cyrilzakka/clinical-trials huggingface dataset:
Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones

The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones

While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.

Eligibility Criteria:
Inclusion Criteria:

- patients with \>2cm kidney stone

Exclusion Criteria:

* Pregnant women
* patients with coagulopathies
* patients with scattered stones who needed several accesses
Single-dose Vaginal Dinoprostone and Hysterectomy

In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect


Eligibility Criteria:
Inclusion Criteria:

* • Patients presenting for hysterectomy for any benign indication including uterine fibroids.

  * Age ≥ 18 years
  * Pre-operative hemoglobin \>8 g/dl
  * Willing to have dinoprostone or a placebo prior to hysterectomy
  * Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* • Patients with known or suspected endometrial/ovarian/cervical cancer.

  * Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
  * Patients currently undergoing treatment for any type of cancer.
  * Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
  * History of allergic reactions to dinoprostone.
Retrospective Study on Anosmias and Ageusias Linked to Infection by Covid-19

Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss.

The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
* Subject with suspected or confirmed Covid-19 infection
* Subject taken care of by the ENT service
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface

To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.

Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
* Patients must not be pregnant

Exclusion Criteria:

* Pregnancy
* Patients unable to give consent
Acceptability of Long-term Progestin-only Contraception in Europe

The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-35 in good general health requesting contraception
* Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception
* Women who have given a written informed consent to participate in the study (if applicable)

Exclusion Criteria:

* The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study
* Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern
A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg
* Not currently taking BP-lowering medication
* Clinician recommends pharmacologic treatment
* Willing to make necessary study visits
* Able to be contacted by phone
* Has a primary care clinician
* At least 18 years old

Exclusion Criteria:

* Known secondary cause of hypertension
* Pregnancy
* Known diabetes, coronary artery disease or renal disease
* Known sulfonamide allergy or history of gout
* Participant's clinician recommends he/she not enroll
* Hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit
* Baseline visit systolic visit BP average \< 140 mmHg and diastolic BP average \< 90 mm Hg
* Resting heart rate \< 55 beats per minute
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind, controlled prospective study.

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury,randomized, single blind, controlled prospective study.

Forty patients will be selected and randomized into two groups: the first group of 20 patients will receive three-time injection of UC-MSC and the remaining 20 patients will comprise the control group.

Every patient will maintain their standard treatment of paraquat poisoning, with maximum tolerated dosage without side effects.

The day of last infusion will be considered day zero. From that moment, followup will be divided into 2 d,7 d,14 d, 28 d and 2 m.

Clinical results will be analyzed after completion of 2 months of followup.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 60 y(including 15y)
* A history of ingestion paraquat, and hospitalization within 96 hours after paraquat poisoning
* No previous organic disease history of serious heart, liver, kidney and lung, etc;
* Patients with moderate poisoning (oral dose of 20-40mg of PQ ion/kg of body weight)
* Patient or his legal agent signed informed consent voluntarily
* Capable of good communication with researchers and follow the entire test requirements

Exclusion Criteria:

* Refused to sign informed consent
* Elderly high-risk patients
* Socially and mentally disabilities
* Hepatitis B, hepatitis C, HIV and tuberculosis patients
* Pregnant or perinatal women
* Severe organ failure patients
* Patients participated in clinical trials of other drugs within 3 months
* Other circumstances not suitable to the trial(mixed toxicants poisoning)
A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. Finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects, between 18 and 55 years old (inclusive);
* body mass index (BMI) of 27-40 kg/m2;

Exclusion Criteria:

* likely allergy or sensitivity to any components of Trodusquemine for Injection based on known allergies to drugs of the same class, or which, in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine HCl;
* any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
* any subject with a history of severe allergy or bronchial asthma;
Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice.

In addition to the effectiveness of Effentora® therapy, safety, general feasibility and the impact of therapy on the patients' quality of life are of interest.

Eligibility Criteria:
Inclusion Criteria:

* decision to start treatment with Effentora
* prescription in accordance with Summary of Product Characteristics (SmPC)
* personally signed and dated Informed Consent document

Exclusion Criteria:

* any subject considered unsuitable according to SmPC
Regional Anaesthesia for Painful Injuries After Disasters

The goal of the RAPID study is to fundamentally transform the way serious injuries are managed after earthquakes and other disasters by introducing a novel and cost-effective method for pain control. The study will enroll patients in the aftermath of a major earthquake to determine whether regional anesthesia, either with or without ultrasound-guidance, can reduce suffering from lower limb injuries, the most common earthquake-related injury, above and beyond the current standard of care for pain control in these settings.

The Regional Anaesthesia for Painful Injuries after Disasters (RAPID) study aims to evaluate whether regional anesthesia (RA), either with or without ultrasound (US) guidance, can reduce pain from earthquake-related lower limb injuries in a disaster setting. The proposed study is a blinded, randomized controlled trial among earthquake victims with serious lower extremity injuries in a resource-limited setting. After obtaining informed consent, study participants will be randomized in a 1:1:1 allocation to either: standard care (parenteral morphine at 0.1 mg/kg); standard care plus a landmark-guided fascia iliaca compartment block (FICB); or standard care plus an US-guided femoral nerve block. General practice humanitarian response providers who have undergone a focused training in RA will perform nerve blocks with 20 ml of 0.5% levobupivacaine. US sham activities will be used in the standard care and FICB arms and a normal saline injection will be given to the control group to blind both participants and non-research team providers. The primary outcome measure will be the summed pain intensity difference calculated using a standard 11-point numerical rating scale reported by patients over 24-hours of follow-up. Secondary outcome measures will include overall analgesic requirements, adverse events and participant satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older) presenting to an MSF field hospital with one or more lower limb injuries .

Exclusion Criteria:

* multi-system trauma
* severe respiratory distress
* hypotension
* altered mental status
* active infection at the sight of injection
* known current pregnancy
* unable to provide informed consent.
* known allergies to local anesthetic agents or narcotic pain medication
* receiving antithrombotic therapy or with a preexisting coagulopathy
* likely to receive regional anesthesia for alternative reasons within two hours of screening
An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

T-1101 is a novel anti-cancer agent being developed by Taivex Therapeutics Corporation, and is being studied in a phase I dose escalation trial, protocol TAI-001. That trial's primary aim is to study the safety and tolerability of T-1101 (Tosylate) in subjects with advanced refractory solid tumors, and provides for a maximum of 2 cycles of treatment. At the end of 2 cycles of treatment, it is likely that some patients will be continuing to receive clinical benefit from T-1101 (Tosylate). The intention of this program is to enable these patients to continue to receive T-1101 (Tosylate) at the discretion of the principal investigators and Taivex Therapeutics Corporation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced malignancy who are receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment.
2. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.
3. Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of T-1101 (Tosylate) in this long term extension trial.
4. Patients who have completed the End of Study assessments in their originating study. Every effort should be made to conduct the End of Study visit such that the patient does not have any interruption in T-1101 (Tosylate) dosing.
5. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.
2. Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy).
3. Progressive or untreated metastatic brain or meningeal tumors.
4. Pregnancy or breastfeeding. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of highly effective contraception during the period of therapy. Highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, or a vasectomized partner.
5. Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation

The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant


Eligibility Criteria:
Inclusion Criteria:

* Living or deceased donor renal allograft
* Men and women, 18 to 70 years old
* Subjects who have received a de novo kidney transplant, who have completed the initial study treatment through Month 12, and are willing to sign informed consent will be eligible to continue into the long term extension phase

Exclusion Criteria:

* Pregnant or breastfeeding women
* Epstein Barr Virus (EBV) negative serology
* First time renal transplant with panel reactive antibody (PRA) ≥ 50% or retransplantation with PRA \> 30%
* Graft loss due to AR
* Positive T-cell or B-cell crossmatch
* Recipients/donors with HIV or hepatitis B/C
* Active tuberculosis (TB)
* Immunosuppressive therapy within 1 year of enrollment
* UNOS ECD organs will be excluded
* Body mass index (BMI) \> 35 kg/m²
* Subjects who have developed any malignancy (other than non-melanoma skin cancer) or other medical condition that, in the investigator's opinion, should not be treated with an experimental immunosuppressive drug like belatacept
Green Coffee Extract Supplementation and Oxidative Stress, Systemic and Vascular Inflammation

Metabolic syndrome (Mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. Mets is accompanied by oxidative stress and low-grade inflammation. Green coffee is rich in polyphenols called chlorogenic acids (CGA) which possess anti-inflammatory and anti-oxidative characteristics. Thus, we carried out this trial to examine green coffee extract (GCE) effects on oxidative stress, systemic and vascular inflammation in patients having Mets


Eligibility Criteria:
Inclusion Criteria:

* body mass index of over 25, waist circumference \>102 cm in men or \>88 cm in women,Fasting blood glucose \>100 mg/dL, Triglycerides (TG) \> 150 mg/dL, High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men, Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria:

* insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLU). If this systemic, nutrient intervention is found to alter the microenvironment of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.

The pathogenesis of CVLU involves high numbers of activated polymorphonuclear leukocytes (PMN) that are associated with persistent inflammation in the wound bed 5-9. We propose to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to assuage PMN activity and promote healing of CVLU. If this systemic, nutrient intervention is found to alter the microenvironment of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.

The purpose of this study is to test three fundamental corollaries of our organizing hypothesis in a 2-group, double-blind, randomized, experimental design on CVLU patients. The findings from the proposed experiments will increase our understanding of lipid mediators that influence wound healing and PMN function, and may lead to an innovative approach to reduce the physical and emotional burdens of nonhealing or recurrent CVLU.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* ages 18-85 years
* having at least one existing CVLU between the ankle and knee for ≥ 3 months
* medical clearance to take 81mg/d of aspirin
* prescribed compression therapy; ambulatory
* ankle brachial pressure index (ABPI) of ≥ 0.8
* target wound of ≥ 1 x 1 inches (6.25 cm2)
* can understand English and sign own consent

Exclusion Criteria:

* allergy to fish or seafood
* exposed bone, tendon or fascia around target wound
* receiving warfarin or Plavix therapy
* immunologic related condition (e.g. Crohn's disease, systemic lupus erythematosus)
* chronic inflammatory skin diseases (e.g. pyoderma gangrenosum, psoriasis)
* requiring non-steroidal anti-inflammatory drugs \> 2x a week
* nutritional supplements or corticosteroids
* chronic renal insufficiency
* already in a study related to CVLU.
Evaluating Oral Visual Inspection in the Control of Oral Cancer

Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for oral cavity cancer using visual inspection on oral cancer mortality.

The study population consisted of 13 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the remaining 6 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 35 and older, without a personal history of oral cancer. Informed consent was signed by each participant. The intervention arm consisted of 96,517 participants and the control group consisted of 95,356 participants.

Eligibility Criteria:
Inclusion Criteria: Residing in 13 study clusters in Trivandrum City, Kerala

Exclusion Criteria:

* Diagnosis with oral cancer prior to study
* Bedridden subjects
* Subjects suffering from open tuberculosis or other debilitating diseases