cyrilzakka/clinical-trials huggingface dataset:
DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.

This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.

Eligibility Criteria:
Inclusion Criteria:

Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.

Subjects with psoriasis involving 20 to 50% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas.

Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects whose results from the screening Adrenocorticotropic hormone (ACTH) stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.

History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.

Use within 60 days prior to the baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (UVB) therapy.

Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.

Subjects who have an abnormal sleep schedule or work at night. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.

Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.

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Cingularbio® Heart Valve Clincial Study

This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population

single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients

Eligibility Criteria:
The inclusion criteria were as follows: 1) patient who had heart valve disease requiring a surgical replacement as indicated in the preoperative evaluation; 2) patient aged between 60-85 years; 3) patient whose preoperative heart function less than NYHA functional class IV; 4) patient who signed the informed consent before surgery; 5) patient who agrees to finish the follow-up. The exclusion criteria were as follows: 1) patient with prior valve replacement; 2) patient who requires concomitant tricuspid or pulmonary valve replacement; 3) patient who requires concomitant coronary artery bypass graft surgery; 4) patient with active infective endocarditis or drug abuse; 5) patient whose life time expectancy less than 12 months; 6) patient who was unable to follow anticoagulation treatment.
10-Propargyl-10-Deazaaminopterin Plus Probenecid in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Probenecid may increase the effectiveness of 10-propargyl-10-deazaaminopterin by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of combining 10-propargyl-10-deazaaminopterin and probenecid in treating patients who have advanced solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose of 10-propargyl-10-deazaaminopterin and probenecid in patients with advanced solid tumors.
* Determine the therapeutic activity of this regimen in these patients.
* Determine the toxic effects of this regimen in these patients.
* Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of 10-propargyl-10-deazaaminopterin (PDX) and probenecid.

Patients receive probenecid IV and PDX IV on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive sequentially escalating doses of probenecid and PDX until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 35-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cancer that is potentially incurable by standard chemotherapy, radiotherapy, or surgical procedures

  * Failed prior first-line therapy (patients are also eligible if no effective first-line therapy exists)
* Previously treated or clinically stable brain metastases are allowed
* No leukemia or lymphoma
* No clinically significant pleural effusions or ascites

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 160,000/mm\^3
* Hemoglobin greater than 10 g/dL
* Serum and RBC folate normal

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT or SGPT less than 2 times upper limit of normal

Renal:

* Creatinine no greater than 1.2 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No unstable angina
* No congestive heart failure
* No cardiac arrhythmia

Other:

* Homocysteine normal
* No grade III or IV edema
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy to bone marrow-containing areas and recovered

Surgery:

* See Disease Characteristics
* No prior pneumonectomy

Other:

* No concurrent folic acid or potentially nephrotoxic agents
Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping

Adolescents suffering of ADHD may have impaired driving performance. The investigators would like to check the differences in driving performance in young adults(aged: 15-18 years) with ADHD by driving simulator and seat pressure mapping with and without methylphenidate medication.

Adolescents with ADHD who are treated with one of the methylphenidate medication that is in use in Israel(Ritalin,Ritalin SR,Concerta,Ritalin LA)will be tested by driving simulator and seat pressure mapping by 2 stages: 1.when they are taking the medication that they are taking every day to control ADHD and: 2. without medication ( after 4 day washout period).

Eligibility Criteria:
Inclusion Criteria:

* age 15-18 years Suffering from ADHD treated by methylphenidate before receiving driving license

Exclusion Criteria:

* any other neurological or psychiatric problem under treatment or investment adolescents who have driving license
The Effect of Preoperative Nutritional Assessment and Nutritional Support on Clinical Outcomes

It is a study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation.

It is a multi-center prospective observational cohort study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation. The nutrition risk were evaluated by different methods. The nutrition support regimens and the clinical outcomes were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent of patients or their legal representatives to participate in this study.
2. patients undergoing selective operation without trauma

Exclusion Criteria:

1. Age: \<18 years old or \>80 years old
2. Discharge within 24 hours
3. Accept surgery at 8:00 next day
4. Withdraw of patient's informed consent
A Study to Identify the Risk of Non-alcoholic Fatty Liver Disease (NAFLD) in Patients With Type 2 Diabetes in Clinical Practice and to Evaluate the Clinical Usefulness of Dapagliflozin/Pioglitazone Combination Therapy

The purpose of this study is to identify the risk of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes in clinical practice and to evaluate the clinical usefulness of Dapagliflozin/Pioglitazone combination therapy


Eligibility Criteria:
Inclusion Criteria:

* Among patients with type 2 diabetes, those who are scheduled to administer a fixed-dose combination of dapagliflozin/pioglitazone at baseline (visit 1)
* Those who voluntarily signed a written personal information collection and usage agreement after listening to an explanation about the objective and method, etc. of this clinical study.

Exclusion Criteria:

* Those who have a history of taking a fixed-dose combination of dapagliflozin/pioglitazone at baseline (visit 1).
* Those who are expected to need insulin prescription during the study period.
Mentalizating in Adults Suffering from Narcolepsy Type 1.

The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. Indeed, the hypothesis of this research is that mentalization could be impaired in narcoleptic patients.

Narcolepsy type 1 (NT1) is a rare and still poorly understood pathology which can have a significant impact on patient's daily life. Beyond the experience of their chronic illness, their feelings about the difficulties they go through during their lives seem relatively blunted, as if what could be described as restrictive could be acceptable for them. Moreover, the response generated by constraint, even if it is a refusal, rarely turns out to be impulsive or aggressive.

Rapid Eye Movement (REM) sleep is known to play a role in emotional regulation and also in narcolepsy. These processes both take place in hypothalamus, so, a link between them seems conceivable. Surprisingly, the studies about depression, impulsivity, addictions, facial emotional recognition in narcoleptic patients show results that differs from the expectations of the investigators, and can even be at the opposite. It appears difficult to have a clear idea of the mental state of narcoleptic patients.

Mentalization is a concept with a strong empirical base. It corresponds to ability to understand the mental state, of oneself or others, that underlies overt behaviour. The idea of this research is that this process is modified in narcoleptic patients.

The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. To realise this study a group of patients with NT1 and a control group will complete several questionnaires which are validated about mentalization and other ones. This combination of questionnaire is designed to evaluate the comparability of the groups and search for potential confounding factors.

Eligibility Criteria:
Inclusion Criteria:

For the NT1 patient group:

* Adult patient having been diagnosed with type 1 narcolepsy according to ICSD 3 criteria and the completion of a 48-hour polysomnography at the Sleep Laboratory
* Patient affiliated to or beneficiary of a social security system

For the control group:

* Patient over 18 years old
* Patient followed at Toulouse University Hospital and treated for Obstructive sleep apnea (OSA) with a residual AHI \<5/h, demonstrating the absence of residual OSA under treatment
* Patient affiliated to or beneficiary of a social security system

Exclusion Criteria:

* Patient with a history of autism spectrum disorder, chronic psychotic disorder, or bipolar disorder.
* Patient with a history of cognitive disorders of neurological origin
* Patient with a linguistic level in French that does not allow sufficient understanding to complete the questionnaires
* Patient under legal protection measure, under guardianship or curatorship
* Pregnant or breastfeeding woman
Oral Bioavailability of GLPG0555 in Different Solid Formulations

The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.


Eligibility Criteria:
Inclusion Criteria:

* healthy male
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.

The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.

The TOP Study Part I aims at identifying the most appropriate way of individual intensity prescription. In a descriptive cross sectional study, 20 breast and 20 prostate cancer patients perform singe endurance and resistance training sessions prescribed by means of different methods of intensity prescription. The most appropriate method of intensity prescription is identified through considering predictability/homogeneity of physiological responses as well as perceived exertion and enjoyment.

The TOP Study Part II aims at investigating the most effective training method in terms of enhancing physical fitness for both endurance and strength training. The design is an exploratory four-arm 12-week randomized controlled training intervention trial in 60 breast and 60 prostate cancer patients. In two endurance arms, vigorous continuous training is compared to a polarized program consisting of moderate training and aerobic high intensity interval training (HIIT). Similarly, in two resistance training arms, standard machine based hypertrophy training is compared to training following a daily undulating periodization design.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with early stage breast cancer (M0) or prostate cancer (M0 or M1 with PSA evidence of stable disease)
* 6 to 52 weeks after the end of primary therapy
* ≥18 to 75 years of age
* no regular endurance or resistance training (≥ one session per week) since diagnosis or within the last 6 months
* sufficient German language skills
* willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing
* signed informed consent.

Exclusion Criteria:

* diagnosed with additional other cancer
* brain or bone metastases in M1 prostate cancer patients
* heart failure \>NYHA III, unstable angina pectoris or severe arrhythmia
* uncontrolled hypertension
* reduced standing or walking ability
* any other comorbidities that preclude participation in exercise testing or training.
A Biopsychosocial Treatment for Exhaustion Due to Persistent Non-traumatic Stress

Currently, there are no established theoretical models for developing and maintaining Exhaustion due to persistent non-traumatic stress (ENTS). Therefore, the current pilot study aims to evaluate a Multimodal hybrid intervention built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Since 2009 long term sick-leave rates due to mental disorders have been increasing in Sweden and are today the leading cause of long-term sick leave. Exhaustion due to persistent non-traumatic stress (ENTS) accounts for most of this increase. Unfortunately, despite several published treatment studies, no evidence-based treatments exist for ENTS, and little is still known about the focus of treatment.

Currently, there are no established theoretical models for the development and maintenance of ENTS. Many of the published clinical ENTS trials consist of long (6 months or more) Multimodal interventions (MMI) containing various medical, psychological, and physiotherapeutic methods with a low degree of understanding of what components are critical for treatment success. Even if ENTS patients participating in MMI report symptom improvements and work resumption, MMI is generally personnel intensive and challenging to administer. These factors increase the risk of extended healthcare lead times and obstruct treatment dissemination.

Considering the increasing sick-leave rates due to ENTS, there is an apparent need for more accessible treatments based on pronounced theoretical models focusing on specific change processes. Therefore, the current pilot study aims to evaluate a hybrid MMI built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Outcome measures will be collected before and after treatment and at three and six-month follow-ups. Weekly measurements of putative processes of change will also be collected. The current study aims to evaluate whether this more restricted and theoretically coherent hybrid MMI shows promising results before we test the treatment solely as a cognitive behavioral therapy via the internet in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Referred for Stress-induced exhaustion disorder (SED)
* Fulfilled the criteria for SED
* Scored \> 5 on the Shirom-Melamed Burnout Questionnaire (a cut-off determined by the Health Care Services Stockholm County)
* Scored 19 \> on Karolinska Exhaustion Disorder Scale
* In need of sick-leave due to SED d) access to internet

Exclusion Criteria:

* 100 % sick leave of more than one year
* abuse of alcohol or drugs
* participating in any other form of MMI
* severe depression, moderate/high risk of suicide, psychosis, or untreated PTSD.
Pylorus Dysfunction After Esophagectomy and Gastric Tube Reconstruction. Effect of Pneumatic Pylorus Dilatation During Hospital Stay, Surgical Complications During in Hospital Stay

Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.

Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Previous esophagectomy and gastric tube reconstruction.
* Symptoms suggestive of delayed gastric emptying.
* signed informed consent

Exclusion Criteria:

* Signs of recurrent cancer disease
* no symptoms suggestive of delayed gastric emptying.
* unwillingness to participate
A Study of LY3154207 in Healthy Participants

This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.

Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.

Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.

Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.

Participants may only enroll in 1 of the 3 parts of the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history and physical examination
* Female participants not of child-bearing potential
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
* Have given written informed consent
* Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
* Part C only: Have known allergy or contraindications to itraconazole
FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer

Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a series in local advanced gastric cancer patients.

Patients and methods: The study is a prospective non-randomized study. Patients with histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2 lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with postoperative pathologic staging on patients who underwent radical surgery. Tumor down-staging and the grade of pathologic response are included in a statistical correlation between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival, R0 resection rate, toxicity and prediction of response.


Eligibility Criteria:
Inclusion Criteria:

Eligibility criteria included histologically confirmed gastric cancer, the gastro-oesophageal junction(GEJ) may be involved, but the bulk of the tumour has to be in the stomach; age ≥18 years old, ECOG performance status score ≤2, no prior chemotherapy, TNM stage of T2-T4 or positive regional lymph nodes by endoscopic ultrasound or computed tomography (CT), and adequate hematological, heart, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL).

Exclusion Criteria:

Patients with second malignancies or evidence of severe or uncontrolled systemic disease were excluded.