cyrilzakka/clinical-trials huggingface dataset:
Effect of Molecular Hydrogen Administration on Performance and Body Response on Exercise in National-level Fin-swimmers

The aim of this randomized, double-blind, placebo-controlled crossover trial is to evaluate the effect of hydrogen-rich water consumption on performance, recovery, psychological and biochemical outcomes in elite Czech fin-swimmers.

Twelve Czech national and international-level fin-swimmers participate in this trial. Participants take molecular hydrogen via drinking hydrogen-rich water (HRW) or placebo three days before (1260 ml/day) and during testing day (2520 ml). All participants participate in two testing session and receive HRW and placebo in random order. Each session includes two training units in a 25-m indoor swimming pool and a 24-hour monitored recovery. The first training unit takes place in the morning between 9 and 11 AM and includes three high intensity interval sets. The afternoon training unit includes a continuous 400-m competitive performance. The washout period between testing sessions is 7 days. The variables assessed are as follows: swimming times, heart rate variability, lower limb explosive strength, rating of perceived exertion, subjective perceived muscle soreness, creatine kinase, blood lactate, and protein carbonyls. Statistical analysis is based on analysis of variance for repeated measures with factors: water (HRW and placebo), time, and interaction. Fisher's post-hoc tests is used for pairwise comparisons. The significance level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Junior or adult Czech fin-swimming representative.
* Medical eligibility for competitive sport.
* Good health condition.
* Signed informed consent.

Exclusion Criteria:

* Acute health problems.
* Not following instructions (free of any supplements three weeks before experiment, free of any medicaments, no caffeine at least 24 hours before experiment).
* Menstruation in testing session.
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection

This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.


Eligibility Criteria:
Inclusion Criteria:

* elecitve abdominoperineal resection

Exclusion Criteria:

* rejection of a retrospective data Analysis
* age under 18 years
* meshes other than the funnel-shaped mesh
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to.

This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year
* Have a body mass index of 18.5 to 35 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months
COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults - Impact of Variants (Dyn3CEA - Nosocor Phase 2)

Unlike other respiratory viruses such as influenza and RSV where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of CoV2-CoRSA infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.


Eligibility Criteria:
Inclusion Criteria:

* 1) Children hospitalized in the Pediatric department of the Hospices Civils de Lyon with PCR positive for a variant of the historical SARS-CoV2, 2) Adults hospitalized in the the Hospices Civils de Lyon, for a Covid-19 disease with documented infection by a variant of the SARS-CoV-2 and included in the NOSO-COR study with matching criteria described below.

Exclusion Criteria:

1. Any patient suspected of nosocomial infection.
2. Any patient death during the Covid-19 infection.
3. Any adult patient without children living home.
4. Opposition to participate.
Randomized Controlled Trial of a Novel Laser-aided Orthodontic-periodontal Treatment Strategy

The aim of the study is to assess the effects of low-level laser therapy (LLLT) in patients with periodontitis during orthodontic-periodontal treatment for 12 months on the following aspects: (1) Effects on periodontal status; (2) Effects on alveolar bone remodeling; (3) Effects on cervical dentin sensitivity; (4) Effects on pain and quality of life.

To eliminate any bias, the investigators will initially hypothesize that there is no difference in periodontal status, jawbone remodeling, tooth sensitivity, pain and quality of life in patients having teeth with chronic periodontitis and receiving LLLT with orthodontic treatment versus teeth undergoing orthodontic treatment without incorporation of LLLT.

On the basis of the investigators' pilot study results, 35 patients with chronic periodontitis will be recruited and initially treated for inflammation. Using a randomized split-mouth design,the teeth in experimental (laser) group will receive LLLT while the teeth in the control (placebo) group will receive no laser treatment. The effects of LLLT in orthodontic-periodontal treatment on periodontal inflammation control, jawbone remodeling, reduction of tooth sensitivity, pain relief and quality of life will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Systemically health (with special regard to disease affecting tissue repair);
2. No medications required for periodontal therapy and no use of any antibiotic and/or anti-inflammatory medication in the preceding month;
3. Chronic periodontitis with at least two pairs (clinically matched) displaced single-rooted teeth (each pair of teeth is in the same arch but in two contralateral hemi-arches respectively belonging to the same tooth typology) having at least one site probing depth of 5 mm or more, interproximal attachment loss of 3 mm or more, and radiographic signs of alveolar bone loss.
4. Periodontal status confirmed by periodontal evaluation remains stable for at least 6 months after complete periodontal treatment.

Exclusion Criteria:

1. smoking;
2. pregnancy;
3. under orthodontic treatment.
Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital

Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery.

Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.

Patients will be divided into 2 groups: Group P (treatment) and Group K (control).

Before anesthesia, 2-3 mL of blood will be collected by the researcher from patients in both groups using a red tube.

Patients in the control group will undergo conventional general anesthesia. Patients in the treatment group will undergo conventional general anesthesia combined with epidural anesthesia. Patients will be administered 0.25% Bupivacaine local anesthetic incrementally until the desired volume is achieved based on the targeted segmental block height.

Six hours postoperatively, 2-3 mL of blood will be collected, VAS (Visual Analog Scale) will be assessed 24 hours postoperatively, and QoR-15 (Quality of Recovery-15) will be evaluated postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 65 years
* Patients with ASA physical status I - III

Exclusion Criteria:

* Patients with contraindications to regional anesthesia

  * Patients with mental disorders or psychiatric disorders
  * The patient has a history of allergy to the local anesthetic used.
  * The patient or family refuses to take part in the study
  * BMI \> 30 Kg/m2
Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

This pilot study will explore the ways to link Ontario's remedial system for convicted drinking drivers to medical intervention, assess the receptiveness of the Back on Track client population to effective medical interventions, and assess the feasibility of a full-scale trial of pharmacotherapy for convicted drinking drivers.

Many individuals with Alcohol Dependence do not receive treatment, despite effective treatments being available. A significant healthcare challenge is to find ways to bring people who have alcohol dependence into treatment programs. Drinking drivers are a group that has been shown to have high rates of alcohol dependence. In Ontario, all convicted drinking drivers who want to obtain a drivers license must complete Ontario's remedial program for convicted drinking drivers called Back on Track (BOT). In this program, those with more serious alcohol-related problems are assigned to a group treatment program. While it is likely that many of the individual in this group are experiencing alcohol dependence, currently there is no formal linkage to any medical services for these problems. In this study, the investigators will provide those in the BOT treatment group with information about a 24-week study assessing the effectiveness of naltrexone vs. placebo. This study will also assess the feasibility and level of interest among this population to obtain treatment for alcohol dependence.

Eligibility Criteria:
Inclusion Criteria:

* Male or females - 18 years or older
* Been convicted of drinking driving and allocated to either the education or the treatment group of the BOT program
* Meet criteria for alcohol dependence using the SCID-IV
* Consume more than 14 drinks (female) or 21 drinks (male) per week with a minimum of 2 heavy drinking days (≥ 4 drinks for females and ≥ 5 drinks for males) during a consecutive 30-day period within the 90 days prior to the baseline evaluation
* Willing to receive pharmacotherapy for their alcohol dependence
* Seeking abstinence from alcohol as their main goal

Exclusion Criteria:

* History of other substance use (other than nicotine or cannabis) by DSM-IV criteria in the last 90 days (6 months for opiate abuse)
* Positive urine drug screen
* Psychiatric disorder requiring medication
* Unstable medical condition requiring immediate investigation or treatment
* Pregnancy or lactation
Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet

The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis og osteoarthritis of the knee
* patients must be 18 years or older
* patients must understand and speak danish
* must be able to give signed consent

Exclusion Criteria:

* severe medical illness
* documented osteoporosis
* rheumatoid arthritis
* prior surgery in the knee
* neuropathy
Position of the Endotracheal Tube Cuff in Relation to Cricoid in Children.

To verify the exact location of cuff of the endotracheal tube in children.

The exact location of the cuff of the endotracheal tube in children has not been studied. This study is the first attempt to verify the position of the cuff in the airway with relation to cricoid.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 month to 8 years

Exclusion Criteria:

* Any airway pathology
Pearl Index Study With Low Dose Combined Oral Contraceptive

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women requiring contraception

Exclusion Criteria:

* Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.
Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma

A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic diagnosis of MPM, epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor.
* Patients must have disease limited to the hemithorax.
* Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment.
* Subjects treated with pemetrexed previously will be eligible only if 30 days have elapsed between the last dose of pemetrexed and the date of surgery.
* ECOG performance status of 0-1.
* Medical suitability for resection, including documented medical and cardiac clearance.
* 18 years of age or older.
* Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable due to cognitive impairment to sign informed consent are excluded from the study.

EXCLUSION CRITERIA

* Patients with active invasive cancers, other than MPM, that require additional treatment, except non-melanomatous skin cancer, superficial bladder or cervical cancer, and early-stage prostate cancer
* Pregnant or lactating patients.
* Patients who have a history of HIV disease.
* Patients who have a white count less than 2,500 per cubic mm or platelets less than 100,000/cubic mm.
* Serum creatinine equal or greater than 2.5 mg/deciliter.
* Patients who have severe liver disease including cirrhosis, Grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/deciliter.
* Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
* Patients who have been treated with pemetrexed if the last dose of pemetrexed is \< 30 days to the date of surgery.
* Patients that have been treated with prior Mantle field radiation.
* Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax.
* Subjects who have received more than 2 doses of neo-adjuvant chemotherapy
Auricular Stimulation vs. Relaxation for Pre-exam Anxiety

Title of the study: Auricular acupuncture (AA) vs. progressive muscle relaxation for pre-exam anxiety - a randomised crossover study

Study period: 04 / 2015 - 07 / 2015

Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care, University Medicine of Greifswald

Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle relaxation and vs. no intervention in students, passing the oral exams in anatomy at the University of Greifswald

Design: Prospective randomised crossover trial

Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Progressive muscle relaxation

Number of volunteers: N = 30

Healthy medical students at the University of Greifswald Participants of the oral anatomy exams in spring/summer 2015 Without previous anxiolytic, sedative and analgesic medication No pregnancy or lactating Informed consent

Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase


Eligibility Criteria:
Inclusion Criteria:

1. Medical students at the University of Greifswald
2. Going to take part in oral exams of human anatomy
3. Participants without previous anxiolytic medication
4. Ability to understand and perform PMR
5. Written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Pregnant or lactating women
4. Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
5. Participants who are unable to understand the consent form
6. History of psychiatric disease
Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction

The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.

Eligibility Criteria:
Inclusion Criteria (subjects must):

* Be ≥ 60 years of age
* Have a corrected visual acuity of LogMAR +0.5 (ETDRS)
* Have a documented history of Meibomian Gland Dysfunction
* Have a TFBUT ≤ 5 seconds
* Have an ocular discomfort score ≥ 1
* Have an IOP ≤ 25 mmHg at Visit 1 in both eyes
* Report use of and/or desire to use an artificial tears

Exclusion Criteria (subjects may not):

* Have contraindications to the use of the study medications
* Have a known allergy or sensitivity to the study medications
* Have any ocular infections, or active ocular inflammation
* Have used ocular medications within 24 hours prior to Visit 1
* Be a current contact lens wearer
* Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial
* Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study
* Have a history of prostate cancer
Influence of Different Zirconia Surface Treatments on Biofilm Formation

The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.


Eligibility Criteria:
Inclusion Criteria:

* No systematic antibiotic therapy during the last 3 months
* Good oral health and compliance (PI and BI \<20%)
* No sign of parodontal disease or other inflammatory changes in the mouth
* Non-smoker

Exclusion Criteria:

* Disease that requires antibiotic therapy
* Pressure marks due to the orthodontic apparatus that can not be eliminated
* Other unexpected complications that could be related to the orthodontic apparatus
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.

12 healthy adults will be randomly assigned to receive a single dose of either 40 units ("low dose" group) or 80 units ("high dose" group) of insulin. Participants will undergo image-guided lumbar puncture (spinal tap) performed by a study radiologist. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of the SipNose device to effectively deliver insulin to the central nervous system of humans as measured in the cerebrospinal fluid.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is between ≥18 and ≤ 35 years of age
2. Subject's body mass index is between \>=18.5 and \<=24.9
3. Subject must be proficient in speaking English to comply with instructions and measures for the study
4. Subject can provide written informed consent
5. Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal/surgically sterile.

Exclusion Criteria:

1. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
2. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator
3. Subject has participated in a clinical trial investigation within 3 months of this study.
4. Subject has an insulin allergy
5. Subject has Insulin-dependent diabetes
6. Subject is pregnant or breast feeding
7. Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion