cyrilzakka/clinical-trials huggingface dataset:
Identification of Difficulties During a First Request for a Personal Autonomy Allowance

The objective of this study is to identify the difficulties when first applying for a first Resource Allocation (Personal autonomy allowance - APA) by beneficiaries and their relatives through a qualitative study and secondarily identification of the role of the attending physician during this request.

The APA, introduced since the French law of 2001 aims to improve the care of people with loss of autonomy.

A regular assessment of autonomy in the elderly should be carried out in order to implement ABS as early as possible. The aim is to set up the necessary home help to avoid or delay institutionalisation.

It therefore seems essential to place oneself on the side of the beneficiaries and their relatives in order to identify the difficulties encountered during a first ABS application and their expectations as to the role of the general practitioner during this application?

Eligibility Criteria:
Inclusion Criteria:

* Beneficiaries living in Ille et Vilaine
* requesting for the first time a Resource Allocation (APA)

Or

* Persons requesting for the first time a Resource Allocation (APA)
* Allocation of resources for the benefit of a person residing in Ille et Vilaine

Exclusion Criteria:

* Refusal of Resource Allocation
* opposition to participation in the survey.
Impact of Unrestrictive Exercise Following Mid-Urethral Sling Surgery

To determine the impact of unrestricted postoperative activity on intermediate- and long-term continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence.

To assess the natural return to baseline activity level when patients are unrestricted following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic organ prolapse repair.

Over the last decade, the mid-urethral sling has become the new gold standard in the management of stress urinary incontinence because of its high success rate and minimally invasive nature. However, postoperative management has not kept pace with the modernization of sling surgery. Although formal guidelines regarding the resumption of normal activity levels have not been established, it is general practice to restrict exercise for a minimum of six weeks after surgery.

For the study, if immediate resumption of normal activity has no impact on intermediate- and long-term continence outcomes, it may result in improved quality of life and cost savings from a societal perspective.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant female
* Self-reported stress urinary incontinence
* Incontinence demonstrated on physical exam and/or by an urodynamics study
* Planned mid-urethral sling surgery
* Available for 2 years of follow-up
* Willing and able to complete study assessments per the judgment of the treating clinician
* Willing and able to provide written informed consent

Exclusion Criteria:

* Age \<18 years at time of enrollment
* Concomitant prolapse surgery other than anterior colporrhaphy
* Currently pregnant or \<12 months post-partum
* Unable to read, write, or comprehend English
Effects of PDE-5 Inhibition on Postprandial Hyperglycemia in Type 2 Diabetes

An increase of blood flow and capillary permeability decrease the impact of an endothelial barrier for glucose and insulin allowing them to reach their target cells in peripheral insulin sensitive organ in the human body. It is well known that insulin-resistant type 2 diabetes patients have an impaired blood flow in skeletal muscle and it is therefore important to elucidate means to reverse this metabolic defect.

The investigators have in a recently published study in type 2 diabetes patients used a drug against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several vascular territories, to increase muscle blood flow in type 2 diabetes patients who were studied after fasting overnight.

The aim of this study is to test the hypothesis that tadalafil, compared to placebo, increases muscle glucose uptake and lowers blood glucose following a mixed meal served to type 2 diabetes patients.

An increase of blood flow and capillary permeability decrease the impact of an endothelial barrier for glucose and insulin allowing them to reach their target cells in peripheral insulin sensitive organ in the human body. It is well known that insulin-resistant type 2 diabetes patients have an impaired blood flow in skeletal muscle and it is therefore important to elucidate means to reverse this metabolic defect.

The investigators have in a recently published study in type 2 diabetes patients used a drug against erectile dysfunction, the PDE-5 inhibitor tadalafil, with known effects on several vascular territories, to increase muscle blood flow in type 2 diabetes patients who were studied after fasting overnight. In fact, the investigators observed that tadalafil compared to placebo increased glucose uptake in muscle in parallel with an augmented capillary recruitment in muscle. This was the first publication to show that the pharmacological principle to inhibit the enzyme phosphodiesterase-5 (PDE-5) may mediate an increased muscle glucose uptake and, hence, may be a novel strategy to lower blood glucose in type 2 diabetes patients.

The aim of this study is to test the hypothesis that tadalafil, compared to placebo, increases muscle glucose uptake and lowers blood glucose following a mixed meal served to type 2 diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal state, defines as natural amenorrhea for at least 12 months.
2. Age; females 52-65 years, males: 40-65 years.
3. Type 2 diabetes based on fasting plasma glucose or 2-hr glucose after an OGTT.
4. Diabetes duration less than 5 years.

Exclusion Criteria:

1. Patients with concurrent use of nitrates or NO donors, history of heart or cerebrovascular disease, cardiac failure (stages NYHA II-IV), uncontrolled hypertension (\> 160/100 mm Hg), significant diabetic complications, and inadequate glycemic control (HbA1c \> 7%, ref value 3.5-5.3%)
2. Patients on glitazones, insulin, beta-blockers, ACE-inhibitors and corticosteroids
Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.

Participants will be selected from 3 local oculoplastics surgeons' procedural slates during the study period. Eligible participants are those who will be undergoing bilateral eye procedures. They will be randomized into one of two groups: Group A will receive tapping on their forehead for their first eye injection of local anesthesia, and then vibration to their forehead for the second eye. Group B will receive the reverse. Pain scores will be aggregated and an average taken to help determine which method is superior. The vibration assist device (variety of facial massagers are available on Amazon for roughly $16-20CDN) is being considered in addition to the current standard of tapping or no tactile distraction at all during the injection of local anesthetic. The 11-point pain Visual Analog Scale will be used to help grade pain experience after each eye is frozen. To help qualify, if there is a difference, the patient will be asked if they felt one technique was better than the other by a little, quite a bit, or a lot.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion Criteria:

* previous eyelid surgery
* inability to give consent
Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

Interventions of both groups:

Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days.

Triamcinolone acetonide Group: 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.

Patients in both groups were reexamined after treatment at different intervals (day 3, day 5, day 7, and day 10).


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤6 mm in size in the oral cavity and who gave written consent for participation.
* Only single ulcers were considered for the study.
* Systemically healthy patients.

Exclusion Criteria:

* The study excluded patients with a history of associated systemic disease.
* Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous aphthae, and smoking.
* Patients with a history of hypersensitivity to the used agents.
* Pregnancy and lactation
Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples

The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are:

* Will the intervention be feasible and acceptable to young adult couples?
* Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning?

Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up.

Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Both partners in the couple are 18-29 years old
* In a committed romantic relationship (e.g., dating seriously, cohabiting, married) with each other for at least 3 months
* Face-to-face contact their partner at least 5 days per week
* Live in Washington State
* Have a valid email address and access to a cell phone
* Report alcohol and cannabis co-use at least three times in the past month
* Willingness to: complete online surveys during the allotted time frames, receive text messages and emails from the project, complete a baseline session, and participate during the same time period as their partner

Exclusion Criteria:

* Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources
ATG-F VS ATG for the Prevention of GVHD

Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged \<65 years
* Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of ATG or ATG-F.
A Study to Evaluate Effectiveness of Sublobar Dissection in Patients With Non-small Cell Lung Cancer

A study to evaluate effectiveness of sublobar dissection in patients with non-small cell lung cancer

This is a multi-centre real-world non-interventional observational study. The study data on patient demographic/tumor biological characteristics and clinical treatments were retrospectively collected to evaluate effectiveness of sublobar dissection in the Chinese patients with non-small cell lung cancer who received sublobar dissection.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old;
* Patients who received sublobar dissection from 2014 to 2017 (segment dissection/wedge dissection/segment and wedge dissections);
* Patients who received selective or systematic lymphadenectomy;
* Pathologically diagnosed patients with non-small cell lung cancer;
* Pathological staging: I, II

Exclusion Criteria:

* Patients who received cancer treatments before surgeries (adjuvant therapies including chemotherapies, radiotherapies, target therapies);
* Patients who received late-phase or intolerant palliative lobectomy or compromise sublobar dissection;
Phase 1/2 Study of HQK-1001 in Patients With Beta Thalassemia

The purpose of this study is to evaluate the safety and tolerability of HQK-1001 administered daily for 8 weeks in subjects with beta thalassemia intermedia


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of beta thalassemia intermedia or hemoglobin E beta thalassemia
* Average of the initial two hemoglobin levels of less than 10 g/dL within ≥ 30 days prior to randomization.
* Age ≥ 12 and ≤ 60 years
* Able and willing to give informed consent or assent (if less than 18 years of age) and comply with all study procedures
* If female and of childbearing potential, must have a documented negative pregnancy test at Day -1 and must agree to use one or more locally medically accepted methods of contraception in the month prior to randomization, through the entire study, and for 4 weeks after the last dosing of study medication

Exclusion Criteria:

* Spleen palpable ≥ 2 cm below the left costal margin
* Pulmonary hypertension requiring oxygen therapy
* QTc \> 450 msec on screening ECG
* Infection with hepatitis C, hepatitis B requiring therapy
* Known infection with HIV
* Red blood cell (RBC) transfusions within 2 months prior to administration of study medication with stable hemoglobin levels
* Fever greater than 38.5°C in the week prior to administration of study medication
* ALT \> 4x upper limit of normal (ULN)
* Baseline elevation of CPK value prior to randomization
* Treatment with hydroxyurea within 2 months prior to administration of study medication
* Cancer diagnosis within 5 years of randomization (except for non-melanoma cutaneous malignancies)
* Serum creatinine \> 1.5 mg/dl
* Received investigational systemic therapy within 30 days prior to randomization
* Currently pregnant or breast feeding a child
* Subject history of clinically significant arrhythmias or syncope
* Known current drug or alcohol abuse
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.


Eligibility Criteria:
Inclusion Criteria:

* Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis \& stage
* Patients received no more than 2 previous systemic chemotherapy regimes
* Life Expectancy \> 12 weeks
* Patients must be at least 3 months from the completion of cranial radiation therapy

Exclusion Criteria:

* History of poorly controlled high blood pressure
* Recent major surgery prior to entry into the study
Cutaneous and Systemic Reactions to Metal Implants

The purpose of this study is to evaluate if metal patch testing in metal allergic patients is useful for predicting the development of allergic skin disease or systemic symptoms in patients who recieve a metal orthopedic implant.

This prospective cohort study will enroll patients with a history of metal allergy who require implantation of a metal orthopedic device. Patients will be followed for one year after surgery to determine if any symptoms including rash, itch, joint pain, joint swelling, and/or joint failure develop post implantation.

Patients will be recruited from two sites: (1) Divisions of Orthopedics and Allergy \& Immunology, Winthrop University Hospital, and (2) Division of Immunology, and Allergy Section, University of Cincinnati Medical Center.

Eligibility Criteria:
Inclusion Criteria

1. Age ≥18 years with a history of metal allergy who require joint repair (hip, knee and/or shoulder)
2. Able to undergo patch testing

Exclusion Criteria

1. Patients on oral immunosuppressant medications within 4 weeks of patch testing or topical corticosteroids to the back within 1 week of patch testing
2. Patients who are pregnant or breastfeeding
Pulmonary Hypertension Biorepository and Registry

Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

The aim of this project will be to establish a broad and wide-ranging registry and biorepository of blood samples from patients with pulmonary hypertension, including all WHO groups I-V to be used for future research in these areas. This will be both a retrospective and prospective project. The registry and biorepository will be utilized to study and grow our knowledge of the cellular mechanisms and mediators of the disease and, in turn, contribute to advancements in treatment.

Eligibility Criteria:
Inclusion Criteria:

1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)
2. The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization
3. Patient is ≥ 18 years of age or older

Exclusion Criteria:

1. Participant declines to participate (living patients only)
2. Participant is unable to provide informed consent (living patients only)
DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)

Solid tumours contain varying degrees of hypoxia. Studies show hypoxia to be associated with poor local control and survival, as hypoxia is a cause of resistance to radio- and chemotherapy and the development of a more aggressive tumour.

Previous attempts to measure hypoxia have been biased because the techniques have been invasive, not repeatable or difficult to apply on a routine basis. There is great interest in trying to measure hypoxia in tumours as this could lead to individualized hypoxia-modifying therapy and prediction of treatment response. Additionally the investigators' knowledge of change in hypoxia over time is limited, but of great interest as individualised treatment, such as intensity-modulated radiation therapy (IMRT) is emerging.

18F-FAZA, appears promising. It is a nitroimidazole, which gets trapped in hypoxic cells and can be detected by a positron emission therapy (PET) scan. Compared to other nitroimidazoles, 18F-FAZA has superior biokinetics and thereby is believed to provide a faster and clearer image of hypoxia.

The investigators' hypothesis is that 18F-FAZA can be used as a prognostic marker in HNSCC.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven squamous cell carcinoma of the pharynx, larynx, oropharynx and hypopharynx
* Curative intent and no prior treatment
* Age \>= 18 years
* stage T1-4 N0-N3 M0.
* Informed consent according to local guidelines and national law
* The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
* Fertile women must use contraceptive devices (IUD or oral contraceptives)

Exclusion Criteria:

* No serious concurrent medical disease
* No metastasis
* No prior disease that can affect the treatment, evaluation or outcome of current disease
* No pregnant or breastfeeding woman
Carb Quality and CHD in US Adults

This is an analysis conducted in the Nurses Health Study and the Health Professional Follow-Up Study, both prospective cohort studies, where the investigators systematically investigated the association between carbohydrate quality using a variety of metrics in relation to coronary heart disease. This was a secondary data analysis of previously collected data in both cohorts.

In this study, the investigators studied the association between carbohydrate quality and coronary heart disease using prospective cohort studies among US adults. Carbohydrate quality was evaluated using a variety of metrics including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intake, as well as the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber. The Nurses' Health Study (NHS) and the Health Professionals Follow Up Study (HPFS) started in 1984 and 1986, respectively, and were followed-up every 2-4 years thereafter until 2012. Participants include in this study had up to 28y of follow-up. All participants were free of known diabetes mellitus, cancer or cardiovascular disease at baseline. Cox proportional hazards regression models were used to assess the relationship between dietary measures of carbohydrate quality and incident CHD (nonfatal myocardial infarction and fatal CHD).

Eligibility Criteria:
Inclusion Criteria:

* Participants of these two cohorts

Exclusion Criteria:

* Participants with diabetes, coronary heart disease, or cancer at baseline
* Participants with missing exposure information at baseline
* Participants with implausible food frequency questionnaire info (females: kcal \< 500 or \> 3500; males: kcal \< 800 or \> 4200)
* Participants who left 10 or more items blank on the food frequency questionnaire
Prehospital Analgesia INtervention Trial (PAIN)

The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.


Eligibility Criteria:
Inclusion Criteria:

* Transport after injury to a participating PAIN Trauma center
* Patient with compensated shock as defined by Shock Index (SI) ≥0.9
* Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center

Exclusion Criteria:

* No IV access
* Age \<18 years
* Females \<50 years of age
* SBP\>180 mmHg at time of enrollment
* Advanced airway management prior to first dose administration
* Known allergy to fentanyl citrate or ketamine hydrochloride
* Known prisoner
* Objection to study voiced by subject or family member at scene
* Pain treatment contraindicated by local protocol
* Wearing a "NO PAIN STUDY" bracelet