cyrilzakka/clinical-trials huggingface dataset:
Understanding Probability in Children

To make medical decisions involving pros and cons, one also has to understand probability and percentages. This is a preliminary study to evaluate the ability of children to understand probability and percentages.

The concept of patients making decisions with respect to their health care is well accepted in adult medicine but, the value and importance of decision making in the care of children is not recognized. The major objection raised against allowing children to express their opinions concerning outcomes is that children do not understand probability.

One way of assessing children's ability to understand probability is to test their mathematical knowledge using tests focused on probability and percentage.

We have designed a set of questionnaires with 10 questions each, taken from the US Department of Education's National Assessment of Educational Progress (NAEP). They are divided into 3 different groups (4th, 8th, and 12th grade), based on grade-level. We have also obtained the average percentage of correct-incorrect answers given to these questions by students nationwide, and the scoring system used to assess the student's proficiency level.

In this preliminary study we intend to present this set of 10 mathematical questions to children and to one of their parents.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ages 11 to 18 years.
2. Spoken and written English as primary language of both parents and children.
3. Children scheduled to receive anesthesia.
4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Children with known mental retardation, of any nature.
2. Children who attend schools for children with special needs.
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique


Eligibility Criteria:
Inclusion Criteria:

* Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy

Exclusion Criteria:

* Age less than 18 years
* Denied written informed content
* Previous axillary operations (except for sentinel node biopsy)
* Preoperative radio-chemotherapy
* Scheduled reconstructive breast operation
Effect of Nebulized and Intravenous Hypertonic Saline 3% on the Management of Patients With Acute Respiratory Distress Syndrome

The aim of our study is to compare between the effect of nebulized and intravenous injection of hypertonic saline 3% on the outcome of patients with acute respiratory distress syndrome.

Acute Respiratory Distress Syndrome (ARDS) is a life threatening form of respiratory failure, characterized by acute, diffuse, inflammatory lung injury that results in increased alveolar capillary permeability and the development of non-hydrostatic pulmonary edema.

Clinically, ARDS manifests as marked hypoxemia and respiratory distress; patients often progress to respiratory failure that requires invasive mechanical ventilation in the intensive care unit.

No specific pharmacological treatment is available for ARDS, which is associated with high morbidity and mortality. The mainstay of therapy in ARDS is supportive therapy and invasive mechanical ventilation based on lung-protective strategies using low tidal volume (VT) at 4-6 ml/kg of predicted body weight (PBW) and plateau pressure (p PLAT) below 30 cm H2O, but other adjunctive therapies have been trialed with various degrees of efficacy, including neuromuscular blockade, prone positioning, recruitment maneuvers (RMs), vasodilators, and extracorporeal membrane oxygenation (ECMO).

Hypertonic saline 3% NaCl with 513 mEq/L of Na and 513 mEq/L of Cl is a potent anti-inflammatory agent, and immunomodulator, which exerts inhibitory effects in several stages of the inflammatory cascade. Hypertonic saline, at a cellular level, decreases alveolar macrophage activation, polymorph nuclear leucocyte recruitment, priming and activation, as well as cell surface adhesion molecule expression. High plasma sodium contributes to high plasma osmolality which can be lung protective and would seem to be a logical choice for treatment of ARDS.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 60 years old.
* Both sexes.
* Patients with mild and moderate ARDS whose PaO2/FiO2 ratio ≥ 150 according to the Berlin definition of Acute Respiratory Distress Syndrome.

Exclusion Criteria:

* Refusal to participate in the study.
* Malignancy.
* Patients on chemotherapy.
* Decompensated renal, hepatic and cardiac disease.
* Patients with hypernatremia whose serum Na above 155 mEq/L.
* Patients with ARDS whose PaO2/FiO2 ratio \> 150.
Fatigue in Systemic Lupus Erythematosus

The aim of this study is to investigate the effects of biopsychosocial status, quality of life, functional status and hematological markers on fatigue in individuals with SLE.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria
* Being 18 years of age or older

Exclusion Criteria:

* Not being able to speak or understand Turkish fluently
* Having a psychiatric illness that will affect cooperation
* Heart failure or lung pathology that will affect daily life activities
* Additional autoimmune disease
Genistein as a Possible Treatment for Alzheimer's Disease.

Genistein is an isoflavone that has antioxidant and neuroprotective effects on Alzheimer's disease (AD).

A few years ago our group reported that genistein increased PPARg (peroxisome proliferator activated receptor gamma) levels. By the way, activation of retinoid X receptor (RXR)-PPARg dimer, will make overexpressing apolipoprotein E (apoE), which mediates the degradation of amyloid beta (AB). Therefore, we believe that if this phytoestrogen administration increases the availability of the transcription factor, it can increase apoE, and also AB degradation.

The main aim of this study is to determinate the effect of 60 mg BID of genistein administration, during 360 days, compared to placebo group, in AD patients.

Alzheimer's disease is devastating in terms of personal wellbeing as well as for society. Any effort to prevent and/or treat this disease is always sought after. Recently, an exciting new possibility was opened by modulating a cellular component called RXR-PPARG. A successful experimental treatment for Alzheimer's was found by activating RXR. But we previously showed that a component of soya, i.e., genistein, is able to activate the other part of the RXR-PPARG molecule, i.e., the PPARG moiety. Genistein, moreover, does not have the undesirable effect of bexarotene and is a food component. Our preliminary results in animals indicate that genistein is effective in the treatment of experimental Alzheimer's in mice. Epidemiological evidence shows that individuals who live in Eastern societies who have a high genistein intake (because they eat a lot of soya) have lower rates of Alzheimer's disease.

Thus we propose a controlled clinical trial to test if administration of the food component genistein is able to prevent or cure, at least partially, Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild cognitive impairment (MCI) compatible with prodromal AD.
* Mini-Mental State Examinations (MMSE) score between over 24 inclusive.
* CSF levels of AB, p-TAU compatible with AD.
* 18 years or older.
* Must have a study partner who is able and willing to comply with all required study procedures.
* Willing and able to provide informed consent by either the subject or subject's legal representative.

Exclusion Criteria:

* Patient who does not meet the inclusion criteria.
* Thyroid abnormalities with or without treatment.
* Immune abnormalities in blood analyses.
* Patient suffers hormone dependent neoplasia.
* Take a diet rich on isoflavones.
An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma

This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
* Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
* Male or female patients over 18 years of age
* Patients with a life expectancy of at least 2 months
* Patients must have given written informed consent
* Patients with a Karnofsky Performance Status score of ≥ 50%
* Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

Exclusion Criteria:

* History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
* Concomitant use or anticipated use in the period of the study of radiotherapy
* Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
* Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
* Females who were pregnant, planning to become pregnant or lactating
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
* Haematological indicators:

Haemoglobin \<9.5g/dl White blood cell count \<3.5 x 109/l Platelets \<100 x 109/l
Evaluated the Efficacy and Safety of APCP on Hair Health

This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.


Eligibility Criteria:
Inclusion Criteria:

* Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
* A person capable of maintaining the same hair shape and color during this human body application test
* A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form

Exclusion Criteria:

* A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
* As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
* A person who plans to manage and operate hair supplies, hair products during this human body application test
* A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
* A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
* Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)
* A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1
* A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
* A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
* A person who is sensitive to or allergic to food ingredients for this human body application test
* A person who is deemed inappropriate by the tester for other reasons
Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units

The administration of high-dose chemotherapy followed by the infusion of blood or bone marrow stem cells (stem cell transplantation) from a matched donor has become standard treatment for patients with high-risk or relapsed hematological cancers. Currently, donors are found for approximately 80% of people who require such treatment, although the chance of finding a donor is much lower in some ethnic communities. In the current study the investigators will offer patients requiring transplantation, but for whom well matched donors cannot be identified either from within the family or on the donor registry, a transplant from a half-matched (haploidentical) family member. A myeloablative conditioning regimen and un-manipulated peripheral blood stem cells will be used. Post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil will be used to prevent graft versus host disease (GVHD). The primary outcome measure will be 6 month survival free from graft failure, relapse and grade 3-4 acute GVHD. Other outcomes of interest will include the frequency of Cytomegalovirus (CMV) or Epstein-Barr Virus (EBV) requiring treatment, overall survival and progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* A hematological malignancy such as acute leukemia or myelodysplastic syndrome requiring hematopoietic stem cell transplantation.
* A haploidentical family member willing to donate.
* Suitable performance status, organ function (as defined locally) and disease status for transplantation.
* Patients with acute leukemia must be in morphological complete remission. Patients with chronic myelogenous leukemia must be in chronic phase and those with lymphoma must have chemosensitive disease (at least partial remission to most recent chemotherapy regimen).
* Given written, informed consent to participate in a clinical trial.

Exclusion Criteria:

* An 8/8 matched sibling donor or matched unrelated donor (based on high-resolution typing as appropriate), available within a time frame acceptable to the treating physician
* Patients with an available single allele or single antigen mismatched donor (7/8 or 9/10) or available cord blood donor can be included at the discretion of the treating team, according to local institutional practice.
* Prior allogeneic transplant
* Any exclusion criteria for allogeneic stem cell transplant, as defined by the program. Examples typically include pregnancy, significant comorbidity, and active uncontrolled infection.
Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair

A caudal anesthesia is one of the most commonly used technique providing intra and postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct analgesic drugs to local anesthetics for caudal block is common. The most commonly used drugs are opioids, clonidine, and ketamine. However, their use has been limited by adverse effects in children.

Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is the fourth most abundant cation in the body. It has antinociceptive effects in human and these effects are primarily based on the regulation of calcium influx into the cell. Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA) receptor and such NMDA antagonism prevents the central sensitization from nociceptive stimulation. Many study suggested that epidurally administered magnesium could reduce the postoperative pain in adults. But few studies are available about the use of magnesium in pediatrics.

The investigators performed prospective randomized double-blind study to examine the analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing inguinal hernia repair.

80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours.

After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain Measurement, PPPM), and adverse effects were evaluated for 48h.

The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation. 48 hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-II,
* children aged 2 to 6 yr
* weight under 20kg
* undergoing inguinal hernia repair

Exclusion Criteria:

* Hypersensitivity fo any local anesthetics,
* bleeding diathesis, infections at puncture sites,
* pre-existing neurological disease,
* patients taking Calcium channel block,
* patients taking opioid
Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Platinum Retreated in Patients with Platinum Sensitive mTNBC

Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. Performance status no more than 2
3. Life expectancy longer than 3 months
4. Histological proven unresectable recurrent or advanced breast cancer
5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER \<1%, PR \<1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+).
6. Patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. Platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose).
7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
8. Radiation therapy within 4 weeks prior to enrollment
9. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
10. Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

1. Patients had prior treatment with vinorelbine
2. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
3. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
6. Uncontrolled serious infection
7. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
Mechanisms of Mitochondrial Defects in Gulf War Syndrome

The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the "power plants" of the body. Mitochondria take the food you eat and break the food down into a form of energy that the body can use. The investigators propose that Gulf War Syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. This study will be the first investigation of mitochondrial function in Gulf War Syndrome. The investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify Gulf War Syndrome, and ultimately develop treatment protocols for Gulf War Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Short-term memory loss or a severe inability to concentrate that affects work, school or other normal activities
* Muscle Pain, myalgias
* Pain without redness or swelling in a number of joints
* Intense or changing patterns of headaches
* Unrefreshing sleep
* After any exertion, weariness that lasts for more than a day

Exclusion Criteria:

* Organ failure (e.g. emphysema, cirrhosis, cardiac failure, chronic renal failure)
* Chronic infections (e.g. HIV/AIDS, hepatitis B or C)
* Rheumatic and chronic inflammatory diseases (e.g. systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis.)
* Major neurologic diseases (e.g. multiple sclerosis, neuromuscular diseases, epilepsy or other disease requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
* Diseases requiring systemic treatment (e.g. organ or bone marrow transplantation; systemic chemotherapy; radiation of brain, thorax, abdomen, or pelvis)
* Major endocrine diseases (e.g. hypopituitarism, adrenal insufficiency)
* Myocardial infarction, heart failure
* Morbid obesity (body mass index \>40)
* Permanent psychiatric exclusions: Lifetime diagnoses of bipolar affective disorders, schizophrenia or any subtype, delusional disorders of any subtype, dementias of any subtype, organic brain disorders, and alcohol or substance abuse within 2 years before onset of the fatiguing illness.
* History of allergic reaction to lidocaine
* History of keloid formation with skin incisions.