cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects

A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations.

Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body mass index (BMI) range of 18.5 - 29.9 kg/m2, inclusive. The subject weighs at least 50 kg (screening).
* Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 3 months after final study drug administration.
* Male subject must not donate sperm starting at screening and throughout the study period and for at least 3 months after final study drug administration.

Exclusion Criteria:

* Known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
* Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.
* Any history of seizure including a febrile seizure in childhood, loss of consciousness, transient ischemic attack, or any condition that may pre-dispose to seizure.
* The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check in.
* Use of grapefruit or marmalade in the week prior to admission to the Clinical Unit, as reported by the subject.
* Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
Comparison of Denture Base Adaptation and Per-iimplant Tissue Health Between CAD and CAM Implant Overdenture

Background: Complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology.

Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue and denture adaptation were evaluated using clinical parameters

Background: In recent years, complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. This clinical study compared the soft tissue health between CAD/CAM-milled and 3D-printed implants that retained complete overdentures.

Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.

Eligibility Criteria:
Inclusion Criteria:

poor denture adaptation co-operative patients

Exclusion Criteria:

metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.
Effects of App-based Versus Personal On-site Instruction on Neuromuscular Activity in Injury Prevention Exercises

Therefore, the aim of the present study was to evaluate neuromuscular characteristics observed during a single bout of selected and validated injury preventive exercises instructed by an app (in accordance with 'Get set - Train smarter') versus gold standard instruction, supervision and feedback provided on-site by an expert. The present evaluation targets a population of female football and handball players without any previous exposure to injury prevention training.


Eligibility Criteria:
Inclusion Criteria:

* female handball or football player (≥ 18 years old) competing at sub-elite level (i.e., 2-3 weekly training sessions)

Exclusion Criteria:

* previous traumatic knee injury, lower limb injury at the time of testing and/or previous engagement in injury prevention practices.
Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

In this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery.

Colorectal surgery can be applied for many reasons, among these reasons, colorectal cancer (CRC) takes the first place. With the understanding of the pathophysiological effects of analgesics better, the use of regional techniques in providing analgesia for patients undergoing colorectal cancer surgery has come to the fore. Depending on the surgical procedure, pain faced by patients is an important problem that must be deal with in the postoperative period.

In this study, the hypothesis was determined as "Pre-operatively, erector spina plane block (ESPB) performed as part of multimodal analgesia reduces postoperative morphine consumption and pain scores."

The patients were divided into two groups :

Group ESP (erector spinae plan):

In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Group GA (general anesthesia):

In this group, patients will be administered only IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years
* ASA I , II patients
* BMI\<35 kg/m2 (body weight \<100 kg , \>45 kg)
* Patients who underwent colorectal surgery

Exclusion Criteria:

* Patients who underwent abdominoperineal resection
* Patients who were evaluated as unsuccessful block in the dermatomal examination performed after the block was applied.
* Patients diagnosed with OSAS
* Pregnancy and breastfeeding
* Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
* Hypersensitivity to local anesthetics or a history of allergy
* Patients with a history of opioid use longer than four weeks
* Patients with severe psychiatric diseases such as psychosis or dementia that limit cooperation with the patient.
* Patients with anatomic deformity ( advanced scoliosis and kyphotic patients. Patients with pectus carinatum and pectus excavatum-like chest deformity )
* Patients who do not want to participate
* Patients who have had previous colorectal surgery, excluding diagnostic biopsies
* Patients who could not be reached by phone to inquire about their pain score at 3rd month.
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer

To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced recurrent or progressive NSCLC proven cytohistologically
* Karnofsky performance status (KPS) ≥60
* Life expectancy ≥ 2 months
* No history of severe diseases of major organs including liver, heart, and kidney
* No previous intrapleural therapy
* Written informed consent

Exclusion Criteria:

* Active thoracic cavity or systemic bleeding
* Active pleural or systemic infection.
* Known sensitivity to Bevacizumab or Cisplatin
* Refusal to participate in the study.
Repetitive Transcranial Magnetic Stimulation to People With Cannabis Use Disorder (SToP-C-rTMS x CUD)

This study is to explore if repetitive transcrinal magnetic stimulation (rTMS) with different stimulation schedules will be equally effective in reducing carving, frequency of cannabis use, and the severity of cannabis use disorder in participants suffering from cannabis use disorder (CUD).

The investigators assume the hypotheses as:

1. Multiple rTMS sessions can reduce craving for cannabis, severity of CUD, frequency and amount of cannabis use.
2. Different rTMS treatment schedules have differences in reducing the craving for cannabis and severity of CUD, and prolonging relapse of cannabis use.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and communicate in English and/or Chinese SToP-C-rTMS x CUD
* Able to give informed consent
* Using cannabis or marijuana as the primary psychoactive substance of abuse
* Diagnosed with Cannabis Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)

Exclusion Criteria:

* Age \<18 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed with the following disorders, including neurodevelopmental disorders, DSM-5 defined substance use disorder greater than moderate in severity, and neurocognitive disorders
* Contra-indicated to have rTMS, including subjects with electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator \[ICD\], cerebral shunts, cochlear implant, etc.), with metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.), pregnant, with any known or history of neurological conditions including cerebral vascular accidents, epilepsy, brain tumor or space occupying lesion, poorly controlled or unstable diabetes mellitus, and receiving unstable dose(s) of antipsychotics, antidepressants, benzodiazepines and/or anticonvulsants in the past 6 months
Effects of Artificial Sweetener on Gastrointestinal (GI) Peptide Secretion

The purpose of this study is to examine the influence of artificial sweeteners (aspartame, acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of gastrointestinal satiety hormones in humans.

Artificial Sweeteners significantly lower energy density of foods and beverages. They are used by diabetics as sugar substitutes as well as by consumers as aids for dietary control. Despite numerous studies which show mainly no influence of artificial sweeteners on glucose metabolism and food intake, discrepancies consist about the real effects of artificial sweeteners. Studies by Blundell and Hill in 1986 have however shown that the consumption of artificial sweeteners resulted in an increase of appetite ratings; the efficiency of AS has therefore been questioned. With respect to the world wide increase in the prevalence in obesity, it seems important to clarify whether artificial sweeteners can help regulate body weight or not. This study will explore the effect of artificial sweeteners on the release of the gastrointestinal satiety hormones PYY, GLP-1, GIP and ghrelin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject with a body-mass index of 19.0-24.5
* Normal eating habits
* Age 18-40 years
* Stable body weight for at least three months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness
* history of gastrointestinal disorders
* food allergies
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction

The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.


Eligibility Criteria:
Inclusion Criteria:

* Males (aged 18-60) and females of non-childbearing potential (aged 18-60;
* BMI between 19.5 to 32.0 kg/m2;
* Outpatient, scheduled to undergo surgical extraction of 2 or more impacted 3rd molars (with at least 1 partial bony mandibular extraction);
* use of only the following preoperative medications 2% lidocaine with epinephrine and nitrous oxide;
* Able to complete the requested information on analgesic questionnaires and able to comply with study procedures and restrictions;
* Able to read, comprehend and sign the consent form;
* Deemed medically healthy to participate in the study, with normal or clinically insignificant medical history, physical examination, lab tests and ECG results;
* No contraindications to the study drug, it excipients or any of the study medications including rescue medications.

Exclusion Criteria:

* Presence of a clinically significant medical condition;
* Positive test for HIV, Hepatitis B or Hepatitis C;
* Use of any prescription or over the counter medication or supplement in the 48 hours before dose of study drug until discharge;
* Acute local infection at the time of dental surgery;
* Females who are pregnant, lactating or of child-bearing potential, or who provide a positive pregnancy test result at screening or check-in;
* Males not undertaking adequate measures to prevent their partner becoming pregnant throughout the study;
* Clinically significant laboratory values;
* Clinically significant abnormal ECG;
* History or presence of alcoholism, or alcohol or substance abuse (within previous 2 years), or routine consumption of 3 or more alcoholic drinks per day;
* A positive urine drug test;
* Routine use of analgesics 5 or more times per week;
* Presence or history (within 2 years of enrolment) of bleeding disorder(s) or peptic ulcer disease;
* History of allergic reaction to any drug, including penicillin;
* Ingestion of caffeine containing foods or drinks in the 24 hours before dose of study drug;
* Consumption of alcohol in the 48 hours before dose of study drug, or a positive alcohol breath test at check-in;
* Consumption of grapefruit or grapefruit containing products in the 7 days before dose of study drug;
* Use of tobacco or nicotine substitutes within 1 month of dose of study drug, or inability to refrain from use of nicotine between check-in and follow up;
* Treatment for depression in the 6 months prior to enrolment;
* Use of another investigational drug in the 60 days before enrolment;
* Donation or loss of 50-500 mL of blood in the 30 days prior to enrolment, or more than 500 mL of blood in the 56 days before enrolment;
* Previously entered into this study;
* Study site or Sponsor employees or relatives of employees directly involved in the study;
* Any other condition that (in the opinion of the Investigator or sponsor) makes the subject unsuitable for the study.
Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder

This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment.


Eligibility Criteria:
Inclusion Criteria:

* Preschool children
* Aging from 3 to 5 years old

Exclusion Criteria:

* Diagnosis for medical conditions or mental retardation
Hypothermia After In-hospital Cardiac Arrest

ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.

This is a randomized controlled multicenter trial. Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°C. Inclusion criteria are: Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. Exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. The primary endpoint is mortality for all causes after six months. Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale, and in-hospital-mortality.

Eligibility Criteria:
Inclusion Criteria:

* in-hospital cardiac arrest
* restoration of spontanous circulation
* unconsciousness
* age over 18
* initiation of mild therapeutic hypothermia is possible within 4h after resuscitation

Exclusion Criteria:

* active bleeding
* suspicion of intra cranial bleeding
* severe infection
* aquired immun deficency
* severe rhythm disorders
* suspicion of cerebral insult
* known severe cognotive deficit before the index event
* pregnancy
* pre existing disease which makes 6 months survival unlikely
Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes

The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.

The hypothesis is that both levels of interventions have effect on HbA1c with the more intense Group intervention having superior effects.

Regularly physical activity may decrease the risk for type 2 diabetes, cardiovascular diseases, overweight and premature deaths. Despite the evidence that physical activity is beneficial to health,it is often ignored and underused aspect in diabetes care. The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

Ability to communicate in Swedish Age 40-80 years Type 2 diabetes: Diagnosed type 2 diabetes with a duration of \>=1 year Pre-diabetes: HbA1c \>39-\<47, Fasting plasma glucose \>5.6 mmol/l

Exclusion Criteria:

* Myocardial infarction in the past 6 months
* serum creatinine \>140
* diabetic ulcer or risk for ulcer
* prescribed insulin in past 6 months
* additional disease prohibiting physical activity
* have experienced repeated hypoglycaemia or severe hypoglycaemia in past 12 months
* classified in very hard-intensity activity according to Stanford Brief Activity Survey
* having no access to internet.
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics

Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.


Eligibility Criteria:
Inclusion Criteria:

* Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics

Exclusion Criteria:

* None
Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c over 7%
* No contraindication with NovoMix® 70

Exclusion Criteria:

* Type 1 diabetes
* Subjects participating in a clinical trial or another observational study
* Subjects under previous basis-bolus insulin therapy
* Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method
Effects of Theraplay on Hand in Cerebral Palsy

Among the neurological conditions known as cerebral palsy are those that impact muscle tone, mobility, and cooperation. Cerebral palsy that affects only one side of the body is known as hemiplegic cerebral palsy. Damage to one side of the brain causes this disorder, which usually manifests as before, in the middle of, or soon after birth. The ability to use one\&#39;s hands with coordination and expertise to accomplish tasks that call for control and accuracy is known as hand dexterity. For those who have cerebral palsy, hand dexterity can be a major issue. Developing hand dexterity is crucial as it might augment an individual\&#39;s capacity to execute routine tasks and attain greater autonomy.Convenient sampling will be used to carry out a randomized control study.

Twenty two subjects will be divided into two groups at random. The experimental group will receive Theraplay therapy, which is a program that includes various play-based activities like playing with wooden puzzles, clay and blocks, making wraps, bubble tennis, and special handshakes, claps, and high fives, in addition to designed conventional therapy. The control group will receive designed conventional physical therapy exercises for the affected hand, such as hand weight-bearing exercises, stretching and strengthening exercises, and exercises using sponge balls.

The course of treatment will run for eight weeks. As outcome measures, the GMFCS and MACS scales, the box and block test, finger tapping, and the nine-hole peg test will be employed.

Data will be analyzed on SPSS version 25; the normality of the data will be checked and tests will be applied according to the normality of the data either it will be a parametric test or non parametric based on the normality.

Group A: The control group will receive a designed conventional physical therapy program for the affected hand like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises.

Group B: The experimental group will receive Theraplay therapy or a program and different play-based activities like playing with wooden puzzles and playing with clay and blocks, special handshake claps high fives, making wraps, and bubble tennis in addition to designed conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ages of both boys and girls range from 6 to 12 years
* Based on the Modified Ashworth Scale, the degree of spasticity is between 1 and 1+.
* Capable of grasping, releasing, and reaching with the afflicted hand
* Capable of comprehending and adhering to instructions

Exclusion Criteria:

* Children with mixed C.P., ataxic, athetoid, and mental retardation
* Visual and auditory issues
* Upper limb congenital malformations, Convulsions
* Youngsters who have recently sustained upper extremity trauma