cyrilzakka/clinical-trials huggingface dataset:
Discontinuation Study of Imatinib in Adult CP CML Patients Who Have a Complete Molecular Response to Imatinib

This prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript

Imatinib (IM) treatment has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML) and approximately 50% of CP CML patients who received IM treatment achieve complete molecular response (CMR) at 6-7 years.(Hochhaus A et al. Leukemia 2009;23:1054-1061, Hughes et al. Blood 2008;112:334) The recent data from a study aimed to assess whether IM can be discontinued in patients with a CMR lasting at least 2 years showed the probability of persistent CMR at 12 months was 41%, and suggested IM can be safely discontinued, at least in some patients with sustained CMR. (Mahon et al. Lancet Oncol 2010;11:1029-1035) However, to define whether discontinuation of IM treatment can be safely employed, further validation and much longer follow-up are needed.

Aims This prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript.

Primary Objective:

* To evaluate the probability of persistent undetectable molecular residual disease (UMRD) and MR4.5 at 12 months after discontinuation
* To measure the duration of persistent UMRD and MR4.5 after discontinuation
* To identify contributing factors for sustained undetectable transcript

Secondary Objective:

* To evaluate the probability of major molecular response (MMR) loss
* To evaluate the time taken to lose MMR at 12 months after discontinuation
* In patients with loss of MMR, the probability of re-achieving MMR/MR4.5
* To measure the time taken to re-achieve MMR/MR4.5 after IM resumption
* To identify contributing factors for sustained re-achieve MMR/MR4.5

Trial Design This is a prospective, multicenter, non-randomised IM discontinuation study.

Response Evaluation After discontinuation, molecular response was monitored using RQ-PCR assay every month up to 6 month follow-up, every 2 months up to 12 month follow-up, and every 3 months thereafter. The loss of MMR, MR4.5, and UMRD were defined on 2 consecutive assessments.

If loss of MMR occurred, IM treatment was re-introduced. Written informed consents were obtained for all patients

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years-old) Ph+ CP CML patients who were treated with IM for more than 3 years in sustained MR4.5 or undetectable transcript for at least 2 years are enrolled. MR4.5 or undetectable transcript must be sustained by 2 consecutive RQ-PCR assay within 6 months

Exclusion Criteria:

* Patients were diagnosed with AP or BP CML
* Ph+ ALL
* Received cytotoxic chemotherapy or any other TKIs except imatinib
* Any evidence of on-going graft versus-host disease (GVHD)
* Relapsed patients after allogeneic stem cell transplantation
Characterizing Malignant Tumors Using Ultrasound Doppler Imaging

The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.


Eligibility Criteria:
Inclusion Criteria:

* Women presenting for routine abdominal/vaginal ultrasound

Exclusion Criteria:

* Pregnant women
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.

Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep.

The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance.

Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.

Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. OSA lead to desaturation and often lead to an arousal.

Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.

The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively low compliance.

Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake. Odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .

Eligibility Criteria:
Inclusion Criteria:

1. OSA diagnosed; AHI≥20
2. Male and Female Aged 40 to 70 years old
3. Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study
4. BMI\< 35
5. Patient is willing and able to give his/her written informed consent

Exclusion Criteria:

1. Chronic lung disease (including Asthma and COPD)
2. Congestive Heart Failure
3. Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment
4. History of severe nasal allergies or sinusitis or difficulty breathing through the nose
5. Persistent blockage of one or both nostrils
6. Any previous operation or trauma to the nose
7. Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure
8. Any use of antipsychotic, Hypnotic drugs
9. Major neurological diagnosis
10. Active malignant disease including chemotherapy or radiotherapy treatment
11. Pregnant or lactating women
12. Drug abuse
13. Medical history of epilepsy
Baby Smell Visual Stimulus Program Cortical and Breast Oxygenation Milk Amount Mother-Infant Attachment

In this study, the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the NICU on cortical and breast oxygenation (rSO2), amount of breast milk and mother-infant bonding was investigated.

One of the conditions that prevent the preterm baby from being close to the mother in the early period is cesarean delivery and subsequent removal to the NICU. In the first hour of life, the process immediately after birth, when the newborn is alert, makes eye contact, focuses, finds the unaided mother's breast and begins to feed, deteriorates in babies in need of intensive care and mothers begin the experience of parenting with delayed attachment. The mother experiences high levels of stress due to changes in many parental roles such as being physically separated from her baby, not being able to breastfeed effectively, not being able to care for her baby and the intensive care environment, and experiencing a delay in lactation with the effect of cesarean delivery. In the literature, many interventions have been implemented to reduce the negative effects of mother-infant separation on lactation and attachment in mothers who have given birth by cesarean section. However, there is no published research examining the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the NICU on cortical and breast oxygenation (rSO2), amount of breast milk and mother-infant bonding. In addition, being able to assess how the mother's cortical and breast oxygenation changes while smelling her baby's scent and watching her/his video will further strengthen the results of the measurement tools.

Eligibility Criteria:
Inclusion Criteria:

Infant

* Born at 28-37 (36+6) weeks of gestation
* Admission to the NICU in the same hospital as the mother immediately after birth Mother
* To agree to participate in the study,
* To give birth by cesarean section,
* To be able to use the Turkish language,
* To pass the smell test (to correctly identify the 3 different types of smell presented),
* Not to have been diagnosed with depression etc. Psychiatry at the time of the study

Exclusion Criteria:

Infant

* The presence of conditions that affect the baby's original smell (baby born with Meconium, Hepatitis C and HIV infected baby)
* Infant who underwent interventional intervention in the head area
* The baby whose suction function is sufficient and who can suck breast milk

Mother

* Admission to Intensive Care,
* Being covid positive (as the sense of smell will be affected),
* Having a mental, neurological, nasal related disease,
* Having a communication problem
The Effect of Acute Resistance Exercise on Inhibitory Control

The current study is a five-arm, single bout program aiming to assess the effects of training volume and intensity of acute resistance exercise on inhibitory control on neurocognitive function with respect to event-related potential in adults aged 20 - 26 years.

The current study is expected that 175 healthy adults will be recruited and randomly assigned to control group, low volume-moderate intensity, moderate volume-moderate intensity, high volume-moderate intensity, or moderate volume-low intensity group, with 35 participants in each group. Participants will be required to conduct two experiments. The first was the familiarity experiment, which consisted of the experiment description, the familiarity test, and the 6 Repetition Maximum (RM) test. The process lasted about 3 hours. The exercise group was given a warm-up exercise before the intervention, followed by resistance exercise, including Bench Press, Rowing, Deadlift, and Squat, all completed on the Smith machine. After the exercise, the group was given a cool down, while the control group was given 30 minutes of reading. Before and after the intervention, Stroop, event-related potential and fingertip blood lactate were measured, and another fingertip blood lactate was measured 10 minutes after the intervention, which lasted about 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* The dominant hand is right-handed
* 18.5 \< BMI \< 26
* Can cooperate with fingertip blood collection
* No color blindness and epilepsy
* Not taking medications that affect brain function
* Irregular exercise (more than 150 minutes per week for 3 months)

Exclusion Criteria:

* The participants who do not meet the inclusion or The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) Criteria.
Safety and Effectiveness of Nintedanib in Korean Patients

The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been started on Ofev in accordance with the approved label in Korea
* Patients who have signed on the data release consent form

Exclusion Criteria:

* Patients for whom nintedanib is contraindicated according local label of Ofev

  * Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients
  * Women who are pregnant or nursing
  * Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment
Effects of Myofascial Release Therapy and Endurance Training on Mechanical Back Pain

This study is a randomized clinical trial to determine the effects of myofascial release therapy versus endurance training of trunk extensor muscles on pain, disability and muscle endurance in patients with mechanical back pain. A sample of 24 patients will be taken and divided into two groups each with 12 patients. Group A will receive myofascial release therapy and conventional physical therapy while group B will endurance training of trunk extensors and the conventional physical therapy protocol. The conventional physical therapy protocol will include a hot pack, back care advice, and postural modifications. The session will be around 40 to 45 min for each patient with four sessions per week. A total of four-week treatment regime will be given to the patients and assessment of the patient's pain, disability, and endurance with NPRS (numeric pain rating scale), Rolland Morris Disability Questionnaire and Sorenson Test will be done at the baseline, after the completion of treatment at pre interventional and post interventional to observe the long-term effects. The data will be analyzed using SPSS.

Mechanical low back pain is an injury of an anatomic structure in the low back. It accounts for 97% of cases arising from spinal structures such as bone ligaments, nerves, etc. In chronic low back pain, exercise therapy has become a first-line treatment and should be routinely used. Fascia is a form of connective tissue made up of collagen, surrounds the body parts, and resists tissue tensile load. Fascial injury and adhesions are common and can lead to pain, restricted motion, and swelling. The treatment of the fascial injury is necessary to relieve those symptoms. There are many treatments for mechanical back pain and this study focuses on two new treatment techniques for mechanical back pain. The first is the myofascial release therapy, a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues. The other treatment technique is the endurance training of the trunk extensor muscles that involve the treatment which is directed to endurance training of erector spinae and latissimus dorsi. The current study is novel in a way that there is limited literature about myofascial release therapy versus endurance training of trunk extensor muscles in patients with mechanical back pain. Both methods were employed to see if they improve pain along with accompanying disability and muscle endurance.

Eligibility Criteria:
Inclusion Criteria:

* History of mechanical low back pain
* Back pain without association with leg pain

Exclusion Criteria:

* Any bony, soft tissue or systemic disease

  * Pregnant females
  * Radiculopathy
  * Patient with spinal deformities and fractures
Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome

Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance. In some patients, the disease can progress into steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and end-stage liver disease.

Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up.

To date, histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis. the procedure is however associated with significant complication in 0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo the liver.

The aim of the study is to evaluate, in a population of patients with the metabolic syndrome, whether non-invasive tests may identify those with hepatic fibrosis.

At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and elastography by MRI will be performed. Those tests will be repeated within 2 months.

A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography) tests are suggestive of hepatic fibrosis.

This study will allow to determine

* whether hepatic fibrosis may be detected by non-invasive means in patients with NAFLD/NASH.
* whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity
* whether the presence of fatty liver interfere with the results of the fibroscan and the elastography.
* whether there are metabolic factors associated with an increased risk of fibrosis in this population.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome with 3 out of 5 criteria (ATP III definition)

Exclusion Criteria:

* alcohol intake \> 20g/day (women), \> 30g/day (men)
* chronic liver disease of other cause: viral hepatitis (HBV, HCV), Wilson's disease, haemochromatosis, alpha1 anti-trypsin deficiency, drug-induced, ...
* decompensated cirrhosis (Child-Pugh 3)
* body weight \> 120 Kg
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers

A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.

This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks.

The study will comprise of:

* A Screening Period of maximum 28 days for both Part 1 and Part 2.
* Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days.
* Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days.
* An outpatient Follow-up Period of approximately 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants with suitable veins for cannulation or repeated venipuncture
* All females must have a negative pregnancy test
* Females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of contraception
* BMI between 18 and 32 kg/m\^2 and weigh at least 45 kg

Exclusion Criteria:

* Has received another new chemical entity
* History of any disease or disorder which may put participant at risk in the study
* Current or recurrent disease of clinical significance
* Medical history of malignancies except for cervical carcinoma and non-melanoma skin cancer (NMSC)
* Any clinically important illness, medical/procedure, or trauma
* Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening
* Any positive result on screening for serum hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)
* History of latent or active tuberculosis (TB) or exposure to endemic areas
* Evidence of active TB or untreated/inadequately/inappropriately treated for latent TB
* Positive testing for Covid-19 prior to dosing, case of Covid-19 within 4 weeks, or long-term Covid-19-related sequelae
* Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG), and any clinically important abnormalities in the 12-lead ECG
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of liver metastases from various primary tumors
* Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
* Lesions of ≤3 cm in maximum diameter
* At least one FDG-avid lesion to be treated\*\*\*
* INR \< 1.5\*
* Platelet count ≥ 50,000

Exclusion Criteria:

* Age \< 18
* Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection
* INR \> 1.5 that cannot be corrected with fresh frozen plasma \*\*
* Platelet count of \<50,000 that cannot be corrected with transfusion
* More than 3 tumors in the liver
* More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
* Presence of any peritoneal Carcinomatosis

  * For patients on Coumadin, general clinical guidelines for IR ablation will be followed.

    * For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed
VitamIN D Treating patIents With Chronic heArT failurE

Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.

This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.

Eligibility Criteria:
Inclusion Criteria:

* Class II or III CHF
* Stable symptoms (on otherwise optimally tolerated medical therapy)
* Able to give written informed consent

Exclusion Criteria:

* Currently taking vitamin D supplementation
* Untreated valvular heart disease
* Existing class I indication for vitamin D therapy
* History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia
* Heart failure due to anaemia or thyrotoxicosis
* Renal failure (GFR \<30l/min)