cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD)

A retrospective, observational, single-arm, non-randomized cohort study of ocular treatment in nAMD patients in Japan who had records of at least 12 months of follow-up after their first brolucizumab intravitreal injection. Patients who had records of at least 12 months of visits after the first brolucizumab injection (index date) were identified during the index period and were recruited during the data collection/recruitment period.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of nAMD.
2. Patients 50 years of age or older at index.
3. Received first injection of brolucizumab during the index period.
4. Gave signed or verbal informed consent.

Exclusion criteria:

1. Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and who had diagnoses of diabetes-related macular degeneration within 6 Months prior to the index date.
2. Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date.
3. Patients who had any contraindication and were not eligible for treatment with brolucizumab according to the label.
4. Patients who were treated with more than 3 types of anti-vascular endothelial growth factor (anti-VEGF) before the index date (5th line brolucizumab patients or more).
5. Patients participating in parallel in an interventional clinical trial.
6. Patients participating in post-marketing surveillance with brolucizumab.
Real Versus Sham Manual Therapy for RCRSP

A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.

The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.

The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.

For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.

The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* unilateral shoulder pain of non-traumatic origing lasting more than three months.
* Pain evoked with active shoulder movements.
* Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
* Minimal or no rest pain (less than 3 points in a numeric pain rating scale).

Exclusion Criteria:

* Other shoulder pathologies than RCRSP.
* Systemic diseases.
* Neural symptoms.
* Neck pain.
* Radiculopathy.
* To have been treated for shoulder pain in the last three months.
HER Salt Lake Initiative

This study aims to understand the long-term health, social, and economic impacts of transitioning a community to Highly Effective Reversible Contraception (HER-C).

The persistently high rate of unintended pregnancy in the US suggests an inadequacy of current prevention models and a need for new approaches to contraceptive acceptability and promotion. Although popularity of Highly Effective Reversible Contraception (HER-C) in the US is steadily increasing, less than 10% of contracepting women use intrauterine devices (IUDs) or subdermal contraceptive implants, which are the most effective methods for avoiding unintended pregnancy.

Poverty is an important predictor of unintended pregnancy where women with incomes below the Federal Poverty Level (FPL) have over a five-fold increased risk of unintended pregnancy relative to women with higher incomes. Because of limited public funds for family planning, low-income women in Salt Lake County have limited access to HER-C, which has high initiation cost but significant cost-saving potential over time. Additionally, contraceptive research has inadequately measured the social impact of HER-C.

The first aim of the HER Salt Lake Initiative is to evaluate the increase in HER-C methods with three strategies: 1) Client centered contraceptive counseling; 2) Removal of financial barriers; and 3) Targeted media campaigns.

The second aim of the HER Salt Lake Initiative is to assess changes in earnings and education among women initiating HER-C compared to other methods of contraception and model the projected lifetime earning potential of women based on their contraceptive method choices.

Eligibility Criteria:
Inclusion Criteria:

* Females
* 16-45 years of age
* Seeking contraceptive counseling and services at four participating Planned Parenthood clinics in Salt Lake County
* Desire to prevent pregnancy for at least one year
* Fluent in English or Spanish
* Their current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment

Exclusion Criteria:

* Currently pregnant and planning to continue the pregnancy, or trying to get pregnant
* Relying on female or male sterilization as contraceptive method
Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed allergic rhinitis during the observational period

Exclusion Criteria:

* Contra indications according to the label
Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control

The goal of this study is to examine the effects of framed mobile messages on young adults' beliefs about their daily Inhaled Corticosteroids (ICS), intentions to take their ICS, adherence, and asthma control. College students (18-29 years) who owned a mobile phone and had a diagnosis of asthma with a prescription for an ICS will be recruited. Participants will be randomized to receive either gain- or loss-framed mobile messages three times per week for eight weeks. Outcomes including beliefs, intentions, adherence, and asthma control will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of asthma
* A prescription for an inhaled corticosteroid
* Enrolled in college
* Between 18-29 years of age
* Owns a mobile phone

Exclusion Criteria:

* Cannot read in english
International Focus Group Discussion on Neuromuscular Monitoring.

Focus-Group based discussion designed to gain more in-depth information on factors that could lead to an increase in the adoption of neuromuscular monitoring taking into account different country-specific contexts.


Eligibility Criteria:
Active EU Anaesthesiologists
A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.

The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.

This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.

All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).

This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:

* who are Turkish citizens
* who are older than 18 years
* who were found out to have mRCC
* who received sunitinib as the first line treatment after finding out the cause for the disease

This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.

This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry.

The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis.

RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.

Eligibility Criteria:
Inclusion Criteria:

* Being a Turkish citizen.
* Being older than 18 years-old.
* Being clinically diagnosed with mRCC and treated.
* Being treated with Sunitinib in first line

Exclusion Criteria:

* Patients whose treatment was initiated but excluded from follow-up for any reason.
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Drop out-rate will be covered in Participant flow section.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

* Known or suspected pregnancy or is lactating.
* History of ectopic pregnancies.
* Any genital infection (until successfully treated).
* Abnormal uterine bleeding of unknown origin.
Treatment for Patellofemoral Pain Syndrome Using Footwear

Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be associated with higher than normal knee joint loading. Footwear has been developed that may decrease these knee loads in healthy subjects, but their effects on patients with PFPS are unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We hypothesize that patients who receive the footwear intervention will show a decrease in knee joint loading, and consequently will show improvements in subjective levels of perceived knee pain over a period of six weeks compared to a control condition.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between 18 and 45 years of age.
* Have been diagnosed with patellofemoral pain syndrome (PFPS) by a physician.
* Have nontraumatic unilateral and/or bilateral peripatellar or retropatellar knee pain.
* Patellofemoral knee pain with and/or after activity.
* Inactivity patellofemoral pain and/or stiffness, especially with sitting with knees held in flexed posture.
* Peripatellar tenderness ± mild inferior patellar pole tenderness.
* Run at least 15km per week.
* Are heel-toe runners (as opposed to forefoot strikers).

Exclusion Criteria:

* Are currently, or have previously, participated in any other forms of treatment for their knee pain.
* Significant articular or periarticular effusion or bursitis.
* Significant joint line tenderness.
* Intra-articular ligamentous instability.
* Patellar apprehension.
* Have undergone any form of knee surgery or arthroscopy.
* Have any other neuromuscular, musculoskeletal or cardiovascular conditions
Ph1 Marinol Interaction Study - Part 2 - 1

This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.


Eligibility Criteria:
Inclusion Criteria:

* Must be between 18 and 45 years of age
* Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence
* Must be seeking treatment at time of study entry
* Must be able to understand and provide written informed consent
* Must provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period
* If female and of child bearing potential, agrees to use birth control.

Exclusion

Criteria:

* Please contact site for more information
Bioequivalence of Ethylenediamine Dihydrochloride Study

The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.

We propose an open, prospective, single-site study to evaluate the bioequivalence of ethylenediamine dihydrochloride in methylcellulose (MC)and polyvinylpyrrolidone (PVP) formulations. Bioequivalence will be determined in minimum of 15 adult subjects, with a clinical history of contact dermatitis and a positive patch test (current or previous) to ethylenediamine ("sensitives").

Eligibility Criteria:
Inclusion Criteria:

* Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 10 years) to ethylenediamine dihydrochloride
* 18 years of age or older, otherwise in good health
* Female subjects of childbearing potential must consent to a urine pregnancy test; results must be negative for study inclusion.
* Informed consent signed and understood by each subject.

Exclusion Criteria:

* Subjects unable to meet inclusion requirements
* Women who are breastfeeding or pregnant
* Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area
* Systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents
* Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
* Acute dermatitis outbreak or dermatitis on or near the test area on the back
* Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity)
* Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study
Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.


Eligibility Criteria:
Inclusion Criteria:

* primary THR
* informed consent

Exclusion Criteria:

* allergies to study drugs
* spinal anesthesia contraindicated
* kidney failure
* epilepsy, psychiatric disease, neurologic deficits
* revision surgery
* neuropathies in the lumbar area
* no informed consent
* pregnancy
* alcohol/opioid abuse
* emergency surgery/intensive care
DBS of PPN to Improve Walking in Chronic SCI Patients

Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Recent groundbreaking research has demonstrated that deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR) greatly improves locomotion in a rat model with incomplete SCI. The pedunculopontine nucleus (PPN - a specific nucleus within the MLR) in humans has already been established as an auxillary DBS target in Parkinson Disease (PD), to improve motor control and locomotion. DBS of other targets has also been safely used in humans with SCI for chronic pain. These findings suggest that DBS of the PPN may have potential as a therapeutic intervention in the SCI population to improve locomotion. Our goal is to conduct a pioneering study in 5 select motor-incomplete chronic SCI patients that cannot functionally ambulate to examine if bilateral DBS of the PPN improves walking

This prospective repeated measures study of the implantation of bilateral PPN electrodes in a small series of chronic SCI patients will aim to examine safety, feasibility, and potential efficacy. This research will investigate the effects of electrode implantation, electrical stimulation and intensive locomotion training over a 1-year period. Motor assessments will be performed at regular intervals with stimulation on and off in a double-blind fashion (subjects and researchers will be unaware of stimulation setting), to determine if subjects have improved ambulation with stimulation on compared with off, and if their ambulation improves over the course of the study observation period with stimulation on.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 (at time of enrolment)
* SCI that occurred greater than 2 years ago
* Current neurological status of AIS grade C or D, can stand with aids but not functionally ambulate
* Residence in GTA

Exclusion Criteria:

* Other substantial medical conditions causing physical restrictions, neurological deficits, or causing excessive risk of surgery
* Professional or other time commitments affecting availability for numerous hospital visits
* Contraindications to MRI (eg. metal in eye)
* Women that are pregnant (according to a bHCG serum/urine test at time of screening), or are actively seeking to become pregnant
Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
* Body mass index (BMI) below 40.0 kg/m2
* HbA1c between 7.5-13.0%

Exclusion Criteria:

* History of drug or alcohol dependence
* Mental incapacity, unwillingness or language barriers precluding adequate
* Subjects previously screened to participation or having already participated in this trial
* Receipt of any investigational drug within the last month prior to this trial
* Known or suspected allergy to trial products or related products
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help doctors find CNS metastases and plan treatment.

PURPOSE: This randomized clinical trial is studying how well MRI finds CNS metastases in women with stage IV breast cancer.

OBJECTIVES:

Primary

* Determine survival (without neurological symptoms due to CNS metastases) in women with HER2/neu-overexpressing stage IV breast cancer who undergo gadolinium-enhanced magnetic resonance imaging (MRI) of the brain once every 4 months vs once every 12 months for early detection of CNS metastases.

Secondary

* Determine the total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases in these women.
* Determine the total number of hospitalization days required in these women.
* Determine the overall survival of these women.
* Evaluate a cross-platform, manufacturer-independent MRI technique for diagnosis of brain metastases that could be used in future studies in the IRIS and ULB-Canceropôle networks.
* Compare 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging in these women.

OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients undergo gadolinium-enhanced magnetic resonance imaging (MRI) of the brain at baseline (to exclude CNS involvement) and then once every 4 months (or earlier if symptoms possibly related to CNS involvement develop) in the absence of the development of CNS metastases.
* Arm II: Patients undergo gadolinium-enhanced MRI of the brain at baseline (to exclude CNS involvement) and then once every 12 months (or earlier if symptoms possibly related to CNS involvement develop) in the absence of the development of CNS metastases.

Patients complete neurological symptoms questionnaires at baseline, every 6 weeks during study intervention, and at the completion of the study.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Stage IV disease
* HER2/neu-overexpression (3+ by immunohistochemistry AND/OR gene amplification by fluorescence in situ hybridization)
* Undergoing treatment with trastuzumab (Herceptin®) (alone or together with chemotherapy) once weekly or 3 times weekly AND has achieved responding or stable disease for ≥ 12 weeks
* No CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal carcinomatosis)
* No uncontrolled metastatic disease at study entry
* Hormone receptor status

  * Not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Karnofsky performance status 70-100%
* No contraindication to MRI scan

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique

patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .


Eligibility Criteria:
Inclusion Criteria:

* Patients' age range from 18-60 years.
* Patients with horizontal bone defect in anterior maxillary area.
* Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria:

• Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).