cyrilzakka/clinical-trials huggingface dataset:
A Study of BGM0504 in Participants with Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);

  * Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (\< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose \<1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.
  * Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
  * Be of stable weight (± 5%) for at least 3 months before screening;
  * Have HbA1c between ≥7.5% and ≤11.0%；

Exclusion Criteria:

* ■ Previous diagnosis of type 1 diabetes, special type diabetes;

  * There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
  * Have had chronic or acute pancreatitis any time prior to study entry;
  * Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
  * Mentally incapacitated or speech-impaired;
  * Suspected or confirmed history of alcohol or drug abuse;
  * Pregnant or lactating woman;
  * The investigator considers that there are any other conditions that make it inappropriate to participate in this study.
Impact of Exclusive Breast-Feeding in Guinea Bissau

Exclusive breastfeeding is promoted by the World Health Organization (WHO) with the aim of improving infant health. The specific objective of the study was to examine the effect of exclusive breast-feeding on morbidity and mortality in a randomised prospective study. Children born by mothers recorded as living in the study area during pregnancy was randomised at birth. WHO recommendations to postpone introduction of water and weaning food were told to the mother by 2-weekly home visits. All study children were followed from birth till 1 year of age according to morbidity, hospitalisation and mortality.

Examine in a randomised trial whether postponing of introduction of water and weaning food as recommended by WHO reduces infant morbidity and mortality. Results obtained from observational studies are likely to be due to reverse causality as the mother her self chooses when to introduce water and weaning food. Only a few randomised studies have examined the effect on infant morbidity, and no study has investigated the impact on infant mortality in a low-income country. The study was conducted at Bandim Health Project (BHP) which has conducted a demographic health surveillance system since 1978. Mothers and children were identified by the BHP routine registration. All children born between March 1 2000 until February 28th 2001 in the study area and whose mothers were recorded as living in the area during pregnancy were eligible for inclusion. Children who died within 7 days of birth were excluded in order to avoid birth related morbidity and mortality leaving a total of 1300 children for the study. At birth all children were allocated to an intervention group or a control group. All mother and child pairs were visited bi-weekly by a local, special trained health worker. By individual health education the mothers were motivated to delay introduction of water and weaning food to 6 months of age according to recommendations given by WHO. All mother and child pairs in the control group were visited by the same health assistant. By these visits only information on feeding status was obtained and no intervention given. Further more all study children were followed by assistants blinded to the randomisation with: bi-weekly diarrhoea morbidity interview, monthly anthropometry, including weight, height and arm circumference. All children were followed up to 12 months of age. Demographic as well as socio-economic data, data on hospitalisation, deaths and migrations were obtained from the BHP routine registration system. These data will be collected until the age of 3 years of the child.

Eligibility Criteria:
Inclusion Criteria:

* Children born in the study area in the period 1st March 2000 till 28th February 2001 by mothers recorded as living in the area during pregnancy.

Exclusion Criteria:

* Death before 7 days of age
Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia

The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.

* Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are responding to therapy.
* During the second week of the study patients will also begin receiving rituximab intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later depending upon the response.
* A determination of how the patient is responding will be made based on testing conducted at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it is determined that the disease is not progressing, patients will begin a second phase of treatment which includes 4 additional weekly infusions of rituximab and the continuation of oral thalidomide.
* If it is determined at the 12-week evaluation, or at any time thereafter, that the disease has progressed (by studying serum immunoglobulin M (IgM) levels, bone marrow involvement, tumor cells, and/or development of new signs and symptoms) then the patient will be removed from the study.
* Periodic examinations and tests will be done to determine how the patient is doing, what response and side effects (if any) the patient may be having from the study drugs. If patient is responding to therapy then they will remain on this study and followed for a period of two years.
* Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending for 2 years following the last treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy
* Baseline staging requirements
* Absolute Neutrophil Count \> 500/microliter (uL)
* Platelet Count \> 25,000/uL
* Serum creatinine \< 2.5mg/dL
* Total bilirubin and transaminase (SGOT) \< 2.5 X Upper Limit of Normal (ULN)
* Greater than 18 years of age
* Life expectancy of 3 months or greater
* Eastern Cooperative Oncology Group (ECOG) status performance of 0-2

Exclusion Criteria:

* Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry
* Pregnant or lactating women
* Serious co-morbid disease
* Uncontrolled bacterial, fungal or viral infection
* Active second malignancy
The Gore SCAFFOLD Clinical Study

Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy

This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old at informed consent
* Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
* Patient is willing to provide written informed consent prior to enrollment in study.
* Patient is either:

  * Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; OR
  * Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology
* Patient must be considered high risk for adverse events during carotid endarterectomy

Note: Additional inclusion criteria may apply

Exclusion Criteria:

* Patient has life expectancy of less than one year.
* Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke.
* Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or Deep Vein Thrombosis (DVT) treated within 6 months).
* Patient has had an acute myocardial infarction within 72 hours prior to the index procedure.
* Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments.
* Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure.

Note: Additional exclusion criteria may apply
Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects

Steinert's disease is an orphan disease. The prognosis of patients with this disease is conditioned by cardiac involvement. Search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. The first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from muscular dystrophy type 1 followed CHU Poitiers.
* age ≥ 18 years

Exclusion Criteria:

* duration QRS\> 120 ms ECG permanent ventricular stimulation
* trouble segmental kinetic obvious to echocardiography in visual analysis
Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults

The purpose of this study is to determine the effect of transcranial magnetic stimulation with different stimulation modes ( 1Hz, 10Hz, sham stimulation ) on cerebral autoregulation.

Current studies have shown that repetitive transcranial magnetic stimulation (TMS) can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with ischemic stroke.Dynamic cerebral autoregulation (dCA), refers to a complex process in which small intracranial arteries contract or relax to maintain relatively stable cerebral blood volume when systemic arterial blood pressure changes, which can predict the prognosis of patients with ischemic stroke. In this study, we hypothesis that TMS provides neuro-protection by means of improving dCA.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years, \< 60 years, both genders；
2. Willing to participate and sign the informed consent；
3. Bilateral temporal windows were well penetrated;

Exclusion Criteria:

1. Complaints of previous or existing chronic organic diseases ( stroke, Parkinson 's disease, hypertension, diabetes, etc. ), mental diseases ( bipolar disorder, personality disorder, schizophrenia, etc. ), or cognitive impairment;
2. Suffering from infectious diseases in late one month;
3. Pregnancy or breast-feeding;
4. Sleep disorders, anxiety and depression,
5. Alcohol or drug abuse;
6. History of prescription drugs or over-the-counter (OTC) drugs in the past 2 weeks;
7. History of epilepsy or family history of epilepsy;
8. Implants ( stents or metals );
9. Other conditions that the researchers think are not suitable for the project.
Comparison of Modified With Conventional Adaptive Servoventilation Processes

The objective of this study is to compare the modified adaptive servoventilation control algorithm of the with the standardised algorithms of routinely-used servoventilation processes (AutoSet CS2) in terms of the effect on obstructive and central events. The aim is to normalise breathing during sleep and hence eliminate the sleep-related breathing disorder, resulting in even more effective treatment of nocturnal breathing disorders in patients with cardiovascular diseases and sleep apnoea, to ensure optimum therapy success.

Patients with cardiovascular disorders frequently suffer from sleep-related respiratory disorders (SRRD), such as obstructive sleep apnea (OSA) or a specific form of central sleep apnea, Cheyne-Stokes breathing (CSB, periodic breathing). However there is also a significant incidence of complex nocturnal breathing disorders, with both obstructive and central components. Sleep-related breathing disorders of this kind cause decreases in arterial oxygen saturation through brief hypopneas and apneas. Disturbed breathing also causes the patient to wake frequently during the night (arousals), usually during the hyperventilatory phase of CSB. Repeated arousals cause fragmentation of sleep, and therefore a deep sleep deficit. This leads to increased sleepiness during the day and impaired cognitive performance.

Previous studies have shown that Cheyne-Stokes breathing can be treated effectively with adaptive servoventilation. An enhancement to the routinely used algorithm (AutoSet CS2) has been created which allows the algorithm to differentiate between obstructive events and Cheyne-Stokes breathing, and better respond to apneas and hypopneas to eliminate the sleep-related breathing disorder and normalise breathing during sleep.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* consent in writing
* complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea
* AHI \> 15/h

Exclusion Criteria:

* acute cardiac decompensation
* acute myocardial infarct within the last 3 months
* post-resuscitation condition within the last 3 months
* post-stroke condition with difficulty in swallowing or persisting hemiparesis
* abuse of medication, alcohol or drugs
* pregnancy
* known to be suffering from a tumour
Hearing Aids, Counseling and the Significant Other

The purpose of this study is to examine the effect of enhanced patient-centered counseling (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid outcomes.


Eligibility Criteria:
Inclusion Criteria: Both men and women with hearing loss and their live-in partners will serve as subjects in this study. The subjects with hearing loss will have a mild to moderately-severe hearing loss in both of the ears, will have word recognition scores of 40% or better bilaterally, and will be about to get new hearing aids. Live-in partners may also have up to a moderately-severe degree of hearing loss but cannot have prior experience with hearing aids nor have plans to get hearing aids during the course of their participation in this study. Their word recognition scores should also be 40% or better bilaterally. All subjects also will meet the following additional inclusion criteria:

1. Age 20-85 years;
2. Intact mental status as assessed by the Mini-Mental State Examination (MMSE; Folstein, Folstein \& McHugh, 1975);
3. No evidence of any major medical illness requiring long-term assistive care, as determined by the Katz Index of Independence in Activities of Daily Living (Katz, Down, Cash \&Grotz, 1970);
4. Able to read and respond to English; and
5. Willing and able to give written informed consent to participate in this investigation.

Exclusion Criteria: Failure to satisfy any of the requirements listed above or if their live-in partner fails to meet the criteria.
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<2000.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic hepatitis C
* informed consent to data collection

Exclusion Criteria:

* co-infection with HIV or HBV
* previous treatment with peginterferon and/or ribavirin
Single Pill to Avert Cardiovascular Events

The purpose of this study is to determine whether a polipill improved the compliance with treatment compared to usual care that use two or more drugs,in patients at high cardiovascular risk or previous cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥ 18 years old;
* Patient that could written informed consent;
* Patient with current atherothrombotic cardiovascular disease or at high cardiovascular risk, defined as:
* Patients with previous Coronary Artery Disease (miocardial Infarction, estable or instable angina pectoris or coronary revascularization procedures);
* Patients with previous miocardial Infarction, defined as medical registry (with documentation of at least 2 criterias: clinical symptoms,patological electrocardiogram and elevation of cardiac enzymes- CK-MB and/or troponin);
* Patients with previous brain ischemia (stroke or transient ischemic attack)
* Patients with confirmed previous peripheral arterial disease (Coronary Artery Bypass procedures or angioplasty or amputation due peripheral arterial disease)
* Patients with no established cardiovascular disease but at high cardiovascular risk, defined as 15% or more in 5 years (using the Anderson Framingham scale, 1991)

Exclusion Criteria:

* contraindication for any of the polipill
* If the physician opinion is that terapeutical change could harm the patient (for example, heart failure, need of high beta blocker dose for treatment angina symptons and for the atrial fibrillation rhythm,severe hypertension \[degree 3\], malignant hypertension or renal insufficiency
* Acute clinical conditions/ surgeries
* Psychiatry clinical conditions(for example, schizophrenia, serious depression)
* pregnant or lactation women
* women at fertile period mulheres not using effective contraceptive methods (oral contraceptive, condom, intrauterine device)
* liver siseases (AST/ALT/FA upon 3 x normal superior limits / bilirrubin upon 1,5 X normal superior limits / diagnosed Liver Cirrhosis
* Renal disfunction (any laboratorial exams upon 3 x normal superior limits)
* Previous participation on other clinical trial
* The participant is unable or refuse to give informed consent.
Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis

The goal of this clinical trial is to investigate the effects of the increase in the physical activity level of women at risk for osteoporosis in the post-menopausal period on the physical fitness, functional fitness age and quality of life. The main question it aims to answer is:

• Does the increase in the level of physical activity positively affect the physical fitness parameters (strength, endurance, balance, agility and flexibility), functional fitness ages and quality of life of post-menopausal women with moderate to high osteoporosis risk?

Participants in the intervention group were given the Otago Exercise Program, which will last 3 days a week and an average of 30 minutes per day for 12 weeks. The exercises were done one-by-one with a physiotherapist. No program were applied to the participants in the control group, and they were asked to continue their daily living activities in the same way.

Researchers will compare two groups to see if there is a difference in effects of Otogo Exercise Program on physical fitness, functional fitness age, and quality of life.

The osteoporosis risks of the participants were calculated according to the Osteoporosis Self-Assessment Tool for Women (OST). Women have medium and high risk were included in the study.

Otago Exercise Program includes strengthening exercises consisting of knee extension, knee flexion, hip abduction, ankle dorsi flexion, and 12 balance exercises consisting of plantar flexion and squatting, walking backward, walking and rolling back, sideways walking, tandem stance, tandem gait, standing on one leg, heels walking on toes, walking on tiptoe, sitting and standing, climbing and descending stairs, and backward tandem walking.

• In addition, moderate-intensity walking exercise for 30 minutes a day, 2 days a week, was recommended to the patients in experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Being at medium-high risk as a result of the Osteoporosis Self-Assessment Tool for Women (OST)
* Being 54 years old and over
* Being in the post-menopausal period

Exclusion Criteria:

* Having a broken history
* Having a history of surgery in the last 1 year
* Having a cognitive or physical condition that will prevent them from exercising
* Exercising regularly for more than 30 minutes a day, at least 3 days a week