cyrilzakka/clinical-trials huggingface dataset:
Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells

Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells

In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate 1%

Eligibility Criteria:
Inclusion Criteria:

* inflammatory-dystrophic diseases of the cornea:

  1. Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment
  2. Dystrophic diseases of the cornea, accompanied by edema
  3. Burns of the cornea
  4. Neurotrophic forms of keratitis
  5. Persistent post-traumatic, postoperative, contusion keratitis and keratopathy

Exclusion Criteria:

1. Pregnancy.
2. Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial infections.
3. Cancer or leukemia
4. Any diseases in the stage of decompensation.
5. Mental disorders.
6. Anomalies of eye refraction
Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section

The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of delivery by vacuum in C/S with normal caesarean section.


Eligibility Criteria:
Inclusion Criteria:

* term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.

Exclusion Criteria:

* Elective cesarean
A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase

The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
* Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of asparaginase, with or without daunorubicin
* Functioning Central Venous Access Device
* Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
* Males and females,age 1 year(365 days) to \< 18 (17 years and 364 days) years.

Exclusion Criteria:

* Subjects scheduled to have \> 3 Lumbar Punctures over the course of the study treatment period
* Prior history of documented DVT or PE in the past 3 months
* Known inherited bleeding disorder or coagulopathy
* Major surgery \[excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy\] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
* Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) \> 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children
* Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment
* Liver dysfunction manifested by SGTP (ALT) \> 5X Upper limit of normal (ULN) and/or Aspartate aminotransferase (AST) \>5 X ULN and/or direct (conjugated) bilirubin \> 2X ULN
* Renal function \< 30% of normal for age and size as determined by the Schwartz formula
* International normalized ratio (INR) \> 1.4 and activated partial thromboplastin time (aPTT) \> 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment.
* History of allergy to apixaban or Factor Xa inhibitors
* History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity
* Any investigational drug being administered during the study

Other protocol inclusion/exclusion criteria may apply
Metabolic Cluster Analysis in Septic Shock Patients

Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.


Eligibility Criteria:
Inclusion Criteria:

- Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion (elevated lactate and/or ScvO2 \< 70%).

Exclusion Criteria:

* Age under 18 years old
* Uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (\> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids.
* Patients receiving continuous renal replacement therapies, since the CO values obtained from the thermodilution techniques might be potentially affected.
Study of Dietary Additive Phosphorus on Proteinuria and Fibroblast Growth Factor-23

Phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. While these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. In this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. Then, participants will be randomized to a higher phosphorus period (\~2gm/d) and a lower phosphorus period (\~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives.

The investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (FGF-23) during the higher phosphorus period compared to the lower phosphorus period.

The Study of Dietary Additive Phosphorus on Proteinuria and FGF-23 (SODA-POP) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate \>= 45 ml/min/1.73m2; and urine albumin/creatinine ratio \>=17 mg/g for men or \>=25 mg/g for women).

Eligibility Criteria:
Inclusion Criteria:

Adults at least 21 years of age with at least microalbuminuria

Exclusion Criteria:

Estimated glomerular filtration rate \<45ml/min/1.73m2, poorly controlled diabetes or hypertension, nephrotic syndrome, hyperparathyroidism, Paget's Disease, multiple myeloma, uncontrolled thyroid disease, chronic antacid use, use of phosphorus binders, phosphorus supplements, or high-dose vitamin D, inability to complete feeding study, investigator discretion
SOLACEA-H in Heparin-sparing Haemodialysis

The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU)

This is a randomised, crossover, open-label, prospective, multicentre post-marketing clinical follow-up study comparing two medical devices used (SOLACEA-H dialyser vs HYDROLINK-NVU dialyser) for their intended purpose.

Each patient will be followed for approximately 2 months, depending on the number of sessions in the anticoagulant reduction phase.

Patients will be offered the study by the investigator during a dialysis session as part of routine practice. If the patient accepts and signs the informed consent form, he or she will receive a succession of dialysis sessions including first the SOLACEA-H then the HYDROLINK-NVU membrane, or vice versa, depending on randomisation.

Eligibility Criteria:
Inclusion Criteria:

* On haemodialysis for at least 3 months
* Dialysis in a haemodialysis department of the Ramsay-Santé group
* No active infection
* Medically stable
* Blood flow ≥ 300 ml/min
* Haemoglobin level stable and within recommended norms for a dialysis patient, id est \> 10g/dl
* Bipunction
* No known allergy to SOLACEA H or HYDROLINK-NVU
* Willingness to comply with study procedures for the duration of the study
* For women of childbearing age: effective contraception, or absence of active pregnancy (negative pregnancy test)
* Member or beneficiary of a social security scheme
* Patient having been informed and having signed an informed consent form

Exclusion Criteria:

* Patient on oral anticoagulants for the duration of the study
* Patient on dialysate for the duration of the study
* Patient Medically unstable or fragile
* Severe hepatic impairment
* Patient hospitalised without consent
* Concurrent participation in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breast-feeding or parturient women
* Patient unable to receive heparin
* Known allergy to latex or phthalates
Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube

This study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in women who have surgery to have their fallopian tubes removed. Participants will take a low dose of aspirin for 2 weeks before their surgery. A portion of the removed fallopian tubes will also be collected for future research and routine pathology purposes.

Subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to remove fallopian tubes removed to determine whether aspirin decreases inflammation in the fallopian tube. Subjects will also submit blood samples at their initial visit with their oncologist, at the time of surgery and at the pre-operative visit to measure inflammation markers and blood counts. A portion of the subject's fallopian tube will be collected for future research studies.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing gynecologic surgery for presumed benign indications that includes the removal of their fallopian tubes. This may include sterilization procedures, hysterectomy or partial or full adnexectomy.
* Eligible women will have fulfilled their childbearing desires
* Age \> 21 Considered low risk for prevalent fallopian tube cancer (not undergoing risk reducing surgery for a known BRCA mutation or other known hereditary predisposition syndrome, family history of ovarian cancer in a first degree relative.

Exclusion Criteria:

* Males
* Women who have presumed or known gynecologic cancer
* Women less than 21 years of age
* Women currently on either regular aspirin therapy, non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen or chronic steroidal anti-inflammatory medications.
* Women with known bleeding diathesis or bleeding disorder.
* Women who do not consent for removal of both fallopian tubes.
* Women with a history of gastritis or peptic ulcer disease requiring treatment. (Patients with a history of occasional H1 or H2 blocker use for gastro esophageal reflux disease are NOT excluded).
* Women with reported aspirin or NSAID allergy
* Women with asthma and/or nasal polyps
Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy

The purpose of the study is to investigate the clinical usefulness of serum levels of immunologic profiles including pro/anti-inflammatory interleukins, other detectable serum biomarkers including transforming growth factor b1 (TGFb1) or soluble major histocompatibility complex Class I chain-related peptide A (sMICA), and leukocyte subpopulations in head and neck cancers patients receiving curative radiotherapy, as prognostic biomarkers for disease recurrence and survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck cancer receiving curative radiotherapy in NTUH radiation therapy department.

Exclusion Criteria:

* Patients with head and neck cancer NOT receiving curative radiotherapy in NTUH radiation therapy department.
A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer

This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Carcinoma of the colon and/or rectum
* Disease progression during or within 6 months of last dose of oxaliplatin containing first-line combination therapy for metastatic disease
* ECOG performance status 0-1
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Prior treatment with monoclonal antibody/small molecule against epidermal growth factor receptor (EGFR)
* Prior treatment with irinotecan
* Radiotherapy within the last 4 weeks before first dose of study drug (except for limited field palliative radiotherapy for bone pain relief)
* CNS metastasis
* History of or active autoimmune disorders/conditions
Role of Imaging in Complications of Sinusitis

This study aims to assess the diagnostic performance of CT and MRI in the diagnosis of complications of rhinosinusitis in comparison to clinical and operative findings.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed as sinusitis with clinically suspected complications through history and physical examination (site, onset, character of pain, constitutional symptoms, duration).

Exclusion Criteria:

* Patients with absolute or relative contraindications for cross sectional imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Effectiveness of Epidermal Growth Factor-containing Ointment on the Solar Lentigines

Subjects were randomly assigned to groups for treatment with either an EGF-containing ointment (the study group) or the vehicle alone (petrolatum; the control group). The EGF ointment included recombinant human EGF (1 μg/g). Random numbers used for assignment to groups were provided by the randomization function of SAS.

The subjects received one session of laser treatment with a Q-switched (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser of their solar lentigines after enrollment. . The end point of laser treatment for lentigines was immediate whitening. The subjects then applied the EGF ointment or vehicle twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of solar lentigines that occurred after adulthood
* age of 20 years or older.

Exclusion Criteria:

* uncontrolled systemic or chronic disease
* hypersensitivity to the ingredients of the ointment
* current use of skin whitening agents
* a history of other laser treatments within the past 6 months
* pregnancy
* lactation.
A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma

This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic, transcranial injection into their tumor or as an intravenous injection given daily for 3 \& 5 days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6 weeks until study completion. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)
* technically unresectable HGG
* initial definitive therapy such as surgery with or without adjuvant radiation
* subject elected not to undergo treatment with Gliadel wafer
* if receiving corticosteroids, dose is stable or decreasing for past 7 days
* KPS: at least 70
* absolute neutrophil count \> 1500/mm\^3
* absolute lymphocyte count \> 500/mm\^3
* platelet count \> 100,000/mm\^3
* hemoglobin \> 10 g/dL
* for intratumoral cohort, coagulation profile favorable to surgery
* estimated glomerular filtration rate \> 50 mL/min
* ALT \< 3 times ULN and bilirubin \< 1.5 mg/dL
* negative serum pregnancy test

Exclusion Criteria:

* cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)
* more than 2 recurrences including present recurrence
* Gliadel wafer or wafers implanted within the past 8 weeks
* taking more than 8 mg of dexamethasone per day
* for intratumoral cohorts, injection of tumor would require violation of ventricular system
* any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the past 4 weeks
* for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet agents that cannot be stopped
* allergy or intolerance to 5-FC
* HIV positive
* g.i. condition that would prevent ingestion or absorption of 5-FC
* any investigational treatment within the past 30 days
* pregnant or breast feeding
* received Avastin
* history of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than 5 years.
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.


Eligibility Criteria:
Inclusion Criteria:

1. Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments.
2. Age equal or more than 18 years
3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
4. Patient voluntarily provides written informed consent to participate, in compliance with local law.

Exclusion Criteria:

1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
2. Required use of restricted medications.
3. Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding.
4. Any medical condition which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol.
5. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation
6. Hepatic impairment evidenced by the following baseline laboratory findings:

   * AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN
   * AST or ALT more 2.5X ULN and total bilirubin more 2X ULN
Experimental Medicine in ADHD - Cannabinoids

Adult patients with ADHD commonly report an improvement in behavioural symptoms when using cannabis with some reporting a preference towards cannabis over their ADHD stimulant medication. The EMA-C study aims to investigate the effects of a cannabis based medication, Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.

This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in improvements in behaviour and cognition above that of the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* The study is open for both men and women aged 18-55 who meet DSM 5 criteria for ADHD (N= 30). Subjects will be either unmedicated or medicated with stimulant medication only and be willing to come of this medication for 1 week before and for the duration of the study. To ensure that this does not disadvantage patients we will only include those on stimulant medication who do not take medication on a regular basis and where short periods of medication are not thought by both the patient and psychiatrist to represent a clinical problem in the overall control of the symptoms and impairments. For example, by including patients who are considering a "stimulant drug holiday", which is a common clinical procedure in ADHD. Subjects must not use other prescription and non-prescription medication or recreational drugs during the study.

Exclusion Criteria:

* Exclusion criteria will include autism spectrum disorders and other psychiatric disorders including recurrent major depression, bipolar I disorder, any psychotic disorder and obsessive compulsive disorder and learning difficulties defined as an IQ \< 70. Neurological problems and known or suspected history of a drug or alcohol dependence disorder. Subjects who are using or have used cannabis or cannabis based medications in the 30 day period prior to study entry. Concurrent history of renal, hepatic, cardiovascular or convulsive disorders. Females who are pregnant or breastfeeding. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use two effective forms of contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (Note: a male condom should not be used in conjunction with a female condom).