cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Eligibility Criteria:
Inclusion Criteria:

Preoperatively, subjects must have had:

* Been scheduled for myomectomy via laparotomy or laparoscopy.
* Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
* Been \>=18 years of age.
* Provided voluntary written informed consent.
* Been willing to comply with all aspects of the treatment and evaluation schedule.

Intra-operatively, subjects must have had:

* Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.

Exclusion Criteria:

Preoperatively, subjects must not have had:

* Been pregnant.
* Had a pelvic malignancy.
* Had acute pelvic inflammatory disease.
* Had an immune compromised condition.
* Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
* Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.

Intra-operatively, subjects must not have had:

* Had a pelvic malignancy.
* Had a pelvic or abdominal infection.
* Had acute pelvic inflammatory disease.
* Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.
Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier

Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.

The application of endometrial ablation (EA) has significantly increased in the past 10 years. It is an effective treatment for heavy menstrual bleeding with functional aetiology. However, the risk of post-ablative intracavitary scarring after EA is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. CLEAN is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. The objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.

The study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with Novasure system (Hologic) A follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of IUAs according to the American Fertility Society.

Eligibility Criteria:
Inclusion Criteria:

* Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
* Women 30 years old or older;
* Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
* Subjects who can comply with the study follow-up and other study requirements.

Exclusion Criteria:

* Cavity length \<4 or \>8
* Perforation during ablation procedure
* Previous adhesiolysis procedure or diagnosis of Asherman's disease.
* Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
* History of cervical or endometrial cancer
* Active pelvic infection or history of pelvic peritonitis
* Known contraindication or hypersensitivity to Womed Leaf component
* Current participation in another clinical investigation that has not yet received the primary endpoint
* Any other condition that makes participation in the study contrary to the patient's best interests.
An Evaluation of Re:MIX: a Teen Pregnancy Prevention Program With Young Parents as Peer Educators, EngenderHealth

This study uses a cluster-level randomized controlled design to evaluate the efficacy of Re:MIX in reducing the incidences of early sexual behavior, unprotected sex, oral sex, pregnancy, and STIs. Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and peer educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks). Participants were in 8th, 9th, and 10th graders attending three public charter schools in Travis County, Texas. Comparison classes either received an alternative program that focused on health, nutrition, and fitness, or business as usual. This study was conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.


Eligibility Criteria:
Inclusion Criteria:

* Students in 8-10th grade classrooms in three public charter schools in Travis County, Texas

Exclusion Criteria:

* None
Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.

Study Objectives:

Primary:

* To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
* Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.

OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.

GROUP I (ULTRA-HYPOFRACTIONATION \[UH\]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.

GROUP II (MODERATE HYPOFRACTIONATION \[MH\]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.

After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
* ECOG performance status 0-2
* Patient must be deemed able to comply with radiation treatment and surgery

Exclusion Criteria:

* History of prior radiation to the same area to be irradiated
* Pregnancy
* Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to provide written informed consent. Subjects must read, sign, and receive a copy of the informed consent prior to any study procedures, including withdrawal of any antihypertensive medication.
* Males and females \>= 18 years of age.
* Uncontrolled hypertension defined as an average systolic blood pressure \>= 140 mmHg and/or an average diastolic blood pressure \>= 90 mmHg. This applies to both people not taking any blood pressure medications and people taking just one blood pressure medication.
* Presenting at least 2 of the following:

  * Obesity;
  * High triglycerides;
  * Low HDL cholesterol;
  * Elevated fasting glucose.

Exclusion Criteria:

* Women of child bearing potential who are not using adequate birth control.
* Women who are pregnant or breastfeeding
* Diabetics
* Systolic blood pressure \>= 180 mmHg.
* Diastolic blood pressure \>= 110 mmHg.
* Stroke within past 12 months.
* Myocardial infarction and heart revascularization procedure or acute angina within past 6 months.
* Moderate to severe heart failure.
* Significant kidney or liver disease.
* Cancer in past 5 years.
* Drug or alcohol abuse.
* Gout
* Lupus
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib). In osimertinib treated subjects, T790 testing is not required.
* No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy. For participants who were treated with osimertinib, T790M testing is not required.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC).
* Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
* Eastern Cooperative Group (ECOG) Performance Status 0-1
* Life expectancy is at least 3 months

Exclusion Criteria:

* Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
* who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
* Carcinomatous meningitis
* Active, known or suspected autoimmune disease are excluded
* ALK translocation
* Known SCLC transformation
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria apply
Cognitive Rehabilitation in Parkinson's Disease

We are testing a computer game-style rehabilitation program for people with Parkinson's disease (PD). People with PD often have difficulty with motor planning, such as initiating or starting movements. We believe that our program will improve performance on a movement initiation task as well as on activities of daily living, such as walking, preparing a meal or opening a medicine bottle. We will measure brain function using functional MRI before and after training to identify brain areas that are involved in improved performance. If effective, computer based training will be an inexpensive treatment for motor planning deficits in PD that is free from side effects and easy to administer to a large number of patients.

Our approach is to use PD-based adaptive training to improve performance on IG movement initiation in patients with PD. We have three aims, 1) to systematically evaluate cognitive rehabilitation in people with Parkinson's disease (PD), 2) to examine the neural mechanisms subserving cognitive rehabilitation in PD and 3) to assess the ecological validity of cognitive rehabilitation in PD. We will focus on a single aspect of cognitive function, the decision to initiate a movement. Movements can be internally generated (IG) or externally cued, and motor deficits in PD are typically linked to IG movements. The protocol is designed to drive beneficial neuroplastic changes using a paradigm similar to those that have shown promising results in traumatic brain injury patients. In addition, we will use fMRI to measure activity in underlying basal ganglia-thalamocortical circuits. Finally, because the goal of any research regarding the pathophysiology of disease is to improve the lives of patients with the disease, behavioral and neuropsychological measures will be correlated with fMRI measured functional abnormalities before and after training. Improvement in the initiation of movement has the potential to dramatically improve daily functioning including reducing falls, improving language production and improving proficiency of activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PD dominant on the right side with a Hx of response to dopamine replacement.

Exclusion Criteria:

* Contraindication to MRI
* History of stroke or significant head trauma
* Significant vision impairment
* Hx of brain surgery or claustrophobia
* Medication change \<4 weeks
* Atypical PD
* Severe tremor
* Presence of motor fluctuations or dyskinesia
* Significantly impaired limb or joint function
* Significant memory impairment
* Depression or daytime sleepiness
Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy

European Resuscitation Council 2021 Guidelines and Advanced Life Support Provider Courses teach that the oxygen supply must be removed from the patient during defibrillation to the distance of minimum of 1 meter. Scientific articles describe few incidents of fire during defibrillation in oxygen - enriched atmospheres.

The study aims to performed a series of measurement of the oxygen concentration in the environment around the patient with different airway management used and ventilation provided.


Eligibility Criteria:
Inclusion Criteria:

* patients at the intensive care unit bed or on the operating theatre with oxygen therapy prescribed/indicated

Exclusion Criteria:

* no oxygen therapy started
* situation not allowing measurement
Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement

Less is known about pain and opiate use at home directly after total knee replacement (TKR). Regarding side effects, low opiate use is desired. An e-health application, PainCoach app, was developed to guide patients in pain control and opiate use.

The aim of this study was to investigate the effect of the PainCoach app on pain and opiate use in TKR patients in the first two weeks at home after surgery. The hypothesis was that the use of this app would decrease pain and opiate use.


Eligibility Criteria:
Inclusion Criteria:

* Planned for primary TKR

Exclusion Criteria:

* No possession of a smartphone or tablet
* Contra-indication to any of the pain medication used in the study
* No email address
* No internet at home
* No thorough command of the Dutch language
* Suffering from memory disorders
* Surgery under general anaesthesia
The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers

The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study;
5. Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7;
6. Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.20 or better in each eye with their habitual contact lens type;
7. Has a history of artificial tear or rewetting drop use at least once in the last 30 days;
8. Is willing to use the Xiidra study drops twice a day on a daily basis (irrespective of CL wear) and to stop use of any habitual rewetting drops and/or artificial tears over the course of the 12-week treatment phase;

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer;
3. Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study;
4. Has any known ocular disease and/or infection, that's either currently active\* or has occurred within the previous 30 days;
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease);
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable, including but not limited to topical cyclosporine, any other topical ophthalmic medication, antihistamines, and aspirin;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);\*\*
8. Has undergone refractive error surgery such as LASIK within the last 12 months;
9. Has a history of yttrium-aluminium-garnet laser posterior capsulotomy within the previous 6 months,
10. Is an employee of the Centre for Ocular Research \& Education; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Early Clinical Evaluation of 18F-LY3546117 in Tumor Imaging

Immuno-Oncology (IO) therapies have revolutionized cancer therapy and are becoming the standard of care for many cancers. Monitoring how well IO therapies work against cancer is difficult due to the complexity of the immune system and the fact that an immune response may initially increase, rather than decrease, the size of a tumor. An early response marker would be beneficial to determine which patients should remain on a given treatment or combination of treatments, and which patients should seek other treatment options. 18F-LY3546117 is a radiolabeled tracer that binds to a specific protein (Granzyme B) that is found in the human immune system and is thought to trigger programmed cell death. It is thought that imaging Granzyme B activity in tumors and elsewhere in the body using a Positron Emission Tomography (PET) scan will allow doctors to monitor the progress of IO therapy.


Eligibility Criteria:
Inclusion Criteria (Cohort 1):

* At least one imageable tumor greater than or equal to 15 mm in the longest diameter
* Confirmed diagnosis of cancer with a high likelihood of response to immuno-oncology therapy (melanoma or non-small cell lung cancer, or other malignancies with sponsor approval) and planned mono- or combination therapy with immuno-oncology therapy
* Life expectancy of greater than 6 months

Inclusion Criteria (Cohort 2):

* At least one imageable tumor greater than or equal to 15 mm in the longest diameter or a tumor assessable by PET in the opinion of the radiologist
* Received treatment with an immune checkpoint inhibitor with evidence of response
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Subjects who plan to receive chemotherapy or radiation therapy during study participation
* Prior history of failed immune checkpoint inhibitor therapy
* Subjects who require steroid or other immunosuppressive medications within 2 weeks of the PET scan.
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using effective methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening and agree to avoid becoming pregnant for 24 hours following study drug administration.
* Females and males must agree to refrain from sexual activity or to use effective contraceptive methods for 24 hours following study drug administration and during study participation
A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia

Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly.

Primary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months

130 patients registered, 112 randomized. 56 pats in each treatment arm. 12 months study duration. Rate of Major Molecular Response was at 12 months 53 vs 82 % (p=0.002) in favour of the combination arm.

Eligibility Criteria:
Inclusion Criteria:

Chronic myeloid leukemia in imatinib induced complete hematological remission. Intermediate/low risk, ECOG \< 2

Exclusion Criteria:

Les than CHR after 3 months imatinib high risk More than 6 months from diagnosis ECOG \> 2 Pregnancy

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