cyrilzakka/clinical-trials huggingface dataset:
A Study to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause

Symptoms of perimenopause and menopause can significantly affect overall quality of life. It is hypothesized that daily supplements can reduce the severity of these symptoms. This 12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy Supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue, and brain fog. Participants will take the product daily and complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12. Upon conclusion of Week 12, participants will be asked to count how many gummies remain in their jar.


Eligibility Criteria:
Inclusion Criteria:

Women aged 40-65 years old Must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes Must experience hot flashes and/or night sweats at least 5 times per day Can be either natural or surgical menopause (or perimenopause) Willing to adhere to the study protocol for the duration of the study

Willing to consult with their physician prior to starting the trial if taking any of the following medications:

Levothyroxine Liothyronine Calcipotriene (Dovonex) Digoxin (Lanoxin) Diltiazem (Cardizem) Verapamil (Calan, others) Thiazide diuretics Atorvastatin (Lipitor) Warfarin - Might increase the amount of time it takes for blood clotting. Minosalicylic acid (Paser) Colchicine (Colcrys, Mitigare, Gloperba) Metformin (Glumetza, Fortamet, others) Proton pump inhibitors (omeprazole (Prilosec), lansoprazole (Prevacid) or other stomach acid-reducing drugs) Phenytoin (Dilantin) Antihypertensive drugs Phenobarbital (Luminal) Amiodarone (Cordarone) Levodopa

Exclusion Criteria:

Not experiencing hot flashes and/or night sweats at least 5 times per day Has taken herbal supplements or multivitamins within the last 1 month Current use of conventional hormone replacement therapies, or plan to start during the study duration Current use of hormonal birth control, or plan to start during the study duration Known allergies to any product ingredients including the purified isoflavone genistein History of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear Anyone with any known severe allergies requiring the use of an epi-pen Unwilling to adhere to the study protocol Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders No planned invasive medical procedures for the duration of the study Pregnant or breastfeeding
Exercise Effect on Aerobic Capacity and QOL in Heart Failure

Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion.

Background:

Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion.

Objectives:

The primary objectives of this randomized clinical trial were to determine whether subjects, with moderate to severe chronic HF, who completed a 12-week individualized program of cardiopulmonary training (exercise group) would have significantly greater (i) quality of life, measured by the Rand Short Form-36, and (ii) aerobic fitness, measured by oxygen uptake during symptom limited maximal metabolic treadmill testing, than subjects who met weekly with an investigator and received vital sign measurements (non-exercise group).

Methods:

A randomized controlled clinical trial was utilized. Individuals who met the inclusion criteria were randomly assigned to either an exercise or control group. Individuals in the exercise group received 36 weeks of exercise training (primary outcome variables were measured at 12 weeks). Participants in the control group received weekly visits with a nurse for 12 weeks.

Status:

Ongoing data analysis for publication. Final report submitted.

Eligibility Criteria:
Inclusion Criteria:

Left ventricular ejection fraction less than or equal to 40%. Stable heart failure.

Exclusion Criteria:
The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function

The purpose of this study is to assess the influence of the body posture correcting therapy on pelvic floor muscles function and urinary incontinence problem.

This randomized, controlled study was aimed to asses influence of a six week global posture correction therapy on pelvic floor muscles function and urinary incontinence problem. Participants were randomly divided into two groups. All subjects overcame assessment of pelvic floor muscles (sEMG, manometry and digital) and completed questionnaire about urinary incontinence problem and general health condition connected with lower tract symptoms. Both groups had a pelvic floor education (what is it, where are the pelvic floor muscle, how to correct contract them etc.) Additionally, the study group had a six week therapy focused on body posture correction. Therapy consisted of manual therapy (once per week) and correction exercises.

Eligibility Criteria:
Inclusion Criteria:

* stress urinary incontinence (confirmed by a medical examination)
* female
* age between 25 and 45 years old

Exclusion Criteria:

* gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
* menopause
* spinal and pelvis injuries
* chronic diseases of the circulatory and respiratory system
* neurlogical accidance
Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy

This study evaluates genetic testing to improve risk assessment and advance efforts to develop precision management for breast cancer by studying saliva samples for genotyping and evaluate associations with pathologic diagnoses and detailed pathologic and radiologic features.

PRIMARY OBJECTIVES:

I. To collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) (and related single nucleotide polymorphisms \[SNPs\]) to final diagnosis of ductal carcinoma in situ (DCIS), invasive breast cancer or benign breast disease (BBD); BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise.

II. To relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries.

III. To relate PRS (and related SNPs) to molecular markers in pathologic lesions and background tissues, including associations with breast cancer (BC) molecular subtypes (e.g., luminal, triple-negative (basal) and human epidermal growth factor receptor 2 \[HER2\] overexpressing) and biomarkers in BBD and lobules.

OUTLINE: This is an observational study.

Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* \* Women over the age of 18 years

  * Able to provide informed consent
  * Referred for a radiologically guided breast biopsy

Exclusion Criteria:

* \* Men

  * Women under the age of 18 years
  * Unable to provide informed consent
A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults

The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal mix in powder form and its effects on anxiety and the biomarkers for chronic stress.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between the ages of 21-65.
* No concerns that would confound the study as determined by study physicians.
* Women must not be pregnant or become pregnant for the duration of the study.

Exclusion Criteria:

* The subject has a history of hypersensitivity to any of the compounds used in the study
* The subject is pregnant or breast feeding. Note: If the potential subject is a post-menarche female, a urine pregnancy test must be performed within 24 hours prior to study drug administration and confirmed negative in order for the potential subject to eb enrolled.
* History of Psychiatric Illness or Chronic Stress or Anxiety
* Hypertension, cardiovascular disease, liver, hypokalemia, or kidney disease or other health concerns that the study physician feels may confound study results
* Individuals who are cognitively impaired or who are not able to give informed consent
* Any routine prescription medication that the study physician feels may cause drug interaction with Soulera or alter the prescription medications' activity
* Previous participation in a clinical research trial within 30 days prior to randomization
* The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana
* The subject uses or has used in the past 30 days any steroid formulation, be it topical like face cream, ocular as in an eye drop, nasal as in a spray, injection or pill.
* The subject is a current smoker or uses tobacco products such as chewing tobacco.
* The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
* The subject is a night-shift worker and therefore presumably has an altered cortisol diurnal rhythm and is also unable to comply with the required cortisol collection times of the study
Health Effects of Silver-Mercury Dental Fillings

The purpose of this study is to determine whether there are detectable health effects of low-level mercury exposure (from normal exposure to mercury-containing dental fillings) in the known target organs/systems affected by elemental mercury exposure.

The Casa Pia Study of the Health Effects of Dental Amalgam in Children is a randomized, prospective clinical trial with the overall goal of determining if there are detectable health effects due to exposure from mercury-containing dental amalgam fillings. Children, thought to be the population most susceptible to any possible health effects, were randomly assigned to one of two treatment groups (total n=507). Subjects were originally enrolled at ages between 8-10 years of age. To participate, subjects must have: Dental caries in at least one posterior tooth; no prior exposure to dental amalgam; a blood lead of \<15ug/L; a urinary mercury level of \<10ug/L; an IQ as measured by the CTONI of \>67; and no prior or existing serious medical or neurologic condition. One group received only dental filling materials other than those containing mercury (plastic and ceramic composites), while the other group received mercury amalgam fillings where appropriate (in large restorations in back teeth), but the alternative materials everywhere else. Both treatment regimens are standard-of-care throughout the world. Subjects receive ongoing dental care via the study clinics, and continue to receive dental fillings as needed based on group assignment. The target organs of mercury exposure are renal and neurological. Baseline and annual repeated measures are taken on all subjects for renal function, nerve conduction velocity and a large battery of neurobehavioral tests. Follow-up is planned for a period of 7 years

Eligibility Criteria:
* Age 8-10 years of age
* Dental caries in at least one posterior tooth.
* No prior exposure to dental amalgam
* Blood lead of \<15ug/L
* Urinary mercury level of \<10ug/L
* IQ as measured by the CTONI of \>67
* No prior or existing serious medical or neurologic condition
Safety Study of Abatacept to Treat Refractory Sarcoidosis

The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.


Eligibility Criteria:
Primary Inclusion Criteria:

* Diagnosis of sarcoidosis for at least 1 year with lung disease
* Active disease despite current treatment
* On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days

Primary Exclusion Criteria:

* Previous treatment with Abatacept
* Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab)
* Currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide
* Previous treatment of IVIg within the last 6 months
* History of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks
* History of congestive heart failure
* HIV
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of East Asian or Southeast Asian origin, \>/= 18 years of age
* Presence of chronic genotype 1 hepatitis C infection
* Treatment-naïve

Exclusion Criteria:

* History or presence of decompensated liver disease
* Presence or history of non-hepatitis C chronic liver disease
* Positive for hepatitis B or HIV infection
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.

Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.

The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* WHO status : 0, 1 or 2.
* Age \> 18ans
* Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
* Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
* Possible location of the tumour by clinical examination, CT-scan
* Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
* Neutrophils \> 1000/mm3.
* Platelets \> 100 000/mm3.
* Blood créatinine \< 15 mg/L. Blood bilirubine \< 30 mg/L
* Prothrombin rate \> 70 %.
* Social insurance
* Informed consent

Exclusion Criteria:

* WHO status : 0, 1 or 2.
* Age \> 18ans
* Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
* Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
* Possible location of the tumour by clinical examination, CT-scan
* Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
* Neutrophils \> 1000/mm3.
* Platelets \> 100 000/mm3.
* Blood créatinine \< 15 mg/L. Blood bilirubine \< 30 mg/L
* Prothrombin rate \> 70 %.
* Social insurance
* Informed consent
Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19

Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona.

This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2

COVID-19 has become a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of COVID-19 are emergently needed. In Maricopa County there has yet to be a clinical trial to evaluate people who are SARS-CoV-2 positive with mild symptoms. This study will measure the improvement of COVID-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of Hydroxychloroquine, Indomethacin and Zithromax.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age
2. Willing and able to provide written informed consent prior to performing study procedures
3. Confirmed Sars-CoV2 infection by PCR
4. Have mild symptoms of Sars-CoV2
5. Must show documentation of Sars-CoV2 to screening visit
6. Must have had recent hematology and chemistry results
7. Must be able to take heart rate daily
8. Must agree to Skype/Facetime daily
9. Must agree to take temperature daily
10. Must agree not to enroll in another study of an investigational agent prior to completion of Day 14 of treatment.

Exclusion Criteria:

1. Known to be allergic to research drugs or drug excipients
2. Incapable of providing informed consent
3. Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection
4. Pregnancy, possible pregnancy or breast feeding
5. Prolonged QT interval (\>450)
6. Moderate to severe symptoms of Sars-CoV2
7. Renal failure
8. Hepatic failure
9. NSAID use
Oxygen Toxicity: Mechanisms in Humans

The goal of this clinical trial is to learn about the mechanisms of oxygen toxicity in scuba divers. The main questions it aims to answer are:

* How does the training of respiratory muscles affect oxygen toxicity?
* How do environmental factors, such as sleep deprivation, the ingestion of commonly utilized medications, and chronic exposure to carbon dioxide, impact the risk of oxygen toxicity?
* How does immersion in water affect the development of oxygen toxicity?

Participants will be asked to do the following:

* Undergo a basic screening exam composed of health history, vital signs, and some respiratory function tests
* Train their respiratory muscles at regular intervals
* Exercise on a cycle ergometer both in dry conditions and underwater/under pressure in the context of medication, sleep deprivation, or carbon dioxide exposure

Researchers will compare the performance of each subject before and after the possible interventions described above to see if there are changes in exercise performance, respiratory function, cerebral blood flow, and levels of gene expression.


Eligibility Criteria:
Inclusion Criteria:

* Equal numbers of male and female
* Non-smokers
* Aged 18-45 years
* Males will be required to have VO2 peak \> or equal to mL/kg min
* and females \> or equal to 30 mL/kg min

Exclusion Criteria:

* Pregnancy
* Cardiorespiratory disease, including hypertension
* Neuromuscular disease
* Anemia
* History of hemoglobinopathy, including sick cell disease and trait
The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) from Hemp Oil in patients with Chronic pain, anxiety and insomnia. It is believed that CBD will improve pain anxiety and sleep quality and reduce opioid use. The study will last a total of 4 weeks and involve onsite visits in addition to weekly pain assessments.

The proposal is to conduct a interventional cohort pilot study to evaluate the effectiveness of CBD on the management of chronic pain, anxiety and insomnia.

Subjects will be pre-screened from new and existing patients as well as from referral sites for the diagnosis of chronic pain. Potential subjects will be screened for pain \>3 months who are using oral analgesic including narcotics and or physical therapy to reduce pain.

Those meeting all inclusion and exclusion criteria will receive a comprehensive history and physical exam and undergo informed consented at the Screening Visit. Baseline survey data will be collected including various pain rating surveys. The patient's will be monitored for compliance to complete the weekly rating using a research phone application.

Subjects will receive either CBD tincture or CBD topical cream.This will be dosed daily for a total of 4 weeks. Patients will be evaluated on three pain rating scales: On initial evaluation and 4th week evaluation, patients will be asked to fill out The Brief Pain Inventory and Pain Disability Index. Once weekly, a Numeric Rating Scale.

On initial evaluation and at 4th week evaluation, narcotic dosing will be reviewed and recorded. Quality of sleep and anxiety scale will also be recorded for the four weeks using the Hamilton Anxiety scale and Sleep Quality Assessment at the start and end of the 4 weeks. At initiation and conclusion of study blood work to evaluated levels of CBD in each patient. Subjects will be screened for side effects as well as records of pain medication use throughout the duration of the study

Eligibility Criteria:
Inclusion criteria:

* Patients with pain \>3 months who are using oral analgesic including narcotics and or physical therapy to reduce pain.
* Patient provides informed consent
* Older than 21 years old,
* Previously have used CBD or marijuana
* Speaks English

Exclusion criteria:

* Patients who are receiving interventional pain procedures or surgery within 30 days
* for their pain
* Patients who have had pain \<3 months
* Presence of serious medical illness
* Pregnant females
* Use of P450 modifying medications.