cyrilzakka/clinical-trials huggingface dataset:
Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings

The aim of the present study was to investigate subjective appetite during 8 hours after intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.

Energy-dense foods that require little effort to consume and that are rapidly digested may cause passive over-consumption by failure to provide a feeling of fullness corresponding to the energy content. A diet that is predominantly based on such foods may lead to overweight. It is therefore important to identify properties of foods that facilitate energy balance by creating a high satiety per calorie. A number of studies have confirmed that foods naturally rich in dietary fiber promote the feeling of fullness and reduce hunger in the short term.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 60 years
* body mass index (BMI) 18-27 kg/m2
* a habit of consuming breakfast, lunch and dinner everyday
* fasting plasma glucose 4.0-6.1 mmol/L
* haemoglobin (Hb) in men 130-170 g/L, in women 120-150 g/L
* thyroid-stimulating hormone (TSH) 0.3-4.0 mlE/L
* willingness to comply with the study procedures

Exclusion Criteria:

* intake of medicine likely to affect appetite or food intake
* any medical condition involving the gastrointestinal tract
* eating disorder
* smoking
* consumption of more than three cups of coffee per day
* change in body weight of more than 10% three months prior to screening
* consumption of any restricted diet such as vegan, gluten-free, slimming etc.
* pregnancy, lactation or wish to become pregnant during the study period
The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers

A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia with the effects of GAA expected to be dose-dependent. Due to the fact that hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and neurodegenerative diseases, different dietary agents were used in the past for the treatment of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or folic acid. In the context of GAA loading the question arises whether intake of betaine, choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2 (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure assessed every second week throughout the study. Plasma B-vitamins and blood and urine metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along with adverse-effects indicators assessed every second week throughout the study. Selected body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to monitor the effects of experimental treatments on body hydration and protein synthesis. This research will test the hypothesis that a combination of GAA with homocysteine lowering nutrients attenuates the elevation of T-hcy, and will further display the size-effect of each additive used.


Eligibility Criteria:
Inclusion Criteria:

* healthy male and non-pregnant females
* moderately physically active
* aged 20 to 30 years
* not currently taking any dietary supplement for the past 2 months

Exclusion Criteria:

- total plasma homocysteine above 15.5 µmol/L
Personalized Perioperative Care Based on Patient Reported Outcomes Measures

In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians.

Reliable PROMs, like the Quality Of Recovery 15 (QoR-15) questionnaire, are available for patients experiencing surgery. These PROMs are significantly used as endoints for clinical interventions assessment. These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway.

However data about the efficacy of PROMs-based perioperative clinical follow up are lacking.

The clinical hypothesis is that a PROMs (QoR-15) based perioperative clinical care is more efficient that the usual care non based on the QoR-15.

The study is a multicenter randomized controlled trial comparing 2 groups:

* A control group, including the usual conventional follow-up by the surgeon and the attending physician.
* An experimental group including, in addition to the usual conventional follow-up, the follow-up by nurses specialized in the evaluation of the PROMs using the french version of the QoR-15 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* Benefiting from an osteo-articular surgery
* Subject affiliated to a social health insurance plan
* Able to understand the objectives and risks of the research and to give a dated and signed informed consent

Exclusion Criteria:

* Inability to administer the QoR-15f questionnaire (cognitive impairment, language barrier)
* Subject under court protection
* Subject under guardianship or curatorship
* Patient whose rehabilitation will be performed in a secondary hospital
* Patient having already benefited from a previous follow-up by the OPTIMISTE team
* Patient included in a therapeutic trial that may impact postoperative quality of recovery.
A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

* Men and women 19 years or older with OAB symptoms for ≥ 3 months.
* Subject who is willing and able to complete the voiding diary correctly.
* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

Main Exclusion at Screening (Visit 1):

* Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
* Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
* Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
* Clinically significant benign prostatic hyperplasia at the discretion of the investigator
* Had bladder or lower urinary tract surgery within 12 months from the screening visit
* Medical history of malignant tumor in urinary system or pelvic organs
* \>150 mL of post-void residual volume in the screening test
Cilengitide in Treating Patients With Acute Myeloid Leukemia

This randomized phase II trial is studying how well cilengitide works in treating patients with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth

PRIMARY OBJECTIVES:

I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.

SECONDARY OBJECTIVES:

I. Determine overall survival of patients treated with this drug. II. Determine the safety and toxicity of this drug in these patients. III. Determine the biological activity of this drug in cells from these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.

Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.

In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML)
* In first complete remission after at least 1 course of induction chemotherapy AND 1-2 courses of consolidation chemotherapy for newly diagnosed AML, as defined by the following:

  * No evidence of disease in bone marrow
  * Recovery of peripheral blood counts

    * Platelet count \> 100,000/mm\^3
    * Absolute neutrophil count \> 1,500/mm\^3
* Must be able to start study medication within 60 days from the start of the last consolidation therapy
* Must not have a suitable donor, refused, or ineligible for hematopoietic stem call transplantation
* None of the following AML subtypes or chromosomal translocations:

  * Acute promyelocytic leukemia
  * t(8;21)
  * t(16;16)
  * inv(16)
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* See Disease Characteristics
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance \> 60mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No prior investigational agents specifically designated as an antiangiogenic agent
* No concurrent prophylactic hematopoietic colony-stimulating factors
* See Disease Characteristics
* Recovered from prior consolidation chemotherapy
* No other concurrent anticancer therapies
* No other concurrent investigational cytotoxic agents
Major Allergen in Wheat Anaphylaxis in Thai Population

* To study Major allergen in Wheat anaphylaxis in Thai population
* To study and compare demographic data between group of wheat anaphylaxis

Wheat is one of the most common causes in food-induced anaphylaxis and food dependent, exercised induced anaphylaxis. Gold standard for diagnose food allergy is double blind placebo control food challenge, but it is a high risk procedure. The accuracy of skin prick test and specific IgE assay showed unsatisfactory results. It might be explained by these tests may not detect all of the major allergens in wheat allergic patients. Previous studies showed that the major allergens of wheat dependent, exercised induced anaphylaxis are omega5 gliadin, followed by high molecular weight glutenin. For IgE-mediated wheat allergy, the major allergens varied among studies, including omega5 gliadin, glutenin, alpha/beta/gamma gliadin, and the water-soluble part of wheat allergens. There is no study to direct compare the major allergen between patients who have low wheat specific IgE and very high wheat specific IgE. Also, there is no data about the major allergens of wheat anaphylaxis in Thai population.

Eligibility Criteria:
Inclusion Criteria:

* Wheat anaphylaxis patient aged 1-60 years, who received treatment at division of allergy, department of Pediatrics and Medicine, Siriraj Hospital from 2001 to 2016

Exclusion Criteria:

* Loss follow up
* No consent form
* Celiac disease, Autoimmune disease was diagnosed
Physical Endometrial Manipulation and Its Effect on ICSI

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .

Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate

Eligibility Criteria:
Inclusion Criteria:

* Infertile female age 20-35 years
* Previous Failed one ICSI trial
* normal basal hormonal profile \[FSH, LH\] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
* patent tubes
* normal Husband semen analysis

Exclusion Criteria:

* Ovarian factor of infertility
* Tubal factor of infertility
* Endometrial factor of infertility
* Male factor of infertility
Calcineurin Inhibitor Sparing After Kidney Transplantation

Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.

It is clear that minimizing the use of CNIs may be beneficial to some or all kidney transplant recipients. The purpose of this study is to determine whether minimization of these CNI drugs will improve patient survival rates and long-term kidney function.

If the subject agrees to participate in this research project, they will be randomly assigned to one of two different immunosuppression drug combinations. All of the drugs used in this study are standard FDA Approved immunosuppressive drugs currently in use by transplant patients. It is unclear however, which combination provides a better long-term outcome.

If after six months of being on the study the subject has not experienced a rejection episode that excludes them from participating in the second phase of this study, they will asked whether or not they would like to continue the study. If they decide to participate in Phase II, there will be another randomization to one of two different immunosuppression drug combinations. This will involve either being assigned to a group that will have their CNI dose lowered or a group that will have their CNI drug stopped and replaced with a non-CNI drug called Sirolimus. Phase II begins at 6 months post-transplant and a second consent will be obtained for those who participate in Phase II.

Eligibility Criteria:
Inclusion Criteria:

* Kidney Transplant Recipients \> 18 years old
* First or Second Kidney Transplant only

Exclusion Criteria:

* Kidney Transplant Recipients \< 18 years old
* Kidney Transplant Recipients who have a history of \> 2 kidney transplants
* Kidney Transplant Recipients with an already functioning non-renal transplant
* Kidney Transplant Recipients who receive another organ simultaneously at the same time of their kidney transplant (example: Kidney/pancreas, kidney/liver)
* Non-skin malignancy with 2 years previous to enrollment
* Donor Specific Antibodies to kidney donor
A Study to Investigate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants

The primary objectives of this study are to determine the effect of multiple doses of ALXN2080 on the single-dose PK of rosuvastatin and to determine the effect of multiple doses of ALXN2080 on the single-dose PK of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, triplicate 12-lead ECG, screening clinical laboratory profiles (hematology, clinical chemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
* Body Mass Index (BMI) within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening.
* Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders.
* History of meningococcal infection.
* History of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome).
* History of clinically significant hypersensitivity or idiosyncratic reaction to the study intervention or related compounds.
* History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 14 days prior to Period 1 Day 1.
* History of significant multiple and/or severe allergies (hay fever is allowed unless it is active), including significant hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, amoxicillin, aminopenicillin, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to provide empiric antibiotic therapy or treat an active infection.
* Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* History of malignancy within 5 years prior to screening, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
* Known hepatic or biliary abnormalities (including participants with Gilberts syndrome).
* Participants with a history of cholecystectomy or gall stones.
Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced hematologic malignancies.

This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase 2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM)

In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM). All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.

As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone to further evaluate this triple combination.


Eligibility Criteria:
Disease-Specific Inclusion Criteria

Patients must have one of the following diseases that is either relapsed or refractory to 2 or more prior treatments:

* NHL: At least one measurable lesion
* WM: Measurable IgM, with a minimum level of ≥ 2x ULN
* MM: Serum M-protein ≥ 0.5 g/dL and/or urine M-protein ≥ 200 mg/24 hr. In Part 2, disease that is considered measurable per the IMWG criteria

Other Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life Expectancy of at least 3 months
* Adequate hepatic, renal, cardiac and hematological function

Exclusion Criteria

* Any other current malignancy
* Treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug
* Recent bone marrow transplant
* Unable to receive medications by mouth
* Major surgery within 28 days before the first dose of study drug
* Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
* Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to the first dose of study drug
* Refractory nausea and vomiting or other situation that may preclude adequate absorption
* Other conditions that could interfere with treatment
Inflammatory Response to Paramyxovirus Infection in an Ex-vivo Model of Bronchial Epithelial Cells in Allogeneic HSCT Recipients

Introduction. Chronic graft-versus-host-disease (GVHD) is the main late noninfectious complication after allogeneic hematopoietic stem cell transplantation (HSCT) that can affect several organs. Bronchiolitis obliterans syndrome (BOS) is recognized as pulmonary chronic GVHD. A diagnosis of a lower respiratory tract infection in the first 100 days following transplant has been associated to the development of BOS. One hypothesis is that the first stage driving to BOS is a previous aggression of bronchial epithelial cells by various factors such as chemotherapy and radiotherapy. Thereafter, data suggest that viral infections, in particular Parainfluenza viruses could be a trigger for BOS. The alloimmune reaction activated by the respiratory virus could lead to the fibrosis process. Our hypothesis is that the bronchial epithelium of allogeneic HSCT recipients has phenotypic specificities that are associated with a specific response to the viral respiratory infections (in particular paramyxovirus) leading to the development of BOS.

Main objective. To characterize and compare the inflammatory response after infection with Parainfluenza 3 virus in an ex-vivo model of bronchial epithelial cells obtained from allogeneic HSCT recipients and controls.

Objective secondary. To characterize the phenotypic specificities of allogeneic HSCT recipients' bronchial epithelium.

Methodology, and experimental plan. Prospective, monocentric research. Bronchial biopsies obtained from patients, will be completely differentiated after 21 days of culture. Epithelial cells will be infected by the virus strain Parainfluenza 3. Transcriptome of the cells from both allogeneic HSCT patients and controls, infected and non-infected will be analyzed 48 hours after infection.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic HSCT patients \[case\]
* requirement of ng bronchial fibroscopy with bronchial biopsies for the exploration of FEV1 decline \[case\]
* non Allogeneic HSCT patients \[control\]
* .requirement of bronchial fibroscopy for exploration of a lung mass or of interstitial lung disease, requiring bronchial biopsies \[control\]

Exclusion Criteria:

* Minor or major patients protected
* Radiotherapy or chemotherapy \[control group\]
* Respiratory infection
* History of smoking \>= 15 packs/yr
Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study

This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
* Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

- There are no exclusion criteria for entry into this study