cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

The objectives of this study are:

1. To compare the OCTA image quality between the SPECTRALIS and the predicate.
2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.

Eligibility Criteria:
Inclusion Criteria:

All subjects:

* Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
* Age ≥ 22

Subjects with Normal Eyes:

* Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
* Corrected visual acuity ≥ 20/40 in each eye
* No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye

Subjects with Pathology:

* Subjects with retinal conditions in at least one eye.
* Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Exclusion Criteria:

* Subjects unable to read or write
* Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
* Subjects who cannot tolerate the imaging procedures
* Subjects with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
* Subjects with contraindication to pupillary dilation in study eye
A Safety and Efficacy Study Evaluating CTX001 in Participants With Transfusion-Dependent β-Thalassemia

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in participans with transfusion-dependent β-thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of transfusion-dependent β-thalassemia (TDT) as defined by

  1. Documented homozygous β-thalassemia or compound heterozygous β-thalassemia including β-thalassemia/hemoglobin E (HbE). Participants can be enrolled based on historical data, but a confirmation of the genotype using the study central laboratory will be required before busulfan conditioning
  2. History of at least 100 mL/kg/year or ≥10 units/year of packed RBC transfusions in the prior 2 years before signing the consent or the last rescreening for patients going through re-screening
* Eligible for autologous stem cell transplant as per investigator's judgment

Key Exclusion Criteria:

* A willing and healthy 10/10 Human Leukocyte Antigen (HLA)-matched related donor is available per investigator's judgement
* Prior allo-HSCT
* Participants with associated α-thalassemia and \>1 alpha deletion or alpha multiplications
* Participants with sickle cell beta thalassemia variant
* Clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the investigator
* White blood cell (WBC) count \<3 × 10\^9/L or platelet count \<50 × 10\^9/L not related to hypersplenism

Other protocol defined Inclusion/Exclusion criteria may apply.
Berberine and Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.


Eligibility Criteria:
Inclusion Criteria:

* normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
* newly detected Polycystic Ovary Syndrome

Exclusion Criteria:

* any concomitant medication
* presence of liver, renal and thyroid disease
* smoking
* drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Addressing Systemic Health Disparities in Early Identification and Treatment of Autism Spectrum Disorder (ASD): ABCD Project

The intervention under examination is designed to promote parents' school engagement following the transition from Early Intervention (EI) to preschool for parents of young children who were diagnosed with ASD through our screening and assessment protocol. The brief intervention employs principles of motivational interviewing to address not only the particular child characteristics and needs associated with ASD but also the unique, system-related challenges of navigating the special education system and advocating for appropriate services. Motivational interventions with parents are designed to elicit parents' specific, action-oriented goals for themselves and their children, enhancing motivation to pursue change, and addressing and resolving obstacles or sources of ambivalence.

By identifying and capitalizing on parents' strengths, empowering parents to develop specific goals, and improving parents' readiness to engage actively with their children's school, teacher, and educational team, we expect that this brief intervention will lead to higher levels of parental school involvement, higher special education engagement, and closer and more productive parent teacher relationships.


Eligibility Criteria:
Inclusion Criteria: Parents of children who participated in our screening and assessment study, whose children received diagnoses of autism through our assessment, AND

* whose children are turning 3 and transitioning out of Early Intervention services.

Exclusion Criteria: Children who are medically complex OR

* have a previous diagnosis of ASD outside of our study OR
* Don't have a parent/guardian who speak/understand sufficient English or Spanish to complete study materials OR
* Don't qualify for Early Intervention services
Effects of Black Pepper on the Absorption of Nutrients in Vegetables

The objective of this project is to determine the extent to which eating black pepper together with vegetables increase the absorption of carotenoids (a class of important nutrients) in the vegetables such as beta-carotene.

Black pepper has multiple health-promoting effects, many of which are associated with the relatively high levels of piperine it contains. Piperine can enhance the oral bioavailability of nutraceuticals in foods due to its inhibitory activity on drug metabolizing enzymes such as cytochrome P450 and p-glycoprotein in the gastrointestinal mucosa. This decreases the first-pass metabolism of nutraceuticals thus increasing their levels in the systemic circulation. Numerous studies in both animals and humans have validated the efficacy of piperine in boosting nutraceutical bioavailability. However, most of these studies utilized highly purified sources of both piperine and nutraceuticals, and therefore do not provide direct evidence on the ability of black pepper (used as a spice) to enhance the bioavailability of nutraceuticals in real foods.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 year old healthy adults

Exclusion Criteria:

* those who are \<18 or \>30 years old, have a BMI of \<20 or \>29 kg/m2, have a weight change \>4.5 kg (9.91 pounds) in the past 3 months, exceed exercise activities of a recreational level over the past 3 months, have any diseases, especially intestinal disorders including lipid malabsorption or lactose intolerance, had abnormal liver or kidney function tests.
* Those who smoke, consume more than two alcoholic drinks per day, use medication affecting lipid profiles or dietary supplements affecting plasma cholesterol (e.g., Benocol or fiber supplements) will also be excluded.
* Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
Effect of Intravesical B.C.G and Gemcitabine on Semen Quality and Testicular Volume

To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume.

Local chemotherapy has become one of the alternative strategies in treatment of cancer as many side effects on organs in human body. Despite this, also local chemotherapy has adverse effects too. One of these cancers in which local chemotherapy is used and one of the most five prevalent cancers in Egyptian men and the 3rd highest incidence numbers for specific cancer cases in Egypt in 2020,also It represents the 3rd highest mortality number from cancer in Egypt by 19% of men's mortality is bladder cancer. It is divided according to the staging system into 2 main types: the non-muscle invasive (T1) and muscle invasive (T2).The most common method used to treat T1 baldder cancer are TURT followed by local intravesical immunotherapy (like Bacillus Calmette Guerin) and chemotherapy (Gemcitabine and Mitomycin C). These drugs systemically can cause side effects like urgency, frequency, low grade fever, malaise, effect on high proliferative tissues like bone marrow, skin, hair, and seminiferous tubules....etc. Some rare side effects are acute respiratory distress syndrome and hepatic toxicity. The effect of these drugs on seminiferous tubules is still a controversy as most of the research field is focusing on systemic use, also the lack of researches focusing on local intravesical use. It can cause infertility especially in young patients with cancer who seek fertility and they are not married or not having children. The problem of fertility and urogenital cancer is multifactorial and there is a gap of knowledge as low incidence number of bladder cancer in young patients and the lack of he studies focusing on fertility in cancer patients. This study is going to unmask the mystery of one of local immunotherapy and immunotherapy and there effect on semen and testicles.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients from 20 to 60's year old (the years of reproductive active men)
2. Non muscle invasive bladder (T1 or less) urothelial carcinoma who are elected to intravesical immunotherapy or chemotherapy after TURT

Exclusion Criteria:

i. T1 carcinomas of bladder in which intravesical immunotherapy and chemotherapy is contraindicated ii. Patients under conditions that may affect sperm number, e.g. Systemic chemotherapy, radiotherapy and previous history of genitourinary tuberculosis, Prostatic carcinoma,...etc iii. Abnormal semen parameters or abnormal hormonal profile (hypogonadism) that interfere with the study, especially azoospermia and aspermia
An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus

This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects


Eligibility Criteria:
Inclusion Criteria:

* Subjects six (6) months of age and older
* Subjects who have:

  * Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to the institution's standard of care, and;
  * Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AEDs), according to the institution's standard of care, and;
  * Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agents and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an EEG burst or seizure suppression pattern.

Exclusion Criteria:

* Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
* Children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder
* Subjects who have any of the following:

  1. a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;
  2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
  3. fulminant hepatic failure;
  4. no reasonable expectation of recovery or life-expectancy of less than 30 days.
* Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol
Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).

Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.


Eligibility Criteria:
Inclusion Criteria:

* Age from over 20 to under 60 years
* Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy
* Mid-low rectal cancer (distance from anal edge≤12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
* Expected curative resection through both L-PANP-TME and O-PANP-TME; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent
* Urinary and sexual function normal preoperatively

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous pelvic surgery
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Contraindication of heart, brain, lung, etc dysfunction
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer
* Rectal cancer invades surrounding tissues
* Existence of genuine incontinence or severe stress incontinence preoperatively
NeuroStar TMS Therapy System: Utilization and Outcomes

The major objective of this observational study is to describe clinical outcomes of patients receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder

Exclusion Criteria:

* Contraindications to treatment with TMS
Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding whether the therapeutic effects of DBS are associated with inhibition or excitation of target neurons, the introduction of new activity into the network, or a combination of these mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation frequency.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson disease who have undergone subthalamic deep brain stimulation

Exclusion Criteria:

* Patients who are unable to follow verbal instructions
* Patients who are unable to tolerate being off their Parkinson's medications for 12 hours
* Patients who are medically unstable
The Phenomenon of "Chronic Lyme"; an Observational Study

The current study is set up to chart clinically and laboratory findings in Norwegian patients with symptoms attributed by themselves or their doctor to ongoing chronic Bb infection. Objectives is to assess laboratory findings in relation to established diagnostic criteria and to form a picture of the burden of symptoms and illness perception in this group of patients. The study is essentially exploratory, and is supposed to raise rather than to test hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms attributed by themselves or their doctor to ongoing chronic Bb infection

Exclusion Criteria:

* None
Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome

The investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome.

injections in lacrimal gland four times during the study for each patient

Eligibility Criteria:
Inclusion Criteria:

* Platelet counts, and clotting factors in the standarts
* Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist

Exclusion Criteria:

* Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
* Patients with complete stenosis of both lacrimal meatus in the treated eye
Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

Exclusion Criteria:

* Acute bowel obstruction requiring urgent surgical intervention
* Deemed by treating physician to have high risk of acute bowel obstruction
* Concurrent active perianal sepsis
* Internal fistulising disease in association with strictures (entero-enteric stulas)
* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Pregnancy
* Inability to undergo MRI small bowel due to a contraindication.
Mindfulness and Romantic Relationship Quality

The overarching aim of this proposal is to experimentally test whether a mindfulness intervention improves relationship quality. Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research. After the 14-day period, couples will attend a lab visit and provide relationship quality data.

Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Thus, both partners will either complete the mindfulness intervention (developed to increase attention towards and acceptance of current experiences) or a relaxation-based active treatment comparison intervention (developed to parallel the structure of the mindfulness intervention without the attention towards or acceptance of present experiences). Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research, which demonstrated that the mindfulness intervention reduced stress reactivity and improved daily well-being. After the 14-day period, couples will attend a lab visit and provide multi-method relationship quality data.

Eligibility Criteria:
Inclusion Criteria:

* Couples living together for at least 2 years
* Both partners must be fluent in English
* Both partners cannot already engage in regular systematic mind-body practice (\>2 times per week).
* Both partners must have daily access to an internet-enabled smartphone to complete the intervention

Exclusion Criteria:

-