cyrilzakka/clinical-trials huggingface dataset:
Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy

This is a prospective, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. In addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the robotic assisted treatment /conventional laparoscopic surgery to multiple access and/or to a laparotomic (open) approach will be documented.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* BMI ≤40 kg/m2
* indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
* indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer
* indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer
* size of uterus and vagina allows for retrieval by the vaginal route in cancer patients
* written informed consent

Exclusion Criteria:

* known extensive intra-abdominal adhesions
* anaesthesiological contraindications to laparoscopy
* women with pacemaker or other implants where electrosurgery is to be avoided
* women with known defects of the hemostasis
* pregnancy
* other internal or anatomical criteria that preclude a minimal invasive approach
* inability to understand patient information
EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS

The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are:

* the evaluation of the antibody response after complete vaccination
* the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)

All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

Liver(LT) and kidney(KT) transplant patients are at high risk of mortality from COVID-19(16-29%, 28%; respectively). Although transplant patients undergo a full vaccination course(3 doses), they are frequently low-responders and long-acting-antibody prophylaxis (LAAB) has been proposed. However, the efficacy of these strategies has not yet been demonstrated in LT and KT.

The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are:

* the evaluation of the antibody response after complete vaccination
* the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)

All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level \<100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

Eligibility Criteria:
Inclusion Criteria:

* KT and LT transplant patients in follow up in Tor Vergata University
* Age \>18 years
* At least 3 month post transplantation

Exclusion Criteria:

* pediatric recipients
* Active covid infection at the time of the study
* Pregnancy
* Allergy to any ingredients included in the vaccine
* Acute liver or kidney acute rejection proven by biopsy
* Acute Febrile state with either leucopenia or leucocytosis
* High dose of corticosteroid at study timing (pulse methyl prednisolone)
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.

This will be an open-label study to investigate the PK of tenapanor and AZ13792925 in breast milk of lactating female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 15 days prior to the first dose administration. Subjects will receive tenapanor from Days 1 to 4 and will be monitored for 24 hours after the last dose of tenapanor. On Day 4, breast milk to evaluate concentrations of tenapanor and AZ13792925 will be collected pre-dose (Hour 0), 1, 2, 4, 6, 8, and 24 hours post-dose. Subjects will return for a Follow-up visit, 5 to 7 days (Day 10±1) after the last dose. All breast milk not used for PK analyses will be discarded (not fed to infant) starting on Day 1 after the first dose of tenapanor is administered until Day 7 (72 hours after last dose of tenapanor).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:

  1. Females greater than or equal to 18 years of age.
  2. Body mass index between 18.0 and 35.0 kg/m2, inclusive.
  3. In good health with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory as determined by the Investigator.
  4. Females must be non-pregnant.
  5. Has been breastfeeding or actively pumping for at least 4 weeks.
  6. Willing to continue regular pumping in order to maintain milk supply for the duration of the study.
  7. Will not feed infant breast milk while taking tenapanor and for 72 hours post the last dose of tenapanor.
  8. Weaning must not be underway, to ensure an adequate milk supply.
  9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Exclusion Criteria:

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:

1. Significant medical or psychiatric disorder, as determined by the Investigator that would interfere with participation.
2. Use or intend to use any prescription or non-prescription medications 4 days before first dose of tenapanor until Day 6 of the study, unless deemed acceptable by the Investigator and/or Sponsor.
3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
4. Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
5. Loose stools (Type 6 or 7 on the Bristol Stool Form Scale) ≥2 days in the past 7 days
6. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half-lives prior to dosing.
7. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study
Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.


Eligibility Criteria:
Inclusion Criteria:

* Patients having immediate breast reconstruction with tissue expanders
* Unilateral or bilateral reconstructions
* Ages 25 - 65
* All breast cancer stages and types

Exclusion Criteria:

* BMI \> 35
* Active smokers
* Diabetics
* History of radiation or planned radiation
* Immunocompromised patients
The Effect of Integrated Leading, Managing and Governing for Result Model Towards Institutional Delivery

The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia.

To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited.

Therefore, this study hypothesize that institutional delivery are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?

The investment on integrated health system leading, managing and governing for result model narrow down health system gaps.

The need to integrate these three distinct, but not hostile paths is that mostly: leading is people oriented process, managing is task oriented process and governing is organization oriented path.

Moreover, these paths are reflected even in a single person, task, or organization. Thus, testing and implementing integrated model is cost effective.

Eligibility Criteria:
Inclusion Criteria:

* All staff nominated by the respective districts that have been selected, but not deployed yet, for integrated health system leadership, management and governance for intervention by Amhara regional health office in the study setting have been included.

Exclusion Criteria:

* No exclusion criteria
Housing Conditions: Evaluation, Advocacy and Research in Toronto Community Housing

This project will examine whether a health promotion campaign using community organizing and joint advocacy by a coalition of tenants, health providers, social service agencies and advocates can lead to improvements in building conditions and health in social housing.

This community based participatory research project will bring together patients of the St. Michael's Hospital Academic Family Health Team (FHT) who are tenants of Toronto Community Housing Corporation (TCHC) with health providers, legal service staff at the Health Justice Program, social service agencies and advocacy organizations to advocate to improve building conditions in three TCHC buildings. The researchers will evaluate the acceptability and feasibility of this health promotion campaign as well as changes in the state of housing and self rated physical and mental health of tenants.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Living in one of the three TCHC buildings

Exclusion Criteria:

* under 18 years old
Clinical Phase II Trial to Evaluate CD34+ Cells Mobilization and Collection in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene. FANCOSTEM-1

Fanconi anemia (FA) is a congenital disease characterized by bone marrow failure and increased incidence of malignant tumors. The Project pursue the optimization of the collection of hematopoietic progenitor cells for later use in another clinical trial entitled "Clinical Trial Phase I/II to evaluate the safety and efficacy of the infusion of autologous CD34+ cells mobilized with mozobil and filgrastim, and transduced with a lentiviral vector carrying the FANCA gene (Orphan Drug) for patients with Fanconi Anemia Subtype A ". The objectives of this study are, therefore, to assess the safety and efficacy of CD34+ cells mobilization with mozobil and filgrastim, which is postulated the most efficient for the collection of CD34+ cells from FA patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 1 year
* diagnosed of Fanconi's anemia confirmed by instability chromosomal test with diepoxy-butane or mitomycin C
* At least one of the following parameters must be higher than these values: Hemoglobin:8,0 g/dL; neutrophils: 750/mm3; platelets: 30.000/mm3
* Lansky index\> 60%.
* Left ventricular ejection fraction \>50%.
* To grant informed consent in agreement with current law norms
* Women in childbearing age must obtain a negative result in the pregnancy test in serum or urine in the visit of selection and accept the use of suitable contraceptive methods since at least 14 days prior to the first dose of mobilizing treatment until the 14 days following the last

Exclusion Criteria:

* Evidence of myelodysplastic syndromes or leukemia, or cytogenetic abnormalities predicted of these syndromes in bone marrow aspiration. Cytogenetic analyses performed 2 months before starting study are accepted
* Patients with active infection process or any other underlaying severe medical process
* Severe Functional alteration of organs (hepatic, renal, respiratory)(?3), according to National Cancer Institute (NCI CTCAE v3) criteria
* Haematopoietic transplant
* Any disease or concomitant process that is not compatible with the study as per investigator opinion
* Patients not elegible because of an psico-social evaluation
* Patients that received transfusional support during the last 3 months.
* Pregnant or breastfeeding women
Role of Dietary Protein Intake in Elderly Adults

The investigators examined the effects of dietary protein intake in a mixed meal at two levels of protein amount on whole body protein metabolisms in older adults.

The investigators determined the total anabolic response to an amount of protein intake commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate muscle protein synthesis (35g). Men and women, ages \> 60 years will be studied under two levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary intake of calories and protein will be stabilized by providing subjects their entire diets. On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on Aging (IOA) to determine the total anabolic response to the particular amount of beef intake, which will be repeated with the other amount of protein in mixed meal after a minimum 7-day washout interval. The investigators measured whole body protein kinetics, muscle fractional synthetic rate, and plasma amino acid profile.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages \> 60 years

Exclusion Criteria:

* History of diabetes
* History of malignancy in the 6 months prior to enrollment
* History of gastrointestinal bypass surgery (Lapband, etc)
* History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
* Pregnant females
* Subjects who do not or will not eat animal proteins
* Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
* Subjects who report regular resistance exercise (more than once per week)
* Hemoglobin less than 9.5 mg/dL at the screening visit
* Platelets less than 150,000 at the screening visit
* Subjects who are not willing or able to suspend aspirin for several days prior to their muscle biopsies
* Subjects who have been prescribed a blood-thinning medication (Coumadin, lovenox, heparin, Plavix, etc.)
* Concomitant use of corticosteroids (ingestion, injection or transdermal)
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers,
* Age 18 - 35 years

Exclusion Criteria:

* Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
* Regular intake of medication
* Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
* Anovulatory pre-treatment cycle
Mobile App in Addiction

The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

Eligibility Criteria:
Inclusion Criteria:

* Teenagers or young adults from 12 to 18 years old (included)
* Consultant for addiction to cannabis and / or tobacco and / or alcohol and / or screen
* Treated within the Functional Unit of addictology
* For minors, after parental consent

Exclusion Criteria:

-
Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis

This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.

COVID-19 is in the midst of a global pandemic. Elderly patients are often susceptible and at high risk. Elderly patients on maintenance hemodialysis are often accompanied by a variety of complications, malnutrition is a common complication with an incidence of 23-73%. Due to a variety of risk factors, COVID-19 infection tends to develop into severe disease, and it takes longer for nucleic acid to turn negative.

This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60 and above;
2. Patients receiving hemodialysis with clinically confirmed end-stage renal disease
3. Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type
4. Patients who can eat on their own;
5. Patients had good compliance, fully understood the study content and signed informed consent.

Exclusion Criteria:

1. Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia.
2. In an unstable state of vital signs such as shock.
3. In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack
4. Patients with moderate to severe cognitive impairment or mental diseases;
5. People who are allergic to intestinal nutrients
6. Refuse oral nutritional supplements
[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy

This is a Phase 1 study is to visualize biodistribution of a PET tracer called \[18F\]F-AraG (VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.

This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation dosimetry of the Positron Emission Tomography \[18F\]FAraG (VisAcT) in cancer patients selected for immunotherapy and/or radiation therapy. Each patient may have up to two \[ 18F\]FAraG PET imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging session, patients will receive a single injection of \[18F\]FAraG and undergo a whole-body PET scans an hour after injection of the tracer. Following each imaging session, the patient will be called within 72 hours to note any side effects.

Optional - Blood samples may be collected at up to 9 time points post-injection to analyze whole-blood/plasma time activity of \[18F\]FAraG in addition an urine sample may be collected post scan.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with identified tumor mass
* Cancer patients expected to undergo immunotherapy and/or radiation therapy

Exclusion Criteria:

* Under the age of 18
* Pregnant women
* Women who are breastfeeding
* Individuals with known or suspected substance abuse
* Individuals unable or unwilling to comply with the study procedures
Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Active disease as defined by both \>=6 tender or painful joints on motion and \>= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL

Exclusion Criteria:

* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L
* History of any other rheumatic autoimmune disease other than Sjogren's syndrome
* No malignancy or history of malignancy
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy