cyrilzakka/clinical-trials huggingface dataset:
Multicenter Study on the Correction of Prolapse Via Laparoscopy

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.

Exclusion Criteria:

* History of abdominal prolapse reconstructive surgery.
* History of prolapse reconstructive surgery with vaginal meshes.
* Stage I according to the POP-Q classification or asymptomatic prolapse.
* Medical contraindication for general anaesthesia.
* Patient preference for vaginal surgical treatment.
* Patient does not wish to participate in the study.
Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program

This study was conducted to test the possibility of preventing or delaying the development of type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma glucose concentrations by internet-based diabetes prevention program.

Diabetes is common and rapidly increasing, because of obesity, unhealthy eating habits, and physical inactivity in Korea. Many studies reported that lifestyle modification related in the primary prevention of diabetes in multiethnic populations. The aim of this study is to determine whether internet-based interventions in those at high risk may delay the development of type 2 diabetes mellitus, and thereby reduce the incidence of cardiovascular diseases and strokes in Korean populations. In January 2008, participant recruitment began in Chung-ju city, a rural area in Korea. The subjects with impaired glucose tolerance or elevated fasting plasma glucose concentrations were selected from initial screening and then randomized to either a control or intensive lifestyle group to carry out intervention over 4 years. The primary outcome of this study is the development of diabetes by ADA criteria. To confirm the onset of diabetes, all subjects have an OGTT at the interim 6-month and each annual visit. Also, systematic evaluation examination will be done at the same time. The proportion of subjects developing diabetes in each group and the factors relating the progression will be estimated using statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age of 30-69 years
* BMI ≥ 20 kg/m2
* Impaired glucose tolerance :

  2h postprandial glucose (75 g OGTT) 140-199 mg/dl or Impaired fasting glucose : Fasting plasma glucose 110-125 mg/dl

Exclusion Criteria:

* Diabetes at baseline
* Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
* Unable to communicate with clinic staff, Pregnancy and childbearing
Accelerated Treatment of Endocarditis

Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks with one or two types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant burden on health systems. Current guidelines fail to use available data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 750 patients, approx. 200 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus). Interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria.
2. The patient may be included \<14 days after beginning of relevant antibiotic treatment.
3. Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus.
4. Patients ≥ 18 years.

Exclusion Criteria:

1. Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (\> 20 mg / day)).
2. Incapability to give informed consent for participation.
3. Relapse Endocarditis (Endocarditis with the same bacteria within six months).
Electro-acupuncture for Gait and Balance in Parkinson's Disease

Gait and balance disorders, key contributors to fall and poor quality of life, represent a major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of acupuncture in recent years in PD, its efficacy remains unclear, largely due to methodological flaws and lack of high quality studies using objective outcome measures. In a patient and assessor-blind pilot study, investigators objectively assess the efficacy of electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in patients with PD.

In this study, investigators employee objective innovative body-worn sensor technologies to assess potential mobility-associated outcomes of PD. Investigators compare acute changes in gait and balance that occurred after repeated administration of two interventions: A specific real EA and a sham EA. The design of the experiments uses a control that accounts for both placebo and possible some active components of a generalized needle-insertion-based procedure. By using a sham control, the investigators were able to more fully test whether the specific EA intervention could lead to changes in objective gait and balance parameters, or subjective self-reported improvements that are beyond placebo induced effects and the natural course of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. Community-dwelling men or women ages 55 years or older with diagnosis of PD;
2. patients who have the ability to walk 20meters without walking assistance; and
3. patients who are stable without anti-PD medication(s) change for at least 1 month. The PD diagnosis was made by movement disorder specialists based on the UK Brain Bank criteria and supported by DaTscan (Ioflupane I 123 injection) when possible.

Exclusion Criteria:

1. patients who have received previous acupuncture;
2. patients who have had DBS;
3. patients with any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study; and
4. patients with non-PD related gait disorders.
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age;
* rheumatoid arthritis for \>= 6 months;
* receiving permitted DMARDs, at a stable dose, for \>= 8 weeks prior to baseline;
* current inadequate clinical response to DMARDs.

Exclusion Criteria:

* major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
* rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* unsuccessful treatment with an anti-TNF agent;
* previous treatment with tocilizumab.
Rectus Sheath Block and Local Wound Infiltration in Pediatric Laparoscopic Appendectomies

Laparoscopic appendectomy surgeries are among the most commonly performed procedures in childhood. However, they are associated with moderate to severe postoperative pain. Regional nerve block techniques are recommended for postoperative pain management. This research compared the two most frequently used methods: rectus sheath block and local wound infiltration.

Acute appendectomy surgeries are one of the most frequently performed surgeries in childhood. Minimally invasive (laparoscopic) surgical methods are recommended, especially in abdominal surgeries, due to rapid wound healing, rapid recovery, less bleeding, and shorter hospital stays compared to open surgery. In addition to all these advantages of laparoscopic surgeries, postoperative somatic pain is expected to be less compared to open surgeries due to the small incisions in the abdominal wall. However, when the pain severity of children who underwent laparoscopic appendectomy was evaluated using the pain scoring scale, it was seen that the median pain scores were ≥7 in 5% of the children (severe pain) and ≥4 in 25% (moderate pain). Clinical practice guidelines also recommend the use of regional anesthesia and analgesia methods as part of multimodal analgesia in the prevention of intraoperative and postoperative pain. We also routinely use regional anesthesia and analgesia methods successfully and effectively in our daily practices in our clinic.

Rectus sheath blocks, which are known to be effective in midline incisions, and local anesthetic infiltrations of the wound site, which do not require special technical knowledge about regional anesthesia, are routinely applied in our clinic in every case. Although both methods provide clinical benefits, it is unknown which one is superior to the other.

Eligibility Criteria:
Inclusion Criteria:

* Older than 8 years
* Younger than 18 years
* Minimal invasive appendectomy (3 port)
* Consent to participate

Exclusion Criteria:

* Younger than 8 years
* Older than 18 years
* Convert to open abdominal surgery
* Do not consent to participate
Enhancing Community Participation Through Peer-Delivered Decision Support

The purpose of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI).

The overarching goal of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illnesses (SMI). We will use a single-group, pre-post, convergent mixed methods design to explore implementation and whether and how the intervention impacts decision-making and community participation outcomes. We will aim to recruit 40 participants in this intervention study. This design will enable us to link themes regarding participants' experience of the intervention with quantitative measures of decision-making and community participation.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age;
* Experiencing a SMI, as determined by: (a) self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder, and (b) self-reported current or past functional impairment due to experiencing mental health challenges in one or more major life areas (i.e., work school, social activities)
* Able to identify at least 2 areas of community participation that individuals want to be doing more in in the next 6 months
* Current sufficiency of community participation (i.e., number of important participation areas done enough / number of important participation areas) of 50% or less.

Exclusion Criteria:

* Unable to provide informed consent, as assessed by research staff using an active recall method
* limited ability to act on decisions due to self-reported legal, residential, or guardianship restrictions.
S9031-9333-0106-0112-A Study of Biomarkers in Samples From Patients With Acute Myeloid Leukemia Treated With Standard Chemotherapy With or Without Gemtuzumab Ozogamicin

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.

OBJECTIVES:

* To determine whether measuring biomarkers in less-differentiated acute myeloid leukemia (AML) blasts significantly improves their predictive accuracy to predict clinical outcomes for patients receiving induction/consolidation chemotherapy with and without gemtuzumab ozogamicin.
* To develop and validate novel predictive biomarker models for predicting clinical outcomes for AML patients receiving induction/consolidation chemotherapy with and without gemtuzumab ozogamicin.

OUTLINE: DNA and RNA extracted from archived bone marrow and peripheral blood samples are analyzed for genomic mutations (CEBPA, FLT3, IDH1/2, KIT, NPM1, RUNX1, TP53, and WT1) and transcriptional biomarkers (BAALC, CCNA1, CD34, CEBPA, ERG, EVI1, FLT3, IL3RA, MCL1 \[two splice variants\], MN1, RUNX1, and WT1) by PCR and real-time PCR. Data are then analyzed by the Gene Scan software.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pretreatment bone marrow (BM) and peripheral blood (PB) samples obtained from Southwest Oncology Group ( SWOG) Leukemia Repository for adult patients enrolled on SWOG-9031, SWOG-9333, SWOG-S0106, and SWOG-S0112
* Samples restricted to those patients from these studies with at least 3 or more vials of remaining material in the SWOG Leukemia Repository and vials containing at least 1.5 x 10\^7 cells/vial
* Samples from patients who received standard induction with cytarabine (ARA)/daunorubicin hydrochloride (DNR) with the addition of gemtuzumab ozogamicin (Mylotarg®) on one arm of S0106

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.

The study will include 42 evaluable patients suspected of having pancreatic cancer and for whom an echo-endoscopic biopsy (EUS-FNA) and/or biliary drainage is planned.

In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:

* the level of circulating tumor cells (CTC) per milliliter of blood,
* cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).

A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.

Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40-85 years old;
* BMI\< 30 kg/m2;
* Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
* Affiliation to, or beneficiary of, a social security scheme.

Exclusion Criteria:

* Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
* Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
* Biliary drainage or attempt at prior biliary drainage outside the center ;
* Preliminary oncological treatment for pancreatic pathology covered by the study;
* Clinical and/or image-visible (CT/MRI) carcinosis ;
* Ascites visible on imaging (CT/MRI) ;
* Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons;
* Contraindications to an endoscopic procedure.
Management of Noninvasive Ventilation in Hypoxemic Patients

The investigator aimed to manage noninvasive ventilation in patients with hypoxemic respiratory failure.

Patients with hypoxemic respiratory failure were enrolled in this study. The investigator collected the data at beginning and first stage of noninvasive ventilation to analyze the efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the investigator also aimed to develop a scale to predict the efficacy of noninvasive ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.

Eligibility Criteria:
Inclusion Criteria:

* PaO2/FiO2 less than 300; PaCO2 less than 50 mmHg; Respiratory rate more than 25 breaths/min or presence of labored breath.

Exclusion Criteria:

* Requirement of emergency intubation; Sequential use of noninvasive ventilation after extubation;Use of noninvasive ventilation after accident extubation.
Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence

In this study, the effect of an electronic device attached to a push through pill package and a smart phone application on chronic disease medication adherence is studied.

In this study study two different groups of medicine users are recruited. Both groups have 50 patients each. In the first study the participants are using oral medication for diabetes and in the second study the participants use new direct oral anticoagulants.

Participants use medicine reminder system consisting of an electronic device and an smart phone application. In the beginning of the study the reminder system is collecting data on how the patients are taking their medication for the first two months. Smart phone application is not providing any reminders and participants can't access the app to see the details.

After two months the application will be unlocked so that it starts reminding the users to take their medication at the right time. in this phase the patients can view their medication data from the application. The reminder phase of the study lasts for two months. After these two plus two months, the results are analyzed and published.

The study continues after these four months for the next four months and after that, the long term results are analyzed.'

The primary outcome is the possible change in the adherence between control and active period.

Eligibility Criteria:
Inclusion Criteria:

* use of direct oral anticoagulants or oral diabetic drugs
* age of 18 or more
* subjects have been using a smart phone

Exclusion Criteria:

* patients who don't use their medication without help
Addressing Disability Effectively With Psychosocial Telemedicine

This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care. The investigators aim to lay the foundations that will shift the paradigm of IBD clinical practice towards a new horizon of holistic and equitable high-value care.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC)
2. Willingness to complete the baseline survey online. Participants in Aim 1 with moderate-to-severe disability based on the IBD Disability Index (IBD-DI) will be invited to the Aim 2 clinical trial
3. Able to consent and complete surveys in English.

Exclusion Criteria:

1. no/low disability (IBD-DI \<35) on the baseline survey
2. inability or unwillingness to participate in telemedicine with a therapist
3. Have an existing relationship with a mental health specialist within the past 3 months
4. Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
Exercise Activity-Based Bolus Decisions in Type 1 Diabetes

The purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in Type 1 Diabetes.

Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. The aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 Diabetes for at least one year
2. Using an insulin pump for at least 6 months
3. Age 18-65
4. Uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections
5. Access to internet and willing to upload data during the study
6. Willingness to maintain consistent activity regimen for 28 day collection period
7. Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all women of child bearing potential. Subjects who become pregnant will be discontinued from the study.
8. Demonstration of proper mental status and cognition for the study.
9. An understanding of and willingness to follow the protocol and sign the informed consent.

Exclusion Criteria:

1. Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
3. Pregnancy and intent to become pregnant during trial.
4. Use of acetaminophen is not allowed when CGM is in use
5. Use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide \[GLP\]-1 agonists, metformin)
6. Currently uses a clearly defined method for insulin bolusing to compensate for significant activity (e.g. marathon runner who uses temporary basal rates routinely and has separate basal profiles to account for exercise)
7. Inability to be physically active for more than 30 minutes per day.
8. Current enrollment in another intervention clinical trial.
Comparison of Immune Response Following Surgical Management of Renal Tumors

Examine the effects of renal surgery on the immune system.

Prospective study examining the effects of different surgical procedures on immune function. This may have bearing on overall cancer specific recurrence and survival.

Eligibility Criteria:
Inclusion Criteria:

* Kidney tumor patients scheduled for open or laparoscopic surgery

Exclusion Criteria:

-