cyrilzakka/clinical-trials huggingface dataset:
Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

The purpose of this study is to measure the levels of serum proteins and other biomarkers in cancer patients and in patients suspected of having cancer. We believe that some of these markers may be useful for confirming the diagnosis or for selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

This is a blood serum collection study at Stanford University for patients with cancer at a variety of disease sites. The purpose of this study is to collect and store blood serum from patients before, during, and after anti-cancer therapy to find new biomarkers that signal disease or response to anti-cancer therapy. The collection and analysis of these biomarkers may lead to improved diagnostic and treatment therapies for certain cancers in the future. We are also interested in collecting blood serum from healthy individuals such as the spouses, relatives, and friends of cancer patients to obtain healthy controls for comparison

Eligibility Criteria:
1. Age \> or = 18; for the samples collected under the NIH grant, no subjects below the age of 20 will be enrolled.
2. Prior diagnosis of cancer or suspected of having cancer
3. Karnofsky performance status of greater than 70
4. Standard pretreatment evaluation
5. Signed Stanford University Human Subjects Committee consent
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past).
* Conn (West Haven Criteria) score of \< 2.
* Mini-Mental State Examination (MMSE) score \> 24 at screening.
* ≥ 18 and ≤ 85 years of age.

Key Exclusion Criteria:

* Active COVID-19 that is unresolved
* History of SBP
* History of EVB or AKI-HRS within 6 months
* History of OHE episode (Conn score ≥ 2)
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

Epilepsy is a chronic neurologic disorder characterized by seizures. Beside seizures people suffering from epilepsy experience several challenges related to education, work and everyday life such as learning-, problem-solving-, memory-, concentration-, attention difficulties and fatigue.

It is generally approved that physical activity (PA) has a positive effect on physical as well as mental factors. However, people with epilepsy are found to be less active and PA is rarely offered or recommended as supplement to anti-epileptic medical treatment. Few studies have investigated the effect of PA in subjects with epilepsy and additional studies of high methodical quality are needed to enable evidence-based information and counselling.

This study is carried through as a randomized controlled trial which investigates the effect of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic Epilepsy aged 15-50.

The study hypothesis is that participation in a 10-week cardio exercise program will induce a positive change in cognitive function (concentration and attention) and possibly in brain-derived neurotrophic factor (BDNF). In addition it is expected that the intensity and duration of the 10-week cardio exercise program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age: 15-50
* Resident: Fyen, Denmark
* Epileptic syndrome: Juvenile Myoclonic Epilepsy

Exclusion Criteria:

* Physical handicaps which complicate participation in physical activity
NPD Measurement in Infants

Nasal Potential Difference measurements (NPD) have been performed in Israel since 1996. NPD measurements are used to assess the voltage across nasal epithelium, which correlates with the transport of sodium and chloride across cell membranes. NPD was first demonstrated to be abnormal in Cystic Fibrosis (CF) in 1981 and the technique has since been used to increase our understanding of this condition. It is now established as an important diagnostic tool and more recently has been used to assess the effectiveness of new treatments such as gene and alternative therapy (Knowles 1995; Wilschanski 2003).

The nasal cavity is accessible which makes it a good site to examine the ion transport characteristics of airway epithelia. Less than a centimetre into the nose the squamous ("skin type") epithelium becomes ciliated pseudocolumnar epithelium, characteristic of the proximal airways.

The change in NPD with the perfusion of different solutions is demonstrated. By employing NPD protocols with perfusion of different solutions and drugs, different aspects of the nasal ion transport characteristics can be examined. In CF, this ion transport profile is abnormal and the NPD measurement has a number of features that differentiate CF from non-CF. This methodology is well established for measurements in subjects over 6 years of age.

Measurements on smaller children and infants have been very difficult to perform. We propose a new method using smaller, single lumen catheters with much lower perfusion rates (0.2 ml/min compared to up to 5 ml/min with the adult method) .Perfusion measurements will be possible in newly born infants. Obviously this opens up the potential for using NPD as a diagnostic test in babies. This is important as the diagnosis of CF is often difficult to make or refute in babies because of the problems in collecting enough sweat. This may be the ideal diagnostic test for CF in the neonatal nursery in infants with meconium plug syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age below 6 years
* Patients who suspected for CF due to pulmonary and/or gastrointestinal symptoms

Exclusion Criteria:

* Age over 6 years
The Influence of the Nutritional Status of Women Between 30 and 45 Years of Age on the Condition of the Skin and Body Composition

Goal is to investigate the differences in skin condition and body composition among women with different dietary habits aged 30-45 years. Study will be focused onto sub-groups of female subjects following omnivorous, vegetarian or vegan diet.

Investigators will investigate differences among female subjects aged 30-45 years following one of the following diet for at least 3 years:

* vegan
* vegetarian
* omnivorous

Study will focus into the differences in dermal protein density and dermal thickness, skin hydration and trans-epidermal water loss. Study will focus also into body composition, specifically into % of body fat and % of lean body weight.

Eligibility Criteria:
Inclusion Criteria:

* women
* aged 30-45 years
* vegan or vegetarian or omnivorous diet for at least 3 years,
* body mass index (BMI) between 18.5 and 25.

Exclusion Criteria:

* smoking or have smoked in the past (quit less than 3 years ago),
* pregnancy or breastfeeding,
* pre-menopause
* medications that increase skin dryness (e.g. retinoids),
* visiting solariums,
* visiting of the fitness center more than 3 times a week,
* regular consumption of protein supplements (including food supplements with collagen),
* chronic and acute skin diseases,
* chronic and acute diseases of the gastrointestinal tract (e.g. celiac disease),
* lactose intolerance,
* various diets (e.g. health, slimming),
* damaged skin in the test area (inner forearm),
* hyperhidrosis or increased sweating,
* diseases that cause a chronically damaged skin barrier (e.g. atopic dermatitis, ichthyosis),
* cancer diseases,
* pacemaker.
Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT

This study is being conducted to find out what effects (good and bad) that a combination of treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery can be performed. Current treatments for this stage of pancreas cancer offer less than ideal results, with little opportunity for treatment with curative intent.

Subjects must have biopsy proven adenocarcinoma of the pancreas which is bidimensionally measurable on CT. Cancer must be considered locally advanced (not able to be treated surgically). Subjects must not have received prior treatment for pancreatic cancer. Subjects must not have received prior radiation therapy to the abdomen or pelvis (for any reason). Subjects cannot be receiving immunosuppressive therapy (e.g. prednisone, methotrexate). Eligible subjects will receive initial chemotherapy regimen to include eight cycles of Gemcitabine and Docetaxel. All subjects will be re-evaluated for surgery - if tumor has shrunk enough, subject will undergo surgery, followed by additional chemotherapy of Oxaliplatin, 5FU and Alpha-interferon and radiation therapy; once subject has recovered from side effects of the chemo/radiation therapy, they will receive a final chemotherapy regimen of four cycles of Gemcitabine and docetaxel. Subjects who are not surgical candidates after eight cycles of chemotherapy will undergo an additional four cycles of Gemcitabine and docetaxel followed by reassessment for surgery. If they are a surgical candidate, they will undergo surgery followed by chemo/radiation therapy regimen. If they are not a surgical candidate, they will undergo the chemo/radiation therapy regimen.

Subjects may be removed from the study treatment for the following reasons:

* The investigator feels the subject is not benefitting from treatment
* The subject chooses to discontinue for any reason
* The subject experiences side effects which are considered to be unacceptable
* The subject has an increase in the size of their tumor

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the pancreas
* Tumor must be radiographically bidimensional by abdominal/pelvic CT
* Cancer must be locally advanced and not considered immediately treated by standard surgical procedure
* No prior therapy for pancreas cancer

Exclusion Criteria:

* Women who are pregnant or lactating
* Subjects who have received prior external beam radiation to the abdomen or pelvis
* Subjects receiving chronic immunosuppressive therapy (prednisone, methotrexate)
Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).


Eligibility Criteria:
Inclusion Criteria:

1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
2. Patient had relapsed or refractory disease and received at least one prior therapy.
3. Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
4. Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.
5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Patient had adequate bone marrow and organ function.

Exclusion Criteria:

1. Patient had received previous treatment with PI3K inhibitors
2. Patient had evidence of graft versus host disease (GVHD).
3. Patient had active or history of central nervous system (CNS) disease.
4. Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
5. Patient had a score ≥ 12 on the PHQ-9 questionnaire.
6. Patient had a GAD-7 mood scale score ≥ 15.
7. Pregnant or nursing women
8. Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.
Sildenafil Impact on Ventricular Function in Patients With Heart Failure

Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or Sildenafil. After one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.

Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or sildenafil. After one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.

The first and second exams will be performed by the same staff. All patients will be evaluated by two, three and four chambers view. Left and right ventricle quantification analyses will be performed by Argus software.

Eligibility Criteria:
Inclusion Criteria: Patients with heart failure in stable clinical condition compatible with New York Heart Association functional class I to III. Eligibility criteria is consent to participate in the study after receiving detailed information about procedures, possible clinical benefits, and risks.

Exclusion Criteria: patients with new diagnosed lesions during the procedure, eg pulmonary mass and important claustrophobia, low blood pressure ( systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg) nitrate or nebivolol use over the last 48 hours, metallic non MRI compatible implantable devices.
Coughing at Time of Cervical Biopsy

To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.

Colposcopy is a frequently practiced examination and Colposcopy guided biopsy causes pain. A few trials Investigated whether medical interventions such as the application of lidocaine led to reduced pain perception with inconsistent results. Only one trial compared coughing versus no coughing at the moment of biopsy. Although the results of this study did not lead to a significant difference between the two study arms, coughing seems to positively affect pain perception.

Since the patients are, in the best case, their own controls when it comes to subjective parameters such as pain perception, we prefer a cross-over rather than a parallel group design.

Based on the descriptive variables for pain during biopsy with and without cough determined in the pilot study, a case estimate for a prospective randomized cross-over study will be carried out. Since two biopsies are usually taken from the cervix in daily practice, the now planned pilot study in a cross-over design envisages the following two study arms:

1. Group I: Patients cough during the first biopsy, they do not cough during the second biopsy
2. Group II: Patients cough during the second biopsy, they do not cough during the first biopsy

The primary Outcome measure is the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS).

Eligibility Criteria:
Inclusion Criteria:

* Completed 18 years of age
* written informed consent
* first colposcopy
* Clinically indicated colposcopy in case of an abnormal PAP smear or screening result and/or clinical abnormalities on the cervix uteri
* Necessity to take exactly two biopsies

Exclusion Criteria:

* Performing only one biopsy or more than two biopsies
* Performing an endocervical curettage (biopsy on the endocervix)
* Vaginal bleeding at the time of examination
* inadequate colposcopy
* Cervix uteri cannot be fully visualized
* Pregnancy
* Patients with insufficient German language skills
* known anxiety disorders or depressive disorders
* Treatments already carried out on the cervix uteri
* Patients with a chronic or acute illness that influences the perception of pain or lead to permanent pain due to the disease itself
* psychosomatic illnesses
* Chronic use of pain medications or psychotropic medications or other medications that may have an influence on the sensation of pain
Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP.

To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion.

ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion.

Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Primary admission for a severe trauma
* Out-of-hospital transfusion or RBC transfusion within the first hour following hospital admission
* Clinical prediction or ABC score (Assessment of Blood Consumption) ≥ 2 of massive transfusion defined by a transfusion of at least 10 CGR during the first 24 hours or 3 CGR during the first hour.
* Informed consent signed by a relative or emergency procedure

Exclusion Criteria:

* Cardiac arrest before randomisation
* Secondary transfer from another hospital (a technical stop is accepted)
* Post-traumatic lesions out of therapeutic resources with death expected in the hour following hospital admission
* Anti-coagulation treatment (K anti-vitamine, new oral anticoagulant)
* Pregnancy
* Hypersensitivity to active substances or one of the excipients of KANOKAD®
* Patient treated with an experimental medicine within the last 30 days
* Decision of therapeutic limitation before randomisation
* Patient protected by article L1121-7 of the French Public health code.
* Knowledge of a contraindication to the use of NaCl 0.9% at the dose of 1 mg/kg (hyperchloremia, hypernatremia...)
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
* Suspected or confirmed infection due to a gram-positive organism

Exclusion Criteria:

* Complicated skin and skin structure infection due to gram-negative organisms
* Complicated skin and skin structure infections requiring more than 7 days of therapy
* Uncontrolled diabetes
* Chronic systemic immunosuppressive therapy
* AIDS with CD4 count \< 200 cells/mm3
* Uncontrolled hypertension
* Mild moderate or severe renal failure
* Severe hepatic disease
* Neutropenia
* Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
* Women who are pregnant or nursing
The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants

ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.

Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.

Objective: This randomized controlled double-blinded experimental study was carried out to determine the effects of daily exercise program on bone mineral density and cortisol level in preterm infants with very low birth weight matched for birth weight, gestation week, and gender.

Study design: The study was performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. Daily exercise program was implemented in preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10 minutes. Before and after the study the following were evaluated in preterm infants in the exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone mineral density, serum biochemical parameters and cortisol levels.

Eligibility Criteria:
Inclusion Criteria:Inclusion criteria for the infants were as follows:

* postnatal age of 1-5 days,
* gestational age of 28-32 weeks,
* birth weight of 1,000-1,500 gr,
* no diagnosis of necrotizing enterocolitis (NEC), digestive system or chromosomal abnormalities, skin diseases, intrauterine growth retardation (IUGR), SGA, and large gestational age (LGA),
* no history of surgical intervention, and
* no medical treatment except for appropriate vitamin supplements and antibiotic treatments.

Exclusion Criteria:

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