cyrilzakka/clinical-trials huggingface dataset:
To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

A pharmacokinetic study to compare 2 clinical formulations of linifanib.

This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Eligibility Criteria:
Inclusion Criteria

1. Age is greater than or equal to 18 years.
2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
4. Subject must have adequate bone marrow, renal and hepatic function as follows:

   * Bone Marrow: Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (1.5 X 10\^9/L); Platelets \>= 75,000/mm\^3 (75 X 10\^9/L); Hemoglobin \>= 9.0 g/dL (1.4 mmol/L)
   * Renal function: serum creatinine \<= 2.0 mg/dL (0.81 mmol/L);
   * Hepatic function: AST and ALT \<= 1.5 X ULN unless liver metastases are present, then AST and ALT \<= 5.0 X ULN; bilirubin \<= 1.5 mg/dL (0.026 mmol/L)
5. Subject must have Partial Thromboplastin Time (PTT) \</= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) \</= 1.5.

Exclusion Criteria

1. Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
2. Subject has undergone major surgery within 21 days of Period 1, Study Day 1.
3. Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1, Period 1).
4. Current enrollment in another clinical trial.
Prevalence of Sexually Transmitted Infections (STIs) Into Prison in Reunion

Since the beginning of the 2000s, there has been a steady increase in the incidence of STIs in France. In Reunion, the few figures available seem to show the same phenomenon, especially for syphilis. The unfavorable socio-economic context, which is characterized by high levels of precariousness, significant population exchanges (immigration, travel) with neighboring countries, behaviors around sexuality or screening for STIs different from those observed in mainland France are all factors testify to the singularity of the Reunion island in relation to the metropolitan France with regard to the risk factors of STIs.

STI management has become a priority in public health; in particular, the 2010-2014 HIV and STI control plan emphasized the need for their surveillance and screening. These are often asymptomatic infections that can cause serious complications if they are not treated (infertility, ectopic pregnancies, maternal-fetal infections, ...). Screening them in at-risk populations is therefore essential to reduce their prevalence.

The prison population is a vulnerable population, possibly exposed during the incarceration but also upstream of it (generally low levels of education, over-represented disadvantaged social categories, low access and use of care, high prevalence of risky behaviors). ). Some prevalence studies of STIs in these populations have been carried out in metropolitan France, indicating a prevalence higher than that observed in the general population. There is little data on the subject for the prison population in Réunion; Given the local specificities, it seems necessary to improve the epidemiological knowledge of STIs in this prison population in Réunion, in order to be able to adapt the prevention and care measures, the conditions of detention presenting potentially aggravating situations (promiscuity, confinement). , hygienic conditions, ...).


Eligibility Criteria:
Inclusion Criteria:

* imprisoned at Domenjod prison between 01/02/2018 and on 04/30/2019
* able to answer a questionnaire,
* domiciled in Réunion at the time of incarceration,
* incarceration medical examination carried out within 7 days incarceration,

Exclusion Criteria:

* incarcerated by transfer from another penal institution
* having had antibiotic therapy in the 3 months before the inclusion consultation.
Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children

Kalaripayattu is an ancient martial art of India which has been practiced for centuries. It is mentioned in Vedic litrature of Ayurveda,Dhanurveda and Yoga. The main elements of Kalaripayattu include training in physical, combat, breathing exercises, higher form of meditation and specific class of medical treatments. The purpose of the experimental study is to determine the effect of kalaripayattu on psychological well-being and behaviour in children.


Eligibility Criteria:
Inclusion Criteria:

* Children from 8 years to 12 years of age
* Parents agreed to informed consent

Exclusion Criteria:

* Physical disabilities
* Diagnosed Mental or behavioural disorder
* Practicing other exercise, physical trainings or yoga
Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter

AIMS \& OBJECTIVES To evaluate the effectiveness of administering of Carica folia mother tincture to healthy individual's Platelet count.

Sample Details:- Students, Doctors and non-teaching staffs of Father Muller Homoeopathic Medical College are taken up for the study. A minimum of 60 persons will be selected and will be divided into two groups, Control \& Experiment by lottery method.

Voluntary participation in the study is expected. 30 persons in each group. One group will receive Carica folia mother tincture and other group will receive placebo.

Complete Blood count including platelet count will be measured for all 60 subjects before commencing the study.

The drug namely Carica Folia mother tincture will be procured from Father Muller Homoeopathic Pharmaceutical Division which compiles with the standards of Homoeopathic Pharmacopeia of India.

Daily dosage -30 drops of Carica Folia mother tincture in 30 ml of distilled water morning and night for 3days.

On 4th day complete blood count including platelet count will be estimated for all 60 subjects.

Research Methodology and Statistics:

Pre \&Post with Control Design is done. Data from the sample is collected and is subjected to Paired 't' test and unpaired 't' test.

HYPOTHESIS:-

Null hypothesis:

No significant changes in complete blood count and platelet count before and after the intervention.

Alternate hypothesis:

There is significant variation in complete blood count and platelet count before and the intervention.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* Age group- 18yrs to 25yrs
* both sexes
* free from any type of medicinal agent at least 15 days before commence the intervention.

Exclusion Criteria:

* person suffering from any illnesses
* age group below 18yrs and above 25yrs.
* person taking any medicinal agents, vitamins or any kinds of supplements will not be considered as subject.
Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis

A prospective study will be conducted at the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology Faculty of Dental Medicine, Assiut branch Al-Azhar University. Patients with head and neck cancer under RT, CT treatment participated in this study were selected from South Egypt Cancer Institute. During clinical examination the medical history of the patient will be recorded. Data related to base illness, type and stage of RT treatment, association or not to chemotherapy will be collected during the whole treatment. After clinical examination, the patients will receive a kit containing toothbrush, dentifrice, and subsequent oral hygiene instruction. Then the patients will be classified into 3 groups as follow: Group I (control group): the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. Group II: the patients will be treated by using 0.15% bezaydamine hydrochloride. All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. Group III: the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa.


Eligibility Criteria:
Inclusion Criteria:

-patients with head and neck carcinoma were scheduled to receive a RT treatment (two dimensional techniques), covering a wide area of the head and neck region, The RT protocol of the hospital for head and neck cancer patients consisted of treatment sessions 5 days a week, 2Gy per fraction, with a total dose of 70 Gy over 7 weeks (35 sessions). A minimum dose of 50 Gy was delivered to the oral cavity of all patients in the study, either exclusively or associated with chemotherapy.

Exclusion Criteria:

* Karnofsky performance status (KPS)less than 60% .
* Hypersensitivity to benzydamine or typical NSAIDs.
* Patients were excluded if they had lock jaw, any previous medical condition (s) hampering wound healing (e.g., diabetes mellitus).
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).


Eligibility Criteria:
Inclusion Criteria:

* Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
* The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
* The subject must voluntarily sign and date the informed consent form.
* Subject completed the post-treatment period of an eligible prior study.

Exclusion Criteria:

* The investigator considers the subject unsuitable for the study for any reasons.
* Receipt of any investigational product from Day 1 and while enrolled in this study.
A Single Dose Study Of PF-06678552 In Healthy Subjects

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg
* Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions

This study is to determine whether intrauterine instillation of Juveena hydrogel following adhesiogenic hysteroscopic procedures (TCGP + Juveena) can safely and effectively reduce the incidence and severity of intrauterine adhesions (IUA) compared to TCGP alone.

This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena Hydrogel System when used to reduce the occurrence of IUA in women undergoing TCGPs associated with a high prevalence of post-procedural IUA (i.e., adhesiolysis for moderate to severe adhesions or myomectomy of multiple or large myoma). A second look hysteroscopy (SLH) will be performed at the Week 8 visit to evaluate the presence and severity of IUA.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal
2. Candidate for one of the following hysteroscopic procedures:

   1. Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically
   2. Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease
3. Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
4. Subject is willing to undergo an SLH at the Week 8 visit.
5. Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.
6. Subject has signed the IRB/EC approved informed consent

Exclusion Criteria:

1. Postmenopausal
2. IUD present at time of TCGP (unless removed before or during procedure)
3. Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
4. Planned intrauterine interventions post-TCGP through the Week 8 visit.
5. Recent intrauterine surgery within 6 weeks before the planned study procedure.
6. Pregnant (positive pregnancy test) or lactating.
7. Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies.
8. Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection.
9. Use of systemic corticosteroids within 1 week of study procedure.
10. Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP.
11. Known allergy to FD\&C No.1 dye or polyethylene glycol (PEG).
12. Known clotting defects or bleeding disorders.
13. Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
14. Participating or considering participation in a clinical trial of another investigational drug or device during this study.
Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff and on Their Professional Activity.

The aim of this research is to identify the consequences of the Covid-19 on the physical and psychological health of the nursing staff of the Intercommunal Hospital of Villeneuve-Saint-Georges and on their professional activity thanks to a self-questionnaire.

This anonymous self-questionnaire is intended for all the CHIV care workers who were infected by the coronavirus during the first wave and identified by the occupational health service.

The covid-19 pandemic has had an important impact in the world, in France, it has put our health system under tension. We know that a health crisis of this magnitude can induce psychological and physical disorders, particularly in exposed caregivers.

Systematic occupational medicine consultations of all medical and paramedical personnel, whether tenured or not, working at the Villeneuve Saint Georges Hospital (CHIV) who presented a Covid-19 between February 1 and June 30, 2020, allowed us to note the presence of multiple after-effects.

The present study evaluates the consequences of the disease on the physical and psychological health of these caregivers and on their professional activity.

Eligibility Criteria:
Inclusion Criteria:

1. Major patient
2. Part of the medical and paramedical staff working at the CHIV,
3. Having been reached by Covid-19 during the first wave, between February 1st and June 30th 2020.
4. Patient affiliated to a social security system

Exclusion Criteria:

* None
Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children

Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.

Study design :

Inclusion visit at 20 weeks of gestation :

* randomization
* start of supplementation (GOS/inulin or placebo)

Phone call at 24 weeks of gestation :

* checking tolerance
* checking observance

  32 weeks of gestation visit :
* replenishment of prebiotics
* collect of AE

Day 1 : assessment of the Transepidermal Waterlos evaluated by a TEWAMETER

Delivery/per partum Visit

At M3 : The national recommendations for the dietary diversification of the child will be transmitted to the patients

At M6 : evaluation of AD prevalence by parents

At M12 : Pediatric dermatology consultation

* clinical exam of child
* the SCORAD
* the POEM questionnaire
* prevalence of AD
* skin prick tests
* FDQLI score
* assessment of the Transepidermal Waterlos evaluated by a TEWAMETER
* prevalence of food allergies

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with an eutocic pregnancy before 20 weeks of gestation
* women with personal history of atopy diagnosed by a healthcare Professional
* Women accepting a complete avoidance of dietary supplements containing prebiotics or probiotics during study supplementation
* women accepting dermato-pediatric follow-up during the first year of life of the new-born (Phone calls at 24 weeks of gestation and 6 months of child and a consultation at 12 months of age)
* non Tobacco user women
* women over 18 years
* women without history of severe gestational diabetes

Exclusion Criteria:

* women not giving up on intake of dietary supplements containing prebiotics or probiotics during study supplementation
* women refusing dermato-pediatric follow-up during the first year of the newborn
* ongoing allergy and/or intolerance to cow's milk proteins
* term \>21 weeks of gestation
Comparison of Microtrauma in Urethra After Usage of Different Catheters

The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study.

Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week.

The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization.

The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization.

The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality.

The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. Healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half \>50 years old)
3. Negative urine dipstick test (no blood in the urine) before randomization

Exclusion Criteria:

1. Intake of anticoagulants at enrolment and during the study period
2. Intake of antibiotics at enrolment and during the study period
3. Urinary tract infection (UTI) at enrolment and during the study period
4. Known abnormalities or diseases of the lower urinary tract with the exception of BPH
5. Kidney stones
6. Tumour in the urinary tract
7. Known Sexually transferable diseases in the urinary tract during the study period
8. Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
9. Previous enrolment or randomisation of treatment in the present study
10. Simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator
11. Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Augmented Reality Location-Based Games on Physical Activity

This study aims to examine the effects of an augmented reality location-based game intervention on behavioral and psychological factors related to physical activity among middle-aged and older adults. The study adopts a quasi-experimental design, targeting community-dwelling individuals aged 40-59 or 60 and above, who engage in sedentary work patterns exceeding 6 hours daily. Recruitment is scheduled to commence in February 2025 at the Xinyi Health Service Center in Taipei City. Participants will be assigned to either the experimental group or the control group based on enrollment timing. A minimum of 41 participants will be recruited, divided into two experimental groups and two control groups. The experimental group will participate in an augmented reality location-based game featuring different step count goals every two weeks, daily step count reporting, and goal achievement encouragement. The control group will maintain their usual routines without any intervention. The intervention will last for 8 weeks. Research instruments will include a basic demographic questionnaire, the short-form Taiwan Physical Activity Questionnaire, the Exercise Self-Efficacy Scale, the Exercise Motivation and Barriers Scale, blood pressure measurements, and the Quality of Life Scale.


Eligibility Criteria:
Inclusion Criteria:

1. Meet one of the following conditions: middle-aged to senior citizens aged 40 to 59 years old or senior citizens aged 60 years old or older who work more than 6 hours a day in a sedentary lifestyle
2. Able to walk independently without the use of aids.
3. Have a smart phone with an application (Pikmin Bloom) that can be installed and can access the Internet and GPS.

Exclusion Criteria:

1. Patients who have been diagnosed by a doctor as suffering from dementia, mental illness or major diseases.
2. Those who are unable to do intense exercise as mentioned in the medical advice.
3. Those who cannot go out for long time, such as family caregivers.
4. Those who have regular exercise habits: average daily steps over 5,000 steps or 30 minutes of leisure-type physical activity more than 3 times a week.
5. Those who will not use the AR adaptive game (Pikmin Bloom) at the end of the 2-day test period.