cyrilzakka/clinical-trials huggingface dataset:
Non-Invasive Optical Spectroscopic Methods for Dehydration Identification in Marathon Trainees

Dehydration can result from exposure to harsh environments including hot and dry desert climates. Soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized.

The research can use low power laser technology to take measurements of muscle tissue water content in volunteers before and after marathon training runs to detect dehydration. Two slightly different devices can be used to detect dehydration. 1). diffuse optical spectroscopy and 2). spatial frequency domain imaging-modulated imaging The researchers can determined by use other methods to assess the level of dehydration status in runners. These methods will include taking weight and temperature before and after run, skin-fold measurements pre and post run, and obtaining saliva samples from before and after run. The researchers can determine the study use non-invasive, laser light technology measure tissue water concentrations, as an indicator of dehydration.

Eligibility Criteria:
Inclusion Criteria:

* male female ages of 18 and 60
* training for a marathon

Exclusion Criteria:

1. Poorly controlled diabetes mellitus
2. Diabetes insipidus (excessive urination of water) as diagnosed by your physician
3. disorder of the intestine
4. Irritable bowel syndrome with excessive diarrhea, as diagnosed by a physician
5. Congestive heart failure and subsequent use of a diuretic "water pill" to remove excess water from the body
6. Have poor kidney function
7. Have been diagnosed with hyperthyroidism/hypothyroidism by your physician
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release, both under fed and fasted conditions.


Eligibility Criteria:
Inclusion criteria:

- Healthy male or female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition
The Breath-2 Trial

This is a randomized, cross over, experimental trial in which carotid body function will be evaluated in 35 healthy subjects during partial muscle relaxation and after recovery from muscle relaxation


Eligibility Criteria:
Inclusion Criteria:

\* age \> 18 years

Exclusion Criteria:

* BMI index \> 30 kg/m2
* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia or any other muscle disease;
* Any neurological or psychiatric illness (including a history of anxiety).
* ASA class 3 or higher
* Gastro-oesophageal regurgitation
Mental Health and Cognitive Dysfunction: A Multicenter Study at Pediatric Rehabilitation Clinics in North Norway

Patients referred to pediatric rehabilitation services have often cognitive deficits/intellectual disabilities.Neurocognitive assessment is, hence, important when designing treatment plans.

Children and adolescents with cognitive deficits and intellectual disabilities (ID) have a high risk of developing mental health problems. There is lack of knowledge about such comorbid mental disorders in the health service. There are also few validated instruments for assessing mental disorders among children and adolescents with cognitive deficits and ID both in Norway and abroad.

The main aims of the current multicentre study are to:

Investigate psychometric properties of different psychiatric instruments for children and adolescents. Investigate change and stability of symptoms over time. Investigate user satisfaction. The study will include Pediatric Rehabilitation Services at hospitals in Tromsø, Hammerfest and Bodø and will include in total 320 patients aged 4 to 18. We will use information from parents, teachers and patients, in addition to clinician-rated measures. Patients will be assessed at intake and after six months. We have conducted a pilot study in the period from 2012 to 2013.

1. Investigate psychometric properties of a structured psychiatric interview

   (DAWBA) and a symptom measure (SDQ) in clinical samples of children and

   adolescents with cognitive deficits and intellectual disabilities. We will

   investigate the instruments' reliability and convergent validity with the

   Aberrant Behavior checklist (ABC), the DBC and the Social Responsiveness

   Scale (SRS), in addition to the clinician-rated severity of children's mental

   health problems measured with the CGAS and HoNOSCA.
2. The psychiatric instruments will be administrated at intake and after six

   months. We will investigate prevalence rates and indicators of disorder

   severity (comorbidity and persistence), including risk factors (socioeconomic

   status, parenting styles).
3. Investigate user satisfaction with the health service, i.e., the Pediatric

Rehabilitation Services.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 4 years to 18 years
2. Written informed consent to participate
3. Fluent in Norwegian
4. Normal or corrected to normal vision and hearing

   -

   Exclusion Criteria:

   -
Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase

It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.

The investigations will be carried out by a specialized physiotherapist from the neurology department.

The experiment consists of three successive phases:

* First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.
* Second : Rest period
* Third: control phase with measurement of the maximum grip force every ten minutes without vibration.


Eligibility Criteria:
Inclusion Criteria:

* Age:18 to 85
* Acute stroke (less than 7 days)
* Paretic upper limb: 3 or 4 to the MRC score and able to obtain a value of at least 10 kilograms on the handgrip strength
* Able to sign a consent form
* Affiliated to a social insurance

Exclusion Criteria:

* Person under tutorship or curatorship,
* Sleepiness
* Pregnancy or breastfeeding woman
Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder

To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole

To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole, and to observe the indicators of improving patients' cognitive function and adverse drug reactions, so as to provide evidence-based evidence for supplementing the treatment guidelines for obsessive-compulsive disorder

Eligibility Criteria:
Inclusion Criteria:

* The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V), as well as the definition of refractory OCD, are as follows: failure to respond to oral treatment with at least two effective doses of antidepressants, including: Fluoxetine (≥20mg/ d), fluvoxamine (≥200mg/d), sertraline (≥150mg/d), and paroxetine (≥ 40mg/d) were all treated for at least 12 weeks. The Yale-Brown compulsive scale (Y-BOCS) score decreased by \< 35%.
* The total score of Yale- Brown compulsion scale (Y-BOCS) ≥16 points. (3)age 12 \~ 45 years.

Exclusion Criteria:

* Exclusion of severe organic brain disease;
* Severe physical illness;
* Other mental disorders such as tics, disruptive disorders, eating disorders and autism spectrum disorders;
* Pediatric streptococcal infection causedby autoimmune neuropsychiatric disease (PANDAS);
* Alcohol and drug dependence; Angle-closure glaucoma;
* Suicidal tendencies;
* Previous history of drug allergies related to research;
* Pregnant and lactating women.
Local Anaesthetic for Transvaginal Egg Collection in IVF

The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. All women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.

Transvaginal oocyte retrieval is the most common method of oocyte collection in IVF cycles. A variety of different methods are used to provide analgesia/anesthesia for oocyte collection. Our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. The aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.

Eligibility Criteria:
Inclusion Criteria:

* About to undergo transvaginal oocyte retrieval

Exclusion Criteria:

* Already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period)
* Allergy to lignocaine
* Oocytes only to be collected from one ovary
* Procedure expected to be exceptionally painful
Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)

Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as heart-lung-machine. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the HLM arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during this extracorporeal procedure and thus act as potential candidate products for the result of hypotonic phases during usage of heart-lung-machine.

We will determine differences in RBC fatty acids profiling in patients before and after heart-lung-machine intervention. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.

It is believed that during HLM there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing an operation with the aid of the heart-lung machine for cardiac surgery
* Age over 18 years
* Ability to consent
* There is a written consent of the study participant

Exclusion Criteria:

•none
Local and General Immune Response After Coronavirus Disease (COVID-19) Vaccination in Volunteers

This study aims to gain more insight in the immunological characteristics and immune response on a local level (the nose) and systemic level (the blood) of healthy people vaccinated with the current available COVID-19 messenger ribonucleic acid (mRNA; BNT162b2) and viral vector based (ChAdOx1) vaccines.

The immunological assays that will be performed on blood include immunophenotyping, serologic testing and cytokine analysis. Deep characterization of patients' immune profile offers a unique opportunity for comprehensive understanding of the mechanisms behind severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination. The investigators will study immunological functions on the level of both adaptive and innate immunity by performing extensive immunophenotyping, cytokine analysis and RNA sequencing analysis. Biomarker analysis will be performed on protein and on RNA single cell level. Infectivity of different cell types including macrophages will performed. These analyses will be performed at the Human Immunodeficiency Virus (HIV) Cure Research Center (HCRC) laboratory.

Nasal fluid: The investigators will compare the immune response and immunoglobulin production in nasal secretions before and after SARS-CoV2 vaccination. The investigators aim to compare the local versus the systemic (blood/serum) response to SARS-CoV2 vaccination. Further, patients that had a proven SARS-CoV2 infection will be compared with patients that never had COVID-19 symptoms nor antibodies.

Questionnaire: a questionnaire will be filled in by the individual to assess if the individual went through a previous SARS-CoV2 infection and experienced symptoms post vaccination. The questionnaires are available as supplementary documents.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18-100 years)

Exclusion Criteria:

* People with a compromised immune system Active treatment with chemotherapy HIV infection with cluster of differentiation 4 (CD4) count below 200/µl Combined immunodeficiency Treatment with methylprednisolone \>16mg for more then 2 weeks Transplant patients Diagnosed Chronic Rhinosinusitis with Nasal Polyps
* Known pregnancy at the time of screening
* Inability to give informed consent or absence of legal representative who can give informed consent.
* Any contra indication for receiving the SARS-CoV2 vaccination
The Arthritis, Diet, and Activity Promotion Trial

The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years.
* BMI ≥ 28 kg/m2.
* Knee pain on most days of the month.
* Sedentary lifestyle pattern (\<20 min exercise per week for last 6 months)
* Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care.
* Radiographic evidence of grade 1-3 knee osteoarthritis.

Exclusion Criteria:

* Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes.
* Mini-mental state exam score \<24.
* Inability to walks without a cane.
* Reported alcohol consumption \>14 drinks/week.
* Inability to complete protocol.
* ST segment depression.
* Participation in another research study.
Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed grade 1, 2, or 3A FL;
* Patients received prior anti-lymphoma treatment;
* At least one evaluable lesion according to 2014 Lugano criteria;
* Age 18 years or older;
* Eastern Cooperative Oncology Group (ECOG) of 0-2;
* Life expectancy \> 3 months;
* Able to participate in all required study procedures;
* Proper functioning of the major organs:

Exclusion Criteria:

* Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;
* Histological transformation of follicular lymphoma;
* Known central nervous system lymphoma;
* Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;
* Subjects who have received prior treatment with ibrutinib, or other BTK inhibitors;
* Uncontrolled active infection, with the exception of tumor-related B symptom fever;
* Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug;
* Subjects who progressed or become refractory while on treatment with PI3K inhibitors are excluded. However, subjects who were responding to PI3K inhibitors, but had treatment discontinued due to toxicity, are eligible;
* Patients require treatment with strong CYP3A inhibitors;
* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening;
* Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 16-45 years of age.
2. Moderate to moderately-severe facial inflammatory acne vulgaris
3. Fitzpatrick skin phototype I-III

Exclusion Criteria:

1. Pregnant, lactating, nursing or planning to become pregnant
2. Tattoo in the treatment area
3. Active skin disease, excessive scarring or excess facial hair in the treatment area
4. Certain current or recent acne treatments
5. Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
6. Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
7. Known allergy to gold
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia

The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and child assent, if applicable.
* FA confirmed by genetic testing with two expanded guanine-adenine-adenine (GAA) repeats.
* FA functional stage of \>1 to \<5 and ability to walk 25 feet with or without an assistive device.
* Male or female subject between the ages of 10 and 25 years, inclusive.
* If female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. Female subjects of child-bearing potential must have a negative serum pregnancy test result at Screening, a negative urine pregnancy test result at Baseline, and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

* Any unstable illness that in the investigator's opinion precludes participation in the study.
* Use of any investigational product within 30 days prior to randomization.
* A history of substance abuse.
* Presence of clinically significant cardiac disease (as determined by the investigator based on electrocardiogram \[ECG\] and echocardiogram results at Screening). Specifically, an ejection fraction of \<40% or a prolonged QT interval (\>50% of cycle duration) will result in exclusion. If the investigator notes any other clinically significant abnormalities on the ECG or echocardiogram, the subject may be eligible if they are provided clearance from a cardiologist.
* History of hypersensitivity to interferon (IFN)-ɣ or E. coli-derived products.
* Presence of moderate or severe renal disease (estimated creatinine clearance \<50 mL/min) or hepatic disease (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2x the upper limit of normal) as evidenced by laboratory results at Screening.
* Clinically significant abnormal white blood cell count, hemoglobin, or platelet count as evidenced by laboratory test results at Screening.
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated. Subjects will be adolescents with non-alcoholic fatty liver disease (NAFLD), and it will also examine liver biology using blood tests and magnetic resonance imaging (MRI).


Eligibility Criteria:
Key Inclusion Criteria:

* Willing to participate in the study and provide written informed consent.
* Male and female adolescent subjects aged 12 to 17 years
* Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 30 days prior to Screening.
* Non alcoholic fatty liver disease
* Diabetes or prediabetes
* A screening MRI consistent with liver inflammation and fibrosis

Key Exclusion Criteria:

* Current or history of significant alcohol consumption
* History or presence of liver disease (other than NAFLD/NASH)
* History or presence of cirrhosis and/or history or presence of hepatic decompensation
* Any diabetes other than Type 2
* Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure \> 100 mmHg)
* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.),
* Unable or unwilling to adhere to contraception requirements
* Any contraindications to a MRI scan
* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
Comparison of Using Regular or Rotary Polypectomy Snare for the Resection of Colorectal Polyps

This clinical trial is being conducted to assess whether the rotary polypectomy snare could decrease the time to removal of colorectal polyps


Eligibility Criteria:
Inclusion Criteria:

18-85 year;

Patients with colorectal polyps ;

informed consent;

Exclusion Criteria:

patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure;

known coagulopathy;

history of inﬂammatory bowel diseases;

Hemodynamically unstable;

pregnancy