cyrilzakka/clinical-trials huggingface dataset:
Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning.

60 patients will be randomly assigned as control groups, paraffin group, and coconut group in a 1:1:1 ratio (30 patients in each group).

Inclusion criteria:

* Patients with symptomatic acute aluminum phosphide poisoning
* Age is more than 12 years of both gender
* Patients presenting within 6 hours post-ingestion of aluminum phosphide (Papade and Vanjari, 2019).

The diagnosis is made on the basis of:

1. The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide.
2. Reliable identification of the compound based on the container brought by patient attendants.
3. Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test).

   * Group (I): Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube (Control group)
   * Group (II): Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube (Paraffin group).
   * Group (III): Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube (Coconut group).
   * All patients will continue to receive the standard supportive treatment according to Tanta University Poison Control Center protocol, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation and antiarrhythmic agents if indicated.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with symptomatic acute aluminum phosphide poisoning

  * Age is more than 12 years of both gender
  * Patients presenting within 6 hours post-ingestion of aluminum phosphide

Exclusion Criteria:

* • Patients less than 12 years of age

  * Pregnant and lactating women.
  * Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
  * Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).
Synera Venipuncture Pain

Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS


Eligibility Criteria:
Inclusion Criteria:

* Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study.
* Is 18 years of age or older.
* Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment.
* Male or female patients
* Has signed the most recent Patient Informed Consent Form
* Has signed a Patient Authorization Form (HIPPA)

Exclusion Criteria:

* Patients with sensitivity to lidocaine, tetracaine, or any other component of the product
* Known sensitivity to any components of test materials (sulphites and adhesives)
* Patients with damaged or broken skin at the designated patch site
* Pregnant or breastfeeding women patients
* Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit
* Previous irradiation to the site of the patch
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L

The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different nicotine levels in smoking healthy subjects in relation to Nicorette® inhalator.

The entire study will last between 16 to 49 days per subject. This includes :

* a screening period of up to 4 weeks prior to admission,
* 1 day of admission (Visit 2): after all inclusion/exclusion criteria are checked, all eligible subjects will be enrolled and perform a product test, first with P3L (at nicotine dose levels of approximately 50 μg/puff) and subsequently with Nicorette® inhalator (3 to 5 inhalations for each product).
* 4 days of on-site product use (one day with Nicorette® inhalator \[Visit 3\] and three days with P3L \[Visit 4, Visit 5 and Visit 6\]),
* 1 to 3 days between each product use and
* a 7-day safety follow-up period (discharge + 7 days), during which there are no scheduled investigational visits, and during which adverse events (AEs) and serious adverse events (SAEs) can be spontaneously reported by the subjects and the follow-up of AEs/SAEs will be conducted by the study investigational site.

Subjects will come to the investigational site the night before each assessment day, at least 12 hours prior to the product use, on Visit 4, Visit 5, and Visit 6. Subjects will stay overnight at the investigational site between the admission visit (Visit 2) and Visit 3. Smoking or use of any tobacco/nicotine-containing products or electronic cigarettes, apart from product use assigned on the assessment days, will not be allowed during their stay at the investigational site. Smoking will be allowed once the subjects have left the investigational site.

The maximum concentration of nicotine (Cmax) and the area under the concentration-time curve from start of product use to the last quantifiable time point (AUC0-last) will be derived from multiple blood sampling pre- and post-product use, and corrected for baseline nicotine concentration.

Eligibility Criteria:
Inclusion Criteria:

* Subject is Caucasian
* Smoking, healthy subject as judged by the Investigator
* Subject smoked at least 10 commercially available non-menthol cigarettes (CCs) per day for the last 4 weeks
* Subject has smoked for at least the last 3 years prior to screening
* Subject does not plan to quit smoking in the next 3 months

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
* Subject has donated or been in receipt of whole blood or blood products within 3 months prior to Admission Visit
* Female subject is pregnant or breast feeding
* Female subject does not agree to use an acceptable method of effective contraception
* Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy
Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma

In this study, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Diagnosis of renal cell carcinoma
* Metastatic disease
* Predicted life expectancy over 2 months
* Patient referred for first line drug therapy
* Standard imaging evaluation 12 weeks prior to inclusion
* Planned for standard imaging within 16 weeks after start of therapy
* Informed consent

Exclusion Criteria:

* Lack of proper compliance to accept continuous samplings
A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ZL-1218 as a single agent and as combination therapy in subjects with advanced solid tumor malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women ≥ 18 years of age. If 18 years is not the age of majority, then adult men and women ≥ age of majority per local regulation.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Life expectancy \> 12 weeks.
* Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.Subjects must have at least one target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI scan.
* Subjects must have a site of disease which is not previously irradiated and is safe and amenable to biopsy per the treating institution's guidelines. Subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines.
* Subjects must have a site of disease which is not previously irradiated and is safe and amenable to biopsy per the treating institution's guidelines. Subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines.

Exclusion Criteria:

* Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
* Prior exposure to CCR8 inhibitor (anti-CCR8 antibody) or hypersensitivity to any ingredient of the study drug.
* Out of range value within 10 days prior to the first dose of study treatment.
* Subjects have received a live or live-attenuated vaccine within 30 days of planned start of study therapy.
* Subjects with known history of, or any evidence of active, non-infectious pneumonitis.
* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study drug.
* Treatment with any systemic anti-cancer treatment (including investigational products) within 4 weeks before first dose of study drug.
* Non-palliative radiotherapy within 2 weeks prior to first dose of study drug or have had history of radiation pneumonitis.
* Major surgery within 4 weeks of the first dose of study drug.
* Infections requiring systemic antibiotic therapy.
* Any medical conditions that would, in the investigator's judgement, prevent the subject's participation in the clinical study due to safety concerns, compliance with the study procedures, or interpretation of the study results.
Comparison of the Effect of Spinal Manipulation by Gender

The purpose of the study was to compare and evaluate the effects of spinal manipulation in patients with chronic mechanical low back pain by gender.

Sixty-two participants with a diagnosis of mechanical low back pain participated in the research. 62 individuals were split into two groups based on gender. These were divided into male (n=31) and female (n=31) groups. For four weeks, spinal manipulation was applied twice a week to both groups. The World Health Organization Quality of Life Assessment Short Form (WHOQOL-Bref) was used to evaluate quality of life; the Pittsburg Sleep Quality Index (PSQI) and McGill Pain Questionnaire were used to evaluate sleep quality; Visual Analog Scale (VAS) was used to evaluate pain; Oswetry Disability Index (ODI) was used to evaluate pain-related disability; and a scale was used to evaluate the treatment quality. Range of motion in the hips and lumbar region was measured with a goniometer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic mechanical low back pain
* Between the ages of 18 and 50
* Read and speak Turkish well enough to give informed consent and follow study instruction
* Being able to come for outpatient manipulation treatment
* Body mass index below 28

Exclusion Criteria:

* Currently involved in a legal proceeding related to back pain for which a workers' compensation claim is pending and have or have applied for permanent disability related to these problems
* Pregnancy
* Having any kind of malignancy
* Having any kind of osteoplastic disorders
* Having osteomyelitis, septic intervertebral discs and TB
* History of a spinal fracture and stenosis
* Inflammatory low back pain
* History of severe osteoporosis
* History of any kind of bleeding disorders
* Taking steroids, anticoagulants, paracetamol, antidepressant drugs or drug-like substances
* Having any orthopedic and/or rheumatologic disease affecting the pelvic region
* Conservative or physical therapy for the lumbar region for the past 6 months
A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies.
2. Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
3. Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

1. Active infection requiring treatment.
2. Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy.
3. Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
4. Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) \>480 msec at screening except for right bundle branch block.
French Observational Study of Complications Associated With Anticoagulants and Antiplatelet Treatment in Retina/Vitreous Surgery

Anticoagulants and antiplatelet treatments are frequently prescribed treatments to prevent or treat thromboembolic complications and reduce morbidity and mortality related to cardiovascular risk factors. In retina/vitreous surgery, there are rare but potentially serious risks of hemmorrhagic complication resulting in irreversible loss of visual acuity. There is no clear consensus on how to proceed during the perioperative period with regard to the continuation or discontinuation of anticoagulant and antiplatelet treatments in these types of surgery. the purpose of the study is to identify complications at 1 month depending on the type of surgery with or without discontinuation of antithrombotic treatments. Practitioners are not asked to change their modus operandi. The hypothesis is that there is no excess risk of peri- or post-operative hemorrhage in retino-vitreous surgery in patients treated with antithrombotic compared to untreated patients and that therefore discontinuation of these treatments before surgery is not necessary.


Eligibility Criteria:
Inclusion Criteria:

* person who has expressed willingness to participate
* person over 18 years of age
* person with a retinal-vitreous condition requiring scheduled surgery (epi-retinal membrane surgery, vitreous traction surgery, macular hole surgery).

Exclusion Criteria:

* person subject to legal protection (curatorship, guardianship)
* person deemed mentally incompetent
* pregnant, parturient or breastfeeding woman
* adult unwilling or unable to consent
* patient who has already participated in the study
* person with a physical or mental disability that does not allow participation.
* a person who has participated in any study of an experimental medical product within the previous 3 months
* person who experiences any of the following during the ophthalmological examination:

  * severe or proliferating diabetic retinopathy
  * intra-vitreal hemorrhage
  * tractional retinal detachment
  * subretinal or retrohyaloidal hematoma.
Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.

The goal of this clinical trial is to compare a behavioural lifestyle intervention program (BL) to usual care (UC) in breast cancer survivors. The main questions it aims to answer are:

1. If the participants of the BL group will lose more weight than the UC group.
2. If the participants of the BL group will have more lifestyle benefits than the UC group.

Volunteers will participate in a 24-week behavioural program. This program aims to improve their nutrition and physical activity in order to lose at least 10% of their initial body weight.

Eligible participants should be female breast cancer survivors between the ages of 18 and 65, with a BMI between 25 and 40 kg/m2, and no active cancer therapy or ongoing treatment, except for hormonal or immune therapy.

The usual care (UC) group will receive WCRF cancer prevention recommendations. The behavioural lifestyle intervention program (BL) group will participate in a 24-week intervention targeting diet and physical activity to lose weight.

The program will be considered successful if participants lose at least 10% of their initial body weight. A secondary goal is to improve their nutrition and physical activity levels. The third and last goal is to improve their overall quality of life and their anxiety levels.

The behavioral program includes in-person online meetings, group online sessions, and digital counseling material. Considering that participants will be residing all around Greece, an internet videoconferencing technology will be required.

A qualitative study incorporating focus groups undertaken prior to this study to establish the methodology resulted in the utilization of synchronous and asynchronous media, as well as a combination of in-person and group sessions.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 40 kg/m2

Exclusion Criteria:

* active cancer or any ongoing treatment except hormonal or immune therapy
Belatacept in Liver Transplant Recipients

The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant


Eligibility Criteria:
Inclusion Criteria:

* First time recipient of deceased donor liver transplant
* Age 18-70
* Hepatitis C virus (HCV) positive recipients
* For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52)

Target Disease Exclusions:

Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age \< 12 or \> 65 years d) Non heart-beating donors e) Anticipated cold ischemia time \> 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient

Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative

Medical History and Concurrent Diseases

1. Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation
2. Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio \> 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR \< 40 ml/min/1.73 m\^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease \[MDRD\]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment.
3. Subjects with known HIV
4. Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years.
5. Subjects with a history of cancer within the last 5 years

Allergies and Adverse Drug Reactions

a) Hypersensitivity to any medications that will be used in the protocol

Prohibited Treatments and/or Therapies

1. Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease
2. Subjects who received maintenance corticosteroids at a dose of \> 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease
3. Subjects who have used any investigational drug within 30 days prior to the Day 1 visit
4. Subjects previously treated with belatacept
Effects of a Synbiotics-containing Starter Formula on Infant Growth

In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.

Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.

The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.

Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Age at point of enrolment ≤14 days
* Birthweight ≥2500g and ≤4500g
* Full term infant ≥37 weeks gestation and ≤42 weeks gestation
* Singleton births
* Having obtained his/her or his/her legal representative's informed consent

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth
* Significant pre-natal or post-natal disease
* Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
* Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
* Patient who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial prior to the beginning of this study