cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma

The goal of this study is to determine if human RB1-deficient induced pluripotent stem cells (iPSCs) can produce retina, and, furthermore, can give rise to retinoblastoma in culture. This unique opportunity to study the initiation of retinoblastoma in the developing retina will shed light on the cell of origin for retinoblastoma and allow the investigators to study the earliest molecular and cellular events in retinoblastoma tumorigenesis.

OBJECTIVES:

* To establish the feasibility of producing induced pluripotent stem cells (iPSCs) from retinoblastoma patients with germline RB1 mutations (RB1-deficient iPSCs).
* To validate human RB1-deficient iPSCs by confirming karyotype, pluripotency and RB1 mutation.
* To differentiate the RB1-deficient iPSCs into retina as a model of the initiation of retinoblastoma in the developing retina.

This is an observational study where a small skin cell sample or peripheral blood sample will be used to produce iPSCs. After RB1-deficient iPSCs are produced, their karyotype and RB1 mutation will be confirmed and their pluripotency will be tested by studying the expression of pluripotent genes and proteins according to standardized guidelines established for human iPSCs. After validation of the RB1-deficient iPSCs, they will be differentiated in the laboratory into retina following established protocols.

Eligibility Criteria:
Inclusion Criteria:

* Research participant with heritable retinoblastoma and one of the following criteria:

  * Family history with RB1 mutation identified
  * Diagnosis of bilateral retinoblastoma
  * Diagnosis of unilateral retinoblastoma with RB1 mutation or MYCN amplification identified
* Participant or legal guardian/representative is able and willing to provide written informed consent.

Exclusion Criteria:

* Participants who do not meet the inclusion criteria will be excluded.
Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

The aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Women without menstrual cycles whithin the last 12 months and FSH\>30IU/L
* Healthy women
* Women that were not using drugs with potential vascular effect whithin the last 1 year
* Women that never used hormone replacement therapy

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* thrombophlebitis or thromboembolic disorders
Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at high risk for preterm birth.

Preterm labour involves multiple causes - one of the most significant factors being a prior history of preterm birth. Infection is another major cause of preterm labour (PTL) and is estimated to cause up to 30% of PTL. Bacterial Vaginosis (BV) is an alteration in the endogenous vaginal microflora preceded by a decreased presence of Lactobacilli species and increased growth of gardnerella and other pathogens. BV is a strong risk factor for PTL, and is associated with a 40% increased risk in some populations. Initial studies suggested that the treatment of BV with antibiotics could decrease the incidence of PTL, but this has not been confirmed by randomized trials. There is substantial evidence that the "normal" lactobacillus dominated urogenital microflora play an important role in maintenance of a healthy urinary and reproductive tract.

One hundred and sixty (160) women at high risk for PTL, based on a prior history of preterm birth, will be approached at their first antenatal visit to participate. Recruitment of 54 patients with symptomatic or asymptomatic BV (based on Nugent Scoring). Women with documented BV will be randomized to either treatment with lactobacilli preparation (n=27) or placebo (n=27). Women with symptomatic BV will be treated with oral Metronidazole prior to starting the lactobacilli or placebo. None of the subjects, researchers or clinical staff will know which preparation each woman receives.

This study will be the first to examine the ability of lactobacilli preparations to maintain a normal vaginal flora in pregnant women. In addition, the results will potentially serve as the basis for a multi-centre RCT to determine efficacy of this treatment in preventing preterm birth.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with previous incidence of preterm labour
* otherwise healthy
* over 18 years of age
* able to provide informed consent
* less than or equal to 16 weeks gestation
* singleton pregnancy
* normal uterine cavity

Exclusion Criteria:

* significant medical complications (preeclampsia, thrombophilia, hypertension)
* multiple pregnancy
* less than 18 years of age
* patients receiving antibiotics or other antimicrobial therapies at time of recruitment
* fetal complications such as intrauterine growth restriction or other abnormalities
* diabetes
* documented need for cervical cerclage
* patient enrolled in other clinical trials
Retroclavicular Block in Vascular Surgey

The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform .

The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . first described the block's use in the ED setting for a variety of indications . Because of its different needle entry point, the retro clavicular (RCB) approach offers an almost perpendicular needle-ultrasound (US) beam angle.

Regional anesthesia (RA) offers several advantages over general anesthesia (GA) for upper limb orthopedic surgery. One of the advantages is the improvement in postoperative pain, which leads to decreased use of postoperative opioids needs and reduces the recovery time for patients . A variety of approaches for regional blockade for upper extremity surgery have been described.

Dexamethasone is a corticosteroid drug that has been used as an adjuvant to reduce postoperative pain.

The use of peri neural dexamethasone (i.e. dexamethasone added to the local anesthesia solution) as an adjuvant to peripheral nerve block to improve analgesia provided by local anesthetic alone . Peri neural dexamethasone, as an adjuvant to peripheral nerve block, has been associated with faster onset of anesthesia , longer duration of anesthesia/analgesia decreased postoperative pain intensity and decreased postoperative analgesia requirements compared with local anaesthetic alone . The exact mechanism by which dexamethasone reduces pain is not known. The decrease in pain intensity and the prolonged analgesia attained with the use of perineural dexamethasone may be the result of a local, or systemic action, or both . Dexamethasone may act locally on glucocorticosteroid receptors to induce vasoconstriction, thereby decreasing systemic absorption of local anaesthetics . Other potential mechanisms of action include suppression of C-fibre transmission of pain signals and direct action on the nerve cell to reduce neural discharge . Dexamethasone may act systemically by reducing the inflammatory response caused by surgical tissue injury .

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing upper limb vascular surgey .

Exclusion Criteria:

* - Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
* Altered conscious level.
* Pregnancy.
* Body mass index (BMI \> 35).
* Patients who have difficulty understanding the study protocol.
* Patients who have any known contraindication to study medications.
* Patient refusal.
A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions

Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed cancer of any primary tumor type, Patients with Malignant Pleural Effusion or Ascites who remain poorly controlled after at least one systemic antitumor therapy and at least one local therapy (intracavitary administration of chemotherapeutic agents and/or biological response modulators, other than cisplatin.)
2. At least a medium amount of malignant pleural effusion or ascites conformed by confirmed by B ultrasound, Clinical judgment requires local therapy.
3. Karnofsky Performance Status ≥60
4. Life expectancy of at least 3 months
5. Adequate hematologic, cardiac, renal, and hepatic function
6. The serum pregnancy test of female subjects of childbearing age during the screening period was negative; With a fertile female/male subjects must be willing to throughout the study period (i.e., for the first time since the drug delivery to the end of the study drug dosing after 90 days) to take reliable contraceptive methods, including but not limited to: abstinence, male partners have accepted vasectomy, female sterilization, intrauterine device effectively and effective birth control pills.

Exclusion Criteria:

1. Participating in or receiving investigational treatment in another clinical trial within 4 weeks prior to first dosing, or participating in a device clinical trial within 4 weeks Evidence of bleeding diathesis, serious infection
2. Received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration;
3. Endostatin, bevacizumab, Ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy
4. Has not recovered from any adverse event due to any intervention to ≤1 prior to initial administration (except for hair loss, hearing loss, and neurological or endocrine disorders of ≤2 requiring alternative treatment)
5. Had undergone medium to major surgery other than diagnosis or biopsy within 28 days prior to first administration, or who were expected to undergo major surgery during the study period
6. Bilateral pleural effusion or enveloped pleural effusion or ascite
7. With severe COPD or a history of intestinal adhesions
8. uncontrolled primary brain tumor or central nerve metastatic tumor with significant intracranial hypertension or neuropsychiatric symptoms
9. Active infections that require systemic treatment
10. Pregnant or lactating women
11. history of illness, treatment, or laboratory abnormality that may interfere with the outcome of the study and prevent subjects from participating fully in the study, or participation is not considered by the investigator to be in the subjects' best interest.
Stent Geometry in Sutureless Bioprosthetic Valves

A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
* Provide written informed consent

Exclusion Criteria:

•Contraindication for CT with intravenous contrast injection
A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

This is a pilot trial to test perampanel (Fycompa; Eisai, Inc.) in ALS patients. The investigators will focus on safety and preliminary signs of efficacy. Perampanel is approved by the FDA for treatment of seizures in patients with epilepsy. In this study, perampanel will be used off-label for adults with ALS at an oral medication dose on the low end of the recommended dose range for epilepsy. This study will consist of two treatments arms: perampanel and matching placebo randomized at a 1:1 ratio. Subjects will receive medication for 9 months.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of ALS
2. first clinical weakness within past 3 years
3. slow vital capacity \>= 60% of predicted within 1 month of treatment
4. may be on stable dose of riluzole for at least 30 days, or otherwise agree to not initiate riluzole for duration of the trial
5. may be on stable dose of edaravone for at least 30 days, otherwise agree to not initiate edaravone for duration of the trial
6. can travel to Stony Brook to receive medical care
7. must have a monitor who can be contacted at regular intervals to report on subject's clinical/psychiatric status

Exclusion Criteria:

1. use of tracheostomy or mechanical ventilation within last 3 months
2. hepatic insufficiency or abnormal liver function
3. renal insufficiency
4. clinically significant psychiatric disorder
5. active malignancy
6. history of HIV, clinically significant chronic hepatitis, or other active infection
7. history of stomach or intestinal surgery or condition that could interfere with absorption, distribution, metabolism or secretion of study drug
8. history of alcohol or substance abuse within 3 months prior to entry (subjects will be instructed to refrain from alcohol during the study)
9. use of strong cytochrome P4503A inhibitors or inducers, anticonvulsants or other drugs known to interact strongly with perampanel.
10. pregnancy or lactation
11. clinically significant medical condition (other than ALS) that would pose a risk to the subject if they were to participate
12. know hypersensitivity to perampanel
13. currently participating, or has participated in a study with an investigation or marketed compound within 3 months of entry
Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device

The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen \[FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin\]
3. Age \>18y
4. ECOG 0-2
5. Patient compliant with the study procedures

Exclusion Criteria:

1. Patient not fit/suitable for aforementioned chemotherapy regimen at baseline
2. Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves
3. General vulnerability affecting the participation in the trial
Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study

To investigate the patient-related risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.

Objective: To investigate the patient-related risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control. Methods:A total of 131 patients will enroll in the study. Univariate and multivariate logistic regression analysis is used to determine the patient factors associated with peri-implant disease. The variables include age, gender, smoking and alcohol consumption, presence of diabetes, cardiovascular disease, osteoporosis, bruxism, bleeding upon brushing, reason for extraction, oral hygiene and periodontal status.

Eligibility Criteria:
Inclusion Criteria:

Patients implanted at least one implant and restored with implant-supported fixed partial dentures and single crowns.

The implant-supported fixed partial dentures and single crowns were in function at least one year.

Exclusion Criteria:

Jaw radiotherapy treatment before and after implanting. Patients who have bruxism, xerostomia or the adjacent teeth periapical periodontitis.

Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.

Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.
The Efficacy and Safety of Sirolimus for Plastic Bronchitis

There is no confirmed drug therapy for plastic bronchitis. The study wish to test the effectiveness and safety of sirolimus (rapamycin) in patients with lymphatic plastic bronchitis.

Plastic bronchitis is a rare respiratory disorder characterized by formation of gelatinous or rigid cast of bronchial tree. Confirmed drug therapy for plastic bronchitis is lacking. Recently, part of plastic bronchitis has been found to have dysfunction of lymphatic circulation in the lung. Pulmonary lymphatic perfusion syndrome (PLPS) is regarded as a major mechanism of lymphatic plastic bronchitis. Sirolimus (rapamycin) has not been studied in plastic bronchitis, however, it has been shown effective in several lymphatic disorders, such as lymphangioleiomyomatosis, generalized lymphatic anomaly (GLA) including lymphangiomatosis, etc. We wish to test the effectiveness of sirolimus in lymphatic plastic bronchitis.

Eligibility Criteria:
Inclusion Criteria:

* plastic bronchitis
* pulmonary lymphatic perfusion syndrome demonstrated on 68Ga-NEB positron emission tomography (PET)

Exclusion Criteria:

* Pregnancy and breastfeeding
* Severe cardiovascular, hepatic and renal dysfunction
* allergy to sirolimus or 68Ga-NEB
Blood Pressure Monitor Clinical Test (Cuff Range: 15-24,20-34,30-44,22-42）

The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device.

Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm


Eligibility Criteria:
Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial
Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder

The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder


Eligibility Criteria:
Inclusion Criteria:

* Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02)

Exclusion Criteria:

* Males
* Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years
A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.

Patients must have:

* HIV infection.
* CD4 count 50 - 500 cells/mm3.
* Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
* No active opportunistic infection or visceral Kaposi's sarcoma.

NOTE:

* Patients with hemophilia may be enrolled at discretion of investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Symptomatic neuropathy.
* Acute hepatitis.

Concurrent Medication:

Excluded:

* Antiretrovirals other than specified in protocol.
* Chronic therapy for an active opportunistic infection.
* Immunosuppressive therapy.

Prior Medication:

Excluded:

* Any prior protease inhibitor or d4T.
* Any nucleoside analogs within 2 weeks prior to study entry.
* Investigational agents or immunomodulators within 30 days prior to study entry.

Required:

* More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).
Assesment of the Efficacy of Personalized Parent-child Psychotherapy in Children Under 3 Years Old

This study aims to assess the efficacy at 4 months of a personalized strategy comparatively to a standard Psychodynamic Integrative Therapy, on childrens' symptom improvment

3 evaluations are performed: before treatment, at the end of the treatment and one year after the treatment.

evaluations include assessment of: children's symptom parent-infant interaction quality parental competencies parental perception of the child by his/her parent parent-therapist alliance hair cortisol concentration

Eligibility Criteria:
Inclusion Criteria:

* Families who are requesting a consultation for functional or behavioural problems of their child
* Children under the age of 3

Exclusion Criteria:

* Parents suffering from a severe untreated psychiatric disorder
* Difficulties in speaking French
* Children with Autistic spectrum disorder
* Families already in care