cyrilzakka/clinical-trials huggingface dataset:
Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702

GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. The study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? How much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? Does the study medicine affect memory, attention and problem-solving skills? What are the effects when the study medicine and dextromethorphan are taken together.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non childbearing potential
* Generally healthy
* Body mass index 19 - 29.9 kg/m2 (inclusive), body weight greater than or equal to 50 kg for males and greater than of equal to 45 kg for females
* Normal Laboratory test results

Exclusion Criteria:

* Abuse of drugs or alcohol
* Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months
* ECG abnormality (personal or family history)
* Psychiatric disorder
* Asthma or a history of asthma
* Medical illness
Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain

The purpose of this study was to investigate the short and medium-term effects of three manual techniques on cervical range of motion and pressure pain sensitivity in subjects with mechanical stress, presenting latent trigger point of upper trapezius muscle.

Myofascial pain syndrome is a common non-articular musculoskeletal chronic pain which has not been yet fully understood. It is characterized by myofascial trigger point. This trigger point is clinically classified as active or latent. Some studies have demonstrated the potential relevance of latent trigger point. In fact, its presence may cause muscle activation pattern alterations, increase nociceptive sensitivity and cause sympathetic activity alterations. Nevertheless, the vast majority of individuals, even asymptomatic, have latent trigger point. High prevalence of myofascial trigger points subsists at cervical and scapular regions.

There is few data regarding myofascial trigger point physiopathology. Furthermore, a diversity of therapeutic interventions consisting of trigger point inactivation and interruption of the vicious cycle is suggested in literature. Nevertheless, the effectiveness of these different interventions in trigger points and the duration of the effects are not yet fully clarified.

Eligibility Criteria:
Inclusion Criteria:

* volunteers with 18 or more years of age
* with a palpable latent trigger point in the fibbers of the upper trapezius muscle
* with an average time of computer work of at least 2h/day.

Exclusion Criteria:

* with a body mass index (BMI) equal or higher than 31 kg/cm2
* with bilateral latent triggers in the fibers of the upper trapezius muscle
* have done any pharmacological therapeutic during any of the 7 days before the study or anti-coagulant therapeutics
* have done any treatment at cervical region during the month before the study
* having cardio-respiratory, neurological, neuro-musculoskeletal, oncologic or systemic pathologies
* having cognitive deficits or psychologic/psychiatric disturbances
* be pregnant
* having a clinical history of cervical, high dorsal, shoulder or cranial surgery or trauma during the prior 12 months.
Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disease of unknown cause. It is a fairly common disease in hot, dry environments, representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist for years with an important visual morbidity and social impact. Corneal changes (e.g. corneal ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical steroid therapy remains the current standard treatment, but in developing countries its use often is chronic and not medically supervised, potentially leading to bacterial infections, steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack the power to control a flare-up. Topical cyclosporine has the potential to offer an efficient but safer alternative to steroid drops in the management of VKC in an African setting. Its safety and efficiency in the management of vernal keratoconjunctivitis have been described in several uncontrolled studies and double-blind, placebo-controlled trials, but those studies were relatively small and involved populations outside Africa with predominantly palpebral and mixed forms of VKC. Controversy still remains on the efficiency of cyclosporine in severe forms of allergic conjunctivitis like VKC. We therefore undertake a larger prospective randomized double-masked, standard treatment controlled clinical trial in Central Africa to compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops, solved in olive oil vehicle, with that of steroid drops in predominantly limbal forms of VKC. During 4 weeks the participants will be randomised to either cyclosporine or dexamethasone as attack treatment for VKC. The 4 weeks thereafter all participants will receive chromoglycate drops as maintenance treatment. Additional objectives are to document any difference in rebound phenomenon while on chromoglycate during the maintenance phase between the 2 treatment groups and to evaluate safety and tolerance of the test medication.


Eligibility Criteria:
Inclusion Criteria:

- at least 5 years of age

Exclusion Criteria:

* being pregnant
* suffering from any other infectious or inflammatory ocular pathology
* using topical/ systemic corticosteroids, antihistamines, non-steroidal anti-inflammatory drugs or immunosuppressives 2 weeks prior to the trial
* been treated with steroid injection 6 months prior to the study
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
Vincristine-induced Peripheral Neuropathy in Adult Survivors of Childhood and Adolescent Leukemia

Vincristine is a major anticancer agent in the management of hematological malignancies. One of the main side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a characteristic side effect of neurotoxic anticancer drugs. CIPN associated with vincristine is typically characterized by distal and symmetrical sensory symptoms (dysesthesia and paresthesia). Motor and vegetative symptoms can also be found. The prevalence of CIPN associated with vincristine during treatment ranges from 12 to 100% in children (depending on the endpoint).

The aim of this cross-sectionnal study will be to explore the CIPN prevalence and severity in adult survivors of childhood leukemia and having been treated by vincristine.

Adult survivors of chidlhood leukemia and having been treated by vincristine will be contacted from the French childhood cancer survivor study for leukaemia (LEA Cohort) in order to seek their participation agreement.

Thereafter patients will received a self-administered questionnaire exploring the chemotherapy-induced peripheral neuropathy and related comorbidities (pain, neuropathic pain, anxiety, depression, health-related quality of life, substance use, physical activity, deprivation). Oncological and sociodemographic characteristics of participants will be recorded.

Eligibility Criteria:
Inclusion Criteria:

- adult patient (\> 18-year) who received a vincristine-based chemotherapy for hematological malignancy in childhood

Exclusion Criteria:

* Secondary cancer (leukemia and/or cancer)
* Active oncological pathology
* Current cancer treatment
* Adults protected
Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion

Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Macular oedema due to retinal vein occlusion

Exclusion Criteria:

* Not living in metropolitan France
Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.

* 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
* Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
* Follow up for one year after last cycle of alemtuzumab.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Liver and renal function test less than twice upper label
* No active infection
* Written informed consent
* One to three regimens of previous chemotherapies

Exclusion Criteria:

* Abnormal renal or hepatic function
* Mycosis fungoides/Sezary syndrome in transformation
* HIV +
* HTLV-1 +
* Pregnancy
* Lactation
ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.

The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
* At least 6 lymph nodes examined.
* Good or intermediate tumour differentiation.
* \<6 weeks before start of adjuvant therapy.
* Oestrogen or Progesterone positive

Exclusion Criteria:

* Premenopausal.
* Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
* In-situ/T4 carcinoma.
* Age \>80 years.
* World Health Organisation performance index \>3.
* Serious accompanying diseases
Epidemiological Profile of Ophthalmological Care in the Public Service in Brazil

Epidemiological study about eye discomfort complaints, comorbidities and diagnosis at a Brazil's ophthalmological public care service

1. 1670 individuals underwent an ophthalmologic evaluation
2. The data were obtained through the analysis of the medical records with the ICD-10 registration
3. The studied variables were age and sex of patient, origin, eye discomfort complaints, comorbidities and diagnosis (ICD-10).
4. The purpose was to evaluate epidemiological aspects of eye diseases in a public service

Eligibility Criteria:
Inclusion Criteria:

* Patients assisted in public service

Exclusion Criteria:
Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities

Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in the world. This is due to high recurrent rate after surgical resection and poor response to chemotherapy and radiotherapy.

Recent studies revealed that peri-tumoral structure and patients' immune status including cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While past studies focused on oncogenes and tumor suppressor genes, recent studies focused on patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated to cancer progression and metastasis.

Natural killer cells, playing an important role in cytotoxic immune system, are revealed to be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer progression and metastasis were accelerated.

This study sought to find the correlation of patients' cytotoxic immune status to cancer progression and status by measurement of NK cell activity in pancreatic cancer patients. This would be basic support to construct a prognostic model of pancreatic cancer for early metastasis and post operational recurrence.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 and under 85
* Control group : incidental found benign pancreatic cyst, non-neoplastic gall bladder polyp (ex, cholesterol polyp), healthy people having no evidence of malignancy in check up within 1 year
* Patient group : histological diagnosed pancreatic cancer patients, clinically diagnosed pancreatic cancer patients by radiologic evaluation
* Agreed to enroll the study and signed informed consent

Exclusion Criteria:

* Patients with other malignancies within 5 years
* Patients treated with steroid due to any reason within 1 year
* Not signed informed consent
A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)

The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.


Eligibility Criteria:
Inclusion criteria:

* Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
* Eczema Area and Severity Index (EASI) score greater than and equal to (\>=) 16 at the screening and baseline visits
* Validated investigator global assessment for AD (vIGA-AD) score \>= 3 at the screening and baseline visits
* \>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
* Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of \>=4
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
* Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit

Exclusion criteria:

* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
* Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
* Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments
* Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
* History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
* Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
* Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study
Colorectal Health Research Champions

The purpose of the Colorectal Health Research Champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research.


Eligibility Criteria:
Inclusion Criteria:

the individual is \> 30 years of age

* They are literate
* They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research.

To participate in a chat hosted by the CHRC the inclusion criteria is:

* adult of any gender
* over 30 years of age.

Exclusion Criteria for chat hosted by the CHRC:

-Those \< 30 years of age
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* A1C \<9%
* Mild neuropathy
* Mild retinopathy
* Mild nephropathy

Exclusion Criteria:

* History of drug or alcohol dependence, heart disease, viral illness, liver disease, advanced kidney disease
* Pregnant or nursing
* Severely overweight
Zaleplon 10mg Capsules Under Fasting Conditions

The objective of this study was to compare the relative bioavailability of Zaleplon 10 mg Capsules manufactured by TEVA Pharmaceuticals USA and Sonata® 10 mg Capsules manufactured by Wyeth Laboratories in healthy, non-smoking adults under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* non-smokers
* at least 18 years of age
* BMI of 30 or less

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are outside the reference ranges may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study. Subjects with intolerance to alcohol or other CNS depressants should not participate in this study.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
* All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
SD vs. NSD Therapy in Elderly AML

It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. In this multi-center study, we are going to evaluate the benefit of SD and non-SD (NSD) therapy in elder AML patients.

It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced. Non-SD (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care. In this multi-center study, we are going to evaluate the benefit of SD and NSD therapy in elder AML patients.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed AML exclusive of APL; Age from 60 years old to 75 years old.

Exclusion Criteria:

Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)