cyrilzakka/clinical-trials huggingface dataset:
89Zr-labeled NY008 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years old, male or female;
2. Patients diagnosed with relapsing or refractory multiple myeloma；
3. LVEF≥50%；
4. ECOG score 0\~2；

Exclusion Criteria:

1. Life expectancy of less than 3 months;
2. Participated in other clinical research within 1 month;
3. Recovery from major trauma (including surgery) within 28 days prior to study treatment;
4. Patients with systemic or locally severe infections, or other serious coexisting diseases;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Patients with allergies or allergies to any component of the imaging agent or antibody;
10. Patients who cannot undergo PET/CT imaging scan;
11. Syphilis, HBV, HCV, or HIV positive subjects;
12. Male and female subjects of reproductive age cannot take effective contraceptive measures;
13. Pregnant or lactating women;
14. Patients with a history of mental illness or related conditions;
15. Other subjects considered unsuitable by researchers.
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome

Stoke Therapeutics is evaluating the long-term safety \& tolerability of repeated doses of STK-001 in patients with Dravet syndrome who previously participated in studies of STK-001. Change in seizure frequency and overall clinical status, and quality of life will be measured as secondary endpoints in this open-label study.

This study is a multi-center, open-label, multiple-dose, safety extension study for patients who have completed another study of STK-001 and meet study eligibility criteria. STK-001 is an investigational new medicine for the treatment of Dravet syndrome. STK-001 is an antisense oligonucleotide (ASO) that is intended to increase the level of productive SCN1A messenger RNA (mRNA) and consequently increase the expression of the sodium channel Nav1.1 protein. This RNA-based approach is not gene therapy, but rather RNA modulation, as it does not manipulate nor insert genetic deoxyribonucleic acid (DNA).

STK-001 is designed to upregulate Nav1.1 protein expression from the nonmutant (wild-type) copy of the SCN1A gene to restore physiological Nav1.1 levels. Nav1.1 levels are reduced in people with Dravet syndrome. Stoke has generated preclinical data demonstrating proof-of-mechanism for STK-001.

Eligibility Criteria:
Inclusion Criteria:

* Completed dosing with STK-001 and the End of Study Visit in Study STK-001-DS-101 or Study STK-001-DS-102, with an acceptable safety profile per Investigator judgment.
* Had satisfactory compliance with study visits and procedures in Study STK-001-DS-101 or Study STK-001-DS-102 per Investigator and Sponsor judgment.
* Completed Study STK-001-DS-101 or STK-001-DS-102 within 4 weeks of the start of their participation in Study STK-001-DS-501 unless approved by sponsor.

Exclusion Criteria:

* Met any withdrawal criteria from Study STK-001-DS-101 or STK-001-DS-102.
* Currently treated with an antiepileptic drug (AED) acting primarily as a sodium channel blocker, as maintenance therapy, including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, rufinamide or cenobamate.
* Clinically significant unstable medical conditions other than epilepsy.
* Clinically relevant symptoms or a clinically significant illness (in the judgment of the Investigator) at Screening or prior to dosing on Day 1, other than epilepsy.
* Spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt.
* Treated (or is being treated) with an investigational product (other than STK-001) since participating in Study STK-001-DS-101 or STK-001-DS-102.
* Participating in an observational study, they are excluded unless approved by the Sponsor.
Percutaneous Kirschner Wires With Mutual Linking Technique in the Management of Proximal Humeral Fracture

This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures


Eligibility Criteria:
Inclusion Criteria:

* both sexes
* Age from 60 to80 years
* 2 or 3 parts fracture
* recent injury less than 3 weeks

Exclusion Criteria:

* 4 parts fracture
* old injury more than 3 weeks
* previous surgeries or pathologies affecting shoulder range of motion
Postoperative Pain After a Laparoscopic Cholecystectomy

Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or ASA 2
* uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery
* no choledocholithiasis
* no associated surgical procedures
* no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain
* no ascites
* no carcinomatosis

Exclusion Criteria:

* conversion to laparotomy
* need to keep an escat drain
Scleroligation for Eradication of Gastroesophageal Varices.

Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.

Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.

Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.

Exclusion Criteria:

* Patients were excluded if they had malignancy of any origin.
* Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
* Other potential causes of GIT bleeding.
* Patients with previous endoscopic or surgical intervention for varices were also excluded.
New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.

This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Eligibility Criteria:
Inclusion Criteria:

* Obesity grade I (BMI 30-34,9)
* Weight variance less than 5% in the last 3 months.
* Previous diagnosis of diabetes type 2.
* Insulin requirement, alone or along with oral agents
* Capacity to understand the procedures of the study.
* To agree voluntarily to participate of the study, signing an informed consent.

Exclusion Criteria:

* Positive Anti-GAD antibodies
* Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
* History of hepatic disease like cirrhosis or chronic active hepatitis.
* Kidney dysfunction (creatinine \> 1,4 mg/dl in women and \> 1,5 mg/dl in men).
* Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
* Recent history of neoplasia (\< 5 years).
* Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
Latent Myofascial Trigger Points in the Craniocervical Region

Myofascial pain is a clinical problem that has generated interest, debate and confusion for decades. According to studies anywhere between 33 and 97 % of patients with musculoskeletal pain visiting physicians and manual therapists are diagnosed with Myofascial Trigger Points (MTrPs). MTrPs are localized, hyperirritable points that are associated with palpable nodules in taut bands (TB) of muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain. The myofascial trigger points (MTrPs) are common in healthy subjects and in patients with musculoskeletal pain, and could produce sensitive disturbances and motor dysfunctions


Eligibility Criteria:
Inclusion Criteria:

* Neck pain

Exclusion Criteria:

* myelopathy
* fracture
* infection
* dystonia
* tumor
* inflammatory disease
* fibromyalgia
* or osteoporosis
The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation

The purpose of this study is to evaluate the effect of dexmedetomidine on hemodynamic responses during laryngoscopy and double lumen endotracheal intubation and assess the adverse effect related to complications of dexmedetomidine.

The cardiovascular responses to laryngoscopy and tracheal intubation are mediated by both sympathetic and parasympathetic nervous system. The hemodynamic responses resulting from sympathetic nervous system stimulation are tachycardia, cardiac arrhythmias, hypertension, increased intraocular pressure, increased intracranial pressure, bronchospasm and myocardial ischemia. Tachycardia is one of the major predictor of intraoperative myocardial ischemia and causes an imbalance of myocardial oxygen supply and demand. Although hemodynamic responses to laryngoscopy and intubation is transient, these effect may be harmful to patients suffering from myocardial and cerebrovascular diseases. The placement of double lumen endotracheal tube may produce similar or greater pressor response than endotracheal tube because of larger sizes and greater carinal stimulation.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status I-III
* Undergoing Elective Thoracotomy or Thoracoscopy
* Required Left Sided-double Lumen Endotracheal Intubation

Exclusion Criteria:

* Patients with bradycardia (heart rate \< 50 beat per minute) or heart block
* Suspected of Difficult Intubation
* Patients Who Are at Risk for Rapid Change of Hemodynamics
* Allergic to Dexmedetomidine
* Hepatic or Renal Impairment (Preoperative Serum Creatinine \> 1.5 mg/dl)
* Pregnancy
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

The aim of this study is to improve clinicians' calculation, interpretation and communication of familial colorectal cancer risk, as well as patients' risk perception and uptake of referral for genetic counselling or for surveillance by colonoscopy for their relatives at risk.

Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.

Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.

The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colorectal cancer before the age of 70
* Diagnosed in one of the participating hospitals
* Able to read and understand Dutch

Exclusion Criteria:

* Previous referral for genetic counseling
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body Mass Index (BMI): 18.0 - 32.0 kg/m2
* Normal renal function at screening

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease
* Any contraindication indicated in the MTX package insert
* History or presence of chronic bacterial or viral infection
* History or presence of an autoimmune disorder
* Any significant acute or chronic medical illness
* Active TB requiring treatment or documented latent TB within the previous 3 years
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

Other protocol defined inclusion/exclusion criteria could apply
Intravenous (IV) Nitroglycerin for Versions in Multiparous Women

Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).

Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials.

This study is designed to answer the following questions for multiparous women:

Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?


Eligibility Criteria:
Inclusion Criteria:

* any non-cephalic presentation
* singleton pregnancy
* \>/= 37 weeks gestational age
* normal amniotic fluid volume
* reassuring fetal heart rate

Exclusion Criteria:

* labor
* ruptured membranes
* history of third trimester bleeding
* any pre-existing uterine scar
* pregnancy induced hypertension and gestational diabetes
* oligohydramnios and polyhydramnios
* intrauterine growth restriction or macrosomia
* hypotension or any serious medical illness
* inability to comprehend consent form
Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

The aim of this observational study is to answer the following questions in individuals with acute and chronic exposure to organophosphates. The main questions to be addressed are

1. What are the prognostic values of neuroinflammatory markers?
2. What are the genotoxic effects of organophosphates?
3. what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?

This is a cross-sectional study that aims to assess the possible prognostic value of markers of neuroinflammation and nerve damage in patients with acute and chronic exposure to organophosphate pesticides by conducting a full proteomic and metabolomic profile. The possible genotoxic effect of common organophosphate pesticides will be studied as well. This will be conducted in parallel to the assessment of traditional markers of inflammation and oxidative stress. The target populations are patients with acute and chronic exposure to organophosphates with a total estimated number of 90 including individuals assigned to the control group with matched age and gender.

Eligibility Criteria:
Inclusion Criteria:

* For the control group: healthy individuals without previous exposure to organophosphates, with the specified age limits.
* For the acute exposure group: patients with acute exposure to organophosphates, with the specified age limits
* For the chronic exposure group: patients with chronic exposure to organophosphates, with the specified age limits

No restrictions on comorbidities in the three groups except those mentioned under Exclusion Criteria

Exclusion Criteria:

* Pediatric patients.
* Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.)
* Patients who does not meet the inclusion criteria.
A Study on the Use of Healthcare Resources and Costs of Attention Deficit Hyperactivity Disorder (ADHD) in Adults in England

The main aim of the study is to learn about the demographic and clinical characteristics, healthcare resources utilization (HCRU) and costs associated with before and after ADHD diagnosis in England. No study medicines will be provided to participants in this study. The record available in Clinical Practice Research Datalink (CPRD) database and Hospital Episode Statistics (HES) database for ADHD participants will be assessed.


Eligibility Criteria:
Inclusion Criteria

1. Age greater than or equal to (\>=) 18 years at the beginning of the patient observation period (that is 18-months prior to the adult ADHD diagnosis to ensure they would have been seen in adult health care services).
2. First record of an adult ADHD diagnosis between 01st January 2016 and 30th June 2018.
3. Data availability in the database at least during the 18-months before and after the index date.

Exclusion Criteria

A participant will be excluded from the study if their CPRD linked to HES electronic medical record data includes:

1. Incomplete information for key demographics (that is, missing age or sex).
2. Clinical history of a diagnosis of ADHD during childhood or adolescence.
3. Prescription of a licensed adult ADHD medication (that is, methylphenidate, lisdexamfetamine, dexamfetamine, atomoxetine) during the pre-index period.
Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study

This study evaluates Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority (INTENDED for SGM) in identifying the patient, support person and provider barriers to quality care in SGM breast/chest cancer survivors.

PRIMARY OBJECTIVE:

I. To determine the important ways the iCanDecide breast cancer decision aid needs revised for SGM people, and how best to integrate a culturally-relevant tool into clinical practice.

OUTLINE: This is an observational study.

AIM 1: Interview transcripts from SANGRIA study utilized to explore the values, preferences and key considerations for breast cancer treatment decision making in SGM individuals.

AIM 2: Patients are assigned to 1 of 2 groups.

GROUP 1: Cancer survivors participate in a focus group on study.

GROUP 2: Breast cancer clinicians undergo a semi-structured interview on study.

Eligibility Criteria:
Inclusion Criteria:

* SURVIVORS:

  * Self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender
  * Must be a breast cancer survivor, in active treatment or completed active treatment in the last 10 years (not including hormone therapy)
  * Be over age 18
  * English-speaking
  * Received care in the US

BREAST ONCOLOGY CLINICIANS: Physicians, advanced practice providers, nurses, psychologists and social workers will be eligible if they:

* Provide care and/or surgical decision support to individuals diagnosed with early stage breast cancer in the US
* Are English-speaking
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin

The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

The purpose of this study is to:

* Compare quantitatively the number of vegetative cells in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection
* Compare quantitatively the number of spores in the stool over time for patients presenting with their first episode of C. difficile infection having been treated with either fidaxomicin or vancomycin.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and above
* First diagnosis of C. difficile infection
* Treatment for C. difficile infection less than 24 hours
* Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 1 year, surgically sterile (i.e., documented tubal ligation or hysterectomy) for at least 90 days, abstinent, or agree to use 1 of the following forms of contraception from the time of signing the Informed Consent form (ICF) until 30 days after leaving the study site: a nonhormonal intrauterine device (IUD) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, or a sterile sexual partner.

Exclusion Criteria:

* History of hypersensitivity to fidaxomicin or vancomycin
* Pregnant or breast-feeding
* Active treatment with other therapies with activity against C. difficile
* Receiving any peristaltic agents
* Medical history including ulcerative colitis or Chron's disease
* Ordered to be nothing by mouth or cannot swallow the study medication
* Participation in another clinical research study utilizing pharmacological treatment within 1 month or five half-lives of the medication whichever is longer
* Any other reason felt by the investigator to potentially affect the outcomes of the study