cyrilzakka/clinical-trials huggingface dataset:
Broccoli Sprout Extract in Treating Patients With Breast Cancer

This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.

PRIMARY OBJECTIVES:

I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.

II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).

III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.

IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.

SECONDARY OBJECTIVES:

I. To determine tolerability of ITC-BSE and compliance in breast cancer patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.

ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

After completion of study treatment, patients are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (no menstrual cycle in the past 12 months)
* Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS)
* No neoadjuvant endocrine therapy or chemotherapy within 12 months
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Willing to avoid cruciferous vegetable intake during the study period (2 weeks)
* Demonstrate the ability to swallow and retain oral medication
* Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
* Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers
* Intolerance to broccoli/ITC-BSE taste
* Current ingestion of broccoli sprout extract, which may confound study results
* Current or recent treatment for any malignancy within the last one year, which may affect biomarkers
* History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
* Current diagnosis of Gastroesophageal Reflux Disease (GERD) with grade \>3
A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty

This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty

This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty. Through this study, we anticipate that the potential usefulness of multimodal cocktail analgesic injections in various aspects of spinal surgery will be demonstrated, offering valuable insights and possibilities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty
* Recorded preoperative upper limb pain (Visual Analog Scale \[- VAS\] ), neck pain (VAS), Japanese Orthopaedic Association (JOA) scores, and Neck Disability Index (NDI) scores.
* Adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities
* Cognitive function at a level that enables them to comprehend and adhere to study procedures

Exclusion Criteria:

* Previous surgical treatment of the cervical spine.
* Adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy.
* Hypersensitivity reactions to mixed medications used in Cocktail therapy. (morphine 5 mg, ropiva 150 mg, tamceton 40 mg, epinephrine 1 mg, ketocin 60 mg, jetiam 1 g).
* Patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.
Effects of Ward Cats in Patients With Substance Abuse, Depression and Psychosis at UPK Basel

The aim of this study is to explore the relationship between ward cats and patient satisfaction and stations atmosphere in patients with substance abuse, depression and psychosis. Moreover, we wanted to investigate the patients perception of the ward cats and the relationship between station atmosphere perceived by the employees working wards with and without cat at UKP Basel.

The following tools were used to address these aims:

* Available MüPF data regarding patient satisfaction of 170 inpatients during 2016 was analyzed.
* Available MüPF data regarding patient satisfaction of 151 inpatients during 2017 was analyzed.
* 33 patients were interviewed regarding their perception of the cats
* 30 staff members at the wards filled in questionnaires regarding station atmosphere (EssenCES)

Eligibility Criteria:
Inclusion Criteria:

* Inpatient of the 7 wards at UPK Basel diagnosed with substance abuse, depression and psychosis
* staff working at these wards

Exclusion Criteria:

* none
Comparing the Effects of Yoga Nidra to Yoga Nidra With Pain Acceptance Intention and Motor Imagery on Pain Outcomes

Yoga Nidra is a scripted mind-body intervention (MBI) that uses guided relaxation technique in a reproducible sequence of mechanisms that naturally produce a parasympathetic response. This is a randomized controlled trial in which participants will be randomly assigned to one of three interventions: 1) yoga nidra (Yoga Nidra Script Basic), 2) yoga nidra with pain acceptance (Yoga Nidra Acceptance Intention), 3) yoga nidra with pain acceptance and Explicit Motor Imagery (Yoga Nidra Acceptance Intention and Visualization).


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain in the neck, low back, shoulder, hip, elbow, knee, wrist, or ankle that has lasted for over three months
* Pain intensity rated as 3/10 or higher in the past 24 hours (0=no pain, 10=worst pain imaginable)

Exclusion Criteria:

* non-English speaking
* systemic medical conditions that affect sensation (such as uncontrolled diabetes)
* History of surgery or fracture within the past six months
* any blood clotting disorders (such as hemophilia)
* any contraindication to the application of ice (blood pressure \&gt; 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* Exceed pressure and heat sensory thresholds
* Unable to access internet or email
* Pregnant
Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules

Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg \[Test Formulation, Torrent Pharmaceutical Ltd., India\]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. \[Reference Formulation, AastraZeneca LP, USA\] in Healthy Human Volunteers Under Fed Conditions.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* Inability to communicate or co-operate.
* Administration of any study drug in the period 0 to 3 months before entry to the study,
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of pre-existing bleeding disorder.
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* HIV, HCV, HBsAg positive volunteers.
* History of alcohol or drug abuse.
* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
* Positive to Breath alcohol test.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 35°C or more than 37.5°C.
* Respiratory rate less than 12/minute or more than 20/minute.
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* Recent History of kidney or liver dysfunction.
* Volunteers suffering from any psychiatric (acute or chronic) disorder.
* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus

To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.

Intermittent energy restriction (IER) and time-restricted eating (TRE) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. Investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. Both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes in the past 10 years.
2. Age 21-65 years
3. BMI of 25 - 45 kg/m2
4. HbA1c of 6.7-9.5%, or those with A1c of \<6.7% on glucose-lowering medications
5. Ability to participate in a graduated physical activity program
6. Clearance from study physician.

Exclusion Criteria:

1. Inability to attend health education meetings.
2. Weight change of \>=5% in the previous 3 months.
3. Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
4. Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program.
5. Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
6. Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
7. Pregnancy or lactation within the previous six months
8. Weight of \>450 lbs
9. Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Atorvastatin in Moderate Active Crohns Disease

Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohns disease
* C-reactive protein level \> 2 mg/L in absence of an infection
* Fecal calprotectin \> 250 mg/kg or CDAI \> 150

Exclusion Criteria:

* CDAI \> 450
* Prednisolone dosage above 15 mg/day
Collaborative Assessment of ICU Recovery Needs

The primary purpose of this study is to better understand the impact of the Society of Critical Care Medicine (SCCM) THRIVE Collaboratives on patients, their families and clinicians.

The investigators have formed an international and interprofessional evaluative team with experts in the field in an effort to explore interactions between survivors and THRIVE. This approach is reflective of the international ethos of SCCM and its collaboratives, with the potential to improve the generalizability of this survivorship research to different health systems.

The aims of this qualitative study are:

1. To identify elements that helped survivors in their recovery, as well as potential obstacles
2. To capture elements of survivorshop that are generalizable, regardless of participation in the THRIVE collaboratives
3. To gain knowledge to be incorporated back into the collaboratives

Patients, family members, and clinicians will be interviewed and their responses analyzed for themes of ICU recovery including elements that patients and families find helpful to recovery, barriers and facilitators to different models of post-ICU support, including peer support and post-ICU clinics, and drivers of improvement in post-ICU care. Patients, carers, and clinicians with a wide variety of survivorship experiences are encouraged to participate, including those who have participated in a THRIVE collaborative support site (peer support or clinic).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who survived a critical illness, and their carers, who were identified by collaborative members or self-identify as having been through a THRIVE Program.
2. Patients who survived a critical illness, and their carers, who did not participate in a THRIVE program.
3. Clinicians directly involved in the care of ICU survivors in the outpatient setting, who have participated in a THRIVE initiative through the Society of Critical Care Medicine.

Exclusion Criteria:

* N/A
E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent

In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

Eligibility Criteria:
Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ....)
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects

To evaluate the safety of a personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.


Eligibility Criteria:
Inclusion Criteria:

* no participation in a similar study 2-weeks prior
* may be post-menopausal or have had a hysterectomy
* if sexually active, and of child bearing potential, subjects is using adequate non-barrier method of birth control
* free from any vaginal disorders
* sexually active and in a monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
* personal lubricant user and agrees to replace her usual personal lubricant with the investigational product
* can start regardless of where they are in their cycles
* agrees to use the provided investigational product at least four time weekly over the two week study period
* exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam
* willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study
* agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area
* willing to use a urine pregnancy test provided to them at baseline and on third visit
* standard medical history form on file
* signed informed consent
* completed HIPAA
* dependable and able to follow directions as outlined
* receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination.

Exclusion Criteria:

* pregnant, nursing or planning a pregnancy
* currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
* known allergies to vaginal or any cosmetic products
* reports history of recurrent bladder, vaginal infections or incontinence
* exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
* uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception
* participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation
* receives a score higher than 0/5 for erythema, edema or \>0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities
Retro-walking Versus Forward-walking Training Using Underwater Treadmill in Patients With Knee Osteoarthritis

The purpose of this study Will investigate and compare the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA

In the current study, Sixty subjects from both genders, the dominant side only will be involved. They will be divided in to three equal groups: group A (experimental1), group B (experimental 2), group C (control), they will be signed a consent form to share in this study which aimed to investigate the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA

Eligibility Criteria:
Inclusion Criteria:

1. 60 patients with chronic knee OA.
2. Age ranges from 40-60 years old of both genders.
3. body mass index (BMI) 25- 35kg/m2.
4. The degree of osteoarthritis was mild or moderate and have a Kellgren- Lawrence radiographic grade of of1-3.
5. unilateral knee osteoarthritis involvement.

Exclusion Criteria:

1. hydrophobia.
2. pregnancy.
3. infection.
4. psychiatric disorder.
5. haemorrhagic diathesis.
6. cardiac pacemaker.
7. all Subjects with deformity of hip, knee \& ankle.
8. any CNS or PNS involvement.
9. recent steroidal or intraarticular injections (3 months).
10. systemic inflammatory disease and bone malignancy.
Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals

Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged between 20 to 60.
* Systolic pressure below 140
* Score of C-CAGE Questionnaire below 8 (male)/6 (female)
* Prohibiting other supplements before 2 weeks of the study and during the study
* Prohibiting alcohol drinks before 24 hours of the study
* Prohibiting caffeine drinks before 12 hours of the study

Exclusion Criteria:

* Alcohol or drug allergy
* Liver, kidney, cardiovascular, or chronic diseases
* Other severe disorders
* Hypertension
* Pregnancy or lactation
* Already involved in clinical testing
* Other supplements
Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

- Patients who withdrew from one of the qualifying studies (i.e. patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism \[HPT\]; in particular parathyroid hormone \[PTH\], calcium and phosphorus levels in blood associated with kidney failure) due to kidney transplantation.

Exclusion Criteria:

- Patient has any kind of disorder that compromises the ability of the subject to give written informed consent
Intravenous Allopurinol in Heart Failure

This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.

Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.

The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* The patient is willing and able to provide informed consent
* Clinical diagnosis of chronic heart failure
* Ejection fraction (EF) \< 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
* No significant coronary disease at cardiac catheterization
* New York Heart Association (NYHA) Class I-IV symptoms
* Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.

Exclusion Criteria:

* Metallic implant prohibiting magnetic resonance (MR) evaluation
* Inability to lie flat for MR study
* Administration of additional investigational drugs
* Calculated creatinine clearance \< 50 mL/min
* Allergy to allopurinol
* Current gout flare
* Currently taking oral allopurinol
DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor


Eligibility Criteria:
Inclusion Criteria:

* Full term (≥ 37 weeks) healthy primigravida parturients ASA2
* with single fetus scheduled for vaginal delivery
* with cephalic presentation
* requesting labor analgesia.

Exclusion Criteria:

* Allergy to dexmetomidine.(based on previous history)
* Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
* Twins.
* Malpresentation.
* Preeclampsia or gestational hypertension
* Uncontrolled diabetes HBA1c ≥ 6.5%
* Uncontrolled renal failure
* Uncontrolled liver disease
* Bleeding tendency or coagulopathy.
* Contraindication or patient refusal to epidural block.
* Body mass index ≥ 35.