cyrilzakka/clinical-trials huggingface dataset:
A Study of TAK-861 for the Treatment of Narcolepsy Type 1

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861.

The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (NT1).

The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:

1. TAK-861 Dose 1
2. TAK-861 Dose 2
3. Placebo

The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.

Eligibility Criteria:
Inclusion Criteria:

1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^2).
2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
3. The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\].

Exclusion Criteria:

1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
4. The participant has a history of cancer in the past 5 years.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has a history of epilepsy, seizure, or convulsion.
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression

This research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 19-65 years
* Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
* Informed consent

Exclusion Criteria:

* Use of medication for bipolar depression or other psychotropic drugs
* Current Axis I mental disorders other than bipolar depression based on structured clinical interview
* Current borderline or antisocial personality disorder based on structured clinical interview
* Major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc)
* Hypersensitivity to divalproate or valpromide
* Diagnosis of porphyria
* Current or past liver diseases
* Severe dysfunction in liver or pancreas
* Use of mefloquine
* Alcohol or substance abuse/dependence
* Intelligence quotient of 80 or below
* Contraindications to magnetic resonance imaging
* Pregnancy or breastfeeding
* Allergy or intolerance to the study drugs
Study of Prediction of Ovarian Reserve in Yong Breast Cancer Patients Treated With Chemotherapy

The purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (POI), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-Müllerian hormone (AMH) detection method.

Young breast cancer women are often treated with adjuvant chemotherapy and neoadjuvant chemotherapy regiments include cyclophosphamide, anthracyclines and a taxane. These treatments can adversely affect ovarian function across the lifespan, causing premature menopause, infertility, and POI. AMH is currently the most robust marker of prediction of ovarian injury in cancer patients during chemotherapy in compare with other sexual hormone marker (such as follicle stimulating hormone (FSH), inhibin B) and ovarian volume, and is a more convenient way of prediction of ovarian reserve compare antral follicle count (AFC). But most of the patients' AMH levels become undetectable (using common AMH kits) after several cycle of chemotherapy, and some of these patients' AMH levels will maintained at a low level after chemotherapy, while others will recover. Using the ultrasensitive AMH detection method is expected to accurately assess the ovarian reserve during the chemotherapy treatment, predicting the risk of ovarian failure, and providing patients with ovarian and fertility function protection recommendations, such as using GnRHa regents during treatment and providing assisted reproductive technology consultants.

Eligibility Criteria:
Inclusion Criteria:

1. Female 18-50 years.
2. Suffering from breast cancer.
3. Treated with adjuvant or neoadjuvant chemotherapy.
4. Having regular menstrual cycle before chemotherapy.

Exclusion Criteria:

1. Bilateral oophorectomy or ovarian irradiation before enrollment.
2. Prior chemotherapy.
3. Oral contraceptives before enrollment.
4. Pregnancy or lactation.
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

The study aimed to examine the efficacy and safety of tVNS as a complementary approach for NT1 by conducting a double-blind, randomized, sham-controlled trial. The specific objectives of the study were as follows: To evaluate the effects of complementary tVNS on the ability to maintain wakefulness, severity of narcolepsy, mood and quality of life in patients with NT1


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires
2. The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126
3. Local residence for more than 3 months
4. Willingness to follow the trial plan as scheduled

Exclusion Criteria:

1. History of a clinically defined neurological or sleep disorders other than NT1
2. Any psychiatric disorder involving a history of psychosis
3. Any chronic condition affecting the ability to read or comprehend written instructions
4. Any substances abuse within the past 12 months
5. Pregnant or nursing
6. Metallic implants or devices contraindicating tVNS
High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers

The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is much higher than previously assumed, with approximately 10 % of patients undergoing non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study furthermore showed that patients treated with a high inspiratory oxygen fraction during surgery had a higher 1 year mortality compared with patients treated with a low inspiratory fraction. This was especially significant among patients undergoing cancer surgery. A possible explanation, is that a high oxygen fraction results in oxidative stress and endothelial dysfunction.

With this randomized cross-over study we wish to investigate the effect of a high inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The primary outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a measure for the effect of oxygen on the autonomic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent

Exclusion Criteria:

* Smoking, or ex-smoker Any kind of medication on a daily basis History of atopic dermatitis Known familiar hypercholesterolemia History of arteriosclerotic disease in the first and second-degree relatives Known or unknown arrhythmias, as measured by the baseline HRV-recording
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).


Eligibility Criteria:
Inclusion Criteria:

* Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
* Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
* Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
* Meets the criteria to receive lymphodepleting chemotherapy
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

* History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
* Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
* Hepatitis B infection
* Hepatitis C infection defined as (anti hepatitis C virus \[HCV\] antibody positive or detectable HCV ribonucleic acid \[RNA\]) or known to have a history of hepatitis C
* Seropositive for human immunodeficiency virus (HIV)
* Uncontrolled autoimmune disease
Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age \>18 years, \<75 years.
2. Lesion suitability for BVS deployment: target vessel calibre \>2.3mm and \<3.8mm reference diameter, without significant tortuosity or calcification.
3. Listed for single-vessel PCI procedure.
4. Lesion length≤28mm (to accommodate single BVS/DES)
5. Preserved left ventricular ejection fraction (EF≥50%).

Exclusion Criteria:

1. Patients with confirmed myocardial infarction within the preceding 2 months.
2. Allergy or intolerance to aspirin, clopidogrel, prasugrel or ticagrelor or contraindication to 12 months' dual antiplatelet therapy.
3. Contraindication to use of adenosine (asthma/chronic lung disease with documented bronchoreactivity).
4. Significant known comorbidity or terminal condition with life expectancy \<6 months.
5. Pregnancy.
6. Coagulopathy or warfarin treatment.
7. Significant renal impairment (baseline creatinine\>130 mmol/l).
8. Other comorbid condition that may affect microcirculatory function or troponin release (eg. Seropositive inflammatory conditions).
9. Inability to comply with follow-up requirements.
10. Target lesion in left mainstem, saphenous vein or arterial grafts.
11. Chronic total occlusion.
The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy

The purpose of this graduate student research study is to explore the effects of a new treatment known as Intraneural facilitation (INF) on Diabetes Mellitus Type 2 (DMT2) subjects who have moderate - severe below ankle neuropathy symptoms. Since INF has shown success in the clinic and significant improvements have been found in a recent pilot study, this study aims to further explore these effects on DMT2 subjects suffering from DPN. The investigators would like to investigate if INF improves blood flow in the foot, if it decreases the pain and improves the sensation, and if it improves the overall quality of life.

The demographic data (age, height, gender, and weight) will be collected from each subject. All subjects will go through the following protocol: First, subjects will complete pre-testing measurements consisting of 5 tests; Pain Quality Assessment Scale, Semmes-Weinstein Monofilaments, NeuroCom SMART Balance Master, Quality of Life- Diabetic Neuropathy Scale (QOL- DN), and Zeno Walkway. Patients will then be randomized into two groups and blinded by the treatment. Patients who draw "Group 1" will be given the INF treatment and patients who draw "Group 2" will be given the SHAM treatment. Patients will then be completing 3 weeks of INF treatment, or SHAM treatment for 3 visits per 3 week, totaling 9 treatment visits. Post treatment, patients will then return for the same 5 measurements completed at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
* Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
* ≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
* Between age 50-75 years

Exclusion Criteria:

* Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
* Any lower extremity amputations or wounds
* Documented active alcohol and/or drug misuse
* Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
* DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
* Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
* Other severe chronic medical condition requiring active treatment
* Morbidly Obese patients
* Pregnancy (self reported)
Preemptive Co-infiltration of Triamcinolone Acetonide with Ropivacaine for Postoperative Pain in Major Spinal Surgery

Patients undergoing major spinal surgery usually experience moderate to-severe postoperative pain. Inadequate pain control may lead to severe complications.

Local infiltration analgesia (LIA) with a local anesthetic, is a simple, minimally invasive, and effective postoperative pain management technique. However, LIA with local anesthetic alone can only last for a short time, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. Triamcinolone acetonide as an adjunctive infiltration to local anesthesia presented a superior analgesic benefit compared with local anesthesia alone in various types of surgeries. To date, no studies have evaluated the additive analgesia effects of triamcinolone acetonide on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of triamcinolone acetonide and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.


Eligibility Criteria:
Inclusion Criteria:

Age 18-65 years; Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia; American Society of Anesthesiologists (ASA) physical status of I-III; Anticipated full recovery and cooperation within 2 hours postoperatively.

Exclusion Criteria:

History of spinal surgery; Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS); Body mass index (BMI)\<15kg/m2 or \>35kg/m2; Peri-incisional infection; History of diabetes mellitus and other metabolic diseases; History of severe cardiopulmonary, hepatic or renal dysfunction; Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value); History of allergies to any of the study drugs; History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery; Use of systemic steroids within 1 week before surgery; History of psychiatric disorders, chronic neck or back pain; History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively; Pregnant or breastfeeding; Refusal to sign informed consent.
A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects

This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) Japanese subjects and White subjects (origins in Europe, the Middle East, or North Africa)
* Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg

Exclusion Criteria:

* History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
* Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
* Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic

Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.

ASPIRE is focused on the first trimester, a critical and vulnerable period when all of a baby's organ systems form and the placenta - the crucial connection between mom and baby - develops.

Currently, there are no data about the effects of COVID-19 infections in the first trimester. The study will provide critical information to:

1. Guide the care of pregnant women
2. Protect the safety of their babies and families
3. Help those considering pregnancy in the future understand what it means to be pregnant in this new era

The investigators are recruiting 10,000 women from the start of pregnancy and will track COVID-19 exposures using frequent serology testing. The investigators will collect information during and after the pregnancy to try to determine the effects of COVID 19 for mom and baby.

Participants will be asked to do the following throughout pregnancy:

* Submit frequent, quick (\<1 minute each) symptom tracking reports using your mobile phone and/or computer.
* Collect finger-stick blood samples from home at several points throughout your pregnancy.
* Give permission to review medical records related to your pregnancy, delivery and baby's development.
* Complete questionnaires online about your health during your pregnancy and after delivery of your baby.

Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* Participant is 4-10 weeks pregnant (gestation)

Exclusion Criteria:

- Male (biologically unable to achieve pregnancy)
Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital

Strabismus (or squint) is defined as the presence of misalignment between the visual axes of the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into comitant (if the amount of misalignment between the 2 eyes remained equal in all directions of gaze) and incomitant (if the amount of misalignment varied in different directions of gaze). If the squinting eye was deviated inward, it is termed as a convergent squint or esotropia and if the squinting eye is deviated outward, it is termed as a divergent squint or exotropia. Pediatric esotropia may be congenital or acquired. Congenital esotropia is a well-defined entity with an onset prior to 6 months of age, characterised by a large stable angle, cross fixation, and a limited potential for binocular single vision. Acquired childhood esotropia may be paralytic or non-paralytic. The non-paralytic or concomitant type, which is neither congenital nor secondary to ocular pathology, can be divided into three main groups: (1) Accommodative esotropia, which may be fully accommodative, partially accommodative, or accommodative with convergence excess; (2) Non-accommodative esotropia; (3) Esotropia associated with neurological dysfunction, in particular cerebral palsy and hydrocephalus. The last group of esotropia will be excluded from our study. Pediatric strabismus must be treated early to maximize the potential for binocular vision and decrease the risk of amblyopia. Treatment goals include good vision in each eye (no amblyopia) and straight eyes (orthotropia). Both conditions are necessary to produce stereopsis, which is a third goal. Strabismus in children may result in undesirable appearance, amblyopia, impaired stereopsis, diplopia, and negative psychological effect.


Eligibility Criteria:
Inclusion Criteria:

1. Infants and children up to the age of 12 years.
2. Primary Concomitant convergent squint (1ry concomitant esotropia)
3. Candidate for surgical correction of squint

Exclusion Criteria:

* 1. Children with:

  1. Paralytic squint
  2. Consecutive esotropia
  3. Any neurological disorders e.g. hydrocephalus.
  4. History of previous squint surgery
  5. History of previous other ocular surgery (e.g. congenital cataract \& glaucoma) 2. Children who missed follow up.
The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures

The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women with one or more tumors in reproductive system

Exclusion Criteria:

* Pregnant women
* Unable to give consent