cyrilzakka/clinical-trials huggingface dataset:
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.

This is a phase I, single center, randomized, double-blind and parallel group clinical trial.

The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.

At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®.

Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years old (including 18 and 65 years old), healthy male subjects.
* Body mass index (BMI) within the range 19-28kg/m2.
* History, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant.
* Volunteered to participate in this clinical trial, capable of giving written informed consentan.
* The subject (including the subject's partner) takes effective contraceptive measures.

Exclusion Criteria:

* Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study.
* Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
* Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
* Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies.
* Those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement Treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (\>1000 IU/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

PRIMARY OBJECTIVES:

I. To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).

SECONDARY OBJECTIVES:

I. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.

III. To compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.

OUTLINE:

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.

After completion of study treatment, patients are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are willing to participate.
* Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure.
* Ability to understand and willingness to sign a written informed consent document (ICD).

Exclusion Criteria:

* Known allergy to proflavine or acriflavine.
* Pregnant females.
Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin

The purpose of this study is to determine the safety and feasibility of conditioning with fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML) undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible sibling donors.


Eligibility Criteria:
Inclusion Criteria:

Patient Selection

1. Availability of a HLA compatible sibling donor
2. Age \>18 years
3. Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
4. Poor risk acute myeloid leukaemia, de novo or transformed from MDS
5. Ineligibility for standard conditioning allograft due to age or co-existing morbidities

Donor selection

1. Related donors compatible for HLA-A, B, C, DRB1 and DQB1 by molecular typing.

Exclusion Criteria:

Patient selection

1. Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
2. Hepatic disease, with AST \> 2 times normal.
3. Severe hypoxaemia, pO2 \< 70 mm Hg, with decreased DLCO \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted.
4. Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
5. Patients who have received previous treatment with Thymoglobuline
6. HIV-positive patients.
7. Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
8. Life expectancy severely limited by diseases other than MDS or MPD.
9. Serious concurrent untreated infection
10. Patients with limited life expectancy for other reasons
11. Serious psychiatric/ psychological disorders
12. Absence of /inability to provide informed consent

Donor selection

1. Age \>75 years, unless independently assessed to be medically fit to donate
2. Donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
3. Donors who are HIV-positive, or hepatitis B or C PCR positive.
4. Donors who are medically unsuitable to donate
Safety and Efficacy Investigation on the Effects of ClearSkin Non-ablative ER:Glass 1540nm Laser Module in the Treatment of Acne Scars.

The ClearSkin module, Er: Glass 1540nm, is largely used in the treatment of acne vulgaris and acne scars. The non-ablative ER:Glass 1540 nm laser deeply penetrates the skin, causing thermal damage to the sebaceous glands, destroying P. acnes bacteria and reducing sebum production, while leaving the epidermis intact. The integrated vacuum mechanism extracts accumulated sebaceous material from the pores, while contact cooling protects the skin, reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis. Based on this background, the investigators have considered a pilot study aimed at assessing the efficacy and safety of the ClearSkin Module in treating subjects with facial acne scars.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 50 years
* Presence of mild to moderate facial acne scars (according to Goodman \& Baron's scale)
* Subjects in reasonably good general health, according to the Investigator's judgment;
* Subjects who agree to avoid tanning during the entire investigational period;
* Subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal, or application of any cosmeceutical/pharmaceutical without the consent from the PI only.
* Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgment.
* Subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs.

Exclusion Criteria:

* Subjects with active infections
* Subjects with a history of keloid scarring or hypertrophic scar formation
* Subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months
* Subjects who have been tanning within the past 30 days;
* Previous surgical treatment of the area selected for the treatment with the investigational device;
* Subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site;
* Subjects with the presence of tattoos at the treatment site
* Subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.)
* Subjects with history of autoimmune disorder or evidence of immunosuppression;
* Subjects with collagen vascular diseases
* Subjects with thrombocytopenia
* Subjects with peripheral vascular disease
* Subjects with Melasma
* Pregnant or lactating subjects
Mentor MemoryGel Post-Approval Study

In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.


Eligibility Criteria:
Inclusion Criteria:

1. Female, age 18 years or older (22 or older for breast augmentation patients)
2. U.S. resident

Exclusion Criteria:

1. If a saline participant, current or past, unilateral or bilateral, silicone breast implants
2. Active infection anywhere in her body
3. Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
4. Currently pregnant or nursing
Trunk Extension Endurance Among Physical Therapy Students

College students from physical therapy department will be assigned into four groups. Participants will be tested for trunk extensors endurance and will be given endurance training program to do at home for 6 to 8 weeks. Spinal mobility and lower extremity mobility will be measured. Isokinetic outcome measures for extension and flexion at two different speeds will also be measured at baseline, after 6 and 8 weeks.

Active physical therapy students who are healthy and free from any significant pain at the spine will be recruited to participate in intervention endurance training. Participants will be assigned into four equal groups; doing trunk extension form lying on stomach while breathing normally and arching trunk backwards as long as tolerated. Group one will have arms above head, group two will have hands behind head, group three will have hands parallel to the trunk, and group four will receive instructions only and will act as control group. Spinal mobility of forward bending, backwards bending, right and left side bending will be taken. Straight leg raising and quadriceps flexibility will also be taken. Isokinetic measurements including peak torque, peak torque/body weight, average peak torque, work and average power will be taken at baseline, 6 and 8 weeks. Participants will have a training volume of 2 sets of 10 repetitions, 2 minutes rest in between, 2x/day for 6 to 8 weeks. Endurance timing will be measured in seconds using stop watch. If participant managed to maintain the trunk extension position for 4 minutes, time is recorded and it is considered as ceiling time.

Eligibility Criteria:
Inclusion Criteria:

* Active college student free from any spinal pain or pain 3/10 on pain intensity numeric pain rating scale, willing to participate

Exclusion Criteria:

* have had spinal surgery or pain at the spine more than 3/10 on pain intensity numeric pain rating scale.
ProSight: a Multi-centre Interventional Study Evaluating MCED in Asymptomatic Population

This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.

Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol.

Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app.

Participants will be actively followed for 1 year from the date of the blood draw.

Eligibility Criteria:
Inclusion Criteria:

* 40-74 years old
* Able to provide a written informed consent and willing to comply with all parts of the protocol procedures

Exclusion Criteria:

* With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
* Have definite contraindications of cancer screening examination and diagnostic procedures
* Unable to comply with the protocol procedures
* Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
* Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion.
* Recipients of anti-tumor therapy within 30 days prior to screen
* Pregnancy or lactating women
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to screen
* With autoimmune diseases
* Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
* Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)
FDG-PET/CT Imaging as Early Predictor of DP

In this study the investigators would like to describe FDG-PET/CT responses in patients who are receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects will undergo two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan at about 1 month after infusion.

In this study the investigators described FDG-PET/CT responses in patients who were receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects underwent two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan at about 1 month after infusion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled on the study UPCC 13413 Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-Cd19 Attached To Tcr And 4-1bb Signaling Domains In Patients With Chemotherapy Resistant Or Refractory Cd19+ Lymphoma CART-19 autologous T-cell trial with relapsed or refractory DLBCL and FL. As this is a pilot study, we plan to enroll 4 subjects from the two disease types of interest.
* Subjects ≥ 18 years of age
* Subjects able to provide informed consent and agree to comply with study procedures

Exclusion Criteria:

* Subjects who are pregnant or lactating.
* Subjects will be co-enrolled in this study and UPCC 13413 and therefore must comply with the UPCC 13413 Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-Cd19 Attached To Tcr And 4-1bb Signaling Domains In Patients With Chemotherapy Resistant Or Refractory Cd19+ Lymphoma requirements pertaining to pregnancy, lactation, conception and contraception use throughout their participation in both studies.
Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients

The population continues to increase in weight. Currently there are no guidelines in the dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for patients \<120 kg and 3 grams for patients \>120 kg is used as the dose for surgical prophylaxis. This makes no provisions for weight based dosing. There has been some recent data which states this might not be enough for the obese patients. The primary objective of this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric bypass provides appropriate serum concentrations for a larger percentage of time than the current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The concentration of cefazolin in tissue will also be measured to help assess this question.

The hypothesis of this study is that customary doses of antibiotics, when administered for perioperative surgical prophylaxis, are insufficient to achieve adequate antibiotic concentrations in blood and tissues of morbidly obese patients (defined as a BMI greater than 40 kg/m2) and that these patients are therefore placed at high risk of surgical wound infections and poor clinical outcomes. Cefazolin is a first-generation cephalosporin commonly used for perioperative surgical prophylaxis in colorectal, abdominal, bariatric, gynecologic and obstetric, or orthopedic total joint arthroplasty surgical procedures. Previous cefazolin pharmacokinetic (PK) analysis in obese patients led to conflicting results and recommendations. It is not clearly know to what extent the pharmacokinetics of cefazolin in morbidly obese patients differ from those of non-obese patients. Specific dosing guidelines are then lacking. The main objective of this study is to assess the pharmacokinetics of cefazolin in morbidly obese after administrations of a standard recommended 2-3 g dose or a weight-base 30-mg/kg dose

Eligibility Criteria:
Inclusion Criteria:

1. BMI greater than 40
2. No known history of allergy to cephalosporins
3. Scheduled for elective gastric bypass or laparoscopic Roux-en-y gastric bypass procedures
4. Able to read and understand English

Exclusion Criteria:

1. Patients \<18 years of age or \>89 Years of age
2. Pregnant women, prisoners and decisionally challenged subjects will be excluded
Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass

Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool to accurately assess ascending aorta disease. To date, several studies have reported that EAS is superior to TEE and surgical palpation


Eligibility Criteria:
Inclusion Criteria:

patients underwent who isolated off-pump coronary artery bypass

Exclusion Criteria:

1. combined carotid procedures
2. preoperative cerebral haemorrhage
3. nonoperative unstable vital signs such as ventricular fibrillation or cardiac arrest
Short Course Terlipressin for Control of Acute Variceal Bleeding

The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.

The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.

Eligibility Criteria:
Inclusion Criteria:

* Acute esophageal variceal bleed
* Liver cirrhosis
* Child's score \</= 11

Exclusion Criteria:

* Patient on Mechanical ventilator and or ionotropic support
* Active angina, Recent Myocardial infarction or dynamic EKG changes
* Failure to control variceal bleed on initial endoscopy
* Gastric variceal bleed
* Spontaneous bacterial peritonitis at presentation
* Hepatocellular carcinoma or other liver metastatic malignancy
* Portal vein thrombosis
Chemsex, Perceived Risks and Coping Strategies.

The research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves.

This qualitative study has a comprehensive objective. The aim is to identify the risks perceived by MSM practicing Chemsex and their coping strategies. The study is based on individual semi-directed interviews and focus group. The criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. Participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. At the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the Montpellier University Hospital in France as well as to an association fighting against AIDS in Montpellier.

Data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.


Eligibility Criteria:
Inclusion criteria:

* an age greater than or equal to 18 years
* being a man having sex with men
* having used psychoactive substances in a sexual context at least once in the past 12 months.

Exclusion criteria:

- to refuse to participate to the study