cyrilzakka/clinical-trials huggingface dataset:
Effect of Carbohydrate-protein Co-ingestion on Short-term Recovery

The purpose of this study is to determine whether the consumption of a carbohydrate, carbohydrate plus protein, or placebo sports drink during a 2-hour recovery period effectively moderates performance decrements during a subsequent bout of high-intensity exercise. This information will benefit any endurance-trained masters class athlete who may need to compete or train multiple times a day.

To test the hypothesis, this study will utilize a randomized, double-blind, placebo-controlled between-subject design to examine the effects of carbohydrate (CHO) and carbohydrate-protein (CHO-P) supplementation on short-term recovery following aerobic interval exercise (INT) and time to exhaustion (TTE) testing in maters class athletes. After completing the informed consent and screening process (Visit #1), each participant will be assessed for their anthropometric measures as well as body composition and will complete a graded exercise test to volitional exhaustion on a cycle ergometer to determine VO2peak. Forty-eight to 72 hours after Visit #1, or VO2peak testing, participants will return to the lab for familiarization with the INT exercise protocol and TTE test (Visit #2). Within forty-eight to 72 hours after familiarization (Visit #2), participants will return to the lab for Visit #3 to complete INT exercise and TTE, a 2-hour passive recovery period including the consumption of one of three treatments (CHO, CHO-P, PLA), followed by repeated INT exercise and TTE, heart rate variability and sweat rate determination. Participants will also complete the Nutritional Recovery Practices, Knowledge, and Beliefs of Australian Triathletes survey during the 2-hour recovery period. Participants will be asked to complete the ASA24®, an automated self-administered 24-hour dietary assessment tool during the 5-9-day period between familiarization (Visit #2) and the experimental protocol (Visit #3).

Eligibility Criteria:
Inclusion Criteria:

* Men between the ages of 35 and 59 years
* Free of any physical limitations as determined by the Exercise Preparticipation Health Screening Questionnaire for Exercise Professionals (PHSQEP), and a Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
* Regularly engaged in endurance exercise (running, cycling, swimming) for a minimum of three years, a weekly training volume of 5-10 hours, and a maximal oxygen uptake of 45.00 ml·kg-1·min-1 or higher as determined by completion of VO2peak assessment (Visit #1).

Exclusion Criteria:

* Recent musculoskeletal injuries or surgeries
* Any chronic illness that requires continuous medical care
* Current incarceration, cognitive impairment or inability to provide consent
* Present or past use of performance-enhancing drugs
A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)

A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+)


Eligibility Criteria:
Inclusion Criteria:

1. Patient is between 18\~60 years
2. Patient is HBV DNA positive with DNA levels ≥ 5 x 10\^5 copies/mL within 30 days of baseline.
3. Patient is documented to be HBsAg positive for \> 6 months and Patient is HBeAg positive.
4. Patient has ALT levels \>=80IU/L, prothrombin time(INR)\<1.7 and a serum albumin level of at least 3.5 g/dL.
5. Patient has hemoglobin levels \>=11.5g/dl(if woman) or \>=12.5g/dl(if man)
6. Women of childbearing potential must have a negative urine pregnancy test(β-HCG) taken within 14 days of starting therapy.
7. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
3. Patient is coinfected with HCV or HIV.
4. Patient with clinical evidence of decompensated liver disease or HCC
5. Patient has WBC levels \< 3.0x10\^9/L
6. Patient has Platelets levels \< 90x10\^9/L
7. Patient has alpha fetoprotein levels \> 100ng/mL
8. Patient has a history of Thyroid disease.
9. Patient has a history of autoimmune hepatitis.
10. Patient is pregnant or breast-feeding.
11. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
12. Patient has a clinically relevant history of abuse of alcohol or drugs.
13. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
14. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women of nonchildbearing potential, age 18 to 50 years.

Exclusion Criteria:

* Any previous or current clinically significant medical condition or disease.
Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.


Eligibility Criteria:
Inclusion criteria :

* Patients aged between 18 and 85 years (both inclusive)
* Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion

Exclusion criteria :

* Any non-selection criteria, which could have occurred after the selection visit
* Positive urinary or blood pregnancy test (for female patients of child bearing potential)
* Any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome
* Severe renal impairment detected in the local laboratory test
* Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test
* Stroke due to cerebral venous thrombosis
* Brain MRI showing a severe microangiopathy
* Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct
* Qualifying ischemic cerebral event older than 192 hours at inclusion
* Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome,
* Repeated prolongation of ECG QTcF
* Patient or authorised representative refusing to attend study visits or to take part in the study
AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

For until very recently CLL has been considered an uncurable disease, with the only few exceptions of a part of patients capable of undergoing and successfully standing allogeneic stem cell transplant. However, the introduction of chemoimmunotherapy in particular the FCR (fludarabine, cyclophosphamide, rituximab) regimen has established a relevant population of IgVH mutated patients, who remain relapse-free for up to 10 years with a clear plateau at this level. However, for the largest proportion of all CLL patients the disease is still associated with a reduction in life expectancy as compared to a matched population.

The field has made further substantial progress by the introduction of BTK inhibitors and Bcl2 inhibitors, novel antibodies as well as by the understanding of the role of minimal residual disease (MRD), mutations and their clonal evolution over time as risk factors and factors governing the kind and duration of therapy.

Due to the limited follow up of frontline therapy trials using novel drugs, it is not yet clear, what the long-term results with many of the new drugs will be. Particularly, long-term PFS, the potential for cure and the long-term safety issues remain relevant parameters requiring examination, as are infections, interactions with other drugs or quality of life issues.

CLL has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of this disease.

This registry is designed as multicenter observational cohort of patients with CLL. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Eligibility Criteria:
Inclusion Criteria:

* The registry will include patients ≥ 18 years with CLL.

Exclusion Criteria:

* There are no specific exclusion criteria.
First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer

CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Part I is divided in to two subparts, in both subparts patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702 and efficacious regimen. Part Ia will explore every other other day dosing (QOD); Part Ib will explore weekly dosing (Q7D). In part II of the study, patients will be given the recommended part/phase 2 dose (RP2D) Q7D. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 18 years of age at time of informed consent
* For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
* Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression
* Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide).
* Eastern Cooperative Oncology Group performance status of 0-1
* Adequate liver function
* Adequate hematopoietic function
* Testosterone level ≤ 50 ng/mL (or 1.73 nmol/L)
* Patient has a life expectancy of greater than 12 weeks

Exclusion Criteria:

* Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology
* Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD)
* Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment
* Patients with peripheral neuropathy CTCAE Grade \>/= 2
* Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients
* Patients with untreated or imminent spinal cord compression
Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home

Nowadays, resistance to anti-infectives has become a global public health problem and its increased prevalence threatens human health.

To date, few studies have focused on drug compliance in the paediatric population and it varies according to the pathology This drug adherence in the paediatric population is directly linked to outpatient care by the parents or the child's immediate family. In addition, there are no studies on adherence to antibiotics prescribed at the end of hospitalization in the paediatric population.

In this context, it seems urgent to seek an intervention capable of leading to responsible and appropriate use of antibiotics in order to improve efficiency in the drug management of acute paediatric infections.

This pilot study would characterize pediatric patients and determine the compliance rate in this population.


Eligibility Criteria:
Inclusion Criteria:

* The patient is under 16 years of age (\< 16 years of age).
* The patient is admitted to a full hospitalization in one of the 2 paediatric units of the University Hospital of Nîmes.
* The patient is discharged with a prescription for anti-infectives to be taken at home, for a maximum of 30 days.
* The patient and the holder of parental authority are available for a follow-up of 1 month after discharge from hospital.

Exclusion Criteria:

-
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.

Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.

This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-89 years old
* Women diagnosed with high-grade VIN (diagnosed by pathology)
* Women referred for vulva sparing treatment for dysplasia
* Women available for follow-up of treatment for 12 months

Exclusion Criteria:

* Women who are pregnant
* Women with low-grade VIN dysplasia (diagnosed by pathology)
* Women with vaginal intraepithelial neoplasia(VAIN)
* Women requiring vulvectomy for treatment
* Women unable to provide informed consent
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO)

OH dependence is associated with DA receptor changes. Both, the apomorphine test and the D2Rec SPECt are usefull for monitoring DA receptor status. We aimed at studying whether DA receptor hypofunction, assessed by means of the apomorphine test and the D2Rec SPECT, is a marker of relapse in detoxified OH dependents patients.


Eligibility Criteria:
Inclusion Criteria:

* alcohol dependence
* alcohol dependence length at least 8 years.
* male
* age 25 - 60 years

Exclusion Criteria:

* other drug dependence (except nicotine dependence)
* another major axis I psychiatric diagnosis
* comorbid neurological disorder
* comorbid cardiovascular disorder
* comorbid metabolic disorder
* brain injury
* apomorphine allergy
* iode allergy
* diazepam allergy
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia

A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).


Eligibility Criteria:
Inclusion Criteria:

-Presbyopia in each eye that impacts daily activities.

Exclusion Criteria:

* Use of any topical ophthalmic medications, including artificial tears
* Contact lens use in either eye within 14 days or planned use during the study
* History of eye surgery
* Diagnosis of any type of glaucoma or ocular hypertension
A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).


Eligibility Criteria:
Inclusion Criteria:

* Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
* Subjects must be able to understand the information provided to them and give written informed consent

Exclusion Criteria:

* Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry
Sentinel Node in Colon Cancer

More than 20% of patients operated on for colon cancer without node metastasis will develop visceral metastases. The purpose of the study is to determine sentinel lymph nodes with two methods: blue injection and isotopic detection. Sentinel nodes will then be analyzed by immunohistochemy to detect micrometastases. No adjuvant therapy will be proposed to the patient if there are only node's micrometastases and survival will be analyzed in regard to the presence of these micrometastasis.


Eligibility Criteria:
Inclusion Criteria:

* adult
* colon cancer
* open surgery

Exclusion Criteria:

* emergency surgery
* metastases
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma

BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have failed platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* KPS 60%
* Histological confirmation of urothelial carcinoma , with metastatic disease
* Measurable disease
* Previously treated with platinum-based chemotherapy administered

Exclusion Criteria:

* Radiographic evidence of cavitary or necrotic tumours
* Active brain metastasis.Leptomeningeal metastasis
* Chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors
* Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
* Prior treatment with BIBF 1120 or other VEGFR inhibitors
* Significant cardiovascular diseases:
* Pericardial effusion
* Significant bleeding or thrombosis
* Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
* Major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period
Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease

The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.

The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.

The secondary objectives are:

* To determine the increase in health care with the specialist (gastroenterologist or endocrinologist).
* To determine which noninvasive evaluation strategy favors any treatment of fatty liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.

Exclusion Criteria:

* Patients with other liver disease.
* Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver.
* Patients with alcohol consumption greater than 140 gr. per week
* Patients who have received blood transfusion before 1990