cyrilzakka/clinical-trials huggingface dataset:
Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus

This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.

Purpose:

* To investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes
* To investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods
* To evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes

Contents:

* Evaluation of the status of diabetes in gastric cancer patients with DM after gastrectomy

  * Comparison of two reconstruction types after gastrectomy Bypass duodenum and upper jejunum: Roux-en-Y gastrojejunostomy Preservation of duodenal passage: Gastroduodenostomy
  * Analysis for biochemical markers reflecting diabetic status: fasting glucose, postprandial 2h glucose, HbA1c, C-peptide, lipid profile
* Correlation of parameters associated with diabetes and GI hormones

  * Measurement of GI hormones which have an effect on glucose tolerance

    * Insulin, glucagon, IGF-1, GLP-1, Neuropeptide Y, Ghrelin, Leptin
  * Correlation of reconstruction methods, parameters of diabetes and GI hormone levels
  * Evaluation of mechanism of Roux-en-Y gastrojejunostomy on controlling diabetes
* Evaluation of Feasibility of Roux-en-Y gastrojejunostomy in gastric cancer surgery in patients with DM

  * Degree of high blood glucose control, the amount of antidiabetic medication, costs for DM treatment, quality of life assessment
  * Analysis for the mechanism of gastrointestinal physiology to diabetes control

Eligibility Criteria:
Inclusion Criteria:

* Patient who are older than 20 years and younger than 80 years
* Histologically confirmed gastric adenocarcinoma located lower one third of stomach
* Postoperative confirmed pT1N0, pT2N0, pT1N1
* Informed consent

Exclusion Criteria:

* Previous history of treatment for other malignancy or inflammatory disease
* Preoperative uncontrolled serious comorbidity
* Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
* Patient who experience any complications requiring reoperation following gastrectomy
Efficacy Study of Segmentation of PGD Treatment

A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of the study is to assess the feasibility and effectiveness of segmentation in terms of pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD cycles.

Experimental questions

1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically transferable embryos are cryopreserved by vitrification prior to consecutive in utero transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer cumulative with transfer of supernumerary cryopreserved embryos?
2. Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?

Design The proposed design is a pragmatic, prospective randomised controlled trial


Eligibility Criteria:
Inclusion Criteria:

* 1st, 2nd or 3rd cycle of PGD in which embryo transfer was performed
* Indications for PGD: monogenic indications and X-linked disorders with a 25-50% risk of transmission and that are not associated with reduced ovarian response
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.

Exclusion Criteria:

* POLYCYSTIC OVARIAN SYNDROME (Rotterdam criteria \*)

  \* At least two of the following three features: (i) Oligo- and/or anovulation (ii) Clinical and/or biochemical signs of hyperandrogenism (iii) Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumours, Cushing's syndrome)
* Poor responders (Bologna criteria \*\*)

  \* \* At least two of the following three features: (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (POR); (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles, or anti-Mullerian hormone (AMH) 0.5-1.1 ng/ml).
* Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
* anticipated high response: AMH \>5.0 ng/ml or AFC \>20
* Endometriosis ≥ grade 3
* Age \> 40 years and 364 days
Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Eligibility Criteria:
Inclusion Criteria:

1) 18 to 69 years

Exclusion Criteria:

1. Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
2. Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures.
3. Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT)

Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.

The purpose of this project is to offer remote hearing aid adjustment as an additional support for new hearing aid users.


Eligibility Criteria:
Inclusion Criteria:

* \>18 yr of age
* new hearing aid user

Exclusion Criteria:

* \<18 yr of age
* experienced hearing aid users
High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients

This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection.

Cytomegalovirus retinitis (CMVR) is a serious vision-threatening disease. Intravitreal antiviral drug delivery was used as first-line treatment in several studies when systematic injection has been ruled out. The reported dose of intravitreal injections of ganciclovir (IVG) varied from 200 μg/0.1 ml to 5mg/0.1 ml in patients with AIDS. There was no consensus on the dose of ganciclovir in the treatment of CMVR in HIV-negative patients. Previous work showed the safety and the efficacy of 1mg IVG. The investigators proposed that a higher dose of ganciclovir (6mg/0.1ml) for the first injection followed by lower dose for maintenance may indicate a better result. Therefore, this study was performed to evaluate the therapeutic effect and safety of initial high-dose IVG for CMVR in HIV-negative patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CMVR by ophthalmological examination
* Positive CMV-DNA in aqueous humor approved by real-time PCR.
* HIV-negative.

Exclusion Criteria:

* Diabetic retinopathy,
* Glaucoma.
* Optic neuritis.
Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves.

The aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after TAVI with balloon-expandable THVs.All patients will undergo a transthoracic echocardiogram in the operating room prior to aortic valve implantation. In addition, two catheters (one in the ventricle and one in the aorta) will be used to invasively measure the transvalvular gradient both before and after aortic valve implantation. The invasive measurements will be performed in different positions of the ventricle and aorta simultaneously. At the end of the procedure, aortic gradient measurement by echocardiography shall be performed again. A maximal three months follow-up is expected.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and able to give consent
* Severe symptomatic native aortic valve stenosis with indication for TAVI according to 2021 ESC/EACTS Valvular Heart Disease Guidelines.
* Use of balloon-expandable THV
* Written informed consent

Exclusion Criteria:

* Emergency or urgent treatment indication
* Patients under hemodynamically unstable conditions.
* Previous bioprosthetic aortic valve implantation
* Patient cannot adhere to or complete the trial protocol for any reason
Lean Mass Evaluation of Cirrhotic Patients With Ascites With the Use DXA

Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population.

From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC).

Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo.

This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population.

Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population.

From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC).

Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo. After signing an informed consent, BC will be estimated by bioelectrical impedance analysis and by reference method (DXA). The data obtained by both methods are statistically treated to obtain specific BIA prediction equations for the evaluation of cirrhotic patients.

This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population. Such knowledge, in turn, can serve as a new tool for nutritional assistance in treating this disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-60 years) of both sexes;
* Signing the free and informed consent;
* Show interest, conditions and availability to participate in all procedures included in the study protocol;
* liver cirrhosis Carrier

Exclusion Criteria:

* Refusal to participate;
* Patients who have made liver transplantation;
* Physical Amputation;
* Swelling in the lower limb;
A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma

This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 18 years of age or older
* Pathological diagnosis of follicular lymphoma (any grade)
* Documented relapse or progression following prior antineoplastic therapy
* Have received 4 or more prior doses of rituximab
* At least 1 measurable tumor mass (\>1.5 cm in the long axis and \>1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
* No clinically significant central nervous system lymphoma
* Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group \[ECOG\] status ≤2

Exclusion Criteria:

* Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (PSA) \<1 ng/mL are not excluded. Subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
* Prior treatment with VELCADE® or bendamustine
* Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
* Nitrosoureas within 6 weeks before Day 1 of Cycle 1
* Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
* Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
* Major surgery within 2 weeks before Day 1 of Cycle 1
* Platelet transfusion within 7 days of Day 1 of Cycle 1 (applies to subjects enrolled in the dose escalation phase only. This does not apply to subjects enrolled in phase 2 of the study).
* Ongoing therapy with corticosteroids. Prednisone ≤15 mg per day or its equivalent is allowed.
Fatigue and Recovery: a Comparison Between Trail and Marathon

Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year.

Some studies focused on fatigue and recovery following 30-to-40-km trail races or marathon but no direct comparison between both disciplines have been done yet. A direct comparison between marathon and trail would aim to better understand if the occurrence of fatigue is more important or if the recovery is longer in one of the two disciplines. The comparison is also a way to better understand mechanisms involved in fatigue and recovery following a trail and a marathon. Then, this research could be applied to improve specificity of training and prevent risk of injuries. This project aims to compare fatigue and recovery following a trail and a marathon.

Eligibility Criteria:
Inclusion Criteria:

Common for MARASIM, TRAILSIM and TRAILNAT:

* Male or female
* 18-55 years old
* Endurance runners who run at least one running session of 20 km per week
* Being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years
* Refrain from participating to a competition one month before the first visit and during the duration of the study
* To have a medical certificate of no contraindication of running practise in competition
* Registered with a social security scheme
* Having given the written consent freely

Specific for the 3 groups :

* Specialist of trail running (TRAILSIM and TRAILNAT)
* Specialist of road running (MARASIM)

Exclusion Criteria:

* Subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems)
* Subjects who present chronic or central neurological pathologies
* Subjects deprived of liberty or who should be legally deprived
* Subjects who report to take forbidden products by the World Anti-Doping Agency
* pregnant or breastfeeding woman
Convalescent Plasma for the Treatment of COVID-19

This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.

This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Laboratory confirmed diagnosis of SARS-CoV-2
* Admitted to an acute care facility for the treatment of COVID-19 complications
* Informed consent provided by patient or legally authorized representative
* Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease

Severe Disease defined as any of the following

* Dyspnea
* Respiratory rate \> 30/minute
* Oxygen saturation \<94%
* Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300
* Lung infiltrates \>50% within 24 to 48 hours

Life-threatening disease defined as any of the following

* Respiratory failure
* Septic shock
* Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

Exclusion Criteria:

* Receipt of pooled immunoglobulin in past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products
Crave Crush Behavioral Study

The purpose of the research is to determine if participants who take "Crave Crush" will report lower cravings and palatability ratings of candy as compared to subjects who receive the placebo. Participants are self-selected university students who pass our table and verbally agree to participate in a research study about taste preferences. Data will be recorded anonymously.

When students approach the table, research assistants will ask them to choose their favorite kind of candy from an assortment. They will ask the subjects to rate their craving for the candy before they taste it. After they try the candy, the research assistants will ask them to rate its palatability. Then they will rate their craving for another piece of candy. A research assistant will flip a coin to determine whether the subject will receive Crave Crush or placebo. While the Crave Crush or placebo is dissolving in the mouth, the students will fill out a short questionnaire with an identification number. The questionnaire will ask for their age, gender, ethnicity, approximate height and weight, and a few questions about their dietary habits.

After the tablet dissolves, research assistants will ask the students to rate their craving for another piece of candy. Research assistants will ask participants if they would like another piece of candy and have them assess palatability again. The process of offering a piece of candy and asking subjects to rate palatability will occur up to five times. Finally, subjects will be asked if they would like to take a few pieces of candy for the road and if they say yes, the number of pieces they take with them will be noted. The study activities should last no more than 5-10 minutes per participant.

Eligibility Criteria:
Inclusion Criteria:

* University student, having eaten within the last hour, having slept within two hours of their normal amount

Exclusion Criteria:

-