cyrilzakka/clinical-trials huggingface dataset:
Clinical Of Drug-eluting Stent Versus Excimer Laser Ablation Combined Drug-coated Balloon To Treat Arteriosclerosis Occlusive Disease Of Lower Extremity

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.

Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.

Eligibility Criteria:
Inclusion criteria： 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up.

Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions （grade 4 in the PACSS scale）; 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/μL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.
Short Term Outcome of Pediatric Fracture of Neck Femur Fixation by Plate and Screws

the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm K wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.

the incidence of femoral neck fracture in children ranges between 0.3 and 0.5 of all childhood fractures per year. the incidence is maximum at the ranges of 11 and 12 years with a male preponderance ranging from 1.3 to 1.7:1. in contrast to osteoprotic proximal femur fractures in the eldery. although rarely seen in children fracture neck of femur has aconsiderable risk of complications such as avascular necrosisos femoral head, coxa vara, non union, delayed union, premature physeal arrest and infection. in infants and toddlrs below age of 2 years, closed reduction and fixation with smooth 1.8 or 2 mm K wires may be carried out, in children there are many methods of fixation, cannulated 4,4.5 screws, plates,dynamic hip screw.

Eligibility Criteria:
Inclusion Criteria:

* children between 2 and 16 years having fracture of neck femur

Exclusion Criteria:

* patients more than 16 years, cases with open fractures, preexisting deformity, other pelvic or ipsilateral femoral injuries
Qualitative Study for Pain Measurement Using Innovative Health Technology

The present study is a multicenter, explorative, qualitative study. The primary endpoint of this study is to evaluate to which extent the collection of data with regard to pain caused by illness or treatment can be optimized using health technology solutions. For this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted.

Secondary variables are the evaluation of the patients' pain experience and the general patients' willingness to collect data with regard to pain by using technological devices themselves or with support of healthcare professionals.

The present multicenter study is an explorative, qualitative study. It shall be evaluated from the patients' point of view if and how the collection of data with regard to pain, caused by illness or treatment, can be optimized using health technology solutions. A health technology solution could for example be an app for registering the intensity and localization of pain. The aim of this study is to examine, if such a solution would be accepted by patients with acute or chronic pain and how a fitting solution should be designed to meet the patients' requirements. Existing methods for pain measurement as well as possibilities for the development of new methods will be examined and evaluated during the interviews.

To arguable this issue the interviews comprise different topics like:

* the patients pain experience in everyday life, e.g. how the patients cope with pain in everyday life and how and if this is documented;
* experiences with and the thought of regular pain recording;
* an evaluation if patients tend to be willing to record their pain using technological devices by themselves or rather with support of healthcare professionals.

It is the aim to use the results of this study for the development of a new and improved version of pain registration. The results of the study will be summarized in a report and handed over to a startup company. Thereupon the startup company has the possibility to develop a technological solution that represents the patients' need at its best.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Pain intensity \> 4 (numeric ranking scale 0-10)
* Legal capacity
* Written informed consent

Exclusion Criteria:

* Lack of willingness to cooperate
* Lack of consent
* Lack of ability to follow instructions
* younger than 18 years
Developing a Nutritional Supplement to Increase Collagen Synthesis in People

The purpose of this study is to test whether a natural product supplement can potentiate the increase in collagen synthesis following the ingestion of collagen protein. The investigators have developed a model of natural (GRAS certified) products that stimulate collagen synthesis, in vitro. The investigators will determine whether the natural product supplement can potentiate the collagen synthetic response to the ingestion of collagen protein. Basal and fed serum will be isolated and these samples will be used to treat human engineered ligaments.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults (18-30 y)

Exclusion Criteria:

* Pregnancy
* Smoking
* Receiving any medication that may interfere with the study outcomes
Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis

Brief Summary Template for the Study:

The goal of this observational study is to examine the relationship between digestive symptom scores, serum pepsinogen indices, and histopathological OLGA and OLGIM systematic staging of the gastric mucosa in patients with chronic atrophic gastritis(CAG), aiming to determine the degree of correlation between clinical manifestations, non-invasive laboratory tests, and the gold standard of diagnostic histopathology.To evaluate the comprehensive therapy, readiness and acceptance of acupuncture, utilization rates of various acupuncture therapies, self-assessed efficacy of acupuncture, and endoscopic histopathological alterations in patients with CAG.According to the aforementioned study, it is anticipated to enhance the optimization of acupuncture clinical research protocols for chronic atrophic gastritis, improve treatment efficacy, and offer more effective and rational therapy alternatives for patients.The main question it aims to answer is:

To determine if the outcomes of combined serologic testing of symptoms in patients with CAG can serve as a method for monitoring disease development and if long-term follow-up can be supported？

A group of participants with recorded GI symptom scores and blood pepsinogen levels will respond to online survey questions regarding the severity of their chronic atrophic gastritis progression over the course of 1 year.

This study is a multicenter cross-sectional pilot survey

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the diagnostic criteria for chronic atrophic gastritis;
* Individuals aged 18 to 75 years, irrespective of gender;
* Capable of comprehending and consenting to participate in this study by signing the informed consent form.

Exclusion Criteria:

* Autoimmune gastritis (type A chronic atrophic gastritis);
* Patients diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy or other examinations or patients diagnosed with high-grade intraepithelial neoplasia by upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
* Patients with confirmed or unable to exclude malignant tumors, especially esophageal and gastric cancers; patients with other upper gastrointestinal tract pathologies such as peptic ulcer or Barrett's esophagus;
* Those who cannot complete the questionnaire due to unconsciousness, inability to communicate normally or other reasons; those with incomplete information.
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 18 years of age or older
* Diagnosis of RRMS
* Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously

Exclusion Criteria:

* Unable to perform subcutaneous self-injection
* Pregnant, or trying to become pregnant, or breast feeding during the study
Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).

Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999). Aim of our clinical study is to examine, whether proton pump inhibitors have an influence on myocardial contraction of human myocard and we want to ascertain the amount of influence of a H+/K+ ATPase on myocardial contraction. Therefore the mechanism of a putative inhibition by proton pump inhibitors is at our focus. These findings will be of major credit regarding treatment of patients with congestive heart failure with common proton pump inhibitors. We want to find out, whether this intake may have a negative inotropic effect on the heart failure myocard.

Eligibility Criteria:
Inclusion Criteria:

1. Only patients older than 18 years. Range 18 to 80 years
2. Only cooperative patients
3. Only patients with a need for a coronary angiography, independently from our study
4. Only patients with a left ventricular ejection fraction as demanded in the study protocol
5. Only patients with clinical symptoms of congestive heart failure, corresponding to New York Heart Association stage NYHA II or III
6. Only patients without oral or i.v. application of a proton pump inhibitor up to 48 hours prior to the study catheterization

Exclusion Criteria:

1. Manifest or severe accompanying diseases, despite of diabetes mellitus
2. Intravascular or oral application of proton pump inhibitors within the last 48 hours
3. Intake of Metformin within the last 24 hours
4. Status post heart transplant
5. Pregnancy
6. Known intolerance of pantoprazole
7. severe side effects of the tested substance pantoprazole, as well as pharmacokinetic interactions through CYP isoenzymes
8. Existance of side effects as given in the pantoprazole drug information, among others disturbances of blood- and lymphatic system, leukopenia, thrombopenia, affections of gastrointestinal tract, nerve system affections, psychiatric affections, renal or bladder affections
9. Participation in a other clinical trial
Biliary Atresia, Hepatic Buffer Response and Sevoflurane

To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Children suffering from hepatobiliary disease also have an hepatic arterial buffer response (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening.

To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Eligibility Criteria:
Inclusion Criteria:

* persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;
* increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (\>60%);
* elevated liver enzymes;
* ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;
* with radionuclide imaging confirmation of obstructed biliary excretion

Exclusion Criteria:

* concomitant cardiovascular or abdominal organ malformations
Urdu Version of Foot and Ankle Disability Index: A Reliability and Validity Study

The purpose of this research is to translate Foot and Ankle Disability Index in Urdu and determine the validity and reliability in patients with plantar fasciitis and correlate IT with Quality of Life Short Form-36 and the Visual Analog Scale.

As per recommendation of the English Version of Foot and Ankle Disability Index will be translated and culturally adapted. Foot and Ankle Disability Index along with its correlation scales will be distributed in the seventy plantar fasciitis population that will be selected according to inclusion exclusion criteria and through convenience sampling technique. To check the inter and intra observer reliability of Foot and Ankle Disability Index, Short Form-36 to measure the quality of life and Visual Analog Scale to measure pain will be filled by participants.

Eligibility Criteria:
Inclusion Criteria:

* Inability to achieve 20 degrees of active dorsiflexion
* Heel pain
* Mid foot pain
* Heal swelling
* Mid foot swelling
* Achilles' tendon tightness diagnosed on the base of Windlass test

Exclusion Criteria:

* Recent foot injury
* Fracture
* Infections
* Surgical procedures
* Tendon injury
* Hypermobility
* Neuromuscular disorders
* Impaired sensation
* Open sores
* Skin disease
* Active deep vein thrombosis or thrombophlebitis
* Bruises
* Varicose veins
* Burn Scars
Feasibility and Safety of IV Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy

The purpose of this study is to evaluate the safety and feasibility of the IV loading strategy in patients who are selected to receive sotalol.

This is an open-label single arm study investigating the safety and feasibility of an intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed Consent will be obtained from all patients prior to enrollment in the study. Patients will be admitted to the hospital in accordance with standard hospital protocol for oral sotalol loading.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between 18 - 85 years old
* Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol therapy
* History of highly symptomatic atrial fibrillation who are scheduled for sotalol therapy
* Creatinine clearance ≥60 mL/min
* Subject has provided informed consent prior to initiation of any study-specific activities/procedures

Exclusion Criteria:

* Baseline bradycardia (\<50 bpm) off all antiarrhythmic drugs and or Atrioventricular nodal blocking drugs
* Sick sinus syndrome, unless a functioning pacemaker is present.
* Any known sensitivities to beta-blockers
* Uncontrolled heart failure
* Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block
* Recent (within 7 days) surgical or catheter ablation procedure
* Severe electrolyte abnormalities (including serum K\<3.5)
* Known use of other QTc prolonging drugs (See Appendix A)
* Recent (within 7 days) sotalol use
* Baseline QTc \>450 ms
* Severe reactive airway disease - defined as difficulty breathing from bronchial tubes, swelling and overreaction to an irritant
* History of Torsade de Pointes (TdP)
* Pregnancy or breastfeeding
* Left ventricular ejection fraction (LVEF) less than 35%
Family Lifestyle Actions and Risk Education Study

The overall purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a family-focused behavioral intervention ("FLARE", which stands for Family Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive behaviors among children at elevated risk for the disease.

Test the feasibility and acceptability of FLARE, a family-focused behavioral intervention that is designed to improve and maintain adherence to photoprotection (e.g., use of sunscreen) and screening (e.g., implementation of self skin exams). We expect that the feasibility of the intervention will be supported by at least 75% of participants attending at least 3 intervention sessions. We also expect that the acceptability of the intervention (e.g., overall satisfaction, ease of participation, perceived utility of intervention) will be supported by mean ratings that indicate adequate levels of acceptability across participants (e.g., mean rating of "satisfied" or "very satisfied" for overall satisfaction).

Pilot test the efficacy of the FLARE intervention with children at elevated risk for melanoma and their primary caregiver.

We will also explore the potential impact of the FLARE intervention on melanoma preventive behaviors among siblings of the child who receives the intervention, as well as the child's other parent/caregiver (if another parent/caregiver is available).

Eligibility Criteria:
Inclusion Criteria:

Children

* Are 8-17 years old AND
* Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma AND/OR
* Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing

Adults

* Are at least 18 years old AND
* Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child) AND
* Have at least one child under age 18 who is living in the same household AND
* Have a personal history of melanoma and/or family history of melanoma) AND/OR
* Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing

Exclusion Criteria:

* Individuals who do not speak, read/write English will be excluded because FLARE involves regular interaction between study staff and research participants in English and completion of study questionnaires and interviews in English
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Rotator Injury:

* Strength/range of Motion
* ASES, VAS

The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 years old
* Diagnosed with rotator cuff injury that will not be treated surgically

Exclusion Criteria:

* Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months
* Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements
* Have poorly controlled type I or type II diabetes (HgB A1C \> 9.5%) or renal insufficiency (GFR \< 60 ml/min).
* Have an inability to participate in rehabilitation exercises.
* Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease
* Have musculoskeletal pathology in a neighboring joint or structure
* Have an allergy to any component of the nutritional supplement
* Are consuming warfarin
Single and Multiple Ascending Dose Study of KN-002

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 - 55 years old
* Willing and able to give informed consent and comply with the study
* Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
* Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
* Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
* Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3
* Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4

Exclusion Criteria:

* Clinically significant laboratory test abnormalities
* Clinically significant abnormal blood pressure and/or pulse rate
* Resting ECG clinically significant abnormalities
* Respiratory tract infection within 6 weeks of screening
* Positive test for active COVID-19 within 2 days prior to administration of IMP