cyrilzakka/clinical-trials huggingface dataset:
Effects of Speed Endurance Training on Agility and Functional Performance in Soccer Players

Ethical approval is taken from ethical committee of Riphah International university Randomized Control Trial (RCT) will be conducted at Pakistan Cricket Board (PCB) Lahore, through convenience sampling technique on 44 athletes of soccer which will be allocated using random sampling through computerized generated number into Group A and Group B, 6 athletes will be in each group. Group A (interventional) will be given conventional training along with Speed Endurance Production (SEP) Training. Group B (Control) will be will be given conventional training

A Randomized Control Trial (RCT) will be conducted at Pakistan Cricket Board (PCB) Lahore, through convenience sampling technique on 44 athletes of soccer which will be allocated using random sampling through computerized generated number into Group A and Group B, 6 athletes will be in each group. Group A (interventional) will be given conventional training along with Speed Endurance Production (SEP) Training. Group B (Control) will be will be given conventional training There will be 3 sessions in a week for 8th week. Outcome measures will be agility T-Test to measure agility, speed endurance will be measured by 40 meters sprint test and functional performance will be measured by Yo-Yo Intermittent Recovery Test Level 2. The baseline scoring will be on 1st day, follow up will be taken at 4th week and 8th week. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* • Male Soccer Players will be included

  * Age from 15 to 30 years will be included
  * Soccer athletes that playing from past 6 month to one year will be included

Exclusion Criteria:

* Age above 30 years will be excluded

  * Soccer player with injuries (eg: Ankle sprain, meniscal injury, Hamstring strain) will be excluded
  * Any long-term injury (eg: fracture of lower extremity bones) will be excluded
Perioperative Endothelial Dysfunction

More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die within 30 days post-operatively, and of these patients 45% will die from vascular causes such as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex and to date not fully elucidated. The physiological stress response associated with the surgical procedure is believed to be central in the development of perioperative cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and increases the production of catecholamines and cortisol. These drastic systemic changes lead to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.

The endothelium is a regulator of vascular homeostasis, vascular tone and structure and exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is characterized by a decreased vascular bioavailability of nitric oxide probably due to an increased degradation of nitric oxide via its interaction with locally produced reactive oxygen species. No clinical studies have investigated whether peri- and postoperative endothelial dysfunction is associated with an increased risk of perioperative myocardial injury. Endothelial dysfunction may be a key element in the development of perioperative myocardial injury.

The aim of this observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period.


Eligibility Criteria:
Inclusion Criteria:

• Patients scheduled for elective colon cancer surgery

Exclusion Criteria:

* Not capable of giving informed consent after oral and written information
* Previously included in the trial
* Surgery within 7 days of the trial
Utility of Defining ARDS and Past and Current Definitions of ARDS

Acute Respiratory Distress Syndrome (ARDS), marked by acute hypoxemia and bilateral pulmonary infiltrates, has undergone multiple definitions over the years. Challenges persist regarding the ARDS definitions, leading to various revisions. Through the Delphi study, the investigators aims to gather global opinions on the conceptual framework of ARDS, assess the utility of current and past definitions, and explore the role of subphenotyping. The diverse panel's collective expertise will contribute valuable insights for refining future ARDS definitions and enhancing clinical management.

Acute respiratory distress syndrome (ARDS), characterized by acute hypoxemia and bilateral pulmonary infiltrates that are not attributable to heart failure, has seen multiple definitions over the years. The primary purpose of a formal ARDS definition is to identify a homogenous cohort among patients with acute hypoxemic respiratory failure (AHRF), facilitating research, therapeutic trials, and prognostic assessment.

The validity of the conceptual framework of ARDS, however, has been challenged and uncertainties exist regarding the utility of ARDS definitions. Amongst other reasons, the lack of consensus on the conceptual model and diagnostic criteria have led to numerous revisions of the definition of ARDS. Furthermore, categorizing ARDS to assess treatment effects has had limited success, and subphenotypes have been proposed in part to address this issue.

The Delphi methodology has been used to generate expert consensus on components of the ARDS definition. Consensus process through a Delphi minimizes individual or professional dominance and peer pressure bias through a careful selection of experts, anonymous voting and monitoring attrition rates during Delphi rounds. A rigorous Delphi would be useful to assess the utility of the conceptual model of ARDS, past and current definitions of ARDS, and the value of categorisation of ARDS by means of subphenotyping.

Through this Delphi study, the investigators intend to assess the challenges in the conceptual framework of ARDS, past and current ARDS definitions, ongoing efforts in ARDS categorization and will develop consensus statements for future research in the definition and subphenotyping of ARDS.

Eligibility Criteria:
Inclusion Criteria:

* At least 5 years of clinical experience as a staff member, with care for AHRF or ARDS patients or preclinical expertise (of more than 5 years) in AHRF or ARDS;
* At least 5 publications (original studies) as a leading or senior author or member of the steering committee of an observational study or a randomised controlled trial in AHRF or ARDS;

Exclusion Criteria:

* Not more than 25% of panellists from the previous or current definitions of ARDS (including the Berlin Definition of ARDS, the Kigali Modification of the Definition of ARDS, and the New Global Definition of ARDS)
* Not more than 70% of the panellists from each sex; and from each of high and low-middle-income countries
Neoadjuvant Goserelin for Triple Negative Breast Cancer

This is a phase II randomized trial that will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast cancer. Targeting LHRH might decrease resistance to chemotherapeutic agents in the neoadjuvant setting and increases clinical and pathological response rates. Additionally, exploring potential surrogate markers (as AR and LHRH receptors) for molecular distinct subtypes of TNBC.

Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of locally advanced TNBC and some selected early cases followed by surgery with or without adjuvant radiotherapy. NACT is aimed to induce pathologic complete response (pCR) in tumor and lymph nodes, pCR is proofed to be a surrogate and reliable predictive factor of survival rates in TNBC. This study will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy. Following completion of neoadjuvant therapy, patients will undergo breast conservative surgery or mastectomy. Post-neoadjuvant chemotherapy axillary staging will be required, but the choice of the procedure will be at the physician's discretion. Postoperative radiation therapy will be given at the physician's discretion. The use of partial breast irradiation techniques will not be allowed. The primary endpoint will be the rate of pathologic complete response. The secondary endpoints will be 3-year-disease free survival, clinical response and toxicity. Exploratory endpoints will be correlation of the LHRH receptor expression level with the pCR. The sample size for the trial will be 180 patients accrued over a period of 2 years. Definitive analysis of the primary endpoints is expected at year 3.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women between 18 and 60 years.
2. Histologically proven, newly diagnosed invasive carcinoma of breast.
3. Tumors must be ER, PgR negative and HER2-neu negative.
4. Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.

Exclusion Criteria:

1. pregnant females at time of diagnosis of breast cancer.
2. bilateral breast cancer.
3. already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy
4. history or concomitant diagnosis of another primary malignancy.
5. concurrent treatment with oral contraceptives or hormone replacement therapy (OCPs or HRT must be stopped at least 4 weeks prior to randomization).
Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer

The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.

Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years.
* Renal mass ≤ 5cm

  * The treating renal mass must be ≤ 5cm. Other renal masses (cysts etc.) of any size will not make the subject ineligible
* Biopsy proven Renal neoplasm

  * All histology of renal cancers are included including oncocytoma
* Growth of renal mass \>2mm in radiographic scans must be demonstrated within a one year period.
* Ability to understand and the willingness to sign a written informed consent.
* Subject is able to undergo either an MRI or administration of contrast agent for CT
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  * Has not undergone a hysterectomy or bilateral oophorectomy; or
  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

* Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.

  * If other renal masses received RFA or cryoablation or surgery, then these patients are eligible.
* Subjects received previous abdominal radiation
* Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
* Female subjects who are pregnant or planning to become pregnant during the course of SABR.
A Research Study Investigating Safety and Concentration in the Blood After One Dose Tablet of the New Medicine Monlunabant in Healthy Weight Japanese and Caucasian Men

The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.


Eligibility Criteria:
Inclusion Criteria:

* Male.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* For Japanese participants, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
* For Caucasian participants, self-reported European descent or white Latin-American descent.
* BMI 18.5-24.9 kg/m\^2 (both inclusive) at screening.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous randomisation in this study.
* Previous rescreening for this study.
* History of Major Depressive Disorder within the last 2 years from screening.
* Presence or history of any psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, depression, and anxiety) as judged by the investigator.
* Suicidal ideation corresponding to type 4 or 5 or suicidal behaviour on the Columbia-Suicide Severity Rating Scale (C-SSRS) as assessed at screening or any history of suicidal attempts.
* A Patient Health Questionnaire 9 (PHQ-9) score greater than 9 as assessed at screening.
Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent prior to any study-related procedures are performed
* Men and women 18 years of age or older at the time of informed consent signing
* Intestinal failure resulting in Short Bowel Syndrome
* At least 12 months of continuous PN dependency
* 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
* PN required at least 3 times weekly
* A stable PN volume for four weeks prior to dosing

Exclusion Criteria:

* History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
* Participation in clinical study within 30 days for drug or 90 days for antibody
* Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
* Use of iv glutamine within 30 days prior to screening
* Use of teduglutide
* CD patients who have been treated with biological therapy within 6 months of screening
* IBD patients who require chronic systemic immunosuppressant therapy
* More than 4 SBS- or PN-related hospitalizations within 12 months of screening
* Unplanned hospitalization within one month of screening
* Pregnant or lactating women
* Body weight \> 88kg
* Body mass index (BMI) \< 15 kg/m2
* Severe hepatic impairment or disturbed renal function
* Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period
* Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
* Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results
* Significant active, uncontrolled, untreated systemic diseases
Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips in Pediatric Patients

The purpose of the study is to compare cosmetic outcomes of simple facial lacerations in children repaired with Dermabond (skin glue) compared with Dermabond (skin glue) with underlying steristrips (skin adhesive strips).


Eligibility Criteria:
Inclusion Criteria:

* Age ≤17 years old
* Presents with simple, linear facial laceration requiring repair
* English or Spanish speaking parents or guardians

Exclusion Criteria:

* Laceration to lips, nose, ear, eyelids, eyebrows
* Laceration requiring multi-layer closure
* Laceration requiring sub-specialty care
* Laceration that has previously been repaired
* Animal/human bites
* Lacerations \>5cm in length
* Allergy to adhesive
The Effect of Cochlear Implant on Postural Control

Some patients are having balance problems after cochlear implant surgery. There are contradictory reports about the effect of the implant on postural control. While the cochlear implant is working, an electrical current is continuously stimulating the cochlear nerve which is in close proximity with vestibular ganglion and nerve. This stimulation may contribute to vestibular signals to the central system. The aim of the study is to investigate if this stimulation has any effect on postural control.

Adult patients who had unilateral cochlear implantation will be included. Postural stability measurements will be done by the Biodex Balance System. Three preprogrammed main tests and their 9 subtests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).

Eligibility Criteria:
Inclusion Criteria:

* Patients who had cochlear implant surgery before

Exclusion Criteria:

* Bilateral Cochlear implants
* Neurologic disease
* Communication problem
* Additional disability
Humanin Isoforms in Cardiac Muscle and Blood Plasma and Major Complications After Cardiac Operation

Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation.

Hypothesis of the study is that previously described elements are related to each other.

Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications).

Specimen collection:

* Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C.
* Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Ischemic heart disease in medical history
* Planned on-pump coronary artery bypass graft (CABG) operation
* Signed informed consent by patient

Exclusion Criteria:

* Age \<18 years
* Planned isolate valve or aortic operation
* Patient is in another study with an intervention
* Absence of signed informed consent
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Participants who completed study P261-401 (NCT01390220), a randomized double-blind study of USL261 (intranasal midazolam) versus placebo to acutely treat a seizure cluster episode, were eligible to to enroll in this open-label extension study (P261-402). The participant's caregiver administered a USL261 5 milligram (mg) dose for a seizure episode meeting study criteria. A second USL261 5 mg dose could be administered after 10 minutes and up to 6 hours after the first dose for persistent or recurrent seizures, unless the participant met exclusions to administration of the second dose. A participant could have more than 1 seizure cluster episode treated during his/her study participation.

Eligibility Criteria:
Inclusion Criteria:

* Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
* Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator

Exclusion Criteria:

* Has experienced status epilepticus during or since the P261-401 study
* In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
* Has a neurological disorder that is likely to progress in the next year
* Has a history of acute narrow-angle glaucoma
* Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
* Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
* Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
* Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
* Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401