cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma

Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma


Eligibility Criteria:
Inclusion Criteria:

* Unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography.
* In Patients with previous unilateral salpingo-oophorectomy (USO)
* Unilateral ovarian endometrioma with any size is eligible
* 20 ≤ Age ≤ 45 and premenopause
* Plan to undergo conservative surgery for endometriomas

Exclusion Criteria:

* Pregnant women or women who were suspected to be pregnant
* Women with current venous thromboembolism or history of such diseases
* Women with current arterial disease or cardiovascular diseases (e.g. myocardial infarction, cerebrovascular diseases, or ischemic heart diseases) or history of such diseases
* Women with current diabetes with vascular lesions or history of such diseases
* Women with current severe liver diseases or history of severe liver diseases with abnormal liver function
* Women with current liver tumor or history of liver tumor
* Women with current or history of sex-hormone dependent malignant tumor or women who were suspected to have a sex-hormone dependent malignant tumor
* Women with vaginal bleeding of unknown causes
* Women with a history of allergic reaction to elements of DNG
* Women with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Women whose non-compliance is expected
* Lactation (treatment with DNG is not recommended in lactating women due to possible excretion in breast milk)
* Any medication that could result in an excessive accumulation, impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results
Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements

Soy and whey protein have different concentrations of leucine, an amino acid known to be a particularly potent simulator of muscle protein synthesis. The purpose of this study is to determine whether matching soy and whey protein supplements for leucine content instead of by total protein content would contribute to differences in strength increases and muscle growth in response to 12 wk of resistance training.


Eligibility Criteria:
Inclusion Criteria:

* non-smoking
* body mass index (BMI) 18.5-24.9
* recreationally active

Exclusion Criteria:

* participated in structured weight training during the previous 12 month
* vegetarian or vegan
* presence of chronic disease
* pregnant, postpartum up to six months, lactating, or intention to become pregnant
* allergy to whey or soy
* changes in body weight more than 10 pounds in the past three months
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 3

The current best practice is a three-stage classification consensus guideline as published by the International Society of Lymphology (ISL). Severity of lymphedema is however not only determined by presence of pitting (which is the phenomenon when the swollen area has a dimple (or pit) after you press it for 5 to 10 seconds) and presence of adipose tissue or not, but is also determined by the volume of the edema, a quantification of the condition of the skin and the location/expansion of the edema over the body. Currently a severity score considering these different aspects does not exist. Although there is consensus that the ISL staging systems is a necessary part of the diagnosis of lymphedema, it gives not enough information about the severity of the lymphedema. A more detailed and comprehensive classification system applicable for primary and secondary lymphedema and considering multiple edema characteristics, remains to be formulated.

The researchers objective in this study is to develop a diagnostic set, including a 'severity score', for patients with LLL.


Eligibility Criteria:
Inclusion Criteria:

Patient group

* Unilateral or bilateral, primary or secondary LLL
* Objective diagnosis of lymphedema: ≥ 5% volume difference between both legs OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow
* Age ≥ 18 years
* Able to read, understand and speak Dutch

Healthy controls

- Age, gender \& BMI-matched healthy controls

Exclusion Criteria:

* Pregnant participants
* Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
* Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable)
2. Infant gestational age ≥37 completed weeks
3. Infant birth weight of ≥2.5 kg and ≤4.5 kg
4. Singleton birth
5. Infant postnatal age ≤28 days (date of birth = day 0)
6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
4. Infants with special dietary needs other than standard infant formula
5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
7. Currently participating or having participated in another interventional clinical trial prior to enrollment
A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children

A case-control cohort study to develop and validate the performance of a whole blood gene expression test to distinguish sepsis infection from uninfected systemic inflammatory response syndrome cases in symptomatic adults and children without comorbidities.

The purpose of this prospective, non-interventional study is to develop and validate a blood gene expression test for diagnosing the cause of sepsis in adults and children with symptoms of infection.

Sepsis affects 31.5 million people globally leading to 5.3 million deaths each year. Sepsis is particularly harmful to immunodeficient patients undergoing cancer therapy with 3.7 percent to 6.4 percent of cancer patients diagnosed with sepsis in the US in their first year after cancer diagnosis. Current tests to diagnose the infectious cause of sepsis rely on blood cultures which takes 24-48 hours to complete; leading to delays in early treatment critical to reduce the risk of developing sepsis shock and possibly death. In addition, around 50 percent of severe sepsis cases are culture negative, confounded acute infections not detected in the blood, by viral infection or uninfected patients exhibiting systemic inflammatory response syndrome (SIRS). Since sepsis often progresses to sepsis shock within 72 hours, suspected sepsis cases are usually immediately treated with antibiotics until results from testing distinguish the cause of symptoms. This leads to the over-use of antibiotics and delays appropriate treatment for those without bacterial infection or un-infected SIRS.

A quick and accurate diagnostic blood test may enable early discrimination of the cause of sepsis resulting in faster more appropriate treatments and reduced sepsis complications and death.

The study will collect blood samples from participants presenting symptoms of acute infection, without co-morbidities and follow symptom severity and mortality for 28 days.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* Clinical suspicion of an acute infectious disease
* Presence of at least ONE of the following:

  1. Temperature ≥ 38°C or Temperature ≤ 36°C
  2. Heart rate \> 90 bpm
  3. Respiratory rate \> 20/min
  4. Self reported fever/chills
* Symptom duration ≤ 7 days

Exclusion Criteria:

* Received antibiotics or antivirals in the past 2 weeks.
* Previous infection in previous 2 weeks
* Primary or secondary immunodeficiency
* Proven or suspected HIV, hepatitis B or hepatitis C infection
* Current immune-suppressive or immune-modulating treatment
* Active hematological malignancy
* Other illnesses that affect life expectancy
Multidisciplinary Follow-up of Patients With Amyotrophic Lateral Sclerosis

Analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a Cohort study at Geneva University Hospitals.

Since April 2010 a quarterly follow-up is available for patients with ALS at Geneva University Hospitals. It takes place in the outpatient unit of the Department of Neurology, and includes interventions by the multidisciplinary team of the " Center for Amyotrophic Lateral Sclerosis and related diseases ". This new tracking method can help improving quality of life of patients and their families by adapting medical care, proposing communication aids, facilitating access to specialized examinations and anticipating pulmonary, nutritional and neurologic complications. Moreover, it speeds up administrative procedures, improves the flow of information between medical teams inside and outside the hospital and it allows and encourages discussion about advanced directives.

Since June 2012, the multidisciplinary follow-up is monitored through a Cohort study that was approved by the ethical committee (NAC 11-062R). We collect clinical examination findings, anthropometric evaluation, blood analyses, pulmonary function tests, respiratory muscle strength, arterial blood gases, nocturnal oximetry, and evaluation by occupational therapists and by physiotherapists on a quarterly basis. Nerve conduction studies are done at the beginning of the follow-up to identify the degree and extent of loss of upper and lower motoneurons in ALS and to help guiding the diagnosis. MRI and analysis of cerebrospinal fluid are also acquired at the beginning of the follow-up in order to rule out other diagnoses which can mimic ALS. Definite, probable or possible ALS is defined according to the Revised El Escorial and Awaji criteria \[16-17\]. Patients are referred to a genetic counselor who helps making informed decisions regarding genetic issues. The data collected are inserted into the Secu-Trial database, which is managed by an assistant provided by the Clinical Research Center.

Eligibility Criteria:
Inclusion Criteria:

Amyotrophic Lateral Sclerosis fulfilling the El Escorial criteria (definite, probable, possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy

Exclusion Criteria:

Patients with other neurological diagnoses than mentioned in the inclusion criteria
Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer

RATIONALE: Anticoagulants, such as lepirudin, may help prevent blood clots from forming in patients who have received chemotherapy for small cell lung cancer.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lepirudin in treating patients with recurrent or advanced small cell lung cancer.

OBJECTIVES: I. Determine the dose, safety, and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy.

OUTLINE: This is a dose escalation (in individual patients) study. Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days. Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached. The patient then continues treatment on the maximum tolerated dose. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

1. Pathologically confirmed recurrent or extensive stage small cell lung cancer.
2. Received at least one prior chemotherapy regimen
3. Measurable or evaluable disease that has not been irradiated
4. No pleural effusions, bone metastases, brain metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion
5. Brain metastases allowed if patients received cranial irradiation and have no clinical evidence of brain metastases

PATIENT CHARACTERISTICS:

1. Age: Not specified
2. Performance status: Karnofsky 60-100%
3. Life expectancy: Not specified
4. Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
5. Hepatic: Bilirubin no greater than 2.0 mg/dL PT and aPTT normal
6. Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
7. Cardiovascular: No unstable heart rhythm No unstable angina No clinical evidence of congestive heart failure No prior cerebrovascular accident or stroke No uncontrolled or severe hypertension
8. Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
9. At least 6 weeks since any signs or symptoms of bleeding No history of bleeding disorder
10. No bacterial endocarditis or other active infection

PRIOR CONCURRENT THERAPY:

1. Biologic therapy: Not specified
2. Chemotherapy: At least 3 weeks since prior chemotherapy
3. Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy
4. Surgery: At least 6 weeks since major surgery, trauma, or needle biopsy of any organ
5. Other: No concurrent anticoagulant or platelet inhibitor therapy
Autoimmune Hepatitis in Pediatric Patients

Autoimmune hepatitis (AIH) is an immune-mediated and inflammatory liver disorder. It is currently divided into types 1 and 2, differentiated and defined by the presence of specific autoantibodies. The objectives are to describe the prevalence and incidence of type 1 and 2 autoimmune hepatitis and to analyze the clinics, biochemical and histopathological profiles at diagnosis and follow-up, initial therapy, response to therapy and long-term follow-up in three Italian centers of patients with type 1 and type 2 AIH.

Background: Autoimmune hepatitis (AIH) is an immune-mediated and inflammatory liver disorder with typical onset in pediatric age. It is currently divided into types 1 and 2, differentiated and defined by the presence of specific autoantibodies. AIH type 1 (AIH-1) is characterised by smooth muscle and/or antinuclear autoantibodies (SMA/ANA) while anti-liver kidney microsomal (anti-LKM) or liver cytosol type 1 (anti-LC1) identified AIH type 2 (AIH-2). The conventional treatment is based on corticosteroids and azathioprine as first line therapy. The optimal duration is not clear definied, however it should be extended for at least five years due to the frequent relapses.

Aims of the study: The primary objective is to describe the prevalence and incidence of type 1 and 2 autoimmune hepatitis on a selected italian pediatric population. Secondary objectives are to analyze the clinical, biochemical and histopathological profiles at diagnosis and follow-up, type of treatment received, response to therapy and long-term follow-up.

Methods: The investigators conducted a retrospective and prospective cohort study on patients aged ≤ 18 years who the diagnosis of AIH 1 and 2 between 01/01/1989 and 31/12/2019 and were followed in three Italian pediatric centers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years at the time of diagnosis
* Diagnosis of autoimmune hepatitis type 1 or 2 according to the Mieli-Vergani score: a pre-treatment score\> 15 or post-treatment\> 17 indicates a definite diagnosis of Autoimmune Hepatitis; a pre-treatment score between 10 and 15 or post-treatment between 12 and 17 indicates a probable diagnosis.

Exclusion Criteria:

* Age\> 18 years at the time of diagnosis
* Presence of other causes of liver disease
* Presence of overlap syndrome (hepatito-cholangitis)
PET in Breast Cancer Receiving Neoadjuvant Chemotherapy

Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer.

The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. pathologically-confirmed breast cancer by core needle biopsy,
2. initial clinical stage II or III,
3. objective measurable lesion,
4. ECOG performance 0\~2,
5. previously untreated,
6. adequate bone marrow, hepatic, cardiac, and renal functions
7. age 20\~70
8. agreement with this trial, and written informed consent

Exclusion Criteria:

1. history of other cancer
2. active infection
3. pregnancy
4. psychologic disease
5. uncontrolled heart diseases
6. male
Enhanced Provision of Male Circumcision (MC) for HIV Prevention, Rakai, Uganda

Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and Southern African countries, and the long-term sustainability of MMC programs could best be achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of EIMC provided by non-physicians is unknown.

Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda. 501 healthy neonates aged 1-28 days with normal birth weight and gestational age were randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days. Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local Anesthetics (EMLA) cream and a 24% sucrose solution.

The objective was to assess the acceptability and safety of neonatal male circumcision performed by clinical officers (equivalent to US physician assistants) and nurse midwives, using the Mogen clamp.

This was a randomized, blinded trial of circumcision using the Mogen clamp under topical anesthesia in healthy male infants aged 1-28 days, with normal birth weight and gestational age, performed by trained clinical officers or nurse midwives, randomized 1:1 in Rakai District, Uganda.

Mothers of male infants born in 4 health centers were invited to participate and signed an informed consent for screening and enrollment. Infants were screened on enrollment prior to randomization (1;1) to clinical officer and nurse midwife circumcision providers.

Follow up was via a phone call at 24 hours, 7 days and 4 weeks post-circumcision.

Eligibility Criteria:
Inclusion Criteria:

* age 1-28 days
* birth weight \>= 2,500 gm
* gestational age \>=37 weeks
* no illness. normal temperature
* no genital anatomic abnormality

Exclusion Criteria:

* age \>28 days
* birth weight \<2,500 gm
* gestational age \<37 weeks
* Ill health
* genital abnormality
Variance of Video Games Playing Patterns Among Adolescents With Psychiatric Disorders

As the use of video games (VG) is rapidly increasing, many studies have tries to understand the effects of VG on the children and adolescents playing them.

Most of the research was directed towards negative effects (especially violence, attention and school performance), producing mixed results.

Recently, more studies had focused their attention on the opposite angle: The influence of the player's mental and behavioral parameters, influencing his VG playing patterns. The focus of most of these researches was time of playing, addictive patterns and exposure to violence.

The current study will try to characterize the variance of VG playing pattern among adolescents diagnosed with psychiatric disorders, in order to better under the rich interaction between a player and his VG, and to understand whether VG playing patterns holds diagnostical clues for the child's diagnosis and his inner world.

The participants will be asked to attend 2 session, 2 hours each, at 3-14 days interval.

At the first session, after signing consent form, will asked to fill out questionaires regarding demographic data, personality, empathy trait, aggression state and trait and computer games usage.

also, they will be asked to complete HTP and TAT psycho-diagnostic tests. Then, using heart rate variability (HRV) and Galvanic skin response (GSR), monitor of sympathetic tonus will be measured while playing a shooting and race game.

At the end of the first session, they will be asked to fill additional aggression state questionaire.

On the second session, monitored by HRV and GSR, they will be asked to play a role playing game (RPG) and real-time strategy game (RTS). At the end of session, they will be asked to fill additional aggression state questionaire.

Parameters of playing patterns collected from the VG will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-18
* Diagnosis matching one of the defined research arms, made by a childhood and adolescents psychiatry specialist
* Playing various computer games regularly, for at least 2 years
* Informed consent has been given by the minor and his parents

Exclusion Criteria:

* Organic sensory depravation (blindness, deafness)
* Motor dysfunction, relevant of using keyboard, mouse or remote
* Additional psychiatric diagnosis, apart the one matching the arm to which he was allocated
* Using illicit drugs during the previous 48 hours