cyrilzakka/clinical-trials huggingface dataset:
Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies

This study will compare the outcomes of study participants who have had peripheral blood stem cell transplantation or with those who have had bone marrow transplantation from an unrelated donor for the treatment of serious hematological malignancies.

This study is a randomized, open-label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells verses marrow from unrelated donors for transplantation in patients with hematologic malignancies. The study will be comparing two-year survival probabilities between process has many steps after a matched donor is found. The donor also needs to give permission to join this study. Participants will be randomized to either peripheral blood stem cells (PBSC) or bone marrow. The kind of transplant the participant receives is random. Neither the participant nor the doctor may choose the type of transplant.

Participants will receive vaccinations for diphtheria, tetanus, hepatitis B and pneumococcus. Blood samples will be drawn as part of a participant's normal care. Blood samples will also be collected to see if infection fighting cells are working. These samples will be collected at 12 weeks, one year and then yearly until three years post transplant. Information will be collected from the participant's medical history. Participants will also have phone interviews conducted and questions will be asked about their physical and emotional health. Participants taking part in this study may be followed for up to 5 years.

Eligibility Criteria:
Participants may be eligible if they are between the ages of 18 to 66 years and are undergoing unrelated blood stem cell transplantation for the first time for the treatment of their hematological malignancy. Additional eligibility criteria will be gathered and evaluated by the transplant physician to determine if an individual is eligible to take part.
Long Term Follow-Up for RGX-111

RGX-111-5101 is a long-term follow up study that evaluates the long term safety of RGX-111 in participants who have received RGX-111 (a gene therapy intended to deliver a functional copy of the alpha-L-iduronidase gene (IDUA) to the central nervous system) in a separate parent study.

This is a prospective, multicenter, observational, follow-up study to evaluate the long-term safety of RGX-111 after a single administration. Eligible participants are those who previously participated in a clinical study where they received a single IC or ICV administration of RGX-111. Enrollment of each participant in this study should occur on the same day or after the participant has completed the end of study (EOS) visit or early discontinuation visit (EDV) from a previous (parent) clinical study. Participants will be followed for up to five years after RGX-111 administration (inclusive of the parent study) or until RGX-111 is commercially available in the participant's country, whichever occurs first. No treatment will be directed under this observational protocol. The total study duration for each participant may vary depending on when s/he enrolls in the current study following RGX-111 administration in the parent study.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible, a participant must have previously received RGX-111 in a separate parent trial.
* Participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent.

Exclusion Criteria:

* None.
Mind Body Therapy for the Treatment of Chronic Pain

Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient 18 \> years old
* Chronic back pain
* Pain persistent for ≥3 days/week for the past 3 months prior to enrollment
* Willingness to consider mind-body intervention

Exclusion Criteria:

* Patients \< 18 years of age
* Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome. Pain related to disc disease is not an exclusion unless there are neurological impairments.
* Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia and bipolar disorder.
Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification

Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs


Eligibility Criteria:
Inclusion Criteria:

* Age related, uncomplicated senile cataracts

Exclusion Criteria:

* presence of glaucoma,
* shallow anterior chamber (ACD \< 2.1mm),
* pupillary dilatation \< 6mm,
* extremely dense cataracts,
* posterior polar cataract,
* subluxated cataract,
* white mature cataract,
* diabetic retinopathy,
* high myopia (defined as AL \> 25mm),
* uveitis, or
* previous ocular trauma/surgery.
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring. This is an additional continuation of the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, to follow the offspring through 10 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's airway function tests. The investigators aim to demonstrate sustained improvement in airway/pulmonary function and trajectory through 10 years of age.

The primary outcome of this longitudinal follow-up study is the comparison of airway function tests (specifically the forced expiratory flow between 25%and 75% of expired volume \[FEF25-75\]) measured yearly through 10 years of age by forced expiratory maneuvers with spirometry between the children of the pregnant smokers randomized to vitamin C (500 mg/day) versus placebo during pregnancy. The occurrence of wheeze obtained with quarterly standardized respiratory questionnaires will also be compared between the two groups of children. This is a follow-up of the original "Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function" (VCSIP) trial.

The secondary outcomes are:

1. A single low dose high-resolution computed tomography (HRCT) image of the lungs (acquired during inspiration) will be done at 10 years of age in offspring of pregnant smokers who were randomized to vitamin C (500 mg/day) versus placebo during pregnancy. Image analysis will be performed by Dr. Miranda Kirby's Quantitative Image Analysis in Medicine laboratory at Ryerson University in Toronto, ON using certified pulmonary image analysis software. The airway lumen cross sectional areas to at least the fifth generation of airways will be compared between the two groups of children. The number of airways and the lumen, wall, and total cross sectional areas and the segment lengths will also be quantified.
2. A secondary aim is to quantify the differences in DNA methylation between the two groups and measure the correlation between the differences in DNA methylation and respiratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women and their offspring randomized to vitamin C versus placebo during pregnancy as well as pregnant nonsmokers and their offspring enrolled as the reference group in the original VCSIP study

Exclusion Criteria:

* participants who specifically withdraw consent
Impact of Hybrid Closed-Loop Systems on Sleep and Psychosocial Outcomes in Youth With T1D and Their Parents

This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants.

Sleep is important for everyone, including youth with type 1 diabetes. New technology has shown improvements in glycemic variability, especially overnight. This study evaluates the impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures. Study measures occur prior to starting the hybrid closed-loop system, immediately after starting the system and at 3 and 6 months after starting the system.

Eligibility Criteria:
Inclusion Criteria:

* Child diagnosed with type 1 diabetes for at least 3 months
* Child receives clinical care at the Barbara Davis Center for Diabetes
* Child starting an advanced HCL system as part of routine diabetes care
* Child currently living with a parent who is willing to complete surveys for this study
* Family able to read and speak English
* Parent lives at home with the child with type 1 diabetes
* Parent able to read and speak English

Exclusion Criteria:

* Child has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
* Child participating in an interventional research protocol
* Child unable to complete study procedures
* Parent has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea
* Parent unable to complete study procedures
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower
* Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:

  * Coronary artery disease
  * Cerebrovascular disease
  * Peripheral arterial disease
  * Chronic kidney disease defined as:

    * eGFR \<45 millilitres/minute/1.73 meter squared (mL/min/1.73m\^2) and UACR \>30 milligram/gram (mg/g) (0.030 mg/mg)
    * eGFR \<60 mL/min/1.73 m\^2 and UACR \>100 mg/g (0.100 mg/mg), or
    * eGFR \<75 mL/min/1.73 m\^2 and UACR \>300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)
* A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

Diabetes related:

* Participants have Type 1 Diabetes or any history of diabetic ketoacidosis

CV related:

* Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:

  * Myocardial infarction
  * Acute coronary syndrome
  * Stroke, or
  * Coronary, peripheral, or carotid artery arterial revascularization procedure.
* Have acute decompensated heart failure requiring hospitalization.
* Have New York Heart Association (NYHA) Classification Class IV heart failure at screening

Kidney related:

* Participants have an eGFR \<20 mL/min/1.73 m\^2 at screening
* Have UACR \>5000 mg/g (5.000 mg/mg) at screening
* Have received any form of dialysis ≤ 90 days from the date of randomization
* Have either undergone a kidney transplant or have a transplant procedure scheduled

Other medical conditions:

* Participants have had or plan to have a surgical treatment for obesity,
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
* Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction
Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.

The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.

The investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.


Eligibility Criteria:
Inclusion Criteria:

* soon to complete inpatient treatment for opioid addiction
* living in southern Norway

Exclusion Criteria:

* psychosis/major depression, currently not treated
* pregnancy
* liver enzymes: ASAT or ALAT \> threefold above upper boundary
* maintenance treatment with methadone or buprenorphine
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-01-69

To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility Criteria:
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.
Time Restricted Eating in Haematological Malignancies

The goal of this clinical trial is to learn if time restricted eating (TRE), a form of intermittent fasting, can impact health outcomes in patients with chronic lymphocytic leukemia (CLL). The main questions it aims to answer are:

* In patients with CLL, is there a decrease or stabilization in cancer cell counts associated with TRE compared to baseline?
* Is there a decrease in immune cell autophagy (a cellular recycling process) activity associated with TRE compared to baseline?
* Does adherence to a TRE regimen improve patient experience and quality of life?

Immune cell autophagy activity in cancer patients will be compared to a subset of control participants without cancer.

Participants will:

* Adhere to a 16/8 fasting regimen, which involves eating as normal for 8 hours per day and fasting (only consuming water, black coffee or black tea) for the remaining 16 hours. They will follow this intervention for their choice of either 3 or 6 months.
* Complete monthly blood collections
* Complete weekly journal entries to record weekly weight and timing of first and last daily meals
* Complete weekly safety check-ins with a study team member for the first 4 weeks of the study and then bi-weekly thereafter
* Complete 3 quality of life questionnaires
* Provide 3 stool samples (optional component of study)
* Complete an end of study interview (optional component of study)


Eligibility Criteria:
Inclusion Criteria:

Experimental Participants: Diagnosis of CLL or SLL, Age 18-85, Peripheral blood lymphocytes \>20 x 10\^9/L, Hemoglobin \>90g/L, Platelets ˃90 x 10\^9/L, BMI of \>=20kg/m2, ECOG Performance Status \>=2; not following any form of IF for 4 months prior to study.

Control Participants: Absence of cancer diagnosis (active or historical), Age 18-85, Peripheral blood lymphocytes \<5 x10\^9/L, BMI of \>=20kg/m2, ECOG Performance Status \>=2; not following any form of IF for 4 months prior to study.

Exclusion Criteria:

Experimental and Control Participants: Unable to give consent, On medications required to be taken with food during the fasting window, Pregnant or breastfeeding, Diabetes mellitus, BMI drop to \< 18.5kg/m2 at any time during study, Anti-lymphoma therapy within the past 3 months, Expected to initiate anti-lymphoma therapy within the next 3 months, Unable to fast due to a digestive system disorder, \> 85 years of age (due to frailty, increased risk of infection, and burden of additional blood collections).
Perceptual Deficits in Schizophrenia

In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises.

The study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. Some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.

Schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. The disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. Current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. Computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. Our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training.

In this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia or schizoaffective disorder
* English speaking and reading

Exclusion Criteria:

* current substance abuse
* visual impairment
* neurological conditions
* current enrollment in another research study
Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

An version of the standard scale for syndrome differentiation of Yin Deficiency Syndrome is not available yet for Chinese medicine.

The aim of this study is to develop and validate the standard scale for syndrome differentiation of Yin Deficiency Syndrome. The study is divided into two steps. The first step is to develop the standard scale for syndrome differentiation of Yin Deficiency Syndrome through expert consultation (Delphi method). The second step is to apply the scale in the participants and find out the diagnostic cut-off value of the scale by comparing it with the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Subject will be recruited from the current outpatients' clinic activity of the affiliated hospitals of Beijing University of Chinese Medicine and Nanjing University of Chinese Medicine. Subjects must be able to read and write in Chinese. After obtained informed consent we will ask them to participate to this study.
* All the subjects need to fill in the scale of Yin Deficiency syndrome and be diagnosed by a specialist in traditional Chinese medicine (TCM) to determine whether they have Yin deficiency syndrome. The judgment of TCM experts is the gold standard.

Exclusion Criteria:

* Participates who not meet eligibility criteria