cyrilzakka/clinical-trials huggingface dataset:
Safety of Ataciguat in Patients With Moderate Calcific Aortic Valve Stenosis

This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with Ataciguat results in significant reductions in blood pressure in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Male or female sex
* Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2
* Aortic valve calcium levels greater than 300 arbitrary units from chest CT
* Ejection fraction \>50%

Exclusion Criteria:

* History of orthostatic intolerance or symptomatic hypotension
* Positive pregnancy test during screening visit
* Nitrate use or α-antagonist medication use within 24 hours
* Systolic blood pressure \<110 mm Hg
* Mean systemic arterial pressure \<75 mm Hg
* Severe mitral or aortic regurgitation
* Retinal or optic nerve problems
* Recent (≤30 days) acute coronary syndrome
* Oxygen saturation \<90% on room air
* Congenital valve disease
* Hepatic dysfunction/elevated liver enzymes
* Prescription of drugs known to alter nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling (sildenafil, nitrates, etc.)
* History of orthostatic intolerance
* Concomitant participation in other trials at Mayo Clinic or elsewhere.
The Effect of Chiropractic Manipulation on Spine-related Pain and Balance in Older Adults

The effect of chiropractic manipulation on spine-related pain and balance in older adults.

Chronic pain and risk factors for falls in older adults are significant public health issues. In order to evaluate an appropriate role for chiropractic in managing these problems in the population, this pilot cohort study will take multiple measurements, both self-reported and functional, on a sample of older adults with chronic spine-related pain who are recruited from the local community and receive chiropractic care in the Cleveland Chiropractic College health center over a four-week period.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60 or older
2. spine-related pain of \>3 months duration (by self-report).

Exclusion Criteria:

1. Non-ambulatory
2. chiropractic care or physical therapy within the past month (by self report)
3. contraindications to manipulation, as determined by the clinician through physical exam and x-rays (if indicated)
4. absence of indications for CMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation
5. unable to understand English adequately to complete study forms.
Efficacy of Weekly Versus Daily Folic Acid Supplementation

Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows:

1. weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;
2. weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;
3. daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and
4. daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.

The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.

Eligibility Criteria:
Inclusion Criteria:

* female
* aged 15-49

Exclusion Criteria:

* pregnant
* lactating less than 3 months
* severely anemic
Telomeres Parameters in Celiac Disease

Celiac disease is an autoimmune process that causes destructive changes in the epithel of the small bowel and it is also a pre-malignant state (e.g lymphoma). The aim of the study is to examine telomere length and other parameters of genetic instability from peripheral blood lymphocytes of patients with celiac disease compared with healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* patients with celiac disease

Exclusion Criteria:

* known malignancy
* cannot sign informed consent
* under age 18
Abuja Heart Study: Prospective Epidemiological Investigation of Cardiovascular Diseases

This is a multi-site prospective epidemiological investigation of cardiovascular disease (CVD) among Abuja residents from the rural and metropolitan area.

Sub-Saharan Africa continues to fight the battle of infectious diseases such as HIV/AIDS, Tuberculosis and Malaria. But given all the international efforts geared to curing and containing these diseases, and with progress made in various countries, Sub-Saharan Africa is now heading into another type of epidemic, cardiovascular disease (CVD). Predicted statistics have shown that cardiovascular diseases will become the leading cause of death in developing countries within the next 10 to 15 years, however relatively few population-based studies have examined CVD in Africa .

Although control of communicable ,childhood ,and maternal diseases has benefited from an international efforts on clinical care, policy and implementation,such large scale effort are lacking for CVD and have left both policymakers and individuals with decisions on health issues without adequate information.

Prior to the commencement of the study,series of community meetings and focus groups discussions will be held to identify ways to enhance participation. An extensive examination will include a series of questionnaires dealing with lifestyle habits, medical history, social and cultural factors, physical assessments which include height, weight,central blood pressure assessment of arterial stiffness and autonomic function and laboratory measurements for cholesterol, other lipids, glucose ,c-reactive protein among others.

Eligibility Criteria:
Inclusion Criteria:

* Some history of cardiovascular disease,PLWHA
* Patients have to agree to participate by signing a consent
* 18 years and older

Exclusion Criteria:

* Stroke
Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus

This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).


Eligibility Criteria:
Inclusion Criteria:

* patients with a systemic lupus with ACR criteria (at least 4 criterias)
* patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion Criteria:

* patients who refuse to sign the informed consent
* patients who are under guardianship
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting

The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical guidelines, reminder systems, comprehensive disease state management tools, benchmarked quality reports, and academic detailing on the use of evidence-based heart failure therapies in cardiology practices. This study is a quality improvement initiative that is being conducted through review of patient records.

IMPROVE HF, the largest US outpatient HF patient registry, has substantially contributed to our knowledge of how systolic HF and post MI left ventricular systolic dysfunction (LVSD) patients are treated in the outpatient setting.

The findings of IMPROVE HF clearly support this guideline and may help to establish a model framework for future performance improvement programs for outpatient cardiology practices.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Primary or secondary diagnosis of heart failure or prior myocardial infarction (heart attack)
* Moderate-to-severe left ventricular dysfunction (LVD) as demonstrated by an ejection fraction \< or = 35% and/or a qualitative assessment of LVD of moderate-to-severe or severe LVD
* Patient has been seen at the clinic at least twice in the past 2 years
* Patient received care from the physician participating in the study

Exclusion Criteria:

* Patient has died
* Patient is not expected to survive for 12 months due to medical conditions other than heart failure
* Patient has undergone heart transplant surgery
10-year Follow-up After Tibial Tubercle Transposition

Patellofemoral pain is a common complaint especially in young adults. It can be caused by patellar maltracking. Part of this is a patella alta. When patellar maltracking is the cause of the problem and conservative therapy fails, surgery, a tibial tuberosity transposition, may be considered. Most research has been done in patients with recurrent patella luxation. However, in patients without luxation, research is scarce.

It is known that patients with patella alta have an increased risk of developing patellofemoral chondropathy due to increased pressure. With this study, we aim to investigate whether and how a tibial tuberosity transposition in patients with patella alta and no instability affects the degree of patellofemoral chondropathy and patient satisfaction after 10 years. This will allow us to educate patients regarding long-term outcomes better.

Anterior knee pain is a common complaint, especially in younger and active adults. An obvious source for anterior knee pain is patellar maltracking, which is often associated with patella alta (a high-riding patella). Due to maltracking, the cartilage of the patella can face a greater amount of pressure, which can cause cartilage damage. When conservative treatment fails, a surgical intervention can be considered. One of the surgical options is performing a tibial tubercle transfer (TTT), where the patella is being distalized and medialized. As a result, the improvement in patellar tracking will reduce the pressure on the retropatellar cartilage. The TTT has been proven effective in patients with patellar instability but less is known about patients without instability. Specifically, whether these patients face a higher risk of developing retropatellar cartilage damage ('retropatellar chondropathy') due to this intervention is currently unknown.

The primary aim of this study is to determine the incidence and the degree of retropatellar chondropathy 10 years after a TTT in patients with anterior knee pain without patellar instability. The secondary aim is to evaluate the long-term patient reported outcomes (PROMs) 10 years after a TTT in patients with anterior knee pain without patellar instability.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Participated in an earlier cohort study
* Underwent a tibial tubercle transposition between 2012 and 2015
* Preoperative MRI available

Exclusion Criteria:

* No preoperative MRI is available
* Patellar-related surgery after the initial surgery
* Female patients that are (expecting to be) pregnant
A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
* Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level \>= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
* Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
* Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
* Live, attenuated vaccine within 4 weeks before the first dose of study treatment
* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia \[any grade\] or peripheral neuropathy to Grade \<= 2)
* Received a cumulative dose of corticosteroids equivalent to \>= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
Malmö Breast Tomosynthesis Screening Trial

To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.

Mammography is the only approved method for breast cancer screening, but not all tumors can be detected with mammography. The main reason is overlapping structures that can either mimic or hide a tumor on a 2-dimensional image like mammography. Digital breast tomosynthesis, (DBT) is a 3-dimensional x-ray technique that has been developed during the last years. A tomographic technique like DBT, which reduces or eliminates the detrimental effect of over- and underlying tissue, can probably help to find more tumors. This study aims to investigate whether more breast cancers can be detected with DBT compared to full field digital mammography (FFDM) in population invited to screening. An interim analysis will be performed during 2013 including the first 7,500 women of the study cohort.

Eligibility Criteria:
Inclusion Criteria:

* women 40-74 years old
* in the regular population based mammographic screening program in Malmö, Sweden.

Exclusion Criteria: pregnancy and women not speaking English or Swedish

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Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure

The interest on gastrointestinal (GI) dysfunction in CKD has been growing in the last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the blood. Another mechanism by which GI dysfunction contributes to systemic symptoms in CKD is related to metabolic activity of the dysbiotic microflora growing in the gut of these patients to generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in CKD. In the present paper the investigators investigated the effect of a probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in CKD patients not on dialysis yet.

In patients with chronic kidney disease (CKD), alterations in gut microbioma are posited to be responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin, that has been associated to CKD progression and cardiovascular mortality.

This double blind randomized placebo controlled pilot study evaluates whether Probinul-neutro®, a synbiotic preparation that normalizes intestinal microflora, may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in non-dialyzed CKD patients.

Thirty patients on III-IV CKD stages were randomized to receive either Probinul neutro® or placebo for four weeks. Total plasma p-cresol concentrations was assessed at baseline, and 15 and 30 days after treatment start. At the same study times, ease and frequency of defecation, upper and lower abdominal pain, stool shape, borborygmi and flatus were quantified by subjective assessment questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* eGFR between 20 and 60 mL/min (stage 3-4 CKD, according to the K/DOQI CKD classification)

Exclusion Criteria:

* severe infections
* diabetes
* malignancy
* history of food intolerance
* autoimmune disorders
* severe malnutrition
* clinical conditions requiring artificial feeding
* kidney transplant
Implantation in Posterior Maxilla in Cases With Insufficient Bone

Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation.

The first group lacks a palatal process, while the second group has a palatal process. Then, compare the initial primary stability of implants in the maxillary bone-type (D4) that were inserted tilted in the palatal process of the maxilla, palatally from the maxillary sinus, with implants inserted axially into the maxillary sinus by using a manual torque wrench.

Increasing the initial primary stability intensity value increases the success rate of implants in general and also allows immediate or early loading procedures to begin. In addition, to avoid complications resulting from inserting implants into the compromised maxillary sinus according to the Summers method. The most important of these is perforation of the mucous membrane lining the maxillary sinus and the possibility of its application in pathological cases of the maxillary sinus, such as chronic maxillary sinusitis and the presence of mucous retention cysts, in which intervention according to the usual Summers method is not indicated.

Despite the previous advantages obtained by this method, there are some disadvantages to the technique of tilting the implants in the palatal direction from the maxillary sinus, which are the limitation of its application to cases with a palatal process of the maxilla in the upper jawbone, which requires performing a three-dimensional radiograph. It was observed in this study and after studying the cross-sections that sufficient thickness for this process was less likely present than in cases of its absence. In addition, prosthetic procedures are generally difficult in tilted implants compared to axial implants.

Eligibility Criteria:
Inclusion criteria for both groups:

* Patients must have inadequate bone density in the posterior region of the upper jaw.
* Patients should maintain good oral hygiene.
* The surgical site must be free from infection.
* There should be no contraindications for oral surgery.

For the first group:

- Patients in the first group must have a palatal process of the maxillary bone determined by radiographic examination.

Exclusion criteria:

* Patients with adequate bone volume to receive an implant.
* Patients with systemic diseases that impair metabolism or healing at the surgical site.
* Patients with contraindications for surgery, including cardiovascular disorders, blood clotting disorders, anticoagulant use, or uncontrolled diabetes.
* Patients receiving medications that affect bone metabolism, such as corticosteroids, oral contraceptives, hormonal treatments, or those undergoing chemical or radiological therapies.
Adult Social Interaction

This study will collect vocalization data from healthy adults during regular daily activity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Subjects willing and able to comply with requirements of the protocol
* Healthy

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and able to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape
* Non-English speaking subjects
The Influence of MCIMT (Modified Constrained Induced Movement Therapy), Bilateral Intensive Treatment, and NDT Approach on the UL Function in Children With Hemiplegic Cerebral Palsy

The purpose of this pilot study was to compare unimanual training (CIMT) and bimanual training (HABIT) protocols aimed to improve ability of the involved hand in children with hemiplegia. Both protocols were conducted in an educational setting for 2 hours a day for 2 months, one-hour group session and one-hour individual therapy session conducted by occupational therapists or assistants.

The children in the CIMT group practiced various tasks using their involved hand with the contralateral hand constrained with a mitt. The children at the HABIT group practiced various bimanual tasks without constraint.

Twelve children (2 - 6.5 yrs.) participated in this study. The inclusion criterion included minimal extension movement of the involved wrist, and for the CIMT group, the ability to of tolerates the mitt. The children were matched in relation to cognitive level and MACS score and randomly divided into the two intervention groups.

Each child's assessment included the Quality of Upper Extremity Skills Test (QUEST), the Assisting Hand Assessment (AHA), and the Blocks and Box for children above age 5 yrs old. Range of motion (ROM) was assessed using an electronic gonimeter, and muscle tone was recorded using surface EMG and the Tardiue scale. The Child Health Questioner (CHQ) was completed by the parents before, and 6 months after, the intervention. Children were assessed starting two month before, and two month after, the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Children with Hemiplegia

Exclusion Criteria:

* No ability for a minimal extension movement in the wrist