cyrilzakka/clinical-trials huggingface dataset:
The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.

The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome.

In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.


Eligibility Criteria:
Inclusion Criteria:

* 1. Women over age 40 with histological evidence of hormone receptor positive breast cancer.

  2. Post- menopausal 3. Adjuvant AI therapy. 4. Significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy.

  5. Currently not in an active directed exercise program (\>60 minutes 2x/wk)

Exclusion Criteria:

1. Preexisting RA or fibromyalgia. 2. Systemic metastasis 3. ECOG performance status of greater than 2.

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Assesment of Complications and Surgery Timing in Postcovid Thoracotomy Patients: Single Center Experience

Covid-19 infection has caused delay in many surgeries. Besides Covid -19 infection may be a potential problem in especially major surgeries such as thoracotomies. Surgery timing, complications, intensive care unit stay and vaccination status are important issues that should be learned from post-covid cases.The aim of the study is to learn lessons from post-covid thoracotomy cases.

Patients who had covid-19 infection before thoracotomy were assessed by their datas, Postoperative complications, intensive care unit stay, vaccine status, time period between covid infection and surgery were collected from patients' files and statistical analysis performed.

Eligibility Criteria:
Inclusion Criteria:

* undergoing thoracotomy
* had covid infection before surgery

Exclusion Criteria:

* age under 18
* missing data
A Comparison of Posture, Balance and Flexibility in Between Adolescent Ballet Dancers and Sedentary Individuals

Ballet dance are typical specific movement which require balance ability and postural control. Ballet dancers use specific balance exercises. It can be expected, that dancers have an advanced sense of awareness for the placement and motion of their bodies. The effect of ballet dancing on adolescents is still unclear. Therefore, the aim of this study is to determine whether ballet dance has an effect on balance, posture and flexibility in adolescents.

Ballet is as a superlative combination of art and sport that requires high demands musculoskeletal conditioning which works on the development of coordination, balance and associated with efficient strength and flexibility. Balance is a key skill for dance performance for dancers especially for ballet. Ballet dancers use specific balance exercises. It can be expected, that dancers have an advanced sense of awareness for the placement and motion of their bodies. The support surfaces are variable in ballet training, this may also be the reason dancers can better use the information from the somatosensory and vestibular systems. It could be assumed that the effect of ballet training will have a positive effect on postural stability in standing. Postural balance is the act of achieving, maintaining or restoring a state of balance during any posture or activity. It is still unclear whether balance, flexibility and posture in adolescent ballet dancers is different than sedentary adolescent. Therefore, the aim of this study was to assess whether there are differences in balance between adolescent ballet dancers and sedentary adolescent and if these differences are associated with the flexibility and posture. To compare the postural balance between both groups the unipedal standing was chosen, which reduces the quantity of useful and accurate somatosensory information available to the postural control system. Posture analysis and flexibility tests were performed in both groups to compare flexibility and posture on balance. We purpose to compare balance parameters, posture and health quality parameters in adolescent ballet dancers and sedentary adolescent groups.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 7-17 years
* Volunteer
* Does not have any cognitive, mental and psychological problems,
* Does not have any systemic diseases such as rheumatoid arthritis,
* Does not have any neurological problems,
* Additionally, the criteria for the ballet dancers included more than 1 years of ballet experience, and for sedentary they included no experience in competitive sport or activity.

Exclusion Criteria:

* Having severe neurological, visual and auditory problems that may prevent the application of assessment parameters
* Children and their families who cannot obtain written consent from their families.
* Having communication problems
The Impact of Dyad Exercises on Well-being and Connection in Young Adults

Many people are experiencing low well-being and loneliness, particularly due to the COVID-19 pandemic. As the world is opening back up, it is crucial to determine methods to help people grow closer again and boost subjective well-being. One promising method is contemplative dyad meditation, which has hardly been studied. This is a method in which two people have a structured dialogue with each other while contemplating a prompt, as they alternate between listening and speaking. It is related to but different from other methods that have previously been shown to increase connection, such as the "fast friends" exercise. In "fast friends", two people answer a series of increasingly personal questions in a dialogue.

Here, 180 participants between 18-35 years will be randomly allocated to three conditions (stratified by gender): (a) contemplative dyad meditation training, (b) "fast friends", or (c) no-intervention. Participants in the dyad meditation group will receive professional meditation training followed by 2 weeks of regular meditation practice. Participants in the "fast friends" group will meet regularly during 2 weeks to practice "fast friends" exercises. The impact of the interventions on well-being, loneliness, mindfulness, and related measures will be investigated. After the interventions have finished, participants' physiology (heart rate) and brain waves (using electroencephalography \[EEG\]) during the respective exercises will also be measured to explore potential biological mechanisms. Of particular interest are heart rate variability (HRV, often linked with higher well-being), frontal alpha asymmetry in the EEG (linked with positive affect and approach), and biological synchrony in these variables between the two interacting individuals.

Both dyad meditations and "fast friends" exercises are predicted to improve closeness, thriving, loneliness, affect, depression, anxiety, and social interaction anxiety compared to no-intervention. Moreover, dyad meditation is predicted to have stronger effects than "fast friends" in terms of increasing mindfulness, self-compassion, and empathy. Dyad meditation and fast friends will show differential physiological signatures (e.g., lower heart rate and higher averaged alpha power for meditation).

This study may reveal effective methods to improve well-being and connection and provide insights into their biological mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Current student, staff, or employee at the University of Pennsylvania (for safety reasons)

Exclusion Criteria:

* none
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study
* Men and women aged 18 years or older
* Previous diagnosis of herpes zoster
* Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
* Cooperation and willingness to complete all aspects of the study
* Completion of at least 4 daily diaries during the week preceding randomisation
* A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

* Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
* Active herpes zoster lesion or dermatitis of any origin at the affected site
* Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
* Significant or unstable medical or psychiatric disorders
* Drug or alcohol abuse in the preceding 2 years
* Severe renal function impairment, as shown by calculated creatinine clearance values \< 30 mL/min at screening
* Relevant clinical laboratory abnormalities (e.g., Na+ \<130 mmol/L, alanine (ALT) or aspartate (AST) transaminases \>2.0 times the upper limit of the normal, white blood cell count (WBC) \<2,500 cells/mm3)
* Previous participation in any study with eslicarbazepine acetate
* Pregnancy or breast feeding
* History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
* History of non-compliance
* Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
* Participation in a clinical study within 3 months prior to screening
* Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.
A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused ABBV-400 to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).

ABBV-400 is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage 1 receives a different dose of ABBV-400. Each treatment arm in stage 2 receives the optimal dose of ABBV-400 or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met over-expressed (OE) refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries.

In stage 1, participants will receive intravenously (IV) infused ABBV-400 dose A or B. In stage 2, participants will receive the optimal dose of IV infused ABBV-400 or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study duration will be approximately 4 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \>= 12 weeks per investigator assessment.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Exclusion Criteria:

* Prior systemic regimen containing c-MET targeting antibody or Antibody Drug Conjugate (ADC).
* History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
* Active infection as noted in the protocol.
The Relationship With Mad Honey Containing Grayanotoxin and Ovary Tissue

For our working group, eighteen healthy Sprague-Dawley female rats were recruited and separated into three groups in an experimental animal laboratory.

Group 1 was given mad honey (n:6) (80 mg/kg); Group 2 was given normal honey (n:6) (80 mg/kg), and Group 3 was the control group (n:6). The groups were given normal and mad honey by oral gavage for 30 days in this study. Rats were anesthetized intramuscularly with 50 mg/kg ketamine and 5 mg/kg xylazine on the 30th day of the study. At the conclusion of the study, female rats in the proestrus phase of the estrous cycle (as indicated by vaginal smear) were sacrificed and their ovarian tissues were placed in neutral formalin solution.

Honey poisoning is caused by consuming honey produced by bees that feed on Rhododendron family plants. Rhododendron poisoning goes by names such as mad honey poisoning or grayanotoxin poisoning. The purpose of this study is to determine the effects of grayanotoxin in mad honey on ovarian tissue folliculogenesis in terms of cell death and nitric oxide expression. Three groups of 18 female Sprague-Dawley rats were formed. The first group received mad honey (80 mg/kg), the second group received normal honey (80 mg/kg), and the third group is control. The first and second groups received normal and mad honey by oral gavage for 30 days before being sacrificed under anesthesia The caspase 3 immunostaining group observed a moderate to a strong response, particularly in the granulosa cells of the Graaf follicles in the mad honey group, while the normal honey and control groups observed a weak to moderate reaction. In the mad honey group, immunostaining for caspase8 and caspase 9 revealed a moderate immunoreaction in the granulosa cells of the Graaf follicles, while expression was weak in the normal honey and control groups. The TUNEL approach revealed that the majority of Graaf follicles that exhibited TUNEL positive in the mad honey group and progressed to atresia were Graaf follicles. The iNOS immunoreaction revealed a high level of expression in the mad honey group, particularly in several Graaf follicles. In all three groups, a weak reactivity to eNOS immunostaining was seen in both Graaf follicles and theca external layers. According to the findings of apoptotic and nitric oxide marker expression, it was determined that mad honey may result in an increase in follicular atresia in ovarian follicles when compared to normal honey and control groups.

Eligibility Criteria:
Inclusion Criteria:

* healthy rats

Exclusion Criteria:

* patient rats
* not eating rats
Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)

The study aims to describe the current use of dalbavancin among diabetic patients with infections in a real-world clinical setting in Italy and Spain.

The study aims to describe the current use of dalbavancin in diabetic patients suffering from infections proven or suspected to be caused by Gram-positive or mixed Gram-positive and Gram-negative bacteria (with dalbavancin chosen for treating the Gram-positive component) in Italy and Spain.

As overall strategies to reduce the risk of developing severe infections and poor treatment outcomes among diabetic patients are under-researched and should be explored. This study could increase the knowledge of infection management among diabetic patients treated with dalbavancin in order to support appropriate clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of dalbavancin treatment initiation
* Male and female patients
* Patients who received dalbavancin as targeted or empirical therapy to treat Gram-positive bacterial infection or as anti-Gram-positive component of a treatment regimen for mixed infection (e.g., with concurrent antibacterial or antifungals drugs for covering Gram-negative strains or fungi)
* Patients who received the last dose of dalbavancin according to the current standard clinical practice at least 30 (+7) days before enrolment in the study
* Patients with known type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at the time of infectious disease of interest diagnosis
* Patients with available retrospective data in medical charts, including information about dalbavancin treatment and diabetes history
* Patients who gave informed consent and personal data processing consent to take part into the study following local regulation.

Exclusion Criteria:

* Patients enrolled in a clinical trial in which treatment with dalbavancin was managed through a study protocol
* Patients diagnosed with any hyperglycemic state other than T1DM or T2DM at the time of dalbavancin treatment initiation
* Patients with long-term infection (over than 12 months of duration) at the time of dalbavancin treatment initiation
* Previous participation in this study. Participation is defined as having given informed consent in this study
* Pregnant or breast-feeding patients from start time of dalbavancin treatment initiation till enrolment visit.
Examining the Impact of School-based Dental Screening

This study examines the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.

Background: Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. School-based dental screening could be a potential intervention that might impact uptake of service and subsequently dental caries.

Aim: To examine the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.

Methods: This is a cluster randomized controlled trial comparing referral of screened-positive children to a specific treatment facility (King Saud University Dental College Hospital) against the current practice (information letter advising parents to take their child to a dentist). A total of 1000 children in 12 schools will be recruited. Schools (clusters) will be randomly selected and allocated to either group using computer software. Clinical assessment for dental caries will be conducted at baseline and after 12 months by dentists using the World Health Organisation (WHO) criteria. Different clinical teams will be used for each trial group to ensure blinded outcome assessment. Data on socio-demographic, behavioural and dental visits will be collected at baseline and follow-up. Outcome measures will be the change in number of decayed teeth and the number of dental visits over 12 months.

Discussion: This project will use a robust design to provide high level of evidence on the clinical benefits of school dental screening. The findings will potentially inform policies related to the continuation/ implementation of school-based dental screening in Saudi Arabia.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 11 years (1st -5th grade at school) at baseline.
* Both Saudis and non-Saudis.
* Children for whom the person with parental responsibility has signed the consent form

Exclusion Criteria:

* Children in 6th grade (12-year-olds) as they would have left schools by the time of the follow-up assessment (12 months later).
* Children with any medically compromised condition such as congenital heart disease, haematological conditions, immune deficiency disease and end-stage renal disease.
* Children that refuse to participate (assent) in the study.
Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of paclitaxel and cisplatin, given after surgery in treating patients with cancer of the esophagus or stomach.

OBJECTIVES: I. Evaluate the disease free survival and overall survival of patients with adenocarcinoma of the esophagus, gastroesophageal junction, or cardia receiving post-operative adjuvant paclitaxel plus cisplatin.

OUTLINE: Patients undergo esophagogastrectomies within 4-12 weeks prior to the study. Patients receive intravenous paclitaxel over 3 hours on day 1, followed by intravenous cisplatin. Treatment is repeated every 21 days for 4 courses. Patients exhibiting disease recurrence or unacceptable toxic effects are removed from the study. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and then every 12 months thereafter.

PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the esophagus, gastroesophageal junction or cardia T2N1, T3 any N, T4 any N, and negative margins Proximal and distal margins of resection must be negative No metastases Must be within 4-12 weeks from date of surgery and clinically without evidence of local-regional or distant recurrence

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 120,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN Renal: Creatinine within institutional normal limits Cardiovascular: No New York Heart Association class III or IV heart disease No symptomatic coronary artery disease No myocardial infarction within 6 months No clinically significant conduction system abnormalities such as second or third degree heart block or bundle branch block Neurologic: No symptomatic peripheral neuropathy No psychosis Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No significant hearing loss No concurrent uncontrolled infection or medical illness No concurrent malignancies within 3 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No history of allergy to drugs containing cremophor No hypersensitivity to E. coli derived proteins

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics