cyrilzakka/clinical-trials huggingface dataset:
The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men.

Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to check if there is a correlation between serum or hair testosteron levels and serum or hair cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation between serum and hair testosterone levels and cortisol levels and serum inflammatory markers.

If such correlation will be found- then it is possible that excess cortisol or an abnormal inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.

Eligible participants are type 2 diabetic men who visit our clinic, as part of their routine medical surveillance, and other 10 healthy volunteers (men) as a control group.

All the participants will sign an informed consent form. The study will include 30 type 2 diabetic men, (40-55 years old) and 10 healthily volunteers (same age group).

In addition to routine blood test of blood count, kidney function and liver enzymes will be taken blood samples of total testosterone serum levels, total cortisol serum levels and serum inflammation markers levels, and also a sample of head-hair for cortisol and testosterone levels (1 cm of occipital hair weighing 50 mg).

Optional: from patients who will agree to visit the clinic after 8 hours-fast will be also taken one additional blood sample of fasting glucose, insulin and C-peptide levels, in order to estimate their insulin resistance status, and it's possible correlation to the other measures.

From the 10 healthy volunteers In addition will be taken blood and hair samples of the above parameters, as a control.

Eligibility Criteria:
Inclusion Criteria:

* men age 40-55
* type 2 diabetic

Exclusion Criteria:

* HIV
* septic disease
A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects

This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects

This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.

Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.

Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.

Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males between the ages of 18 and 45 years, inclusive
* Normal clinical chemistry, hepatic function, hematology, thyroid function
* Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
* Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
* Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0

Exclusion Criteria:

* Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
* Current treatment or treatment within 30 days with another investigational medication
R3THA Rehabilitation Feasibility and Usability Study

The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.


Eligibility Criteria:
Inclusion Criteria:

1. must be between the ages of 20 and 80
2. must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
3. must have internet access at home.
4. must be comfortable performing basic functions on a computer, such as browsing the internet.
5. must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.

Exclusion Criteria:

Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.

2) Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke
Evaluating for a Correlation Between Osteopathic Examination and Ultrasonography on Thoracic Spine Asymmetry

Context: Thoracic spine is a common area of focus in osteopathic manipulative medicine (OMM) for a variety of conditions. Thoracic spine somatic dysfunction diagnosis is achieved by palpating for asymmetry at the tips of the transverse processes. Previous studies reveal that, instead of following the rule of threes, the transverse processes of a given thoracic vertebra generally align with the spinous process of the vertebra above. Ultrasonography has been widely used as a diagnostic tool to monitor musculoskeletal conditions. Ultrasound has the advantage of absence of radiation, and has shown comparable results to gold standard modalities like MRI in some areas of the spine. In the case of thoracic somatic dysfunction, ultrasound can be used to determine the location of each vertebral transverse process and its relationship with the spinous process. Previous studies have investigated the correlation between osteopathic manipulative medicine and ultrasonography of the cervical, lumbar, and sacral regions. However, no study has yet compared osteopathic structural examination with ultrasonographic examination of the thoracic vertebral region.

Objective: To determine whether there is a dependable correlation of osteopathic palpatory findings of the thoracic transverse processes with the measurements of ultrasonography.

Methods: Subjects were student volunteers recruited from the Midwestern University - Glendale campus. A non-toxic, non-permanent marker was used to mark bony landmarks on the skin to be used by the osteopathic examiners. Two osteopathic physicians (OMM1, OMM2) separately performed structural exams by palpating T2-T5 transverse processes to determine vertebral rotation. Two trained sonographers (US1, US2) separately scanned and measured the distance from the tip of the spinous process to the adjacent transverse processes of the vertebral segment below. Demographic variables were summarized with mean and standard deviation. Interexaminer reliability was assessed with percent agreement, Cohen's Kappa, and Fleiss' Kappa. Recruitment and protocols were approved by the MWU Institutional Review Board.


Eligibility Criteria:
Inclusion Criteria:

* First- and Second-year osteopathic medical students who received an email notification
* Masters program students who received an email notification

Exclusion Criteria:

- A history of or currently diagnosed with scoliosis, spondylosis, spondylolisthesis, herniated disc, spinal fracture, or surgery to the spine
Influence of Inhaler Compliance on the Treatment of Asthma Patients

The major goal of "Influence of Inhaler Compliance on the Treatment of Asthma Patients" is to explore compliance rate outcome in adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to American Thoracic Society (ATS) definition and diagnosis. The major endpoints include:

1. To increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by Asthma Supportive Kits
2. Eventually achieve best asthma care and management.

All participants will use Asthma Supportive Kits for 24 weeks and return visit on week 5, 12, 24. Based on collected data, the study compares intervention and control group to see if active reminder intervention may effectively alter compliance rate, and corresponding outcomes, e.g., asthma control status, acute exacerbation events.

1. Upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an MDI medicine.
2. The asthma supportive kit registers every puff taken when the patient uses his/her MDI. The records are monitored by study nurses and calculated compliance ratio on rolling basis.
3. By enrollment, the patient is RANDOMLY assigned to Intervention and Control group. For the Intervention group in each study phases, when the given compliance ratio drops below 80% (as monitored by asthma supportive kit), the study nurse will actively engage to remind on medicine taking. For the Control group, the compliance ratio is calculated but to active engagement is applied.
4. All the patients adheres with regular asthma treatment mechanism, regardless to group assigned.

Eligibility Criteria:
Inclusion Criteria:

1. Adult asthmatic patients (20-80 years old)
2. With mild to moderate persistent asthma according to ATS definition and diagnosis
3. Willing to use Budesonide+Formoterol.
4. Adequately use inhaler
5. Without evident intentional non-adherence
6. Agree asthma is a common and potentially serious chronic disease
7. Willing to sign Informed Consent Form

Exclusion Criteria:

1. Inadequately use inhaler
2. Disagree asthma is a common and potentially serious chronic disease
3. With uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;
Haemochromatosis and Periodontitis

Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. It is strongly associated with the major pathogenic "red complex", including Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an infection. Recent advances in the pathogenesis of periodontal disease have suggested that polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response can induce inflammation-mediated damage in periodontal tissues2-4. Interestingly, currently periodontitis is associated with a growing number of systemic diseases, including cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary haemochromatosis8.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 35 to 64 years with homozygosity hemochromatosis C282Y
* Patients regularly enrolled in a health insurance plan
* Patients with at least 10 natural teeth
* Patients who have given informed written, dated and signed consent

Exclusion Criteria:

* Diabetic patients
* Simultaneous participation in another study
* Pregnant or lactating women
* The incapacitated persons and persons deprived of their liberty
* Patients who do not speak French, both written and spoken
* Patients previously included in this trial
* Patients with heart valves or endovascular equipment (risk of infective endocarditis ...)
* Patients with a history of maxillofacial surgery
* Patients whose oral status is considered incompatible with entry into the study, at the discretion of the investigator
* Patients on drugs that can cause gingival hypertrophy, such as Hydantoins (phenytoin), Dihydropyridines, Diltiazem or Ciclosporin
* Patients on medication that can cause gingival bleeding (anticoagulants, antiplatelet agents and aspirin).
Analysis of Predictive Factors for Urinary Leakage After Partial Nephrectomy for Renal Hilum Tumors

In this study, we plan to explore the risk factors closely related to the occurrence of urinary leakage after partial nephrectomy for renal hilum tumors through retrospective analysis of multicenter clinical data, thereby providing clinical guidance value for the prevention of postoperative urinary leakage.


Eligibility Criteria:
Inclusion Criteria:

* CT or MRI angiography indicates a renal hilum tumor, and the patient has undergone partial nephrectomy;
* The Eastern Cooperative Oncology Group (ECOG) performance status score is between 0 and 1, and the age is between 18 and 75 years old;
* The clinicopathological data are complete;
* There is no infection, autoimmune disease, hematological disease, or other malignancies.

Exclusion Criteria:

* The patient has surgical contraindications;
* There are congenital malformations of the urinary system, obstructive nephropathy, or other diseases that seriously affect the function of the urinary system before surgery;
* The patient has received relevant treatments that may affect the results of this study, such as radiotherapy in the kidney area, a history of kidney surgery, etc.;
* There are tumors in both kidneys.
Characterization of Two Novel Mutations in the Apob Gene

The pilot study has the target to evaluate the outcomes of two novel mutations in the gene of Apolipoprotein B (ApoB). ApoB is the main part of the low-density lipoprotein (LDL). LDL is the main transporter of cholesterol from the liver to the periphery. The two novel mutations lead to a heavily truncated Apolipoprotein B. Therefore the patients show severely decreased ApoB and LDL-Cholesterol levels. The acquired disease is known as "Familial Hypobetalipoproteinemia". Beside the protection from cardiovascular disease due to decreased LDL-Cholesterol, patients tend to show elevated serum aminotransferases, fatty liver and occasional cases of cirrhosis and carcinoma.

To elucidate the differences in lipoprotein assembly the investigators aim to characterize the changes due to the mutations in the patients. Family members not carrying the mutations are the control group. The assessment includes lipoprotein fractionation, MRI scans of the liver and a thorough assessment of medical history of all patients to look for potential side effects of the mutation.

The only intervention needed for the study is to draw blood samples of every participant. The necessary positive vote from the ethics committee of the Medical University of Innsbruck is given.


Eligibility Criteria:
Inclusion Criteria:

* Full legal age
* Written Informed Consent
* Diagnosed hypobetalipoproteinemia
* Exception of it are the controls
* Controls have to be family members
* Exclusion of a truncating mutation in the ApoB gene

Exclusion Criteria:

* No diagnosed hypobetalipoproteinemia
* No truncating mutation in the Apo B gene
* Exception of it ar the controls
Neck-Trunk Stabilization Exercises and Bobath Therapy Spastic Diplegic Cerebral Palsy

Physiotherapy is widely used in the treatment of children with cerebral palsy. This study is conducted to identify the most appropriate physiotherapy approach. The purpose of the study is to compare two physical rehabilitation strategies i.e., Neck-trunk stabilization exercises and Bobath therapy, to investigate their effectiveness on trunk control and upper limb function. The aims of treatment are to influence muscle tone and improve postural alignment by specific handling technique.

The study will be a Randomized Clinical Trial conducted at the physiotherapy outpatient clinic of the tertiary care hospital in Sialkot, Idrees Hospital. Following the approval of the BASR, the study will be completed within six months. The sample will be taken using a non-probability convenient sampling technique, and the sample will be randomly divided into two groups. A sample size of 44 patients will be taken in this study. There will be two groups. Both groups will receive conventional therapy consisting of stretching, strengthening, range-of-motion exercises, positioning, and electrical stimulation. Group A: This group will receive Neck-Trunk Stabilization exercises. Group B: This group will receive Bobath therapy. The total intervention protocol will be given for six weeks' duration, with three sessions per week of about 45 minutes each. Outcome measures tools will be Segmental Assessment of Trunk Control (SATCo) and Manual Ability Classification System (MACS). Children with spastic diplegic cerebral palsy will be measured at baseline and after 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with spastic diplegic cerebral palsy
* Children with score of GMFCS \[2\] \[3\] \[4\] levels(2, 16).
* Signed consent form from parents/guardians.

Exclusion Criteria:

* Children with visual impairments
* Children with major auditory impairments
* Children with previous orthopedic surgery and Botulium toxin-A injection at least for 6 months
* Children having pharmacological intervention for the inhibition of spasticity
* Contractures
* Uncontrolled seizures
* Focal spasticity
eegCap Application in Paediatrics wiTh redUced GCS in REsus

Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as \< 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.

See study protocol attached

Eligibility Criteria:
Inclusion Criteria:

Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) \< 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline

Exclusion Criteria:

* Polytrauma
* Open head wounds
* Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management
GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment.

Our hypothesises are:

Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint).

1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints).
2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study.
3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.
4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CD based on accepted endoscopic and histological criteria (according to ECCO guidelines (17) )
* Age ≥18 years
* A minimum disease duration of five years
* Remission defined by Faecal calprotectin \< 100 and CRP level within normal values for a minimum of 1 month
* Baseline values:

  * CRP normal
  * Faecal calprotectin \< 100
* Ileocoecal and/or colic localization of disease (Montreal phenotype classification)
* One or more IBS-like-symptoms (abdominal pain and discomfort, diarrhea, constipation)

Exclusion Criteria:

* Stricturizing CD
* Obvious stenotic symptoms
* Previous major gastrointestinal surgery
* Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)
* Medication altering gastrointestinal motility
* Hepatobiliary disease (PSC)
* Diabetes Mellitus
* Metabolic disorder
* Bacterial overgrowth (hydrogen breath test)
* Planned MR scan in the four weeks following capsule intake (safety precaution)
* Abdominal diameter \> 140 cm
* Implanted electronic devices (pacemaker, ICD, etc.)
* Diagnosed sleep disorder
* Pregnancy and breast feeding
Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma

The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.


Eligibility Criteria:
Inclusion Criteria:

* Persistent asthma for more than 1 year
* Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
* In good health as demonstrated by medical history and physical exam
* Negative urine pregnancy test
* Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy

Exclusion Criteria:

* Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
* Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study
* History of chronic pulmonary diseases other than asthma
* Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study
* Current tobacco usage
* Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
* History or evidence of drug or alcohol abuse
* Diagnosis or evidence of an infectious illness within one month of Visit 1
* Clinically significant diseases as assessed by the study doctor
* Participation in another clinical study with an experimental drug within one month of start of the study