cyrilzakka/clinical-trials huggingface dataset:
A Possible Effect of Oxytocin During Interaction Between Humans and Animals

The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals.

The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals and filling in instruments measuring anxiety and stress.

Eligibility Criteria:
Inclusion Criteria:

* woman
* age 20-30 years old
* physical capable of being in a farm environment and have contact with cows

Exclusion Criteria:

* pregnancy
* breastfeeding
* anxiety for blood sampling
* anxiety for animals
* allergies
* psychiatric diagnoses
* medication
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers

The purpose of this study is to investigate the absorption, metabolism and excretion of \[14C\] PD 0332334 to characterize plasma, fecal and urinary radioactivity and identify any metabolites of \[14C\] PD 0332334.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Healthy male subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
2. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).
3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
4. Subjects who are willing and able to comply with scheduled confinement period, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, orallergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
2. Subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
3. Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage

Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as spontaneous subarachnoid hemorrhage.
* SSAH patients aged (18-70 years) of both sexes

Exclusion Criteria:

* History or current evidence of any CNS disease other than SAH which may cause cardiac complications.
* History or current evidence of medical illness as endocrinal and metabolic disorders which may cause cardiac complications
Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. MINS is defined as an elevated postoperative troponin level (≥0.03 ng/mL) within 48 hours after surgery. Approximately 400 patients will be enrolled, with 200 patients in each positioning group (supine and prone). The primary outcome is the incidence of MINS, assessed through troponin measurements and electrocardiogram (ECG) findings. Secondary outcomes include intraoperative complications, duration of surgery, and postoperative recovery metrics. The study seeks to determine whether surgical positioning impacts MINS risk, potentially guiding safer surgical practices.

Myocardial Injury after Noncardiac Surgery (MINS) is a significant perioperative complication associated with increased morbidity and mortality. This study investigates whether surgical positioning (supine vs. prone) during percutaneous nephrolithotomy (PNL) influences the incidence of MINS. Patients aged 18 years and older undergoing PNL for kidney stones will be enrolled in a prospective cohort study at \[Institution Name\]. Exclusion criteria include pre-existing cardiovascular disease, elevated baseline troponin levels, or major intraoperative complications. Approximately 400 patients will be divided into two groups based on surgical positioning: 200 in the supine group and 200 in the prone group. Troponin levels will be measured preoperatively and at 24 and 48 hours postoperatively, with MINS defined as a troponin T level ≥0.03 ng/mL. Electrocardiograms (ECGs) will be performed to detect ischemic changes. Secondary outcomes include intraoperative hypotension, surgical duration, and postoperative hospital stay. Data will be analyzed using chi-square tests and logistic regression to adjust for confounders such as age, comorbidities, and surgical duration. The study aims to provide evidence on the impact of positioning on MINS, potentially informing safer surgical protocols for PNL.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 years.
* Patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Known coronary artery disease, heart failure, or other significant cardiovascular conditions.
* Elevated preoperative troponin levels (≥0.03 ng/mL).
* Major intraoperative complications (e.g., severe bleeding requiring transfusion).
* Inability to comply with study procedures.
Lifestyle Change for Better Health

The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25.0 to \<40 kg/m2 (allows for use of assessments such as DXA to be included)
* History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma
* Under clinical surveillance with no evidence of disease

Exclusion Criteria:

* WHO performance status 3-4 or deemed physically unable to participate by physician
* Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year
* History of bariatric surgery
* Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis)
* Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years
* Current congestive heart failure, signs or symptoms indicative of an increased acute risk for a cardiovascular event
* History of myocardial infarction, coronary artery bypass or angioplasty, conditions requiring chronic anticoagulation (recent or recurrent DVT)
* Resting systolic blood pressure of \>160 mmHg or diastolic blood pressure \>100 mmHg
* Eating disorder that would contraindicate weight loss or physical activity
* Alcohol or substance abuse
* Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or taking daily or extended release psychotropic medications in the previous 12 months
* Report exercising more than 100 minutes per week over the past 3 months (NOTE: includes physical activity performed for sport, fitness, or recreational activity; physical activity performed as part of occupation or household chores is not included)
* Weight loss of greater than 5% or participating in a weight reduction diet in the past 3 months
* Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments
Influence of Hydration and Functional Aerobic Capacity on the Nonlinear Dynamics of Heart Rate in Healthy Individuals

The objective of this study is to analyze the influence of hydration and functional aerobic capacity in young and healthy individuals on non-linear heart rate dynamics as a technique that favor faster and more efficient recovery cardiac autonomic modulation.


Eligibility Criteria:
Inclusion Criteria:

* include healthy and male individuals, age between 18 and 30 years and physically active.

Exclusion Criteria:

* individuals who smoke and drink, those who have infections, metabolic and respiratory diseases that may interfere in the results and orthopedic problems.
Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis

Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis
* Only patients who have not been treated with an anticholinergic within the last year are to be considered for inclusion

Exclusion Criteria:

•Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with nab-paclitaxel or 4 cycles of trastuzumab with nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive 4 cycles of epirubicin in combination with cyclophosphamide, then complete 1 year of trastuzumab.

Eligibility Criteria:
Inclusion Criteria:

* With signed consent
* Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique
* Breast cancer stage at presentation: stage I-III
* HER2-positive breast cancer defined as 3+ score by immunohistochemistry in \> 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization
* Known hormone receptor status (estrogen receptor and/or progesterone receptor)
* Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1
* Baseline left ventricular ejection fracture \>= 50% measured by echocardiography
* Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male
* Negative serum pregnancy test for women with fertility
* Willing to obey the study protocol

Exclusion Criteria:

* Stage IV disease
* Previous anti-cancer therapy or radiotherapy for any malignancy
* History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
* Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy
* Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered
* Serious cardiac illness or medical condition
* Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
* Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization
* Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
* Not able to swallow the drug
* Pregnant or lactating
Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2

Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays on the effectiveness of nicotine replacement therapy. This may lead to improved cessation interventions for all smokers, particularly women.

Currently, about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, such as the taste, sight, and smell of smoke. Tailoring treatment to the separate needs of subgroups, such as men and women, may produce better outcomes. The purpose of this study is to assess the influence of gender on the effectiveness of transdermal nicotine treatment in a group of male and female smokers.

Participants in this double-blind, dose-comparison study will complete separate sessions in a random order.

Each session will last approximately 6.5 hours and will correspond to a specific transdermal patch dose (0, 7, 14, or 21 mg). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. Cognitive, behavioral, subjective, and physiological measures will occur during study visits. Specifically, the NRT dose response to tobacco suppression and cigarette blunting effects will be compared in women and men.

Eligibility Criteria:
Inclusion Criteria:

* Daily cigarette use of 15 or more cigarettes for at least 2 years
* Screening CO level of or greater than 15 ppm
* Normal or corrected-to-normal vision
* Willing to abstain from tobacco products for 8 or more hours prior to testing

Exclusion Criteria:

* History of chronic health problems or psychiatric conditions
* History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes
* Pregnancy (tested by urinalysis)
* Scores greater than 17 on the Beck Depression Inventory
* Lack of a high school degree or GED
Cotton Sock in Pediatric Patients With Leg-foot Splint

The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The problems persist also after placing a polyurethane foam dress at the heel in the immediate postoperative period. The aim of this study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous lesions.


Eligibility Criteria:
Inclusion Criteria:

* Children aged \> 3 years
* Treated for flat foot
* Children with intact skin at the heel

Exclusion Criteria:

* Caregivers who cannot speak Italian
* Those who refuse to give their consent to take part in the study
* Patients with lower limb casts
Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy

Periodontal disease is an oral disease characterized by microbially associated, host-mediated inflammation of the periodontium. In the treatment of periodontal disease, conventional periodontal therapy includes both surgical and non-surgical approaches. Non-surgical therapy (i.e. scaling and root planing - SRP) remains an essential part of periodontal therapy. Here, diseased root surface debridement utilizing different hand and ultrasonic instrumentation is performed to facilitate periodontal re-attachment and to reduce the bacterial mass in the periodontal pocket.

In the last decade, the use of lasers (light amplification by stimulated emission of radiation) has occupied part of the dialogue within periodontology due to several proposed advantages. In the arena of periodontology, laser use, as an adjunct to non-surgical therapy, was demonstrated to enhance periodontal healing; however, it is still the matter of debate. Among laser applications, low-level laser therapy is recommended for its pain-reducing, woundhealing and anti-inflammatory effects.

Hyaluronic acid is a non-sulfated glycosaminoglycan and a major component of the extracellular matrix. It is found in various body fluids, such as gingival crevicular fluid, saliva, serum and synovial fluid. Anti-inflammatory, anti-edematous and anti-bacterial activities of hyaluronic acid have been investigated in dentistry, specially in periodontology.

Each participant will be assigned in one of three groups. In each group there will be 15 participants. Different treatment protocols will be carried in each group as follows: group one (scaling and root planing), group two (scaling and root planing + LASER), group three (scaling and root planing + hyaluronic acid). Under local anesthesia we will perform scaling and root planing of the teeth in two sessions. The procedure be made with the use of ultrasonic (PiezoLED Scaler, KaVo, Biberach, DE) and hand instruments (Gracey, Hu Friedy, Chicago, IL, USA). In group one, only scaling and root planning (SRP) will be made. In group two, the use of a diode laser (Dentsply Sirona - SIROLaser Blue) will be added to the therapy. In group three, after the performance of SRP, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcular.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* nonsmokers
* untreated periodontal disease (stage 3, grade B or C)
* plaque index will not exceed 20%
* at least 20 teeth in oral cavity

Exclusion Criteria:

* systemic diseases with impact on periodontal health
* medication with impact on periodontal health
* smokers
* pregnant and lactating women
* patients treated with antibiotics in the last 12 months
* patients who had undergone periodontal treatment in the last year
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).


Eligibility Criteria:
Inclusion Criteria:

* Participant must have completed Study M13-740 through Week 52.
* If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion Criteria:

* For any reason participant is considered by the investigator to be an unsuitable candidate
* Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
* Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
Sacral Neuromodulation and Pudendal Somatic Afferents

Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is.

This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder
* Non-obstructive urinary retention

Exclusion Criteria:

* Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)
Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months

With the advent of measures to try to decrease the incidence of transfusion-related acute lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma from female donors who have been pregnant in order to reduce the transfusion of plasma that may contain HLA antibodies. This has led to a decrease in the number of donors available for the production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the United States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within 24 hours of collection is called FP24, and it is produced when whole blood cannot be processed within the 8-hour time period for the generation of FFP. Studies of coagulation factors in FFP and FP24 have shown that coagulation factor activities are adequate to maintain hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably in adults, and occasional hospitals are using these products interchangeably in neonates. However, studies concerning the use of FP24 in neonates have not been performed.

The investigators propose a single center prospective pilot study comparing the clinical efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring plasma for an International Normalization Ratio (INR) of 1.5 or more.

This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg) is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated by the patient's clinicians, and monitored with prothrombin time (PT), partial thromboplastin time (PTT), and INR.

Half the patients will be randomized by the Blood Bank to receive FFP, the other half FP24. All patients will be monitored in the usual way, with careful clinical observation and with PT/PTT/INR, to be drawn once in 12 or 24 hours based on clinical necessity. If a patient needs additional transfusions, the same type of product will be administered for each episode.

Eligibility Criteria:
Inclusion Criteria:

* Nonsurgical neonates and babies up to age 6 months with INR 1.5 or more who are deemed clinically to need plasma infusion.

Exclusion Criteria:

* Patients who are being prepared for surgery, or during or after surgery.
* Patients with congenital anomalies, chromosomal anomalies, or heart defects.
* Patients whose parents refuse to consent.