cyrilzakka/clinical-trials huggingface dataset:
A Long-Term Study of JNS007ER in Patients With Schizophrenia

The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period.

This is a 48-week, multicenter, open-label (all people know the identity of the intervention), non-controlled, arbitrary-dose study. The patients included in this study are those who participated in the preceding double-blind (neither physician nor patient knows the treatment that the patient receives) comparative trial (study JNS007ER-JPN-S31) of JNS007ER and completed the study, or those who remained in the study up to the evaluation at 2 weeks and discontinued the study after that for insufficient treatment efficacy. The study will assess the safety of JNS007ER in the clinical recommended dose range in a long term treatment. The dosage will be started at 6 mg/day, and it can be increased or decreased 3 mg at a time depending on the patient's symptom within the range of 3 mg/day to 12 mg/day. For dose adjustments, the investigator will evaluate the psychiatric symptoms before defining the dose change.

Detailed Description: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia
* Patients who have given their own consent in writing to participate in the study
* Patients untreated with antipsychotics within 28 days before the screening test
* Patients who have completed Study JNS007ER-JPN-S31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy
* Patients participating in Study JNS007ER-JPN-S31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75%

Exclusion Criteria:

* Patients diagnosed with a mental disease other than schizophrenia
* A total PANSS score \> 120 at baseline
* Substance-related disorders
* Parkinson's disease complications
* Current or a past history of convulsive disease such as epilepsy
* Current or a past history of cerebrovascular accident
* Diabetes mellitus
* Significant hepatic or renal impairment
* Significant cardiovascular disorders
* Abnormal results of hematological examination, blood chemistry test and urinalysis at screening
* Pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive
* Contraindications to risperidone products
* Patients who discontinued Study JNS007ER-JPN-S31 due to an adverse event not related to the underlying disease
* Patients judged inadequate by the investigator to participate in the study
A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood

The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 1819479 in plasma.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minutes (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Psychosocial Treatment of Depression in Parkinson's Disease

The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).

CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their depression.

Eligibility Criteria:
Inclusion Criteria:

In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:

* Written informed consent.
* Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
* Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
* Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
* Men or women 40-80 years of age
* HAMD-17 scores \> 14 at screen visit
* Score of 25 or greater on the Mini-Mental Status Examination
* Willing to come to MGH for screening and study participation

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded from the study:

* Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
* Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores \> 28
* The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
* Subjects who meet DSM-IV criteria for dementia
* Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
* Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed
Long Term Effects of Raloxifene Treatment on Bone Quality

This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of long-term treatment with raloxifene on histomorphometry and bone quality in patients who participated in the Continuing Outcomes Relevant to Evista Study.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the CORE protocol within 3 months (90 days) prior to study entry and enrollment.
* Have taken randomized study material for at least 7 years since enrollment in the MORE protocol. If the patient opted not to receive randomized study material for a period of 6 months at any point during either the MORE or CORE protocol, this period must have occurred in its entirety before Visit 3 of the CORE protocol.
* Overall, were at least 75% compliant with randomized study material during the MORE and CORE protocols.

Exclusion Criteria:

* Have an allergy or other intolerance to tetracycline hydrochloride that would preclude its administration in conjunction with the bone biopsy procedures. If the patient is not allergic to all tetracyclines, then this exclusion may be waived by the sponsor and a different tetracycline to which the patient is not allergic may be used.
* Have undergone two previous transiliac bone biopsies (one in each iliac crest). Patients with one previous transiliac bone biopsy are eligible provided that the new sample is obtained from the contralateral iliac crest.
* In the opinion of the investigator, have any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the procedure (for example, coagulation abnormality, extreme obesity, etc.).
* Have a history of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.
* Have a history of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.

This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will be screened to achieve 20 subjects completing the study. Subjects will be randomized to receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be continued with a standard diet during the ZS treatment period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
3. Ability to have repeated blood draws or effective venous catheterization
4. Willing to consume food and beverages using a standardized daily diet containing 40 (± 10%) mEq/day sodium and 128 (± 10%) mEq/day potassium provided by the research site

Key Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 3 months
2. Subjects who were receiving concomitant medications including vitamins, dietary supplements and herbal preparations within 2 weeks prior to Study Day 1 of the Diet Run-in Period.
3. Current and/or past history of alcohol abuse within the past year or a positive results (exceed normal range) of breath test for alcohol abuse
4. Current and/or past history of drugs abuse within the past year or a positive drug abuse screen, e. g. methylenedioxymethamphetamine, opiate, barbiturates, benzodiazepines, ketamine, cocaine, amphetamine, methamphetamine, marijuana, and methadone.
5. Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening.
Retrospective Analysis on Distal Humerus Fractures

The purpose of this study is to evaluate preoperative objective measurements for distal humerus ORIF patients and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. Open reduction internal fixation surgical management of a distal humeral fracture performed by principal investigator at St. Elizabeth Healthcare

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age
Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis

This study is to investigate the effects of controlled whole-body vibration training on reducing the likelihood of falls among healthy population and people with multiple sclerosis. (NOTE: research not covered by sponsored funding)

For each population, the participants will be randomized into two groups.

Eligibility Criteria:
Inclusion Criteria:

For healthy population:

* Aged between 18 and 75
* No known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment

For people with multiple sclerosis

* Self-reported multiple sclerosis and confirmed by the physician
* No significant relapse within the past 8 weeks
* To be able to walk independently a length of 25 feet
* Score on Patient Determined Disease Step \< 7

Exclusion Criteria:

* Subjects use any sedative of any type.
* The heel bone density is less than -2.0
Efficacy of a Virtual Reality-Enhanced Gagne's Instructional Model

Gagne's conditions of instructional learning theory, it presumed that several learning levels was exist that require different instruction types, and external and internal environments, commonly referred to as "conditions of learning".

According to Robert Gagne's conditions of instructional learning theory, it presumed that several learning levels was exist that require different instruction types, and external and internal environments, commonly referred to as "conditions of learning", for every learning type. These internal conditions related to the learner's preexisting knowledge and external ones related to the instructions and teaching strategies provided by the instructor. The theory emphasizes the importance of both internal and external factors in creating a conducive learning environment that fosters effective learning outcomes According to this theorist, there are five primary knowledge categories, including verbal information, cognitive strategies, attitudes, and motor and intellectual skills.

Eligibility Criteria:
Inclusion Criteria:

1. Agreement to participate in this study.
2. Have a Microsoft team's account and able to use it.
3. No previous participation in any gerontological educational course either compulsory or elective.

exclusion Criteria: previous participation in any gerontological educational course either compulsory or elective.
Safety of Direct Oral Anticoagulant During Pregnancy

Pregnancy is a major risk factor of thromboembolic disease (2 to 10 increased risk of thromboembolic event for pregnant women). This risk is related to the physiological changes inducing venous stasis and hypercoagulability.

Thromboembolic disease is the first preventable cause of death during pregnancy (in France 1.1 maternal death per 100 000 living births.

The recommended treatment for pregnant women is low molecular weight heparin requiring subcutaneous injections daily. Vitamin K antagonists are contraindicated due to a teratogenic risk. Direct oral anticoagulants (DOAC) are easier to use.

Currently available preclinical and incidental exposure data on DOAC in pregnant women are very limited and insufficient to conclude on their safety. Therefore, its use during pregnancy is currently contraindicated for the grounds of precaution. The use of reimbursement data from the Système National des données de santé (National Health Data System) would provide more information on accidental exposure to DOACs during pregnancy, thanks to its completeness.

The primary objective of SACOD is to compare the prevalence of adverse perinatal outcomes in pregnant women treated with a direct oral anticoagulant versus pregnant women treated with heparin and Vitamin K antagonist.

The secondary objectives of the SACOD study are to i) determine the frequency of patients exposed to a direct oral anticoagulant during pregnancy according to pregnancy, ii) measure the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with a direct oral anticoagulant therapy, iii) compare the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with direct oral anticoagulants compared with pregnant women treated with heparin and a vitamin K antagonist, iv) compare the prevalence of adverse perinatal outcomes in pregnant women with Antiphospholipid syndrome treated with a direct oral anticoagulant versus pregnant women treated with heparin and anti-vitamin K, v) measure the incidence of thrombo-embolic episodes during pregnancy under anticoagulant treatment.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women exposed to an anticoagulant

Exclusion Criteria:

* women not covered by national health insurrance
High Altitude Area- A Risk Factor For Gastric Perforation?

This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest.

INTRODUCTION : This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest.

DISCUSSION : High altitude associated dyspepsia is a common phenomenon and some studies done in high altitude population have recorded high incidence of antral gastritis and mucosal atrophy on histo-pathological evaluation. This is also supported by high incidence of H.pylori infection. The presence of atrophic gastric mucosa associated with antral gastritis, when exposed to hypobaric hypoxemic conditions faced by soldiers posted to heights above 15000ft , may leads to increased intra-luminal pressure and ischemia which probably predisposes individuals for gastric antrum perforations.

CONCLUSION : This is a relatively untouched topic as we have not found studies on high altitude related gastric perforations and probably this is the first case series of its kind. The acknowledgement of this phenomenon may pave way for further studies for defining the role of high altitude in gastric perforations.

Eligibility Criteria:
Inclusion Criteria:

* Individuals located in High Altitude Area (\>10,000ft).
* presented as perforation peritonitis.
* intra-operatively found to be perforated peptic ulcers.

Exclusion Criteria:

* Not located in High Altitude Area.
* intra-operatively perfoarations sites other then stomach and duodenum.
LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer

This multicenter randomized controlled clinical trial proposed the criteria for selecting patients with early-stage left-sided pancreatic cancer and aimed to compare the perioperative and oncological outcomes of patients within the criteria who underwent laparoscopic radical antegrade modular pancreatosplenectomy versus laparoscopic distal pancreatosplenectomy.

Although prospective comparative studies are lacking, laparoscopic distal pancreatosplenectomy (LDP) was considered to be feasible, safe, and oncologically equivalent for treating pancreatic ductal adenocarcinoma (PDAC). However, the extent of posterior resection and the oncological safety of achieving complete N1 lymph node resection in LDP remain uncertain. Strasberg proposed radical antegrade modular pancreatosplenectomy (RAMPS) for the treatment of resectable left-sided PDAC and confirmed that this technique can achieve negative margins and satisfactory survival. Given the oncological equivalence of laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) and its advantages in short-term outcomes, several studies have assessed the feasibility of LRAMPS as the standard treatment for resectable left-sided PDAC. However, previous studies on LRAMPS have mostly included tumors staged T2 and above, and there is currently no research on the routine use of LRAMPS for early-stage tumors. We proposed the criteria for selecting patients with early-stage left-sided PDAC: (1) diameter ≤ 4 cm; (2) located ≥ 1 cm from the celiac trunk; (3) didn't invade the fascial layer behind the pancreas. This multicenter open-label randomized controlled clinical trial aims to compare the perioperative and oncological outcomes of patients within the criteria who underwent LRAMPS versus LDP.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as resectable left-sided pancreatic cancer before surgery.
* Imaging tumor diameter ≤ 4 cm.
* Located ≥ 1cm from the celiac trunk.
* Tumor didn't invade the fascial layer behind the pancreas.
* Be able to comply with research protocol.
* Voluntary participation and signed informed consent.

Exclusion Criteria:

* Received neoadjuvant therapy.
* Presence of liver or other distant metastasis.
* Multifocal or recurrent disease.
* History of other malignancies.
* Simultaneously participating in other clinical trials.