cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
* Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
* Females of non-childbearing potential (surgically sterile \[hysterectomy or oophorectomy\] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
* Males must be unable to procreate (defined as surgically sterile \[i.e., had a vasectomy ≥6 months prior to screening\]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
* Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).

Exclusion Criteria:

* Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
* Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
* Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
* Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
* Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.
Developing a Simple Recognition System of Acromegaly

We will compare the features of 3D stereophotography of acromegaly patients with that of healthy people. We hope to develop a computerized model to help screening acromegaly patients for early detection and treatment.

Background: Acromegaly is a slowly progressive disease caused by growth hormone (GH) excess. The estimated prevalence of the disease is 40 cases/1000000 population with 3-4 new cases/1000000 population per year. Most patients have classic manifestations due to acral and soft tissue change, including thickening of the calvarium, increased size of frontal sinus, enlargement of the nose, prognathism, and widely spaced teeth. The hands and feet are large, thickened and bulky. Acromegaly was also associated with many comorbidities including cardiovascular complications (acromegalic cardiomyopathy and arterial hypertension), respiratory complications (sleep apnea), metabolic complication (impaired glucose tolerance, diabetes mellitus), joint and bone complications (carpal-tunnel syndrome, osteoarthritis).3 The outcome of growth hormone level suppression after transsphenoidal surgery is far better for microadenomas (80-90%) than for macroadenomas (less than 50%). Furthermore, higher growth hormone level at diagnosis was related to poor prognosis. An early detection of acromegaly with early intervention was desirable. However, due to the slowly progression of the disease, times from symptom onset to diagnosis were 5.2 to 5.9 year4.

Current method to diagnose patients with acromegaly was to check serum GH and insulin-like growth factor 1 (IGF-1). However, tests for growth hormone and IGF-1 are currently unavailable in most hospitals in Taiwan and were expensive. We want to find a better screening tool for acromegaly with less expensive and high efficacy. Due to specific facial appearance of acromegaly, there were studies to recognize acromegaly by computer program1,2,3. They tried to develop computer programs to separate facial photographs of patient with acromegaly and normal subjects. The accuracy could reach 71.9% to 86%. Due to enlarged hand with increased soft tissue in patients with acromegaly, we also want to compare the difference of face, hand and feet morphology and face, hand and feet X ray of acromegaly patients with those of normal population. We hope to set a computer model to early detect acromegaly patients in Chinese people.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years old, Acromegaly patients or Healthy Adults

Exclusion Criteria:

* Pregnancy. Age less than 20 years old or older than 80 years old
Effect of Phonophoresis With Vitamin B12 on CTS

The purpose of this study is to investigate efficacy of phonophoresis with vitamin B12 on median nerve distal latency, pain level and hand grip strength in patients with carpal tunnel syndrome. At least Fifty four Patients from both sexes will be recruited for this study from various hospitals in 6th October city

* Group A (n = 27): will receive Phonophoresis with Vitamin B12 gel.
* Group B (n = 27): will receive placebo phonophoresis with Vitamin B12 gel.

Median nerve distal latency, hand grip strength and numerical pain rating scale will be measured at baseline and after 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. at least Fifty Four patients with Mild to moderate CTS.
2. Age will range between 18 to 60 years old.
3. All patients will have Body mass index between 18.5 and 29.9 kg/m2.
4. Diagnosed by a physician according to American Association of Electrodiagnostic recent guidelines. (Jablecki et al., 2002).
5. A positive clinical provocative tests for CTS (Tinel test and Phalen test),
6. Patients with history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking.

Exclusion Criteria:

1. Diabetic patients.
2. Hypertension patients.
3. Pregnant women
4. Cardiovascular patients
5. Patients with cervical spondylosis
6. Patients with cervical disc prolapse
7. Patients with Thoracic outlet syndrome
8. Patients with Carpal tunnel release surgery
Eccentric Exercise and Fatigue in Multiple Sclerosis

The goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: is eccentric resistance training more fatiguing than traditional resistance training in persons with MS?. Participants will be asked to come for two sessions for two weeks. In the first week, subjects will undergo a bout of either traditional or eccentric resistance training. The next day they will return to assess their level of fatigue. The following week the subject will return and undergo whatever type of training they did not experience the first week, and it's effects on fatigue will again be assessed. The difference between the subjects level of fatigue for either condition will be compared.

Persons with multiple sclerosis (MS) have mobility deficits. Exercise is commonly used to treat these mobility deficits, but must be done so judiciously in order to limit the effects of fatigue, one of the most common disease findings. In persons with MS ,fatigue can limit the amount of exercise performed. Eccentric training, where a muscle is lengthened under resistance has been shown to produce greater gains in strength with less energy expenditure when compared to traditional strength training where a muscle is both lengthened and shortened under resistance. However, eccentric strength training has been shown to result in delayed onset muscle soreness, which may also limit how much exercise a person with MS can perform. The purpose of the study is to compare the impact of eccentric versus traditional strength training programs on fatigue and persons with multiple sclerosis. The hypothesis is that there will be no difference in fatigue measurements between the two conditions. If the hypothesis is correct, it will suggest that eccentric training should be the subject of further study to assess it's feasibility and effectiveness, in treating mobility deficits in person with multiple sclerosis.

A randomized crossover design will be used. Ambulatory participants with a diagnosis of MS will be randomized into either a eccentric or traditional training condition. Each training condition will consist of a single session of training. The following day, the patient will return and their levels of fatigue assessed. The next week, the subjects will return and crossover, undergoing whatever type of training they did not experience in the previous week, and the impact of the training will again be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of Multiple Sclerosis.
* Ability to walk for 6 minutes continuously with or without assistive device
* Ability read, understand and sign and informed consent

Exclusion Criteria:

* Evidence of recent exacerbation in the last 2 months prior to starting the study
* Orthopedic, cardiopulmonary, or non -MS neurologic condition that could interfere with carrying out the study protocol
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects

This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).


Eligibility Criteria:
Inclusion criteria:

* Subjects with mild to moderate stable asthma but no other lung problems.
* Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
* Non-Smokers.
* Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.

Exclusion criteria:

* Any significant illness.
* Subjects with heart problems.
* Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
* Subjects who take medication for their asthma, or other conditions, not compatible with this study.
* Subjects who are over sensitive to salbutamol or to ipratropium.
Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients

The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis \> 50%.

Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patients in women\> 60 yo or men \> 55 yo, with high risk of coronary artery disease (EF \< 40%, ECG abnormalities, renal failure , 2 others risk factors of atherosclerosis)

Exclusion Criteria:

* previous documented CAD acute coronary syndrome
Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)

The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention.

This study is a randomized, prospective, multi-center, efficacy study with a DES control group assessing the 6-month loss in FFR in patients treated with the "matrix coated paclitaxel-eluting PTCA-balloon catheter" SeQuent® Please and commonly used DES for small vessel de novo and side branch lesions. 100 patients will be studied in total with two equivalent treatment groups DEB \& DES of 50 patients each.

Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years of age.
* Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
* Patients must agree to undergo the angiographic 6-month and clinical follow-ups at 12 and 36 months.
* De novo coronary lesions including side branches in native coronary arteries (reference vessel between ≥ 2.0 and ≤ 3.0 mm, lesion length ≤ 25 mm as angiographically documented)
* Diameter stenosis pre procedure must be either ≥ 70 % or ≥ 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris.
* Fractional Flow Reserve (FFR) must be less or equal to 0.75.

Exclusion Criteria:

* Patients with a life expectancy of less than 12 months
* Patients that were treated with one or more DES during the last 12 months which would not allow 3-month dual antiplatelet therapy if the patient were randomized in the DEB treatment group.
* Patients who are obliged to be on dual antiplatelet aggregation therapy for more than 3 months following study inclusion
* Patients with acute (\< 24 h) or recent (48 hours) myocardial infarction
* Patients with severe congestive heart failure or with severe heart failure NYHA IV or with severe valvular heart disease
* Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP and/or fluid challenge)
* DES treated lesion(s) during the last 12 months.
* Thrombus burden (STEMI, NSTEMI) and/or total occlusion in the culprit segment
* In-segment stenosis of the native vessel within the 5 mm adjacent to the stent
Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study

A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.

160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.

Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy above week 37
* Indication to induce birth
* Unripe cervix
* Term date set by US before week 21

Exclusion Criteria:

* Ripe cervix
* Prematurity (\<37w)
* IUFD
* Letal malformations
* Low lying placenta
* Multiple pregnancies
* Breakage of amniotic fluid
* The woman does not understand norwegian
Risk Identification Factors for Pulmonary Function Impairment in AIDS Patients Recovered From Severe Pneumonia

Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population.

This is a prospective, single-center, non-randomized, clinical observational cohort study. It involves monitoring lung function at discharge (baseline, 0w), and at the 4th, 8th, 12th, 24th, and 48th weeks in patients recovering from severe pneumonia with AIDS. Basic demographic data, HIV RNA quantification, routine blood tests, blood biochemistry, arterial blood gas results, oxygenation index, immune function (CD3+, CD4+, CD8+ T cell counts), and imaging studies are also collected. Multifactorial logistic regression analysis is used to screen for clinical predictors of lung function decline in patients recovering from severe pneumonia

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection;
2. Progression to the AIDS stage: CD4+ count \<200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;
3. Age between 18 to 65 years;
4. Meet the diagnostic criteria for severe pneumonia, with reference to the 2021 treatment guidelines for community-acquired pneumonia developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA).

Exclusion Criteria:

1. Concurrent central nervous system lesions, severe liver disease, or cirrhosis;
2. Concurrent AIDS-related or non-related tumors;
3. Women who are pregnant or breastfeeding;
4. Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;
5. Alcohol abuse or drug use;
6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial
Early Use of Airway Pressure Release Ventilation (APRV) in ARDS

Airway pressure release ventilation (APRV) is a time-cycled, pressure controlled, intermittent mandatory ventilation mode with extreme inverse I:E ratios. Currently it is considered as a non-conventional ventilatory mode. The investigators aim to compare APRV with conventional mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS).

Despite the advances in technology and ventilatory modes, mortality of ARDS is still around 40%. Besides prone positioning, the best approach of management is low tidal volume ventilation (LTV). This 'protective ventilation' strategy is not aways effective to improve oxygenation and is associated with an increased requirement of sedation and neuromuscular blocking agents, which increase length of stay and morbidity. APRV is a ventilatory mode based on relatively high and sustained continuous positive pressure, combined with a short phase of release to allow carbon dioxide removal. It also allows unrestricted spontaneous breathing throughout respiration, independent of the ventilator cycle. Providing sustained inflation while limiting duration and frequency of release phase permits limiting volume loss, resulting in progressive and improved alveolar recruitment, an increased alveolar surface area available for gas exchange and improved ventilation-perfusion matching.

In this multi-center, prospective, randomized, controlled, open trial, the investigators aim to compare the effects and safety of the early application of time-controlled adaptive method of APRV and conventional ventilation with LTV strategy in patients with severe to moderate ARDS.

Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory distress syndrome, according to the Berlin definition of ARDS, with adjusted pO2/FiO2 for altitude \<300, and less than 48 h of endotracheal mechanical ventilation

Exclusion Criteria:

* Pregnancy
* Less than 18 years-old
* Expected duration of mechanical ventilation less than 48 h
* Preexisting conditions with an expected 3-month mortality exceeding 50%
* Concurrent chemotherapy
* Confirmed intracranial hypertension
* Catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation
* Pneumothorax at enrollment (resolved or not)
* Do-not-resuscitate order
Clinical Study on the Effect of a Synbiotic on Body Fat Mass

In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors for CVD and diabetes in overweight type 2 diabetics is investigated.

The effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat and liver steatosis were shown by several meta-analyses for the total variety, as described above. Some probiotic species/strains, however, seem to be more efficacious. The lactobacilli used in this trial were selected for their anti-inflammatory properties and based on induction of defensins in enterocytes. Therefore, one may expect more pronounced effects of these strains on traits of the metabolic syndrome, which is driven by low grade inflammation, than those found in the meta-analyses for the whole variety of probiotics without discriminating species and strain specificity.

The combination of these Lactobacillus strains with acacia gum is expected to enable even more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in the gut and, hence, are supposed to promote their propagation and, hence their effects. The dosage of 10 g/day acacia gum was demonstrated to be sufficient for enhancing fecal lactobacilli and bifidobacterial.

Eligibility Criteria:
Inclusion Criteria:

1. Overweight or obese (BMI ≥ 25)
2. Type 2 diabetes
3. Age ≥ 18
4. Written informed consent

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from enrollment into the study:

1. Subjects currently enrolled in another clinical study
2. Subjects having finished another clinical study within the last 4 weeks before inclusion
3. Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
4. Condition after implantation of a cardiac pacemaker or other active implants
5. Antidiabetic drugs except metformin
6. Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
7. History of hepatitis B, C, HIV
8. History of or present liver deficiency as defined by Quick \< 70%
9. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics containing supplements etc.)
10. Major cognitive or psychiatric disorders
11. Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
12. Simultaneous study participation by members of the same household
13. Pregnancy and lactation
14. Any diet to lose body weight
15. Eating disorders or vegan diet
16. Anorexic drugs and laxatives
17. Present drug abuse or alcoholism
18. Legal incapacity
Lignocaine Nebulization for Attenuation of Intubation Stress Response

To study the effect of lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia

The pressor response to laryngoscopy and tracheal intubation is a very important issue in hypertensive pregnant patients that can lead to increased maternal intracranial pressure, cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal mortality. The catecholamine release associated with laryngoscopy and intubation also causes uteroplacental vasoconstriction and adversely affect the neonate well-being.

Therefore, the precise control of stress is necessary during general anesthesia in pre-eclamptic patients.Various drugs are used to suppress the pressor response including opioids, lidocaine, along with α and β adrenergic blockers.

in this study the investigators will evaluate the effect of lignocaine nebulization on attenuation of the pressor response.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia
* Scheduled for caesarean deliveries under general anesthesia

Exclusion Criteria:

* severe obesity (BMI ≥ 40 )
* Cardiac patients
* History of diabetes
* Renal dysfunction (Elevated creatinine ≥ 2 mg\\dl)
* Hepatic dysfunction (Elevated hepatic enzymes three times above normal value)
* Known fetal anomalies