cyrilzakka/clinical-trials huggingface dataset:
Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre

The main hypothesis:

The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The groups waiting for rehabilitation is compared with the group receiving rehabilitation

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Eligibility Criteria:
Inclusion Criteria:

* Patients with physical disabilities admitted to treatment at BHC

Exclusion Criteria:

* Patients with severe cognitive disorders
Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women

The purpose of this study is to compare the effectiveness of a relationships based antenatal intervention (Mellow Bumps) against a comparison intervention (Chillout In Pregnancy) and also against the normal antenatal care which is received during pregnancy (Care As Usual). The Mellow Bumps intervention will seek to improve maternal anxiety and maternal sensitivity whilst the Chillout In Pregnancy intervention will aim to improve only maternal anxiety. This will allow the researchers to determine what type of intervention, if any, is most successful at improving the outcomes of the mother and child. This will be measured by looking at the mother's stress response, anxiety, depression and irritability, the baby's stress response and the interactions between the mother and the baby. Participants in the study will be pregnant women who would be between 20 and 30 weeks pregnant at the start of the antenatal intervention. Participants will be chosen to take part in one of the three conditions (Mellow Bumps, Chillout In Pregnancy or Care As Usual) at random. All participants will be asked to complete questionnaires and give saliva samples prior to the intervention. The questionnaires will also be repeated at the end of the intervention and at a follow up occurring eight to twelve weeks after birth. Consent will also be sought to take saliva samples from the baby before and after a routine blood test when the baby is five days old. This information will then be evaluated to establish the effectiveness of the proposed interventions.

Lower than anticipated recruitment numbers have resulted in changes to the planned methodology of this trial. Firstly, participants were allocated to the three arms in groups/blocks of 6. Secondly, randomisation of the final group recruited was abandoned.

Eligibility Criteria:
Inclusion Criteria:

* pregnant, between 20 \& 30 weeks gestation at start of intervention
* Identified by midwives as meeting Special Needs in Pregnancy (SNiP) criteria
* basic understanding of written and spoken English

Exclusion Criteria:

* not identified as vulnerable through SNiP criteria
* less than 20 weeks or more than 30 weeks gestation at start of intervention
Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery

Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents. Most U.S. states and all national heart organizations require that angioplasty be done only at hospitals that can also perform open heart surgery. The reason for this is that there is a risk that angioplasty can cause injury to the heart artery that might require open heart surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart surgery will be needed is very small. Nevertheless, without more research, many state Departments of Health and all national heart organizations do not want to change the requirement for having on-site open heart surgery wherever angioplasty is performed. Some States already allow this; and European heart organizations already allow it, as well.

This study is designed to determine whether the safety and benefits of angioplasty are the same at hospitals that perform angioplasty either with or without open heart surgery backup.

Patient who enter the study have a heart catheterization at a hospital without a heart surgery program. If they need angioplasty, then they are randomized to either stay at the hospital without heart surgery for their angioplasty or to be transferred for the procedure to a hospital with heart surgery. For every four patients, three stay at the hospital without heart surgery and one is transferred.

The study is designed to show that there is no detectable difference between the safety and benefits of the procedure at the two types of hospital (with and without heart surgery). The cost of the procedure at the two hospital types is also compared.


Eligibility Criteria:
Inclusion Criteria:

Pre-catheterization:

* Must be undergoing diagnostic cardiac catheterization for suspected CAD
* Be at least 18 years of age
* Must not be pregnant (negative pregnancy test) or must not be of childbearing potential must be able to give informed consent.

Post-catheterization:

* Coronary artery disease judged to be clinically and angiographically significant
* Ability to perform PCI with equipment available at the local site
* Procedure risk judged to be not high (see below)

Exclusion Criteria:

Pre-catheterization:

* Inability to give informed consent
* ST-segment elevation myocardial infarction
* Pregnancy

Post-catheterization:

* High likelihood of requiring a device not available at the hospitals without SOS
* No need for PCI
* Need for coronary artery bypass surgery
* High procedural risk (see below)

High procedural risk criteria are:

* PCI of unprotected left main coronary artery
* PCI of left circulation lesion in the presence of critical (\>70%) unprotected left main coronary artery lesion
* Poor left ventricular function (EF\< 20%) and need to perform PCI in a vessel supplying significant myocardium
Lung Cancer Symptom Assessment and Management Intervention

The purpose of this study is to develop and test the usability of a computerized symptom assessment and management intervention system in a laboratory setting (phase I) and its feasibility in a clinical setting in a group randomized trial (phase II).


Eligibility Criteria:
Inclusion Criteria:

* HCPs: attending physician, thoracic medical oncologist, expected to work in the setting for at least 2 years.
* Patients: 21 years of age or older; diagnosis of Stage IIIA, IIIB, IV non-small cell lung cancer OR limited or extensive stage small cell lung cancer; receiving care in the out-patient setting; receiving treatment with chemotherapy +/- additional therapies; English speaking.

Exclusion Criteria:

* Patients: Any patient who needs emergent care, routine visits scheduled less than once a month
PCOS Patients' Immune Alterations

In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients.

PCOS patients and healthy women were recruited in outpatient clinics of three hospitals, and peripheral blood was retained for flow cytometry after completing relevant examinations. In this study, flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescence-labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 18-45 years;
* Voluntarily participate in the experiment, willing to sign the informed consent.
* According to the Rotterdam consensus, polycystic ovarian syndrome (PCOS) needs to meet the presence of two of three of the following criteria: oligo-anovulation, hyperandrogenism, and polycystic ovaries (≥ 12 follicles measuring 2-9 mm in diameter and/or an ovarian volume \> 10 mL in at least one ovary).

Exclusion Criteria:

* Female patients younger than 18 years old or older than 45 years old;
* Ovulation disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction (hyperthyroidism, hypothyroidism);
* Congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, adrenal tumors, and other diseases causing hyperandrogenemia;
* Severe liver and kidney dysfunction (more than 3 times the normal value)
* Type 1 diabetes, monogenic mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes;
* History of malignant tumor;
* Severe infection, severe anemia, neutropenia, and other chronic diseases of the system;
* Patients undergoing total hysterectomy or ovarian adnexectomy;
* Mental illness, dementia, or other cognitive behavioral problems;
* Hypoglycemic drugs that may affect insulin resistance and androgen levels, including thiazolidinedione, metformin, SGLT-2i, acarbose, and glucagon-like peptide-1 receptor agonist (GLP-1RA), have been used in the past 3 months;
* Take letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, antiandrogens (spironolactone, cyproterone acetate, flutamide, etc.), and other medications for PCOS treatment within the last 3 months.
* Pregnant or lactating patients;
* Female patients with a BMI less than 20kg/m2.
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.

Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject must be able to read and understand English.
3. Subject must have a type 2 diabetes diagnosis.
4. In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
5. Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
6. Subject must be willing to allow venous samples to be obtained to test HbA1c.
7. Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.
8. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
9. Subject must be available to participate in all study visits.
10. Subject must be willing and able to provide written signed and dated informed consent.

    Exclusion Criteria:
11. Subject is a member of the Study Staff.
12. Subject has a diagnosis of type 1 or gestational diabetes.
13. Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
14. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
15. Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
16. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
17. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
18. Subject currently is participating in another clinical trial.
19. Subject is unsuitable for participation due to any other cause as determined by the Investigator
Continuous Venovenous Hemodiafiltration Versus Sustained Low-efficiency Hemodialysis for Critically Ill Patients With Acute Kidney Injury in Intensive Care Unit

The investigators conducted a comparison trial between SLED and CRRT in critically ill patients to evaluate the outcome for all cause mortality at 30 day . The secondary outcome were recovery of renal function, complications during therapy and duration of hospitalization.

The investigators performed a single center experience accumulated over 12 months since February 2009 with a continuous venovenous hemodiafiltration (CVVHDF) and hybrid technique named sustained low-efficiency dialysis (SLED). The primary end point was death from any cause by day 30. Intensive care unit (ICU) patients were eligible for inclusion when serum creatinine was \> 2 mg/dL, and renal replacement therapy (RRT) was initiated. The selected patients were treated with CVVHDF or SLED.

Eligibility Criteria:
Inclusion Criteria:

- The inclusion criteria were

1. AKI requiring RRT
2. Hemodynamic instability defined by systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 60 mmHg
3. Patients requiring initiation to vasopressor support

Exclusion Criteria:

* Patients with pre-existing chronic kidney disease ( eGFR less than 30 mLmin/1.73m2) were excluded
The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue

The purpose of this study is to assess the efficacy of dynamic tape in prevent shoulder muscle fatigue.

After being informed about the study and the potential of risk, all participants will undergo a screening to determine eligibility for study entry and giving written informed consent.

We will include 20 participants who have pitch 100 times with dynamic taping or shame taping in randomized sequence. There must be more than 2 weeks resting between 2 test. We will test maximal force in shoulder flexion, extension, abduction and adduction before and after test. We also record spins and speed of baseball for performance outcome.

To our hypothesis, we suggest dynamic taping could decrease the arm fatigue after long-term pitching.

Eligibility Criteria:
Inclusion Criteria:

* more than 20 years old
* amateur baseball player
* could tolerate pitching 100 times

Exclusion Criteria:

* shoulder pain who could not tolerate 100 pitching
* upper limb surgery history
* Allergy to topical agent
A Study to Evaluate the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register

The objectives of this analysis is to determine the incidence of anemia occurring in patients with chronic kidney disease (CKD) in primary care (i.e. prior to any eventual referral to nephrology care). This analysis also evaluates patient characteristics, anemia treatment and associated cardiovascular risk.

Data will be derived from the Stockholm CREATinine Measurement (SCREAM) cohort, a repository of laboratory data of individuals residing and accessing healthcare in the region of Stockholm and who underwent a creatinine assessment between 2012 - 2018.

Eligibility Criteria:
Inclusion Criteria:

* Patient entered in SCREAM between 2012 and 2018
* With two consecutive plasma-creatinine test(s) indicating an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2
* With at least one eligible Hb after eGFR \< 60 mL/min/1.73 m\^2. The date of the first eligible Hb test is the study entry point/index date of the study.

Exclusion Criteria:

* Patient who has had a recent pregnancy or childbirth (issued diagnosis within 2 years prior to index date).
* Patient with ongoing/recent cancer (diagnosed within the previous 3 years), haematological diseases or leukaemia.
* Patient with chronic infections (hepatitis, tuberculosis, or human immunodeficiency virus \[HIV\]); note by definition chronic infections are chronic and look back period will be to 1997.
* Patients with anemia at baseline (index date), defined by an anemia diagnosis in the year prior, a baseline Hb value within the anemia range according to the WHO definition, or the presence of a recent dispensation of ESA or iron (up to six months prior).
* Patient referred to nephrologist within the previous 2 years from cohort entry/ index date.
Effect of a Specific Phenolic Compound on Blood Pressure

The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic BP after ingestion of a high fat meal.

The study's main objective is to investigate the effects of acute consumption of a preparation containing 100 mg of a specific phenolic compound (patent pending, P201531587) on systolic blood pressure (BP) after ingestion of a high fat meal.

The secondaries objectives are:

* To evaluate the effects on diastolic BP.
* To study the phenolic compound bioavailability and to analyze its metabolites for determine the phenolic compound consumption biomarkers.
* To evaluate the effects on endothelial function by ischemic reactive hyperemia (IRH).

The sample size was calculated using a previous studies using systolic blood pressure (SBP) as the primary outcome measure. A total of 14 subjects are needed, assuming variance components of approximately 20.0, to detect differences between treatments (placebo and phenolic product) of 10 mmHg, with a bilateral significance level of α=0.05, a power of 80% and a standard deviation of 11.82 mmHg at the baseline.

To compare the main variable efficiency of the products of study as well as secondary variables of efficiency, will carry out analysis of the covariance (ANCOVA) with basal value as covariable, followed by the Tukey test for determining multiple differences. All tests will be carried out with significance to bilateral level of 5%. It is considered significant value p\<0,05. The data will be analyzed using the "SPSS" program version 22.

The statistical analysis will follow the principles specified in the guidelines of the International Conference on Harmonization (ICH) E9 and CPMP/EWP/908/99 ICH E9 Points to Consider on Multiplicity Issues in Clinical Trials.

Eligibility Criteria:
Inclusion Criteria:

* Adults men or women (\>18 years old)
* Blood pressure (with no drug intervention) ≥130 mm Hg systolic blood pressure ≤ 159 mmHg
* No evidence of chronic disease
* Written informed consent provided before the initial screening visit.

Exclusion Criteria:

* Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥100 mm Hg or taking antihypertensive medication
* Body mass index (BMI) ≥ 35 kg/m2
* Glucose (fasting state) \>125 mg/dL
* LDL-cholesterol \>189 mg/dL
* Triglycerides \>350 mg/dL
* Pregnant or intending to become pregnant
* Use of medication, antioxidant, or multi-vitamin supplements
* Chronic alcoholism
* Intense physical activity (5h/week)
* Intestinal disorders
* Following of a vegetarian diet
* Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
* Being intolerant or suffer from allergy to any of the products of the high fat meal (white bread, olive oil, boiled egg, cheese) or to the products of the study.
* Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
* Failure to follow the study guidelines.
Assessment of Memory in Children With Kabuki Syndrom

Mnesic function has not, at present, been evaluated in patients with Kabuki Syndrome. Some data from the neuroimagery suggest an impairment of memory function. The objective of our study is to assess the mnesic function of children with Kabuki Syndrom.

Kabuki Syndrome (SK - OMIM 147920 and 300867 ORPHA: 2322) is a rare genetic disease with a prevalence of approximately 1/32 000 and responsible for a malformation syndrome with mild to moderate intellectual impairment. SK is due to mutations in the KMT2D and KDM6A genes. As part of a national PHRC (AOM 07-090, clinicaltrial NCT01314534, The investigators were able to perform psychometric tests type WISC4 and MRI type VBM). Disability in SK is characterized by a heterogeneous cognitive profile with strengths and weaknesses when calculating IQ. Brain MRI reveals small hippocampi compared to controls. These 2 data are partly contradictory because the strengths of the patients with SK are a working memory and a verbal comprehension index high compared to the other indices of the tests WISC-IV.

The objective of the research is to better understand the mnesic function of children with SK.

25 children aged 6 to 16 will be recruited. The diagnosis of SK will have been authenticated by the demonstration of a mutation in the KMT2D or KDM6A gene.

The memory assessments will be conducted in one visit for each child, who will perform a memory assessment with a neuropsychologist, using the CMS scale.

Eligibility Criteria:
Inclusion Criteria:

* Child from 6 to 16 years old
* Presents an already established diagnosis of Kabuki syndrome.
* Free, informed and written consent signed by the participant's parents, and the investigator (at the latest inclusion day and before any research required by the research).

Exclusion Criteria:

* Be under 6 years old or over 16 years old
* Do not master the French language
* Not having access to language
* Deafness not paired
* Blindness.
Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery

Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. However, its effect has not been validated for scleral buckling surgery, which is used to treat retinal detachment, a medical emergency that can lead to permanent blindness. In this study, the investigators will randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo to the other half. The investigators will then compare the postoperative symptoms of the two groups in order to determine whether dexamethasone should be used for scleral buckling surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-79 years old
* Scheduled for scleral buckle surgery to treat a retinal detachment
* Consent to participate in study

Exclusion Criteria:

* Pregnant or nursing
* Prior treatment with steroids
* Severe diabetes mellitus (HbA1c \> 8%)
* Use of opioids, sedatives, or any kind of analgesics \<1 week before scleral buckling surgery
* History of alcohol or drug abuse
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 60 years of age.
* Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
* Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
* Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

* Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
* First episode of psychosis.