cyrilzakka/clinical-trials huggingface dataset:
Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)

Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an effective treatment for anxiety-related symptoms while lacking the severity of adverse effects seen with other medications. Given the wide availability of products containing CBD on the market today, from tinctures to coffee additives, and the undetermined potential for drug-to-drug interactions, medical supervision of CBD intake and formulation-specific clinical research is necessary. Therefore this study aimed to observe the effects of a specific hemp-derived full spectrum CBD formula on anxiety-related symptoms in a group of volunteers. The investigators will examine the self-reported anxiety symptoms in relation to use of a specific CBD formulation (25mg solvent-free full spectrum CBD capsules) in a cohort of adults diagnosed with generalized anxiety disorder. This open-label, cohort study will be conducted at six clinic sites in the United States (including Puerto Rico) from June 2020 through October 2020. The six physicians recruited to participate in the study were each actively prescribing CBD in their practices and were actively caring for patients with anxiety symptoms. Anxiety levels will be measured in enrolled participants diagnosed with generalized anxiety disorder each week for a period of eight weeks using the Generalized Anxiety Disorder 7-Item Scale (GAD7). Participants will also be instructed to take a daily 25mg capsule of CBD. The investigators hypothesize that this formula, when carefully developed and administered by a healthcare professional, will significantly reduce anxiety symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 85 years old.
* Research participants of both sexes.
* Good health conditions and without conditions that characterize them as belonging to the risk groups associated with adverse reactions to the product ingredients.
* Research participants with the potential to become pregnant may be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective.
* Signature of the Free and Informed Consent Form.

Exclusion Criteria:

* Initiation of or changes in use of medication or therapies in the past 2 weeks of start of study.
* Pregnancy or breastfeeding.
* History of hepatic compromise with transaminases of 2 times the upper limit of normal or cirrhosis.
* Diagnosis of Bi-Polar disorder, Schizophrenia or Suicidal Ideation.
* Current use of recreational marijuana, medical marijuana, or other CBD formulations.
* History of any substance or alcohol abuse.
* Current use of High Dose or Extended-Release Narcotics.
* Patients diagnosed with sleep apnea.
Dose-Ranging Study of the Bimatoprost Ocular Insert

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* At least 18 years of age
* Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
* Best corrected-distance visual acuity score equivalent to 20/80 or better
* Stable visual field
* Central corneal thickness between 490 - 620 micrometers

Inclusion Criteria at the Randomization Visit:

("T" is defined as time and "hr" is defined as hour\[s\])

* IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
* Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
* IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.

Key Exclusion Criteria:

* Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
* A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
* Cup-to-disc ratio of greater than 0.8
* Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
* Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
* Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
* Past history of any incisional surgery for glaucoma at any time
* Past history of corneal refractive surgery
* Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
* Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
* Inability to adequately evaluate the retina
* Participants who will require contact lens use during the study period.
* Participants who currently have punctal occlusion
* Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease

This study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (PN) for patients with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis as Crohn's disease according to definition;
2. Bowel resection;
3. With parenteral nutrition at least 5 days
4. 18 years old\<age\<75 years old;
5. Sign the informed consent.

Exclusion Criteria:

1. Emergency surgery;
2. With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction;
3. Incomplete laboratory data;
4. With parenteral nutrition before surgery;
5. Pregnant;
6. Allergy of ω-3 polyunsaturated fatty acid.
Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.

Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.

In the control group:

1. Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.
2. The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes
3. No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing

In the intervention group:

1. Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
2. Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.
3. No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Anterior region (minimum of four teeth at each surgical site)
* Age range (18-45) years old
* Plaque-induced inflammatory gingival enlargement
* Altered passive eruption
* No clinical attachment loss
* Systemically healthy individuals

Exclusion Criteria:

* Gingival enlargement due to any systemic predisposing factors
* Pregnancy and/or lactation
* Allergy
* Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.
* Acute or untreated periodontitis
* Systemic disease that could influence the outcome of the treatment (i.e. Diabetes)
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.

Our preliminary studies have shown that whole body FDG-PET imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in FDG accumulation parallel changes in PSA after treatment. This suggests that changes in FDG metabolism may provide an early assessment of treatment outcomes. In previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. This design is characterized by:

1) Evaluation of uptake on a site-by-site basis in relation to conventional studies 2) Standardization of uptake values in tumor relative to a normal organ 3) Controlling for progression using standard measures of progression including a rising PSA, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. In the present study we are evaluating fluorinated dihydrotestosterone (FDHT) in addition to FDG. FDHT is targeted to the AR and has been shown in preliminary studies to visualize prostate cancers in man. This study will apply our established methods to investigate FDHT imaging in patients with progressive prostate cancer. In the selected cases where tumor is available, we will study associations between FDHT accumulation and AR expression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed prostate cancer.
* Progressive disease manifest by either:
* Imaging modalities:
* Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or
* Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
* Visible lesions by either CT, bone imaging, or MRI consistent with disease.
* Informed consent.

Exclusion Criteria:

* Previous anaphylactic reaction to either FDHT or FDG
* Hepatic: Bilirubin \> 1.5 x upper limit of normal (ULN), AST/ALT \>2.5 x ULN, albumin \< 2 g/dl, and GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN
* Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min
Longitudinal Imaging Biomarkers of Disease Progression in DLB

The Researchers are trying to determine the paths of change in imaging biomarkers of Dementia with Lewy bodies (DLB) and their associations with rate of cognitive and functional decline.

The proposed project will enroll 90 subjects with probable DLB, 60 from Mayo Clinic Rochester (MCR) and 30 from Mayo Clinic Jacksonville (MCJ). Additionally, 45 controls will be enrolled, 30 from MCR and 15 from MCJ. We will obtain up to six assessments in each subject over the 5 years of the study, baseline, six month and annually thereafter. We will follow these cohorts with clinical and biospecimen data collection annually and once at six months, and CSF collection annually within the guidelines of the Parkinson's Disease Biomarker's Program (PDBP). Clinical neuroimaging will be performed annually and include: a) dopamine transporter imaging with Ioflupane (123I) SPECT (DaTscan) as the biomarker of LBD-related loss of dopaminergic activity, b) structural MRI AD- signature atrophy as the biomarker of AD-related neurodegeneration, c) β-amyloid (Aβ) deposition on PET as the biomarker of Aβ pathology. In patients from the MCR site, we will investigate AV-1451 PET. Since the specificity of AV-1451 PET is not established for tau deposition in DLB, we will investigate this biomarker in a subset of DLB patients to determine the pattern of AV-1451 uptake compared to clinically normal controls, and its association with atrophy, Aβ load and clinical disease progression in DLB.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable DLB, at least 18 years of age, reliable informant who personally speaks with or sees the participant at least weekly, sufficiently fluent in English, must be willing and able to consent to the protocol and undergo up to 6 visits over 5 years, willing and able to undergo neuropsychological testing and no contraindication to MRI imaging.

Exclusion Criteria:

* Presence of another neurologic disorder which could impact findings, such as multiple sclerosis, brain tumors, etc., unwilling to return for follow-up yearly and undergo neuropsychological testing and MR imaging, if undergoing Tau imaging cannot have QT Prolongation, do not have a reliable informant.
Whole-Brain Dynamics in the Natural Menstrual Cycle vs. an Ovarian Stimulated Cycle: Impact of Hormonal Fluctuations on Healthy Women Undergoing Ovarian Stimulation

The investigators aim is to investigate the brain's dynamic complexity across three phases of an ovarian stimulation cycle (basal, pre-OPU, mid-luteal), to observe the impact of externally administered hormones, and compare it with the corresponding phases of a natural menstrual cycle (early follicular, pre-ovulatory, mid-luteal) in the same woman. Brain activity patterns will be examined using resting-state fMRI in a sample of young, healthy, naturally cycling women.

The investigators seeks to fill a significant gap in our understanding of the impact of ovarian stimulation on brain dynamics, an area that has not been previously explored. By investigating the brain's dynamic complexity across controlled ovarian stimulation cycle the investigators aim to shed light on how externally administered hormones influence brain activity patterns. Utilizing resting-state Functional Magnetic Resonance Imaging to examine a sample of young, healthy, naturally cycling women, this research will provide crucial insights into the safety and neurophysiological effects of ovarian stimulation. Understanding these effects is essential for ensuring the well-being of women undergoing oocyte freezing and other fertility treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age group: 25 - 35 years old
* BMI: 20 - 30
* Anti-Mullerian Hormone (AMH): 1.3 - 5.9 ng/ml
* Regular Menstrual Cycle: 26-35 days
* In case of previous use of hormonal contraception: wash-out period of 3 month
* Meet standard safety and eligibility criteria for MRI scanning, including the absence of contraindications such as metallic implants, claustrophobia, or other medical conditions that preclude MRI

Exclusion Criteria:

* History of ovarian surgery
* Pathology of the ovaries
* Mental health disorders
* Use of medication influencing brain function
* Ongoing use of hormonal contraception (this would include OCP, but also patches and Mirena containing IUD)
Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)

The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit.
* Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus.
* Patient has a diagnosis of DGP with no history or evidence of mechanical obstruction, symptoms for at least 3 consecutive months preceding the Screening Visit, and delayed gastric emptying of solids documented within 2 years of the Screening Visit.
* Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient's gastroduodenal symptoms.
* Patient is compliant with eDiary completion.
* Patient agrees to refrain from making any new, major lifestyle changes.
* Patient is fluent and literate in English.

Exclusion Criteria:

* Patient has a history or current symptoms of any organic or structural disease that, in the opinion of the investigator, can cause abdominal pain or discomfort and may confound the assessment of DGP symptoms.
* Patients with rumination syndrome, cyclic vomiting syndrome, anorexia nervosa, or bulimia.
* Patient is currently using a gastric electric stimulator or has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
* Patient has been hospitalized within the 2 months prior to the Screening Visit for uncontrolled diabetes mellitus, DGP, or associated malnutrition.
* Patient reports significant diarrhea during the four weeks prior to the Screening Visit, or more than 2 days during either week of the Pretreatment Period.
* Patient has had surgery of the GI tract any time before the Screening Visit, an appendectomy or cholecystectomy during the 3 months before the Screening Visit, non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months, or other major non-GI surgery during the 30 days before the Screening Visit.
* Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable).
Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer

The purpose of this study is to explore the clinical outcomes of indocyanine green fluorescence using in laparoscopic radical right hemicolectomy for right colon cancer（T1-T4a N+ M0）


Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 18 and 75 years old 2. Confirmed adenocarcinoma cancer pathologically 3. Location of tumor: from the cecum to the right third of the transverse colon 4. CT showed right colon cancer: T1-T4a N+ M0 5. ASA scores I-III 6. ECOG (Eastern Cooperative Oncology Group) scale performance status of 0 or 1 7. Patient or family member, able to understand the study protocol and willing to participate in the study, providing written informed consent

Exclusion Criteria:

* 1. Simultaneous or heterochronic multiple primary colon cancer 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery 3. Unsuitable for laparoscopic surgery (e.g., extensive adhesions due to previous major abdominal surgery; unsuitable for pneumoperitoneum for various reasons, etc.) 4. Pregnant or lactating women 5. Have a history of serious mental illness 6. History of iodine allergy 7. History of other malignant diseases within the last five years 8. History of prior neoadjuvant chemotherapy or radiation therapy 9. History of unstable angina or myocardial infarction within the last 6 months 10. History of continuous systemic corticosteroid use within one month
Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.

Twenty patients will be randomized into each group. In all University Hospitals the treatment protocol will be same. Randomization will be performed using a sealed envelope technique.

Before surgery all patients will be examined clinically. After conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures.

If the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively.

Surgical technique:

Surgery will be done by experienced paediatric orthopaedic surgeons. Normal orthopaedic exposures will be used. The cyst is opened so that square window is done to the cortex. A sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. A mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. The tumour is resected as thoroughly as possible. After curettage 5% phenol is inserted to the cavity and it is neutralized with saline. Cyst volume is evaluated using saline (ml). Then the cyst is filled with morsellized femoral head allograft or bioactive glass (BG-S53P4) according to randomization. The biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. If the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. If the cyst is in hand region then the granule size is 0,5-0,8mm. At the end of the operation the window's roof is inserted back. All the time X-ray is used to ensure that the whole cyst is treated properly. Osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture.

After surgery the diagnosis will be confirmed histopathologically.

All patients will receive standard anesthesia.

Postoperatively an X-ray will be taken. Radiographic controls after surgery will be held at 1 Mo, 3 Mo, 6Mo, 12Mo and 24Mo. Three months control and two years control will be accompanied with MRI.

If the cyst is found after a pathologic fracture, the fracture is healed first with the cast +/- traction and MRI will be taken before surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected aneurysmatic bone cyst in all areas, not spinal.
2. Other large simple bone cyst in load bearing areas
3. Simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas

Exclusion Criteria:

1. Malignancy
2. Bone marrow disease
3. Other than aneurysmatic or simple bone cyst
4. A secondary aneurysmal bone cyst (ABC associated with another underlying lesion)
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

The purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.


Eligibility Criteria:
Inclusion Criteria:

* Appropriate for gestational age newborn

Exclusion Criteria:

* Not appropriate for gestational age newborn