cyrilzakka/clinical-trials huggingface dataset:
Computed Tomography Coronary Angiography Before Stent Implantation

The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.

Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups:

Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease
* Planned stent implantation into single lesion in native coronary artery
* Planned stent diameter: 2.5-4.0 mm

Exclusion Criteria:

* Women younger than 50 years
* Lesion location in left main coronary artery
* Atrial fibrilation or other significant arrythmia
* Severe chronic obturatory pulmonary disease
* Hyperthyroidism
* Known allergy to contrast media
* Glomerular filtration rate \< 30
* Treatment of bifurcation lesion
* Stent implantation for in-stent restenosis
Osteoporosis Research Registry

The aim of this research registry is to collect information on individuals with osteoporosis, those with risk factors for osteoporosis, and comparative healthy controls. Bone mineral density measurements will be done on these individuals to determine bone health.

The goal of this project is to develop a registry of research subjects with OP, with a risk of developing OP, and healthy controls. DXA scans will be performed on willing individuals at the spine, hips, and forearms and possibly the legs and heels in order to determine BMD. Subjects will also be asked to provide two (10 ml) blood samples, which may be used to analyze Vitamin D levels and/or other bone markers. By participating in the registry, subjects will be considered for current and future clinical research studies.

Eligibility Criteria:
Inclusion Criteria:

* Any subjects who give written informed consent

Exclusion Criteria:

* Any individual who is not willing or able to give written informed consent
A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* Total knee arthroplasty
* Age \> 18
* Tolerance for study drugs
* Written informed consent

Exclusion Criteria:

-
Presurgical Evaluation of Skin Cancers Using HIFU

1. To ensure complete elimination of lesions with maximum preservation of function and aesthetics.
2. To elaborate the Ultrasonographic features of skin cancers.
3. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..
4. To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.

The skin is the most superficial and largest body organ, due to its function as a surface covering for the body, enables the performance of noninvasive diagnostic and investigative procedures.

Of all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).

Techniques such as high frequency ultrasound (HFUS) enable the real-time study of cutaneous lesions, making them excellent pre-operative tools varying considerably in their penetration, resolution, and applicability.

High frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a painless non-radioactive imaging diagnostic method based on the reflection of sound waves through body tissues.

High frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic perilesional area.

High frequency ultrasound examination of each lesion should consist of:

1. A morphologic study analyzing the structural sonographic pattern and margins;
2. the measurement of the largest transverse diameter and thickness;
3. Color Doppler USG for perilesional vessels ; and
4. in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 30 \& 80 years.
* Lesions clinically apparent locally malignant, or malignant.
* Lesions with or without visible ulcerations.

Exclusion Criteria:

* Surgeon unable to visualize tumor on clinical examination.
* Patients unfit for surgery.
Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief

This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.

Eligibility Criteria:
Inclusion Criteria:

* Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
* Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is \>= 5 as measured on a 0-10 NRS rating.
* Participant with a peri-malleolar edema (sub-malleolar perimeter difference of \>=20mm between injured and uninjured ankle)

Exclusion Criteria:

* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain.
* Pregnancy , Breast Feeding and Substance Abuse
Cardiovascular Risk Profile Among Mexican-Americans

To characterize the epidemiology and genetics of apolipoproteins A-I, A-II, B, C-II, C-III, and E in a population of Mexican-Americans in Starr County, Texas.

BACKGROUND:

Evidence has established that the distribution and burden of several common chronic diseases among Mexican-Americans differ from that in the general population. These diseases include diabetes (almost exclusively noninsulin dependent diabetes), hypertension, and gallbladder disorders. While progress was made towards an elucidation of their epidemiology within this population, there was a paucity of data regarding other cardiovascular risk factors, most notably, the distribution of lipoproteins and their constituent apoproteins. With regard to the apolipoproteins, there were only minimal data from any population dealing with their distribution and relationships in the general population or pedigrees. This project provided as complete a profile on the distribution of metabolic cardiovascular risk factors as could be claimed for any other study of comparable size and provided baseline values for apo A-I, A-II, B, C-II, C-III and E.

DESIGN NARRATIVE:

One thousand randomly selected individuals were given a complete physical examination. From those 1,000, 100 probands with gallbladder disease were selected. Approximately 1,200 first degree relatives of the probands were invited to participate in the study and given a physical examination. Additionally, 100 control individuals, their spouses and first degree relatives were followed longitudinally for five years. Blood samples were obtained for determination of total cholesterol, LDL cholesterol, HDL2 and HDL3 cholesterol, and genetic markers. Data were collected on age, sex, body mass and fat distribution, diet, smoking, and alcohol consumption. Annual follow-up assessed the dynamics of changes in apolipoprotein levels and profiles and those factors which contributed to their change. The random and longitudinal data were combined with pedigree data to determine the effects of major genes, polygenes, and the environment on the variability of each apolipoprotein and on the relationship between these and other risk factors. An assessment was made in 100 individuals of the contribution of genetic variability at the DNA level in determining apolipoprotein levels.

Eligibility Criteria:
Participation in prior survey of Starr County, Texas where 1,004 representative individuals of the population aged 15 and older were selected. The community was first mapped and random blocks selected. All individuals in households on selected blocks were enumerated and then 1 age eligible individual from each household was selected for a complete physical evaluation. From these, 250 individuals were identified as probands and their, primarily, first degree relatives were selected for the same examination. 1,254 individuals were seen in this phase.

These individuals became eligible for the more complete profiling of apolipoproteins funded by the referenced grant.
A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma

This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* For patients with metastatic basal cell carcinoma (BCC), histological confirmation of distant BCC metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is Response Evaluation Criteria in Solid Tumors (RECIST) measurable using computed tomography (CT) or magnetic resonance imaging (MRI).
* For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable.
* For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
* For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (GDC-0449).
* For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib.

Exclusion Criteria:

* Prior treatment with vismodegib or other Hedgehog pathway inhibitors.
* Pregnancy or lactation.
* Life expectancy of \< 12 weeks.
* Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement.
* Concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
* Recent, current, or planned participation in an experimental drug study.
* History of other malignancies within 3 years of the first day of treatment with vismodegib in this study (Day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
* Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
Block Duration After Spinal Block and iv Dexamethasone.

It has been largely demonstrated that iv dexamethasone prolongs the duration of analgesia after peripheral nerve block. However, data are missing regarding the duration of analgesia after spinal block. The objective of this randomized controlled double-blinded trial is to assess whether intravenous dexamethasone administered after a spinal block, before the surgery would prolong sensory block characteristics without impacting the motor block duration.


Eligibility Criteria:
Inclusion Criteria:

* Patient with ASA I-III status ;
* Patient scheduled for an osteosynthesis surgy of the lower limb

Exclusion Criteria:

* Polytrauma patient
* Pregnancy
* Contraindication to spinal anesthesia
* Contraindication to dexamethasone administration
* Patient with chronic pain
Water Intake and Glycemic Response : Preliminary Study

Glycemic index concept is widely used to determine impact of a food to blood glucose. Several studies showed that water content and intake after meal may influence glycemic response of the meal and thus have an effect on the result of GI measurement. Currently these studies found conflicting results. Therefore, this study aims to determine whether water intake, specifically after meal, may influence the glycemic response and glycemic index value of the meal.

Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-40 years
* fasting blood glucose 70-99 mg/dL
* Indonesians

Exclusion Criteria:

* having diabetes
* smoking
* if women, pregnant or lactating
* being allergic to food used in this study
* having gastrointestinal disturbance
* in regular medication
* refusal to sign the consent form
Medical Education Intervention for Medical Students

The doctor-patient relationship was becoming worse. More and more work-related violence has happened to physicians and nurses. A portion of medical students felt depressed and thought that the career future was gloomy. The study was designed to measure the empathy, an vital element of professionalism, well-being of mental and study emotion. Furthermore, the investigators explored an intervention of group study to promote medical students' professionalism, mental health and study emotion.

A total number of 200 junior medical students are going to be enrolled according to inclusive criteria. They are divided into two groups, one group is given education about medical humanities when the other group is not given any intervention but the same room and time.The outcomes including empathy, depression, quality of life, burnout and self-efficiency are measured before, during and after the trial.

Eligibility Criteria:
Inclusion Criteria:

* 1 age 18 to 25 years
* 2 junior students majoring in clinical medicine
* 3 no mental diseases previously

Exclusion Criteria:

* Did not meet inclusion criteria
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.

Eligibility Criteria:
PARTICIPANT INCLUSION CRITERIA

* Stage II-III multiple myeloma or have progression after initial treatment of Stage I disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included.
* Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at Stanford University Medical Center.
* 18 to ≤ 75 years of age
* Karnofsky Performance Status \> 70%.
* Corrected Carbon monoxide diffusing capacity (Dlco) \> 60%
* Left ventricle ejection fraction (LVEF) \> 50%.
* Alanine aminotransferase (ALT) ≤ 2 x normal
* Aspartate aminotransferase (AST) ≤ 2 x normal
* Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease.
* Estimated creatinine clearance \> 50 mL/min.
* Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor with one antigen/allele mismatch in (HLA-A, B, C or DRB1).
* Signed informed consent.

DONOR INCLUSION CRITERIA

* At least 17 years of age
* HIV-seronegative
* Must be capable of giving signed, informed consent
* No contraindication to the administration of filgrastim
* Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate

PARTICIPANT EXCLUSION CRITERIA

* Prior allogeneic hematopoietic cell transplantation
* Uncontrolled active infection
* Uncontrolled congestive heart failure or angina
* HIV-positive
* Pregnant or nursing

DONOR EXCLUSION CRITERIA

* Serious medical or psychological illness
* Pregnant or lactating
* Prior malignancies within the last 5 years except for non-melanoma skin cancers
A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)

This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m\^2 and body weight 50 to 100 kg, inclusive
* Nonpregnant and nonlactating females
* Agreement to utilize effective contraception among men and women of childbearing potential

Exclusion Criteria:

* Known allergy or hypersensitivity to study drug or components
* History of alcohol or drug abuse within 12 months prior to study drug, or positive test for alcohol or drugs of abuse
* Receipt of an investigational agent within 30 days of 5 half-lives prior to Day -1
* Biological therapy within 90 days prior to Day -1
* Parasitic or Listeria monocytogenes infection within 6 months prior to Screening
* Receipt of blood products within 2 months prior to study entry
* Donation or loss of blood/plasma within up to 6 months prior to study drug, depending upon volume
* Receipt of live attenuated vaccine within 1 month prior to study drug
* Use of tobacco- or nicotine-containing products within 14 days prior to Screening
* Use of any prescription or nonprescription medication within 14 days prior to study drug
Esophageal capsaïcin Infusion and Mucosal Integrity

Reflux is common, especially after large meals. In general, this can do no harm. However, if reflux occurs often and causes troublesome symptoms and or complications, it is called gastroesophageal reflux disease (GERD). Long exposure to gastric acid causes the mucosa of the esophagus to loose its integrity, which is thought to lead to the symptom of heartburn. Several food products can also impair the esophageal mucosa integrity and thereby influence reflux symptoms. One of these products is capsaicin, the pungent ingredient of red peppers. Use of capsaicin often leads to worsening of complaints in patients with GERD and can cause symptoms in healthy volunteers, possibly due to its effect on the mucosal integrity.

In this study the investigators want to investigate the effect of capsaicin infusion on mucosal integrity. The investigators will evaluate mucosal impedance and the histology of the esophageal mucosa. In addition, the investigators also aim to assess the involvement of the TRPV1 receptor by evaluating the possible release of neuropeptides in the esophageal mucosa.


Eligibility Criteria:
Inclusion Criteria:

* No history of gastrointestinal disease, especially gastro-esophageal reflux disease.
* BMI = 18-25 kg/m²
* Caucasian race
* Subject signed the informed consent form and is able to adhere to study protocol

Exclusion Criteria:

* Age \<18 years
* Erosive esophagitis or gastric ulceration during endoscopy on PPI in the past or during the experiment
* Use of regular (\> 1 x per week) dietary capsaïcin (in additives as Tabasco/sambal/chili sauce or Indian, Mexican or Thai food dishes)
* Allergy to capsaïcin
* Use of medication affecting GI function (prokinetics) or antisecretory medication (PPI) within 3 days prior to endoscopy.
* Multisystem diseases (including severe cardiopulmonary disease, collagen diseases, coagulation disorders)
* Esophageal motility disorders
* Previous esophageal or gastric surgery
* Use of anticoagulants or a history of coagulopathy
* Pregnancy
* History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)