cyrilzakka/clinical-trials huggingface dataset:
A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease.

Hypothesis:

The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
* Target Lesion length \<200mm
* Planned follow-up available for at least 24 months
* Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization

Exclusion Criteria:

* Life expectancy \<24 months
* Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy
* Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Prior stenting at the location of intended stenting
* Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
* Enrolment of study investigator, his/her family members, employees and other dependent persons
* If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Effects of Foam Roller Versus KT Tape on Delayed Onset Muscle Soreness

Objective of this study is to compare the effects of foam roller with KT tape on DOMS. The university going students will be divided in two groups, with one group receiving Kinesio Tape as intervention and other Foam Rolling as intervention. Pain and range of motion will be assessed before and after the intervention and the effects of both interventions will be compared.

Delayed Onset Muscle Soreness (DOMS) is a common phenomenon experienced after unaccustomed or intense physical activity, characterized by muscle discomfort, pain, and reduced range of motion. Various interventions have been conducted to alleviate DOMS symptoms, including the use of foam rollers and Kinesiology Tape (KT tape).

This randomized controlled clinical trial aims to compare the effects of foam roller and KT tape interventions on reducing DOMS and improving muscle recovery. The participants would go for a single session of High Intensity Interval Training (HIIT) to induce DOMS. Group-A participants would receive KT taping afterwards, while Group-B participants would receive foam rolling as intervention. Their effect would be measured using Visual Analog Scale (VAS), Tenderness Grading Scale, Knee Range of Motion (ROM) and Vertical Jump Height. This study delves into the applications and potential benefits of KT tape and foam roller in managing DOMS, shedding light on their effectiveness and how they can contribute to enhancing post-exercise recuperation and overall well-being.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with normal BMI (18.5 to 25 Kg/m2)

Exclusion Criteria:

* Individuals with history of metabolic or musculoskeletal disease.
* Individuals with any recent acute injury.
* Athletes exercising regularly and regular gymnasium going individuals.
The Effect of Environmental Pollution on the Prognosis of Gastric Cancer

Gastric cancer is one of the common malignant tumours worldwide, with a high incidence especially in East Asia. Although the occurrence of gastric cancer is closely related to genetic factors, lifestyle and dietary habits, in recent years, environmental pollution, especially air pollution, has received more and more attention as a potential carcinogenic factor. Numerous studies have shown that harmful substances in the air such as including passive smoking, soot and oil smoke exposure, incense burning exposure, occupational exposure and outdoor work, PM2.5, PM10, nitrogen oxides, sulphur dioxide, etc. may not only induce the occurrence of gastric cancer, but also affect the prognosis of gastric cancer patients. This experiment intends to determine the extent of the influence of air pollution on the prognosis of gastric cancer by analysing the survival data of gastric cancer patients in areas with different pollution levels. In addition, the association between air pollution levels and postoperative recurrence in gastric cancer patients was investigated to find possible mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥18 years;
* patients diagnosed with gastric cancer by pathological biopsy before surgery;
* patients without chemotherapy, radiotherapy, targeted and immunotherapy before enrolment;
* willing to participate in this study and sign the informed consent;
* complete clinical data.

Exclusion Criteria:

* patients with other primary malignant tumours other than gastric cancer;
* patients with systemic diseases such as severe cardiopulmonary insufficiency that affect the choice of treatment plan;
* patients who are not suitable for enrolment as assessed by the investigator;
* incomplete clinical data.
Encouraging Calcium Absorption and Bone Formation During Early Puberty

Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life. The purpose of this study is to compare calcium absorption and bone growth in boys and girls on diets including either a nondigestible oligosaccharide (NDO) or simple sugar.

Rapid increases in bone mass occur during calcium absorption and bone calcium deposition during puberty, and these increases can enhance peak bone mass and ultimately decrease the lifetime risk of osteoporosis. However, dietary, hormonal, and genetic factors likely affect increased bone mass. This study will examine if adding NDO to a pubertal diet allows more absorption of calcium by the body, producing stronger bones. The study will also assess how the hormones produced by the body during puberty affect bone growth and whether genetic factors affect calcium absorption or bone growth.

This study will last 2 years. At study entry, baseline pubertal hormone levels and bone mass will be assessed. Both a dual-energy X-ray absorptiometry (DEXA) scan and a calcium stable kinetic study measuring calcium absorption will be performed. Participants will then be randomly assigned to receive calcium fortified food with or without added NDO for 1 year. Calcium absorption will be measured again at 2 months. After the first year, calcium kinetic, hormonal, and DEXA studies will be performed and compared to baseline results. A final DEXA scan will be performed at the end of 2 years.

Eligibility Criteria:
* Tanner Stage 2 or 3
* Girls must not have started menstruating
* In the 10th to 90th percentile in body mass index (BMI) for their age
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>18 years of age
* American Society of Anesthesiologists (ASA) physical status 1-3
* Undergoing either lower abdominal surgery defined as Laparoscopic Hysterectomy (female), Laparoscopic Myomectomy (female), Laparoscopic Colectomy (male/female)
* Physically and mentally able to give full informed consent to participate in this study and complete all study assessments within the timeframes required (including electronic diaries should patient be discharged prior to day 4)
* Capable of returning the diary after POD 4 by mail (preferably) or upon follow up visit.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL.
* Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study.
* Any chronic condition requiring use of opioids for treatment of a medical condition for 2 weeks or more prior to surgery.
* Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
* Patients that would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
* Any patient with diagnosed or potential metastatic disease.
* Any condition that in the investigator's opinion might be harmed or be a poor candidate for participation in the study (such as patients requiring long acting opioids as part of the induction medications).
* Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
* History of suspected or known addiction to, or abuse of, illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.

Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean section for any reasons

Exclusion Criteria:

* Involuntary
Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema

The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.


Eligibility Criteria:
Inclusion Criteria:

\>18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:

Women of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction

The main purpose of this study is to determine the tolerability and safety of LY3461767 with any side effects that might be associated with it. Study drug will be provided in a continuous subcutaneous infusion lasting 24 hours to 96 hours, depending on the cohort. Blood tests will be performed to check concentrations of LY3461767 in the bloodstream and how long it takes the body to get rid of it in participants with chronic heart failure with reduced ejection fraction (HFrEF). The study will last up to 3 months and may include 5 visits.


Eligibility Criteria:
Inclusion Criteria:

* Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential
* Have a body mass index (BMI) of \</= 45.0 kilograms per square meter (kg/m²)
* Have chronic stable heart failure (New York Heart Association (NYHA) classification II and III) on guideline directed heart failure therapy for at least 6 months prior to enrolment
* Have not changed optimal guideline directed therapy in the last 1 month prior to screening, If treated with oral diuretics, dose must be stable for at least 2 weeks prior to screening
* Have Left Ventricular Ejection Fraction (LVEF) \< 40%
* Have a record of N-terminal pro b-type natriuretic peptide (NT-ProBNP) ≥ 200 picograms per millilitre (pg/mL) or a BNP value of \>/= 60 pg/mL within the past 12 months prior to screening

Exclusion Criteria:

* Have myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke in the last 90 days prior to screening
* Have acute decompensated heart failure requiring IV diuretics within 12 weeks prior to screening
* Have cardiac amyloidosis, accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.
* Have any moderate-to-severe stenosis of the mitral and/or aortic valve or moderate-to severe or greater mitral and/or aortic regurgitation.
* Have a history or presence of hepatic, pancreatic, or biliary tract disorders
* Have a history of malignancy or active malignancy at screening.
* Have not had age-appropriate cancer screening as recommended by the American Cancer Society and per medical judgment
18F-Fluorocholine for the Detection of Parathyroid Adenomas

The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Biochemically proven hyperparathyroidism and an indication for surgery
* Age \>= 13 years old
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
* Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Pregnancy.
European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection

The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.

The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized.

Eligibility Criteria:
Inclusion Criteria:

* subject is older than 18 years of Age
* written informed consent has been obtained
* subject Needs a Revision surgery of the hip, knee or shoulder prosthesis

Exclusion Criteria:

* subject is currently enrolled in another investigational study
* inability to read and understand the participant's Information
* subject is younger than 18 years of age
Achieving Control of Asthma in Children In Africa

The main aim of the study is to identify altogether 3000 children aged between 12 and 16 years old with asthma symptoms in six sub-Saharan African countries. The study furthermore aims to assess their asthma control, current treatment, knowledge of and attitudes to asthma, as well as the barriers to achieving good asthma control.

Asthma prevalence in young people has been rising in several African countries during the last decade, reaching between 10% and 20% in Central Africa, and up to 20% in South Africa. In addition, asthma related mortality in many African countries is high. South Africa has the third highest asthma related mortality rate in the world. Yet to date, a lack of asthma research and research infrastructure means that we do not have the evidence to either inform advocacy or to develop interventions that improve asthma outcomes.

This study aims to collect data about asthma prevalence and to identify existing barriers to effective asthma management of young people in 6 sub-Saharan countries: Malawi, South Africa, Zimbabwe, Uganda, Ghana, and Nigeria. Each of these countries identifies 500 young people with asthma between 12 and 16 years of age through a screening questionnaire in schools. These 3000 young people with asthma symptoms fill in a survey about asthma, including questions around asthma control, current treatment and access to care, asthma knowledge, asthma attitudes, smoking and environmental influences. Some of the participants also discuss asthma related topics in focus groups. A subset of the participants furthermore do Spirometry and FeNO testing. In addition to the data collection, the study develops and tests options for an intervention aimed at improving asthma control, including the adaption of a United Kingdom - based theater play about asthma awareness. The development of WiFi infrastructure and IT solutions is promoted by the study, where appropriate.

Eligibility Criteria:
Inclusion Criteria:

* aged between a minimum of 12 years, and
* a maximum of 14 years

Exclusion Criteria:

* Age less than 12 years
* age more than 14 years
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis

This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI);
3. Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation;
4. Patients or their guardians who can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can accept follow-up;

Exclusion Criteria:

1. Patients with clinical symptoms consistent with ST-segment elevation myocardial infarction or/and ECG changes within 12 hours prior to the procedure;
2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
3. Patients with in-stent restenosis;
4. Patients with unprotected left main coronary artery disease;
5. Patients who plan to treat 3 or more lesions at the same time;
6. Patients with severe calcified lesions;
7. Patients in whom the guidewire cannot pass through the lesion;
8. Women who are pregnant or lactating;
9. Patients who are participating in the clinical trial of other drugs or medical devices;
10. Other patients considered by the investigator to be unsuitable for this trial.