cyrilzakka/clinical-trials huggingface dataset:
Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices

The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.

We aimed to test the non inferiority of the proportion of non users of street-opioids after one year of treatment in patients inducted in primary care (PC) vs.those inducted in a specialised center for substance dependence (CSAPA).

In this multisite, open-label, randomised controlled non-inferiority trial, opioid dependent individuals were randomized to start methadone either in PC or in a CSAPA. After stabilization of methadone dosage (\~2 weeks), patients could change arm. Follow-up assessments through medical questionnaires and phone interviews was scheduled at month 0 (M0, enrolment) M3, M6, M12. The opiate treatment index (OTI) was used for computing the proportion of patients reporting no use of street opioids in the last month at M12 (primary outcome) in those inducted in PC or in a CSAPA and the non inferiority margins.

Primary analysis was by intention to treat (ITT)

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years patients needing methadone for their opioid dependence who are either naives of methadone treatment (prescribed) since at least 1 month
* need to switch from buprenorphine to methadone treatment
* negative test for pregnancy

Exclusion Criteria:

* co-dependent on alcohol and benzodiazepines,
* inmates,
* pregnant women,
* individual in irregular situation or who cannot be joined by phone.
Seizure Treatment in Glioma

Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

Currently, treatment of glioma patients with a specific anti-epileptic drug (AED) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients.

Levetiracetam and valproic acid are the most commonly used AEDs in glioma patients. Both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing AEDs, therefore not interfering with chemotherapeutic drugs. However, it is not known whether one drug is more effective than the other in reducing seizures.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven or suspected diffuse astrocytoma (Isocytrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS.
* Adult patients: ≥18 years of age
* First epileptic seizure, no longer than 2 weeks ago
* Monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization
* Willing to provide written informed consent

Exclusion Criteria:

* Previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks
* History of non-brain tumor related epilepsy
* Pregnancy
* Presence of contra-indications for use of levetiracetam or valproic acid
Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

Sarcopenia can be easily observed in patients with hemodialysis. However, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. The investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. In 2021, the investigators conducted a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis to confirm the effectiveness. This study is a follow-up study, conducted as a randomized controlled trial.

This is a prospective, 1:1 randomized controlled study with 40 patients with hemodialysis who were diagnosed as sarcopenia or frailty in our previous cohort study. Combined intervention will consist of resistance exercise and nutritional supplementation for 12 weeks. The primary outcome of this study is muscle mass and handgrip strength after 12 weeks' intervention. All functional outcomes will be measured at 0, 4, 8 and 12 weeks after intervention. The data will be analysed using the intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemodialysis
* Community-dwellers
* Able to walk with or without assistive devices for more than 100 meters

Exclusion Criteria:

* A person with cancer disease.
* People with psychiatric symptoms.
* A person who has an absorption disorder or has a history of resection of the small intestine or colon
* Pregnant women
* A person treated for acute bacterial infections
* A person who is in a wheelchair due to inconvenience in walking.
Effects of Pancreaticoduodenectomy on Glucose Metabolism

Pancreaticoduodenectomy (PD) involves removing the head of pancreas, duodenum, common bile duct, gall bladder, and/or distal stomach. In general, the postoperative changes are thought to be moderately severe, and about 20% of these patients go on to develop new clinical diabetes. PD-related factors of glucose metabolism will include removal of half of the pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight loss (on average, \~8% of body weight), and removal of putative diabetogenic factor in resected neoplasm. However, effect of removal of duodenum on glucose metabolism after PD has never been studied. The investigators plan to examine this issue by comparing fasting plasma levels of insulin, fasting plasma glucose, C-peptide, HbA1C, HOMA-insulin resistance, GLP-1 response after a standard meal, and body mass index (BMI) of patients before and after PD.

Questionaire All studied patients will be requested to self-complete a detailed questionnaire that collects information on demographic data, including usual adult height and weight, and history of DM in first-degree relatives. Existing medical conditions, including DM, duration of these medical problems, and current medications will also be inquired. The database will also include details of weight measured at the time of recruitment and body mass index (BMI), calculated as weight (kg)/height2 (m2). All studied patients will have FBG levels measured. Patients receiving prescription antidiabetic medications for previously diagnosed DM will be classified as having DM regardless of their FBG value. Among patients not reporting treatment for DM, classification of DM status will be based on the American Diabetes Association criteria; patients will be classified as having DM if the FBG level is ≧126 mg/dL (7 mmol/L), as having impaired fasting glucose (IFG) if their FBG is between 100 and 125 mg/dL (5.6-6.9 mmol/L), and as having normal fasting glucose (NFG) if their FBG value is ≦99 mg/dL (5.5 mmol/L).

After withdrawal of anti-diabetic medications for 12 h, the patients were asked to fast overnight for 12 h, then were given 200 ml of formula (220kcal, 14g of protein, 28 g of carbohydrates, and 5 g of fat; Modifast, Stocksund, Sweden) within 10 min through a NG tube on post-operative day 5 (proximal feeding group \[PFG\]) and a jejunostomy feeding tube (distal feeding group \[DFG\]) on post-operative day 6. The below parameter will be checked, including

1. HOMA insulin resistance assessment (HOMA-IR)
2. GLP-1
3. GIP
4. C-peptide
5. Insulin
6. Glucose

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving pancreaticoduodenectomy

Exclusion Criteria:

* history of pancreatitis
* hepatic dysfunction (Child-Pugh \> 2)
* renal dysfunction (serum creatinine concentration \> 3 mg/L, hemodialysis, or both)
* pregnancy
PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia

The purpose of this study is to evaluate the predictive value of 18F-FDG PET probe signal in de novo diagnosed or refractory/relapsed patients with acute myeloid leukemia. It is hypothesized that the intensity of 18F-FDG signal, an indicator of glucose uptake capacity, in various cell subsets of bone marrow will improve the predictive effect of clinical standard prognostic work-up.

Rationale:

FDG is incorporated by leukemia cells and other cell subsets in bone marrow micro-environment of various degree. The heterogeneous FDG uptake is a promising marker for predicting response to treatment. The investigators will collect bone marrow under standard clinical work-up after 18F-FDG PET/CT scan and correlate the FDG signal intensity with clinical and genomics features of the patients to explore its prognostic significance.

Objective:

The primary objective of this research project is to investigate the intensity of FDG PET probe based glucose uptake signal in predicting induction treatment response of AML. As secondary objectives, this analysis will be applied to calculate the overall predictive specificity and sensitivity of FDG probe avidity in predicting PFS and OS.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute myeloid leukemia, non APL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients voluntarily participated in this study and signed the informed consent

Exclusion Criteria:

* Pregnant
* Uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)
Butyrophilins Role in Colon Cancer

quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer


Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 18 years old,
* Signed participation consent,
* Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting.
* Performance Status (PS) 0 or 1
* affiliated to the social security or beneficiary

Exclusion Criteria:

* Rectal cancer, colon cancer recurrence
* Emergency of colon cancer Surgery
* History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis)
* Patient who received neoadjuvant therapy other than chemotherapy
* Patient treated with immune-suppressors or long-course corticosteroids \<12 months
* Pregnant women or likely to be pregnant (without effective contraception) or breastfeeding,
* Person in urgent situation, person under legal protection measure, or unable to express his / her consent,
* Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons
The Difference Between Daily and Alternative Day Use of Icodextrin

Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients.

However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use.

Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.

1. Patients who met the inclusion criteria will be enrolled in this study.
2. Randomization.
3. Treatment A: daily icodextrin for 2 weeks. Treatment B: icodextrin is used every other day and original glucose-based dialysate is used every other day for a total of 2 weeks. The duration of icodextrin exchange is unchanged from the participants' original dialysate exchange regimen (typically, 8 to 14 hours). The interval is two weeks (the original dialysate was resumed). Participants would receive treatment A-B or B-A, depending on randomization.
4. Participants would record daily peritoneal ultrafiltration volume, long dwell ultrafiltration volume, dialysis prescription, urine volume, body weight, home blood pressure monitoring and complaints of discomfort.
5. Before the start of treatment (day 0), after the end of treatment period 1 (day14), at the end of washout period (day28), and at the end of treatment period 2 (day42), blood samples are collected for blood glucose, blood lipids, BNP, amylase, blood electrolytes, alkaline phosphatase. The participants' weight, blood pressure, dialysis prescription, daily ultrafiltration volume, urine volume, long dwell ultrafiltration volume and BCM measurement results would be recorded on the visit day. In the last 10 enrolled patients, blood samples would be collected for detection of icodextrin metabolites. After the end of treatment period 2, participants could choose the prescription of dialysate according to their own wishes and would be followed up for another 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1. End-stage renal failure

  2. Patients with regular peritoneal dialysis in our center

  3. 18-75 years old

  4. Patients who currently use glucose dialysate for prolonged abdominals

  5. Sign informed consent

Exclusion Criteria:

* 1. The expected survival time is less than 3 months

  2. Known peritoneal dialysis tube dysfunction

  3. Peritonitis occurred within one month

  4. Known peritoneal effusion

  5. Known allergy to icodextrin
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections

The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).

Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years and agreement to participate by signing the consent form.
* Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge).

Exclusion Criteria:

* Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection.
* Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study.
* Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up.
* Pregnant or high risk for pregnancy.
The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms

The purpose of this study is to test whether attention bias modification training is an effective neurobehavioral therapy to improve depressive symptoms.That is whether attention bias modification training is superior to placebo in reducing depressive symptoms over 1 year after training.

Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* A score of 14 or higher on the Beck Depression Inventory-II

Exclusion criteria :

1. a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
2. any concurrent psychotherapy;
3. any concurrent psychotropic medication.
Evaluating the Accuracy of Microvessel Ultrasound Imaging for Detecting Extent of Disease in Patients With Angiosarcoma of the Skin

This study evaluates the accuracy of a new ultrasound technology called microvessel imaging for detecting the extent of disease among patients with angiosarcoma of the skin. Microvessel ultrasound imaging uses high frequency waves to visualize vessels in the skin that are not easily seen using other imaging tests.

PRIMARY OBJECTIVE:

I. To determine the accuracy of depicting extent of disease of cutaneous angiosarcoma before and after neoadjuvant treatment compared to clinical photographs, magnetic resonance imaging (MR) or positron emission tomography (PET)/computed tomography (CT) imaging and surgical pathology both on skin biopsies and surgical excision.

OUTLINE:

Patients undergo microvessel ultrasound imaging on study.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosed with cutaneous angiosarcoma of the breast or scalp and scheduled for trimodality therapy
* Twenty one years of age or older

Exclusion Criteria:

* Unwilling to consent to microvessel ultrasound imaging
* Younger than 21 years of age
A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds \>120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
Redefining BMI: The Body, Mind, and Inflammation Trial

Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women. The primary purpose of this study is to test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity, as well as improving biomarkers of inflammation and metabolic risk over 12 months compared with a traditional behavioral weight loss intervention. This treatment program will be tested in emerging adult (EA) women ages 18-25 years old with a BMI of 25-50 kg/m\^2.

This is a 2-arm, parallel randomized controlled pilot trial designed to test the preliminary efficacy of a novel integrated lifestyle intervention for emerging adult (EA) women, compared to a developmentally adapted behavioral weight loss arm. Thirty-two participants (female, 18-25 years, BMI 25-50 kg/m\^2) will be randomized to 1 of 2 arms: 1) Integrated Lifestyle Intervention (ILI); or 2) Behavioral Weight Loss (BWL). The primary goals are to test the preliminary efficacy of ILI to reduce adiposity over 12 months compared to BWL, and to test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL. Assessments of adiposity, inflammatory cytokines, cardiovascular disease (CVD) risk factors, and behavioral and psychological treatment targets will occur at 0, 4, 8 and 12 months. In addition, putative psychological mechanisms of action will be explored to inform a future trial.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-25 years
* Body mass index (BMI) 25-50 kg/m\^2
* Female

Exclusion Criteria:

* Currently pregnant or lactating
* Current involvement in a weight loss program or current use of weight loss medication
* Lost \>5% of their body weight in the previous 3 months
* Uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
* Diagnosis of type 2 diabetes and/or impaired fasting blood glucose
* Diagnosis of type 1 diabetes
* Rheumatologic and gastrointestinal conditions associated with severe systemic inflammation
* Medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis
* Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
* Current or recent (during the past 3 months) use of medications that may impact weight or metabolic function
* Current or recent (during the past 3 months) use of anti-inflammatory medications
* Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months
* Hospitalization for depression or other psychiatric disorder within the past 12 months
* Uncontrolled bipolar disorder or psychotic disorder
* Current suicidal intent
* Planning to move from the area within the study period
* Unwilling to be randomized to either study condition
* Unable to read and speak English