cyrilzakka/clinical-trials huggingface dataset:
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP


Eligibility Criteria:
Inclusion Criteria:

* Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
* Able and willing to give written informed consent

Exclusion Criteria:

* Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
* Poorly controlled hypertension during Study C935788-047 or Study C935788-048
* Significant infection, an acute infection such as influenza, or known inflammatory process
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery

Need for perioperative blood transfusion is still high in certain types of oncological abdominal surgery. Allogeneic blood transfusion may be detrimental in cancer patients undergoing a potentially curative resection of malignant tumor, although the detailed mechanism of this effect is still under debate. We plan to evaluate whether a new, rotational thromboelastography-guided algorithm (ROTEM) to guide hemostatic resuscitation intra-operatively decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured. 60 patients having a potentially curative pancreaticoduodenectomy (or resection of cauda of pancreas), total removal or partial resection of kidney and open radical cystectomy are recruited when an active blood loss of more than 1500 ml is estimated and/or measured and are randomized into two groups: one will be treated conventionally, ie. using massive transfusion protocol (MTP) if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18, radical cystectomy, total or partial nephrectomy for malignant disease or pancreaticoduodenectomy planned and estimated intraoperative hemorrhage over 1500ml, written and informed consent

Exclusion Criteria:

* Known hemophilia or von Willebrandt's disease (treatment planned beforehand in collaboration with haematologist), unacceptance of allogeneic blood products (jehovah's witnesses).
A New Translational Tool for Studying the Role of Breathing in Meditation

A recent National Health Interview Survey reported that breathing exercises were the second most common complementary and alternative medicine practice in the United States, following only the use of "natural products." With such widespread interest in breathing exercises, alone or as a component of practices such as meditation, a need exists for research that examines not only its efficacy, but also investigates potential mechanisms of action. Indeed, a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation Workshop recommended research to clarify biological pathways by which meditation practices, including breathing exercises, can impact health. To explore mechanisms underlying the health effects of breathing exercises, new translational tools are needed that can measure breathing patterns in both the clinic and natural environment. The primary objective of the present proposal is the application of a new technology to the investigation of pathways by which breathing exercises can affect health. For this project, the health-related outcome measure to be studied is a major cardiovascular risk factor, blood pressure.


Eligibility Criteria:
Inclusion Criteria

* Mean 24-hr SBP: 130-139 mmHg
* Female
* \> 50 years of age
* Post menopausal, defined as greater than or equal to one year without a menstrual cycle.
* Body Mass Index (BMI): 19-31
* English speaking (Patients not able to read and speak English will be excluded as the behavioral group interventions are conducted in English)
* Has a personal physician

Exclusion Criteria (Individuals will be filtered in the KP OSCA database according to the following ICD-9 codes):

Respiration:

* 491.X chronic Bronchitis incl COPD
* 492.X emphysema
* 493.X asthma
* 494-496; 500-519: all kinds of chronic pulmonary conditions

Cardiovascular:

* 404.9 chronic ischemic heart disease
* 425.X cardiomyopathies
* 428.X heart failure
* 430-438 cerebrovascular diseases

Kidney:

* 582-583 chronic glomerulonephritis
* 584-588 renal failure

Liver:

- 571.X chronic liver disease and cirrhosis Smoker: 305.1

Psychiatric:

* 290-299 dementia/schizophrenia/ psychoses...
* 303, 304 alcohol or drug dependence
* 317-319 mental retardation

Medications:

* All blood pressure medications
* All tranquilizers, benzodiazepins if prescribed regularly, e.g. every month
* All narcotics if prescribed regularly, e.g. every month

Other:

- Plan to relocate residence outside recruitment area during the intervention or follow- period
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding

To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening
* Heavy menstrual bleeding (HMB) \>80.00 mL associated with uterine fibroid(s)
* Good general health
* Normal or clinically insignificant cervical smear
* An endometrial biopsy performed during the screening period, without significant histological disorder
* Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drug
* Any condition requiring immediate blood transfusion
* Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Abuse of alcohol, drugs, or medicines (e.g., laxatives)
* Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding
Effect of Snacks on Appetite Control

This clinical trial is being conducted to study whether eating certain snacks will reduce your desire to eat and for a longer period of time compared to other snacks. The investigators are testing 2 different snacks. Study #1 will involve eating 2 different seed-like snacks or water. Study #2 will involve eating pita bread with jam, bread with jam or water. The test snack is higher in protein and/or fibre compared to the reference product.

Healthy adults will be recruited to participate in a randomized, controlled, crossover study to investigate whether or not eating snacks made with buckwheat would increase satiety and reduce their energy intake when compared to a comparable snack. Water was included as a non-caloric control. The study consisted of 3 visits and participants would receive a different treatment at each visit. Visits were scheduled at least 7 days apart. Visual analog scales will be used to assess appetite related sensations at 7 time points, fasting, 30 minutes after consuming the snack and then at 30 minute intervals for 180 minutes. Participants will be provided with a lunch and the amount of food consumed will be weighed. I addition, participants will be asked to maintain a food record for the remainder of the day.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18-30kg/m2
* males and non-pregnant or non-lactating females

Exclusion Criteria:

* Diagnosis of disease by a medical doctor that requires medical treatment during the study period.
* Daily tobacco use.
* Physical Activity Level \>1.8.
* Eat meals at irregular or unusual times.
* Food allergy, aversion or unwillingness to eat study foods.
* Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite.
* Presence of a gastrointestinal disorder.
* Score \>65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.
Optimal Placement Duration of Pancreatic Duct Stent

A randomized controlled trial to determine the optimal placement duration of pancreatic duct stents (PDS) inserted during ERCP: 2 vs 4 weeks

Endoscopic pancreatic duct stenting has been increasingly used for the treatment of a variety of pancreatic disorders including chronic pancreatitis, pancreatic duct stricture, drainage of pseudocysts, and the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). Several randomized, controlled trials and meta-analyses have proven a significant reduction in incidence and severity of post-ERCP pancreatitis (PEP) with prophylactic pancreatic duct stenting. The US and European guidelines recommend that pancreatic duct stents (PDS) be placed between 7-10 days and 5-10 days, respectively, in order to prevent PEP in some situations. Therefore, the placement of PDS has been an established essential procedure for preventing a fatal complication, PEP. Furthermore, PDS placement can facilitate difficult common bile duct cannulation. It may help not only to straighten papillary anatomy but also to identify the location of the biliary orifice.

However, PDS tends to become occluded easily due to protein content, calcium carbonate crystals, and bacteria in the pancreatic juice. The occluded PDS can cause acute pancreatitis or abdominal pain. For this reason, the guidelines recommend PDS be placed within 10 days. Because of this policy, the patient must take the inconvenience of undergoing another endoscopic procedure to remove the PDS. However, all patients with occluded PDS do not have symptoms such as pain. In one series, only 6 percent of patients with clogged PDS developed symptoms. The low incidence of symptoms despite a high rate of stent occlusion suggests that the stent may function as a wick around which pancreatic juices continue to drain. In addition, the rate of spontaneous stent dislodgement was relatively high (65-86%) within 30 days according to a previous study. A recent study also reported that prolonged retention of prophylactic pancreatic stents is not associated with increased complications.

Taken together, PDS placed during ERCP do not need to be removed until any symptom develops. In particular, if the investigators can observe PDS for about a month without removing them, the PDS are more likely to pass out spontaneously, which could reduce unnecessary procedures. However, to date, there have been few randomized controlled studies on the optimal placement duration of PDS inserted during ERCP.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent the pancreatic duct stent placement during ERCP

Exclusion Criteria:

* Patients who had pancreatic duct stent for the purpose of pancreatic interventions
* Patients who underwent simultaneous bile duct stenting
Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment

The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile Idiopathic Arthritis satisfying Edmonton criteria
* Ongoing DMARD therapy or AINS for 3 months

Exclusion Criteria:

* Inhability to consent
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors

The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

Feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.

Eligibility Criteria:
Inclusion Criteria:

* Women \< age 71 in good general health.
* Prior diagnosis of breast cancer.
* At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab.
* Body Mass Index (BMI) 30-45 kg/m2.
* By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface.
* Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel.
* Live in the greater Kansas City Metropolitan Area
* Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months.
* Willing to perform unsupervised home exercise for the entire 3 months.
* Willing to participate in a weekly behavioral modification group phone call for 3 months.
* Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise.

Exclusion Criteria:

* Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks
* Individuals with prior bariatric surgery procedures
* Need for chronic immunosuppressive drugs
* Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
* Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
* Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event.
* Currently receiving investigational agents in a clinical trial.
Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.

This study is a blinded, non-randomized, crossover design. Subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following enrollment, subjects will be asked to use a washout dentifrice (#200000035883/001/000) for a minimum of 1 week. Fasting plaque will be collected at Baseline and then again at a duplicate baseline collection up to 1 week after the baseline collection. Subjects will be assigned a new dentifrice (#200000035883/001/000) to use for 12 weeks. After 12 weeks' use, fasting plaque will be collected. There will be a duplicate plaque collection up to 1 week after 12 week collection. Subjects will be given a new dentifrice (#200000040228/001/000) to use for the next 24 weeks. After 24 weeks' use, fasting plaque will be collected, and there will be a duplicate plaque collection up to 1 week after this collection.

Eligibility Criteria:
Inclusion Criteria

* Male and/or female subjects 16 years and above
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
* Caries active subjects will have at least 3 active caries lesions (ICDAS score 1 - 3). Caries free control subjects will either have ICDAS score 0 or ICDAS score of 1 - 3 where the lesion is inactive.
* Available throughout entire study
* Willing to use only assigned products for oral hygiene throughout the duration of the study
* Must give written informed consent
* Must be in good general health

Exclusion Criteria

* Unwilling or unable to sign an Informed Consent Form
* Advanced periodontal disease
* Medical condition which requires premedication prior to dental visits/procedures
* Diseases of the soft or hard oral tissues
* Orthodontic appliances that interfere with clinical assessments
* Impaired salivary function
* Current use of drugs that can affect salivary flow
* Use antibiotics 3 months prior to or during this study
* Use of any arginine containing oral care products such as Colgate Sensitive Pro-Relief and Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer dentifrices 3 months prior to or during this study
* Pregnant or breastfeeding
* Participate in another clinical study 1 week prior to the start of the washout period or during the study period
* Use of tobacco products
* Allergic to common dentifrice ingredients
* Allergic to amino acids
* Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)
Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level

The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.

Although pregnancy is a natural process, the change in physiological and psychosocial balance and the differentiation of roles in life require bio-psychosocial adaptation for the pregnant woman and her environment. In addition to strengthening the uterine and perineal muscles and supporting the spine, yoga is effective in dealing with common problems of pregnancy such as poor blood circulation, blood pressure fluctuations, excessive weight gain, fatigue, edema and urinary problems. The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy week between 24 and 34,
* Able to read and write Turkish,
* No communication problems,
* Those who voluntarily agreed to participate in the research

Exclusion Criteria:

* Those who have risky pregnancies,
* Those with diagnosed psychiatric problems,
* Participating in a different training program (meditation, relaxation, etc.)
First Live Birth Rate With eSET After Preimplantation Methylome Screening (PIMS) Versus Conventional In-vitro Fertilization

To determine whether using DNA methylome to select embryos can increase the live birth rate.

The rationale for the study is to establish the risk/benefit ratio of PIMS in women with in vitro fertilization (IVF) treatment, as DNA methylome is a potential biomarker in blastocyst selection in assited reproductive technology (ART). DNA methylation plays an important role during embryogenesis, global abnormal methylome reprogramming often occurs in human embryos, and DNA methylome pattern is associated with live birth rate. However, there is still no technology using DNA methylome as an indicator in preimplantation embryo screening. Recent paper reported that using Pre-implantation Methylome Screening (PIMS) can select embryos with better methylation state and euploid chromosomes. The efficiency of PIMS needs further validation through randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Women who plan to undergo IVF/ICSI/PGT-A treatment.
2. Women aged 20 years and older.

b) Women who obtain 2 or more good-quality blastocysts that defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 of embryo culture.

Exclusion Criteria:

4.2 Exclusion Criteria

1. Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus unicornate, bicornate, or duplex); untreated uterine septum, submucous myoma, or endometrial polyp(s); or with history of intrauterine adhesions.
2. Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).
3. Women who use donated oocytes or sperm to achieve pregnancy;
4. Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.
Behavioral Activation for Depression Through Virtual Reality

Evaluate the effectiveness of a brief, virtual reality intervention for depressed mood


Eligibility Criteria:
Inclusion Criteria:

* Patient Health Questionnaire - 9 (measure of depression) over 9
* Positive and Negative Affect Schedule (measure of positive and negative affect): positive affect score below 24
* Age over 18 years
* Signs informed consent

Exclusion Criteria:

* Completes more than 20% of evaluations retrospectively (not the day they are assigned)
* Has a severe mental health disorder as evaluated with the MINI International Neuropsychiatric Interview
* Does not sign the informed consent
Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients

Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Successful PCI with at least two of the following high-risk factors:

A. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of \<30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction;

- He/she or his/her legally authorized representative provides written informed

Exclusion Criteria:

* Revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons.
* Pregnant and/or lactating women.
* Life expectancy of less than 2 years.
* Repeat interventional therapy is planned.
* Subject was unable to provide written informed consent.