cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients

The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma.

The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma. At the start of the trial all patients in conjunction with their physicians will select a program of mild to moderate physical activity or exercise to be adopted and maintained on a routine basis. All patients will record perceived exertion and pedometer measurements in a log diary. All patients will be contacted by telephone at set time intervals to encourage them to continue their selected physical activity or exercise. Patients randomized to the intervention arm will also receive induced positive affect and self-affirmation throughout the study period. Patients in the control arm will not receive the positive affect and self-affirmation components.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for this study

* if their physicians consider them medically able to participate, if they are 18 years of age or older
* if they have a diagnosis of mild to moderate asthma based on the NHLBI Asthma Expert Panel's classification system which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function.

Exclusion Criteria:

Patients will be excluded from this study for the following reasons:

* If they are unable to walk several blocks for whatever reason;
* If they have musculoskeletal or neurological deficits that preclude increased physical activity;
* If they have other pulmonary diseases;
* If they have cardiac disease or other severe comorbidity;
* If they are unable to provide informed consent because of cognitive deficits;
* If they refuse to participate.
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.


Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of asthma established for at least 2 years
* Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
* Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
* Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
* At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose

Key Exclusion Criteria:

* Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
* History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
* Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
* History of any cardiovascular, neurological, hepatic, or renal condition
* History of smoking within the past 12 months
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin

The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time. All patients are followed through 144 weeks after initiation of antiviral therapy. The primary objective are to compare the proportion of patient who achieve undetectable plasma HIV-1RNA\<50 copies/ml at week 48. The previous reports demonstrated that the standard doses of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis patients who receiving rifampicin even though plasma levels are somewhat reduced by rifampicin. However, there have been not been a randomized control trial to compare these two regimens. Thus, this trial will provide the efficacy data between these two regimens.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Positive Serology for HIV-1
* Naïve to antiretroviral therapy
* Baseline CD4 cell counts \<250 cells/mm3
* Diagnosed active tuberculosis by clinical features and/or positive acid fast stain and/or positive culture
* Received rifampicin at least 4 weeks but not exceed 16 weeks prior to enrollment
* Willing to participate and sign inform consent

Exclusion Criteria:

* Aspartate transferase enzymes (AST) or alanine transminase enzyme (ALT) \>5 times of upper limit
* total bilirubin \>3 times of upper limit
* serum creatinine) \>2 times of upper limit
* pregnancy or lactation
* receiving immunosuppressive drugs
* receiving any drugs that may have drug-drug interaction with nevirapine and rifampicin
* chronic alcoholic drunken and intravenous drug users
* Previously received single dose of nevirapine to prevent mother to child transmission
* positive for serum cryptococcal antigen
GA 6: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide

This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.

A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes, treatment: lifestyle changes or metformin
* HbA1c \< 75 mmol/mol

Exclusion Criteria:

* diagnosed liver disease
* eGFR \< 60 ml/min/1,73m2
* NYHA III or IV
* anemia.
Influences of Types of Skull Surgery on Temporomandibular Joint Performance

There are two purposes on this study:

- to investigate the effect of craniectomy and craniotomy on temporomandibular joint TMJ) movement, function and quality of life (QoL)


Eligibility Criteria:
Inclusion Criteria:

* over 20 years old
* post-craniotomy or post-craniectomy
* able to follow order

Exclusion Criteria:

* severe orofacial injury
* severe teeth loss
* significant changes of occlusion
Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults

The main purpose of this randomized controlled trial was to assess the feasibility and acceptability of a 12-week Tai Chi program for community-dwelling older adults with chronic multisite pain and a history of falling. In addition, the investigators examined the effects of Tai Chi on pain characteristics, cognition, physical function, gait mobility, levels of pain-related biomarkers, fear of falling and rate of falls in these older adults.

Older adults aged ≥65 years with multisite pain who reported falling in the past year or current use of an assistive device were recruited from Boston area communities. Participants were randomized to either a Tai Chi (N=28) or a light physical exercise (N=26) program, offered twice weekly for 12 weeks. The primary outcomes were feasibility and acceptability of the 12-week Tai Chi/light exercise program. Secondary outcomes included pain characteristics (pain severity and pain interference), cognition (attention and executive function), physical function (walking speed, strength, and balance), gait mobility (singe-task and dual-task gait), levels of pain-related markers (C-reactive protein, interleukin 6, tumor necrosis factor alpha, and beta endorphin), fear of falling, and rate of falls.

Eligibility Criteria:
Inclusion Criteria:

* Age of 65 years and older
* Multisite (2 or more sites) musculoskeletal pain
* At least one fall in the past year, or currently on an assistive device
* A sedentary lifestyle
* Be able to walk 20-feet without personal assistance
* Be able to communicate in English.

Exclusion Criteria:

* Regular Tai Chi practice
* Unstable cardiac disease
* Stroke
* Rheumatoid arthritis
* Degenerative neuromuscular disease
* Parkinson's disease
* Terminal disease
* Dementing illness
Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.


Eligibility Criteria:
Inclusion Criteria:

* The subject has completed the full dosing period in Protocol 137-150.
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.


Eligibility Criteria:
Inclusion Criteria:

* Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
* Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
* Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
* No evidence of liver cirrhosis.

Exclusion Criteria:

* Positive screen for drugs or alcohol.
* Significant sensitivity to any drug.
* Use of contraindicated medications within 2 weeks of dosing.
* Certain predefined abnormal laboratory tests.
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to:

* investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and
* to validate the CDAI for arthritis in systemic sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile and adult Systemic sclerosis patients, with diagnosis according to the ACR/EULAR adult SSc criteria and PRES/ACR/EULAR juvenile SSc criteria respectively
* Clinical signs of arthritis (defined as ≥2 tender and swollen joints)

Exclusion Criteria:

* Presence of significant, long standing articular pain due to other cause than autoimmune disease
* Presence of hand disability caused by other, than autoimmune disease
The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia

The primary purpose of this study is to show whether WBV application has antispastic effect. The secondary aim is to demonstrate whether WBV has neuromodulatory activity on increased stretch reflex and motor neuron activity, which is the basis of the pathophysiology of spasticity.Hypotheses of this study:Whole body vibration in poststroke hemiplegia reduces ankle plantar flexion spasticity.

1. WBV ; reduces plantar flexor spasticity after stroke
2. WBV decreases poststroke spasticity, by decreasing increased stretch reflex and motor neuron activity.

Patients with a stroke of at least 1 month before and with a history of ankle plantar flexion spasticity will be included in the study. Conventional rehabilitation program will be applied to all patients (n=48).The intervention group (n=24) will be applied for 4 weeks, 3days a week, a total of 12 sessions with the WBV powerplate pro5 device. In the WBV group, the frequency and acceleration of vibration will be 30Hz and 18.0m/s2, respectively. The WBV exercise intensity will progressively increase throughout the twelve-session. In the control group, the same procedures will be followed. However, unlike the WBV group, a vibration will be given whose acceleration is attenuated by 99.5%.The surface Electromyography (EMG) and degree of spasticity of soleus muscle will be evaluated at the beginning and end of the all sessions. Soleus H-reflex will be recorded with surface EMG.To obtain the H-reflex response, the posterior tibial nerve in the popliteal region will be stimulated by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records will be taken with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on skin according to the SENIAM protocol. The degree of spasticity will be measured as a soleus muscle tone torque on a fixed angular velocity moving platform.The data will be recorded with the PowerLab data acquisition device

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic / hemorrhagic poststroke hemiplegia aged 18-90 years,
2. Stroke time ≥1 months,
3. Ankle plantar flexor spasticity MAS ≥1,
4. Brunnstrom stage ≥3 for lower extremity,
5. Patients who were standing for more than five minutes and had a static balance

Exclusion Criteria:

1. Cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
2. Lower extremity fracture,
3. Findings or suspicion of active deep vein thrombosis,
4. A history of deep vein thrombosis and pulmonary embolism,
5. Orthostatic hypotension
6. Resistant hypertension,
7. Peripheral nerve lesions such as polyneuropathy, radiculopathy
8. Active inflammatory, rheumatologic or infectious disease,
9. Ankle,knee or hip joint contracture,
10. Presence of panic attacks,
11. Patients with dizziness and balance problems,
12. Patients with not intact skin surface to connect electrodes
13. Patients with communication problems: aphasia, major depression
14. Epilepsy
15. Patients who received botulinum A toxin in the last 6 months
Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation.

To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Healthy volunteers;
* Registered in the national register of healthy volunteers;
* Male or female aged from 18 to 45 years old;
* Able to understand the study instructions;
* Likely to comply with the study schedule and treatment;
* Normal subjective ocular symptoms, Schirmer test \> 10 mm in 5 min and corrected visual acuity \>= 6/10 in both eyes

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Blepharitis;
* Conjunctival hyperaemia (score \>= 2);
* Fluorescein-stained punctuations (score \>= 1b);
* Hypersensitivity to one of the products used in the study;
* Clinically relevant allergy;
* Medical or surgical history incompatible with the study;
* Recent acute illness;
* Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
* Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
* Systemic antibiotics and ocular medications within the last month;
* Contact lenses within the last week;
* Any medication on Day 0 and during the study (except paracetamol and contraceptives).
Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants

This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-CORT125281 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0 to 30.0 kg/m\^2, inclusive
* Provide written informed consent
* Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
* Able to swallow capsules
* Adhere to specified contraception requirements.

Exclusion Criteria:

* Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT125281 at any time
* Have a pregnant partner
* Employees or immediate family members of employees of the study site or Sponsor
* History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
* Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
* Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017; greater than background radiation exposure from other sources exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
* Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
* History of clinically significant cardiovascular, renal, hepatic, respiratory or gastrointestinal disease, neurological or psychiatric disorder
* History and/or symptoms of adrenal insufficiency or any condition that could be aggravated by glucocorticoid blockade (e.g., an autoimmune disease; allergy requiring treatment)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies within 1 week (longer restrictions apply for some medicines).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.


Eligibility Criteria:
Inclusion Criteria:

* Steroid refractory lupus nephritis

  * more than 10mg of steroid failed to control disease activity
  * patients who failed to reduce the amount of steroid
  * patients who couldn't increase the amount of steroid due to side effects

Exclusion Criteria:

* Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
* Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
* CNS( Central Nerve System) Lupus patients
* hepatic failure patients
* Serum creatinine ≧1.5mg/dL
Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma

The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.

Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged \>= 18 years.
* Patients with severe persistent allergic asthma with the following characteristics:
* FEV1 (Forced Expiratory Volume in One Second) \<80% of predicted.
* Frequent daily symptoms (\>=4 days/week on average) or nocturnal awakening (\>=1/week on average).
* Multiple severe asthma exacerbations: either \>=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
* Despite a high dose inhaled corticosteroid \>1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
* With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
* Total serum IgE level \>= 30 to \<=700 IU/ml and suitable serum total IgE level and weight according to Xolair dosing tablets.

Exclusion Criteria:

* Age \< 18 years.
* Smoking history \> 20 pack years.
* Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
* History of food or drug related severe anaphylactoid or anaphylactic reaction
* Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
* Patients with active cancer, suspicion of cancer or any history of cancer.
* Pregnant women.
* Known hypersensitivity to omalizumab or to one of its components.
* Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
* Patients who had participated in a clinical trial in the past 3 months.
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 65 years of age
* Patients undergoing primary kidney transplantation

Exclusion Criteria:

* Recipients of multiple organ transplants
* Prior therapy with CellCept
* Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
* Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept