cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548

The purpose of this study is to evaluate the relative bioavailability and food effect of a new tablet formulation of VX-548 in healthy adult participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>)50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Female participants of childbearing potential
* Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
* History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease

Other protocol defined Inclusion/Exclusion criteria may apply.
Hallelujah Acres Omega 3 Fat Study

This research is being done to study the effect of taking flax seed oil and fish oil on blood lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our health and we want to see how effective both flax seed oil and fish oil are in raising your Omega 3 Score (higher is better). The Omega 3 Score is one of many indicators that may show your personal risk of dying suddenly from a heart attack.

This study is being conducted to compare the response of individuals to flax seed oil or fish oil, measured by blood lipids. Especially the amount of the long chain omega 3 polyunsaturated fats EPA and DHA will be tested. An omega 3 score for whole blood will be measured. The omega 3 score is the percent sum of omega 3 fats in the blood.

The hypothesis is that 5 grams of fish oil will increase the amount of EPA and DHA in a person's blood to a protective level, and that 30 grams (2 tablespoons) of flax oil will not change the blood levels of EPA significantly and not change the blood concentrations of DHA at all, even for a person consuming a low omega 6 oil diet and following a vegan diet high in fruits and vegetables.

Most of the testing of flax and fish oil has not been done in vegans. This trial will extend this testing to this subpopulation.

Eligibility Criteria:
Inclusion Criteria:

* Must have followed the Hallelujah Diet (or very similar diet) for at least the last two years,
* Must have stable body weight (not gained or lost more than 5 pounds of weight over the last three months)

Exclusion Criteria:

* Pregnancy (all pregnant women should take fish oil, not flax seed oil)
* Currently using fish oil, or flax seed oil,EPA, DHA, or flax seed oil with added DHA
* Eating more than 2 teaspoons of flax seed per day
* Diabetes (fish oil may affect blood sugar levels)
* Generally poor health
Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. Aged 20-75 years at enrolment
3. History of edentulism in the study area of at least two months
4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Uncontrolled pathologic processes in the oral cavity
3. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
9. Smoking more than 10 cigarettes per day
10. Present alcohol and/or drug abuse
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrollment in the present study
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
The Effect of Lower Urinary Tract Electrical Stimulation on Renal Urine Production (diuresis)

In previous studies, in which the perception threshold and / or sensory evoked potentials at different points of the lower urinary tract were examined and measured by means of electrical stimulation, a clear increase in the volume of the bladder and thus the urine excretion under the stimulation could be observed. This observation is now to be investigated more closely in a separate study, in order to strengthen the observation with further measured data and to find possible physiological connections. A detectable influence of electrical stimulation in the lower urinary tract on renal urine production would have a significant relevance both therapeutically and for the neurophysiological understanding of interactions between the lower and upper urinary tracts.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

* Written informed consent
* Good mental and physical health
* Age \>18 years

Patients with SCI:

* Written informed consent
* Good mental condition
* Age \>18 years
* Complete spinal cord injury (AIS A)

Exclusion Criteria:

Healthy volunteers:

* Any neurological or urological pathology
* Pregnancy or breast feeding
* Urinary tract infection (UTI), frequent UTIs
* Hematuria
* Any previous pelvic or spine surgery
* Any craniocerebral surgery
* Any anatomical anomaly of the LUT or genitalia
* Any metabolic disease
* Any renal disease
* Any urinary tract malignancy
* Bladder capacity \<150mL or strong desire to void (SDV) already at 60mL

Patients with SCI:

* Any urinary tract malignancy
* Any anatomical anomaly of the LUT or genitalia
* Pregnancy or breast feeding
* Urinary tract infection (UTI), frequent UTIs
* Hematuria
* Any metabolic disease
* Any renal disease
Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV.

Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥ 30 years old
* Patient with BMI ≥ 20
* Written informed consent obtained
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study.
* Patient should be treated according to GOLD guidelines
* COPD patient with GOLD stages III until IV
* Patient with smoking history of at least 10 pack-years
* Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) at least 6 weeks before visit 1
* Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.

Exclusion Criteria:

* Pregnant or lactating females
* Patient with severe immunological diseases and/ or severe acute infectious diseases.
* Patient with heart failure
* Patient with diagnosis of cancer (except basal cell carcinoma)
* Patient with a history of depression associated with suicidal ideation or behaviour
* Patient with moderate or severe hepatic impairment.
* Patient with lactose intolerance
* Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
* Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer).
Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers

1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers.
2. To explore the appropriate dose and provide the basis for the subsequent clinical trials.

48 healthy volunteers will participate in this trial. Participants will be divided into 6 group, 25mg，50mg，100mg，200mg，400mg and 800mg. In each group, 6 participants will take SPH3127 tablet, while 2 participants will take placebo randomly. Safety data and PK/PD data will be collected as protocol described.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults,age \>=18 years.Single gender should no less than a third of total subjects in each group.
* BMI should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female.
* understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent.

Exclusion Criteria:

* during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant;
* abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 1.5 times of the upper limit of normal).
* with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness;
* has a history of drug allergy and allergic constitution;
* took birth control pills within 6 weeks;
* used any drugs (including Chinese herbal medicine) within 1 week;
* participated in blood donation within 2 months ;
* participated in any drug clinical trials (as subjects) within three months;
* any positive result in virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) 、hepatitis c virus (HCV) - IgG antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP);
* addicted to cigarettes, alcohol, drink coffee, strong tea and drug abuse;
* researchers think that exists any unfavorable factors to participate in the test.
Laparoscopic Versus Open Incisional Hernia Repair

Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.

The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* hernia diameter between 3 and 15 cm
* location at the ventral abdominal wall at least 5cm from costae and inguinal area
* indication for elective repair
* age of 18 years or older
* written informed consent.

Exclusion Criteria:

* contraindication for pneumoperitoneum
* an absolute contraindication for general anesthesia
* history of open abdomen treatment
* patients participating in other trials
Human Phototoxicity Test

To determine the phototoxic potential of a topically applied article in human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive;
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* Have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* Have a visible sunburn;
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.

HEAT-PPCI is a single-centre prospective, dual-arm, open-label, randomised controlled trial comparing two antithrombotic agents in patients undergoing PPCI. All patients presenting to the PPCI service at Liverpool Heart and Chest Hospital will be assessed for trial eligibility. The patients will be allocated by randomisation in equal proportions to the two treatment groups receiving UFH (70 units/kg prior to the procedure) or bivalirudin (bolus of 0.75 mg/kg prior to the start of the intervention, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure).

Pre-Specified Subgroup Analyses

* Subgroup analyses looking at the impact of access site comparing radial versus femoral route
* Assessment of the outcomes in diabetic patients receiving oral hypoglycaemic or insulin therapy versus all other patients
* Comparing the outcomes in patients \< or ≥ 75 years of age
* Type of p2y12 receptor inhibiting antiplatelet agent (Examples: clopidogrel, prasugrel, ticagrelor)
* Patients with impaired LV function versus normal LV function
* Patients managed with actual or attempted primary PCI versus no immediate PCI procedure attempted

PLATELET FUNCTION SUBSTUDY A substudy will be performed to assess indices of coagulation and platelet function studies comparing the impact of heparin or bivalirudin therapy on coagulation status at the end of the PPCI procedure. This study will be performed on all patients treated between the hours of 0800 and 1600, Monday to Friday. A single blood sample taken at the time of general blood sampling for routine clinical screening will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial

Exclusion Criteria:

* ≤ 18 years of age
* Known intolerance, hypersensitivity or contraindication to any trial medication
* Active bleeding at presentation
* Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy
* Previous enrolment in this trial
Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus

A Study to identify toxicity and optimal photodynamic treatment parameters using the photosensitizer 2-\[1-hydroxyethyl\]-2-devinylpyropheophorbide-a (HPPH) in high grade dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have biopsy proven high-grade (severe) dysplasia, carcinoma-in-situ or early stage adenocarcinoma;
* Patient may have received prior therapy; e.g. Nd-YAG laser, radiation therapy or chemotherapy. At least one month must have elapsed between prior treatments and PDT.
* Tumors can be primary or recurrent, Stage 0 or I, N0M (any).
* Patients must have no contraindications to endoscopy.
* Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A pregnancy test is required and must be negative.
* Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB.
* Patients must have a Karnofsky status 50 or above.
* Operable patients are not excluded.

Exclusion Criteria:

* Patients with tumors of grade greater than T-1.
* Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
* WBC \<2,000; platelet count \<50,000, prothrombin time 1.5 times above the upper normal limit.
* Patients with impaired renal and/or hepatic function (total serum bilirubin \>3.0 mg/d, serum creatinine \>3 mg%, alkaline phosphatase (hepatic) or SGOT \>3 times the upper normal limit.
* Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.
* If the patient has cancer other than non-melanoma skin cancer they must be deemed disease free by their treating physician.
Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors

This study aims to examine the effects of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness, quality of life and psychiatric symptoms.

This study was designed as a randomized controlled experimental study with a pre-test-post-test and follow-up design to examine the effects of forgiveness-based group psychoeducation on fear of cancer recurrence, forgiveness, quality of life and psychiatric symptoms of cancer survivors.

The aim is to evaluate the effects of a forgiveness-based psychoeducation program on cancer survivors. After the "Informed Voluntary Consent Form" is obtained from individuals who agree to participate in the study, the Introductory Information Form, Heartland Forgiveness Scale, Fear of Relapse Inventory, EORTC QLQ-C30 Quality of Life Scale and Brief Symptom Inventory will be applied. Pre-tests will be applied to the sample determined by an independent statistician. Then, participants will be divided into intervention and control groups by simple randomization method. Face-to-face forgiveness-based psychoeducation will be applied to the intervention group in 90-minute sessions once/twice a week, totaling 6 sessions. In the last session of psychoeducation, a post-test ("Introductory Information Form", "Heartland Forgiveness Scale", "Fear of Relapse Inventory", "EORTC QLQ-C30 Quality of Life Scale" and "Brief Symptom Inventory") will be administered to both the intervention and control groups. The first follow-up test of the study will be administered to both the intervention and control groups 1 month after the post-test, and the second follow-up test of the study will be administered 3 months after the post-test. After the completion of the study and the measurements, it is planned to provide forgiveness-based psychoeducation to the participants in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Written and verbal consent to participate in the study
* Understanding and speaking Turkish
* Being over 18 years old
* Not having any visual, hearing or mental disabilities
* Having been diagnosed with cancer, treated with curative intent and having completed major treatments (surgery, radiotherapy, chemotherapy) within the last 5 years

Exclusion Criteria:

* Not volunteering to participate in research
* Having a visual, hearing or mental disability
* Agreeing to participate in another psychoeducational program conducted simultaneously with the research
* Inability to communicate in Turkish
* Having previously received training in forgiveness and/or coping with fear of relapse
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.


Eligibility Criteria:
Inclusion Criteria:

* A male or female 50 years of age or above at the time of the first vaccination;
* Written informed consent obtained from the subject;
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
* If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
* Previous vaccination against HZ;
* Previous vaccination against varicella;
* History of HZ;
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
* Acute disease at the time of enrolment.
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
* History of or current drug and/or alcohol abuse;
* Pregnant or lactating female;
* Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.