cyrilzakka/clinical-trials huggingface dataset:
Comparison of Effectiveness and Safety Between Electronic Acupuncture and Dry Cupping Therapy in the Treatment of Neck Pain Due to Cervical Spondylosis

Cervical spondylosis is one of the common causes of chronic neck pain. It can significantly affect the quality of life, lead to disabilities, and increase the economic burden on patients. Treatment mainly includes pain relievers, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants or physical therapy. The condition tends to recur frequently; therefore, long-term use of medication can lead to unwanted effects on the digestive system, kidneys, and cardiovascular system.

Dry cupping therapy is a non-pharmacological method that has been shown to be effective in pain management. Cupping therapy has the advantage of being applicable to patients who are afraid of needles and has a wide area of effect.

Given the limitations in evaluating treatment effectiveness and safety, along with the lack of published research discussing the analgesic effects of dry cupping for neck pain caused by cervical spondylosis, the investigators conducted the study on pain reduction and safety of cupping therapy in patients with neck pain caused by cervical spondylosis.

Patients diagnosed with cervical spondylosis who have neck pain will be registered for this study. They will be treated with electroacupuncture or cupping therapy.

The intervention period is two weeks. Electroacupuncture will be performed five times a week while cupping therapy will be performed once every 3 days.

Data on the Visual Analog Scale (VAS) and side effects of electroacupuncture and cupping therapy will be recorded before the study and weekly for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 20 and 60 years, outpatient treatment.
* Individuals diagnosed with cervical spondylosis.
* Individuals report pain intensity between 3 and 8 according to on the Visual Analogue Scale (VAS) on the screening visit day.
* Experiencing neck pain for no longer than four weeks.
* Individuals who volunteered to participate in the study and signed a consent form.

Exclusion Criteria:

* Patients diagnosed with acute or chronic neck pain due to specific causes or with root compression syndrome, spinal cord compression syndrome, or vertebral artery syndrome.
* Patients loss of normal cervical curvature or deformity.
* Individuals with a history of neck trauma, cervical vertebra fracture, or cervical spine surgery, congenital spinal abnormalities, systemic bone and joint diseases.
* Patients have undergone cupping therapy, plastering, or drug inhalation within one week prior to participating in the study.
* Patients used of medications that could affect research outcomes within one week: Pain relievers, muscle relaxants, traditional medicines for treating neck pain.
* Patients suffer from a mental illness or lacks consciousness.
* Patients have a pacemaker, or any metal devices such as screws or plates.
* Patients currently using anticoagulant medications or has a bleeding disorder.
Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations

A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as "no supervision or medical treatment by a medical specialist. Further more to be determined by HCP.
* Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex)
* Infants up to 6 weeks of postnatal age (Including day 42)
* Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed)
* Willingness to change from their regular infant formula to study product
* Parents' or legal guardians' aged up to and including 18 years, written, informed consent.

Exclusion Criteria:

* Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study
* Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
* Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.
Follow-up Home Visits With Nutrition

To assess the effect on geriatric patients of follow-up home visit including nutrition.

The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life

Before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients in nutritional risk

Exclusion Criteria:

* Dementia
* Expected readmissions
* Terminal disease
* Non-Danish speaking
CAN1012 Combined With PD-1 in Patients With Solid Tumors

This is a Phase Ia/IIb, open-label, first-in-human, multicenter, single-arm, dose escalation study of intratumoral CAN1012 combined with PD-1 in patients with Unresectable or Metastatic Advanced Solid Tumors who have exhausted options for standard of care therapy.

The scope of the study is to evaluate the safety of the combination therapy of CAN1012 and PD-1 in human, study its efficacy and pharmacokinetics profiles, as well as explore its pharmacodynamic effects and biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent and willing to comply with the study's requirements.
2. Male or female age ≥ 18 years at screening.
3. Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists.
4. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy. Preferred tumor types include the following:

   Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer
5. Performance status of 0-1 on the ECOG Performance Scale.

Exclusion Criteria:

1. Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
2. Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
3. Has an active infection requiring systemic therapy.
4. Unstable/inadequate cardiac function defined as follows:

   1. New York Heart Association Class 3 or 4 congestive heart failure
   2. uncontrolled hypertension
   3. acute coronary syndrome within 6 months
   4. clinical important cardiac arrhythmia
   5. mean corrected QT (QTc) interval corrected for heart rate \>450msec（male），\>470msec（female）.
5. A history of interstitial lung disease.
6. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
7. Participated in a clinical study of an investigational agent within 30 days of screening.
8. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator.
9. Is pregnant or breastfeeding.
National Bacterial Meningitis Study

Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.


Eligibility Criteria:
Inclusion Criteria:

* clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (\> 10 cells/µL).
* purpura fulminans

Exclusion Criteria:

-
Hernia Reduction Prior to Scheduled TIF Completion

Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device

Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent "troublesome symptoms" per the Montreal consensus definition

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-72 years
2. Dependent upon daily PPIs for \> 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period
3. Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity
4. Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. \> 5.3% of the time with pH \< 4 in a 48-hour monitoring period
5. Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
6. Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from \> 2 cm up to 4 cm inclusive.
7. Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits
8. Signed informed consent Exclusion Criteria

1. BMI \> 35 2. Hiatal hernia ≤ 2 and \> 4 cm 3. Esophagitis Los Angeles grade C or D 4. Esophageal ulcer 5. Esophageal stricture 6. Long-segment Barretts esophagus (Prague: C \> 1, M \> 3) 7. Esophageal motility disorder 8. Pregnancy or plans for pregnancy in the next 12 months (in females) 9. Immunosuppression 10. ASA \> 2 11. Portal hypertension and/or varices 12. History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis 13. Active gastro-duodenal ulcer disease 14. Gastric outlet obstruction or stenosis 15. Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment 16. Coagulation disorders 17. Atypical symptoms including gas bloat and dysphagia. 18. Any other presenting condition that in the opinion of the investigator would not make participation in this study in the patient's best interest.

Post Enrollment Exclusion -

1. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.
Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

Bladder cancer is often treated with cystectomy or radiation therapy. Following radiation therapy patients will often have severe side effects from the treatment. Studies have suggested that simultanously treatment with androgen deprivation therapy during radiation therapy may be able to proctect stemcells in the bladder, thus improving tissue recovering post-radiation, which would result in improved bladder compliance following the treatment and ultimately result in fewer side effects and overall improved patient quality of life.

Bladder cancer (BC) is one of the most frequent cancers in the world and more common in men than female. Gender-related factors may be involved in the pathogenesis of BC.

Studies have suggested that androgen-receptors may be present in the bladder and potentially involved in BC aetiology, thus making BC susceptible for androgen deprivation therapy (ADT).

Currently treatment for BC includes surgery or radiation therapy. ADT include Degarelix, which besides decreasing testosterone, has been shown to reduce the occurrence of BC in rats and promote stem cell recovery following radiation therapy.

Hypothesis ADT will lower the incidence of BC, and the prognosis of BC will vary depending on the type of ADT used. Furthermore Degarelix administered during radiation therapy for BC will reduce the degree of fibrosis in the bladder thus decreasing adverse side effects.

Methods A cohort of patients treated with ADT for PC will be compared to two cohorts of age-matched men with and without PC both without ADT. The incidence of BC will be recorded for every group. Furthermore the cohort of patients with PC and ADT will be divided into subgroups, depending of the type of ADT they have received and the degree of deprivation. They will be compared in terms of incidence and prognosis of BC.

Finally, a small pilot study will be conducted to investigate the effect of Degarelix when administered during radiation therapy for BC.

Perspectives This will be one of the largest studies to investigate the potential influence of sex hormones in the development and prognosis of BC and potentially lead to new treatment options and possibly a new way of reducing radiation side effects.

Eligibility Criteria:
Inclusion Criteria:

* T2-T4 bladder cancer
* radiation therapy
* able to fill out questionnaires
* signed informed consent

Exclusion Criteria:

* KAD prior to TUR-B
* dementia or other cognitive impairment
* metastatic disease
Small+Safe+Well: A Longitudinal Study of TWH in Small Business

Workers in small businesses bear a disproportionate burden of occupational fatalities, illnesses, and injuries. The investigators conducted an intervention research project to determine how an intervention at the organizational level modifies business Total Worker Health (TWH) practices, safety climate, and health climate. In turn, the investigators aimed to determine whether organizational TWH adoption impacts individual workers' lifestyle health outcomes. In addition, the investigators also evaluated the use of the RE-AIM public health impact evaluation framework in the small business setting, with the intention of improving generalizability, maintenance, and dissemination of interventions and of guiding future TWH intervention design for both research and practice. The investigators conducted a lagged randomized controlled trial (L-RCT) to determine how different doses of an organizational-level TWH intervention (Health Links vs. Health Links + TWH Leadership Training) resulted in improvement and maintenance of TWH programming and organizational climates for safety and health, in small enterprises, over 36 months. The investigators also evaluated whether it resulted in improvements in workforce lifestyle health risks. In the short and mid-term, the goals and outputs of this project is a greater understanding of the theoretical underpinnings of TWH interventions and a model to test the implementation of the TWH interventions as well as an improvement the ability of TWH researchers and practitioners to apply this knowledge to TWH intervention design, implementation and evaluation to ensure generalizability. The long-term goal of this project is to impact worker safety, health and well-being through the continued use of these principles in small businesses.


Eligibility Criteria:
Inclusion Criteria:

* Colorado small business with less than 500 employees

Exclusion Criteria:

* Business does not operate in Colorado or has more than 500 employees
Efficacy of VR and Buzzy on Pain and Anxiety

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using external cold and vibration-Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy injection.

In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy.

This study is a prospective, randomized and controlled trial. Children aged 7 to 12 years who required phlebotomy were divided into three groups; buzzy, virtual reality, and controls. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.

The study population consisted of children aged 7 to 12 years who presented to the children's phlebotomy room of the hospital.

Sample of the study consisted of a total of 120 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into three groups: Buzzy (n= 40), VR group (n= 40), and the control group (n= 40).

Data were collected using the Information Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.

Eligibility Criteria:
Inclusion Criterial:

The sample selection criteria of the study were as follows: the children who

* were in the age group of 7-12 years,
* Due to undergo phlebotomy for blood testing,

Exclusion Criteria:

* had chronic diseases,
* had neuro-developmentally delayed,
* had visual, audio, or speech impairments,
* were hospital stay for treatment,
* had a history of sedative, analgesic or narcotic use within 24 hours before admission
Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)

The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.


Eligibility Criteria:
Inclusion Criteria:

* Between age of 22-99
* BMI between 15 and 40 kg/m\^2

Exclusion Criteria:

* Medical history of serious symptomatic, cardiac, or pulmonary disease.
* History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape).
* Cannot lay still for one (1) hour.
* Cannot give written informed consent.
* Unable to follow instructions.
Comparison of 2 Types of Cervical Specimens in Patients With a Pathological Screening Smear

The recommendations on the method and the realization of the cervico-uterine smears are clear. With regard to performing endocervical curettage, several methods are possible without precise consensus. In general, the Kevorkian curette is widely used. However, it is often reported by doctors and patients that curettage is painful. Some articles show that the cytobrush would be less painful. While keeping a percentage of correct curettage failures, it is sought to show that the cytobrush would improve the comfort of the patient during curettage.


Eligibility Criteria:
Inclusion Criteria:

* Women followed for a cervical pathology requiring endocervical curettage:
* AGC type (glandular cell atypia) with positive HPV test
* Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3)

Exclusion Criteria:

* Pregnant woman
* Women under the age of 25 or over 65
* Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material)
* Presence of a vaginal lesion on colposcopic examination
Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption

Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.


Eligibility Criteria:
Inclusion Criteria:

3.1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (XRT) with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. Postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy).

3.1.2 At the time of study enrollment, participants will have completed primary surgical or XRT with or without adjuvant chemotherapy. Chemotherapy will be completed at least 28 days prior to enrollment.

3.1.4 Participants will be women between 18-85 years of age. Women and minorities will be actively recruited. Though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females.

3.1.5 Participants will have a life expectancy of at least 5 years.

3.1.6 Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.

3.1.7 Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

3.2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use \> 5 mg/day prednisone or equivalent, teriparatide).

3.2.2 Use of any investigational drug within past 90 days.

3.2.3 Metastatic breast cancer. High risk for osteoporosis/fractures (BMD \< -2.0, history of non-traumatic fracture). Hyperparathyroidism Hypercalcemia Hypercalciuria (fasting spot urine calcium/creatinine ratio \>0.20) History of renal stones Renal failure with creatinine over 2.0

3.2.4 Considering that vitamin D3 is produced by the human body, allergy to vitamin D3 is not expected to develop. Subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study.

3.2.5 Recent history of excessive alcohol or drug use.

3.2.6 As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.

3.2.8 This study is designed to study women after completing primary therapy for breast cancer. Survivors of previous cancers and HIV-positive subjects will not be excluded.