cyrilzakka/clinical-trials huggingface dataset:
A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).


Eligibility Criteria:
Inclusion Criteria:

* Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
* Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
* Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
* Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.

Exclusion Criteria:

* Subjects with clinically significant electrocardiogram (ECG) values.
* History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
* Receipt of an investigational product within at least 6 weeks prior to study drug administration.
* Subjects with moderate to severe kidney disease.
* Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
* Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.
A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug \[adalimumab or placebo\] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

Eligibility Criteria:
Inclusion Criteria

* Rheumatoid arthritis based on the American College of Rheumatology criteria
* Methotrexate or leflunomide naïve
* Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

* History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
* Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
* Joint surgery involving joints to be assessed within 8 weeks prior to Screening
LORA-PITA IV General Investigation

Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.

Eligibility Criteria:
Inclusion Criteria: Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Postoperative sore throat (POST) is a common outcome of general anesthesia in patients who undergo endotracheal intubation, and the estimated risk varies between 14.4% and 62%. It is one of the most undesirable postoperative anesthesia complications and has a negative impact on patient satisfaction and quality. Mucosal damage, inflammation, and erosion caused by endotracheal intubation all contribute to the development of POST. Therefore, POST is a condition that requires prevention and improvement.

In the study, patients will be divided into two groups. The investigators will include 100 patients undergoing surgery under general anesthesia. The first group will receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive standard anesthesia management as the control group.

Throat pain assessment will be conducted in patients at 2, 6, 12, and 24 hours after surgery.

Between November 2023 and December 2023, a total of 100 patients aged 18-65 with ASA 1-3 classification who are electively scheduled for laparoscopic cholecystectomy will participate in the study. Patients with ASA 4 or higher, those aged 65 and older, those under 18, and individuals with a known allergy to local anesthesia will not be included in the study. Patients who require intubation and are admitted to the intensive care unit or who experience mortality will be excluded from the study.

All patients will undergo preoperative assessment one day before the surgery, and written informed consent will be obtained for participation in the study. Patients will be randomly assigned to groups using a computer-generated randomization table. Patients in Group 1 will receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive standard anesthesia management as the control group.

Demographic data, medical history, American Society of Anesthesiologists (ASA) classification, and pre- and post-lidocaine administration cardiac output (CO) and oxygen consumption (VO2), anesthesia time, surgical duration, as well as the occurrence of postoperative hypotension (systolic blood pressure decreased by more than 20% from baseline or SBP \< 80 mmHg during surgery), nausea and vomiting, hypoxemia (SpO2 \< 90% or PaO2 \< 60 mmHg), hypercapnia (PaCO2 \> 45 mmHg), and agitation during the awakening period will be recorded.

Throat pain will be assessed and recorded at postoperative hours 2, 6, 12, and 24. Throat pain will be evaluated using a throat pain scoring system ranging from 0 (no pain) to 3 (worst imaginable pain). After the surgery, all patients will be transferred to the post-anesthesia care unit (PACU).

Eligibility Criteria:
Inclusion Criteria:

* electively laparoscopic cholecystectomy.

  * ASA I-III,
  * between 18-65 years

Exclusion Criteria:

* ASA IV and above

  • over 65 - under 18 years of age
* lidocaine allergy
Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma

The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with surgery.


Eligibility Criteria:
Inclusion Criteria:

* Clinical or pathological diagnosis of unresectable hepatocellular carcinoma (HCC) based on radiologic criteria, elevated alpha fetoprotein and/or tissue biopsy
* All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study
* Child-Pugh Liver Function Class A/B9
* Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2 at study entry
* Laboratory test results within protocol-specific ranges
* Disease free of prior malignancies for \>/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (Revlimid is only available under a restricted distribution program called "RevAssist.")
* Females of childbearing potential must have two negative pregnancy tests before starting lenalidomide and must agree to use two methods of birth control and submit to pregnancy tests throughout the study.
* Able to take aspirin daily as prophylactic anticoagulation
* Age \>18 years at the time of signing the informed consent form
* Life expectancy of at least 30 days

Exclusion Criteria:

* No serious medical condition, laboratory abnormality, or psychiatric illness (including no evidence of hepatic encephalopathy) that would prevent the subject from signing the informed consent form
* No pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
* No patients who have undergone surgical resection or received chemotherapy, percutaneous ethanol injection, radiation therapy or chemoembolization within 30 days prior to commencement of the study
* No condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* No use of any other experimental drug or therapy within 28 days of baseline
* No known hypersensitivity to thalidomide
* Patients who developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs will be excluded
* No prior use of lenalidomide
* No concurrent use of other anti-cancer agents or treatments
* No known positivity for HIV or infectious hepatitis, type B-8/9 or C
* No active infection not controlled effectively with antimicrobial or antiviral therapy
Borderline COVID-19 PCR Test Result

Follow-up of patients with a borderline PCR result. Data of patients that were re-tested within 96 hours after receiving a borderline COVID-19 PCR result are reviewed.

This is a retrospective study.


Eligibility Criteria:
Inclusion Criteria:

* Every individual that delivers a nasopharyngeal lysate for SARS-CoV-2 RNA determination by PCR.

Exclusion Criteria:

* Patients without a previous borderline COVID-19 PCR result within 96 hours are excluded for the follow-up study.
Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate

Exclusion Criteria:

* Subjects with any clinically important abnormal physical finding at screening.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline.
* Female subjects who are either pregnant or lactating.
Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in Adults

The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.

The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 65 years old
* First transplantation recipients
* PRA \< 30%
* Living or cadaveric donor
* Stable renal function
* Patients not pregnant or breastfeeding , where pregnancy is defined as the woman status from conception to gestation conclusion, through a positive beta hCG test (\>5mUI/mL)
* Provided written informed consent form

Exclusion Criteria:

* Cadaveric donor with expanded criterion
* Multiple organs transplantation
* Kidney cold ischemia time \> 24 hours
* Severe rejection episode - Banf \>IIA
* Glomerular filtration rate \< 35mL/min
* Presence of hard to treat dyslipidemia - severe hypercholesterolemia (\>350mg/dL) or hypertriglyceridemia (\>500mg/dL)
* Proteinuria \> 800mg/24h
* Patients with history of malignancy of any organic system, treated or not, within 5 years, with or without evidence of local recurrence or metastases, other than localized basal cell carcinoma
* Female with childbearing potential without using a reliable contraceptive method.
Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology

Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.

The study is observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study. This study will be offered to any patient with thyroid pathology (hypothyroidism, hyperthyroidism/thyrotoxicosis, benign thyroid nodule, and thyroid carcinoma) followed by our Center with a minimum 3-month follow-up. In the retrospective phase, patients in whom thyroid pathology was diagnosed from 01/01/1995 until the approval of this study will be enrolled, while in the prospective phase those diagnosed from the time of the approval of this study to the next 10 years will be enrolled. In both phases, each patient will be followed for a maximum duate of 20 years.

Patients participating in the study will not undergo any procedure (laboratory or instrumental examination, examination or treatment) that is beyond the scope of normal daily clinical practice. Likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years at the time of diagnosis;
* Patients with thyroid pathology (hypothyroidism, hyperthyroidism/thyrotoxicosis, benign thyroid nodule, and thyroid carcinoma) in whom the diagnosis was made in our Center or another Center from 01/01/1995 until the approval of this study (retrospective phase) or from the time of approval of this study to the next 10 years (prospective phase);
* Obtaining informed consent.

Exclusion Criteria:

* Follow up lasting less than 3 months;
* Incomplete or missing clinical data that may affect the correct assessment of the patient.
Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if there are fewer respiratory infections and improved lung function in patients with CF when taking esomeprazole.

This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Cystic fibrosis
2. Age \> 18 years
3. Stable maintenance medical regimen during the previous 6 weeks.
4. Negative pregnancy test (women of childbearing potential) at both screening and baseline visits.
5. Women of childbearing potential must be using medically acceptable contraception.
6. At least two respiratory exacerbations per year requiring oral and/or intravenous antibiotics for each of the two years prior to study entry, but no more than 4 exacerbations requiring intravenous antibiotics during either of those years.

Exclusion Criteria:

1. Previous anti-reflux or peptic ulcer surgery,
2. Use of proton pump inhibitor (PPI) within the past two weeks
3. Pulmonary exacerbation requiring antibiotics within the previous 2 weeks
4. Parenteral hyperalimentation
5. Cigarette smoking
6. Treatment with azoles, iron, anti-coagulants, digitalis
7. Use of any investigative drugs within the previous month.
8. Use of over the counter acid suppressor agents (not including acid neutralizers)
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

OBJECTIVES:

Primary

* Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.

Secondary

* Determine the survival of patients treated with this therapy.
* Determine distant recurrence of disease in patients treated with this therapy.
* Determine the toxicity of this therapy in these patients.
* Determine the quality of life of patients treated with this therapy.

OUTLINE: This is a nonrandomized study.

Patients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system.

Quality of life is assessed at baseline and then every 3 months for 2 years.

Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan

  * Resectable disease
  * Histological evidence of metastatic carcinoma by intraoperative pathology
* No primary lymphoma, germ cell carcinoma, or small cell lung cancer

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* At least 3 months

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Cardiovascular

* No uncontrolled hypertension
* No unstable angina pectoris
* No uncontrolled dysrhythmias

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious infection
* No other medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis

Endocrine therapy

* Not specified

Radiotherapy

* No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery
* No concurrent external beam radiotherapy to the brain
* Not planning adjuvant whole brain radiotherapy after study therapy

Surgery

* Not specified

Other

* No other prior conventional or investigational local or systemic agents for brain metastasis
Video Interaction Project in Brazil

Early exposure to poverty is associated with adverse impacts on long-term educational achievement. Support of positive parenting is a key strategy to prevent emergence of socioeconomic disparities in child development. This study will assess the feasibility of the pilot implementation of an evidence-based parenting program designed to prevent disparities in child development, the Video Interaction Project (VIP), in Brazil, as an exemplar low- and middle-income country (LMIC), and explore changes in parenting and child outcomes after participation in the program.

This international study will be conducted in Southern Brazil. After translation and cultural adaptation of VIP materials (Aim 1), a qualitative investigation of VIP implementation feasibility (Aim 2) will be conducted using semi-structured interviews and observation of engagement for approximately 50 caregiver-child dyads with children 0-5 years who will participate in 3 VIP sessions. To explore changes in parenting and child outcomes (Aim 3), dyads enrolled in the study (for Aim 2) will complete assessments pre- and post-participation in 3 VIP sessions.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver-child dyads with at least one child age 0 to 5 years;
* Caregiver can be contacted (has a working phone); and
* Caregiver is 18 years old or older.
* Child is 1 day to 5 years old

Exclusion Criteria:

* Caregiver is under 18 years old; and
* Child has a neurodevelopmental disability or known or suspected genetic syndrome
Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma

Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* The patient has pathologically proven hepatocellular carcinoma (any stage)
* All the data required are available from patient's records

Exclusion Criteria:

N/A
Registry to Collect Health Information Related to Fibrolamellar Cancer

The purpose of this study is to collect information about people with fibrolamellar cancer (FLC). This study is a registry of people with FLC around the world. This study will involve collecting information about participants, their medical history and the regular medical care they receive for FLC. The study will not provide treatment for your cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 years or older.
* Personal history of histologically proven fibrolamellar carcinoma (clinical or radiographical suspicion of FLC must be confirmed at MSK or an external hospital)
* Participants must have access to electronic devices that meet the following minimum requirements:

  * Ability to connect to the internet
  * Capability of running modern internet browers (such as Google Chrome, Internet Explorer, Safari, or Mozilla Firefox).
* Participants must have a google account

Exclusion Criteria:

* Participants residing in the European Union (EU).