cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).

This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.

Patients already enrolled in the study, should continue to complete assessments as described in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.

Exclusion Criteria:

* Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
* Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
* Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
* Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
* Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
* Subjects who are either unwilling or unable to undergo examination with closed MRI.
The Effect of Motivational Messages on Emergency Nurses

Aim and objectives: The aim of this study is to examine the effect of motivational notifications applied to emergency nurses on job satisfaction, compassion fatigue and communication skills during the COVID-19 pandemic.

Background: Emergency room nurses working on the front lines during the COVID-19 pandemic; many factors such as excessive workload, prolonged working hours, threat of infection, death of the patients they care for have caused them to experience physical, social and psychological problems.

Design: It is a randomized controlled, open-label study. Methods: This study was carried out with a total of 60 nurses working in the emergency units of two training and research hospitals in Istanbul. Participants were divided into motivational group and control group. Motivational notifications were sent via Short Message Service (SMS) to the mobile phones of the participants in the motivational group (n=30) for 21 days. No motivational notification was sent to the control group (n=30) during this process. Data were obtained with the Individual Introduction Form, Job Satisfaction, Compassion Fatigue and Communication Skills Scale.


Eligibility Criteria:
Inclusion Criteria:The nurses working in the emergency room, working only in the day shift on weekdays, using mobile phones and volunteering to participate in the study were included in the study.

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Exclusion Criteria: Exclusion criteria for the study included being on leave for any reason (maternity, annual, medical) during the study dates, not completely filling in the data collection forms, or withdrawing from the study.

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Nasal Swab Study to Explore the Nasal Microbia

The objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.


Eligibility Criteria:
Inclusion Criteria:

* Adults, male or female, between the ages 18 - 60
* Exhibiting symptoms of an upper respiratory ailment, which may include runny or stuffy nose, sore throat, fever, headache, cough, malaise, or loss of appetite with no indication or intention to treat with excluded medications.

Exclusion Criteria:

* Use of antibiotics, antifungals, antivirals, antihistamines, anticholinergic, anti-inflammatory, any nasal inhaled medications (other than saline), or steroid medications within the four (4) weeks prior to enrollment and during the course of the study. Use of cough suppressants and herbal medications are permitted.
Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood

Observational, descriptive, cross-sectional, monocentric study, This Study is proposed to all couples followed in Assisted Reproduction and CECOS Nord for whom the protocols were stopped when they entered into confinement related to the Covid-19 epidemic on 13 March 2020.


Eligibility Criteria:
Inclusion Criteria:

* couples followed up in Assisted Reproduction and CECOS Nord
* the cessation of assistance reproduction protocols related to the Covid-19 outbreak on March 13, 2020.
* acceptance of teleconsultation

Exclusion Criteria:

* Individuals refusing to participate in the study during the teleconsultation with the referring practitioner.

I- ndividuals who do not respond to the questionnaire
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
* Age ≥ 15 years at the time of consent.
* Must be able to take oral medications (swallow pills)
* ECOG Performance Status of 0-2 within 14 days prior to registration.
* Histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen.
* Patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy.
* No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.
* Prior cancer treatments are not allowed. Patients have to be chemotherapy naïve.
* Absolute Neutrophil Count (ANC) ≥ 1 K/mm3
* Hemoglobin (Hgb) ≥ 10 g/dL
* Platelets (Plt) ≥ 100 K/mm3
* Creatinine ≤ 2 mg/dL
* Bilirubin ≤ 1.5 × upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 × ULN
* Alanine aminotransferase (ALT) ≤ 2.5 × ULN
* No concurrent use of thioridazine or pimozide. No use of agents expected to induce the metabolism of rolapitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and Barbiturates.
* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
* Patients and their partners must agree to use a highly effective method of birth control from the signing of the informed consent form until 90 days following the last dose of rolapitant.

Exclusion Criteria:

* Any untreated central nervous system (CNS) metastases.
* Treatment with any investigational drug within 30 days prior to registration.
* Concurrent participation in a clinical trial which involves another investigational agent.
Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain

This is a prospective single arm study in which patients with moderate to severe chronic elbow or foot plantar pain, in the setting of lateral epicondylitis or plantar fascitis refractory to conservative treatment, will be enrolled.

The primary aim of this study is to estimate the effectiveness and safety of transcatheter arterial embolization (TAE) for changes in elbow or plantar pain with 6 and 12-month follow-up.

This is a prospective single arm, single center study at Chung-Ang University Hospital. Patients with moderate to severe elbow or foot pain, and pain refractory to at least 6 months of physician directed conservative therapy (oral analgesic, physical therapy or local injection treatment) will be eligible for enrollment.

Transcatheter arterial embolization (TAE) is performed after receiving informed consent, and imipenem is used as an embolic material to embolize the target lesion. After the procedure, evaluate the VAS score and limitation of range of motion (LOM) of the joint area.

Follow-up at 1, 3, 6 and 12 months after embolization, and changes of VAS score and LOM are checked.

Eligibility Criteria:
Inclusion Criteria:

* Patients who voluntarily signed a written consent form after receiving an explanation of the purpose, method, and effects of this clinical trial
* Patients who have had pain in the relevant area for more than 6 months and have a history of receiving physical therapy, analgesic anti-inflammatory medication, or local injection treatment
* Patients in whom hypervascularization was confirmed in the relevant area through imaging results (US, CT, MRI) evaluating the cause of pain.

Exclusion Criteria:

* Patients are pregnant or breastfeeding
* Local infection in the painful area
* Patients have a bleeding disease
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.

All enrolled (ChEVAS and Infrarenal) subjects will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

\*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.

Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18-years old
* Subject provided informed consent
* Subject agrees to all follow-up visits
* Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4cm will be included
* Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting

Exclusion Criteria:

* Requirement of home oxygen
* Psychiatric or other condition that may interfere with the study
* Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)
* Known allergy or contraindication to any device material, contrast, or anticoagulants
* Serum creatinine level \>1.8mg/dL
* CVA or MI within three months of enrollment/treatment
* Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement
* Connective tissue diseases (e.g., Marfan Syndrome)
* Unsuitable vascular anatomy that may interfere with device introduction or deployment
* Pregnant, planning to become pregnant within 60 months, or breast feeding.
Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

The Rexon Eye device (Resono Ophthalmic Inc, Trieste, Italy) is a new device based on QMR technology. Quantum Molecular Resonance (QMR) is a technique in which low-intensity, high-frequency electric currents are administered to a biological tissue through contact electrodes. The device applies stimulation to the epidermis of closed eyelids up to the lid margin by means of specially designed goggles. Previous studies have shown that it is relatively safe with high patient satisfaction. Preliminary studies have also shown it is effective for accelerating healing in chronic wounds and treating dry eye symptoms.

In this study, the investigators aim to examine the efficacy of the Rexon eye device for the treatment of dry eye signs and symptoms in a randomized double-blind placebo-controlled fashion among a cohort of prospectively recruited patients with dry eye. The control group will receive a similar application of treatment with the device goggles disconnected from the device, effectively receiving no treatment. The treatment will be performed by research assistants following thorough instruction by the manufacturing company representatives and/or provided material. Participants will be actively questioned on any harms or side effects in every meeting.

Outcomes will be assessed based on clinical signs and by validated questionnaires on dry eye symptoms (OSDI).

Informed written consent will be obtained from all participants involved in the study prior to enrollment. The goal of the study is to evaluate the Rexon device as a possible additional treatment option for patients with dry eye or to establish it has no added benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 years
* Patients who are willing and able to consent and adhere to the research plan
* Patients diagnosed with dry eye or patients who are at risk for dry eye

Exclusion Criteria:

* Active infection of the eyelid or periorbital area
* Patients who are pregnant or lactating
* Patients under the age of 18
* Those scheduled for (\<30 days) or immediately after (\<30 days) ocular surgery (excluding cataract and eyelid surgery)
* Patient who do not adhere to all four treatment sessions.
Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study

The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.


Eligibility Criteria:
Inclusion Criteria:

* Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).

Exclusion Criteria:

* Patients with known rheumatic disorders.
* Known hypersensitivity to HA.
* Synovial diseases like PVNS, under 18y old.
Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT

The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional self-report, and objective functional measures. SWE will be utilized to objectively quantify tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Achilles pain for \> 3 months
* Unilateral symptoms only
* DOD beneficiary, between the ages of 18 and 65
* Clinical diagnosis of Achilles tendinopathy
* Read and speak English well enough to provide informed consent and follow study instructions.
* Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks

Exclusion Criteria:

* Any disease or disease process that would preclude the participant from safely performing any of the exercises or intervention at the discretion of the PI. (Uncontrolled diabetes, cardiac disease, severe COPD, open wounds, current infection, etc.)
* Any LE surgery on either side in the last 2 years
* History of Achilles rupture
* Any vascular disorder (varicose veins, Hx of DVT)
* Leaving post/station in the following 3 months precluding them being able to come in for f/u visits
* Self-report of pregnancy (currently or within last 6 months)
* Other foot/LE disorder that prevents the completion of the eccentric exercises or BFR exercise
* Unable/unwilling to hop on symptomatic leg
* Pain \< 2/10 of average pain on NPRS
* VISA A score \> 80%
* Currently going through MEB/worker's comp
Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

There are several studies that have considered Botulinum toxin A (BoNT-A) injections are effective in treating symptoms for Temporomandibular Joint (TMJ) disorders. BoNT-A injections improve the hyper-tonicity of mandibular muscles and its consequent joint load reduction. Also injections of BoNT-A, for patients with articular disc displacement, resulted in pain relief and return of the normal movements of the mandible. The main goal of this study is to test the beneficial impact of BoNT-A injections in the masticatory muscles of patients submitted to TMJ surgical arthroscopy.

Study Objective:

To investigate the potential performance of incobotulinumtoxin-A (BTXA) in patients submitted to TMJ surgical arthroscopy. Besides the acceptable good outcomes of TMJ arthroscopy, the authors believe that using a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading and pain, improving TMJ arthroscopy results.

The proposed explanation for this study:

TMJ arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ arthroscopy, the authors believe that adding to this treatment a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading, improving TMJ arthroscopic results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with TMJ with indication for arthroscopy
* Age between 12-60 years old
* Minimum level of pain for inclusion should be 5/10 (on a 0-10 VAS scale)

Exclusion Criteria:

* Previous treatment to TMD
* Previous use of facial Botulinum Toxin
* Any contraindication for the use of BTXA according to XEOMIN SmPC
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
* Currently taking around the clock opioid therapy for pain
* Experience on average, 1-4 breakthrough pain episodes per day

Exclusion Criteria:

* Opioid or fentanyl intolerance
* Sleep apnea or active brain metastases with increased intracranial pressure
* COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.

Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 and ≤ 80 years
2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
4. Subject must have a VAS pain scale greater than 45

Exclusion Criteria:

1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
2. BMI greater than 40 kg/m\^2
3. Subject has active infection at the injection site
4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
5. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
6. Subject has documented history of gout or pseudo-gout
7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
8. Subject has received any of the following to the target knee:

   1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
   2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
   3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
   4. History of a total knee arthroplasty
9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
11. Subject has had prior radiation at the site
12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
13. Subject is pregnant or plans to become pregnant within 365 days of treatment
14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
15. Subject is a worker's compensation patient
16. Subject is a prisoner