cyrilzakka/clinical-trials huggingface dataset:
Multidisciplinary Treatment of Chronic Vulvar Pain

Vulvodynia (i.e. chronic vulvar pain without identifiable cause) is a heterogeneous clinical entity with a complex multifactorial causation. It is long lasting and difficult to treat, and the general consensus of current guidelines states that patients with vulvodynia benefit from a compound multidisciplinary intervention targeting mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. However, there is little empiric evidence to support this recommendation. This will be a randomized controlled trial comparing multidisciplinary treatment with standard care for women with vulvodynia.

Patients with chronic vulvar pain constitute a heterogeneous group with regards to causes and moderators of pain. Multidisciplinary teams simultaneously assess contributing factors such as infections and dermatoses and treat known mediators of pain, namely mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. Treatment as usual, on the other hand, is primarily based on a sequential model applying one type of treatment at a time.

The investigator's aim is to compare multidisciplinary treatment including multimodal physiotherapy (intervention group) with standard treatment (control group) in reducing pain, sexual dysfunction and related symptoms in women with vulvodynia.

The study sample will be allocated randomly 1:1 to multidisciplinary treatment by a vulva team or to standard treatment by a specialist in gynaecology. The intervention will include a joint consultation by a gynaecologist and a dermatologist, tailored multimodal physiotherapy by a physiotherapist and guided imagery (mindfulness and relaxation) by use of a sound track during home sessions. The controls will receive standard care by a gynaecologist, who is free to offer any kind of non-standardized treatment.

Treatment effect will be measured at 3 months and at 6-12 months after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and older
* Chronic vulvar pain for ≥3 months of duration

Exclusion Criteria:

* Insufficient Norwegian skills
* Intellectual disability or severe mental disorder
* Severe comorbidity making tailored care necessary (such as active cancer treatment)
Home Blood Pressure in Hypertension Management

This is a prospective randomized study with two arms: the Conventional and Ambulatory blood pressure monitoring arm and the Home blood pressure monitoring arm. The study will include both previously treated and untreated individuals.

Before randomization and in the end of the study, measurements will be performed using all three blood pressure monitoring methods (Conventional, Ambulatory and Home) as well as assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram, carotid-femoral pulse wave velocity and central blood pressure).

The participants will be randomized into one of the two arms. Diagnosis and titration will be decided according to either Conventional and Ambulatory blood pressure measurements or according to Home blood pressure measurements. Subjects will be followed up for one year.


Eligibility Criteria:
Inclusion Criteria:

* Untreated hypertensive adults
* Treated hypertensive adults with uncontrolled blood pressure

Exclusion Criteria:

* Stage III Hypertension
* Secondary Hypertension
* Cardiovascular or Renal disease
* Uncontrolled Diabetes
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent obtained from the subject prior to screening procedures
* Male or female aged 18 years or older at the time of signing the informed consent
* Type 1 or type 2 diabetes
* BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
* Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
* Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
* BCVA ETDRS letter score ≥ 34 in the fellow eye

Key Exclusion Criteria:

* Macular edema due to causes other than DME in the study eye
* Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
* Previous confounding medications / interventions, or their planned administration
* Presence of neovascularisation at the disc in the study eye
* Presence of iris neovascularisation in the study eye
* Uncontrolled glaucoma in the study eye
* Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
* Untreated Diabetes Mellitus
* Glycated haemoglobin A (HbA1c) \> 12%
* Uncontrolled hypertension
A Survey About Hot Flashes in Women Going Through the Menopause

This study is an online survey of women in and around menopause with moderate to severe hot flashes. Menopause, a normal part of life, is a time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.

This study is about collecting information only. There will be no treatment in this study.

This study will provide information about how many women have moderate to severe hot flashes in menopause. It will also provide details on women's experiences with hot flashes.

Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study. The women in this study will already be taking part in consumer panels. Women will be contacted based on their age. They will be asked if they would like to take part in this study.

Firstly, the women will answer questions about whether they are in menopause or are getting close to menopause. They will also be asked how severe their hot flashes are.

From their answers, some women will be asked to complete an online survey. These will be women who are in menopause and have moderate to severe hot flashes. They will provide more details about how hot flashes have impacted their lives. Also, they will answer questions on how hot flashes affect their quality of life. Finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.


Eligibility Criteria:
Inclusion Criteria (primary outcome measure):

- Post-menopausal women

Inclusion Criteria (secondary outcome measure):

* Women currently experiencing, or have experienced in the last month, moderate to severe VMS symptoms (i.e. minimum of 1 moderate to severe hot flushes per day over the last month)
* Peri-menopausal and post-menopausal women

Exclusion Criteria (primary outcome measure):

* Women with current breast cancer treatment
* Women treated with anti-estrogens, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition.

Additional exclusion criterion for secondary outcome measures will be:

- Mild VMS symptoms only
Specimens From Normal Controls

The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research on viral infections and their associations with various diseases including AIDS and cancer. For some research questions, specimens are available from "case" subjects as part of ongoing protocols but are not available from normal "control" subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. This protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

The Viral Epidemiology Branch (VEB) of the National Cancer Institute (NCI) conducts research on viral infections and their associations with various diseases including AIDS and cancer. For some research questions, specimens are available from "case" subjects as part of ongoing protocols but are not available from normal "control" subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. This protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

Eligibility Criteria:
* INCLUSION CRITERIA:

Subjects can be friends of VEB investigator or collaborator, hospital or office workers, repeat volunteer blood donors, etc.

EXCLUSION CRITERIA:

Must not be minors, prisoners, pregnant women or incapable of providing informed consent.
Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women

This study is designed to compare plateau antibody levels of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.


Eligibility Criteria:
Inclusion Criteria:

* Subject who had previously participated in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895), and received at least one dose ;
* Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;

Exclusion Criteria:

* Subject who had used other HPV vaccine products (including marketed and unmarketed vaccines) after participating in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895) ;
* Subject has abnormal coagulation function (such as coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;
* Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.
Administrative Workload in the Intensive Care Unit

A prospective observational study in the Intensive Care Unit and the Medium Care Unit in a university hospital in Amsterdam. Recent studies show that administrative tasks occupy more than 30% of the workload. One-third of these administrative tasks is unrelated to care. The administrative workload of physicians and nurses will be observed and quantified using two different methods. The amount of time physicians and nurses are logged on into the patient data management system (PDMS) will be measured and the time spent on different work tasks will be monitored with a work sampling method. Two different patient data management systems will be compared.

In recent years, regulatory authorities request a growing number of protocols and checklists to improve healthcare. Though the intention is to prevent medical mistakes and to improve patient care, these demands might result in an increased administrative workload for physicians and nurses. Recent studies show that administrative tasks and documentation occupy more than thirty percent of the workload of physicians, of which one-third is unrelated to care. This time spent on administration could lower the amount of time spent with the patient and the patient's family. In the Intensive Care Unit and the Medium Care Unit, most of the administrative tasks are executed within the patient data management system. The way an electronic patient data management system is set up could impact the administrative workload for physicians and nurses. A prospective observational study at the department of Intensive and Medium Care of the University medical centre will be performed with the aim to quantify the time spent on direct patient care versus administrative work. Two different patient data management systems will be compared at different points in time. The Nursing Activity Score and other patient characteristics will be registered for all the admitted patients during the two study periods.

The administrative workload of physicians and nurses will be measured before and after the implementation of a new patient data management system, using the following methods:

* Login time in the electronic patient data management system during fourteen consecutive days in the Intensive Care Unit and the Medium Care Unit
* Timing of activities of physicians and nurses with a work sampling method during five consecutive day shifts in the Intensive Care Unit

Eligibility Criteria:
Inclusion Criteria:

* Admission to the Intensive Care Unit during one of the two study periods

Exclusion Criteria:

* Not applicable
Avandamet Bioequivalence Study Brazil - Fed Administration

The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.

This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals. Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets. Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets. The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years. Their body mass index (BMI) varied between 18,5 and 25. There are no restrictions regarding the ethnic group. The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.

Eligibility Criteria:
EXCLUSION CRITERIA:

* The volunteer has a known hypersensitivity to the study drug or to compounds chemically related;
* History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism;
* History of neurological, endocrine, pulmonary, hamatologic, immune, brain, metabolic or cardiovascular illness;
* Hypo or hypertension of any etiologic that needs pharmacologic treatment;
* The results of the laboratory exams are out of the values considered as normal according this protocol's rules, unless that they are considered as clinically irrelevant by the investigator;
* Has history of alcohol or drugs abuse;
* History of use drug inducing and/or inhibitors of hepatic metabolism within 30 days prior to drug study administration;
* Use of MAO inhibitors two weeks before the start of treatment; - Use of inhibitors of 5-TH reuptake,
* Pregnancy or breastfeeding,
* Smoking;
* Use of regular medication within 4 weeks prior to study iniciation;
* Use of experimental drug or participation in any clinical study within 6 months prior to study iniciation.

INCLUSION CRITERIA:

* Age between 18 and 50 years;
* Body mass index ≥ 18,5 and ≤25,0, can vary up to 15% for the upper limit (18,5 to 28,75);
* Good health conditions;
* Obtain the Informed Consent's signed.
The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children

The purpose of this study is to determine whether Propofol and Sevoflurane affect the oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II, undergoing selective surgery for hypospadias repair.

Exclusion Criteria:

* a history of developmental delay or mental retardation, which could make observational pain intensity assessment outside the norm;
* a history of central nervous system diseases;
* a known or suspected coagulopathy;
* a known allergy to any of the study drugs;
* abnormalities of the sacrum and any signs of infection at the site of the proposed caudal block.
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).


Eligibility Criteria:
Inclusion Criteria:

* Sign written informed consent
* Completed clinical trial 21106/P05701/MK-8265-002

Exclusion Criteria:

* Any (serious) adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106/P05071/MK-8265-002 as judged by the investigator
* Were significantly non compliant with protocol criteria and procedures of trial 21106/P05701/MK-8265-002, as judged by the investigator
* Pregnancy
Robot-assisted Lobectomy Versus Video-assisted Lobectomy

This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.

Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output

All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers
* Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
* Video or robot assisted procedure

Exclusion Criteria:

* Advanced stage of cancer (T3Nx and greater)
* Need of thoracotomy conversion during procedure
* Morphine intolerance or addiction.
Sex Differences in the Risk of Cardiovascular Diseases Associated With Diabetes

To evaluate the risk of cardiovascular events associated with medication use for controlling blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated in primary care

The management and treatment of adult diabetes is far from optimal. The most recent report from the National Diabetes Audit showed that only one in three people with diabetes are achieving recommended standards for controlling blood glucose, blood pressure and cholesterol levels; and only three in five received basic care processes to reduce their risk of diabetes-related complications such as blindness, amputation and kidney disease. Women did 15% worse than men, which may explain some of the reported higher excess risk of coronary heart disease and stroke, consequent to diabetes in women than men. More efficient and equitable care in people with diabetes could lead to substantial cost savings, and would improve the lives of women and men currently living with diabetes.

The objective of this research isto evaluate the risk of cardiovascular events associated with medication use for controlling blood glucose, blood pressure and cholesterol levels in men and women with diabetes treated in primary care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes at or before study entry, and participants who develop new-onset diabetes during follow-up.
* Age ≥ 18 years
* Data collected in the period 1997-2010
* Minimum time since registration of 1 year
* Minimum of 1 year of up to standard data (CPRD quality standard)

Exclusion Criteria:

• None
Peri-operative Vasopressor Support in Patients Operated for an Acute Hip Fracture (AHF)

The incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. As a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. The investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (AHF) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365- days

The incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. As a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. The investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (AHF) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365-days Confounding factors were; all comorbitity, age, ASA grade as well as type of anesthesia

Eligibility Criteria:
Inclusion Criteria

* Patients with an acute hip fracture

Exclusion Criteria

* Only one fracture within time-limit.
* Unretreivable mortality data
Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

Prospective study of Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing during inclusion time carcinologic esophagectomy for esophageal cancer (Adenocarcinoma or epidermoid carcinoma)

Exclusion Criteria: Mortality within 90 postoperative days

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