cyrilzakka/clinical-trials huggingface dataset:
Effect of Lactose, Fructose, Sucrose, Whey Protein, and Soy Protein on Substrate Absorption and Oxidation: a Pilot Study

Does the consumption of various combinations of mono and disaccharides (lactose, sucrose and fructose) and protein isolates (whey or soy) result in altered substrate absorption, substrate oxidation, and glucose regulation? This proposed research will provide data to determine the relative contribution of source of protein (whey vs soy) and carbohydrate (mono- and disaccharides) on the observed effects of dairy products on absorption, substrate oxidation and glucoregulation mechanisms that affect body composition.

Epidemiological research has shown that dairy products aid in weight loss and weight maintenance. Some evidence suggests that this effect is due to the whey component (which contains whey proteins and lactose) of milk. Previous work from our laboratory has demonstrated that chronic administration of whey protein concentrate results in decreased body fat and insulin concentration. Recent research (unpublished) from Castonguay and colleagues (University of Maryland, College Park, MD) has suggested that specific combinations of sucrose, maltose and lactose similarly alter body fat levels in rats. This proposed research will provide data to determine the relative contribution of source of protein (whey vs soy) and carbohydrate (mono- and disaccharides) on the observed effects of dairy products on absorption, substrate oxidation and glucoregulation mechanisms that affect body composition.

Eligibility Criteria:
Inclusion Criteria:

* Male.
* BMI at least 20 and less than 38 kg/m2 and body weight \< 300 lbs.
* Age 25 to 65 years at beginning of study.
* Fasting glucose \< 126 mg/dL.
* Blood pressure \< 160/100 mm Hg.
* Total plasma cholesterol \< 280 mg/dL.
* Nonsmokers or tobacco users (for at least 6 months prior to the start of the study.)

Exclusion Criteria:

* History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
* History of eating disorders.
* Volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.
* Volunteers who have lost 10% of body weight within the last 12 months .
* Volunteers who have been on Atkins, South Beach or similar diet in 3 months prior to start of study.
* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study).
* Known (self-reported) allergy or adverse reaction to dairy products (including lactose) or soy.
* Volunteers who consume whey or soy protein supplements.
Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients, to reduce the level of pain, anxiety and depression. The comparison was made through the scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale (HADS).

Volunteers cancer patients of both gender, aged between 40 and 70 years, susceptible to hypnosis, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS), will be randomized into two groups of 12 participants each. They might or might not present metastasis, whether or not performed cancer surgery, regardless of the location of the primary tumor, with or without concomitant surgical indication. It will be used the Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS) at 3 different times: at baseline, after 7 days and after 2 weeks of the first assessment. It will be done, in the hypnosis group, an hypnosis intervention. It consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression. Then, it will be evaluated the intensity of the pain as well as depression and anxiety in both groups. Finally, the results of both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Both sexes
* Aged 40-70 years susceptible to hypnosis
* Who have cancer of the digestive tract and pain resulting from this cancer treatment These may or may not have metastasis, have done or not cancer surgery, regardless of the location of the primary tumor or its presence,with or without concomitant surgical indication.This will include patients who have pain scores ≥ 3 in the Visual Analogue Scale (VAS).

Exclusion Criteria:

* Patient not suggestible to hypnosis
* Psychotropic drug users,
* Patients with severe psychiatric disorder, except depression and anxiety

  ,- Patient terminally ill cancer
* Patients with tumor or cancer metastasis in the central nervous system, _ Deaf and people with mental disabilities and cognitive.
Effectiveness of Gradual Versus Rapid Weight Loss

This randomized controlled trial aims to compare the 1-year effectiveness of an initial rapid weight loss (RWL) program and a gradual weight loss (GWL) program.

A total of at least 286 participants will be randomized to either a 16-week rapid weight loss (RWL) program; \[an 8-week low-energy-diet (\<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks \<1300 kcal/day and 4 weeks \<1500 kcal/day)\], or a 16-week gradual weight loss (GWL) program (controls); \[estimated total energy expenditure minus 800-1000 kcal/day\]. Thereafter, all participants (both groups) will undergo a 36-week comprehensive weight maintenance program.

Eligibility Criteria:
Inclusion Criteria:

* • Willing and able to give informed consent for participation in the study

  * Living in the eastern part of Norway, mainly Oslo, Buskerud, Vestfold and Akershus
  * Understanding Norwegian language written and spoken easily
  * BMI ≥30.0 kg/m2
  * Stable body weight (\<5 kg self-reported weight change) during the last 3 months before inclusion

Exclusion Criteria:

* • Pregnancy and breast-feeding mothers

  * Suspected non-compliance with regards to visits and/or diet
  * Severe chronic disease (endocrine disease, heart disease, neurological disease, lung disease, disease in the gastrointestinal tract, kidney disease, rheumatism or cancer).
Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model

In this exploratory phase II trial, the possibility of a personalized treatment after resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be obtained, transferred into avatars and treated the same way as in the patient until resistance arises. These resistant tumor cells are subsequently treated by different targeted treatment combinations in the mouse avatar model to find the most active drug or combination of drugs. This drug or combination of drugs may then be offered to the patient after cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients during first-line treatment with cetuximab as well as during second line experimental treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism of resistance seen in the avatar model matches with the mechanism of resistance in the individual patient.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age ≥ 18 years
* Written declaration of consent
* ECOG Performance Status 0-1
* Life expectancy\> 3 months
* Histologically confirmed adenocarcinoma of the colon or rectum at stage UICC III or UICC IV
* Histologically confirmed adenocarcinoma of the colon or rectum in stage UICC II with one of the following risk factors: CEA\> 200; T4 tumor, emergency surgery, \<12 distant lymph nodes, surgery due to intestinal obstruction (ileus)
* Patient agrees to the preservation of tumor material for the purpose of molecular analyzes including the determination of the genetic profile of the tumor (participation in the project "RESIST")

Exclusion Criteria:

* Preoperative Radiotherapy
* Preoperative chemotherapy
* Heart failure\> Grade II (functional NYHA classification)
* Existing concomitant disease or condition that would make the patient unsuitable for a study participation or interfere with the safety of the subject
* Any psychological, familial, sociological or geographical event which does not allow observance of the study protocol
* Additional carcinoma therapy (chemotherapy, radiation, biological therapy, immunotherapy or hormonal therapy) during the study
* Known malignant second neoplasia within the last 5 years (except for a basal cell carcinoma or a carcinoma in situ of the uterine cervix).
A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (Stage IV)
* Progression during or within 3 months following the last administration of standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin. Patients treated with oxaliplatin or irinotecan in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
* Patients who are candidates for and have access to anti-VEGF therapy (i.e. bevacizumab and regorafenib) and anti-EGFR therapy (i.e. cetuximab and panitumumab) and/or TAS-102 must have received appropriate therapy.
* Patients with measurable or non measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \</= 1
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Anti-cancer chemotherapy, biologic therapy or any other systemic therapy if administered prior to the first planned dose of study medication within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of protocol treatment.
* Major surgery within 4 weeks prior to randomization.
* Any known brain or leptomeningeal metastases are excluded, even if treated.
* Known hypersensitivity to 5-FU/LV or patients who as a result of toxicity had to reduce or stop 5-FU infusion at the dose of 900 mg/m\^2/day (total 1800 mg/m\^2/day).
* Known hypersensitivity to irinotecan or patients who as a result of toxicity had to reduce or stop irinotecan infusion at the dose of 120 mg/m\^2.
* Known history of human immunodeficiency virus (HIV) infection. Known chronic hepatitis B or C active infection.
* Known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Patients with QTc interval \> 470 millisecond.
* Uncontrolled intercurrent illness
Game-Based Physical Activity in Childhood Cancer Survivors

This study will test whether a game-based exercise plan can help increase the level of physical activity in childhood cancer survivors. The game-based exercise plan will involve participation by both a childhood cancer survivor and his/her parent or caregiver. This study will also look at whether the game-based exercise plan improves childhood cancer survivors' quality of life.


Eligibility Criteria:
Inclusion Criteria:

Childhood cancer survivor:

* History of treatment for childhood cancer with cardiotoxic therapy (anthracyclines, chest radiation, total body irradiation)
* Off all systemic cancer therapy for ≥ 2 years
* Ability to speak and understand English
* Ability to complete all protocol assessments
* Mobile device with SMS text messaging capability
* Ambulatory and able to perform all study requirements
* Attained age 10-16 years
* Has a parent or legal guardian willing to participate in the study as a dyad
* Willing to receive daily SMS text message alerts
* Not currently exercising at least 30 minutes per day (5 days/week)
* ECOG Performance Status of 0-1

Parent/legal guardian:

* Parent or legal guardian of a childhood cancer survivor treated with cardiotoxic therapy (anthracyclines, chest radiation, total body irradiation)
* Parent or legal guardian of a child age 10-16 years who is at least 2 years from completion of systemic cancer therapy
* Ability to speak and understand English
* Ability to complete all protocol assessments
* Ability to provide informed consent
* Ambulatory and able to perform all study requirements
* Access to a mobile device with SMS text messaging capability
* Is the parent or legal guardian of a childhood cancer survivor who is willing to participate in this study as a dyad
* Willing to receive daily SMS text message alerts
* ECOG Performance Status of 0-1

Exclusion Criteria:

* Survivors, or parents/legal guardians of survivors, with a medical condition that makes it unsafe to complete study requirements are not eligible for this study. This includes a diagnosis of:

  * Severe persistent asthma
  * Known symptomatic coronary artery disease
  * Musculoskeletal defects that interfere with sustained physical activity
  * Any medical or psychosocial condition that, in the opinion of the investigator, would jeopardize the health of the participant during study procedures
Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.

This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Specifically, researchers want to:

* Examine the efficiency of protein intake after exercise on muscle mass and physical abilities;
* Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides);
* Examine the impact of exercise and proteins on liver enzymes;
* Examine the impact of exercise and proteins on a hormone that controls hunger;
* Evaluate the program's impact on the ability of the body to produce energy.

All participants are exercising (resistance training) and ingest one of the 3 different sources of proteins, immediately after training:

* Milk proteins (from milk beverage)
* Essential amino acids (added to a soya beverage)
* No protein (rice beverage - control group)

Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins and EAA will be both superior to control group.

This would represent an interesting finding since milk is more accessible, palatable and cheaper than essential amino acids commercial mix.


Eligibility Criteria:
Inclusion Criteria:

* 65-75 years
* francophone or understanding French
* muscle mass index \< 10.75 kg/m2 (Janssen et al, 2004)
* body mass index \<30kg/m²
* weight stable (\< 2 kg) for 6 mo
* no resistance exercise for 3 years
* controlled blood pressure for at least 6 months

Exclusion Criteria:

* major physical disability
* medical treatment influencing metabolism
* statin treatment
* diagnosis or any sign of kidney disease
Genomic and Proteomic Study of Richter Syndrome (CGPSR)

Biological study on Richter Syndrome (RS), an agressive lymphoma that arises from Chronic Lymphocytice Leukemia (CLL). RS presents with the same histological aspect as primitive Diffuse Large B-Cell Lymphoma (DLBCL), but is associated with a poor prognosis, due to chemorefractoriness.

This study aims at understanding the biological determinants of chemotherapy resistance in Richter Syndrome.

With the help of the French National Research Group on CLL (FILO / French Innovative Leukemia Organization), the investigators are currently gathering fresh frozen cell pellets at CLL stage, and lymph node biopsies at Richter stage. The investigators also gathered lymph node biopsies from DLBCL, as a reference group.

The investigators will perform genomic and proteomic comparative studies between CLL and Richter, as well as between Richter and primitive DLBCL, to understand the biological determinants of clonal evolution and chemorefractoriness of Richter Syndrom.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a Diffuse Large B-Cell Lymphoma arising in the context of a Chronic Lymphocytic Leukemia (group 1) or diagnosis of a primitive Diffuse Large B-Cell Lymphoma (group 2), or diagnosis of a Diffuse Large B-Cell Lymphoma arising in a context of small cells lymphoma, excluding CLL (group 3), or benefit from a diagnostic lymph node biopsy that did not reveal any tumor involvment (primitive or metastatic) (group 4).
* Patients must benefit from a lymph node biopsy at diagnosis.
* Patients must be followed by a FILO (French Innovative Leukemia Organization) member
* Histology of Diffuse Large B-Cell Lymphoma or Hodgkin histology.
* Suitable clinical data available.
* Samples must meet the following requirement :RIN (RNA Integrity Number) \> 5 et DIN (DNA Integrity Number) \> 6.5.

Exclusion Criteria:

• Samples that do not meet the inclusion criteria (insufficient clinical data, analysis impossible due to insufficient sample quality).
Changes in Power and Cylinder Axis of Toric Soft Contact Lenses (LKL)

Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. Due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to SKU limitations. This research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. The study was conducted at Kirana Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort using the VAS method.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 20 - 35 years
2. Patients who do not have a spherical size (plano) to mild-moderate myopia (-1.00 D to -6.00 D) with age over 18 years
3. Minimum astigmatism component ≥0.75 D and maximum ≤ 3 D in one eye
4. The best visual acuity after corrected by LKL Torik is better or equal to 6/15

Exclusion Criteria:

1. History of previous intraocular surgery.
2. History of contact lens use in the last 6 months.
3. history of dry eyes, uveitis, glaucoma and corneal and conjunctival disorders
4. posterior segment abnormalities that reduce the quality of vision
5. Patients with contraindications to wearing contact lenses
6. There are no toric LKLs with exactly the strength and axes required by the patient
Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence

To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

Esophageal carcinoma is an aggressive malignancy and about a third of patients present with distant metastatic disease. While survival is slowly improving with better diagnostic tools and therapy, the overall 5-year survival remains low at 18%. Unlike other malignancies, such as colon cancer and prostate cancer, there is no peripheral blood marker of response or recurrence during treatment in esophageal cancer. However, quantifying cfDNA is a unique and tumor specific avenue that may allow real time response to treatment in esophageal cancer.

To identify esophageal cancer specific mutations, tumor samples will undergo whole exome sequencing. From this data, the investigators will select 10-15 genes to focus their efforts. PCR primers will be designed to detect these tumor specific mutations in the cell-free component of peripheral blood samples over the course of treatment for esophageal cancer.

The investigators will obtain baseline blood (before treatment) and then collect blood after neoadjuvant treatment, after surgery, and then at subsequent visits from the participants.

Eligibility Criteria:
Inclusion Criteria:

* Esophageal Cancer any stage
* Age \>18 years old
* Willing and able to provide consent
* No prior history of neoadjuvant therapy for the esophageal cancer

Exclusion Criteria:

* Age \<18 years old
* Unable to provide consent
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication after pancreaticoduodenectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing pancreaticoduodenectomy

Exclusion Criteria:

* age younger than 18 years old
* ongoing infection
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological disease
* preoperative evidence of widespread metastatic disease