cyrilzakka/clinical-trials huggingface dataset:
Comparison of Lithotripsy Urolithiasis Machines

A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.

This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.

Eligibility Criteria:
Inclusion Criteria:

- Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed

* Age ≥ 18 years old
* Male and female patients
* Patients of all ethnic backgrounds
* Stone size 5-15mm
* Stone location: Renal or proximal ureter
* Stone density: \< 1200 Hounsfield Units
* Skin to stone distance: \< 12cm
* Primary treatment for a solitary stone (must be previously untreated)

Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

Exclusion Criteria:

* Prior treatment for specified stone

  * Multiple stones on treatment side (even if only one is treated)
  * Anticoagulated or history of coagulopathy
  * Prior ureteral stent placement
  * Technical problems/impossibility of localizing the stone on the day of intervention

Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
Immunological Effect of Increasing Doses of Natural Peptide

A trial monitoring the immune effects in 24 people with 4 different doses (1 gram per day, 2 grams per day, 4 grams per day, 8 grams per day) of a natural plant-based protein hydrolysate.

The goal for this clinical proof-of-concept study is to compare immune effects of a novel plant-based peptide on IL-17, Th17 and related immunological mechanisms.

An open-label, escalating dose study design monitoring immune effects in which healthy men and women take doses of a natural protein hydrolysate daily for 6 weeks.

During the first 2 weeks, participants will consume 1 gram/day. For the next 2 weeks, participants will consume 2 grams/day. For the final 2 weeks, participants will be randomly assigned to consume either 4 grams/day or 8 grams/day.

Blood samples are collected at baseline and every 2 weeks. The blood will be used for testing of the numbers of T lymphocytes that secrete Interleukin-17 after ex vivo cell cultures.

Eligibility Criteria:
Inclusion Criteria:

* 24 men and women
* Eating a typical diet that does not exceed an estimated average of 9 grams of salt per day;
* Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;
* Willing to comply with study procedures including: Maintaining a consistent diet and lifestyle routine throughout the study, Consistent habit of bland breakfasts on days of clinic visits, Abstaining from exercising and nutritional supplements on the morning of a study visit, Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

* Previous major gastrointestinal surgery Vaccination during past month;
* Vaccination planned during study;
* Cancer during past 12 months;
* Chemotherapy during past 12 months;
* Diagnosed with an autoimmune disorder;
* Diagnosed with obstructive sleep apnea syndrome (OSAS);
* Currently taking medication containing Levodopa (L-dopa);
* Having received a cortisone shot within the past 6 months;
* Taking anti-inflammatory medications on a daily basis;
* Currently experiencing intense stressful events/life changes;
* Currently in intensive athletic training (such as marathon runners);
* An unusual sleep routine
* Changes to nutritional supplements during the past month;
* Currently taking Vitamin D at a dose higher than 1,000 IU/day;
* Currently taking omega-3 at a dose higher than 1 gram/day;
* Unwilling to maintain a constant intake of supplements over the duration of the study;
* Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
* Known food intolerances related to ingredients in active test product.
Medical Termination of II Trimester Pregnancy

The objective of this study is to compare two groups of women requiring termination of pregnancy from the gestational age of 85 days. All women will receive Mifepristone during their first visit to the out-patient ward. One group of women will receive Misoprostol to administer the first dose (vaginally) at home and 2 hours later they will be admitted to the in-patient ward. They will be informed to present earlier if they start bleeding or experience pain corresponding to more than normal menstrual cramping.

The other group will receive the first dose of Misoprostol (vaginally) when admitted in the in-patient ward (usually in the morning) according to current practice.


Eligibility Criteria:
Inclusion Criteria:

* Women aged \>/= 18 years requesting a termination of pregnancy, for social, medical or foetal indications
* gestational age 85 - 153 days (with ultrasonography),
* willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language,
* general good health,
* single intra-uterine pregnancy,

Exclusion Criteria:

* do not wish to participate or unable to communicate in Swedish or English.
* non-viable pregnancy (confirmed by ultrasonography).
* a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication).
* any pre-existing health conditions for whom the execution of a medical abortion as judged by the investigator could compromise their condition (Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders).
* Fetal malformation that may impact time-to-expulsion (such as hydrocephalus, hydrops/edema) or a duplex pregnancy.
Endomicroscopy and Crohn´s Disease

Purpose:

The main objective of this study is to determine endomicroscopic features of Crohn´s disease.

Background:

Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

Scope:

In patients with Crohn´s disease.

Methods:

Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.

Procedure:

The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Impaired renal function (Creatinine \> 1.2 mg/dl)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Known allergy to fluorescein, acriflavin or cresyl violet
* Residing in institutions (e.g. prison)
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* Refractory primary brain tumors with BRAF mutation that have been diagnosed
* Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
* ECOG score 0-1;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
* Severe active infections requiring systemic anti-infective therapy
* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism

The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects.

Bruxism is an oral habit consisting of involuntary non-functional gnashing, clenching, grinding of teeth and is a very common condition in the general population. Various treatment modalities such as occlusal splints, pharmacologic agent and cognitive-behavioral therapy have been investigated for the management of bruxism, but none is reported to be fully effective. Recently locally injected botulinum toxin has been used in various movement disorders, but its usefulness and objective effects on nocturnal bruxism have not been evaluated using objective measures such as polysomnography. Moreover, there is no systematic study about which site is most appropriate for injection to obtain maximal effects.

The aim of this study is to evaluate the effect of botulinum toxin type A into masseter muscle or both masseter muscle and temporal muscle on nocturnal bruxism using polysomnography and the changes in the bruxism events on polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of sleep bruxism confirmed by wear facets on occlusal splint
* must be able to follow clinical trial procedure
* who are suitable for this clinical trial
* who participated in this clinical trial out of his own free will

Exclusion Criteria:

* who take medications such as benzodiazepine or muscle relaxants
* who have secondary bruxism due to brain injury
* who are pregnant or have the possibility of pregnancy
* who had an botulinum toxin injection during the past three months
* who had an allergic reaction history to botulinum toxin
* who have an infection or skin trouble on injection site
* who have an other treatment plan for bruxism
* who are enrolled in other clinical trials
* who are not suitable for this clinical trials
* who have mandibular dyskinesia or mandibular dystonia
Short Term Observational Study in DEB Patients

The purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and qualitative manner.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent is provided. Patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements.
2. Patient must have a documented diagnosis of DEB based on genetic analysis showing a mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of DEB based on histologic criteria (antigen mapping or electron microscopy).
3. Patient must have at least 5 wounds that are suitable for imaging, in the opinion of the investigator, at the time of enrollment.
4. Patient is willing and able to undergo the protocol-specified procedures.

Exclusion Criteria:

1. Patient has used or is currently using experimental treatment for DEB including, but not limited to, bone marrow transplantation, systemic immune suppression, or experimental procedures that involve live cells, with potential for systemic spread such as gene transfer, stem cell infusions, or other cell type injections such that, in the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data.
2. Patient has squamous cell carcinoma with evidence of locally invasive disease or distant metastases.
3. Patient is pregnant.
Efalizumab for Eczema

The purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).

The study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. Biologic plausibility rests on similarities in pathophysiology of the two conditions. The drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. The subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. Efalizumab is not being compared to placebo or other drugs.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement
* Investigator Global Assessment (IGA) score of "moderate" or worse
* In general good health with well-controlled medical problems
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
* If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.
* Normal platelet count

Exclusion Criteria:

* Patients with known hypersensitivity to efalizumab or any of its components
* Pregnancy or lactation
* Patients receiving immunosuppressive agents
* Prior enrollment in the study
* Participation in another simultaneous medical investigation or trial
* IGA score of "mild," "almost clear" or "clear"
* Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week
* Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy.
* Ongoing, active, serious infection
* History of malignancy (except excised basal or squamous cell carcinoma of the skin)
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury

Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by RT- PCR
* Acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate COVID-19 pneumonia

Exclusion Criteria:

* Critical COVID-19 illness (MAP \< 60 mm Hg, on mechanical ventilator for ≥ 5 days)
* On maintenance hemodialysis or peritoneal dialysis
* Child Pugh C cirrhosis
* Hepatorenal syndrome
* Ascites and/or hepatic encephalopathy
* History of end stage renal disease or CKD with eGFR \< 15 mL/min/1.73m2
* Women who are pregnant or breast feeding
* Receipt of other concomitant experimental therapies
Oncologic and Functional Outcome and Quality of Life in Patients Treated for Laryngeal Cancer

The goal of this observational study is to learn about oncologic and functional outcome and investigate quality of life in patients treated for laryngeal cancer.

Adult (\>=18 years of age) patients treated by surgery and/or radiation therapy are enrolled retrospectively.

The main question it aims to answer is:

Is voice after total laryngectomy with voice prosthesis better than voice after open partial horizzontal laryngectomy? Subjective and objective scales and parameters are used.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for laryngeal cancer diagnosed by histopathologic examination

Exclusion Criteria:

* Patients lost at follow up
* Age \< 18 years
Insulin Glulisine in Type 2 Diabetes Mellitus

Primary objective:

To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.

Secondary objectives:

* To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
* The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.


Eligibility Criteria:
Inclusion criteria :

* Type 2 diabetes mellitus
* Body mass index (BMI) between 35 and 40 kg/m2
* HbA1c ≤10%
* Plasma C-peptide levels ≥0.1 nmol/L.
* Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.

Exclusion criteria :

* Type 1 diabetes mellitus, as defined by the World Health Organization
* Subjects currently taking any insulin
* History of hypoglycaemic unawareness
* Injection site skin thickness \< or = 8 mm
* Contra-indications from

  * The medical history and physical examination
  * Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
  * Blood pressure and pulse
Study of MORF 057 to Evaluate Single and Multi Ascending Doses in Healthy Volunteers

Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 to 65 years old with a body mass index between 18 and 32 kg/m2
* Determined to be medically healthy by the Investigator.
* Use of acceptable methods of contraceptives.
* Ability to provide written informed consent and to understand and comply with the requirements of the study.

Exclusion Criteria:

* History of any malignancy, except basal or squamous cell carcinoma of the skin that resolved or in remission prior to Screening.
* Abnormal laboratory values at Screening.
* Any clinically significant major diseases.
* Female who is pregnant or breastfeeding, or planning to become pregnant during the course of the study.
* Unwilling or unable to comply with the requirements of the protocol.
Thrombosomes® in Bleeding Thrombocytopenic Patients

The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients

The primary objective of the present study was to assess the safety of increasing dose levels of Thrombosomes in bleeding patients with thrombocytopenia. The secondary objective was to explore early signals of clinical efficacy of Thrombosomes in this population. The secondary objectives included: 1) Evaluation of the impact on WHO (World Health Organization) bleeding scores at various timepoints; 2) number and type of blood products infused through day 6 follow-up period; and 3) post hoc analysis of hematology, coagulation, and chemistry.

Eligibility Criteria:
Inclusion Criteria:

* Adults up to 74 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤ 70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.
* Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
* No platelet inhibitor drugs within 5 days prior to infusion and through Day 6 follow-up period.

Exclusion Criteria:

* History or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: transient ischemic attack, stroke, myocardial infarction, stent placement, valve replacement and/or repair
* Currently with an active acute infection, or suspected infection, a single oral temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
* Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT (activated partial thromboplastin time) values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
* History of any inherited coagulation or platelet function, disorder or ITP (idiopathic thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS (hemolytic-uremic syndrome)
* Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
* Treatment with an investigational drug within 1 month of infusion, other than for treatment of their underlying disease