cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma

The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ \[A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient\]) matched related or unrelated donors. Specifically, we will examine:

* The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
* The incidence of transplant related mortality at 100 days.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
* Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.

Exclusion Criteria:

* Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:

  * Cardiac: Ejection Fraction less than 50 percent
  * Renal: Est. Creatinine Clearance less than 50
  * Hepatic: Bilirubin greater than 3.0
  * Pulmonary: Diffusing Capacity for Carbon Monoxide (DLCO) less than 70 percent, or for patient who cannot cooperate with pulmonary function testing, O2 saturation less than 95 percent on room air.
* Performance status: Lansky performance less than 70; Eastern Cooperative Oncology Group (ECOG) status greater than or equal to 2
* Patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone.

  * As part of the standard of care for pre-transplant evaluation subjects will be tested for exposure to viral agents such as hepatitis B, C, HTLV-1/2 and HIV. Subjects testing positive for HI may be rejected as candidates for transplantation, based on the clinical judgement of the stem cell transplant physician.
Prediction Model of Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery

Delirium is a clinical syndrome caused by normal dysfunction of the brain, characterized by reduced awareness and responsiveness to the environment, as well as orientation disorders, incoherent thinking and memory disorders. Delirium indicates poor recovery of cognitive function, decreased ability of daily life, may need to enter nursing homes, and even lead to adverse outcomes such as death. According to a number of clinical studies, middle-aged and elderly people are prone to delirium after undergoing major surgery. Delirium occurs in 31 % -40 % of patients over 50 years old after cardiac surgery. Compared with patients without postoperative delirium, patients with postoperative delirium had significant cognitive impairment within 1 year after cardiac surgery. The occurrence of delirium suggests that the patient 's brain has become fragile, cognitive function has begun to decline, and the risk of future dementia has increased.

Secondly, delirium and dementia have overlapping clinical features and common pathogenic mechanisms. Some scholars even speculate that delirium and dementia represent different stages of a common process. It is generally believed that the peripheral immune system may be involved in the pathogenesis and progression of dementia through the dysfunctional blood-brain barrier. The activation of microglia and astrocytes leads to the release of chemokines, which can recruit peripheral immune cells to the central nervous system. At the same time, cytokines released by peripheral cells can cross the blood-brain barrier and act on glial cells to change their phenotype.

This study is a prospective cohort study of patients aged 65 and over who are about to undergo elective cardiac surgery.CyTOF can achieve accurate immunophenotyping of cell populations while comprehensively and accurately detecting and analyzing cytokines and signaling pathways. Therefore, the detection of peripheral blood biomarkers may effectively predict the risk of long-term cognitive dysfunction and postoperative delirium in patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Patients undergoing elective cardiac surgery with cardiopulmonary bypass
* Sign informed consent

Exclusion Criteria:

* serious dementia, encephalopathy, mental illness or other neurological diseases
* Patients who could not take neurocognitive tests due to other reasons ( such as language, hearing or visual impairment )
* Patients with stage 3 or 4 malignant tumors, and patients with pancreatic cancer, gallbladder cancer, cholangiocarcinoma and other tumors with high malignancy and expected survival time less than 1 year
* American Society of Anesthesiologists ( ASA ) classification IV or V patients
Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children

Children with cerebral palsy may benefit from treatment with botulinum toxin injections to decrease spasticity for improve function and quality of life. These injections cause repeated pain throughout childhood and may be the cause of post-traumatic stress despite drug and non-drug pain management. The Mini-Docs project of the French Red Cross has a module based on a digital device with augmented reality. Distracting the child, the use of this module on a tablet would reduce pain felt during botulinum toxin injections.

Objective: To evaluate the effect of the use of a module with augmented reality (Mini-Docs) on pain during botulinum toxin injections in children with cerebral palsy aged from 3 to 8 years

Method: Randomized controlled trial comparing a group of children receiving the module with augmented reality of the Mini-Docs and drug pain management (nitrous oxide and medications), with a group of children receiving the usual care of pain management that combines drug pain management (nitrous oxide and medications) and distraction techniques. The device with the augmented reality module allows the child to add virtual content to the real images of the care. The pain will be assessed for each child 10 minutes after the injections, using a self-assessment scale (the Faces Pain Scale - Revised) or a heteroevaluation scale (the Face Legs Activity Cry Consolability scale given by the nurse). The study will be conducted in two centers of physical medicine and pediatric rehabilitation of the French Red Cross (Paris and Lyon).

Expected Results:

* Decreasing children's pain during botulinum toxin injections
* Decreasing anxiety in children and parents during injections
* Increasing coping skills in children
* Facilitating of the achievement of the therapeutic goal during injections

Eligibility Criteria:
Inclusion Criteria:

* Cerebral-palsied children, whose diagnosis of cerebral palsy was confirmed by a neurologist reported in the medical record
* Aged 3 to 8 years (until the day before 9 years old)
* With a functional level of Gross Motor Function Classification System (GMFCS) I, II, III or IV
* Treated by TB injection (child with or without a history of TB injections)
* With a sufficient level oral expression to respond to questionnaires and to interact with the nurse for the use of augmented reality device
* Obtaining written parental consent and oral approval by the child

Exclusion Criteria:

* Impossibility to assess pain during the session by the FLACC scale or FPS-R scale
* Visual disturbances excluding to use of the augmented reality device
* Severe cognitive impairment making it possible to answer questionnaires
* Child of functional level child GMFCS V
* Child with a specific request for distraction (eg if the child demands to watch a cartoon). This in order not to interfere with the coping strategies used by the child.
* Refusal on the part of the parents to sign consent, and refusal on the part of child to use the tablet
* Child not benefiting from social security coverage
Prenatal Nutrient Status Study

The purpose of this research is to gather data on nutritional status from approximately 250 pregnant women who are currently taking a prenatal vitamin in order to better understand if the prenatal vitamins that most people use are providing enough nourishment during pregnancy.

Participants will be asked to:

* complete an online survey
* schedule a blood draw for the Study Multivitamin Blood Test
* complete the blood draw visit
* complete a final survey at study end


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Speaks, reads, and understands English
* Lives in the United States
* Lives within a ZIP code from the metropolitan areas where mobile phlebotomists will be available for blood draws
* Assigned female sex at birth
* Currently within weeks 24-34 of pregnancy
* Currently taking a daily prenatal vitamin

Exclusion Criteria:

* Birth sex other than female
* Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin
Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1

The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patient should have completed at least six (6) months of non-operative treatment. Patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.
2. The patient has documented conservative (non-operative) treatment for at least 6 months.
3. The patient has a VAS back pain of ≥ 60 mm.
4. The patient has an ODI ≥ 40%.
5. The patient is at least 18 years of age and skeletally mature.
6. The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
7. The patient is willing and able to comply with study requirements.
8. The patient has agreed to participate in the study.

Exclusion Criteria:

1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s).
2. The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
4. The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation.
5. The patient has an active infection.
6. The patient is pregnant or is planning on becoming pregnant in the next two years.
7. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
8. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium.
9. The patient is currently enrolled in an investigational spine study.
10. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
11. The patient has symptomatic fibrous arachnoiditis
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)

This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination

Exclusion Criteria:

* Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection
* Subject has a fever 72 hours prior to first injection
* Subject has already been vaccinated for Hepatitis A
* Subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component of the vaccine
* Subject has received inactivated vaccines within 14 days of screening or live vaccines within 30 days of screening
In-hospital Cardiac Arrest - Dynamics and State Transitions

The purpose of this study is to analyse transitions in cardiac rhythm and hemodynamic variables during resuscitation of patients with in-hospital cardiac arrest.

In-hospital cardiac arrest carries a grave prognosis, with survival to discharge in the range of 15-20%. Key factors determining outcome include the presenting cardiac rhythm, aetiology, and early initiation of resuscitation. Some cardiac rhythms benefit from defibrillation (shockable rhythms). During resuscitation patients may switch between shockable and non-shockable rhythms, and may show signs of spontaneous circulation temporarily. Depending on rhythm and according to guidelines, patients receive direct current (DC) shocks (defibrillator) and/or i.v. adrenaline, atropine and amiodarone, which may affect state-transitions. We wish to make statistical analysis (time-series analysis, Markov modelling) of these state-transitions and variations in hemodynamic variables during resuscitation, related to CPR interventions and the cause of arrest. The cause of arrest will be determined based on chart records, interview with staff and autopsy if appropriate. One hypothesis is that differences in the patterns of state-transitions may reflect underlying aetiology, which may guide in future decision-making during resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with in-hospital cardiac arrest who are resuscitated

Exclusion Criteria:

* Younger than 18 years old
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=60 years of age;
* \>=5 years postmenopausal;
* confirmed osteoporosis, at increased risk for renal disease.

Exclusion Criteria:

* inability to stand or sit upright for 30 minutes;
* hypersensitivity to bisphosphonates;
* malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
* previous administration of an i.v. bisphosphonate;
* oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
* history of major upper gastrointestinal disease.
A Study of HS-10518 in Healthy Female Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China.

This is a double-blind, placebo-controlled, multiple-dose, single-center phase 1 study in Chinese healthy premenopausal females aged 18-45 years with a regular menstrual cycle (26-32 days). The main purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518, a gonadotropin-releasing hormone antagonist.

About 48 eligible female subjects will be enrolled. The study contains four cohorts.

In each cohort, participants will be randomly assigned to the HS-10518 arm or the placebo arm in a 3:1 ratio. HS-10518/matching placebo will be administered from Day 1 to Day 7. The study duration of each participant is up to \~10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* • Subject is a healthy premenopausal female aged 18-45 (inclusive) at Screening;

  * Subject has a body weight ≥45kg with a body mass index (BMI) of 18-28 kg/m\^2 (inclusive);
  * Subject has a normal menstrual cycle for no less than 2 years (Cycle: 26-32 days, menstrual period: 2-7 days), and have a positive ovulation test in the cycle prior to drug administration;
  * Subject is willing to use highly effective, non-hormone contraceptive methods from signing the consent form until 3 months after the last dose;
  * Subject agrees to draw blood in pre-specified time points throughout the study and to attend the follow-up visit;
  * Subject is able to understand the purpose, process and potential adverse events of the study, and is willing to sign a written informed consent form.

Exclusion Criteria:

* • Subject took caffeine-rich or xanthine-rich food or drink (e.g. coffee, tea, chocolate, cola, etc.), tobacco or alcoholic products within 48 hours prior to drug administration;

  * Subject took any grapefruit, grapefruit juice or other products within 7 days prior to first dose of study drug;
  * Subject has a positive breath alcohol test or a history of alcohol abuse;
  * Subject is a heavy smoker, or smokes ≥5 cigarettes per day, or is not able to cease smoking during the study (including e-cigarette);
  * Subject has a history of drug abuse or a positive urine drug test;
  * Subject is pregnant, breastfeeding or has a positive pregnancy test at Screening
Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy

We will investigate the effect of peritendinous corticosteroid injections, eccentric training and heavy resistance training in male patellar tendinopathy patients. The purpose is to compare the clinical effect of these three treatments in a randomised controlled trial. Also we wish to investigate the treatment mechanisms responsible for the effectiveness of the three treatments.

3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity.

Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI.

Treatment satisfaction will be stated after intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Clinical patellar tendinopathy pain.
* Tendon swelling
* Hypoechoic
* Doppler activity in tendon

Exclusion Criteria:

* Previous knee surgery
* diabetes
* arthritis
* previous steroid injections
A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease

Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that directly inhibits TS. This phase I trial and pharmacokinetic study will describe and define the toxicities, determine the MTD, and describe the plasma pharmacokinetics of ZD1694 in pediatric patients with refractory cancer. The starting dose for this trial will be 2.0 mg/m(2) administered as a 15 minute IV infusion every 21 days.

Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that directly inhibits TS. This phase I trial and pharmacokinetic study will describe and define the toxicities, determine the MTD, and describe the plasma pharmacokinetics of ZD1694 in pediatric patients with refractory cancer. The starting dose for this trial will be 2.0 mg/m(2) administered as a 15 minute IV infusion every 21 days.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically proven malignancy considered refractory to standard therapy. Objective evidence of progression on prior therapy required.

No leukemia.

Bone marrow involvement by tumor acceptable. Marrow biopsy required if there is a history of involvement or peripheral counts are inadequate.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.

Chemotherapy: No more than 2 prior chemotherapy regimens and recovered. At least 2 weeks since myelosuppressive therapy (6 weeks since nitrosoureas).

Endocrine Therapy: Not specified.

Radiotherapy:

No prior central axis irradiation (i.e., skull, spine, ribs, pelvis).

Recovery from toxic effects of prior radiotherapy required.

Surgery: Not specified.

Other: No prior bone marrow transplantation.

PATIENT CHARACTERISTICS:

Age: 21 and under.

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.

Hematopoietic:

(unless histologic evidence of bone marrow involvement by tumor).

AGC at least 1,500/mm3.

Platelet count at least 100,000/mm3.

Hemoglobin at least 8.0 g/dL.

Prior transfusion acceptable.

Hepatic:

Bilirubin no greater than 2 times normal.

ALT no greater than 2 times normal.

Renal:

Creatinine less than 1.5 mg/dL OR

Creatinine clearance greater than 60 mL/min/1.73 sqm.

Cardiovascular: Not specified.

Pulmonary: Not specified.

OTHER:

No significant accumulation of third space fluid.

No significant systemic illness (e.g., infection).

No pregnant or nursing women.

Pregnancy test required in fertile women.

All patients or their guardians must sign an informed consent.
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Body mass index (BMI) between 16-40 kilogram per square meter (kg/m\^2) at Visit 1
* Uncontrolled severe asthma
* A chest x-ray with no abnormality
* Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
* Non-sterilized males or sterilized males who are less than or equal to (=\<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception

Exclusion Criteria:

* Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
* Pregnant or breastfeeding women
* Any other respiratory disease
* Previously taken tralokinumab (the study drug)
* Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
* Known immune deficiency
* History of cancer
* Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
* Any disease which may cause complications whilst taking the study drug.