cyrilzakka/clinical-trials huggingface dataset:
Patient Self-sampling of HPV to Screen for Cervical Cancer

The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.


Eligibility Criteria:
Inclusion Criteria:

* Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
* Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion).

Exclusion Criteria:

* Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy.
* Excluded if no cervix (history of total hysterectomy).
* Excluded if moderate to heavy vaginal bleeding on the day of the visit.
* Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.
* Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure).
* Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush.

(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block in Anterior Cruciate Ligament Reconstruction

The Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related techniques, including regional anesthesia. Arthroscopic knee surgery causes moderate to severe postoperative pain for most patients. Various methods such as different systemic drugs, peripheral or central blocks and intra-articular injections have been developed for the effective, safe and long-term control of this pain. In recent years, it has been shown that regional anesthesia techniques reduce the need for opioids in orthopedic ambulatory surgeries and accelerate recovery and discharge. However, there is no consensus on which is the best approach among these various regional techniques. However, adductor canal block (ACB) and intrathecal morphine (ITM) are the preferred regional methods in the perioperative pain management of knee surgery. In this study, it was aimed to test the effectiveness of intrathecal morphine or adductor canal block added to spinal anesthesia on the quality of recovery in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II adult patients aged 18-65 years undergoing elective arthroscopic anterior cruciate ligament reconstruction will be included in the study.

Exclusion Criteria:

* We will exclude patients with known coagulopathy, allergies to the studied drugs, obesity (BMI \>35kg/m2), renal and/or hepatic insufficiency, chronic pain syndrome, mental impairment, depression, chronic alcoholism, and usage of antidepressant and analgesic drugs before surgery.
Effect of TEAS on Rocuronium Injection Pain

Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing the rocuronium injection pain.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 year aged
* ASA I-III
* Who was to undergo various elective operations.

Exclusion Criteria:

* Cardiovascular surgery
* Patients with pacemakers
* Patients requiring rapid sequential induction
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

The purpose of this study is to evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The investigators will compare education in the low FODMAP diet to a standard healthy diet for improving symptoms in FD.

Functional Dyspepsia (FD) is defined by the Rome III criteria as bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning in the absence of structural or systemic disease that can explain the symptoms. These symptoms have been present for at least 3 months with symptom onset 6 months prior to the diagnosis.

The low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet has been studied in irritable bowel syndrome (IBS) patients and has been shown to have modest benefit in a limited number of small studies. The diet is generally started by complete elimination of fructose, lactose, fructans, galactans, and polyols. Following symptom improvement, these groups are reintroduced one at a time while the patient monitors for symptoms.

Although the low FODMAP diet has never been formally studied in patients with functional dyspepsia, we have noted the FD patients report improvement in their symptoms on the diet. This improvement could be explained by reduction in duodenal and gastric distention with the low FODMAP diet or a change in the duodenal flora.

To date, there have been no randomized trials evaluating dietary modification in FD. The purpose of this study is to evaluate the efficacy of the low FODMAP diet in functional dyspepsia. The investigator's hypothesis is that the addition of the FODMAP diet to standard medical treatment will result in improved symptom control in patients with functional dyspepsia.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years and older
* Diagnosis of FD with either PDS or EPS as measured by Rome III Criteria
* Patients describing inadequate relief of dyspepsia symptoms
* Endoscopy performed in the last 3 years and negative for an organic cause for dyspeptic symptoms
* H pylori negative by non-invasive testing or biopsy. Patients with a history of successfully eradicated H pylori will be included if follow-up testing by stool antigen, urea breath testing, or biopsy is negative
* Celiac disease excluded by serologies or biopsy

Exclusion Criteria:

* Patients with IBS predominant symptoms that are not well controlled
* Patients with a diagnosis of GERD who have uncontrolled heartburn
* History of esophagitis, ulcer disease, or other organic upper GI disease, including a diagnosis of celiac disease, gastroparesis, or vascular disorders of the upper GI tract
* History of surgery involving the esophagus, stomach, or duodenum
* Known lactose intolerance, unless symptoms persist on a lactose free diet
* Known fructose intolerance unless symptoms persist on a fructose free diet
* Patients undergoing active titration of any medications
* Pregnant or breastfeeding women
* Prisoners
3 Years of Anastrozole vs. no Treatment as Extended Adjuvant Therapy for Postmenopausal Women With Breast Cancer

The study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.


Eligibility Criteria:
Inclusion Criteria:

* No disease recurrence at time of randomization,
* patients with breast cancer after surgery,
* 5 years (+/- 12 months) of prior endocrine therapy

Exclusion Criteria:

* Premenopausal patients,
* unknown or negative receptor status,
* Secondary malignant tumor
Investigation of the Relation Between Trigger Digit and Carpal Tunnel Syndrome

The purpose of this study is to comprehend the association between the trigger digit and carpal tunnel syndrome based on the quantification of the tendon and nerve characteristics. It includes three parts.

The first part is an observational study. The aim of the first part is to attempts to measure the gliding and morphological characteristics of the flexor tendons and median nerve in the longitudinal or cross-sectional directions via the ultrasonographical images incorporating with the motion capture experiment of the wrist and fingers. The gliding and morphological features of the tendons and nerve will be compared under different postures or movement patterns of the wrist and hand.

The second part is an interventional study. The aim of the first part is to establishes a novel hybrid rehabilitation protocol which combines the tendon gliding exercise with nerve mobilization to treat either the trigger digit or the carpal tunnel syndrome. A randomized controlled trial to investigate the short-term treatment effect and the follow-up examination will be carried out as well.

The third part is an observational study. The aim of the first part is to investigate the effects of carpal tunnel release on the hand performances from functional perspectives. In addition, a novel wrist orthosis will be developed to eliminate the bowstringing effect of the flexor tendons after carpal tunnel release.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects without any history musculoskeletal diseases
2. Patients with carpal tunnel release surgery

Exclusion Criteria:

* Subjects with fracture or surgery in the upper extremity.
Probiotic Chewables in Allergic Rhinoconjunctivitis Patients

With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). In addition, the investigators aim to study the influence of this probiotic chewable on the microbiome of the upper respiratory tract after administration in adults with AR. The bacterial and cytokine profiles in the naso- and oropharynx will be monitored before, during and after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 at the time of registration;
* Seasonal allergic rhinoconjunctivitis (AR) in the context of grass pollen allergy diagnosed on the basis of anamnesis cfr. ARIA guidelines and positive skin prick test and / or immunocap assay;
* Positive skin prick test (SPT) for grass pollen and / or the presence of specific IgE for grass pollen, confirmed by a medical specialist, measured at the start of the study: Soluprick SQ Phleum pratense pollen 10 HEP - ALK and / or IgE specific immunocap assay Phleum pratense (timothy grass) (g6);
* Body Mass Index in the range of 19-32 kg / m2;
* Instructed during screening and agreed not to use other probiotic products outside of the study during the study period;
* Signed the consent form.

Exclusion Criteria:

* Antibiotic use at baseline and during the study;
* Pregnant women;
* Unstable / uncontrolled asthma (to be determined by investigator-physician);
* Sensitization to dust mites
* History of probiotic use in the past two weeks;
* Current diagnosis of cancer or immunosuppressive therapy within the past 6 months;
* Abnormalities of the oral mucosa;
* Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis cfr. EPOS guidelines);
* Clinically significant bleeding disorder;
* Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial;
* History of regular use (\> 3 days out of 7) of tobacco products within the previous two weeks
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer

A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.

This study is conducted to confirm the pharmacodynamic effects, efficacy, and safety of DKF-MA102 in prostate cancer patients by measuring the changes in serum testosterone levels.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male aged 19 or older
2. Histologically or cytologically-confirmed prostate cancer
3. Serum testosterone level \>150 ng/dL
4. ECOG PS grade ≤ 2
5. Life expectancy of at least 1 year

Exclusion Criteria:

1. History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection
2. History of hormone therapy
3. History of 5α-reductase inhibitor
4. History of radical radiation therapy
5. History of adjuvant male hormone block therapy
6. Severe liver failure
7. Serum creatinine ≥1.5 times the ULN
8. Hormone-independent prostate cancer
9. Diagnosed pituitary adenoma
10. Brain metastasis or spinal cord compression
11. Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period
12. Urinary tract obstruction
13. Cardiovascular disease
14. Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system
15. Uncontrolled diabetes
16. Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs
17. Severe asthma, severe vascular edema, and severe hives
18. Significant infection
19. Lack of self-determination due to psychiatric illness
20. Participating in another interventional clinical trial
21. Pregnant or unwilling to use medically approved contraception
22. Deemed inappropriate to participate in this clinical trial by the investigator
The Effect of Implementation of Bundle for Preventing Blood Culture Contamination in Neonatal Intensive Care Unit

In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

Infections are never as frequent and life-threatening as in the neonatal period. The lack of sepsis-specific findings in the neonatal period, the narrow repertoire of clinical findings in newborns, and the fact that non-infectious clinical conditions frequently encountered in this period have similar findings pose a serious problem for early diagnosis and treatment of neonatal sepsis. Another important problem is that early empirical antibiotic treatment without diagnostic confirmation has to be resorted to very frequently in order to avoid morbidity and more importantly mortality with early intervention. This leads to unnecessary and prolonged treatment of newborns with potentially dangerous broad-spectrum antibiotics as well as prolonged hospitalizations and significant costs.

The rate of contaminated blood culture in the neonatal period is 2.6-18%. In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

Eligibility Criteria:
Inclusion Criteria:

Newborns diagnosed with sepsis

Exclusion Criteria:

Newborns receiving antibiotic treatment
Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.

This is an open-label, single center, trial that will enroll up to 25 participants with circulatory shock after cardiac surgery. Participants will be administered a topical sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using incident dark field microscopy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving elective CABG or valvular surgery requiring cardiopulmonary bypass
* Receiving postoperative catecholamine therapy to maintain a MAP \> 65mmHg, cardiac index \> 2 despite initial fluid resuscitation
* Invasive hemodynamic monitoring

Exclusion Criteria:

* Surgical hemorrhage
* Unable to tolerate sublingual microcirculatory flow imaging
* Known intolerance or allergy to nitroglycerin
* Inadequate microcirculation imaging (based on Massey Score)
Fall Frequency in Children With Cerebral Palsy

The aim of this cross-sectional clinical study is to evaluate the frequency of falls in children diagnosed with cerebral palsy and compare it with healthy controls.

Our study is designed as a cross-sectional controlled study. A total of 23 children aged 5-12 years diagnosed with cerebral palsy, who can ambulate indoors or in the community either independently or with assistive devices, and 23 healthy children of the same age range will be included. Data will be collected on the age of the patients and healthy volunteers, information about their caregivers, frequency of falls, location and time of falls, education level, type of mobilization, presence of additional conditions, whether they receive rehabilitation, frequency of rehabilitation, duration of hospitalization if applicable, occurrence of falls during hospitalization, and presence of injuries. The collected data will be compared with the healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-12 years.
* Diagnosed with cerebral palsy (study group) or healthy without cerebral palsy (control group).
* Ability to ambulate either independently or with assistance indoors or in the community.
* Consent obtained from the participant or their caregiver (parent or guardian).

Exclusion Criteria:

* Refusal to participate in the study.
* Presence of cognitive impairments.
* Existence of neuromuscular diseases, other than cerebral palsy, that would impair walking ability or increase fall frequency.
Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 years or older on the day of inclusion.
* Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
* Participant is in reasonably good health as assessed by the investigator.
* Participant willing and able to meet protocol requirements.
* Participant willing and able to give informed consent.
* For a woman, inability to bear a child or negative serum/urine pregnancy test.

Exclusion Criteria:

* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
* An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.
* Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.
* Self-reported history of severe adverse event to any influenza vaccine.
* Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
* Vaccination planned in the 4 weeks following Fluzone® vaccination at Visit 1.
* Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
* Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
* Receipt of blood or blood products within the 3 months preceding enrollment in the study.
* Diabetes mellitus requiring pharmacological control.
* Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
* Person deprived of freedom by an administrative or court order (having legal or medical guardian).
* For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Prior personal history of Guillain-Barré syndrome.
The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization

the aim of the study is to assess the effect of intralipid as regard efficiency in decreasing myocardial ischemia , given during preconditioning in off pump coronary artery revascularization


Eligibility Criteria:
Inclusion Criteria:

* patients between 40 to 75 undergoing off bump CABG surgery

Exclusion Criteria:

* emergency surgery
* Ejection fraction less than 50%
* redo procedures
* history of allergy to peanuts
Application of Rapid On-site Evaluation in Lymph Node Biopsy of Breast Cancer

The goal of this clinical trial is to evaluate the value of rapid on-site evaluation（ROSE） in lymph node biopsy of breast cancer. The main question it aims to answer is:The ROSE technique was applied to breast cancer lymph node biopsy to improve the diagnostic efficiency and accuracy.

Participants underwent routine lymph node biopsy, and the test personnel conducted routine disease examination and rose technique evaluation on the removed ly


Eligibility Criteria:
Inclusion Criteria:

* Patients had pathologically confirmed primary breast cancer
* Surgical treatment was available

Exclusion Criteria:

* Previous history of surgery on the affected axilla, internal breast or chest
* Pregnant or breastfeeding patients
* Previous radiotherapy or chemotherapy
* Complicated history of other tumors
Four Year Weight Change of Cornell Students

Examining the effect of daily self-weighing on the ability of student to prevent from gaining weight during their four years at Cornell.

A group of freshman volunteers were randomly assigned to one of two groups. Both groups were given an internet based scale (Withings). The experimental group was asked to weigh themselves daily. The controls were asked to weigh themselves three times within one week every six months in response to being contacted by our researchers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Pregnancy
Acupuncture for Chemotherapy-induced Peripheral Neuropathy

In this study, a 24-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of acupuncture for Chemotherapy Induced Peripheral Neuropathy (CIPN) in colorectal cancer patients in Hong Kong.

This is a pilot single-blind, randomized, sham-controlled trial. 84 colorectal cancer patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 12 weeks with 1 session per week and the follow-up period will be 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years old
* newly diagnosed with stage Ⅱto Ⅲcolorectal cancer
* who plan to receive 8 cycles of adjuvant oxaliplatin-based chemotherapy
* who have not received any acupuncture
* life expectancy of ≥ six months.

Exclusion Criteria:

* uncooperative subjects
* not be able to comprehend and communicate
* non-Chinese reading people
* having peripheral neuropathy caused by other diseases, for example, diabetes, stroke
* heart disease, for example, arrhythmia, heart failure, myocardial infarction or patients with pacemakers
* having a bleeding tendency
* be pregnant or lactating women
* having impaired hepatic or renal function
* using any pharmaceutical agents (for example, gabapentin, pregabalin), nutraceutical agents (for example, vitamin B6, vitamin E) and herbal medication for CIPN treatment.