cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ondansetron in LARS Treatment

Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O sequence). It will be one week of washout between the two treatments.

During the treatment questionnaires will be completed by the patients to evaluate the efficacy of the study treatment and the quality of live.

This is a multi-centre randomized, double-blind, placebo-controlled, cross-over study aimed at testing the efficacy of Ondansetron in the low anterior resection syndrome (LARS) occurring as a consequence of surgery for rectal cancer.

Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O sequence). Neither the investigator nor the patient will be aware of the sequence (O-P or P-O) assigned to the patient. One week will elapse between the end of the first treatment and start of the second treatment.

The hypothesis to be tested is that 4 weeks of oral Ondansetron at the dose of 4mg BID induce a variation of the LARS Score at least 7 points (20%) greater than the variation occurring after 4 weeks of placebo.

The sample size calculated for the primary analysis is 38 evaluable patients. Considering an expected attrition rate of about 20%, it is expected to enrol approximately 46 patients in total.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients willing and able to comply with the study procedures
* Female patients of childbearing potential must agree to use a reliable method of contraception
* Written informed consent Patients who have undergone low anterior resection (LAR) for rectal cancer in the last 2 years provided that at least 4 weeks have elapsed since recanalization and 4 weeks have elapsed since any chemo- and/or radiotherapy
* Presence of functioning anastomosis
* Presence of significant LARS symptoms assessed by LARS Score

Exclusion Criteria:

* Known hypersensitivity or allergy to Ondansetron
* Previous Ondansetron antiemetic therapy completed less than 4 weeks before study entry
* Antitumor chemotherapy or radiotherapy completed less than 4 weeks before study entry
* Congenital long Q-T syndrome
* Ongoing treatment with drugs causing prolongation of the Q-T interval
* Uncorrected hypokalemia or hypomagnesemia
* Women who are pregnant or breast feeding or are willing to become pregnant during the study
* Clinically significant concomitant disease states or anastomotic complications which could impair the ability of the patient to participate in the trial
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Autologous Tansfusion REquirements in Bone MArrow Harvest: The ATREMA Study

Despite perioperative autologous donation (PAD) is widely used in healthy bone marrow (BM) donors to restrain the hemoglobin decrease after BM harvest, this practice is not supported by strong clinical evidences and has been abandoned by some transplant teams. The critical revision of data relative to 102 BM collection procedures performed at our center between 2014 and 2018 failed to demonstrate an advantage of 1 over 2 PAD. Conversely, clearly emerged that PAD reduce the hemoglobin levels at BM harvest. Basically, PAD practice consists in the transfer of RBCs from the subject into a plastic bag and back to the subject at BM harvesting. Indeed, the evidence of clinical benefits of PAD in BM donors are still elusive. For this reason, current procedures on unrelated donors recommend iron and vitamin supplementation before the BM harvest, but let the decision to perform or not PAD at collection centers. Detailed data on the safety and feasibility of BM harvest procedures in absence of PAD have been rarely reported. The investigators collect data on BM harvest in healthy donors who don't have PAD collected. The investigators expect that no allogeneic transfusions are required and that Hb levels after collection are similar to those recorded in the historical cohort gathered at the same center receiving 1 or 2 PAD.


Eligibility Criteria:
Inclusion Criteria:

* Familial donors qualified to donate BM hematopoietic stem cells and accepting to participate to this study

Exclusion Criteria:

* Any planned deviation connected with abnormalities in the health status and/or laboratory tests of the donor, even though it does not prevent him from donation.
Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants

We investigate parameters of hemocoagulation and lipoperoxidation in women using combined oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants

It is well known that hormonal contraceptives using increase risk of thrombosis. We conduct parameters of hemostasis in women that use combined oral contraceptives with antiandrogenic activity for contraception and treatment. Considering relationship between lipoperoxidation in platelets and hemostasis we expect that limitation of lipoperoxidation by antioxidants can restrict hypercoagulation and decrease risk of thrombosis.

The purpose of this study is decrease of thrombosis risk in women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone, 30 mcg ethinylestradiol/3 mg drospirenone, 35 mcg ethinylestradiol/2mg cyproterone acetate. Half of the women of each arm (group) receive only combined oral contraceptives (COC), other women receive combined oral contraceptives and antioxidant complex Selmevit.

The blood tests conduct on 19-21 days of the menstrual cycle before COC use (control group) or on 19-21 days of COC use after 1, 3, 6 and 12 cycles.

Also we investigate subjective tolerability, therapeutic effects, menstrual cycle control and adverse effects of COCs in women that have or have no antioxidant complex Selmevit

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-35 years
* Absence of contraindications for COC use
* Informed voluntary consent for examination

Exclusion Criteria:

* Age younger than 18 and older than 35 years
* Refusal or failure to comply with the study protocol
* Drug or alcohol dependence
* Psychiatric diseases
* Severe somatic and allergic diseases
* Pregnancy
* Malignancies
* Taking drugs that affect haemostasis, including hormonal contraceptives during 6 months before study beginning
* Cases of thrombosis among first-line relatives in family history
* Contraindications to the COC use under Eligibility Criteria of hormonal contraception (WHO, 2012)
The Continuation of Erlotinib

Newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. Given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven non small cell lung cancer
2. New developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib
3. patients who are receiving erlotinib as salvage therapy
4. At least one unidimensionally measurable lesion with a diameter \> 10mm using brain MRI
5. at least on unidimensionally measurable or evaluable lesion
6. male or female patients aged \>18 years
7. ECOG performance status 0-2
8. Adequate hematologic function
9. adequate renal function
10. adequate hepatic function

Exclusion criteria

1. leptomeningeal metastases
2. acute severe infection requiring antibiotic therapy
3. significant cardiovascular disease
4. uncontrolled DM
5. severe ophthalmologic disease
Comparing Different Ways of Delivering Humidity to Children With Croup

Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).


Eligibility Criteria:
Inclusion Criteria:

* children aged 3 months - 10 years
* croup score greater than or equal to 2 after a 30 minute waiting period

Exclusion Criteria:

* Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
* symptoms or signs of alternative causes of stridor
* inability of caregivers to understand or speak English and/or sign for informed consent
* history of chronic pulmonary disease except for asthma, or co-existent systemic disease
* previous history of intubation
* duration of present illness \>1 week
* systemic or inhaled glucocorticoids in previous 48 hours
* epinephrine in previous 4 hours
Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients

Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤ age ≤ 75 years.
* Resectable/borderline resectable pancreatic cancer patients diagnosed based on pathological and preoperative imaging evaluation.
* No prior history of any form of anti-tumor treatment.
* At least one measurable lesion.
* Eastern Cooperative Oncology Group (ECOG): 0-1.
* Not participated in any other clinical studies before or during treatment.
* Willingness to participate voluntarily in this study, signing an informed consent form.

Exclusion Criteria:

* History of any other malignant tumor, except for completely resected basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, within the past 5 years.
* Vaccination with live vaccines within 4 weeks prior to enrollment or during the study period.
* Active autoimmune diseases or a history of autoimmune diseases within the past 4 weeks before enrollment.
* Allogeneic bone marrow or organ transplantation.
* Active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors in the gastrointestinal tract, or other conditions determined by the investigator that may cause gastrointestinal bleeding or perforation.
* Evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \>30 mL within 3 months, hematemesis, melena, or hematochezia), hemoptysis (\>5 mL of fresh blood within 4 weeks), or occurrence of thromboembolic events within 12 months (including stroke events and/or transient ischemic attacks).
Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis

The goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are:

i. Is there any difference in duration of bicarbonate (HCO3-) to reach equal or more than 15mmol/L from the initial blood taking in between Sterofundin and NS fluid use in DKA patients? ii. Is there any difference in the level of post-infusion serum sodium (Na+) between Sterofundin and NS fluid use in DKA patients? iii. Is there any difference in the level of post-infusion serum potassium (K+) between Sterofundin and NS fluid use in DKA patients?

Patients will be randomized in a 1:1 ratio to receive IV Sterofundin (intervention) or IV Normal Saline (standard care). The patient will have the respective fluid regime as the main fluid therapy during the first 24 hours of ICU stay. If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.


Eligibility Criteria:
Inclusion Criteria:

* DKA.
* Aged ≥ 18 years old.
* Patients admitted to ICU \< 12 hours after initial fluid resuscitation from emergency department/ ward.

Exclusion Criteria:

* End stage renal failure
* Heart failure
* Started treatment of sodium bicarbonate infusion prior to ICU admission
* Known allergy to Sterofundin
Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).


Eligibility Criteria:
Inclusion Criteria:

* Liver Transplant

Exclusion Criteria:

* Living donor transplants
Protein Requirements In Active Female Populations

Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in active, young adult females using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, active, young adult females who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
* A minimum score of 10 on the Beep Test (a measure of aerobic fitness)

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use
Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.

Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast carcinoma.
* Early stage breast cancer (stage 1, 2, 3).
* No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
* 18 years of age or older.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

* Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
* Major surgery within 28 days of study entry.
* Evidence of CNS metastases.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric, adolescent and adult patients \>/=1 year of age
* Fever \>/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
* Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
* \</=96 hours between onset of influenza-like illness and first dose of oseltamivir

Exclusion Criteria:

* Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
* History of chronic renal failure or clinical suspicion of renal failure at baseline
* Clinical evidence of hepatic compensation at the time of randomization
* Known HIV infection
* Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation

The goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy Intervention (eMBMT) intervention to improve health-related quality of life (HRQoL) and reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-SCT).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* have a primary diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL)
* have a treatment plan for an allogeneic hematopoietic stem cell transplant
* Speak English or Spanish

Exclusion Criteria:

* history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)
* severe cognitive impairment (per the short portable mental status questionnaire)
* hearing impairment
* active alcohol or substance dependence within the past six months
* participated in music therapy or mindfulness programs in the past six months
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women

This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \>40 IU/L, or had been surgically postmenopausal for more than 6 months)
* Women between 45 and 75 years of age.
* Vaginal pH ≥5
* Vulvovaginal atrophy with VHI \< 15
* At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
* Women with active sex lives
* Patients who give written informed consent to participate in the trial

Exclusion Criteria:

* Enrollment in other clinical trials within the previous 1 month.
* Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
* Patients in previous treatment with either oral or topical hormonal products within 1 month.
* Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
* Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
* Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
* Women with no active sex lives
* Women who do not give informed consent;
* Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient