cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis

The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol in adults with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 69 years of age inclusive, at the time of signing the informed consent
* Participant must have a diagnosis of moderately-to-severely active rheumatoid arthritis (RA)
* Participant must have had an inadequate response to, or intolerance to, at least 1 disease modifying antirheumatic drug (DMARD) (nonbiologic or biologic)
* Participant has a negative interferon-gamma release assay (IGRA) at Screening
* Participant has a body mass index within the range 18.0 kg/m2 to 35.0 kg/m2 (inclusive)
* Male or female
* A female participant is eligible to participate if:

  i) she is not pregnant, ii) not breastfeeding, iii) at least one of the following conditions applies:
  1. Not a woman of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and until the Safety Follow-up (SFU) Visit

     Exclusion Criteria:
* Participant has a known hypersensitivity to any components of the study medication(including polyethylene glycol) or comparative drugs (and/or an investigational device) as stated in this protocol
* Participant has clinically significant electrocardiogram (ECG) abnormalities at Screening
* Participant has previously been exposed to certolizumab pegol (CZP)
* Participant has failed treatment with ≥1 tumor necrosis factor (TNF) α inhibitor or was a primary failure for any TNFα antagonist. A primary failure is defined as no clinical disease improvement within the first 12 weeks of treatment (study participants who demonstrated clinical response within 12 weeks of treatment and subsequently lost response after 12 weeks of treatment are eligible)
* Participant has received a live vaccination within 6 weeks prior to Screening or intends to have a live vaccination during the course of the study or within 3 months following CZP treatment in the study
* Participant has received any investigational drug or experimental procedure within 90 days prior to the first dose of IMPinvestigational medicinal product (IMP)
* Participant has a laboratory abnormality at Screening, including any of the following:

  1. \>3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP); or \>ULN total bilirubin (\>1.5x ULN total bilirubin if the participant has a documented pre-study diagnosis of Gilbert's syndrome)
  2. white blood cell count \<3.00x103/μL
  3. absolute neutrophil count (ANC) \<1.5x103/μL
  4. lymphocyte count \<500 cells/μL
  5. hemoglobin \<8.5 g/dL
  6. Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the study participant from completing the study or will interfere with the interpretation of the study results
PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.

This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
2. Age≥18;
3. ECOG≤1;
4. Patient willing to participate;
5. Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.

Exclusion Criteria:

1. Extra-abdominal metastases;
2. Siewert I type gastroesophageal junction cancer;
3. Mechanical bowel obstruction;
4. Allergy to study drugs;
5. History of previous intraperitoneal chemotherapy;
6. Pregnancy of refusal for birth-control at least 6 months post-study treatment
Project Power: An HIV Risk Reduction Intervention for Black Men Who Have Sex With Men and Women (BMSM/W)

The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.

The purpose of this study is to examine the preliminary efficacy, feasibility and acceptability of delivering a culturally and developmentally tailored HIV risk reduction intervention via the Internet in real-time that promotes risk reduction among black men who have sex with men and women (BMSMW). During the Developmental Phase, our activities will consist of completing development (finalizing sessions, completing the manuals) of a theoretically grounded, culturally based, individual intervention, Project POWER, to reduce risk of HIV acquisition and transmission among BMSMW.

The investigators will then conduct a randomized controlled trial (RCT) to test the preliminary efficacy, acceptability, and feasibility of POWER compared to HEALTH. Using chain referral methods, the investigators will recruit 200 BMSMW (100 per arm) and assign them to 1 of 2 conditions (POWER or HEALTH). Participants will complete an assessment battery delivered via ACASI at baseline, immediate post intervention and at 3 months post intervention. The investigators will also measure uptake of HIV and STI testing. Participants will also complete acceptability/feasibility assessments after the

Eligibility Criteria:
Inclusion Criteria:

* Self identify as Black or African descent
* At least 18 years of age
* Resident of Chicago MSA
* Sexually active with men and women

Exclusion Criteria:

* Previously participated in the study
* Identify as transgendered
National Survey on Gastroesophageal Reflux Disease (GERD) Patients

The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> or = 18 years old
* Patient with symptomatic GERD
* Without PPI or H2 antagonist treatment during the 3 previous months
* Agree to take part in this study

Exclusion Criteria:

* Pregnant women
Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
* Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
* The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
* Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
* Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin

Exclusion Criteria:

* Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and \<2 log decrease in HCV RNA at Week 12 from baseline.
* HCV Genotype 2 or 3
* Severe neuropsychiatric disorder.
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
* Known HIV infection or positive HIV at screening.
* Pregnant or breast-feeding patients.
* Underlying autoimmune disease
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated.
* Patients with AML (arising from an antecedent hematologic disease \[AHD\]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML.
* AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML)
* For a diagnosis of AML, a bone marrow blast count of 20% or more is required.
* For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts
* Adequate Organ Function
* ECOG Performance Status 0, 1, or 2

Exclusion Criteria:

* AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.
* Patients with known active uncontrolled central nervous system (CNS) leukemia.
Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34

A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.


Eligibility Criteria:
Participants fulfilling all of the following inclusion criteria are eligible for the study:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend appointments
* Limited ability to describe listening impressions or to use hearing aids/ accessories
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp

Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.

Propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. Propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. The aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. Methods: Forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. Treatment was done in two visits and intracanal medicament was applied for one week in between. Participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.

Eligibility Criteria:
Inclusion Criteria:

* • Asymptomatic patients with age range 20 - 40 years

  * Necrotic, single canal maxillary and mandibular teeth with periapical infection presented as radiolucency or widening in the periodontal membrane space.
  * Medically - free of any systemic disease
  * Teeth with complete root formation

Exclusion Criteria:

* • Pregnant or lactating females

  * Teeth with vital pulps, internal or external resorption or anatomic abnormalities
  * Teeth with cracks, curvatures, root caries and calcified canals
  * Double or triple-rooted teeth
  * Patients with facial swelling, acute pulpal or periapical lesion
  * Teeth that are not indicated for endodontic treatment: Bad oral hygiene, mobile or recessed
  * Previously endodontically-treated teeth
Pathways to Employment for the Long-term Unemployed

This project's aims are twofold (1) to uncover and define the underlying theories of change guiding competing active labor market programs (ALMP) in Sweden, and (2) to assess the relative effectiveness of these competing programs in a theory-based non-randomized controlled trial. The purpose is to assess the extent to which competing ALMPs are effective in moving long-term unemployed individuals (i.e. unemployed for 6 months or more) closer to the labor-market.

Long-term unemployment has a profound impact on the health and wellbeing of individuals, families, and communities. In addition, the effects of long-term unemployment have been found to impact subgroups differently. Today there is scant knowledge on the mechanisms that are influential in moving individuals from long-term unemployment closer to the labor market. This study is designed to answer six research questions using a variety of methods (mixed-methods) and outcome measures (self-report, official register). In addition, this study leverages official register data to construct an untreated control group. This study will assess the extent to which an emerging theory of becoming job ready holds under experimental scrutiny.

This project will engage ALMP program administrators and service providers in semi-structured interviews. A total of 6 competing ALMPs will be included in the study. The transcribed interview material will be used as a basis for program theory reconstruction. All specified program theories will be presented back to program stakeholders for validation. ALMP program effectiveness will be assessed quasi-experimentally with pre- (T1) and posttest (T2) collection of self-reported data. Additionally, official register data from the Longitudinal integrated database for health insurance and labor market studies (LISA) will be collected for all participants. In addition, a matched sample will be collected from LISA to be used as a non-treated control group on final policy outcomes (e.g., employment, salary/wage). This study also assesses program implementation and economic outcomes of competing the competing ALMPs.

Eligibility Criteria:
Inclusion Criteria:

* Unemployed for a period of at least 6 months, and
* 25 years old or younger, or
* born outside of Sweden, or
* 55 years old or older without higher education, or
* has a disability (physical, intellectual, neuropsychiatric, or mental) and
* receives social insurance benefits, or
* receives social welfare benefits

Exclusion Criteria:

* referred for services primarily by the Department of Justice
Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients

Prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ARDS) and in COVID-19 infection.

A large number of patients with COVID-19 suffered from new-onset cardiac disease, therefore, ECG is crucial.

However, there is limited data on the effects of prone position on the ECG in COVID-19 patients.

Prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ARDS) and in COVID-19 infection. The evidence showed that a large number of patients with COVID-19 suffered from new-onset cardiac disease due to inflammatory processes or cytokine storm, therefore, ECG is crucial for making the diagnosis including arrhythmias and myocardial infarction. However, there is limited data on the effects of prone position on the ECG in COVID-19 patients. Therefore, we aimed to identify differences of electrical parameters between prone position and standard ECG including the difference in amplitude and duration of P, QRS, PR interval, QT interval, ST-segment between both positions (supine and prone). Furthermore, we aimed to compare clinical diagnosis from EKG between prone position and standard ECG by the cardiologists.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients who were admitted to the COVID-19 specialized ward
* Age 18 -80 years old
* Suffered from pulmonary infiltration

Exclusion Criteria:

* Intubated patients
* Cardiac arrest patients whether at presentation or during the study period
* ECG cannot be performed due to anatomical defects or superficial skin problems
Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia

The primary objective is to establish the feasibility of using TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who recieved TMS at several timepoints.

Participants will be randomized to either receive transcranial magnetic stimulation (TMS), Sham-TMS (a non-therapeutic TMS coil which sounds and feels similar to normal TMS), or standard treatment during the weeks of wait time before surgery for chronic orofacial pain (COFP). TMS is a noninvasive, painless magnetic device which, when applied to the head for a few minutes, has been shown to reduce pain in people with COFP. The sham TMS is a sub-therapeutic level of magnetcic stimulation which makes the same sound as normal TMS and causes a similar tingling of the skin.

Both those who receive this new pain intervention and those who do not will be asked to fill out a short online survey about their pain at several points during the study. The survey takes about 10 minutes to fill out and each of the 5 TMS sessions last 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facial pain
* Considered an appropriate candidate for surgical or stereotactic intervention - microvascular decompression or stereotactic radiosurgery- ( includes factors such as overall health, chronic medication, comorbidities) and patient preference
* Between ages 18-100
* Able to participate in 5 consecutive TMS treatments
* Has at least 3 weeks between pre-op visit and scheduled date of surgery
* Able to provide consent and complete online questionnaires on their own

Exclusion Criteria:

* Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facial pain)
* contraindication to TMS, per device guidelines:

Metallic implant in or near head Implanted stimulator on or near head recent suicidal ideation history of epilepsy, stroke, or unexplained seizure

- Need for urgent/emergent surgical decompression.