cyrilzakka/clinical-trials huggingface dataset:
Muscle Function After Childbirth

This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed.

Stability of the lumbar spine and pelvis is essential to nearly all activities of daily living, and is achieved primarily by muscular stabilization. Recent studies have shown that postpartum women are more fatigable than nulligravid women during fatiguing tasks with the lumbopelvic stabilizing muscles (23%) and the trunk flexor muscles (52%) at six months postpartum. Postpartum women also demonstrate impaired control of force with the trunk flexor muscles; however, it is unknown if force control during a fatiguing task of the lumbopelvic stabilizing muscles is impaired in postpartum women.

This study has 3 purposes: (1) To quantify limb steadiness during fatiguing exercise of the lumbopelvic stabilizing muscles among nulligravid women and postpartum women; (2) to quantify muscle activity in the trunk, test limb and contralateral limb to provide insight into motor control; and (3) to identify possible factors (inter-recti distance (IRD), physical activity, pain, biopsychosocial factors) that contribute to neuromuscular function (fatigability and force control).

This is a novel, translational study that, for the first time, will quantify lower extremity force control in postpartum women. As this has not been studied before, to the best of the investigators' knowledge, this proposal will be a pilot study to establish means to utilize in power analyses for future studies of larger magnitude. Furthermore, neuromuscular function is not typically assessed clinically in postpartum women, and no tests exist to easily assess fatigability of the lumbopelvic stabilizing muscles in clinic settings. This study will also provide further data to highlight the ASLR Fatigue Task as a possible clinical examination tool and outcome measure to assess fatigability of the lumbopelvic stabilizing muscles.

Eligibility Criteria:
Inclusion Criteria:

* Post-partum
* Primiparous (this is their first child)

Exclusion Criteria:

* multiple gestation
* prescription anti-inflammatory/pain medications that are taken daily
* significant orthopedic conditions that would contraindicate performance of the fatigue task (such as fractures, severe scoliosis, etc)
* cardiovascular \& pulmonary disease
* neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc)
* history of previous abdominal surgery (with the exception of Cesarean delivery)

Nulligravid Women (Controls)

* Women from the surrounding community will also be recruited to serve as controls
* Nulligravid women will meet the same inclusion/exclusion criteria as the postpartum women, with the exception of never having been pregnant
Oral and IV Baclofen in Adult Volunteers

The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation.

This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1:1 manner.

The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible to participate in the study if all of the following conditions exist:

1. Males and females between the ages of 18-65.
2. Subjects are capable of giving informed consent.
3. Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
4. Subject should be medication free, other than study drug, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

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Exclusion Criteria:

Subjects will be excluded from participation in the study if any of the following conditions exist:

1. Women who are pregnant.
2. Women who are breast feeding.
3. Subject has a history of intolerance to IV administration of medication.
4. Subject has a known hypersensitivity to baclofen.
5. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
6. Subject has taken or used any investigational drug or device in the 30 days prior to screening.
7. Subject has taken either prescribed or over the counter medication for 48 hours prior to baclofen administration on either of the study days.
8. Subject reveals clinically significant abnormalities on screening laboratory tests.
9. Subject is a non-English speaker, such that ability to ascertain neurological status would require an interpreter.
Copeptin and HFABP in Cardiac Surgery

In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, \>90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.

The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.

All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years of age)
* Elective surgery
* On-pump cardiac surgery (CABG and/or valvular surgery)

Exclusion Criteria:

* Heart transplantation (HTX)
* ACS at presentation (\< 14 days)
* Emergency surgery
* Preoperative inotropic or mechanical circulatory support
* Left or right ventricular assist device implantation
* Unwilling or unable to provide consent
* Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia
Efficacy and Safety of Chidamide in CBF Leukemia

In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.

In this open-label, randomized, prospective clinical trial, CBF AML(including AML1-ETO or CBF-MYH11 mutated patients) patients who have reached CR are randomised into two groups and receive HDAC or high dose of cytarabine plus chidamide.

In experimental group, patients receive cytarabine at a dose of 3g/㎡/d on the first, third and fifth day and chidamide at a dose of 20mg/d twice a week for 3 months.Patients in control group only receive cytarabine at the same dose.

The safety and efficacy of chidamide is evaluated. The primary outcome is relapse-free survival rate after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 14 to 55 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes) and with AML1-ETO or CBF-MYH11 mutation.
3. Reached CR after induction regimen.
4. ECOG score of ≤ 2;
5. Patients with eligible laboratory examination including liver,renal and heart function.
6. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria:

1. Secondary leukemia.
2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
5. With BCR-ABL fusion gene;
6. Pregnant or lactating women;
7. With ineligible renal or liver function;
8. With active cardiovascular disease;
9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
10. AIDS;
11. Patients had central nervous system involvement when they were diagnosed as AML.
12. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
13. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
14. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG

The use of a graft from the left internal thoracic artery to the left anterior descending artery has become the gold standard for the indication of coronary artery bypass grafting. However, choosing a graft for the second-best coronary artery, focusing on long-term patency, is still a challenge. The saphenous vein using the "no-touch" technique is an alternative to a radial artery graft, but there is little evidence, especially in women. This randomized clinical study aims to compare the patency of these grafts in the second-best coronary artery in women undergoing coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

Women aged 18 years or older and younger than 70 years, undergoing isolated and primary myocardial revascularization surgery, with triarterial coronary artery disease (three vessels involved) in vessels subject to surgical revascularization and left ventricular ejection fraction greater than 35%. The target coronary vessels of the study will be those in the territory of the left circumflex artery and the right coronary artery, which must have at least 1.5 mm in diameter, and with proximal obstructive lesions of at least 70%.

Exclusion Criteria:

1. Preoperative conditions:

   1. Lack of the patient's written informed consent.
   2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \>7 mg/dl.
   3. Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.
   4. Renal failure with glomerular filtration rate (creatinine clearance) \<30 mL/min.
2. Inability to use the saphenous and/or radial vein

   1. Positive Allen test using a pulse oximeter
   2. Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.
   3. History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal
3. Conditions that may affect patient follow-up

   1. Presence of advanced peripheral arterial disease
   2. Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.
   3. Impossibility of tracking due to geographic inaccessibility.
   4. Patients with lack of adherence to guidelines and/or prescribed medications.
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent
* Meet criteria for major depressive disorder without psychotic features.
* Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
* Have had at least one other major depressive episode prior to the one being experienced at study entry.
* You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion Criteria:

* You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
* Any women who are pregnant or breast feeding.
* If you have any serious medical illnesses other than major depressive disorder.
* If you have previously participated in a clinical trial for duloxetine.
* Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.
Improve Osteoarthritis Care

The purpose of The Improve Osteoarthritis Care study is to improve the quality of osteoarthritis care in Norwegian primary care, by increasing the use of recommended treatment modalities and improving patient access to recommended treatments. The study will use tailored implementation strategies, targeting primary care physicians and physiotherapists to improve knowledge and addressing individual barriers to providing recommended treatments.

Previous research has shown that current osteoarthritis care for persons with hip or knee osteoarthritis (OA) in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. The overall purpose of the "Improve Osteoarthritis Care" study is that people with symptomatic hip and knee OA should receive care in line with current recommendations. To achieve this goal, tailored implementation strategies will be applied in order to: 1) Improve the quality of care offered to people with symptomatic hip and knee OA, 2) increase knowledge of recommended OA care among people with hip and knee OA, 3) Increase the number of primary care physiotherapists' offering group-based patient-education and structured exercise as part of their routine clinical practice, 4) Increase the number of general practitioners who have received a summary of the OA treatment recommendations.

To evaluate the effect of the tailored implementation strategy a pre-post design will be applied, and members of the Norwegian Rheumatology Association with self-reported hip or knee OA will be asked to evaluate quality of OA care at the two timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported hip or knee osteoarthritis

Exclusion Criteria:

* Persons who do not understand the Norwegian language
Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease

IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.

The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.

These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.

The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +\> 50% on tissue immunostaining.

The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* IgG4-related disease patients or
* Sjogren syndrome patients or
* Healthy subjects

Exclusion Criteria:

* Presence of autoimmune or inflammatory associated disease
* Age less than 18 years
Orofacial Pain in Multiple Sclerosis

Although the orofacial pain is not typical symptom of multiple sclerosis, more than 50% of the patients experience some kind of pain. Acute pain usually in form of trigeminal neuralgia, that occurred in 2-3% of patients with multiple sclerosis. Chronic pain occurred in 40-50% of patients and most common forms are headache. Aim of this study is to investigate prevalence and evaluate the form of orofacial pain in patients with multiple sclerosis treated in General hospital Varaždin in period from 01.01. 2017. to 31.12.2022. Results of this investigation will determine better understanding orofacial pain , treatment and impact on everyday life.

Multiple sclerosis is a chronic autoimmune disease with an unknown mechanism of origin. Although pain is not a typical symptom of multiple sclerosis, it occurs in more than 50% of patients and has significant impact on the quality of life of patients. Pain syndromes that patients with multiple sclerosis initially have characteristics of somatic and nociceptive pain, and later neuropathic, including trigeminal neuralgia, headaches, Lhermitte's syndrome.

Pain is also often associated with anxiety and depression, which occurs in almost one third of patients.

Pain therapy in these patients is a challenge for many doctors involved in the treatment. Many patients do not have adequate pain therapy due to the disproportion between the fear of interaction with other drugs and side effects, and on the other hand the treatment of basic diseases with the aim of controlling the immune response.

Eligibility Criteria:
Inclusion Criteria:

* multiple scerosis
* age 18-85 years

Exclusion Criteria:

* records with missing data
Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making

The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR) polymorphisms on behavioral responses to social stimuli.

The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce that of negative ones, although it is unclear whether the latter causes blunted emotional responses. After OXT or placebo application participants are exposed to acoustic startle probes presented alone and during viewing of 60 color pictures mostly selected from the 'International Affective Picture System'. The paradigm featured 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part of the experiment, after intranasal OXT or placebo application participants respond to 60 moral dilemmas.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
Assessment and Evaluation of the Safe Childbirth Checklist --Phase II

PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design with data collection from 34 facilities across six intervention districts and four control districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in intrapartum mortality. Data on this was collected over a period of 17 months (November 2013 to April 2015).

The Safe Childbirth Checklist (SCC), a tool that provides reminders and is a job aid to health care providers is a new maternal and newborn care intervention that is being implemented by the Government of Rajasthan with technical support from Jhpeigo. SCC is thus expected to improve the quality of delivery care practices and was implemented in Community Health Centres (CHCs) and District Hospitals (DHs) across seven districts in Rajasthan over a two-year time period (2013 to 2015). PHFI independently evaluated the effectiveness and cost-effectiveness of the SCC in preventing intrapartum (stillbirths and very early neonatal deaths within 3-days after births). Data on 137,000 births was collected over a period of 17 months (November 2013 to April 2015) from 34 facilities with sick newborn care centres (SNC).

Facility records were main source of outcome data. Labor room provided data on stillbirths whereas information on very early neonatal deaths came from SNCs. All Data collection and management was done through software specifically developed for this purpose.

For a better understanding on how maternal and neonatal complications are diagnosed and managed at the facility, in-depth interviews were conducted with the service providers (specialists, physicians, labor room staff nurses, and pharmacists) from the District hospitals and CHCs. In addition, interviews focused on understanding the use, acceptability and feasibility of the SCC among various types of providers.

Cost of this intervention was estimated from a program perspective, and cost effectiveness in terms of cost per perinatal death prevented was calculated.

Preliminary analysis has found that SCC is significantly associated with a 11% reduction in intrapartum deaths.

Permission for this study and data collection has been obtained from the Department of Health and Family Welfare, Government of Rajasthan.

Eligibility Criteria:
Inclusion Criteria:

* All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)

Exclusion Criteria:

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A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode

It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Be a healthy volunteer and be over 18 years of age
* Willing to attend two scheduled visits for application and removal of the device and adverse event review
* Have healthy unbroken skin

Exclusion Criteria:

* Subjects with a history of sensitivity to any one of the components of the device being studied
* Subjects who have a history of skin related disorders to the chest.
* Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
* Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace