cyrilzakka/clinical-trials huggingface dataset:
Protein Supplementation and Muscle Recovery in Football

Soccer is an intermittent sport including a high number of powerful actions such as accelerations, decelerations, changes of direction, jumps and impacts that incorporate a strong eccentric component and may therefore lead to skeletal muscle damage. Indeed, match activity is associated with the onset of muscle damage and an acute inflammatory response that result in attenuated performance for as long as 1 to 3 days. In competitive soccer though, multiple matches are performed within a small-time frame resulting in inadequate muscle recovery and reduced field performance. Supplementation with milk proteins following intense exercise protocols has been shown to stimulate protein synthesis and facilitate muscle recovery. Thus, the aim of the present investigation is to examine the effects of milk protein supplementation on muscle recovery and soccer-specific performance during an in-season microcycle with two matches performed three days apart.

In a double-blind, cross over, repeated measures design 20 men soccer players will receive either placebo (PLA) or milk protein isolate (PRO, 80% casein-20% whey) throughout recovery following two matches performed three days apart. On match days, players will receive a dose immediately after the match (PLA vs PRO: 25g of protein) and then at 3h (PLA vs PRO: 30g of protein) and 6h (PLA vs PRO: 25g of protein) post-match. On each day of the remaining days, players will consume a single dose of PLA or PRO (20g of protein) with breakfast. All players will participate in regular in-season training following matches. Field activity during both matches and daily practices will be monitored using GPS devices. Heart rate will be continuously recorded during each match and training session. Blood samples will be collected at baseline as well as 2 hours after the first match, daily for three days after the first match, 2 hours after the second match and daily for 3 days after the second match. Performance (isokinetic strength, 20-m speed, repeated sprint ability) and muscle soreness will be assessed at baseline daily for 3 days after both matches. Muscle biopsies from vastus lateralis will be collected at baseline and one day after each match.

Eligibility Criteria:
Inclusion Criteria:

* i) participation at elite level (top three division leagues) of soccer competition for at least five years, ii) abstain from consumption of performance-enhancing supplements, antioxidant supplements and medications (for at least 6 months before and during the study), iv) participate in at least six two-hour training sessions per week and played at least one match per week and v) non-smokers.

Exclusion Criteria:

* i) a known milk intolerance or allergy, ii) a recent febrile illness, iii) history of muscle lesion, iv) lower limb trauma and v) metabolic diseases.
A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Histologically confirmed, relapsed or refractory SCLCr
* Aged 18 or over and a life expectancy of more than 2 months

Exclusion Criteria:

* Any evidence of clinically active interstitial lung disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.
Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient

This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing the amount of anxiety, as well as the number of inappropriate firings that a patient with an ICD may experience.

This study is an interventional study of patients with ICDs followed in the Cleveland Clinic Device Clinic. Patients with ICDs experience some level of anxiety which can impact the number of shocks that they receive from their Device. 100 of these patients will be randomized into one of 2 groups; those receiving three sessions of Cognitive Behavioral Therapy (CBT) and those receiving usual care. We hypothesize that if these ICD patients receive short term (CBT) they will experience less anxiety and have a lower rate of device firings than the patients that did not receive CBT. Furthermore, we will study mechanistic pathways involved in the reduction of anxiety in ICD patients. We will extract initial heart rate variability (HRV) data from device interrogation. We hypothesize that the CBT intervention arm will have a higher normalization of HRV. Patients will repeat questionnaires at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Currently has an Implantable Cardioverter Defibrillator (ICD)
* Experiences moderate to high anxiety as demonstrated by the the scores on the questionnaires that will be administered

Exclusion Criteria:

* Unwilling to comply with follow-up requirements at 3, 6 and 12 months.
The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery

The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.

The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar disc surgery in general anaesthesia.
* Patients who have given their written consent to participate and understand the contents of the protocol.
* ASA 1-3.
* BMI \> 18 og \< 40.
* Fertile women need a negative HCG urine test.

Exclusion Criteria:

* Patients who cannot cooperate to the study.
* Patients who do not speak and/or understand Danish.
* Fertile women with a positive HCG urine test.
* Allergy to the drugs used in the trial.
* Alcohol or medicine abuse, assessed by investigator.
* Patients who have had spine surgery before.
* Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
* Daily oral steroid treatment.
Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding

This study is conducted to overcome the problems of conventional indirect bonding technique, through investigating accuracy of two novel three dimensionally digitally printed indirect bonding transfer trays (full arch \& segmented) in terms of accuracy of transferring brackets, rate of immediate bond failure and chair side time.

Fourteen patients (7 in each group) with mild to moderate crowding, requiring orthodontic treatment with full set of permanent teeth including second molars, will be selected for this study. A total of 196 brackets will be used (98 Full Arch Tray and 98 Segment Arch Tray). The same bracket type and bonding material will used in both groups. The accuracy of bracket transfer will be measured by 3 Shape Ortho planner software (Bracket Placement Module), rate of bond failure by counting number of debonded brackets upon tray removal \& chair side time by using digital watch.

Eligibility Criteria:
Inclusion Criteria:

1. Patients seeking fixed orthodontic treatment with full set of permanent teeth including second molars.
2. No sex predilection.
3. Mild to moderate crowding cases (4-6 mm).

Exclusion Criteria:

1. Severely rotated teeth
2. Enamel hypoplasia or hypocalcification.
3. Systemic disease that contraindicates orthodontic treatment.
4. Presence of deep carious lesions or large restorations.
5. No or poor patient's compliance \& bad oral hygiene.
6. Psychological problems.
A Study of KK2269 in Adult Participants With Solid Tumors

This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.

In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.

In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.


Eligibility Criteria:
* Key Common Inclusion Criteria for Parts 1 and 2:

  * Patients who are ≥ 18 years old at the time of informed consent
  * Patients who have disease measurable by RECIST v1.1
  * Patients with an ECOG PS of 0 or 1
  * Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator
  * The specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment
  * Patients who agree to use a medically effective method of contraception
* Key Additional Inclusion Criterion for Part 1:

  •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
* Key Additional Inclusion Criteria for Part 2:

  * Patients with histological or cytological evidence of any of the following disease:
  * Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma
  * NSCLC
  * Patients who are suitable for docetaxel treatment
* Key Common Exclusion Criteria for Parts 1 and 2:

  * Patients with an uncontrolled or serious intercurrent illness
  * Patients with known active central nervous system metastasis
  * Patients with a history of ≥ Grade 3 allergic reaction to any antibody drug
  * Patients with a history of autoimmune disease
  * Patients with a history of HIV, HBV, or HCV at screening
  * Patients who have a history of primary immunodeficiency
* Key Additional Exclusion Criterion For Part 2:

  * Patients with a history of treatment with docetaxel
Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture

The objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants.

Despite the fact that modern medical practice is greatly advanced, pain is inflicted on all Canadian newborn infants in the first days and months of life from blood tests, injections and cannulations designed to prevent, diagnose or manage medical conditions. Procedural pain in newborn infants is a significant burden to infants, their parents, healthcare workers, and society at large.

This study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. However, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infants
* ≥ 37 weeks gestational age.

Exclusion Criteria:

* neonatal intensive care unit (NICU) admission
* asphyxia, seizures
* major birth defect (heart, brain, genetic syndrome)
* circumcised during study
* receiving analgesia/sedatives.
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol


Eligibility Criteria:
Inclusion Criteria:

* age 18 years old or more
* singleton pregnancy at 37 weeks gestation or more
* cephalic presentation
* reassuring fetal heart rate pattern
* admission for labor induction due to medical or obstetrical conditions
* bishop score less than 6
* giving consent and having signed the consent form for this study

Exclusion Criteria:

* parity more than 3
* estimated fetal weight more than 3,500 grams
* non-reassuring fetal heart rate pattern
* having contraindication for vaginal delivery
* previous uterine scar
* suspected abruptio placenta with non-reassuring fetal heart rate pattern
* abnormal bleeding per vagina, except bloody show
* PROM
* having underlying cardiac, hepatic, or renal diseases
* having history of allergy to misoprostol or prostaglandin analogues
* cervical dilatation 3 centimeters or more
* uterine contraction 3 times or more in 10 minute
Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C

The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.

A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008

Eligibility Criteria:
Inclusion Criteria: all of below

* adults aged 18-70 years
* serum anti-HCV antibody (+)
* HCV RNA detectable by PCR
* compensated liver disease (Child-Pugh class A)

Exclusion Criteria: any of below

* HCV genotype other than 1, 2, or 3
* acute hepatitis C
* decompensated cirrhosis or hepatocellular carcinoma
* other liver disease such as hepatitis A or B, or autoimmune hepatitis
* HIV Ab(+)
* severe depression or other psychiatric disease
* previous organ transplantation
* absolute neutrophil count (ANC) \< 1,000 cells/mm3 or platelet count \< 75,000 cells/mm3, or hemoglobin (Hb) \< 13 g/dL for men, \<12 g/dL for women
Effects of Soy Isoflavones on Menopausal Hot Flashes

Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.

Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein).

Eligibility Criteria:
Inclusion Criteria:

No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65

Exclusion Criteria:

Pregnant, BMI\>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days
Guided Self-Help for Depression in Parkinson's Disease

The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program

To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.

Eligibility Criteria:
Inclusion Criteria:

1. Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
2. Clinically significant depression as determined by study staff
3. 35-85 years old
4. Stable medication regimen ≥ 6 weeks
5. No change in mental health treatment in past 2 months _

Exclusion Criteria:

1. Severe depressive symptoms
2. Suicidal plans or intent
3. Significant cognitive impairment
4. Significant motor fluctuations (i.e., ≥ 50% of the day)
5. Unstable medical conditions
6. Receiving CBT elsewhere
Establishment of a LVAD Destination Program in a Swiss Non Cardiac Transplant University Hospital

The goal of this study is to demonstrate the challenges and the effort to set up an artificial heart program as well as to report about the follow-up treatment and the mortality rate


Eligibility Criteria:
Inclusion Criteria:

* Patients who received an LVAD implant

Exclusion Criteria:

* not enough data collected
* stated will of the Patient, that his data can not be used
Feasibility Study of Hematology Parameters in COVID-19 Disease

The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care includes CBC-DIFF and microbial testing.

The objective of this study is to evaluate MDW and/or combination(s) of hematology parameters that best identify patients with COVID-19 disease who tested SAR-CoV-2 positive by standard of care (SOC) COVID-19 testing.

A feasibility study of consecutive adult patients who presented to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care testing involves a CBC-DIFF and microbial testing including RT-PCR testing for SARS-CoV-2 will be enrolled. This study will evaluate MDW and other CPD parameters performance in COVID-19 patients and the ability of MDW to identify RT-PCR positive COVID-19 patients as well as potential added value to RT-PCR tests of MDW. A minimum of 50 COVID-19 positive and 150 COVID-19 negative patients meeting inclusion criteria will be evaluated. Patients with symptoms suggestive of COVID-19 and who have RT-PCR test samples drawn will be retested on the DxH900 hematology analyzer to capture baseline MDW results. In addition, a retrospective data extraction will be performed for those patient samples tested during the Post Market study during the COVID-19 pandemic that meet the revised study population.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \[18-89 years of age\]
* Present to the Emergency Department
* With symptoms suggestive of COVID-19 or respiratory infection
* Whose assessment includes CBC-Diff and RT-PCR testing

Exclusion Criteria:

* Pregnancy
* Prisoners
* \<18 years of age
* \>89 years of age
* Previously evaluated in this study
* No RT-PCR testing
* Sample age \>2 hours from time of draw
* Instrument flags, including vote outs and review flags for the MDW parameter
* Samples stored in refrigerated temperatures
A Study of Flexible Ureteroscopy Proficiency After Training on the Uromentor Simulator

The development of virtual reality (VR) simulators is changing surgical endoscopic education. The translation of VR skills into clinical endoscopic proficiency has been shown by M.PEARLE. The improvement in performing endoscopic tasks after VR training was evaluated on a cadaver. Our goal is to evaluate the performance of novice endoscopists at the operating room by a randomized controlled study comparing subjects randomized to train on a the "UroMentor" simulator to those without VR training.


Eligibility Criteria:
Inclusion Criteria:

* novice urologists without endo-urological experience

Exclusion Criteria:

* none