cyrilzakka/clinical-trials huggingface dataset:
Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia

The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

The primary objective is to assess the safety of multiple doses of BAY1093884.

Eligibility Criteria:
Inclusion Criteria:

* Participants with hemophilia A and FVIII activity \<1% or hemophilia B with FIX activity \<2%
* Participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer \< 5 Bethesda units) who are receiving current on demand treatment with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified)

Exclusion Criteria:

* History or at risk of developing diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis)
* History of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or platelet disorder
* History or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension
* History or at risk for thrombotic microangiopathy
Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer

Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.

The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.

To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.

A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or

Aged 55 and over with weight loss and any of the following:

* Upper abdominal pain
* Reflux
* Dyspepsia

Exclusion Criteria:

* Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion)
* Previous gastro-duodenal surgery,
* Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria

* Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
* The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
* The participant must have at least 3 lifetime episodes of MDD (including the current episode)

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
* Participants who are considered a suicide risk
* History of non-response to 2 or more antidepressants (after adequate treatment)
* Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
* Panic disorder
A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment

This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The anticipated time on study treatment is \<3 months (single dose study)and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 40-80 years of age;
* type 2 diabetes;
* normal renal function, or impaired but stable renal function;
* stable with regard to medication or treatment regimen taken for renal impairment or diabetes.

Exclusion Criteria:

* patients with a renal transplant;
* end-stage renal disease, requiring dialysis;
* nephrotic syndrome, or a history of nephrectomy;
* type 1 diabetes mellitus.
Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity

The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.

We will recruit 80 adult patients with obvious symptom of hypersensitivity after periodontal therapy. They will receive low-energy laser treatment, and the area without the symptom of hypersensitivity will be served as control. Changes in pain status and clinical periodontal index within six months of treatment will be recorded.

Eligibility Criteria:
Inclusion criteria

1.20-80 year-old with their own will and oral cleaning ability 2.Patients who have been diagnosed with periodontitis and have completed periodontal treatment 3.Gingival recession in at least two regions showed sensitivity of teeth (VAS\> 5) 4.No systemic infection 5.No painkillers in the past two weeks 6.Not pregnant or lactating

Exclusion criteria

1.Smoking more than half a pack a day in the past month
Topical Statin Eye Drop in the Management of the Dry Eye

In the first stage, to evaluate the safety of the topical medication produced by Sina Pharmaceuticals, this medication is experimentally tested on 10 volunteer patients. If no side effects occur, eligible patients are enrolled in the study after examination by a specialist. The second stage is a randomized, double-blind clinical trial, during which selected patients are randomly assigned to the control and intervention groups.

For patients in the intervention group, in addition to standard treatment, including eyelid hygiene and the use of artificial tears, a topical drop of Atorvastatin (50 microM) will be administered, one drop eight times a day in both eyes. In the control group, a placebo will be used in the same manner. The patients will be unaware of their assigned group.

Clinical examinations, including Schirmer's test, tear breakup time, fluorescein staining, and completion of the dry eye syndrome questionnaire and dry eye questionnaire, will be conducted before and after the intervention to assess the level of eye dryness.


Eligibility Criteria:
Inclusion Criteria:

* Age\>20 years old
* Dry eye induced by Meibomian gland dysfunction
* Tear break up time less than 10 seconds

Exclusion Criteria:

* Hematologic disorders
* Coagulopathies
* Use of anticoagulant medication
* Use of Peptic ulcer disease
* History of ocular surgeries in the last 3 months
* History of any ocular Malignancies
* History of ocular trauma
* History of statin use
Comparison of Video-Based Versus Written Patient Education on Melanoma

The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma.

We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of melanoma.

Subjects randomized to the video-based education arm will be instructed to watch a video on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. Subjects randomized to the written education arm will receive written information on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. The contents of the video and the written educational materials will be comparable.

At the end of the study period 1 month later, subjects will be interviewed via telephone regarding their understanding of melanoma. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Able to adhere to the study visit schedule and other protocol requirements.
* Capable of giving informed consent.

Exclusion Criteria:

* Non-English speaking individuals.
Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients

This study is designed to study and compare the efficacy and cost-effectiveness of individualized phosphate-lowering therapy in comparison with regular guideline-recommended therapy.

Hyperphosphatemia in hemodialysis patients has been one of the most difficult conundrums for nephrologist for the past two decades. Elevated phosphate contributes to secondary hyperparathyroidism, elevated FGF23 levels, and vascular calcification, which in turn predispose to mortality in this population. Current guidelines recommend limiting dietary phosphate intake, strengthening dialysis and using phosphate binders as three therapies for treatment of hyperphosphatemia. Yet exact clinical implication remains ambiguous: how intense restricted phosphate intake should be and how dosage of phosphate binders and dialysis should be adjusted accordingly. Thus, treatments of hyperphosphatemia have not been effective enough, but appear to be refractory. In the current study, the investigators designed individualized phosphate-lowering therapy based on each patient's phosphate-clearing ability, in order to observe and compare the efficacy and cost-effectiveness of the individualized therapy and the regular guideline-recommended therapy.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years' old
* dialysis vintage more than 3 months on maintenance hemodialysis patients
* using internal arteriovenous fistula
* S\[P\] \> 1.45 mmol/l, PTH (parathyroid hormone, PTH) \< 900 ng/ml
* no residual renal function (RRF)
* stable dietary habit
* clear consciousness and capable of communication
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* severe infection, anemia (Hb \< 60 g/L), hypoproteinemia (Alb \< 30 g/L)
* pregnancy, lactating women
* history of severe coexisting diseases such as, but not limited to, chronic liver disease, myocardial infection, cerebrovascular accident, malignant hypertension
* history of malignancy
* participation in other dietary, drug-related, or any other clinical trials within 1 month
* history of complications related to elevated S\[P\] such as, but not limited to primary hypoparathyroidism, type II vitamin D dependent rickets
* history of non-compliance
* intolerance to the individualized therapy
* in use of calcitonin and diphosphonate
Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease

The aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by various validated questionnaires. The data obtained by these questionnaires are collected together with information obtained by the treating physicians at four time points during the study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative project offers the chance to identify medical services deficits and risk circumstances for the burden of treatments in an oncology-palliative setting and to optimize the quality of patient care.


Eligibility Criteria:
Inclusion Criteria:

* Incurable cancer disease: ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer
* signed and dated Inform Consent Form
* Age ≥ 18 years

Exclusion Criteria:

* Patient is not able to understand and to answer questions
* Patient is in a critical health situation and is directly threatened due to cancer disease or the resulting complications
Brain Energy Metabolism in Patients With Chronic Liver Disease and Impaired Central Nervous System

The purpose of the current study is to look into the pathogenesis of a severe medical condition causing acute episodes on the central nervous system as seen in majority of patients with liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* 6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy,
* 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy,
* 6 healthy subjects age and sex matched

Exclusion Criteria:

* Neurological and/or psychiatric condition,
* Non-treated diabetes,
* Pregnancy/breast-feeding
Effects of Aquatic Physical Training Program on Cardiorespiratory Variables in Patients With COPD

We have as hypothesis that the aquatic aerobic physical training program can help promote beneficial adaptations on the cardiovascular, respiratory and systemic inflammation variables, functional capacity and quality of life in patients with chronic obstructive pulmonary disease (pulmonary emphysema).

First paragraph

* aquatic aerobic physical training program
* beneficial adaptations

Next paragraph

* cardiovascular
* respiratory
* systemic inflammation
* functional capacity
* quality of life

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD ( GOLD I / II / III / IV rating )
* Clinically stable
* Low level of physical activity , according to the IPAQ ( International Physical Activity Questionnaire )
* Absence of exacerbation in the last three months
* Do not participate in a regular exercise program in the past six months

Exclusion Criteria:

* Diabetes Mellitus
* Endocrine Disorders
* Chronic renal failure
* Liver Diseases
* Other lung diseases or inflammatory diseases associated
* Cardiac
* Use of drugs that prevented physical performance
* Musculoskeletal and neuromuscular changes that make it impossible to run experimental protocols
* Dermatological disorders ( cutaneous fistulas , infected wounds , ringworm skin , varicose ulcers )
* Hypersensitivity to the product used for the treatment of pool water
* Rabies
Effects of Vocal Exercises for Spasmodic Dysphonia

The purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following Botox injections for adductor spasmodic dysphonia.

Spasmodic dysphonia (SD) is a neurological disorder characterized by involuntary spasms of the vocal folds resulting in a strained and strangled voice quality. This disorder is quite disabling to patients who suffer from it, particularly affecting patients' quality of life. Botulinum toxin (Botox) has been found to be the most effective treatment for SD. The Botox is injected into the affected muscle resulting in temporary weakening of the muscle. The patients return for injections on average every 3 - 6 months.

There is a suggestion in the literature that increased diffusion of the Botox injectate could improve the effects of the injection. Furthermore, there is literature supporting the use of exercise to increase the diffusion of the Botox. Previous research examined the use of voluntary muscle activity vs. rest immediately following Botox injection for writer's cramp. It was found that the active condition resulted in greater reduction of muscle strength in the injected muscle. Another small study of 9 patients implemented intense exercise comprised of loud reading for one hour and a rest condition of total voice rest for 24 hours. They found that the exercise condition resulted in improved scores on the voice related-quality of life (V-RQOL) measure and concluded that improvement in results of Botox injections may be achieved more consistently with the implementation of exercise following the injection. The exercise used in this study was intense and may be contrary to the overall benefit as the subjects may experience phonotrauma. Timing of the exercise post-injection may also be a factor. Previous literature review revealed combined modality treatment of Botox injection only, Botox with therapy and Botox with sham treatment. They found no significant differences in acoustic stability, V-RQOL, or duration of injection benefit. However, the exercise was initiated 3 weeks post-injection and completed once per week for 5 weeks. Investigators aim to identify what might improve or extend the duration of botox injections for adductor Spasmodic dysphonia.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 21-70 age
3. Diagnosed with pure adductor spasmodic dysphonia
4. Completed 2 consecutive standard of care Botox injection into the thyroarytenoid (TA) and/or thyroarytenoid/lateral cricoarytenoid (TA/LCA) junction with the same dosage

Exclusion Criteria:

1. Receiving Botox to other laryngeal or supraglottic musculature
2. Other neuro-laryngological conditions
3. Those with an average of less than two injections per year
Functional Exercise and Nutrition Education Program for Older Adults

There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.

The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Speak English or attend with a translator;
* ≥ 60 years;
* FRAIL scale score ≥1;
* Have ≥1 diagnosed chronic condition (i.e., diabetes, obesity, cancer (other than minor skin cancer), chronic lung disease, cardiovascular disease, congestive heart failure, hypertension, osteoporosis, arthritis, stroke, or kidney disease).

Exclusion Criteria:

* Currently doing similar resistance exercise ≥2x/week;
* In palliative care;
* Not able to perform basic activities of daily living;
* Cognitive impairment (e.g., unable to follow two-step commands);
* Travelling \>1 week during exposure;
* Absolute exercise contraindications (i.e., if they select "no" to any question in the Get Active Questionnaire they must seek physician approval before exercising)