cyrilzakka/clinical-trials huggingface dataset:
Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients

The main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2 diabetes patients following a chronologically scheduled pattern.

Type 2 diabetes prevalence in adults has grown in the last years in many societies, accompanying the high incidence of obesity-related and other cardiovascular risk factors. Indeed, obesity is the most relevant overnutrition disease worldwide, being more dramatic than a self-esteem problem or an aesthetic issue, since it is associated to different metabolic disorders such as coronary diseases, hypertension, certain tumors, dislipidemia, biliary disorders, immunodeficiencies and insulin resistance. Different studies have shown the efficacy of low-fat diets on weight reduction, which has been associated to an improvement in overweight-related chronic pathological conditions. Additionally, a moderate increase of protein content (up to 30% of total caloric intake) in the diet and the inclusion of low-glycemic index products have been shown as a good tool for weight loss and maintenance. Recent studies have also shown the benefits of partial nutritional interventions, mainly on modifying breakfast intake, on anthropometrical and cardiovascular risk factors in overweight patients.

The study has been designed as a longitudinal nutritional intervention with two consecutive 4-week periods: from week 0 to 4, volunteers will follow their habitual diet. The second period (week 4 to 8), the volunteers' habitual breakfast, mid-morning and afternoon snacks will be substituted by 40-30-30 products, without changing any other parameter of their habitual diet or lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed of type-2 Diabetes
* Under dietary treatment or with Metformin
* Body Mass Index (BMI) Between 22 and 35 kg/m2

Exclusion Criteria:

* BMI under 22 or over 35 kg/m2
* To follow a pharmacological treatment with other drugs but metformin
* To be already insulin-dependent
* To have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
* To suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
* To have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.
Representations of Transplantation in Patients and in Health Care Professionals

Main objective : This project aims to have a better understanding of the influence of representations of patients with mucoviscidosis, their assistants and their medical persons in the choice of patients to accept or not lung transplantation.

Specific objectives :

1. Identify the knowledge, representations, or feelings of patients which could constitute bridles or factors of motivation to use for transplantation.
2. Identify the knowledge, representations, or feelings of medical persons which could constitute bridles or factors of motivation to the "encouraging" proposal to patients of lung transplant.
3. Identify the knowledge, representations, or feelings of assistants which could constitute bridles or factors of motivation to the "encouragement" of lung transplantation at its close.
4. Identify the needs of patients, assistants and medical persons to successfully reduce these bridles to transplantation and increase the factors of motivation.
5. Compare the representations of patients, assistants and medical persons
6. Search representations associated with patients who refuse the transplantation and those who accept the transplantation


Eligibility Criteria:
Inclusion Criteria:

* For patients :

  * Adult patient (those concerned by the suggestion of lung transplant).
  * At the time of transplant indication : after the first suggestion of the medical person, before or after the preoperative graft check-up but before registration on waiting list.
* For medical persons :

  * Medical persons involved in the suggestion of lung transplantation to the patients.
* For assistants :

  * Adult close to the patient and that the patient sees as a resource person and advisor in his choices for the transplant : reference person having a major influence for the patient (spouse, parent, sibling, friend ...)

Exclusion Criteria:

* For patients :

  * Patient with a psychiatric disorder
  * Patient in intensive care unit
  * Palliative care patient
  * Patient aged under 18 years old
  * Patient refusal
* For medical persons :

  * Medical person refusal
* For assistants :

  * Assistant or patient refusal
Trauma-focused Group Music and Imagery With Traumatized Women

This study is a mixed methods randomized controlled trial (Wait List Control), that investigates the effects of Group Music and Imagery (GrpMI) therapy in the treatment of women suffering from Post Traumatic Stress Disorder (PTSD) or Complex PTSD.

The aim is to detect if the intervention has an effect on PTSD symptoms, dissociation, quality of life, and the capability of regulating the autonomic nervous system (ANS).

Participants are adult women suffering from PTSD or Complex PTSD (n=56) that are randomized to three months of weekly (12) sessions of trauma modified GrpMI therapy or no treatment for an equal amount of time (wait list control).

Primary outcome is pre, post and 3 months follow-up measures of PTSD checklist 5 (PCL-5).

Secondary outcome is pre, post and 3 months follow-up measures of dissociative experience scale (DES), positive state of mind scale (PSOM-S), Hopkins symptoms checklist (HSCL-25), somatoform dissociation questionnaire (SDQ-5), and reactivity and recovery of different physiological measures related to arousal regulation ability in a script driven imagery setting.

Eligibility Criteria:
Inclusion Criteria:

* be suffering from PTSD/CPTSD,
* be sufficiently stabilised to tolerate being exposed to trauma treatment and listen to other subjects' stories,
* be able to speak good enough swedish to express themselves without an interpreter,
* have an interest in working with their problems using artistic languages,
* have an ability to work with symbolism and inner images.

Exclusion Criteria:

* difficulties in understanding or making themselves understood in swedish,
* severe personality disorder or neuropsychiatric disorder,
* ongoing alcohol or drug abuse,
* psychotic disorder,
* suicidality,
* serious ongoing medical condition,
* serious psychosocial problems.
Daily Undulating Periodization Methods With Parkinson's Disease

Compare periodized (cyclic) resistance training with and without motor training specific to activities of daily living.

This study will look at how well two different daily undulating training programs (hypertrophy-strength-power training, versus strength-power-functional training) improve participants' physical functions. All testing procedures will take place at the Max Orovitz Laboratory on the Coral Gables campus. This study will involve a 1-week baseline testing phase, a 2-week familiarization phase, a 9-week intervention phase, and a 1-week post-testing window where subjects must report to the lab for 2 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn \& Yahr Classification of Disability, stage 1-3
* can ambulate with or without an assistive device for at least 50 feet
* able to get up and down from the floor with minimal assistance
* has a score of 24 or above on the Folstein Mini-Mental State Exam

Exclusion Criteria:

* Greater than Stage 3 on the Hoehn \& Yahr Classification of Disability
* decline in immune function such as pneumonia or systemic infection
* progressive degenerative disease besides PD
* spinal fusion or other orthopedic surgery in the past six months
* mental disease/psychosis such as dementia
* greater than minimal assistance required for gait and transfers
* inability to make regular time commitments to the scheduled training sessions
* participation in resistance training on a regular basis within the past six months
* inability to provide consent
* pregnancy
* a prisoner
Biomarkers in Multiple Myeloma

The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to a social security regimen or beneficiary of the same
* Signed written informed consent form
* Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.

Exclusion Criteria:

* Pregnant women
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
* Refusing participation
* Patient whose follow-up or life expectancy is less than 6 months.
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)

Exclusion Criteria:

* Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
* Patients having a history of the following within the last six months:

  * myocardial infarction,
  * unstable angina pectoris,
  * percutaneous coronary intervention,
  * severe heart failure,
  * hypertensive encephalopathy, cerebrovascular accident (stroke) or
  * transient ischaemic attack.
* Patients with clinically significant abnormal laboratory values at screening.
* Patients with secondary HTN.
Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).

Provoked vestibulodynia (PVD) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. Although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. Furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. This study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (CBT) and physical therapy (PT).

Eligibility Criteria:
Inclusion Criteria:

* fluent in English
* vulvar pain with attempted vaginal penetration for at least 6 months
* pain limited to vulvar vestibule during cotton swab test

Exclusion Criteria:

* other serious medical, psychiatric, or other pain conditions
* generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally)
* current pregnancy, breastfeeding, or being less than 6 months postpartum
* unwillingness to abstain from other treatments for their PVD pain during the course of the study
HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.

The protocol consists of a SC injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* ACR criteria for Giant cell arteritis (HUNDER 1990)
* Positive Temporal artery biopsy
* Plus standard inclusion criteria for Humira protocols

Exclusion Criteria:

* Prednisone treatment for a different disease at a dose \>15 mg/day
* Corticoid treatment for GCA more than 10 days
* GCA treatment with prednisone \> 1 mg/kg whatever period of time
* GCA treatment with an anti-TNF, MTX, cyclosporine, cyclophosphamide, dapsone or steroid bolus
* Recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality (diplopia, hallucination)
* Plus standard exclusion criteria for Humira protocols
Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants

RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.

PURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.

OBJECTIVES:

* To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.
* To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.

OUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy participant

  * No history of smoking
  * No history of cancer

PATIENT CHARACTERISTICS:

* SWOG performance status 0
* No clinically apparent bleeding diathesis

PRIOR CONCURRENT THERAPY:

* Not specified
Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.

The aim of this study was to describe a novel digital technique to analyze the wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as antagonist. Materials and methods: Ten patients were consecutively included to rehabilitate partial edentulism by dental implants. Both the screw-retained implant-supported metal-ceramic dental prostheses and the natural tooth as antagonist were submitted to a digital impression through an intraoral scan to generate a Standard Tessellation Language digital file preoperatively (STL1), at 3 months (STL2), and 6 months (STL3) follow-up. Afterwards, an alignment procedure of the digital files (STL1-STL3) was performed on a reverse engineering morphometric software and volume changes at the screw-retained implant-supported metal-ceramic dental prostheses and the natural tooth as antagonist were analyzed using Student's t-test. Moreover, Gage R\&R statistical analysis was conducted to analyze the repeatability and reproducibility of the digital technique.


Eligibility Criteria:
Inclusion Criteria:

* in good health, who presented partial edentulism in the posterior upper maxilla, were consecutively included to rehabilitate partial edentulism by dental implants

Exclusion Criteria:

* all those who do not meet the inclusion criteria
SAW Lung Microbiome Study in Smokers and Never-smokers

The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.

The trial aims to analyze changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in healthy (and willing to quit) smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.

Demographic and clinical data of the study subjects are obtained, aiming for homogeneous groups. All personal data are encrypted according to the standard operating procedures of the study site. Pharyngeal and deep nasal swabs are taken.

To avoid contamination of the lower airways from the oropharynx through the bronchoscope, standardized procedures are established according to the German guidelines for bronchoscopy. Before bronchoscopy, the endoscope is flushed with sterile saline which is analyzed for 16S ribosomal RNA (rRNA) to control for residual contaminating bacterial desoxyribonucleic acid (DNA). A 300ml bronchoalveolar lavage with warm normal saline solution is taken from the middle lobe. Three covered and "microbiologically protected" bronchial brushings are obtained from the right upper lobe. This sterile brush is sealed in wax and pushed through the wax just before taking the brushing. All samples are immediately frozen and stored at -80°C until further analyses. For cultivations, samples are kept at 4°C and rapidly processed.

Eligibility Criteria:
Inclusion Criteria:

* Cigarette consumption of at least five cigarettes per day
* Caucasian ethnicity

Exclusion Criteria:

* Continous passive smoking exposure
* Systemic steroid therapy during the previous month
* Chronic lung disease (exception COPD stage Global Initiative on Lung Disease (GOLD) 0/I/II)
* Diabetes mellitus
* Pregnancy or breast feeding
* active tuberculosis (currently or previously)
* respiratory infection in the previous month
* antibiotic therapy in the previous two months
* immunosuppression
* malignancy
* interstitial lung disease
* rheumatic disease with lung manifestation
* member of a collaborative group of the project
Alternative Treatments of Vitamin D Deficiency

The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.

Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D deficiency (\< 25 nmol/l)
* Age 15 or above

Exclusion Criteria:

* Travel south of 45 degrees latitude during the trial.
* Ongoing treatment with vitamin D supplementation.
* Intake of light sensitive medicine, such as tetracyclins.
* Skin light eruptions
Antero-Posterior Knee Stability

A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign the informed consent.
* Patients able to comply with study requirements including stress x-rays and self-evaluations.
* Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
* Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.
* Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* Patients that have had a high tibial osteotomy or femoral osteotomy.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers.
* Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
* Patients with knee fusion to the affected joint.
* Patients with an active or suspected latent infection in or about the knee joint.
* Patients that are prisoners.