cyrilzakka/clinical-trials huggingface dataset:
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)

This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.

The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects in need for contraception will be selected to participate in the trial;
* Each subject must be \>=18 to \<=40 years of age at screening and in need for contraception;
* Each subject must have given birth to at least one child (gestational age \>=28 weeks);
* Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.

Exclusion Criteria:

* A subject must not be pregnant or suspected to be pregnant;
* A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis;
* A subject must not have a history or presence of any malignancy;
* A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;
* A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
* A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of \>=3 times the upper normal limit;
* A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
* A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator;
* A subject must not have vaginal bleeding of undiagnosed etiology;
* A subject must not have dysmenorrhea interfering with daily activities or menorrhagia
OsciPulse D-dimer Efficacy Trial

The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged ≥ 18 years old
2. Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
3. Last known normal \< 24 hours.
4. NIH stroke score ≥5
5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
6. Prescribed mechanical therapy for DVT prophylaxis.

Exclusion Criteria:

1. Inability or contraindication to applying IPC to both legs such as:

   * Evidence of bone fracture in lower extremities
   * Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis,

     * ischemic limb in the legs at the site of IPC placement
   * Acute ischemia in the lower extremities
   * Severe peripheral vascular disease
   * Amputated foot or leg on one or two sides
   * Compartment syndrome
   * Severe lower extremity edema
   * Acute deep vein thrombosis
2. Subjects who received tPA therapy for their stroke
3. Pregnancy or within 6 weeks of postpartum period
4. Limitation of life support, life expectancy \< 7 days, or in hospice care
5. A head-unit is unavailable for the first 24 hours or more
6. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
Expanding Rural Health Cancer Control Capacity

Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.

Study Aims:

* Pilot test the implementation of guideline-based survivorship care planning in a rural setting using patient navigation plus telehealth among underserved rural cancer survivors. Investigators will collect feasibility data on patient recruitment rates and the ability to measure clinical effectiveness outcomes using the electronic health record and patient reports (survivor adherence to recommended disease surveillance, health assessment and cancer prevention/early detection practices).
* Identify the facilitators and barriers to future larger scale implementation of guideline-based survivorship care planning in rural settings to optimize the implementation strategies. Through a mixed methods approach, investigators will address implementation research questions focused on "real world" implementation of the guideline-based intervention in rural areas, including barriers/facilitators and translation to other rural settings. This will allow us to optimize the implementation strategies that will be further evaluated in the future large-scale implementation trial

Eligibility Criteria:
Inclusion Criteria:

* Cancer patient at least 18 years of age at time of cancer therapy
* English-speaking with the ability to provide informed consent
* Received treatment for Stage 0 - III cancer with curative intent
* Completed cancer therapy within the previous 12 months (i.e., 12 months prior to consenting) and in complete remission
MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making

This is a study to investigate if a device that temporarily changes brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how healthy participants make decisions. This study involves 2 visits to MUSC that will each take between 2-3 hours. This study is not a treatment study, but it could help inform studies investigating treatment in the future. Participants in this study will be compensated for their time.

This study aims to investigate whether a single session of excitatory repetitive transcranial magnetic stimulation (rTMS) compared to electrical sham stimulation to the medial prefrontal cortex (mPFC) facilitates rational decision making. Our prior data suggests that decisions are biased depending on if the available options are presented with a negative or positive connotation (even in the case of mathematical equivalence). Work by us and others has demonstrated that even if both options are equal, the negatively framed choice is most often avoided.

Eligibility Criteria:
Inclusion Criteria:

* Is able to read consent document and provide informed consent
* English is first or primary language

Exclusion Criteria:

* • Current psychiatric disorder (as defined by DSM-5 and determined using standardized self-report instruments)

  * Suicide attempt in the past year
  * Lifetime diagnosis of psychotic disorder or bipolar mania
  * Presence of neurological disorder that contraindicates TMS or neurophysiological recording:
  * Seizure disorder
  * Lifetime history of traumatic brain injury with loss of consciousness
  * Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
  * Presence of standard contraindications for rTMS
  * Currently pregnant
  * Significant sensitivity to noise
  * Medical treatments or conditions that lower seizure threshold
  * History of severe brain injury
  * History of seizures/epilepsy
  * Currently taking chronic opiate medications or substances
  * Inability or unwillingness of subject to give informed consent
Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be poor, but the evidence is lacking. Thus, prospective real-life studies of medical management of trigeminal neuralgia are warranted.

Methods: Observational study. Patients were consecutively enrolled in a structured management program at a specialist centre for facial pain. Optimisation of medical treatment, physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program. Medically intractable patients were referred for neurosurgery. Data-collection was prospective using standardised schemes and patient surveys. The aim was to describe the two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50% reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two years.

This study aimed to provide evidence concerning the real-life efficacy of medical management of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised that the two-year prognosis in a group of medically managed TN patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50 % reduction of the overall burden of pain over a two-year period


Eligibility Criteria:
Inclusion criteria:

1. recordings of the intensity of pain at enrolment of the programme (baseline recording),
2. a two-year assessment (end-point recording),
3. recording of effect and side-effects of drug treatment (at baseline and endpoint).

The exclusion criteria

1. initiation of medical treatment at the DHC before May 2012,
2. neurosurgical treatment of TN within the two-year follow-up
3. incomplete two-year follow-up
Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial

This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.

This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
2. Recurrent or refractory Crow-Fukase syndrome.
3. Patients without severe liver or renal dysfunction.
4. Patients without severe neutropenia or thrombocytopenia.
5. Patients without clinically problematic ECG findings
6. Negative on the pregnacy test on the day 1 of cycle 1.
7. Patients who can undertake prevention of pregnancy, if necessary.
8. Patients with written informed consent.
9. Patients who are capable of ambulatory hospital visits every 4 weeks.
10. Patients with informed consent to the registration and rules of RevMate®.

Exclusion Criteria:

1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
3. Patients who have been administered bevacizumab within 12 weeks prior to the registration.
4. Patients who could worsen acutely during the clinical trial period.
5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
6. Patients with malignancies.
7. Female patients who are pregnant or desire childbearing. Males who desire fertility.
8. Patients who allergic to lenalidomide or dexamethasone.
Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients

This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.

This study is multi-center, prospective, long-term follow-up observational study.

Eligibility Criteria:
Inclusion Criteria:

* Age over 19 at the time of obtaining the informed consent form
* Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery
* ECOG 0 or 1
* Scheduled to RO or R1 resection
* Organ function capable of chemotherapy

Exclusion Criteria:

* FOLFIRINOX contraindications among the drug approval requirements
* Palliative Therapy
* Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX
Evaluation of the TRANSEND Program

"Transend" is a program designed to promote the transition of young patients with endocrine or metabolic diseases when they arrive in the adult sector at La Pitié-Salpétrière hospital. The main objective of the study is to compare the rate of patients lost to follow-up at 24 months after the transfer of pediatrics between the Transend group and the (historical) control group.

Adolescence and early adulthood represent important periods for young people suffering from chronic diseases. Several observational studies show needs not covered by care services at this period and significant lost to follow-up rates. "Transend" is a program designed to promote the transition of young patients with endocrine or metabolic diseases when they arrive in the adult sector at La Pitié-Salpétrière hospital (Paris, France). Since September 1, 2016, approximately 500 patients benefited from it.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 32
* Patient with endocrine or metabolic disease
* Patient who had a follow-up in a pediatric department for his endocrine or metabolic disease
* Patient transferred to the adult sector in the endocrinology, metabolism or nutrition department of Pitié-Salpêtrière
* Patient who had a first post-transfer consultation between January 1, 2015 and September 1, 2017
* Patient with a social security protection

Exclusion Criteria:

* Patient who transferred to another adult service before being followed at Pitié-Salpêtrière
* Patient who has expressed his opposition to participate in this research
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity

The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index \[BMI\] \> 50 kg/m2).

Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting.

Superobesity (BMI \> 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity.

This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years.

Eligibility Criteria:
Inclusion Criteria:

* BMI 50-60 kg/m2

Exclusion Criteria:

* Prior obesity operation
* Prior major abdominal surgical procedure
* Severe disabling cardiopulmonary disease
* Malignancy
* Oral steroid treatment
* Condition associated with poor compliance
Somatic Stem Cells in Endometriosis

Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. The existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.

Throughout the life of the woman, the endometrium undergoes a series of continuous modifications that require a highly accurate feedback mechanism and specialized and must be based on the activity of the stem cell population.

Endometriosis is an estrogen-dependent chronic disease characterized by the presence of functional endometrium outside the uterine cavity, mainly in the peritoneum and ovary (Giudice and Kao, 2004). It affects 6-10% of women of reproductive age, often resulting in a series of gynecological problems, including dysmenorrhea, pelvic pain and infertility. The nature of endometriosis suggests that the initiation of ectopic endometrial lesions may be due to stem or progenitor cells, which is consistent with the theory of retrograde menstruation (Starzinski-Powitz et al. 2001; Leyendecker et al. 2002, Gargett, 2006; Gargett, 2007, Sasson and Taylor, 2008). To date, no direct evidence of the role of somatic stem cells of the endometrium in the pathogenesis of endometriosis. However, numerous studies show that ectopic endometrial cells implant in many established models used for the study of endometriosis.(Masuda et al., 2007b; Sasson and Taylor, 2008; Gargett y Masuda.,2010)

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients with endometriosis:

1. Female patients with ovarian endometriosis, peritoneal and recto-vaginal.
2. Aged between 20 and 40.
3. Signing of informed consent for collection and storage of biological samples.

Exclusion Criteria:

1. Contraindications for endometrial biopsy.
2. Failure to sign informed consent for collection and storage of biological samples.
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma

It has been shown that curcumin and cyanidin-3-glucoside (C3G) have anticancer effects. In this clinical trial we compare the affect of their combination vs placebo in a four weeks intervention before endoscopic polypectomy.

Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for testing agents with potential cancer prevention.

Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels of parent agent than natural curcumin.

Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the Apc(Min) mouse model.

The investigators hypothesize that the combination of both agents will decrease the expression of proteins involved in colon tumorigenesis relative to placebo.

The change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic resection in the target adenoma and the normal rectal mucosa will be the response measures.

The primary response measure is the change of immunohistochemical (IHC) expression of β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and apoptosis by P53 in adenomatous and adjacent normal mucosa.

The study design is a phase II, randomized, double blind, placebo controlled, window of opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo. Subjects with histological confirmation of colorectal adenomatous polyps \>1 cm not suitable to immediate complete removal will be enrolled in a 4-week intervention trial before endoscopic polypectomy.

The demonstration of a biological activity of the two agent combination may provide the rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk subjects.

Eligibility Criteria:
Inclusion criteria:

* Subjects with colorectal adenomatous polyps greater than 1 cm in maximum diameter not suitable to immediate complete removal;
* Normal renal and hepatic function;
* WHO Performance status=0;

Exclusion Criteria:

* Presence of hyperplastic polyps and/or flat adenomas;
* Subjects with pre-existing colorectal cancer;
* Presence of carcinomatous tissue in adenoma;
Digital Rehabilitation Environment Augmenting Medical System

D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.

The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise \& light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).

Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients.

Exclusion Criteria: The study team will exclude patients if:

* Their anticipated ICU stay is less than one day
* Patient is intubated and cannot communicate.
* Age: \< 18 years
* Patient with recent (within 6 months) neuro-vascular event, intra-cranial surgery, and/or acute neurological condition as primary ICU admission reason
* Baseline cognitive impairment (e.g., advanced dementia)
* Patients who are unable to wear or use the DREAMS equipment
Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy

To predict prostate cancer and its prognosis by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.

Investigators plan to develop a diagnostic and prognostic evaluation model for prostate cancer according to analyze the abnormal echo of prostate ultrasound images by radiomics. The model was used to perform ultrasound radiomics fusion prostate biopsy, and the accuracy was compared with that of MRI cognitive fusion biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥55 years old.
2. Patients had multiparametric magnetic resonance imaging (mpMRI) data within 3 months before biopsy and tPSA/fPSA within 1 month before biopsy.
3. Patients had any of the following indications for prostate biopsy:

   * Suspicious prostate nodules were found by digital rectal examination
   * Suspicious lesions were detected by B-ultrasound or MRI
   * PSA\>10ng/ml
   * PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values

Exclusion Criteria:

1. malignant tumors other than prostate adenocarcinoma indicated by pathology.
2. Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
3. Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant findings on physical examination, medical history or laboratory tests on screening

Exclusion Criteria:

* Positive test for HIV or Hepatitis B and C
* History of sensitivity to valproic acid or related compounds