cyrilzakka/clinical-trials huggingface dataset:
An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.
* Male.
* 18-45 years old.
* BMI 17.5-30.5 kg/m2.

Exclusion Criteria:

* Alcohol, drug, smoke user.
* Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12-ECG abnormal.
* Treatment with study drug; clinically significant.
Improvement of Sarcopenia in Patients Following Two Different Diets

Sarcopenia is defined as a decrease in muscular strength and muscle mass, accompanied by a decrease in physical performance. Seniors might develop sarcopenia because of a decreased physical activity and a decreased protein intake. Many patients also develop sarcopenia after a long stay in an intensive care unit.

Protein intake is very important when treating sarcopenia. However, meeting the protein requirements at home proves difficult. Oral dietary supplements, given in addition to the other known recommendations, might provide a solution.

This study will assess the efficacy of the oral dietary supplements for the treatment of sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized within the CHU Brugmann, Brussels
* Patients diagnosed with sarcopenia (by means of a dynamometer)
* Patients having stayed in an intensive care unit for longer than 5 weeks

Exclusion Criteria:

* Oncology patients
* Anorexic patients
* Patients having a life expectancy of less than 6 months
* Demented patients
* BPCO patients
* Patients with neuropathies
Comparison of Focused ESWT by Frequency for Patients With Myofascial Pain Syndrome

To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome.

Myofascial pain syndrome is one of the common causes of musculoskeletal pain seen in clinical practice and is characterized by the presence of trigger points associated with sensitive areas such as taut bands of skeletal muscle. It may also be accompanied by referred pain, which is pain in other parts of the body. Although the pathophysiology and etiology of myofascial pain syndrome and trigger points are still unknown, there are reports that myofascial pain is a complex form of neuromuscular dysfunction caused by motor and sensory abnormalities involving both the peripheral nervous system and the central nervous system. Recently, it has been considered as a method of treatment for myofascial pain syndrome. In addition, although pain reduction and functional improvement of focused ESWT in patients with myofascial pain syndrome have been reported, related studies are lacking on the effect of focused ESWT according to the frequency difference. The purpose of the study is to examine the efficacy and safety of focused type ESWT frequency in patients with myofascial pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Those diagnosed with myofascial pain syndrome according to Simon's criteria
2. Pain is 4 points or more on the Numerical Rating Scale (NRS)

Exclusion Criteria:

1. Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke
2. If you have received injection treatment for trigger points within the last 2 months or have had surgery on the painful area within 1 year
3. If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet)
4. If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.


Eligibility Criteria:
Inclusion Criteria:

* The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic
* The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days.
* Subject has been treated with lithium in the past.
* Subject has been treated with divalproex or carbamazepine in the past.
* Subject has been treated with Haldol or haloperidol in the past.

Exclusion Criteria:

* Subjects lacks the capacity to provide informed consent
* Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
* Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.
Vapocoolant Spray Application During Intraarticular Knee Injection

The goal of this observational study is to learn about the effects of vapocoolant spray applied during intraarticular knee injections on pain and anxiety compared to injections without any agent application in patients with knee osteoarthritis.

The main questions it aims to answer are: • Contrary to popular belief, does coolant spray application really reduce pain? • Does it have an advantage over patients with placebo or no spray at all? After intraarticular knee hyaluronic acid application, patients will be asked to indicate injection-related pain and anxiety levels on a 100mm visual analog scale. Researchers will compare the patient groups who were applied coolant spray, placebo spray and injection without any spray.

Patients who underwent intra-knee hyaluronic acid injection due to knee degenerative diseases (osteoarthritis), meniscus and cartilage problems between October 2022 and December 2022 will be prospectively included in the study. Demographic characteristics of the patients (age, gender, body mass index), degree of knee degeneration, and past surgical procedures will be recorded.

Before intra-articular injection can be given, one group will be sprayed with a vapocoolant, and one group will receive a placebo spray, while another group will receive no analgesic treatment while injection. Which patient will be evaluated in which group will be decided by randomization on the website www.random.org.

1 minute after the injection, the patients will be asked to indicate their pain level (1) and anxiety level (2) while inserting the needle on the 100mm Visual Analogue Scale (VAS). The same survey will be repeated after 10 minutes, and whether they are satisfied with the whole process will be measured with the same scale and the results will be recorded. The results will be compared between the groups, and the demographic characteristics of the patients, the level and types of disease, and the effects of vapocoolant spray application will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.

Exclusion Criteria:

* Prior history of injection of the knee joint
* Inability to understand the Visual Analog Scale,
* History of cold intolerance
* Use of pain medications or topical anesthetics within the previous 24 hours
* Abnormal sensation or signs of infection over the injection site.
In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA

In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic \& Spine Center \[this is the location from which participants will be recruited\].

There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.
* Subjects must be at least six months post-operative.
* Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.
* Participants must be able to perform the required activities - stepping up and a deep knee bend.
* Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study

Exclusion Criteria:

* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
* Subjects without one of the two types of knee implants under investigation.
* Subjects who are unable to perform stepping up and deep knee bend.
* Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
* Does not speak English.
The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* Is HIV positive
* Is on a stable raltegravir-containing (400 mg every 12hr) antiretroviral (ARV) regimen for at least 1 month prior to study entry, with no changes, including dose adjustments; and agrees to maintain their current ARV therapy throughout the study.
* Be male, or a non-pregnant and non-breast feeding female at least 18 years of age at the pre-trial (screening)
* Has a Body Mass Index (BMI) =\< 32 kg/m\^2

Exclusion Criteria:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases (excluding HIV)
* Has a history of gastric bypass surgery
* Has a history of cancer (malignancy)
* Has a history of chronic diarrhea within approximately 3 months prior to the pre-trial visit
* Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-trial visit
* Has participated in another investigational trial within 4 weeks prior to the pre-trial visit
* Is currently taking rifampin or atazanavir or is unable to refrain from the use of 1) any proton pump inhibitor from two weeks prior to the study through the completion of Period 4, and 2) any H2-blockers, over-the-counter antacids, calcium supplements or multivitamins from one week prior to the study through the completion of Period 4
* Consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day
* Consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day
* Is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months of screening
Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression

The objective is to examine the efficacy of computerized interventions for increasing well-being and cognitive functioning. The study will seek to validate emerging online delivery methods of psychiatric assessment and treatment. This will allow us to test the efficacy of this intervention in a larger and more geographically broad sample than is possible through traditional recruitment and treatment, and to do so in a highly cost-effective manner.


Eligibility Criteria:
Inclusion Criteria:

* computer and broadband internet access
* 18 years of age
* Elevated anxiety and depression
* Native English speaker

Exclusion Criteria:
Using Mobile Phone Short Message Service (SMS) Reminders to Enhance Appointment Attendance in DM Patients

A randomized controlled trial of patients with type 2 diabetes mellitus with multiple appointments into short message service group and control group. The attendance rate of these two groups of patients will be compared.

The main objective of this study is to evaluate the appointment attendance rate using SMS reminder of nurses and allied health appointments for diabetic patients, when compared to conventional telephone reminder and no reminder. We also aim at determine the factors associated with appointment attendance. Finally, we will also survey patients' acceptance and satisfaction to the SMS service.

This is a single blind randomization study. It will be carried out in Ha Kwai Chung General Outpatient Clinic.

The primary outcome of this study is to evaluate the attendance rate of each individual doctor, nurses and allied health clinic appointments for diabetic patients, as well as their overall attendance rates:

1. Diabetes Complication Screening Clinic (OPAS DMCS/RDNA)
2. Diabetes Nurse Intervention Clinic (OPAS DMIC/RDNI)
3. DM nurse group (OPAS RDNG)
4. Dietitian Counselling (OPAS DC/DG)
5. Physiotherapy (OPAS PTC/PTG)
6. Diabetes Doctor Session (OPAS RDR)
7. Retino photo Assessment (OPAS RDO)
8. Blood taking appointment (OPAS LABT)

The secondary outcomes are:

* Acceptance Rate of SMS Reminder Vs Telephone Reminder Vs no reminder
* Factors associated with acceptance of SMS

  1. Personal Parameters: Age, sex, educational level, occupation, mobile phone models, Habit of using mobile phone service
  2. Disease Parameters: Number and types of comorbidity, disease control (by biochemical markers)
  3. Quality of Life (by SF-6D)
* Reported adverse effects of the reminder system
* Chang in biochemical markers (BMI, HbA1c, LDL-c level) 6-9 months later

Subjects who agreed to participate in this study will first receive a survey on the acceptance of SMS service. For those agree to receive SMS reminder, they will be randomized to:

1. an SMS remind them to come for scheduled clinic appointment 24-72 hours before, or
2. usual care with no reminder / telephone reminder.

Eligibility Criteria:
Inclusion Criteria:

* With diagnosis of type 2 diabetes
* Have more than 1 clinic services appointment under RAMP-DM programme:

  (e.g. blood taking, diabetic nurse individual counselling, group education, diabetic complication screening, retinal photo assessment, dietician counselling, etc)

Exclusion Criteria:

1. Cannot read or receive appointment schedule on mobile phone
2. Do not speak Cantonese/English or read Chinese/English
3. Mentally incapacitated
4. Pregnant Women
Screening for Systemic Amyloidosis Via the Ligamentum Flavum

The investigators will prospectively evaluate for the presence of amyloid deposits in ligamentum flavum (yellow ligament) tissue samples obtained from patients undergoing spinal stenosis surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

Similar to carpal tunnel syndrome, spinal stenosis is associated with systemic amyloidosis and presents earlier than cardiac amyloidosis symptoms - 21-45% of ATTR patients and case reports in AL patients. The investigators' recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 70% of the amyloid-positive group had a history of spinal stenosis and 40% required surgical intervention. Surgical intervention for spinal stenosis could provide an opportunity to screen for amyloidosis through yellow ligament (ligamentum flavum) biopsy.

This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for non-congenital spinal stenosis and spondyloarthropathy. The investigators hypothesize that 10% of such patients will be positive for amyloidosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 years
* Undergoing surgical intervention for non-congenital spinal stenosis and/or spondyloarthropathy
* Able to consent

Exclusion Criteria:

* History of congenital spinal stenosis or congenital spondyloarthropathy
Morning Hypertension and Preminent Therapy Study

It is difficult to control morning hypertension in practical clinical situation. Angiotensin receptor blocker (ARB) and thiazide are suggested to be effective to maintain the antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to control blood pressure level in the next morning and there are little evidence of the combination therapy for morning hypertension. The investigators hypothesized that a losartan 50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese. Patients with morning hypertension were randomized to preminent treatment group or high-dose losartan treatment group. The efficacy and safety were compared after 3-month treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
* Under treatment with any antihypertensive agents

Exclusion Criteria:

* Poorly controlled hypertension (DBP\>120 mmHg)
* Poorly controlled diabetes (HbA1c\>9.0%
* Gout or hyperuricemia (UA\>8.0 mg/dL)
* Serum Cr\>2.0 mg/dL
* Serum K\>5.5 mmol/L
* Liver dysfunction (ALT\>90 IU/L and/or g-GTP\>14o IU/L)
* Secondary hypertension
* Patients who have contraindication for losartan and/or thiazide diuretics
Cognitive Impairment Cohort Study of the Elderly Population in YuGarden

The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.

The main questions it aims to answer are:

* incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
* to build a predictive model for the progression of cognitive impairment

This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.

Eligibility Criteria:
Inclusion Criteria:

1. The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
2. Non-AD patients.
3. The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.
4. The participants agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.
2. Participants who have visual or auditory impairment that hampers the completion of related examination.
3. Situations when magnetic resonance imaging or other examinations are contraindicated.
Capsule Endoscopy as an Alternative to Colonoscopy

This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.

Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).

Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria

Eligibility Criteria:
Inclusion Criteria:

* Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years

  * Rectal bleeding/haematochezia in patients \>50 years who have undergone a colonoscopy \<5 years ago or \<50 years with no risk factors for CRC
  * Chronic constipation/abdominal distension/abdominal pain/diarrhea
  * Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed
  * Recent change in bowel habits
  * Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease

Exclusion Criteria:

* Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis
* Evaluation following fragmented resection (recurrence ruled out)
* Patients with a positive FIT
* Pregnancy or breast-feeding
* Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.
* Allergy or known contraindication to the medications and preparations agents used in the procedure.