cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients

to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria


Eligibility Criteria:
Inclusion Criteria:

* Age =\>18 yrs
* Histologically proven hepatocellular carcinoma
* Non-cirrhosis or Child Pugh A cirrhosis
* Hepatic encephalopathy grade 0 or 1
* Multidisciplinary treatment (MDT)-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining treatment for advanced HCC.
* Minimal life expectancy of 3 months
* Willing and able to attend follow-up examinations
* Willing to stop active traffic participation or controlling machinery during the study period if applicable
* Signed informed consent
* Language: Dutch or English

Exclusion Criteria:

* Child Pugh B or C cirrhosis
* Hepatic encephalopathy grade 2 or more
* Previous systemic treatment for HCC
* Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
* Use of medicinal cannabis for other purposes
* Contra-indications for medicinal cannabis oil:

  * Patients who have experienced a myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction.
  * Patients with known psychotic disorders
  * Female patients who are pregnant or lactating
  * Patients (men or women) intending to start a family
  * Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil
A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

The goal of this study is to see if giving patients information about how smoking affects oral health will help them quit smoking. What we learn from this study will help researchers find new ways to help smokers.


Eligibility Criteria:
Inclusion Criteria:

* Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care
* Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day)
* Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months
* Fluent in English or Spanish

Exclusion Criteria:

* History of mouth or throat cancer
Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain

The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.

This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. In addition, Investigator and patient global assessment, patient preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients who complain of spinal disorder-related chronic pain persisting for 3 months or longer
* Patients who can fully observe the overall clinical study requirements including K-ODI completion at the investigator's discretion
* Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic
* Patients who have never been administered fentanyl matrix over the last one month

Exclusion Criteria:

* Patients with a history of the drug or alcohol abuse in the past or now
* Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
* Patients who are unable to use a transdermal system due to skin disease
* Patients with serious mental disorder
* Patients with history of hypersensitivity to opioid analgesics
* Patients with history of CO2 retention
* Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
Collection of Whole Blood Specimens in Pregnant Women

To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.

This is a prospective multicenter study in which whole blood specimens will be collected from pregnant women scheduled for an invasive procedure.

After the standard-of-care invasive procedure is performed in accordance with the site's clinical procedures, invasive prenatal diagnostic procedure results will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older at enrollment,
* Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
* Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling \[CVS\], amniocentesis, or percutaneous umbilical cord blood sampling \[cordocentesis\]) for cytogenetic analysis of the fetus

Exclusion Criteria:

* Has a known maternal chromosomal anomaly,
* Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
* Has a history of transplant or malignancy, or
* Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
* Already participated in this study (enrolled previously).
Influence of Different Approaches to Dietary Advising on the Effects of Acarbose Treatment in Obese Diabetic Patients Under Real-life Setting

It has been recently suggested, that not the diet by itself, but also patient's adherence to dietary recommendations and all actions performed to improve dietary compliance, may be a significant factor influencing blood glucose control. There are no clinical data on the influence of different approaches to dietary advising on the effects of acarbose treatment in obese diabetic patients under real-life setting in Poland. Thus, the aim of this study was to assess the influence of different approaches to dietary advisory on the effects of acarbose treatment (reflected by changes in HbA1c) in obese DM patients. We also intended to assess the influence of different approaches to dietary advising on the appearance of potential adverse events in acarbose treated obese DM patients.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* age\>18 years

Exclusion Criteria:

* Hypersensitivity to acarbose or any of the excipients
* age\<18
* pregnancy and in nursing
* inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
* chronic intestinal diseases associated with marked disorders of digestion or absorption
* states which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the post-prandial filling of the stomach\] and larger hernias)
* hepatic and severe renal impairment (creatinine clearance \<25 mL/min/ 1,73m2)
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix

The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

If you agree to take part in this study, after you are in the operating room and under general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the cervix. Images will be collected with the probe from the HRME device. The HRME probe is a long thin tube with a camera at the tip. This probe will be applied to the cervix and images obtained. These images will be used for research. This should add about 10 minutes to the total time you are in the operating room.

There will be no change to the planned standard-of-care colposcopy and biopsy.

Follow-Up:

A member of the research team will call you within 30 days after the procedure to ask how you are feeling and if you are having any symptoms. This call should last about 5 minutes.

Length of Study:

Your active participation in this study will be over after the biopsy.

This is an investigational study. The goal of this clinical research study is to learn if it is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Eligibility Criteria:
Inclusion Criteria:

1. Any woman with a confirmed preoperative diagnosis of cervical AIS, including co-existing squamous CIN and/or microinvasive cancer
2. Women undergoing cold knife cone (CKC) of the cervix at MD Anderson
3. Negative pregnancy test for women of child-bearing potential
4. Women who are \>/= 21 years of age and \< 65 years of age
5. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD)

Exclusion Criteria:

1. Women \< 21 years of age and \>/= 65 years of age
2. Women with a known allergy to proflavine or acriflavine
3. Women who are pregnant or nursing
4. Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
Dampening the Reproductive Axis With Continuous Kisspeptin

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.

Delivery of Interventions:

* Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
* On the day of the study, the subjects will have an intravenous (IV) line placed and

  * Undergo up to q10 min blood sampling x 36 hours
  * Receive an infusion of kisspeptin x 24 hours
  * Receive up to two kisspeptin IV boluses

Eligibility Criteria:
* Ages 18-45 years
* A history of clinical diagnosis of PCOS or equivalent clinical features
* BMI \>18.5 and \<35 kg/m2
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \> 90 mm Hg)
* Laboratory studies:

  * Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration
  * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women
* Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of administration
* No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
* No excessive alcohol consumption (\>10 drinks/week) and/or ongoing use of illicit drugs

  • Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation
* Not pregnant or trying to become pregnant
* Not breastfeeding
* No history of bilateral oophorectomy (both ovaries removed)
Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS) is a complex hormonal and metabolic disorder that has been shown to affect women's fertility. It can also share many symptoms with pre-diabetes, and women with PCOS often have an increased risk for type 2 diabetes, heart attack and stroke.

This study aims to assess the feasibility and acceptability of exercise intervention and increased lifestyle physical activity to improve cardiovascular disease risk factors in women with PCOS.

This is a three arm feasibility study in which participants will be allocated to an exercise group, an increased lifestyle physical activity group, or a control group. We will determine the appropriateness of procedures for recruitment, allocation, measurement and retention for the intervention procedures in women with polycystic ovary syndrome.

The investigators will also determine if we are able to detect changes in blood lipid profile, inflammation, and hormonal and metabolic profile as a result of the intervention(s) using blood biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with PCOS according to the Rotterdam Criteria 2003, National Institute of Health (NIH) 1990 criteria or Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.
* Have experienced menarche (their first menstrual bleeding) and be at least 18 years of age.
* Are English speaking.
* Are physically able to perform exercise.

Exclusion Criteria:

* Post-menopausal status.
* Are smokers.
* Are undertaking regular structured exercise defined as \>150min/week.
* Have been taking metformin for less than three months.
* Are taking the oral contraceptive pill (OCP) or have taken in the last month.
* Have any medical condition that may be responsible for the symptoms of PCOS, such as congenital hyperplasia, androgen-secreting tumour, hyperprolactinemia, or Cushing's syndrome.
* Have current cardiovascular disease or a history of cardiac events.
Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics

Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions.

Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control.

The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed before any activity related to the study
2. Age ≥18 years, both sexes
3. Start of AHCL for at least 6 months before enrollment (from 01/01/2021 to 31/12/2023).

Exclusion Criteria:

1. Diagnosis of type 2 diabetes mellitus or other forms of diabetes, such as metasteroid diabetes, secondary to pancreatectomy, related to pancreatitis or secondary to endocrinological disorders, gestational diabetes, maturity-onset diabetes of the young (MODY).
Prediction of the Effectiveness of Hypofractionated Radiation Therapy in Early Stage Lung Cancer by Bio-imaging and Biomarkers

Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival.

The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers


Eligibility Criteria:
Inclusion Criteria:

* Proof of cT1a/b - 2a/b N0M0 NSCLC
* Informed Consent signed
* Resectable tumour
* \> 18 years old
* men and women
Exercise, Acupuncture and Fibromyalgia

Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, who just get guidance for physical activity.

Fibromyalgia syndrome is a chronic musculoskeletal pain of unknown etiology. It is characterized by diffuse musculoskeletal pain or painful specific sites, usually accompanied by sleep disorders, fatigue, morning stiffness, chronic headaches, mental disorders and functional bowel. The diagnosis is essentially clinical, with no abnormal laboratory and radiological features Physical exercises are part of the treatment of fibromyalgia, but does not report studies in children. In general children with fibromyalgia are encouraged to a multidisciplinary treatment including medication, family education and child graduated aerobic exercise, psychotherapy, interventions to reduce pain, stress and improve sleep quality. To date no studies in medical literature with the use of acupuncture and supervised physical activity in juvenile fibromyalgia.

The significant sample of this disease, our recent publications in this research and the lack of systematic study of physical activity and acupuncture have stimulated this research. Assess pain reduction and improvement in quality of life in children and adolescents with juvenile fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Juvenile fibromyalgia diagnosis
* Age between ten to seventeen years and eleven months

Exclusion Criteria:

* Previous treatment with acupuncture;
* Treatment with psychotherapy, exercise training, use of antidepressant and anti-inflammatory drugs in the last month;
* Inflammatory diseases, hypothyroidism and hyperthyroidism
A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers

This prospective, randomized, single-blind, cross-over study will compare the bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, 18 to 55 years of age
* Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements
* Body mass index between 18 and 28 kg/m2
* Negative testing for drugs of abuse

Exclusion Criteria:

* History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs
* Volunteers require co-medications during the study
* Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start
* Having taken any medication with a clearance period of over seven half-life before study start
* Hospitalization or significant illness 30 days before study start
* Having received a investigational drug within 90 days prior to study start
Characterization of Interventricular Conduction Measurements

This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

The aim of this study is to characterize how right ventricular (RV) to left ventricular (LV) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (CRT) system. The study will be performed in conjunction with a CRT implant.

Eligibility Criteria:
Inclusion Criteria:

* Patient is greater than 18 years of age.
* The patient or the patient's legally authorized representative is willing to give informed consent.
* CRT indicated guidelines.
* Patient is receiving a Medtronic IPG or ICD.

Exclusion Criteria:

* Patients who are pregnant.
* Patient is in AF.
* Patient with 3rd degree AV block.