cyrilzakka/clinical-trials huggingface dataset:
Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study

The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.

This is a multicenter, 1-year study that includes a randomized, 6-month, double-blind, placebo-controlled phase and a 6-month open-label extension of galantamine hydrobromide treatment in subjects with severe Alzheimer's disease. The open-label extension is optional for al patients. Patients eligible for the study will be randomized to treatment with either galantamine hydrobromide or placebo over 6 months for the first phase of the study. The principal measures include the results of the Severe Impairment Battery and the Minimum Data Set-Activities of Daily Living tests, to assess aspects of cognition and behavior, and impact on the patient's ability to perform normal daily activities. Additional evaluations include the Neuro-Psychiatric Inventory-Nursing Home Version measure and 2 subscales of the Minimum Data Set tests to further assess patients behavior, social and physical functioning, the level of caregiver support needed, and impact to the patient's caregiver; the Mini-Mental State Examination, to assess cognitive abilities; and external health-and social-service use. Safety and tolerability will be evaluated on the basis of adverse event reports, physical examination, electrocardiograms, vital signs, and laboratory parameters. The study hypothesis is that treatment with galantamine, compared with placebo, will significantly improve cognition and ability to function in patients with severe Alzheimer's disease, and is generally well-tolerated. Galantamine hydrobromide tablets taken by mouth two times daily: 4 weeks at 8 milligrams (mg)/day, 4 weeks at 16 mg/day, increased to 24 mg/day for the remainder of the 6 months. Dose may be reduced at investigator's discretion. Galatamine hydrobromide for additional 6 months in open-label phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's type dementia, rated as severe
* progressive worsening of memory and other cognitive functions
* brain imaging (CTor MRI scan) within last 3 years
* ability to be mobile (aided or unaided) with sufficient vision and hearing to comply with testing.

Exclusion Criteria:

* Dementia caused by cerebrovascular disease
* disturbances of consciousness, delirium, psychosis
* severe aphasia
* or major sensorimotor impairment
* cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency, infections, primary of metastatic cerebral neoplasia, endocrine or metabolic disease or mental retardation, pregnant or nursing women or those without adequate contraception.
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the SURMOUNT-5 study on study treatment

Exclusion Criteria:

* Have Type 1 Diabetes, Type 2 Diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
* Have a prior or planned surgical treatment for obesity
* Have acute or chronic hepatitis
* Have a history of acute or chronic pancreatitis
Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

In the present study, investigators aim to compare intervention using mobile technology (IMT) plus usual care with only usual care in patients with a high risk for cardiovascular diseases (CVD). Investigators hypothesize that IMT plus usual care reduces the CVD risk and improves the secondary outcomes in this population through 12 months of follow-up period. Patients presented to the outpatient clinics in a tertiary hospital (Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Research and Training Hospital, Istanbul, Turkey) who were considered to be eligible according to inclusion and exclusion criteria will be enrolled to the study. The eligibility criteria is; Patients between 20 to 79 years old who are in high risk for CVD (10 years ASCVD risk ≥ 7.5%). Patients with prior CVD events (myocardial infarction, percutaneous coronary intervention, coronary artery by-pass grafting operation, stroke and peripheral artery disease), pregnancy, communication problems, severe neuropsychiatric problems and chronic kidney disease are excluded from the study. In addition, patients that are unable to use smartphone phone are also excluded.


Eligibility Criteria:
Inclusion Criteria:

* Presence of high risk for cardiovascular diseases (ASCVD risk score \> 7.5%).

Exclusion Criteria:

* Patients with prior cardiovascular events including myocardial infarction, percutaneous coronary intervention, coronary artery by-pass grafting operation, stroke and peripheral artery disease.
* Pregnancy
* Patients with communication problems or severe neuropsychiatric problems
* Patients with chronic kidney disease
* Patients who are considered for being unable to use smart phone
Safety and Tolerability of GATE-251 in Normal Human Volunteers

To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers

Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers.

Secondary objectives:

To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of GATE-251 following increasing single doses of GATE-251.

GATE-251 or Placebo: Dose/Mode of Administration: Single dose; oral

Eligibility Criteria:
Inclusion Criteria:

* Agree to effective method of birth control
* If female, negative pregnancy test at screening and Day -1
* Nonsmoking at least 2 years
* BMI 18-30
* Supine pulse rate 30-100

Exclusion Criteria:

* Known hypersensitivity to NMDA receptor drugs
* clinically significant disease in any body system
* QTcF \> 430 ms in males, \>450 ms in females
* positive test for hepatitis B or C
* abnormal liver function tests on Day -1
* History of alcohol or other substance abuse during the previous 5 years
* Positive drug screen at screening or Day -1
* Taken any medication within the past 14 days
Effect of a Symptom Diary on Symptom Care and Symptom Burden in Patients Treated With Chemotherapy: a Before-and-after-study

This study investigates whether the implementation of a symptom diary for reporting and communicating chemotherapy-related symptoms improves symptom care and decreases symptom burden in adult patients treated with chemotherapy.

The hypothesis is studied using a before-and-after design. First, symptom care and symptom burden will be observed in a sample of patients not being offered a symptom diary. Next, the symptom diary will be implemented at the participating hospital and symptom care and symptom burden will now be observed in a new sample of chemotherapy patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18) patients with (any type of) cancer treated with chemotherapy
* Understanding Dutch
* Being able to sign Informed consent

Exclusion Criteria:

* More than 3 lines of chemotherapy treatment in the past
Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine \[BRV-TV\]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 6-8 weeks of age at time of enrollment of either sex;
* Born after a gestational period of 36-42 weeks with birth weight ≥2 kg;
* Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the ICF;
* Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

* History of congenital abdominal disorders, intussusception, or abdominal surgery;
* Known or suspected impairment of immunological function;
* Known hypersensitivity to any component of the rotavirus vaccine;
* Prior receipt of any rotavirus vaccine;
* Fever, with axillary temperature ≥38.1oC (≥100.5oF); measured by study staff.
* History of known rotavirus disease, chronic diarrhea, or failure to thrive;
* Baseline level of ALT or AST \>2.5 times the upper limit of normal;
* Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
* Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study);
* Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
* Infants suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive.
* Prior receipt of a blood transfusion or blood products, including immunoglobulins;
* Any infants who cannot be adequately followed for safety by a home visit;
* Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* Parent/s or guardian of subject unable to maintain diary card
Kidney Allograft Dysfunction Without Reversible Causes

The purpose of this study is to learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. Serum creatinine increased greater than or equal to 25% over baseline with no acute or reversible cause clinically evident.

   Although eGFR is arguably better for estimating kidney allograft function than serum creatinine, pragmatics dictate the use of a change in serum creatinine in the initial selection of patients. These criteria are currently used by transplant coordinators for selection of patients for the kidney biopsy as a part of large on-going study at our center.
2. Adequate (greater than or equal to 8 glomeruli) biopsy showing Chronic allograft injury reported as mild/moderate CAN or CNI toxicity based on the previously used Banff 97 classification and no potentially reversible causes of graft dysfunction, e.g. acute rejection or treatable recurrent disease. Patients with histological evidence of mild recurrent disease that does not appear to be severe enough to explain the deterioration in function, e.g. IgA on immunofluorescence, or changes consistent with early diabetic nephropathy, will not be excluded.
3. Receiving CsA (trough level concentration 75-125 ng/mL) or Tacrolimus(trough level concentration 6-12 ng/mL) plus MMF (or AZA) with (or without) prednisone.
4. Able to give informed consent.

Exclusion Criteria:

1. Urine total protein excretion \>500 mg/g creatinine.
2. eGFR (estimated by MDRD) \<40 mL/min/1.73 m2
3. Triglycerides \>400 mg/dL or total cholesterol \>300 mg/dL
4. Allergy to macrolide antibiotic or rapamycin
5. Women of child-bearing potential not using effective contraception
6. Treated for acute rejection within the past 2 months
7. \<12 months after transplantation
8. Potentially treatable cause(s) of allograft dysfunction, including acute rejection, dehydration, and congestive heart failure.
9. Recurrent or de novo kidney disease that is histologically severe enough to be causing graft dysfunction
10. Polyoma virus (BK) nephropathy, or serum positive for BK by polymerase chain reaction
11. A second, functioning organ transplant.
12. Receiving sirolimus.
13. Patients with any past or present malignancy (other than non-melanoma skin cancer)
CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels \>30 pg/ml.


Eligibility Criteria:
Inclusion Criteria:

1. Women with baseline estradiol \>25 pg/mL
2. Histologically- or cytologically-confirmed diagnosis of NSCLC.
3. ECOG performance score (PS) of 0, 1, or 2.
4. Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease.
5. At least 18 years of age.
6. Adequate bone marrow function
7. Adequate renal function
8. Adequate hepatic function
9. Life expectancy ≥12 weeks

Exclusion Criteria:

1. Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive.
2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
3. Weight loss \>10% in previous 6 months
4. LDH \> 2.5X IULN
5. Both LDH \> 1.5X IULN and ≥ 5% weight loss in previous 6 months
6. BMI \>35
7. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
8. Local palliative radiotherapy \< 7 days before randomization.
9. Radiation with curative intent \< 30 days before randomization.
10. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
11. Grade 2 or greater neuropathy.
12. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization.
13. Clinically significant active infection for which active therapy is underway.
14. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
15. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization.
16. Pregnant women or nursing mothers.
Family Caregiver Online Survey (Dementia and Swallowing Difficulties)

The Family Caregiver Survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. The goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia).

This research aims to increase our understanding of dysphagia-related caregiver burden and inform the development of a comprehensive dysphagia intervention, one that promotes the health and quality of life of both the caregiver and the person with dementia.

Aim 1. Quantify dysphagia's contribution to burden among family caregivers of persons with dementia across the disease trajectory to identify when may be best to intervene.

Aim 2. Characterize the moderating effects of caregiver readiness and support on dysphagia-related burden and care recipient quality of life to identify what are the most appropriate intervention targets.

Eligibility Criteria:
Inclusion Criteria:

* Be a caregiver for a family member (or chosen family member) with dementia
* Have been caregiving for at least 2 months
* Live at home with the care recipient
* Not be paid for the care provided
* Be over the age of 18
* Live in the US

Exclusion Criteria:

* Not be a caregiver for a family member (or chosen family member) with dementia
* Have been caregiving for less than 2 months
* Not live at home with the care recipient
* Be paid for the care provided
* Be under the age of 18
* Live outside in the US
The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy

Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for an effective intervention. Dietary inorganic nitrate therapy, which through its chemical reduction in the body delivers nitric oxide has shown promise in attenuating CIN, but its effectiveness in preserving long-term renal function is unknown.

The NITRATE-CIN trial is a single-centre, randomised double-blinded placebo-controlled trial, which plans to recruit, over a period of 2 years, 640 patients presenting with acute coronary syndromes (ACS) who are at risk of CIN.

Patients will be randomised to either dietary inorganic nitrate therapy or placebo.

The primary endpoint will be the development of CIN (KDIGO criteria). A key secondary endpoint will be whether nitrate therapy impacts upon persistent renal impairment over a 3-month follow-up period. Additional secondary endpoints include the measurement of serum renal biomarkers (e.g. neutrophil gelatinase-associated lipocalin) and urinary albumin at 6, 48 h and 3 months following administration of contrast.

Findings from NITRATE-CIN will potentially demonstrate that nitrate attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing coronary angiography+/-Percutaneous Coronary Intervention (PCI) for NSTE-ACS
2. Requirement for CIN prophylaxis as per Barts Heart Centre Criteria for CIN prophylaxis:

   eGFR\<60ml/min OR 2 of the following: diabetes, liver failure (cirrhosis), age \> 70yr, exposure to contrast in last 7 days, heart failure (or LVEF\<40%), concomitant renally active drugs (ACEi, ARB, NSAIDs, aminoglycosides, diuretics)
3. Aged \>18
4. Patients able and willing to give their written informed consent.

Exclusion Criteria:

1. ST segment myocardial infarction undergoing Primary PCI.
2. Patients with eGFR\<30ml/min or on renal replacement therapy
3. Subjects presenting with cardiogenic shock (systolic blood pressure \<80 mmHg for \>30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation
4. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
5. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
6. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
7. Severe acute infection
8. Pregnancy
9. Breast-feeding mothers.
10. Any Inclusion Criteria not met
A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.


Eligibility Criteria:
Inclusion Criteria:

* This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.

Exclusion Criteria:

* Subject has no new medical contraindications to continue participation in the study.
Physical Stabilization in Post-VATS

Background: Post-video-assisted thoracic surgery (VATS) pain remains an open issue, though most patients experience less acute pain after VATS than thoracotomy. So far, there was no gold standard regarding pain control post-VATS.

Objective: To conduct a randomized controlled trial assessing the effect of physical thoracic stabilization on post-VATS pain control.

Method: The investigators aimed to recruit 40 patients with operable lung cancer in the outpatient clinic from January to December 2021. The patients will be randomized into the intervention or control group. The intervention group will receive physical thoracic stabilization with POSTHORAX ThoraxBelt after the surgery, whereas the control group will have standard care. The follow-up period will last for 6 months.

The study has been approved by the hospital research ethics committee.

Arm 1: Physical thoracic stabilization with ThoraxBelt after VATS Arm 2: Standard care after VATS

Primary outcome: Visual analog scale (VAS) 6 hours, 24 hours, and 48 hours after the surgery.

Secondary outcomes:

1. The accumulated dose of the intervenous patient-controlled analgesic drug.
2. The dose of oral painkiller administered during the hospital stay.
3. Complications related to the ThoraxBelt.
4. Hospital stay
5. VAS before discharge
6. Unanticipated events (ICU admission, a second surgery, death)
7. VAS during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery.
8. Compliance on ThoraxBelt.

Eligibility Criteria:
Inclusion Criteria:

* Operable lung cancer
* Eligible for video-assisted thoracoscopic surgery

Exclusion Criteria:

* Known allergy to ThoraxBelt
* Chest wall Infection or other diseases
* Pregnancy