cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.

This multicenter, randomized, double-blinded study was conducted during the 2014-2015 Northern Hemisphere influenza immunization season to evaluate the non-inferior immune response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day on-study period with a six month safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females aged ≥ 18 years at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the On-study period. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.
* Vaccination against influenza in the previous 6 months.
* Known history of Guillain-Barré Syndrome or other demyelinating disease.
* Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).
* A clinically significant medical condition.
* Pregnant or lactating females.
Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer

The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.

The primary purpose of the study is to determine MTD(Maximum Tolerable Dose) of GX-051 administered in tumor. The second purpose is to evaluate safety and efficacy of GX-051.

Eligibility Criteria:
Inclusion Criteria:

* Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF).
* Very advanced head and neck cancer aged more than 19.
* Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection.
* Baseline ECOG Performance Status 0, 1 or 2.
* Have a life expectancy more than 6 months.

Exclusion Criteria:

* Have no history of prior anticancer treatment.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.Subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year.
* Have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity.
* Patients currently receiving anticancer immuno-therapies Patients who have received prior treatment with an stem cell therapy.
* Have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.).
* Have Graft rejection reaction such as GVHD.
* Have immunodeficiency disease.
* Leukocytes\< 3.0 x109/L.
* Absolute neutrophil count \< 1.5x109/L.
* Platelet count \< 100 x 109/L.
* Have known positive test for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
* Alanine Aminotransferase (ALT) \> 2.5xUNL.
* Aspartate Aminotransferase (AST)\> 2.5xUNL.
* Total Bilirubin\> UNL.
* Have blood Creatinine\> UNL.
* Known allergy to IL-12 or the excipient(s) of the study medication including fetal bovine serum.
* Second primary cancer Metastatic brain tumor or meningioma.
* Have a tumor near a main artery.
* Uncontrolled hypertension.
* Uncontrolled diabetes uncontrolled (arrhythmia).
* Heart failure (more than NYHA Functional Class II); unstable coronary artery disease; myocardial infarction within 6 months.
* Child-Pugh Class C hepatic impairment.
* Severe renal impairment (creatinine clearance \< 30 ml/min) or on dialysis.
* Have active infection or history of recurrent infection.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
* Are considered ineligible by the investigator due to a mental disease or CNS disease.
* Administration of any other tumor therapy, including chemotherapy and radiotherapy within 4 weeks(6 weeks in case of nitrosoureas and mytomycin C) before the beginning of study treatment.
* Patients receiving chronic, systemic treatment with immunosuppressive agent(steroid) or immuno-modulator within 2 weeks prior to screening.
* Have participated in another clinical trial within 30 days prior to dosing.
Outcomes of Triaged Family Care in Advanced Cancer

The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.

The purpose of this study is to:

1. determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care
2. determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low).

A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
* Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
* For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
* Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.

Exclusion Criteria:

* Patients will be excluded if they have multiple primary cancer sites.
* Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.
The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population

This study will look at which, if any, active stretching procedure is most effective at correcting posterior shoulder tightness (PST) in the post-operative population. Posterior shoulder tightness can influence shoulder mobility and function within both a symptomatic and an asymptomatic population. There are previous studies that have examined the effectiveness of different active stretching procedures and their ability to correct PST but only in the asymptomatic population. As clinicians it will be helpful to investigate their effect within a symptomatic population in order to prescribe appropriate and effective stretches within an individual's home exercise program. The study design is a double blinded randomized control trial. During evaluation a passive measurement of PST and internal rotation will be performed. Another therapist, blinded to the measurements, will randomly select which subgroup the individual will be placed in for the first three individuals and this sequence will be followed for the remainder of the participants. At this time the therapist will instruct the individual on the corresponding exercise which they will perform in front of that therapist. The individual will perform this exercise one more time that day and twice the following day and once again upon follow up prior to having internal rotation and PST measured once again. At this point this will be the conclusion of that individuals involvement in the study.

Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely in the post-operative shoulder population.

Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the post-operative population.

Null Hypothesis2: There is no significant difference in the reduction of PST between the horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder population.

Hypothesis2: There is a significant difference in the reduction of PST between the horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder population.


Eligibility Criteria:
Inclusion Criteria:

* arthroscopic shoulder surgery within the past two weeks preceding data collection with
* no surgical complications
* age 18-65.

Exclusion Criteria:

* total shoulder arthroplasty
* hemi shoulder arthroplasty
* open rotator cuff repair
* shoulder fracture fixations
* those that are unable to perform interventions and or tolerate measurement positions
* those seeking an initial evaluation after two weeks from the date of the surgical procedure.
* younger than 18
* older than 65
Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible

Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement \&amp;amp; simultaneous FGG or the conventional FGG protocol prior to implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Adults at or above the age of 18.
* Lower Posterior missing tooth/ teeth with minimal KT \&lt; 2mm
* Sufficient alveolar ridge length minimum 13-15 mm to IAN

  •. Sufficient alveolar ridge width minimum of 6 mm
* Patients able to tolerate surgical periodontal procedures.
* Patients who provided an informed consent and accepted the one-year follow-up period.

Exclusion Criteria

* Patients diagnosed with periodontal diseases (Caton et al., 2018).
* Current or previous smokers.
* Pregnant and lactating females.
* Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
* Patients with active infection related to the site of implant.
* Patients with parafunctional habits.
* Patients with shallow vestibule
Add-on Buprenorphine At Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode

This study aims at investigating if adjunctive buprenorphine at low dose to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode, and at determining the most effective dose.

Participants will be randomized to two doses of buprenorphine (0.4mg and 0.8mg) or placebo. The duration of treatment will be 21 days with 7 days withdrawal period. Two follow-up phone calls at 3 and 6 months will investigate occurence of suicidal behavior.

The main outcome will be changes in suicidal ideas levels during the first week.

Secondary outcomes will be changes in suicidal ideas during the following 21 days, changes in depression and psychological pain levels over the first 28 days, dropout rates, reasons and occurence of side effects over the first 28 days, withdrawal symptoms dung the withdrawal period, changes in neuropsychological and neuroimaging measures between Day 0 and Day 28.

Blood and stool samples will be collected at 4 time points and stored in a biobank for future analyses.

Eligibility Criteria:
Inclusion Criteria:

* The patient has been correctly informed.
* The patient must have given his/her informed and signed the consent form.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least 18 years old and 65 years old at the most.
* The patient is hospitalized or followed in consultation.
* The patient has a current major depressive episode without psychotic features according to the criteria of the "Diagnostic and Statistical Manual of Mental Disorders"
* The patient has a score \> 20 of the "Montgomery-Asberg Depression Rating Scale".
* The patient has a current Scale for Suicidal Ideation (SSI) score \> 8.

Exclusion Criteria:

* The patient is participating in another interventional trial;
* The patient is in an exclusion period determined by a previous study;
* The patient is under judicial protection, or is an adult under guardianship;
* The patient is under compulsory admission;
* The patient refuses to sign the consent;
* it is impossible to correctly inform the patient.
* The patient is pregnant or breastfeeding.
* The patient suffers from schizophrenia;
* The patient suffered from moderate to severe alcohol use disorder or substance use disorder (except tobacco and caffeine) over the last 12 months according to DSM-5 criteria ;
* The patient currently suffers from severe and/or unstable medical condition (including severe respiratory or hepatic insufficiency) or a painful medical condition;
* The patient has a current known sleep apnea.
* The patient currently takes analgesic treatment (including Nonsteroidal anti-inflammatory drug and paracetamol);
* The patient currently takes central nervous depressant drugs at sedative doses (based on the investigator's assessment), including benzodiazepines, antihistamines, and sedative antipsychotics;
* The patient currently takes major CYP3A4 Inhibitors and inducers;
* The patient currently takes has received Electroconvulsivotherapy over the last 3 months.
Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines. The investigators consider that a randomized trials does not appears feasible for both ethical and practical reason and so we suggest a large national observational study.

The investigators will include all nulliparous women that underwent an operative vaginal delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The investigators will collect data about the history of pregnancy, the course of labor, the mode of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The investigators expect a one-year study in 129 recruiting center with 15000 included women.

The primary objective is to assess the protective effect of mediolateral episiotomy against obstetric anal sphincter injury during instrumental delivery in nulliparous women according to the type of instrument used. The secondary endpoints are to investigate the effect of mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The investigators also aim to develop a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery. Finally, the investigators will investigate the impact of fetal presentation ultrasound assessment immediately before instrumental delivery on the mode of delivery.


Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or older
* nulliparity and instrumental delivery of a singleton in cephalic presentation in the previous 72 hours including failure of vaginal instrumental delivery leading to cesarean section

Exclusion Criteria:

* expression of any opposition or objection to study participation
* previous delivery of a fetus at a gestational age greater than 20 weeks, regardless of the mode of delivery
* preterm birth before 34 weeks of amenorrhea
* fetal presentation other than cephalic
* multiple pregnancy
* in utero death
* inability to understand French
* under judicial protection
* without access to a numeric terminal with internet connexion
Trunk Control and Disability in Persons With Multiple Sclerosis

This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old,
* diagnosed with RRMS by an experienced neurologist
* EDSS score ≤ 3

Exclusion Criteria:

* orthopedic or sensory additional problems in the lower extremity
* who had an interventional procedure in the last six months, and had an attack in the last three months
Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio

This study aims to find out the effect of contra lateral head rotation to distance and overlapping of internal jugular vein and carotid artery at cricoid cartilage level by ultrasound guidance on the Malay race in Indonesia

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. 34 subjects were enrolled by using consecutive sampling method. Sample size was calculated by using numeric analytic comparative paired formula with repeated measurement. Inclusion criteria were patients with ASA score 1 and 2, aged between 18-60 years old, no anatomical abnormality in neck. Exclusion criteria were patients who were either obese, has history of previous central venous catheter cannulation, and limitation on contralateral head movement. Drop out criteria was abnormalities of anatomical IJV and CA. Basic demographic data, such as sex, age, body weight and height, body mass index were recorded. Patients were positioned in Trendelenburg (15°) position. Identification triangle of Sedillot at cricoid level in right neck with palpation at angle 0°. USG probe was placed upright at the top of triangle of Sedillot at cricoid level. Identification of IJV and CA was shown in transversal view then the IJV to CA distance and overlap ratio was calculated. Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle.

Eligibility Criteria:
Inclusion Criteria:

* ASA score 1 and 2
* 18-60 years old
* no anatomical abnormality in neck

Exclusion Criteria:

* obese
* has history of previous central venous catheter cannulation
* limitation on contralateral head movement
Genitalia and Androgen in New Born Girls

Normal values for female external genitalia size at birth, particularly clitoris and blood level of androgens are not well known. This study's aim is to collect normal values in 180 newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according to gestational age and birth weight.

The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at birth, and their evolution until Day 3 of life (if the child is still at the hospital).

The investigators also want to establish normal values of blood testosterone, 17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol, deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone), using samples taken for systematic post natal screening of diseases (only in new born of 35 or more weeks of birth).

This is an observational prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female newborns 24 to 41 weeks of pregnancy without sexual development disturbances. Dysmature children - i.e. those with a - 2DS birth weight or height at are not excluded.

Exclusion Criteria:

* Sexual development abnormality, diagnosed pre- or post- birth, endocrine disorder, obstetric trauma affecting genitalia, malformation syndrome, midline abnormalities, congenital cancer, maternal ovary or adrenal tumor diagnosed during pregnancy, mother or father's treatment during pregnancy likely to virilize the fetus, family history of congenital adrenal hyperplasia or neurofibromatosis
A Clinical Comparison of Two Soft Contact Lenses (C24-755)

The aim of this study is to compare the short-term clinical performance of two soft contact lenses.

The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age (18) and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They currently wear soft contact lenses, or have done so within the past two years.
5. They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
9. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.