cyrilzakka/clinical-trials huggingface dataset:
Awareness of Osteoporosis in Ankylosing Spondylosis Patients

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Ankylosing spondylitis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in ankylosing spondylitis patients.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with ankylosing spondylitis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with ankylosing spondylitis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ankylosing spondylitis
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction

The purpose of this pilot study is to evaluate the effectiveness of the active involvement of Community Pharmacists in improving adherence to medical prescriptions in patients with acute myocardial infarction (AMI), reducing the rate of adverse events and / or re-admissions due to cardiovascular disease and reducing overall health costs. The Hospital and Community Pharmacists will collaborate with each other, the patients, heart specialists and primary care physicians, throughout 12 months from the hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Discharged with a primary diagnosis of Acute Myocardial Infarction (AMI, ICD-9 code: 410.x1) from a cardiological ward;
* Required treatment with antiplatelet therapy, beta-blockers, lipid-lowering therapy, Angiotensin-Converting Enzyme Inhibitors (ACEi), Renin Angiotensin System Inhibitors (RASi) and/or mineralocorticoid/aldosterone receptor antagonists at the hospital admission, alone or in combination;
* Agreeable to participate in adherence plan (if randomized to interventional arm) performed by the community pharmacist who has in charge the patient;
* Agreeable to understand and accept the purpose of the study;
* Signed of the informed consent to participate;
* Be complying with the protocols' procedures within the entire period of study.

Exclusion Criteria:

* Any prior history of acute myocardial infarction within 6 months prior to study entry;
* Presence of physical or cognitive impairment or dementia;
* Permanent long-term residence in Hospice or facility residents;
* History or presence of any other cardiovascular disease with a life expectancy of \< 1 year, hypertension excluded.

Other protocol-defined inclusion/exclusion criteria may apply.
Lived Experience of Overweight/Obese Patients Who Have Benefited From a Mindful Eating Program.

The main objective is to understand the lived experience of overweight/obese patients who have followed the mindful eating program at Montpellier University Hospital. Semi-structured face-to-face interviews will be conducted in the Nutrition-Diabetes service by using a questionnaire.


Eligibility Criteria:
Inclusion criteria:

- People who have attended at least 6 out of 8 sessions of the mindful program

Exclusion criteria:

* People who have attended less than 6 sessions of the program.
* Declining participation
A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy

The purpose of this study is to assess REN001 safety in subjects with primary mitochondrial myopathy


Eligibility Criteria:
Inclusion Criteria:

* Subjects must give written, signed and dated informed consent
* Confirmed diagnosis of PMM according to the 2016 Rome Consensus recommendations
* Confirmed mitochondrial mutation with evidence of myopathy
* Able to remain on stable medication throughout the study

Exclusion Criteria:

* Documented evidence of ongoing rhabdomyolysis
* Subjects with motor abnormalities other than related to mitochondrial disease
* Treatment with an investigational drug within 3 months prior to Day 1
* Hospitalised within 3 months prior to screening for any major medical condition
* Pregnant or nursing females
Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease

The purpose of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications.

It is estimated that between 15-20% of children with Crohn's disease will develop complications that can require surgery within the first three years of diagnosis. The purpose of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications.

A total of 2000 children with newly-diagnosed Crohn's disease will be enrolled within 30 days of diagnosis. Up to 28 medical sites in the United States and Canada will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females younger than 17 years of age (before their 17th birthday). An upper limit of 17 years of age was selected as important inclusion criteria to maximize the number of potential subjects that would be diagnosed and followed by a pediatric gastroenterologist for at least 3 years.
* Confirmed or suspected diagnosis of Crohn's disease based on standardized diagnostic criteria. The enrollment should occur within 30 days of diagnosis.
* Able to provide written informed consent or the ability to obtain written informed consent from the parents or patient's legal guardian in conjunction with youth assent.
* Consented to have specimens tested for genetics and immune responses.
* Access to follow-up data for a minimum of 36 months after diagnosis.
* Final eligibility will be determined by the health professionals conducting this clinical trial.

Exclusion Criteria:

* Infectious colitis.
* Final eligibility will be determined by the health professionals conducting this clinical trial.
Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening

The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.

If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.

To conduct a feasibility study on implementing the computer-based screening decision aid for prostate cancer screening in a primary care setting during a 60-minute interview. To aid in informed decision making, the screening decision aid will include a graphical representation of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality, death from competing causes based on a man's unique demographic information. The study team will provide standardized counseling followed by individualized counseling with the screening decision aid. It will assess the quality of the decision making process (patient feels knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in the decision), and quality of the decision.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \> 10 years
* Ability to read English

Exclusion Criteria:

* Personal history of prostate cancer
* Personal history of prostate biopsy or prostate surgery
* Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit
* Cognitive impairment
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
* Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of \> 40% bone marrow blasts after one cycle of chemotherapy induction OR
* Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
* Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
* ECOG performance status \<3 (Appendix 1)

Exclusion Criteria:

* Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
* Abnormal liver function: Bilirubin \>2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
* Active systemic infection
* Known chronic liver disease
* Known diagnosis of human immunodeficiency virus infection (HIV)
* Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
* Pregnant or breast feeding female subjects
Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. In fact local injections can create the pain by itself.However no study compared the effect of forced coughing to local anesthetic spray. The study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age \>18,
* Presence of cervix,
* Patients who need a diagnostic work up for abnormal cervical smear results.

Exclusion Criteria:

* Pregnancy,
* Presence of already known invasive cancer,
* Allergy to anesthetic agents.
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)

This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences.


Eligibility Criteria:
Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

1. Healthy female subjects of non childbearing potential

   Female subjects of non childbearing potential must meet at least 1 of the following criteria:
   1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
   2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
   3. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and are not eligible for this study.
2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. History of drug abuse with less than 6 months of abstinence prior to the baseline visit.
3. History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening.
4. Any medical reason which would contraindicate the administration of oral contraceptives (as per the label) or history of discontinued use of oral contraceptives due to medical reasons.
5. Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
6. Subjects who have a malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
7. Any current evidence of untreated active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
8. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

The scope of the trial is to assess the free progression rate at 2 months for each group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18
* PS-WHO \< or = 1
* Histologically proven cancer
* No other therapeutic proposal
* Treatment can be orally taken
* Radiologic proof of evolutive character of the disease
* Effective contraception

Exclusion Criteria:

* Hypercalcemia ( Ca \> 2.65 mmol/l)
* Breast cancer
* Thrombosis or pulmonary embolism
* Dysphagia, malabsorption
* Polynuclear neutrophil leukocytes \< 1000/mm3
* Treatment with Tegretol
* Active and uncontrolled infection
* Evolutive psychiatric disease
* Pregnant or lactating woman
Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery

This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. The investigators hypothesize that all three groups would have similar pain control; the supraclavicular and suprascapular groups may have better lung function.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral total shoulder arthroplasty
* ASA physical status I-III
* \>18 years old
* Non-pregnant (or lactating)
* Consent to participate in the study

Exclusion Criteria:

* Refusal to participate
* \< 18 years old
* Chronic opioid use
* Localized infection
* Pregnancy or lactating
* Pre-existing coagulopathy
* Allergy to ultrasound gel or local anesthetics
* Diaphragmatic dysfunction
Outcomes of Full Pulpotomy Treatment in Teeth With Symptoms of Irreversible Pulpitis

The aim of this clinical trial is to learn how successful Biodentine and NeoPutty dental filling materials are in treating dental pulp inflammation in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:

Do Biodentine and NeoPutty dental filling materials treat dental pulpitis in participants? Do they reduce the need for root canal treatment?

After the application of Biodentine and NeoPutty dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment.

The researchers will compare the clinical success of Biodentine and NeoPutty dental filling materials with each other.

Participants will undergo a single-session pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.


Eligibility Criteria:
Inclusion Criteria:

* • Patient age must be between 18-50 years

  * Must be able to give written informed consent
  * Must have systemic status (ASA 1)
  * Must have mature permanent molar or premolar (lower upper)
  * Must be symptomatic (spontaneous pain - mild to severe), extremely deep (D4) carious teeth
  * Must have pulp exposure in non-selective carious cleaning procedure
  * Must have vital response in cold test and electric pulp test
  * Must have no periodontal disease
  * Must have restorable teeth
  * Must have teeth without pulp necrosis, sinus tract or swelling/abscess
  * Must have bleeding time less than 10 minutes
  * Maximum two teeth in a patient must be included in the study (must be in different quadrants and must have at least 2 weeks between treatment periods)

Exclusion Criteria:

* Teeth with incomplete root development

  * Teeth without symptoms of irreversible pulpitis
  * Severely affected teeth that do not respond to pulp sensitivity tests
  * Teeth without signs of bleeding after exposure with the pulp chamber
  * Teeth with pulp chamber open to the oral environment
  * Teeth with periodontal pockets greater than 4 mm deep
  * Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
  * Teeth with uncontrolled bleeding
  * Medically risky patients will be excluded from the study.
ICU Patient and Family Comfort Study

The purpose of this study is to evaluate family-led interventions for Intensive Care Unit (ICU) patients' symptoms (i.e., pain and thirst) that will involve ICU patients' family members in the non-pharmacological management of these symptoms. This family involvement may help to ameliorate not only patients' symptoms but also the families' symptoms and promote family satisfaction with ICU care.


Eligibility Criteria:
Inclusion Criteria:

* Patient:

  * in ICU for at least 24 hours;
  * adult;
  * able to self-report;
  * pain and thirst greater than 3 on 0-10 numeric rating scale;
  * English-speaking.
* Family member:

  * 18 years or older;
  * visits patient more than other family members;
  * closest person to patient (can be non-biological).

Exclusion Criteria:

* Patient:

  * in ICU for at less than 24 hours;
  * non-adult;
  * unable to self-report;
  * no pain and thirst greater than 3 on 0-10 numeric rating scale;
  * non-English-speaking.
* Family member:

  * younger than 18 years;
  * visits patient less than other family members;
  * not closest person to patient.
Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness

To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Have a history of redness relief drops use or expressed a desire to use drops for redness relief, within the last 6 months.
* Have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

* Any ocular/systemic health problems.
* Use of any disallowed medications.
Virtual Leisure - Virtual Reality Delivered Recreation at a Closed Psychiatric Ward

Background: The environment at a psychiatric in-patient ward can lead to emotional distress and behavioral deviations in vulnerable individuals potentially resulting in conflicts, increased use of need-based medication and coercive actions, along with low satisfaction with treatment. To accommodate these challenges recreational and entertaining interventions are generally recommended. The tested interventions have, however, shown varying effects and often demand a high degree of planning and staff involvement while also being difficult to adapt to individual needs. Virtual Reality (VR) may help overcome these challenges.

Methods: The study is a clinical trial, employing a mixed-methods design, enrolling 124 patients hospitalized at one closed psychiatric ward in the capital region of Denmark. All patients will be offered VR based stress reduction (e.g., mindfulness/relaxation techniques), entertainment, and distraction regularly during their hospitalization. Feasibility and acceptability will be explored with qualitative interviews supplemented with repeated non-participants observations and focus groups. The effect of the intervention will be assessed by comparing quantitative outcomes (e.g., coercion, need-based medication, and perceived stress) for a 12-month period with VR experiences available to a 12-month period without VR experiences available.

Discussion: It is of significant interest to find non-intrusive interventions with minimal side-effects that may provide an alternative to pharmacological interventions and coercive actions in mental health services. If the VR intervention is found to be feasible and acceptable a larger study can be initiated and if found to be effective in a psychiatric in-patient setting, it can be scaled for use in psychiatric treatment facilities in general where it may benefit a large group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a closed psychiatric ward
* Ability to give informed consent

Exclusion Criteria:

* Significantly impaired vision hindering engagement in Virtual Reality experiences
Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness

This study is is the first step of a full study named CHEMOGENE because it explores the genetic determinant of an alteration of the chemoreflex. This reflex determines hyperventilation when the pressure of oxygen falls in the blood. This happens when subjects travel to high-altitude where oxygen levels diminish in the atmosphere. Subjects with such an altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema associated with a severe headache. In this study we compare subjects tolerant to high altitude (8000 meters)to subjects intolerant to altitude. The chemoreflex is measured i.e. the hyperventilation associated with hypoxia and all subjects are scanned for the genes implicated in the mitochondrial respiratory chain. The idea is that subjects with an impaired oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.

Subjects are selected at an outpatient clinic specialised in the diagnosis of tolerance to altitude, where the chemoreflex is analyzed during a bicycle exercise performed with a oxygen deprived air simulating a 8000 meters altitude.

All subjects will go later to high altitude for trekking usually. The patients are those subjects with an altered chemoreflex who exhibited cerebral edema or pulmonary edema during the trekking.

The controls are the subjects with a normal chemoreflex who did not exhibit any trouble during their journey.

Fourty subjects of each group are included. A blood sample is withdrawn and studied for succinate dehydrogenase genes in a blind fashion.

After completing the inclusion the allelic mutations will be compared in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Chemoreflex sensitivity measured (normal or pathologic)
* Journey to high-altitude (well tolerated or with a severe disease such as pulmonary edema or cerebral edema)

Exclusion Criteria:

* Asthma,
* Arterial hypertension,
* Drug treatment