cyrilzakka/clinical-trials huggingface dataset:
Application of ATP Infusions in Palliative Home Care

Palliative care in cancer aims at alleviating the suffering of patients. A previous study in patients with advanced non-small-cell lung cancer showed that adenosine 5'-triphosphate (ATP) infusions had a favourable effect on fatigue, appetite, body weight, muscle strength, functional status, quality of life, and survival. Based on these promising results, the present study was designed 1. To evaluate whether the beneficial effects of ATP administration observed in patients with advanced lung cancer would also be present in pre-terminal cancer patients of different tumour types, and 2. To test the feasibility of application of ATP infusions in a home care setting.


Eligibility Criteria:
Inclusion Criteria:

* cytologically or histologically confirmed cancer
* medical treatment options restricted to supportive care
* a life expectancy \< 6 months
* World Health Organization (WHO) performance status 1 or 2
* suffering from at least one of the following complaints: fatigue, weight loss \> 5% over the last 6 months, or anorexia

Exclusion Criteria:

* symptomatic angina pectoris
* symptomatic heart failure
* any form of atrioventricular (AV) block (assessed by electrocardiogram)
* life expectancy \< 4 weeks
* concurrent palliative chemotherapy
* cognitive dysfunction, and other diseases hampering adequate follow up
Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors

Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence.

Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* To be of legal age
* Having suffered from primary breast cancer with histological confirmation (I-IIIA)
* Completion of primary carcinoma treatment (surgery, chemotherapy, radiotherapy)
* To be receiving hormone therapy as an adjunct to the process by aromatase inhibitors (exemestane, anastrozole, letrozole)
* To present a functional status according to WHO from 0 (asymptomatic, complete and ambulatory activity) or 1 (symptomatic but completely ambulatory, strenuous physical activity restricted but able to perform sedentary gentle activities)
* To understand correctly Spanish
* To show their approval by signing the informed consent
* Having had musculoskeletal disorders attributable to IA.
24-Hydroxylase Deficiency and CYP24A1 Mutation Patient Registry

You are being asked to take part in this research registry because you or your family member is suspected to have a 24-hydroxylase deficiency.

In this registry we propose to establish and maintain a registry of suspected and confirmed patients with 24 hydroxylase deficiency in an effort to collect data for further investigation. This would be the first and only known registry of its kind. These resources would be made widely available to clinicians and research scientists within Mayo to stimulate advances in the diagnosis and treatment of patients with this disease.

Eligibility Criteria:
Inclusion Criteria:

Patients who have undergone genetic testing for a CYP24A1 mutation with at least 3 of the following:

* Urinary Stone Disease
* Nephrocalcinosis
* Metabolic Bone Disease
* Serum Calcium \>/= 9.6 mg/dL
* Parathyroid hormone (PTH) \< 30 pg/mL
* 1,25-dihydroxyvitamin D \> 40 pg/mL OR a family member of a patient who meets the above criteria

Exclusion Criteria:

Patients who have tested negative for a CYP24A1 mutation with an alternative diagnosis that might explain hypercalcemia/hypercalciuria/stone disease:

* Sarcoidosis
* Lymphoma
* Tuberculosis
* Fungal infections
* Excessive exogenous calcium or vitamin D intake
Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis

The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis.

* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
* Patients will be randomly assigned to one of 2 groups: experimental group (taking a 10 mg tablet of ketorolac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. The patient's pain will be assessed before local anesthetic adminstration. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated.
* During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
* Postoperative pain will be assessed 6, 12, 24 and 48 hours after treatment. The number of patients who will require rescue analgesic medication within the 48 hours postoperatively will be counted.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-45 years old.
2. Males or Females.
3. Mandibular Posterior teeth with symptomatic irreversible pulpitis.
4. Patients with non-contributory systemic condition.

Exclusion Criteria:

1. Patients allergic to any analgesics or antibiotics or anesthetics
2. Pregnant females
3. If analgesics have been administrated during the past 8 hours before endodontic treatment.
4. Irrestorable teeth.
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Determine whether the use of Stratafix Symmetric™ sutures reduces the development of Ventral Incisional Hernia (VIH) in patients undergoing complex GI surgery compared to standard laparotomy closure. Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is a male or female 18 years of age or older.
2. Participant is a current patient at West Michigan Cancer Center.
3. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
4. Participant is willing and able to provide written informed consent before surgery.

Exclusion Criteria:

1. Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
2. Participant has history of previous VIH.
3. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.
Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure

Type of Study: Randomized Controlled Trial Aim: To compare the effectiveness of two doses of sucrose solution for pain relief in neonates after minor procedures.

Participants' Tasks:

Receive either 0.2 ml or 0.5 ml of sucrose solution. Undergo minor procedures. Pain intensity assessment using the Premature Infant Pain Profile (PIPP).

Comparison Groups:

Researchers compared the effects of administering 0.2 ml and 0.5 ml doses of sucrose solution on post-procedural pain in neonates.

This study is a randomized controlled trial conducted at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, from March 2023 to February 2024. It aims to compare the effectiveness of two different doses of sucrose solution (0.2 ml versus 0.5 ml) for pain relief in neonates after minor procedures.

Objective:

To compare the outcome of 0.2 ml versus 0.5 ml sucrose solution for pain relief in neonates after minor procedures.

Study Design:

Randomized Controlled Trial

Study Place and Duration:

Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, March 2023 to February 2024.

Participants and Methods:

Total of 148 neonates enrolled who underwent minor procedures and were admitted to the neonatal intensive care unit.

Randomly divided into two groups:

Group I: Administered 0.2 ml of sucrose solution Group II: Administered 0.5 ml of sucrose solution Pain intensity measured using the Premature Infant Pain Profile (PIPP). Data analyzed using SPSS version 25.0.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term neonates admitted to the neonatal intensive care unit (NICU) and high dependency unit (HDU) at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi.

Exclusion Criteria:

* Neonates with contraindications for sucrose administration, including:

Inability to swallow. Pharmacological muscle relaxation. Heavy sedation. Neonates who are unable to clearly view the infant's face, hindering accurate pain assessment
Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke

This trial aims at collecting standardized data concerning the early neurological clinical recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.

Although this outcome is a major issue of patients' prognosis, it is rarely collected at this stage of their follow-up.

Stroke affects 1 patient every 4 minutes in France, with around 130,000 new patients each year. Early recanalisation is a major prognostic factor and the main therapeutic target in the acute phase of this disease. The recanalisation techniques currently developed are intravenous thrombolysis, intra-arterial thrombolysis and thrombectomy (or embolectomy). These therapies can be combined. Thrombectomy involves endovascular capture of the clot obstructing the intracranial artery.

Recent improvements in thrombectomy techniques have also contributed to the spread of this technique. Neurovascular units include endovascular treatment in their strategy for the early management of acute proximal occlusions of intracranial arteries in almost 1 in 3 cases. This approach is currently the subject of professional agreements. Mechanical thrombectomy has now been validated by studies showing a major reduction (-35%) in the disability associated with severe cerebral infarction and a reduction in mortality, with recanalisation rates ranging from 58 to 72%. This "recanalisation" criterion is of major importance because it largely determines the functional prognosis of patients following a cerebral infarction.

Patients are often followed up in the months following the operation by the neurology department that initially treated them, and in the first few weeks they may be admitted to follow-up care units. As a result, although the clinical outcome at 3 months is a major factor in patient prognosis, this information is rarely available. The aim of this study is to obtain standardised 3-month follow-up data for a large series of patients who have undergone endovascular treatment for stroke.

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke
* endovascular treatment

Exclusion Criteria:

* none
Evaluation of the Efficacy and Safety of Drospirenone in the Treatment of Adenomyosis

Adenomyosis is a common benign condition of fertile women and is characterized by dysmenorrhea, hypermenorrhea, abnormal uterine bleeding, infertility and chronic pelvic pain.

To date, no clear guidelines are available regarding the treatment of adenomyosis, however, resembling endometriosis, as it too is a sex hormone-dependent inflammatory condition, numerous hormonal and non-hormonal treatments are currently being used off-label in the treatment of this condition, succeeding in controlling, sometimes not fully efficiently, the resulting symptoms.

Among hormonal treatments, progestins have been proposed. Decreased expression of progesterone receptors (PR) A and B has been observed in adenomyotic tissue, similar to endometriosis. Progesterone induces antiproliferative activity through binding to its receptors. The observed reduction in PR expression could partially explain the pathogenesis of adenomyosis and the poor response to progestins.

Although adenomyotic tissue has lower levels of PR, a good response to high-dose topical progesterone has been demonstrated. Although several molecules have been tested, such as levonorgestrel, dienogest, and danazol, to date there are no randomized controlled trials on the use of progestins in the treatment of adenomyosis that would allow clear guidelines on their use in this setting.

Among the progestins commercially available today is drospirenone, which is used clinically as a progestin in oral contraceptives. Drospirenone is a synthetic progestin similar to human progesterone and is a potent inhibitor of mineralocorticoid activity. Drospirenone has been shown to significantly reduce the diameter and maximal volume of ovarian endometrioma, reduce dysmenorrhea, reduce postoperative anatomic and symptomatic recurrence rates, and decrease serum CA125 levels. Drospirenone also acts on the endometrium, reducing its proliferation and thus improving menorrhagia symptoms and has also been shown to reduce Ki-67 expression in the human endometrium when administered orally with and without E2.

Despite reports of these clinical effects on endometriosis, the direct effects of drospirenone on adenomyosis have never been tested.

The aim of study is to evaluate the efficacy and safety of drospirenone in the treatment of adenomyosis, and its impact on improved quality of life and sexual life.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older;
* regular menstrual cycle;
* adenomyosis diagnosed by imaging analysis (magnetic resonance imaging \[MRI\] or transvaginal ultrasound);
* no other treatment for adenomyosis for at least 3 months before drospirenone administration;
* painful symptoms (lower abdominal and/or lower back pain) with a score of three points or more on the verbal pain rating scale developed by Harada et al. during the menstrual cycle.

Exclusion Criteria:

* endometriosis or uterine leiomyoma diagnosed by imaging analysis (MRI or transvaginal ultrasound);
* benign ovarian cyst including endometrioma;
* other endocrine diseases;
* severe anemia (hemoglobin concentrations \<8.0 g/dL).
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
* Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
* Received prior AI in combination with a CDK4/6i as the last therapy
* Known TP53 mutation status.
* Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
* Expected life expectancy of \>12 weeks in the judgement of the treating investigator.

Exclusion Criteria:

* Inflammatory breast cancer.
* Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
* More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
* Inadequate hepatic, renal, and bone marrow function.
* Clinically significant cardiovascular disease.
* Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
* Pregnant or breastfeeding women.
Tolerability of Grazax-R in Children

This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.


Eligibility Criteria:
Inclusion Criteria:

* Grass pollen induced rhinoconjunctivitis
* Boys and girls, 5-12 years of age
* Positive skin prick test to grass pollen

Exclusion Criteria:

* Previous treatment with immunotherapy
Very Low Density Lipoprotein (VLDL) Triglyceride Metabolism in Exercise

Purpose:

To investigate VLDL-TG metabolism in exercise in healthy volunteers to determine the contribution of VLDL-TG in exercise and eventual gender differences


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age: 20-50 years
* Premenopausal

Exclusion Criteria:

* Smoking
* Alcohol abuse
* Use of medications
Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy

This study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth. Participants will be randomized to either active or sham treatment and followed for 12 months.

Decreased sensation and decreased sexual satisfaction following vaginal childbirth has the potential to negatively impact overall sexual function and quality of life in many women. Previous research by obstetricians and gynecologists (OB/GYNs) found that changes in sexual health post-childbirth are not often discussed between physicians and their patients. One possible reason these discussions are not being initiated by physicians is the lack of an evidence-based treatment other than surgery.

While traditional surgery can be performed to improve sexual function following childbirth, pain at incision lines and scarring can lead to dyspareunia for months following the procedure, and a surgical procedure can be painful and the sutures may cause dense scarring. The post-operative recovery may last up to seven days before a woman can return to work. Resuming intercourse is not recommended for at least six weeks after these invasive surgeries. For the many women who are not good surgical candidates, due to health issues or situational limitations on downtime or their unwillingness to undergo a surgical procedure to improve sexual function, there is no other option.

The Geneveve Treatment offers a simple alternative to traditional surgery using non-ablative radiofrequency (RF) energy as a non-surgical approach to improve sexual function following vaginal childbirth. It induces a mild, controlled reaction in the submucosal tissues that stimulates the body to deposit collagen, thereby remodeling the tissue without causing scarring.

This study is designed to demonstrate that active treatment (i.e., Geneveve Treatment) is superior to the sham treatment for the primary efficacy and safety endpoints.

The active treatment group will receive a treatment dose of 90 J/cm\^2 and the sham group will receive a sub-therapeutic dose of ≤ 1 J/cm\^2. The participant, the investigator, and all study personnel will be blinded to the assignment for the entire study duration.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age at time of screening and pre-menopausal
* At least one vaginal delivery (\> 37 completed weeks gestation)
* Sexual dysfunction
* Negative pregnancy test at Screening visit
* Sexually active

Exclusion Criteria:

* Currently breastfeeding or recently discontinued breastfeeding
* Medical history of keloid formation, genital fistula, thin recto-vaginal septum or obstetric trauma
* Implantable electrical device
* Medical or immunological condition
* Chronic use of anti-inflammatory drugs
* Current or previous use of local vaginal hormones
* Undergone previous elective surgical or non-invasive procedure(s) at the vaginal introitus
Methadone-Maintained Smokers Switching to E-Cigarettes

Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.

Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.

All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT.

This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.

Eligibility Criteria:
Inclusion Criteria:

* moderate to heavy cigarette smokers (10 cigarettes/day for \> 1 yr; breath CO \> 10 ppm)
* have been receiving methadone for at least three months
* attend at least weekly to receive methadone dose
* speak English
* have a telephone or access to a telephone
* are available over the next 6 weeks
* are interested in switching to either electronic cigarettes or nicotine replacement therapy

Exclusion Criteria:

* use of ECs on \> 2 of the past 30 days
* currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)
* have unstable psychiatric conditions
* have near-daily or daily use of marijuana
* are pregnant
* had a cardiovascular event in the last month
* daily medication for asthma or COPD