cyrilzakka/clinical-trials huggingface dataset:
Periodontal Treatment and Glycemic Control

The purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics.

The selected patients in treatment group will be given mechanical periodontal treatment in the form of scaling and root planning while the non intervention group patients will not receive treatment until the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed patients of Type 2 Diabetes Mellitus for at least 2 years
* HbA1C values \>6.5 % as per ADA criteria
* non smokers
* Patients with at least 16 standing teeth
* At least 8 teeth with one site having Mild to Moderate periodontal disease

Exclusion Criteria:

* Smokers
* Type 2 Diabetics with complications e.g. renal, ophthalmic etc
* Patients with chronic infections
* Patients who get hospitalized or have to change their medications during the course of study
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus

The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Lupus.
* Able and willing to have blood drawn for PK sampling.

Exclusion Criteria:

* Have severe active lupus nephritis.
* Have severe active central nervous system (CNS) or peripheral neurologic disease or other severe neurologic involvement requiring treatment within approximately 3 months prior to screening.
* Have received high dose corticosteroid within approximately 1 month prior to baseline.
* Have initiated or adjusted treatment with immunosuppressant drugs within approximately 1 month prior to baseline.
* Have received plasmapheresis within approximately 3 months prior to baseline.
* Have previously received approved or experimental B cell targeted therapies within the last year.
* Have received any biologic or non-biologic therapy within approximately 3 months or 5 half-lives (whichever is longer).
* Have a history of severe reaction to any biologic therapy.
* Have an active or recent infection within approximately 1 month prior to Week 0.
* Have had a serious infection within approximately 3 month or serious bone/joint infection within approximately 6 months prior to baseline.
* Have evidence of or test positive for active hepatitis B or are positive for hepatitis C or human immunodeficiency virus (HIV).
* Have evidence of active or latent tuberculosis.
* Have significant hematological abnormalities.
Mini-invasive Approaches to Aortic Surgery

There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.


Eligibility Criteria:
Inclusion Criteria:

- Indication for Aortic and/or Aortic Valve surgery

Exclusion Criteria:

- none
Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam

This repeated measures, cluster randomized, cohort trial design was carried out in three provinces in the northern mountainous area of Vietnam. Communes here were randomly selected for community based interventions with local production complimentary foods and marketing and distribution of fortified complimentary foods.

In rural northern Vietnam, childhood stunting rates are high. In Lào Cai province, female subsistence farmers grow crops, but face barriers sending produce to markets. The present intervention purchases local crops from local women subsistence farmers which are processed in local small-scale food processing facilities to produce instant fortified complementary foods for weaning.

Methods: A repeated measures survey was conducted from October to November 2016, with Caregiver-Child(\<2y) pairs (n=800) in the provinces of Lai Chau, Lao Cai and Ha Giang. Anthropometric data of mother/child dyads was assessed and logistic regression analysis of stunted and underweight children explored associated factors. These included: core infant and young child feeding practices indicators, food insecurity, antenatal care check-ups, core water/sanitation, anemia and hygiene indicators.

This project leveraged the experience of the National Institute of Nutrition of Vietnam to ensure HACCP standards during manufacture. Locally grown rice was combined with a Zn/Fe premix before extrusion and hammer-milling. Local vegetables such as: "Sweet leaf" (Sauropus androgynous), pumpkin, Shiitake mushrooms (Lentinula edodes) and carrots were made into complimentary foods and sold locally.

Eligibility Criteria:
Inclusion Criteria:

* Child participants must be younger than 2y at baseline.
* Caregivers must volunteer and were required to give informed written consent

Exclusion Criteria:

* Free from oedema
* Free from physical and mental disabilities
* Free from memory disorders and/or mental illness
A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.

A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).

Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.

Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total).

All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.

Eligibility Criteria:
Key Inclusion Criteria:

* Male and female subjects ≥18 years of age.
* Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
* An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.

Key Exclusion Criteria:

* Subjects with respiratory tract infection (\<4 weeks prior to study start)
* Current smokers or ex-smokers with \<6 months' abstinence or cumulative history of \>10 pack years
* Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
* FEV1 \<80% predicted, measured at screening using spirometry
* History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
* Any clinically significant abnormal laboratory test result(s)
* Inability to comply with the use of prohibited and allowed medications as described in the protocol.
The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns

This will be a prospective clinical study conducted with the approval of the Clinical Research Ethics Committee.

The influence of phototherapy lights on the accuracy of pulse oximetry will be investigated.

Each patient's oxygen saturation will be measured non-invasively via a nondisposable polyethylene neonatal probe taped to the infant's palm, toe, or dorsum of the foot. The probe will be connected to an Massimo Rad97 pulse oximeter that is standardized at the factory. It runs through an automatic systems check when turned on and needs no further calibration before being used. The oxygen saturation measurements will be considered valid when there will be a normal plethysmographic waveform, a fullscale signal strength bar, and a stable heart rate closely approximating an independent electrocardiographic (ECG) pulse rate. The pulse oximeter works by using the technology of plethsmography which allows the detection of an arterial pulse) with oximetry (which measures oxygen saturation at specific wavelengths). The pulse oximeter will be placed on each infant as already described. After a stable pulse oximeter reading was obtained, the value will be recorded ("before") and then the probe will be covered with a standard disposable diaper, shiny side up. When the reading stabilized, the value will be recorded ("during") and then the diaper will be removed.

Eligibility Criteria:
Inclusion Criteria:

* newborn babies (0-28 days)
* to be treated in the Hacettepe University Children's Hospital Neonatal Intensive Care Unit
* receiving phototherapy treatment

Exclusion Criteria:

* Newborn babies with any diseases that affect oxygen saturation including congenital heart disease, chromosomal disease, inborn error of metabolism, anemia, circulatory disorder, hypovolemia or hydrops fetalis
Prospective Validation of CARPET Prognostic Model for Septic Shock After Allo-HSCT

Validation of CARPET prognostic model for septic shock after allo-HSCT: a multicenter, prospective, and cohort study

A clinical prognostic model named CARPET model for septic shock after allo-HSCT has been developed and internally retrospectively validated. A multicenter, prospective cohort study is planned to validate this clinical prediction model again.

The equation of the prediction model for 28-day mortality was as follows:

Probability(28-day mortality)=(exp⁡(Y))/(1+exp⁡(Y)) where Y=2.343+1.328\* Time of septic shock- 0.085\* Albumin + 0.016 \* Bilirubin-0.003\*PaO2/FiO2 +0.127\*Lactate- 0.011 \* Glomerular filtration rate

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* underwent allo-HSCT
* diagnosed with septic shock

Exclusion Criteria:

* experienced septic shock before enrollment
* relapsed or progressed after HSCT
National Mobile Asthma Management System-E Project

Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation, which is a common and frequently occurring disease in the world, and has resulted in a sustained increase of social and economic burden. However, several studies suggest, lots of asthma patients did not get their asthma controlled. The investigators study showed that in China only 28.7% of asthma patients achieve asthma controlled during 2007-2008. In recent years, application softwares of mobile-phones for asthma have gradually increased, studies suggested that application of these application softwares can make treatment more standard, reduce asthma attacks, help patients to control their asthma, improve adherence and these application softwares also show many other advantages. This study is a prospective, multi center, randomized, controlled study, aims to evaluate the efficacy of application softwares in asthma patients, provide a new tool to asthma management.


Eligibility Criteria:
Inclusion Criteria:

1.18 years of age or older, having been resided in the same city during the study; 2.A history of at least 3 months of diagnosed asthma based on the criteria established by GINA 2016; need to be on medication containing ICS or ICS/LABA 3.Asthma out patients with ACT scores﹤20 and MARS - A mean score \< 4.5 ; 4.Owning and Being able to use smart phone that the corresponding software can be successfully installed; 5.Subjects who are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Unable to communicate properly because of visual impairment, hearing impairment and language barrier, or with mental illness or psychological problems;
2. Have a history of tracheal intubation or mechanical ventilation as a result of acute asthma attack;
3. Have respiratory tract infection within the prior 4 weeks; history of thoracic surgery; with comorbidities such as other/structural lung diseases (COPD, bronchiectasis, lung cancer, et al); heart disease; kidney or autoimmunity disease; or other conditions that could potentially effect asthma control or asthma disease status by investigator's medical opinion.
4. Women with pregnancy, or planned pregnancy within one year.
An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. 18 - 70 years
3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail.
4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
5. Signed written informed consent

Exclusion Criteria:

1. Proximal subungual onychomycosis.
2. DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
3. "Spike" of onychomycosis extending to eponychium of the target nail
4. Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
5. Other conditions than DSO known to cause abnormal nail appearance
6. Topical antifungal treatment of the nails within 1 month before screening
7. Systemic use of antifungal treatment within 3 months before screening
8. History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
9. Immunosuppression
10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
11. Known allergy to any of the tested treatment products
12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
13. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :

    * are pregnant or nursing
    * are not surgically sterile
    * are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)
Integration of Family Planning and HIV Services in Tanzania

HIV positive women and couples have broad reproductive health needs that are not always met within HIV services. The integration of family planning (FP) services into Tanzania's HIV Care and Treatment Clinics (CTC) will address the fertility desires of CTC clients and ultimately result in the reduction of unintended pregnancies and HIV incidence. One strategy for integrating FP and CTC services is to use a "facilitated referral" model. Facilitated referrals are enhanced referrals for additional services that have been used in other settings and which are the preferred intervention strategy the Government of Tanzania would like to pilot test. This study will evaluate the feasibility, effectiveness, and costs of implementing a "facilitated referrals" intervention by examining FP use among female clients attending HIV/AIDS Care and Treatment Centers. This study will measure whether there is a reduction in unmet need for contraception among female CTC clients after the facilitated referral integration intervention has been implemented.


Eligibility Criteria:
Inclusion Criteria:

1. Female clients of Care \& Treatment Clinics with CD4 counts \>100, and are WHO Stage I - III. (CTC Clients)
2. Care and Treatment providers who provide services to clients (CTC Providers)
3. Care and Treatment supervisors who are the immediate in-charge supervisor for the CTC clinic. (CTC supervisor)
4. Family Planning providers who provide services to clients. (FP providers)
5. Family Planning supervisors who are the immediate in-charge supervisor for the FP clinic. (FP supervisor)
To Use the Combined Version of ICIQ-SF and Quality of Life Scale in Mixed Urinary Incontinence

The goal of this observational study is detecting the dominant component of mixed urinary incontinence via a combined version of ICIQ-SF and quality of life scale. The main question it aims to answer is:

1. Which component (urgency or stress) urinary incontinence bothers the patient more?

Female patients with mixed urinary incontinence will be given a combined version of ICIQ-SF and quality of life scale on the first visit. Additionally, a bladder diary and 1-hour pad test will be performed on the same visit. After deciding the appropriate treatment, on the 1-month visit (second visit) the same tests will be repeated and scores will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Female patients above 18 years old with mixed urinary incontinence

Exclusion Criteria:

* Non-Turkish speakers
* Poor conscious level
* Immobile patients
A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty

The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring hip arthroplasty

Exclusion Criteria:

* Patients with sensory, neurological, or general health conditions that alter perception of their limb in space
* Patients with vestibular disorders
The Use of Narrow Band Imaging in Screening Colonoscopy

Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.


Eligibility Criteria:
Inclusion Criteria:

* 50-69 year-old asymptomatic subjects at average-risk of CRC
* positive FOBT participating in a national mass-screening program and referred for colonoscopy

Exclusion Criteria:

* ongoing anticoagulation therapy
* inadequate bowel cleansing
* incomplete colonoscopy
* refusing to participate
Biomarker Study in Patients With Trigeminal Neuralgia

Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with primary trigeminal neuralgia (TN).

Sudden and electrick shooting sensation of face is an important clinical feature of trigeminal neuralgia (TN). The severe and excruciating nature of pain intensity associated with TN can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of TN still remains unclear.

Recentrly, there have been a few studies suggesting biomarker levels in the blood and CSF level, however, further study is required to elucidate the action mechanism.

Up to 90% of patients can achieve pain reduction using medical therapy alone. However, 10% -15% of TN cases demonstrate a minimal response to medication with various side effects. Radiofrequency thermocoagulation (RFT) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. Recent study revealed that RFT of the trigeminal ganglion resulted in Barrow Neurological Institute (BNI) pain scale I or II in 71.7% of patients, with a median time to recurrence of 36 months.

Although patients experience significant pain relief after RFT, it is uncertain whether inflammatory cytokine and neurocytokine (CGRP, substance P, VIP) are reduced.

Eligibility Criteria:
Inclusion Criteria:

* TN patients with NRS more than 4
* TN patients who failed medical treatment
* TN patients showing severe adverse reaction with medication

Exclusion Criteria:

* Patients showing allergic reaction to local anesthetics
* Patients with coagulation abnormality
Phase I Biomarker Study (BMS-936558)

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Intervention Model: Parallel Dose Comparison

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Women and men ≥ 18 years of age.
* Histologic confirmation of renal cell carcinoma with a clear cell component.
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
* Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
* Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
* Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

Exclusion Criteria:

* Active or progressing brain metastases.
* Active concomitant.
* Active or history of autoimmune disease.
* Active use of systemic corticosteroids.
* Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.
Emotional Freedom Liberation Technique, Surgical Fear and Anxiety

Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated.

Design: This is a randomized controlled study. Method: A total of 112 patients who were going to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56 participants. The intervention group was provided with Emotional Freedom Technique. The control group received routine face-to-face education. Surgical fear and anxiety were examined.


Eligibility Criteria:
Inclusion Criteria:

* Clinical treatment for Laparoscopic Cholecystectomy
* 18 years of age or older
* Mentally healthy

Exclusion Criteria:

* Agree to participate in the study
Personalized Approach to Promote Healthy Aging

The goal of this clinical trial study is to evaluate the impact of a personalized lifestyle intervention on improving healthspan. The primary questions of interest are whether the personalized intervention will result in improvements in muscle function, immune function, and cognitive function in adults aged 50-85 years. Participants will complete baseline assessments, receive an individualized intervention plan for approximately 3 months, and then complete post-intervention assessments. The intervention includes an exercise plan, nutrition recommendations, and general lifestyle goals that will be personalized to each participant.


Eligibility Criteria:
Inclusion Criteria:

* 50-85 years of age
* Non-smoking
* Ambulatory without the need of an assistive device (walker, cane, etc.) and able to perform exercise testing and exercise training
* English speaking
* Owns a smart phone

Exclusion Criteria:

* Minors and adults younger than age 50 years and older than 85 years
* Pregnant women
* Adults who are unable to provide informed consent
* Prisoners