cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.

In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. \[AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.\]

Eligibility Criteria:
Inclusion Criteria

Your child may be eligible for this study if he/she:

* Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
* Is HIV-positive.
* Is generally healthy.
* Is able to swallow medication in capsule form.
* Has never taken d4T or has never taken 3TC.
* Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

* Has a serious infection at the time of study entry.
* Has a history of severe diarrhea.
* Is unable to take any of the medications in this study for any reason.
* Has a history of certain serious illnesses.
* Has taken any protease inhibitors (PIs).
* Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
* Has taken certain medications.
* Is pregnant or breast-feeding.
STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy.

Participants will be:

* randomly assigned to continue medical therapy or de-escalate medical therapy
* clinically managed according to regular medical care
* asked to provide blood, stool (poop), and tissue samples for study purposes

This is a prospective, randomized clinical trial conducted at a tertiary academic center \[University of Chicago Medicine Inflammatory Bowel Disease (IBD) Center\]. Patients in clinical, biochemical, and endoscopic remission with biopsies showing histologic quiescence or normalization will be identified and approached after consultation with their IBD care team. After enrollment, participants will be randomized to either de-escalation of therapy (de-escalation group) or continuation of current therapy (control group) and monitored for 24 months, both consistent with current clinical practice. After the 24-month period, participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care.

Eligibility Criteria:
Inclusion Criteria:

1. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
2. Patients in deep remission, defined by the absence of endoscopic and histologic signs of active inflammation (i.e. histological normalization or histological quiescence) in all biopsies obtained during colonoscopy, within the last 12 months.
3. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission for at least 6 months.

Exclusion Criteria:

1. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].
2. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.
3. Corticosteroid use after colonoscopy showing histologic normalization or quiescence.
4. Patients with any noted history of primary sclerosing cholangitis or dysplasia (suspected or confirmed).
5. Inability to follow the proposed sample collection and monitoring protocol.
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis of \>/= 6 months duration
* \>/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for \>/=8 weeks at any time prior to study treatment
* Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
* Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion Criteria:

* Pregnant or lactating women
* Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
* Rheumatic autoimmune disease other than RA
* Functional class IV (ACR classification)
* Prior history of or current joint disease other than RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV
New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Mastectomy is a cornerstone operative procedure in breast cancer treatment leaving a raw area behind with possibility of failure of primary closure sometimes with unavailability of facilities of reconstruction. This opened the door for this research to find a formula to predict the need of reconstruction

Surgical intervention for breast cancer includes dealing with the primary tumour, added to it is the axillary dissection with variable options in both of them according to multiple factors. Mastectomy represents a part of several operations as radical and modified radical mastectomy, while in others it may be the whole operation as in palliative simple mastectomy. Moreover, re-excision of local recurrence is another form of surgical intervention.

At the step of mastectomy or re-excision of locally recurrent disease, the challenge of closure may arise, as simple primary closure may not be possible because of wide wound gap. In this situation, reconstruction is unavoidably needed and this situation represents one of two situations in which reconstruction is indicated.

As reconstruction sometimes needs certain expertise which may not be available momentarily and needs previous arrangement. Moreover sometimes mastectomy exceeds the previous expectation leaving a big gap beyond simple approximation, so the investigators developed a formula to assess the need of reconstructive coverage.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer primary or recurrent, early, locally advanced or metastatic, as long as they were assigned to be treated with any procedure in which mastectomy is part or all of the procedure, were included in this study.

Exclusion Criteria:

1. Any patient diagnosed with breast cancer and planned to be treated with conservative breast cancer
2. Any patient whose design for excision was not regular ellipse but an irregularly tailored excision margin
3. Any patient with ischemic flaps (due to excessive tension or wrong dissection) following mastectomy
4. Any patient had skin disease affecting its healthiness
Study Visceral Adipose Tissue and Liver Stifness in a Retrospective Cohort of Diabetes Mellitus Patients

Non Alcoholic Fatty Liver Disease (NAFLD) is an emergent disease worldwide, and soon the leading cause of hepatic transplant in the USA. Among this high number of patients, the current challenge is to detect or even predict patients at risk of inflammation (Non Alcoholic or Steatohepatitis or NASH) and end-stage fibrosis, which are the best predictors of liver-related mortality.

Visceral obesity is intimately associated with metabolic disease and adverse health outcomes, such as diabetes, and NAFLD. It has been demonstrated that visceral adipose tissue-linked inflammation was a risk factor of stroke, myocardial infarction, and others metabolic-related complications.

The aim of this study was to evaluate the association of the quantity and percentage of Visceral Adipose Tissue by Dual X-Ray Absorptiometry and liver stiffness by Fibroscan in patients with type 2 diabetes, and other predictors of fibrosis such as FIB-4 and Fibrotest. We retrospectively collected the data of all the diabetic patients who had undergone a DEXA and a Fibroscan between January 1st, 2014 and Decembre 31th, 2019, in the Universitary Hospital of Nancy, France.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Patients who had undergone a VCTE examen at Universitary Hospital of Nancy between January 1st, 2014 and December 31th, 2019
* - Patients who had undergone a DEXA at Universitary Hospital of Nancy with less than one year of difference with VCTE

Exclusion Criteria:

* Viral, ethylic, drug-linked, genetic, self-immune hepatitis, liver cancer or metatasis ; other causes who could interact with fibroscan or biological markers (thrombocytopenia, undernutrition)
* Type 1 diabetes mellitus
* Weight variation (\>5% of body weight) between DEXA mesure and Fibroscan mesure
* Fail of VCTE examination
* High alcohol consumption (\>30g/day for men and \>20g.day for women)
* Pregnant women
* Other causes of secondary hepatic steatosis (drug-linked, parenteral nutrition, rare diseases...)
* Any other pathology that the investigator would consider not compatible with the research
* Patients in any other research protocol three months before inclusion
* Person referred as in the Public Health code (articles L.1121-5, L.1121-7 and L.1121-8) : pregnant or nursing woman, minor adult, major adult under legal protection, adult unable of giving consent
* Person deprived of their liberty by judicial or administrative decision, person under psychiatric care as described in articles L. 3212-1 and L.3213-1.
Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab

NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is felt to be an actionable and potentially major growth pathway for those tumours that harbour this gene rearrangement. Tumours that harbour NRG1 fusions are driven by HER3 overactivation. Seribantumab is a mono-clonal antibody against HER3, it binds HER3 and inhibits NRG1-dependent activation and HER2 dimerization.


Eligibility Criteria:
Inclusion Criteria:

* Serious, life-threatening condition

  * Not eligible for, or exhausted all other treatment options or causing significant toxicity
  * No other way to access treatment

Exclusion Criteria:

-
Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. Any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (SUDEP). As such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life.

New technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. These devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. One example of this device is the Empatica Embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. This relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers.

Whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. It remains unclear on the value that they can offer to patients. The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Eligibility Criteria:
Inclusion Criteria:

1. The participant is over the age of 18
2. The participant has access to a smartphone
3. The participant has a history of generalised tonic-clonic seizures in the past year

Exclusion Criteria:

1. The participant lacks capacity to give informed consent (e.g. has intellectual disability)
2. The participant is a paediatric patient (aged below 18)
Victus Versus Conventional

Cataract surgery is among the world's most frequently performed operations. It involves removal of an opaque lens from the human eye and implantation of an artificial lens. The operation is performed under local anaesthesia using ultrasound technology, by which the lens is emulsified and removed by suction.

Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can improve the quality of cataract surgery and provide a new best possible standard of quality. In contrast to the conventional method the capsulotomy and the fragemntation are fully automatically performed with a femtosecond laser. In addition, the lens is fragmented by the laser, which substantially facilitates its removal and reduces the operation time.

Study to investigate whether the femtosecond laser cataract surgery causes any significant differences in clinical outcomes as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC).

Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline lens.

EPT of conventional surgery at intraoperative visit \> EPT oflaser-assisted surgery at intraoperative visit


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years
* related cataract
* Ability to follow instructions from the treatment team
* Both eyes to receive surgery

Exclusion Criteria:

* Narrow pupils (in ther. mydriasis \<6mm)
* Narrow orbits
* Sunken eyes
* manifest glaucoma treated with anti-glaucomatous therapy or prior surgery
* Conditions that pose a high risk of complications during surgery
* Known sensitivity to planned concomitant medications
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Patients who are blind on one eye
* Acute or chronic systemic and/or ocular illnesses that are clinically significant and will increase the risk to the subject or confound the outcomes of this study, such as but not restricted to diabetes mellitus, autoimmune/rheumatic or connective tissue diseases, dementia or epilepsy.
* Patients who are pregnant or nursing
* Patients who do not give informed consent
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)

Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.

Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation. Subjects will be followed regularly with office visits at the investigational site at days 15, 29, 57 and weeks 12, 26 for vessel imaging, blood draws and other follow-up tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease (ESRD) who are not, or who are no longer, candidates for creation of a simple autogenous AV fistula (radio-cephalic or brachio-cephalic without requiring transposition) and therefore need placement of an AV graft in the upper extremity to start or maintain hemodialysis therapy.
* Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
* Patients between 18 and 75 years old, inclusive.
* Life expectancy of at least 1 year.
* Negative COVID-19 test within 3 days prior to surgery and negative for symptoms within 14 days prior to surgery.
* Able to communicate meaningfully with investigative staff and able to comply with entire study procedures.
* Willing and competent to give written informed consent.

Exclusion Criteria:

* History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
* Uncontrolled or poorly controlled diabetes; hospitalization for poor glucose control within the previous 6 months.
* History or evidence of severe peripheral vascular disease in the upper limbs
* Known or suspected central vein obstruction on the side of planned graft implantation.
* Documented hypercoagulable state or history of thromboembolic events or history of repeated venous catheter clotting.
* Known Positive COVID 19 test result or known exposure to COVID 19 in past 4 months.
* Known active infection including dental infection, osteomyelitis and other conditions which could present a local or systemic risk of infection.
* Bleeding diathesis.
* Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet therapy. History of heparin-induced thrombocytopenia.
* Contraindication to or known serious allergy to penicillin.
* Ongoing therapy with vitamin K antagonists or direct thrombin inhibitors or factor Xa inhibitors.
* Immunodeficiency including AIDS / HIV or active autoimmune disease, or on immunosuppressant therapy.
* Previous PTFE graft in the operative limb unless the TRUE graft can be placed more proximally than the previous failed graft.
* More than 1 failed PTFE graft in the operative limb.
Probiotics for the Prophylaxis of Migraine

This study aims to understand the efficacy of two probiotic interventions as prophylaxes of migraine symptoms in individuals diagnosed with episodic migraine.

The primary outcome measure will be migraine days per month, but secondary outcome measures such as use of analgesia, the wider impact of migraine (as assessed through the HIT-6 score) will also be assessed. Finally adverse effects will be evaluated.

The study will have three arms: two arms including the two different probiotic preparations and a third placebo arm.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 - 65 years.
2. Signature of informed consent by the patient.
3. Patients with confirmed migraine, diagnosed by a neurologist
4. Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.
5. Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)

Exclusion Criteria:

1. Patients diagnosed with chronic migraine
2. Migraine patients suffering from medication-dependent headaches.
3. Patients suffering from cluster or tension-related headaches.
4. Patients who used antibiotics up to two weeks before the start of the study.
5. Patients who have taken other probiotics in the previous two months.
6. Patients with chronic use of non-steroidal anti-inflammatory drugs.
7. Patients with inflammatory bowel disease (due to increased intestinal permeability).
8. Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.
Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects

ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.

Secondary objective are:

* Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake
* Evaluation on blood pressure of the usual food groups that are the strongest contributors of salt intake.

Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects will begin their first 15-day period with the consumption of St-Yorre mineral water.

Group B will begin the first 15-day period by drinking tap water. After a washout period of 15 days, each group alternates with a new period of 15 days of water consumption monitoring: tap water for group A and mineral water St-Yorre for group B.

For each period salt intake and blood pressure are measured.Three-day food records are also performed for both 15-days periods.

Eligibility Criteria:
Inclusion Criteria:

* Normal blood pressure between 90/60 and 140/90 mm Hg
* Usually drinks tap water;
* Knowing read and write French routinely,
* Possessing an internet connection at home,
* Possessing and knowing how to use a computer or tablet,
* Affiliated with a social security scheme
* Not Trust
* Having signed the informed consent letter

Exclusion Criteria:

* Pregnant or lactating woman
* BMI greater than 35 kg / m²
* Heart failure
* History of cardiovascular disease
* Hypertension treated or untreated
* Renal failure.
Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)

This study examines the possibility that the effectiveness shown for GC-MRT in the treatment of SAD leans on attention control rather than bias modification. Therefore half of the participants will receive the classic GC-MRT course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).

Eligibility Criteria:
Inclusion Criteria:

* A signed consent form
* Men and women between the ages of 18 and 65.
* Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV.
* SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.
* No current pharmaco-therapy.

Exclusion Criteria:

* A diagnosis of psychotic or bipolar disorders.
* A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
* Drug or alcohol abuse.
* Any current pharmacological treatment.
* Any current psychotherapeutic treatment.
* Change in treatment during the study.
* Poor judgment capacity (i.e., children under 18 and special populations).