (CPD)
* Smoke menthol cigarettes for ≥ 6 months
* Verified smoker (CO \>5ppm)
* Functioning telephone
* Interested in switching to E-cigarettes

Exclusion Criteria:

* Interested in quitting smoking
* Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes)
* E-cigarette use on ≥ 4 of the past 30 days
* Uncontrolled hypertension: BP ≥ 180(systolic) or ≥ 105 (diastolic)
* Use of smoking cessation pharmacotherapy in the month prior to enrollment
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine

1. Exploit CT (plain scan), enhanced CT and fMRI based radiomic biomarkers, explore their correlation with the prognostic molecular markers of spinal GCTB(p53/vegf/rank/rankl...), and help accurate diagnosis of GCTB.
2. Exploring a new method of preoperative risk stratification for spinal GCTB, and establishing radiomic model combined with clinical features. Exploring the GCTB biological behavior prediction model and the prognosis prediction of GCTB.

This study intends to conduct a systematic review of patients with spinal GCTB who have undergone standardized imaging (CT or MRI) in our hospital since 2006 to obtain case samples, conduct standardized clinical and imaging data extraction and analysis, and fully integrate histopathology and clinical follow-up results. To preliminarily explore the value of postoperative imaging-based radiomics markers in the preoperative precise diagnosis of spinal GCTB, risk stratification and prediction of tumor biological behavior.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with spinal GCTB who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study.

Exclusion Criteria:

* i) The CT scan was performed more than 1 week before surgery ii) Poor image quality. Such as surrounding structure artifacts; iii) The remaining tumor tissue in the postoperative paraffin specimen is too little to be used for reanalysis; iv) Cases with negative H3F3A (H3 histone, family 3A) staining were excluded; v) Incomplete clinical information.
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery

The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery. The primary endpoint is the assessment of STEELEX® Sternum Set effectiveness for sternal healing at month 1 ± 1 week post-surgery. This study is designed as a prospective, non-interventional, single center, Post Market Clinical Follow-Up cohort study.

The products under investigation will be used in routine clinical practice and according to the instructions of use. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied, and all study visits will coincide with those that will be scheduled for routine follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients.
* Age ≥ 18 years.
* Scheduled sternotomy within the next 3 days.
* Use of STEELEX® Sternum Set + Bone Wax® for sternotomy following routine clinical practice
* Use of STEELEX® Electrode Set in temporary epicardial cardiac pacing during the postoperative phase of open-heart surgery in combination with an external pacemaker following routine clinical practice.
* Written Informed Consent form.

Exclusion Criteria:

* Participation or planned participation in any clinical trial before study follow-up is completed.
* Pregnancy and/or breastfeeding.
* Patient undergoing emergency surgery.
* Patients taking medical consumption that might affect sternal healing (based on investigator's own clinical criteria)
* Patient with any hypersensitivity or allergy to the components of the medical device.
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
* Use of STEELEX® Electrode Set in permanent cardiac pacing or for permanent monitoring.
Haufen Diagnostic Biomarkers of BK Renal Disease

To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Recipient of renal transplant
* Positive for polyoma virus
* Haufen cells present in urine
* Positive for polyoma virus nephropathy

Exclusion Criteria:

* anyone who does not meet the inclusion criteria