cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Fractalkine and Its Receptor in Peri-implantitis

In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.


Eligibility Criteria:
Inclusion Criteria:

* Probing depth of 4-6 mm, bone loss of at least 2 mm on X-ray and presence of inflammatory symptoms in soft tissue
* No systemic disease that may affect the outcome of the treatment
* Patients with healthy periodontium or patients with completed periodontal treatment
* Individuals at least 6 months after prosthesis loading on the implant
* Individuals who do not require further surgery for the treatment of peri-implantitis
* Implants with at least 2 mm keratised gingiva
* Individuals aged 40-60 years

Exclusion Criteria:

* Individuals undergoing radiation therapy
* Individuals who smoke and drink alcohol
* Individuals in pregnancy or lactation
* Individuals who have received antibiotic treatment in the last three months
* Individuals with parafunctional habits
Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring.

In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol.

Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.


Eligibility Criteria:
Inclusion Criteria:

* Participants in an FTC/TDF for PrEP observational or clinical study
* HIV-1 negative individual at the time of enrollment in a demonstration project or clinical study
* Participants with at least one measurement of tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) or tenofovir (TFV) in plasma

Exclusion Criteria:

* This is an observational study and will collect HIV-1 infection and resistance information along with renal or skeletal adverse events without intervention.
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer

Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation.

A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period.

Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population.

Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.


Eligibility Criteria:
Inclusion Criteria:

* Resection of the lung due to confirmed diagnosis of cancer pulmones.
* Elective operation (scheduled operation for at least one day)
* Ready to be randomized
* Patient must be at least 18 at time of operation

Exclusion Criteria:

* Former operation of the lung
* Former heart surgery
* Bradycardia below 40 beats/ min
* Hypotension with systolic blood pressure below 80 mmHg
* AV-blockage of any degree or sick sinus node
* QTc interval above 440 ms for men or above 460 ms for women
* Paroxysmal, persistent or permanent atrial fibrillation or flutter
* Former atrial fibrillation or flutter for more than a month.
* Pregnant or positive pregnancy test
* Breastfeeding
* ALAT of more than twice the normal over limit
* Treatment with monoamineoxidase inhibitors (MAOI)
* Allergy to one or more components in amiodarone
Multihole or Epidural Catheter for Local Anesthetic in the Wound

Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined.

This study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* operation with total hip arthroplasty

Exclusion Criteria:

* allergies to drugs administered
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma

The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.


Eligibility Criteria:
Inclusion Criteria

* Targeted therapy is acceptable within 1-2 months after liver transplantation.
* Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
* All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
* The definition of high-risk patients:
* The PET scan is positive before LDLT;
* Tumors beyond USCF criteria
* Poorly-differentiated tumor;
* The patients who has poor AFP response (\<15%)or AFP\>400 ng/ml after LRT after conventional LRT (RFA、PEI or TACE)

Exclusion Criteria

* Life expectancy is less than 3 months
* Patients are with other malignant tumors simultaneously.
* Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
* Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).
* Preoperative history of severe cardiovascular disease: congestive heart failure \> NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.
* History of HIV infection.
* Severe clinical active infections (\> NCI-CTCAE version 3.0).
* Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).
* Patients with kidney diseases requires renal dialysis.
* Drug abuse, medical symptoms, mental illness or social status that may interfere with participants' participation in research or evaluation of research results.
* Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:

* the ability of MSCs to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).

In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.

Eligibility Criteria:
Inclusion Criteria:

* Trophic Ulcers

Exclusion Criteria:

* diagnosed cancer
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy
Developing an Intervention to Address Suicide Risk During Substance Use Disorder

This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.

Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. Patients for this trial will be screened at the SUD treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.

Eligibility Criteria:
Inclusion Criteria:

* Must be over 18 years of age
* Report a past lifetime suicide attempt
* Report current suicidal ideation
* Resided in treatment for less than 4 weeks
* In treatment for less than 6 months

Exclusion Criteria:

* Mental incompetence (e.g. unable to provide informed consent)
* Diagnosis of schizophrenia or currently psychotic
The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women

It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and will cause low BMD estimation in DXA scan due to insufficient bone mineralization.

We assume that among these postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD. According to the results, bisphosphonates therapy may be an unnecessary treatment.

The objective of this study is to evaluate the impact of severe vitamin D deficiency and its correction on Bone Mineral Density (BMD) in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent.
2. Female age 55-70
3. At least 2 years past menopause
4. 25(OH)D≤ 17.5nmol/L (≤7 ng/ml)

Exclusion Criteria:

1. Vitamin D levels \> 30nmol/L in the past 2 years 2. Creatinine \> 1.2%mg 3. Calcium ≥ 10.2mg/dl 4. Current or previous vitamin D treatment over 2 weeks 5. Previous vitamin D treatment over 2 months in the past 2 years 6. BMI\>35 or BMI\<20 7. Menopause before age 45 8. Type 1 diabetes 9. Concomitant disease:

1. Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease)
2. Rheumatoid arthritis
3. Nephrotic syndrome
4. Chronic renal failure
5. Primary hyperparathyroidism
6. Hyperthyroidism
7. Malignancies excluding skin cancers (within the last 5 years)
8. Kidney stones or history of renal colic 10. Medications:
9. Steroids use (past or present)
10. Anti rejection drugs in the last 5 years
11. Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years
12. Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present)
13. Post menopausal HRT (in the last 10 years)
14. Aromatase inhibitors: Femara, Arimadex (past or present)
15. Current use of PPIs (lanton, controloc, zoton, omepradex etc)
16. Current or past use of anti depressant SSRI (favoxil,cipralex etc)
Physical Therapy on Phrenic Nerve Function

This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression.

Twenty patients from the Spinal Unite represented the sample of the study. Their mean ages were 43 years and they suffering from acute cervical disc compression at the level of cervical 3, 4, 5. Methods: Evaluation was carried out before and after three months of treatment. It included measuring of pulmonary functions (VC, FVC, FEV1, PEF and MVV) by using spirometer, diaphragmatic excursion and thoracic volume via x-ray and conduction velocity and amplitude of phrenic nerve using electromyography. Treatment program included heat application, ultrasound, cervical traction and diaphragmatic breathing exercises.

Eligibility Criteria:
Inclusion Criteria:

* suffered from cervical disc compression for 6-8 months.
* patients examined and referred by physician.

Exclusion Criteria:

* Any cardio pulmonary disorders which may alter pulmonary function.
* They did not receive any physical therapy program prior to their participation in the study.
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions with dosing by applesauce-sprinkle method.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers or light smokers (10 or less cigarettes per day)
* 18 years of age or older
* Body Mass Index of 30 or less
* Males or non-pregnant females
* Normal clinical laboratory test results

Exclusion Criteria:

* Subjects with a significant history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* Subjects who are heavy users of tobacco (smoke more than 10 cigarettes a day, smoke cigars or pipes, or use oral tobacco products) will not be eligible to participate in the study. Light smokers may participate, but can not smoke from 2 hours before dosing until 2 hours after dosing.
* Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate.
* Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.


Eligibility Criteria:
Inclusion Criteria:

• Individuals 18 years or older (Group A)

Ear to be Implanted:

Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

• Children 5 years to 17 years, 11 months (Group B)

Ear to be Implanted:

Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \>80 dB HL; Aided CNC score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

* Previous experience with a current conventional treatment option for unilateral \[SSD\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
* English spoken as a primary language
* Willing and able to provide written informed consent

Exclusion Criteria:

* Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Previous cochlear implantation
* Hearing loss of neural or central origin, including auditory neuropathy
* Duration of profound sensorineural HL \>10 years per self-report
* Active / chronic middle-ear infection; conductive HL in either ear
* Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
* Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
* Evidence of and/or suspected cognitive or developmental concern
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
* Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
* Pregnant or breastfeeding women
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
An Open-label Study of KW-3357

The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.


Eligibility Criteria:
Inclusion Criteria:

* Meet the ACCP/SCCM-defined sepsis criteria
* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Antithrombin activity \<= 70%
* Written informed consent from patient or guardian

Exclusion Criteria:

* Anamnesis or complication of serious drug allergy
* Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
* Pregnant, nursing, or possibly pregnant woman
Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease

The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are comparing infants born premature \<32 weeks gestation to infants born full term \>37 weeks. We hope to evaluate the differences between the two groups in order to learn more about premature lung growth and development.

We hypothesize that infants who were born prematurely but are clinically without chronic respiratory disease have a lower lung diffusion capacity than healthy infants born at full term, when evaluated at comparable post-conception ages. In addition, prematurely born infants that develop chronic lung disease have an even lower diffusion capacity than healthy premature infants and full term infants. A lower diffusion capacity, when normalized to lung volume, would be consistent with decreased alveolarization and alveolar surface area in the infants born prematurely. We will study the age range of 1 to 24 month as this represents the period of rapid lung growth.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 Infants born at \< 32 weeks gestation with Chronic lung disease
* Group 2 Infants born at \<32 weeks gestation without Chronic lung disease
* Group 3 Infants born full term at \>37 weeks

Exclusion Criteria:

* Group 1 and Group 2--No heart disease, no oxygen requirement
* Group 3--No hospitalization for respiratory illness, No asthma, No heart disease, No history of wheezing, asthma or treatment with asthma medications.