cyrilzakka/clinical-trials huggingface dataset:
Echinacea Angustifolia (AnxioCalm) in Anxiety

This study evaluates whether Echinacea angustifolia (AnxioCalm) is a safe and effective treatment for mild to moderate Generalized Anxiety Disorder (GAD) symptoms. Half the participants will receive Echinacea angustifolia and half will receive placebo.

Echinacea angustifolia root extract (AnxioCalm), standardized for the content of echinacoside and its alkamide profile, is intended to be used for 'amelioration of sub-threshold and mild anxiety which are risk factors in the development of Generalized Anxiety Disorder (GAD) and depression' in symptomatic people 'who are not eligible for anxiolytic medication.' Existing medical interventions, which require long periods of repeated administration, have significant safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age (all races and ethnicity)
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM IV) any criteria for Generalized Anxiety Disorder (GAD from 5 to 9)
* mild to moderate symptom severity on the Beck Anxiety Inventory (BAI from 8 to 15)
* Hamilton Anxiety Rating Scale (HAM-A) score from 14 to 17
* Hospital Anxiety and Depression Scale (HADS-A) \[hospital anxiety and depression scale - anxiety subscale\] - 8-10
* Participants score 45-57 points of above on either the state or trait anxiety subscale of the State and Trait Anxiety Inventory of Speilberger (STAI)
* Able to understand and provide signed informed consent
* Able to participate in a 5-week study

Exclusion Criteria:

* Any diagnosed DSM-IV Axis II disorder
* Current DSM IV Axis I diagnosis of Major Depressive Disorder in the 6 month that precede the study. \[to exclude confounding psychiatric factors\]
* Danger of suicidality
* Treatment with Echinacea preparations in the 3 month that precede the study
* Psychotropic medication (especially anxiolytics) in the 3 month that precede the study
* Psychotherapy in the 3 month that precede the study
* Allergic reactions to plants of the Asteraceae family (Echinacea species, etc.)
* Treatment for AIDS or cancer
* Pregnant or lactating women
* Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)
* Alcohol or drug dependence within 3 months
* Allergy to Echinacea preparation
* Allergy to plants of the Asteraceae family (e.g., ragweed, asters, chrysanthemum)
* Allergy to mugwort, radioallergosorbent test (RAST), or birch tree pollen Concurrent tranquilizer, antidepressant or mood stabilizer therapy;
* Subjects receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)
* Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., chamomile, St. John's Wort, Kava kava)
* Women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)
* Any other condition that precludes participation according to the judgement of the investigator
Pre-Operative Prehabilitation Program Women With Gynecological Cancer

The aim of this study is to determine the effect of the prehabilitation program applied to postmenopausal women diagnosed with gynecological cancer before surgery on postoperative recovery, planned as a randomized study with an experimental design with a pre-test post-test control group.

The aim of prehabilitation programs is to eliminate intraoperative complications by increasing the functional capacity and metabolic reserves of patients before surgical treatment and to accelerate recovery in the postoperative period. In addition, it helps the patient to maximize the existing capacity of the patient before the surgery, to know what will happen at each stage of the treatment to be applied to the patient, to feel better physically and spiritually and to understand the roles and responsibilities of the individual care of the patient, as well as making a significant contribution to the positive results of the operation. It is to provide exercise, psychological support, nutritional counseling and optimization of the underlying conditions by stopping negative health behaviors. There are non-eliminable criteria such as age, gender, comorbid diseases before surgery, as well as modifiable factors such as the regulation of the patients nutrition, ensuring psychological well-being, quitting smoking. In particular, some factors directly affect the state of well-being during the perioperative period. Thus, surgeries become safer.As a practice, the prehabilitation program (according to the surgery program) is planned in the preoperative period between 2-4 weeks Dec. Participants who do not comply with the program will be excluded from the sample

Eligibility Criteria:
Inclusion Criteria:

* Patients who are not stage 4 in preoperative evaluation
* Who volunteered to participate in the study
* 6 months have passed since the last treatment (Chemoretapy, Radiotherapy)
* Women who do not have Turkish literacy problems
* Women aged 50 and older who are in the postmenopausal period
* Patients who are scheduled for abdominal surgery

Exclusion Criteria:

* High-risk comorbid diseases such as COPD, heart failure
* Physical and mental conditions that will interfere with nutrition and exercise
* Those with orthopedic and neuromuscular diseases
* Those who are scheduled for surgery by laparoscopic/laparotomic method
* Those who cannot adapt to the program during the preoperative period
* Women who are too depressed during preoperative evaluation
Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
* IOP of \> 21 mm Hg on current treatment

Exclusion Criteria:

* Any previous or current treatment with latanoprost or other prostaglandin analogues
Spanning Bridged Plate in Comminuted Distal Radius Fractures

This study To evaluate the result of using spanning bridge plate in comminuted distal radius fractures.

Distal radius fractures are the most common long bone fracture and the incidence appears to be increasing worldwide. They have been found to account for approximately 17% of all fracture-related emergency department visits. These types of injuries have a bimodal age distribution. The first peak represents young patients involved in high energy traumas, and the second peak represents elderly patients with lower to moderate energy injuries secondary to osteoporosis.Surgical treatment for distal radius fractures varies, as there are numerous techniques for fixation. The goals of fixation are anatomic reduction and stability, as this has been shown to result in improved chances for functional recovery . The use of volar locking plateshas become the standard for treatment of the majority of distal radius fractures requiring surgery . However, adequate fixation for high energy comminuted fractures with or without metadia-physeal extension remains a major treatment challenge. Severely comminuted articular fractures are technically challenging in terms of obtaining an adequate reduction and achieving stabilization with a standard periarticular volar plating technique. The small fracture fragments are often not able to be stabilized with the screws from the volar plate, and the proximally-oriented tension from the forearm musculature acts to pull on the carpus causing further collapse of the articular surface. As an alternate to the volar plate, these types of injuries have been historically treated with an external fixator with or without Kirschner wires. However, it has been reported that highly comminuted distal radius fractures are associated with a 52%-63% complication rate when treated with external fixation . Therefore, despite poor fixation capabilities withthese fracturetypes,thevolarplate remainsthego-to devicefor most surgeons when faced with comminuted articular distal radial fractures. In these circumstances, the dorsal distraction plate (also called dorsal "bridge" plating technique) can serve as an improved fixation technique by allowing comminuted articular fragments to reduce under ligamentotaxis and provide a buttress for the dorsal cortex of the distal radius. In addition, a long dorsal plate can bridge past metaphyseal comminution, which cannot be so easily addressed with standard volar plating . The bridge plate can also be left in place for an extended period of time without the risk of the aforementioned complications of prolonged external fixation use . Finally, the dorsal distraction plate is technically a much easier operation to perform than volar plating for complex articular fractures. Recently, there has been increased use of dorsal distraction plating for these types of injuries .

Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years old
* early trouma (within two weeks)

Exclusion Criteria:

* open fractures
* concomitant limb injuries
* old fractures more than two weeks
* sever osteoporosis and osteopenia.
Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy

The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).

The main questions it aims to answer are:

* If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?
* If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy.

There is not a comparison group in our study.


Eligibility Criteria:
Inclusion Criteria:

* Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy
* Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy
* Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy

Exclusion Criteria:

* Less than 10mm in the maximum diameter of the baseline primary tumor
* Poor MRI image quality with obvious metal or motion artifacts
* The failure to complete the course of neoadjuvant therapy
Choroidal and Retinal Changes After RLRL Therapy in Diabetes and Diabetic Retinopathy

The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.

The goal of this study is to investigate the effect of repeated low-level red-light (RLRL) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. This study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. The control group will use the sham device but with only 5% of the original device's power. Comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up

Eligibility Criteria:
Inclusion Criteria:

1. Aged 35-55 years
2. Diagnosis of type 2 diabetes mellitus
3. No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography

Exclusion Criteria:

1. Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm
2. Patients with complications such as DME and retinal detachment
3. History of ocular surgical operations
4. Severe systemic diseases
5. Those who could not cooperate with the examination for any reason
6. Cognitive impairment or mental illness
7. Patients with other ocular diseases
Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite

The primary objective of the proposed research is to determine the influence of 8 weeks of twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat 120kcal muffin on components of obesity (waist circumference \[waist measurement\], serum glucose \[blood sugar\], triglycerides \[fats in the blood\] and HDL-cholesterol, and blood pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to groups and provided with twice daily 120 kcal servings of either dried apples or muffins for 8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood samples will be collected and analyzed. During each visit to the lab, subjects will be weighed in minimal clothing, tested for body composition using dual energy X-ray absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be performed prior to initiation of the study; one recall will be performed throughout the feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients, vitamins and minerals will be assessed to determine diet quality. All food records will be analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the study include determining the effects of consistent snacking and particular snack foods on metabolism and weight management. There are no major risks to subjects in this study. There are minimal risks when performing venipuncture (blood draws) including bruising, perforation of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of needles, and infection. This study will hopefully allow more understanding and insight into the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized that the twice a day apple snack group will have decreased waist circumference, body adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at the end of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* must be between age 10-16
* must be overweight or obese according to growth charts

Exclusion Criteria:

* regular consumers of apples (one per day)
* supplement users other than multivitamin
Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.

Primary Outcomes Measures:

- Disease control Rate at 8 weeks according to RECIST 1.1 (Tumor response was defined as the percentage of patients with complete response, partial response or stable disease as best overall response).

Secondary Outcome Measures:

* Progression-free Survival
* Overall Survival
* Adverse Events (assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0)

Eligibility Criteria:
Inclusion Criteria

* Histological diagnosis of metastatic colorectal adenocarcioma previously treated with at least two lines of chemotherapy (oxaliplatin and irinotecan regimens) if mutated KRAS or treated with at least 3 lines of chemotherapy (oxaliplatin, irinotecan and cetuximab) if KRAS wild type.
* Disease progression according to radiological or clinical assessment.
* Measurable disease.
* ECOG Performance 0-1.
* Age above 16 years.
* Normal organic function as defined for the following criteria:

  * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL);
  * Total serum bilirubin ≤ 2.0 x ULN-LL;
  * Absolute neutrophil count ≥ 1,500 / mm3;
  * Platelet count ≥ 100,000 / mm3;
  * Hemoglobin ≥ 8.0 g / dl;
  * Serum creatinine ≤ 1.5 x ULN-LL
* Written informed consent before enrollment

Exclusion Criteria

* Diabetic patients taking metformin.
* Patients already treated with mTOR inhibitors.
* Hypersensitivity to metformin, renal or hepatic impairment or other conditions that predispose to lactic acidosis.
* History of acute myocardial infarction in the last 6 months
* Serious illness or psychiatric condition.
* Current participation in other protocols with experimental drugs.
* Suspicion of dihidropirimida dehydrogenase(DPD)deficiency.
* Presence of active infection.
* No ability to ingest food orally.
* Patients with metastatic disease to CNS.
* Patients who underwent major surgery in the last 4 weeks.
* Patients who received chemotherapy in the last three weeks.
* Patients who underwent radiotherapy in the last 2 weeks or who received radiotherapy in the target lesion, if this is the only target lesion.
* Patients using oral anticoagulation (warfarin).
* Pregnant or lactating patients
Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors

A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors.

A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the following advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian epithelial carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-1
* Life expectancy \>3 months
* One the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma
* Patients must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments
* Adequate hematological, liver, and renal function
* Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases

Exclusion Criteria:

* Active and clinically significant (CS) infection
* Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617
* Symptomatic central nervous system (CNS) malignancy or metastases
* Concurrent active or previous malignancy
* Prior organ or allogeneic stem-cell transplantation
* Moderate or severe cardiovascular disease
* Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment
* Received treatment with known strong inhibitors and or inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment
* Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study
* Received treatment with known substrates of organic anion transporting peptide 1B3 (OATP1B3) or BCRP within 14 days or 5 half-lives before the first dose of study treatment
* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
* Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment
Increasing MSM in the Continuum of Care in Kazakhstan

This study addresses the disproportionate representation of men who have sex with men (MSM) in the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) pandemic in Kazakhstan, a country that has seen some of the largest growth in new HIV infections since the turn of the century. Using a stepped wedge trial across 3 cities in Kazakhstan, the proposed study will test a strategic and innovative social network-based intervention for MSM who use drugs in Kazakhstan as a strategy to increase their numbers in the HIV continuum of care.

The intervention is designed to utilize MSM as experts and leverage social network processes to increase the number of MSM in Kazakhstan to be engaged in the HIV continuum of care. The unit of randomization will be a city, with the timing of roll-out of the social network-based intervention in each of the study's cities-Almaty, Nur-Sultan (formerly Astana), and Shymkent-under experimental control. Receipt/delivery of an intervention to enrolled participants will depend on whether the city is in the intervention delivery phase or not. If a participant is in a city during a time period where the intervention is not being delivered then for that time period, the participant is in the control condition. If the participant is in a city during a time period where the intervention is being delivered then the participant (in fact, all participants in that city) will be considered assigned to the intervention group at that time. In theory, all participants will have the opportunity to experience and receive the intervention. Some participants will be enrolled after the intervention has been rolled out in the city in which they reside; thus, they will only experience the intervention condition and not the control condition.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years old;
* identify as male; and
* report oral or anal intercourse with another man in the past 12 months; and
* report binge alcohol consumption and/or illicit use of substances in the past 12 months

Exclusion Criteria:

* has a language or cognitive impairment that would prevent comprehension of study procedures, risks, and benefits (described in Russian during the informed consent process)
Improving Veteran Access to Integrated Management of Back Pain

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.


Eligibility Criteria:
Clinic eligibility:

* Volunteer and return signed clinic participation agreement
* Availability of clinical personnel willing to deliver the treatment interventions (in either arm).
* Staff and location need to be distinct from other enrolled clinics.
* Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.

Participant Survey Eligibility Criteria:

Inclusion Criteria:

1. Age \>= 18
2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
3. Provider determines LBP is appropriate for conservative management
4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider

Exclusion Criteria:

1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
2. No documented phone number in the electronic health record.