cyrilzakka/clinical-trials huggingface dataset:
Revitalization of Traumatized Immature Permanent Teeth

This study aims to assess the hypothesis that revitalization of teeth without (a)symptomatic apical periodontitis have a more favourable outcome in terms of further root development, periapical bone healing, maintaining/regaining pulp sensitivity and survival, than teeth with (a)symptomatic apical periodontitis.

1. Trial objectives

   This study aims to investigate the effectiveness of revitalization procedures, in terms of maintaining or restoring periapical health, further root development and regaining of pulp sensitivity, in immature permanent teeth with (group 1) or without (group 2) (a)symptomatic apical periodontitis .
2. Primary endpoints RRA at 1 year post revitalization. 3 Secondary endpoints Maintained or restored periapical health (evaluated within each group separately due to expected baseline inequivalency between groups) 1 year post revitalization.

4 Other endpoints

* RRA 2 and 3 years post revitalization
* Maintained or restored periapical health 2 and 3 years post revitalization (evaluated within each group separately)
* Pulp sensitivity 1-3 years post revitalization (evaluated within each group separately due to expected baseline inequivalency between groups)
* Tooth survival 3 years post revitalization (even if no further root development and incomplete periapical bone healing with no clinical symptoms).

  5 Trial Design Open, prospective cohort, multicenter Blinded: radiographic assessment and statistical analysis; operators and patients cannot be blinded, due to practically not feasible.

Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Female and male patients
* Age range: 6-18 years
* "Healthy": ASA I and II
* Permanent immature tooth (Cvek stage of root maturation ≤ 2) requiring revitalization
* Etiological factor: (a)symptomatic apical periodontitis post dental trauma or irreversible pulpitis post dental trauma

Exclusion Criteria:

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Patients older than 18 years and younger than 6
* Deciduous teeth
* Cvek root maturation stage \> 2: permanent immature tooth that can be treated by conventional root canal treatment or apexification
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* Bleeding disorders
* Involvement in the planning and conduct of the study
Aetiology of Children With Bronchiectasis in China

This multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records.

This study is divided into two parts. Part I. Retrospective review the 10 years medical records of the children with bronchiectasis from every center, and investigate the etiology of the cases by the standard diagnostic process. Part II. All new cases of bronchiectasis which was confirmed diagnosed at every center from the beginning of the study are made the investigation of the etiology by the standard diagnostic process.

Eligibility Criteria:
Inclusion Criteria:A included patient must be coincident at least one point of the four items of HRCT manifestations.

* Internal bronchial diameter greater than the accompanying pulmonary artery.
* lack of bronchial tapering
* bronchi visible in the peripheral 1cm of lung
* bronchial diameter greater than adjacent segmental bronchi

Exclusion Criteria:Subject will be excluded if she or he has one of the following

* It is unable to provide complete medical records or the current condition can not accept the diagnosis process
* It does not agree to participate in the test
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes

Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.

In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* the diagnostic criteria of DSM-IV for MDD
* 18 to 65 years old
* pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
* physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
* have not received any psychiatric treatment in 2 weeks
* competent to receive a full explanation of this study and give written informed consent.

Exclusion Criteria:

* a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
* AxisII diagnoses, including borderline and antisocial personality disorder
* a notable medical comorbidity
* acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
* regular consumption of omega-3 PUFAs supplements or a habit of eating ﬁsh equal or more than 4 times per week
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

Primary Objective:

To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) \< 7%.

Secondary Objectives:

The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c \<7.0% in patients achieving their FPG target. The percentage of HbA1c \<7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast \<10 mmol/L).

The study duration for each patient will be 27 weeks.

Eligibility Criteria:
Inclusion criteria :

* 18 to 65 years old.
* Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months:
* If on 1 OAD, provided with the following doses (including but not limited to):

  * α-glucosidase inhibitor: 100mg, three times a day (tid);
  * metformin: 1.5-2.0 g/day;
  * sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose;
  * thiazolidinediones: eg. pioglitazone, 30-40 mg/day.
  * Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert.
* If on 2-3 OADs, any range of dose is acceptable.
* HbA1c \>7%, and ≤10.5%.
* FPG \>7 mmol/L.
* Body mass index (BMI) ≥20 kg/m\^2, and ≤40 kg/m\^2.
* Diabetes duration ≥1 year.
* Physician decides to and the patient is willing to start basal insulin (BI) treatment.
* Willing to join the study and sign the informed consent.

Exclusion criteria:

* Type 1 diabetes patients.
* Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months).
* Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening.
* Known hypoglycemia unawareness or recurrent hypoglycemia.
* Hypersensitivity to study drug or its excipients.
* Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up.
* Pregnancy or breastfeeding women.
* Have any mental disorders, lack self-control or not able to express accurately.
* Involved in another clinical trial simultaneously or within a 1 month before start of trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation

The induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This observational study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of antihypotensive drugs during the induction and the surgical procedure in heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD).


Eligibility Criteria:
Inclusion Criteria:

- Heart failure patients scheduled for implantation of left ventricular assist device (LVAD)

Exclusion Criteria:

* Pregnancy
* Presence of another cardiac assist device in the patient (for example ECLS)
* No consent of the patient
A Randomized Controlled Trial of Students for Nutrition and eXercise

Objectives: We conducted a randomized controlled trial (RCT) of Students for Nutrition and eXercise (SNaX), a middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education and marketing.

Methods: We randomly selected schools from the Los Angeles Unified School District (LAUSD) and assigned five to the intervention group and five to a wait-list control group. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student. Pre- and post-intervention surveys assessed psychosocial variables among 2,997 seventh-graders (75% of all seventh-graders across schools).

Hypotheses: For the RCT of SNaX, we hypothesized that SNaX would lead to increases in the proportion of students served in the cafeteria (because SNaX markets cafeterias' healthy foods); increased fruit and vegetable servings (because SNaX increases access to sliced/bite-sized fruits and vegetables); decreased school store snack sales; and greater water consumption. We also hypothesized that SNaX would lead to more positive attitudes about the cafeteria and water, improve obesity-prevention knowledge, and increase intentions to drink water.


Eligibility Criteria:
Inclusion Criteria:

* schools with \>50% NSLP-eligible students (a proxy for low-income) and \<900 - seventh-graders

Exclusion Criteria:

* schools with \<50% NSLP-eligible students and \>900 seventh-graders
To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
* A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
* A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion Criteria:

* A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
* Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
* A history of intolerance or hypersensitivity to any component of the study medications.
PP-Gemcitabine & External Beam Radiation-Sarcomas

The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.

Before the start of treatment, participants will have a physical exam, blood tests, a MRI scan, and a chest x-ray. A PET scan may be done if thought necessary.

Participants will receive the drug gemcitabine by vein along with radiation therapy on Days 1, 8, 22, 29, 43, and 50. Radiation treatments will be given 5 days a week for 5 weeks. The gemcitabine and radiotherapy will be given on an outpatient basis. Chemotherapy and/or radiotherapy may be stopped if side effects become severe.

About 4 to 6 weeks after the final dose of gemcitabine, surgery will be done to remove the tumor or to remove any previous surgical scar and leftover tumor.

During the combined treatment, participants will be seen weekly by the doctor in charge of radiotherapy or by the study nurse. Blood tests will be done every week during treatment. A MRI scan and a chest x-ray will be done within 14 days before surgery. A PET scan will be done if thought necessary.

After the surgery is done, participants will return to M. D. Anderson for follow-up visits every 4 months for the first 2 years, every 6 months for 3 years, and then yearly from then on. An ultrasound and MRI scan (of the extremity or trunk) will be done 3 months after completion of all treatment. Ultrasound scans will be performed at each visit. A MRI scan will only be done again at later visits if needed.

This is an investigational study. Gemcitabine is approved for use by the FDA. Its use together with radiation therapy in this study is experimental. About 36 individuals will take part in the study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with cytologic or histologic proof of Grade II or III resectable soft tissue sarcoma of the extremity or trunk.
2. Patients with both measurable and non-measurable disease. Patients who are S/P pre-referral excision will be eligible.
3. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman.
4. Patients must have a Zubrod Point Scale of 0 or 1.
5. Absolute neutrophil count must be \> 1,500 cells/mm; platelet count greater than or equal to 100,000 platelets/ml; serum creatinine less than or equal to 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 x normal, total bilirubin less then or equal to 1.5 mg/dl.
6. Patients must have no uncontrolled coexisting medical conditions.
7. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.
8. All patients must sign an informed consent.

Exclusion Criteria:

1) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.
Culture Media for Borrelia Burgdorferi Sensu Lato

The main purpose of this study is to compare effectiveness of two different culture media for cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients with erythema migrans.


Eligibility Criteria:
Inclusion Criteria:

* erythema migrans in patients \> 18 years

Exclusion Criteria:

* pregnancy or lactation
* taking antibiotic with antiborrelial activity within 10 days
* erythema migrans localized on face or neck

Each patient (235 subjects) provided two skin samples (470 skin samples).
Food-Effect and Metabolism Study in Healthy Subjects

This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent.
* Must be willing to comply with the requirements of the study.
* Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months.
* Male or female aged 18-50 years.
* Weight more than 45kg, BMI within 18 and 28 kg/m2.
* No clinically significant abnormalities in physical examination and lab tests.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* No history of alcohol or drug abuse within the past year.
* Participation in any clinical trial of an experimental drug or device in the previous 3 months.
* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction

The purpose of this study (PASSION study) is to monitor symptoms of chronic pain before and after 2 weeks of a standard drug commonly used to treat elevated blood pressure compared with 2 weeks of placebo (crossover design) so that we may better understand how blood pressure affects your level of pain. This study is not testing an experimental drug.

The goal of the PASSION study is to determine the extent to which reductions in blood pressure improve pain management via SCS

1. Examine the extent to which reductions in blood pressure (2 weeks of diuretic and 2 weeks of placebo) improve pain management among patients with chronic pain and hypertension compared.
2. Examine the extent to which arterial baroreflex function, which is critical to blood pressure regulation, is impaired in patients with chronic pain and hypertension and is correlated with chronic pain symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, age 40-79
2. Chronic low back pain
3. Permanent spinal cord stimulator implant for chronic pain
4. Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk ≥10%
5. Stage 2 hypertension (BP ≥ 140/90 mmHg)
6. Willing to visit research lab (Fairway CTSU)
7. Willing to undergo a blood draw
8. Able to provide written informed consent

Exclusion Criteria:

1. Any history of abnormal responses (allergy) to thiazide-type drugs
2. Currently taking any antihypertensive medication
3. Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk \<10%
4. BP ≥160/100 (these patients should be promptly treated with 2 medications)
5. Secondary hypertension (e.g., aldosteronism, renal artery stenosis)
6. Symptomatic hypotension (weakness or syncope upon standing)
7. Renal failure
8. Diabetes requiring insulin or glucose-lowering drugs
9. History of neurological disease (e.g., dementias, Parkinson's)
10. History of stroke
11. Current diagnosis of cancer
12. Women who are pregnant or planning to become pregnant
13. Any active infection
14. Subject is unwilling or unable to comply with the protocol
15. If currently taking a NSAID, willing to stop for at least 3 days prior to beginning study and throughout study
Neuropsychiatric Scleroderma Study: Systematic Evaluation of Neuropsychiatric Involvement in Systemic Sclerosis

Systemic sclerosis is a rare disease with vascular involvement and systemic fibrosis. This disease is usually thought to spare central nervous system. However, neuropsychiatric manifestations like depression and cognitive functions impairment seem to be frequent. Pathophysiology of this neuropsychiatric manifestations is currently unknown. White matter hyperintensities have been reported suggested CNS vascular manifestations in systemic sclerosis. Whether this CNS vascular involvement plays a role in neuropsychiatric manifestations in systemic sclerosis is unknown. The primary objective of this prospective and multicentre study is to assess a link between neuropsychiatric manifestations and CNS involvement in systemic sclerosis. Secondary objectives are to assess the frequency of neuropsychiatric manifestations, to compare central nervous system abnormality between scleroderma patient and healthy subjects. Central nervous system involvement and neuropsychiatric manifestations will be systematically assessed through central nervous system imaging and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 yo
* With scleroderma (American College of Rheumatology and/or Leroy et Medsger)
* Informed consent given

Exclusion Criteria:

* Other auto-immune disease
* non french native speakers
* severe arterial hypertension
* diabetes
* anemia
* renal insufficiency
* cranial trauma
* history of neurological disorder or neurotoxic treatment
* pregnancy or breast feeding
* impossibility or non compliance to perform the protocol flow chart
* contra indications to MRI
Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome

Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome.

Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of subacromial impingement syndrome

Exclusion Criteria:

* Patients aged \<20 or \>50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.
Collaborative Care Intervention for Chronic Kidney Disease

The aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

Symptom management is critical to maintain quality of life in those with life limiting conditions. Stepped collaborative care interventions have been widely employed in the primary care setting for the treatment of depression and more recently have been utilized to treat other symptoms (e.g., pain) in a variety of settings. A recent meta-analyses concluded that collaborative care interventions were superior to usual care and are more cost-effective than face to face and pharmacological treatment for depression. Collaborative care interventions have begun to be extended to other settings but have not been tested in patients who are being treated with dialysis. The aims of the present study were to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

Age 18 or older Currently receiving dialysis at UPMC dialysis facility for chronic kidney disease Fluent in English

Exclusion Criteria:

Under the age of 18 years or over 90 years Not fluent in English