cyrilzakka/clinical-trials huggingface dataset:
A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in Japan.

This is a single-arm study to evaluate the efficacy and safety of TMC435 in combination with the standard of care (SoC), PegIFNα-2a (P) and ribavirin (R), in adult, genotype 1 HCV-infected participants who relapsed after previous IFN-based therapy in Japan. The study objective is to evaluate the efficacy of TMC435 by the percentage of participants with undetectable HCV ribonucleic acid (RNA). Participants will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus PR followed by 12 or 36 weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally (via the mouth). Treatment with PR will last 24 or 48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 µg PegIFNα-2a and will be injected by a syringe under the skin once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg), taken orally two times a day after meals. The participants will receive oral capsules of TMC435 (100 mg) once daily up to Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have chronic genotype 1 HCV with HCV RNA level \>= 5.0 log10 IU/mL
* Participant relapsed after previous IFN-based therapy
* Participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.

Exclusion Criteria:

* Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
* Diagnosed with hepatic cirrhosis or hepatic failure
* A medical condition which is a contraindication to pegIFN or ribavirin therapy
* History of, or any current medical condition, which could impact the safety of the patient in the study
Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"

The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on concomitant Brentuximab Vedotin in routine clinical practice.

The drug being tested in this survey is called Brentuximab Vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL).

This survey is an observational (non-interventional) study and will look at the safety of adult patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL in the routine clinical setting. The number of observed patients will be approximately 86 as total (80; Adult participants and 6; Pediatric participants).

This multi-center observational survey will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with relapsed or refractory lymphoma.
2. CD30-positive participants.
3. Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Exclusion Criteria:

1. Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
2. Participants taking bleomycin hydrochloride treatment.
Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease

To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
* 1) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
* 2) Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
* Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
* Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
* Hoehn \& Yahr \> 1 (symptoms on only one side of the body) with treatment and \< 3 (mild to moderate bilateral disease; some postural instability; physically independent).
* Dopamine agonist dose must be stable for ≥30 days preceding the baseline visit.
* For patients who are receiving amantadine or anticholinergics, the dose must have been stable for ≥30 days prior to screening.
* Medically stable outpatients (Investigator's judgment).

Exclusion Criteria:

* receive rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding baseline
* receive levodopa \> 21 consecutive days within 90 days prior baseline
* moderate to severe motor fluctuations
* hepatic impairment
* investigational medications 30 days preceding baseline
* dopamine agonist use \> 5 years prior to baseline
* major depression as defined by Beck Depression Inventory (BDI) short form score greater than 14
* significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score less than 26.
* impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease form (QUIP).
* pregnant or lactating or planning on becoming pregnant in the next 18 weeks
* uncontrolled hypertension. Patients whose hypertension is controlled with medications are eligible.
* Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO inhibitors not allowed
Ibedrift- A Trial Comparing a New Approach to Musculoskeletal Pain Consisting of Education and Peer Involvement to Treatment as Usual

A randomized controlled trial comparing a new approach to musculoskeletal pain consisting of education and peer involvement to treatment as usual. All local government employees in 1-3 Norwegian municipalities will be invited to participate.

The purpose of the study is to systematically test a new treatment method for musculoskeletal pain in Norway. The intervention focuses on attempting to treat musculoskeletal pain outside the traditional medical system as much as possible, to avoid the establishment of a patient identity and passive patient behavior. In addition, participants are given reasons to stay active, and not advice to stay active.

Ibedrift is a randomized controlled trial with the aim of studying the effect of a new treatment regime for musculoskeletal pain, focusing on didactic information about low back pain with peer support. Those participants not in the control group will have the option of contacting a peer advisor, a non health professional trained by the iBedrift crew to give information about back pain and reasons to stay active. For those who have not recovered within a short period of time, and who are randomized to full treatment, the peer advisor can send them directly to health personnel for a brief intervention consisting of a medical examination with screening for conditions that need treatment, counseling and education.

The intervention was done in 2 Norwegian municipalities for all local government employees. Randomization was done at the level of working units (schools, offices etc) which allows for more message containment.

Eligibility Criteria:
Inclusion Criteria:

* All employees above 18 years

Exclusion Criteria:

* Cancer
* Known congenital musculoskeletal disease
* Cauda equina syndrome
Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia

At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear to what extent the disease will devastate cognitive abilities within the next years. This is not only unsatisfying for the patient and the attending physician but also a major problem in the context of clinical trials that aim to establish new therapeutic agents. In clinical trials it is critically important to foresee as precisely as possible the course of the disease. The overall aim of the subproject is to identify a panel of CSF biomarkers to further improve specificity of diagnosis ("disease markers"), to measure disease activity and to predict AD progression ("stage and progression markers").

Within the last years, protein analyses of Aβ-species in the cerebrospinal fluid (CSF) and amyloid-imaging using F18-based PET-tracers have become a part of the diagnostic repertoire in specialized memory clinics allowing a neurobiological, biomarker-based validation of Alzheimer´s disease (AD) diagnosis. This has led to a substantial increase in the specificity of the diagnostic procedure. However, the problem remains that the diverse factors, which influence disease progression are largely unknown, while tools for diagnosis have improved substantially.

We will identify patients for participation in a long-term clinical follow up study. Biomaterial (CSF, blood) will be obtained at baseline and subjected to a detailed protein analysis. In a subset of patients, a lumbar puncture will be repeated to compare baseline and follow up CSF. Within this study, a panel of proteins, comprising Aβ- and Tau-species as well as inflammation, glial and synaptic markers, potentially involved in disease progression will be measured in biomaterial from baseline and from follow up assessment. Clinical data will be correlated with the panel of disease and progression markers.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Alzheimer´s Disease

Exclusion Criteria:

Other neurological or psychiatric diseases Stroke
Acupuncture as a Supplemental Treatment for Bipolar Depression

The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of Bipolar Depression.

Patients receive 8 weeks (12 sessions) of acupuncture treatment plus stable medication. Patients are randomly assigned to receive either acupuncture designed to relieve symptoms of depression or acupuncture designed to relieve some other legitimate physical condition. A comparison group of patients who take medication but do not receive acupuncture is assessed to evaluate the effectiveness of medication alone. Patients participate in clinical assessment each week, which includes visiting with a psychiatrist and completing symptom rating scales.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for bipolar I disorder or bipolar II disorder
* Demonstrate symptoms of depression as determined by a minimum score of 25 on the Inventory for Depressive Symptoms-Clinician Rated Scale
* Have taken stable psychoactive medications for at least 30 days prior to study entry
Developing a mHealth Simulation Platform for Youth

The investigators will conduct a 12-week single group feasibility pilot field study among youth who will use a diabetes technology education application in their natural home environment.

The investigators will purposively select N=20 youth with at least 6 youth from each of 3 age ranges (10-12, 13-15, and 16-18) from eligible participants. Youth will use the software in their home environment for 12-weeks. Youth's diabetes device data will be used to select simulation content, targeted to meet each participant's educational needs. Youth will meet with research staff via video chat at the onset of testing where a URL link to the platform will be shared. Youth will be assigned 3 scenarios/week. At the end of each scenario youth are guided to additional resources in the platform that they may choose to access. Youth will meet with a member of the research team via video chat or phone call weekly to discuss platform issues or confusion as well as any questions regarding self-management content. Platform performance will be monitored by researchers and performance data will be collected and stored within the application database.

Feasibility measures will include recruitment, weekly research sessions attendance, and global attrition data. Sustained engagement measures will be collected from the application database and will include the frequency platform was accessed, number of assigned simulations completed (3 per week), and additional, optional, content accessed. Glycemic control measures including A1C will be obtained from the youth's EHR. Youth's diabetes devices will be downloaded at baseline and at 4, 6 and 12 weeks. Glucose values from device downloads will be aggregated into derived measures of glucose control consistent with American Diabetes Association guidelines on glucose targets. Self-management patterns and responsiveness will be assessed using pre- and post- diabetes device downloads at baseline, 4, 8, and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes \>1 year
* 10-18 years of age
* Currently uses insulin pump or HCL therapy
* Duration of 6 months of pump therapy

Exclusion Criteria:

* Significant learning disability
* Self-reported pregnancy
* Inability to read and write English
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)

This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.

IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in this study.

Identification period of the index date (index period): The patients fulfilling the selection criteria was identified

* Index date: Defined as the date of the earliest brolucizumab injection
* Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
* Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
* Post-index period: The period 180 days after the index date

Eligibility Criteria:
Inclusion Criteria:

1. ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
2. ≥18 years old on the index date
3. ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
4. ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date

   o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.
5. ≥1 follow-up visit after the index date
6. ≥1 VA assessment on the index date or within 90 days prior to the index date

Exclusion Criteria:

1. Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
2. Unknown laterality of the index eye on the index date
The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot

The aim of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

Functional flatfoot is a common foot disease which induces pain and functional decline. Insoles can be used for intervention and correction, especially customized insoles which are made according to different foot types. There have been few studies using 3D printing for customized insoles for functional flatfoot. Besides, compared to traditional method and subtractive manufacturing, the effect of 3D printing customized insoles is still controversial and depends on technology, materials and design.The purpose of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics. Twelve patients with functional flatfoot (foot function index\> 6) aged 20-65 years old will be recruited in this study. Participants plan to wear three kinds of customized insoles fabricated by 3D printing with Nylon and TPU or computer numerical control machine with EVA. F-Scan system and questionnaires will be used to record foot biomechanics and pain after wearing insoles immediately, and foot condition after three weeks. Statistical analysis will be adopted for repeated-measures analysis of variance （ANOVA） for all outcome measures and post-hoc test will be used to test the difference between groups.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 65 years old
* Appearance of decreased medial arch
* Foot posture index score between 6 to 12

Exclusion Criteria:

* History of injuries of the lower extremity within the past 6 months
* Experience of use of orthopedic insole within the past 6 months
* Acute disorders in the lower extremities and spine
* History of surgery on the lower extremities and lumbar spine within the past 6 months
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

Primary:

* To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
* To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Primary:

* To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
* To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age
* Has histologically confirmed non-malignant vulvar pathology
* Is scheduled or planning for WLE/SPV
* Signed informed consent obtained prior to any protocol specific procedures

Exclusion Criteria:

* Unable to give informed consent
* Women who are pregnant or nursing (lactating) women at time of consent
* No prior RT
* No recent antibiotic use within the last 3 weeks or 5.5 times the half-life of the antibiotic (whichever is shorter)
* No history of prior malignancy within the last 3 years that required systemic chemotherapy or radiation
* Not immunosuppressed or compromised
* No active HIV (must have undetectable viral load)
* Chronic treatment with corticosteroids or other immunosuppressive agents including topical corticosteroids in the pelvis. Inhaled corticosteroids are allowed
* No active uncontrolled severe infections (not responding to antibiotics), except acute or chronic pelvic inflammatory disease
* Uncontrolled diabetes mellitus
Iterative Endotracheal Tube Cuff Pressure Monitoring

Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.


Eligibility Criteria:
Inclusion criteria:

* Elderly patient ≥ 18 years old
* Patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023
* Intubated patient with endotracheal tube under mechanical ventilation
* Sedation and curarization
* ASA 1, 2 and 3
* Duration of surgery \> 1 hour
* Subject not objecting to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* ASA 4, difficult intubation and emergency
* Lung pathologies (asthma, COPD, tracheomalacia)
* Severe heart failure
* Septic, cardiogenic or volume shock
* Morbid obesity (BMI \>40)
Anticariogenic Properties of Zamzam Water

The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.

The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. all patients will be into two groups; The first group will use Zamzam water mouthwash for a six months with other preventive protocols including fissure sealants and preventive restorations wherever needed, while the second group will undergo preventive protocols only. During these six months, patients will be reassessed at three and six-month intervals regarding S. mutans count, oral pH, and caries risk level.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged between 18-35 years.
* Systemically- free individuals.
* High caries-risk patients according to ADA (American Dental Association).
* Not on a medication interfering with salivary secretion.
* Co-operative patients approved to participate in the study.

Exclusion Criteria:

* Patients who are already on any mouthwash regime.
* Patients who are on any medication that would alter the salivary secretion.
* Allergy to any of the ingredients of the study products.