cyrilzakka/clinical-trials huggingface dataset:
Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease

A unique multinational study was conducted simultaneously in the USA, England and Australia. The goals of the study were to answer two questions: Does psychosocial support for the family enhance the effectiveness of drug treatment for Alzheimer's disease? Is the added value of psychosocial support the same in all 3 countries?

This study is a single-blind prospective randomized trial with 150 patient/caregiver pairs (50 in each country). Eligibility criteria at baseline require that the primary caregiver is the spouse of the patient; the patient must have a diagnosis of AD, be in the in mild to moderate stage of dementia, be living with the caregiver, and be willing to take Donepezil (Aricept). These participants were randomly assigned to one of two groups: in one group, the intervention consists of drug treatment for the patient plus psychosocial intervention for the caregiver; in the other group the intervention consists solely of drug treatment for the patient.

The intervention for the caregiver consists of 5 scheduled individual and family counseling sessions within 3 months of baseline, and unlimited consultations on request. Assessments were conducted every 3 months for the first year and every 6 months for a second year. There are 3 sources of data: an interview of the caregiver by an independent rater, an assessment of the patient, and a count of the amount of medication used. Thus we will be able to assess the effect of adding counseling to medication for the caregiver, for the patient, and on compliance with medication use.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers

Exclusion Criteria:

* Severe psychological or physical illness
* Unwillingness by either spouse to participate in all aspects of the study
Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).


Eligibility Criteria:
Inclusion Criteria:

* Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

Exclusion Criteria:

* Subjects with any contraindication to the MRI examination
* Subjects with severe renal disease to end stage renal disease
* Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI
Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients

This is an observational study intended to validate results of a previous study done at the Mayo Clinic. Patients are treated with combination chemotherapy and radiation and maintained on oral Xeloda until they can receive liver transplant. A staging laparotomy is performed before chemoradiation in order to identify patients who will most benefit from the treatment and to improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cholangiocarcinoma that has been established preoperatively by at least one of the following criteria:

   1. A positive brush cytology or biopsy result obtained at the time of cholangiography;
   2. Fluorescence in situ hybridization demonstrating aneuploidy;
   3. A serum CA 19-9 value greater than 100 U/mL in the presence of a radiographically characteristic malignant stricture in the absence of cholangitis.
   4. Listed for OLT for hilar cholangiocarcinoma
2. Tumor/stricture is above the cystic duct and is unresectable.
3. A suitable candidate for orthotopic liver transplantation as judged by the liver transplant team. All 3 treatment modalities are not needed to confirm eligibility for this registry trial.
4. \>/= 18 years of age.
5. Willing and able to provide written informed consent.
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days

Eligibility Criteria:
Inclusion Criteria:

* Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:

  * Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
  * Any patient undergoing an allogeneic hematopoietic stem cell transplant

Exclusion Criteria:

* Patients with moderate or severe liver disease, as defined by:

  * AST or ALT greater than 5 times upper limit of normal (ULN), OR;
  * Total bilirubin greater than 2.5 times ULN
* Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women

The purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.

Fractures due to osteoporosis are a major public health problem. Bone density is one of the major predictors of these osteoporotic fractures and is the result of the amount of bone gained in early life (i.e peak bone mass) and subsequent bone loss. Cigarette smoking, physical inactivity and inadequate calcium intake are widely regarded as risk factors for osteoporosis (as well as for other common diseases for the former two). Despite this information being widely available and actively promoted, the prevalence of these risk factors in the population remains unacceptably high. In women (mean age 33) taking part in a study of the determinants of bone mass in children, we recently reported substantial change in these behaviours at 12 months follow-up when women received an information leaflet and individualised bone density feedback. These women were highly selected and it is unclear if this response is representative of all women. With this study, we aim to test whether individualised bone density feedback, combined with either an information leaflet or small group education will change women's osteporosis preventive behaviors and/or bone density.

Specifically, we aimed to test the following hypotheses:

1. Women are more likely to change calcium intake and physical activity if their BMD is low.
2. Group education (in the form of the Osteoporosis Prevention and Self Management course) will be more efficacious at changing these lifestyle behaviours than an information leaflet alone.
3. Bone density feedback and educational intervention have independent effects on behavior and BMD change.
4. Women who improve their physical activity or dietary calcium intake will have a change in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and lifestyle factor) than those who do not alter their behaviour.

Eligibility Criteria:
Inclusion Criteria:

* women aged between 25 and 44 years of age

Exclusion Criteria:

* previous had measurement of bone densitometry
* thyroid disease
* renal failure
* malignancy
* rheumatoid arthritis
* history of hysterectomy
* hormone replacement therapy
* were pregnant or planning pregnancy within 2 years of study entry
* lactating.
Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses

Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.

Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols .

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery patient requiring cardiopulmonary bypass
* moderate or high transfusion risk
* signed informed consent

Exclusion Criteria:

* age \<18 or \>80 years
* known hemophilia
* known thrombophilia
* known thrombocytopathy
* hereditary or acquired coagulation disorder
* active endocarditis
* ejection fraction \<30%
* BSA \< 1.8 sqm
* planned aortic arch surgery
* preoperative thrombocytopenia \<150/nl
* underlying hemostaseological disease
* preoperative anemia
* liver cirrhosis Child B or higher
* preoperative creatinine \> 2mg/dl
* terminal renal insufficiency requiring dialysis
* vitamin k antagonists during 5 days prior to surgery
* pregnant or breast-feeding women
* known allergy against allogeneic blood products or coagulation factors
* refusal of blood transfusions
* any concomitant investigational agent or participation in another trial
A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis

This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.


Eligibility Criteria:
Inclusion Criteria:

* 18\~65 years old (including lower limit), no gender limit；
* You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study；
* You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3；
* The patient can communicate well with the investigator and follow the research and follow-up procedures；
* Understand and voluntarily sign the informed consent form.

Exclusion Criteria:

* You must not have prior treatment with an oral Janus kinase (JAK) inhibitor；
* You must not have received a phototherapy within 4 weeks prior to entry into the study；
* You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)；
* You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse
Human Pulpal Response After Pulp Capping With Four Different Agents

Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.

The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation \& dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.

Eligibility Criteria:
Inclusion Criteria:

* Patients aging from 10 to 16
* Patients who need to extract 4 premolars for orthodontic purposes
* the teeth should be free of caries and clinical symptoms
* Through thermal tests and radiographic examination absence of any pathology is confirmed.
* Periapical radiographs demonstrating absence of any pathology
* no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds.
* Absence of any systematic disorder
* No consumption of drugs of any kind
* All patients and their parents need to sign a fully informed consent.

Exclusion Criteria:

* If any of the teeth shows caries, restoration, crack or hypocalcification
* presence of any periapical pathosis
* Teeth that seem sensitive to cold, hot, percussion or pressure
* any systematic disorder
* consumption of drugs of any kind.
Lipitor as a Treatment for Alzheimer's Disease

The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.

This study is a phase II, placebo controlled, double-blind, one year trial investigating the effect of HmG-CoA reductase inhibitor atorvastatin calcium in the treatment of persons with possible or probable Alzheimer's disease. Subjects may continue to take stable doses of Aricept and Exelon. Following enrollment, participants will make visits to the study center every three months for blood tests and neuropsychological testing.

Eligibility Criteria:
Inclusion Criteria:

* Prior to participation in this study, each prospective study individual must sign an informed consent form.
* Diagnosis of probable or possible Alzheimer's disease according to NINDS-ADRDA and DSM-IV criteria.
* Not actively participating in another clinical drug trial.
* MMSE range 12-28 at entry.
* Hachinski Modified Ischemic score \< or =4.
* Accompanied by appropriate caregiver who can aid in administration of medication and make assessments.
* Good general health as evidenced by physical, neurological and clinical laboratory examination.
* Education level \> or = 9th grade or equivalent.
* Fluent in the English language.
* Reliable caregiver.
* Able to complete neuropsychological tests.
* Ambulatory.
* On stable doses of medications for the treatment of non-excluded medical conditions for four weeks prior to screening.
* Able to participate in all scheduled evaluations.
* Geriatric Depression Scale \< or = 20.
* Not exceeding 400 IU of Vitamin E for 30 days.
* For patients currently taking donepezil, they must remain on a stable dose for at least three months. Individuals taking stable doses of other cholinesterase inhibitors can be included, but no study subject may initiate use of any cholinesterase inhibitor after entrance to trial.
* Individuals of both sexes over 50 years of age will be eligible.

Exclusion criteria:

* Significant neurological or psychiatric disease other than Alzheimer's disease.
* Patients with known or suspected Parkinsons's disease or dementia with Lewy bodies.
* Significant systemic illness (including uncontrolled hypertension) or organ failure.
* History of mental illness within one year or history of significant untreated cardiac or thromboembolic vascular disease (arrythmias, unstable angina, CVA, deep venous thrombosis, or pulmonary embolus).
* Current chronic use of anti-cholinergic medications (anti-histamines, and Artane or Cogentin). Stable doses of anxiolytics, sedatives, hypnotics, antipsychotics and SSRI antidepressants are acceptable. The use of any antipsychotics or tricyclic anti-depressants must be reviewed prior to entry.
* Diagnosis of major depression according to DSM-IV criteria in the last two years.
* Allergies to atorvastatin or HMG CoA reductase inhibitors.
* Pregnant women.
* History of head injury.
* On a cholesterol lowering drug at time of enrollment.
* History of significant liver disease and or elevated transaminases.
* Cholesterol level lower than 90 mg% at initial screening
We Walk Plus Study for Older Adults With Intellectual Disabilities

Determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities (ID).

We Walk Plus study consists of: (1) a user friendly physical activity tracker (i.e., Fitbit Charge HR ); (2) user-centered social networking (e.g., Fitbit community); and (3) the iCardia platform for monitoring daily Fitbit physical activity and wear time and sending personalized text-messages targeting physical activity and self-efficacy. The specific aims of this two-arm RCT pilot are to: 1) assess the feasibility and acceptability of the We Walk Plus intervention and 2) explore the preliminary efficacy of We Walk Plus on physical activity and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with mild or moderate intellectual disabilities;
* ages 35-60;
* able to speak, read English and willing to provide consent to enroll;
* able to follow instructions and walk, physically inactive;
* willing to receive SMS, wear Fitbit throughout the study;
* living with family or in a community residence;
* support persons are willing to assist participants to ensure the Fitbit functions properly.

Exclusion Criteria:

* Inability to follow instructions;
* diagnosis of coronary disease or uncontrolled hypertension, smokers, physically active;
* participating in a health promotion program;
* having mental illness or behavior problems;
* support persons unable or unwilling to assist participants with Fitbit devices, if needed.
Synthetic Cranioplasty PEEK Versus UHMWP

The purpose of this study is to report the investigators experience with synthetic reconstruction of cranial defects using computer guided milled UHMWP, in terms of benefits and limitations both clinically and radiographically in comparison to PEEK implants.

Statement of the problem:

To this date, there is still no consensus on the ideal material for cranial reconstruction. Research journey involved the use of autologous grafts, allografts, xenografts, and a wide array of synthetic materials for cranioplasty. The autologous bone flap, although associated with less infection than allo or xenografts, is not always a possibility after comminution or osteomyelitis and still has the common drawbacks of storage, aseptic bone flap necrosis (ABFR) and the need for a second surgery. Titanium offers lower cost but is quite difficult to shape, radiopaque and exhibits high dehiscence with thin skin biotypes. Polyetheretherketone (PEEK) has been gaining popularity during the recent years for lower rates of graft failure, however, it still holds a risk of postoperative inflammatory complications, is of exceedingly high cost most studies utilizing it are retrospective and observational.

Rationale for conducting the research:

Cranioplasty procedures carry functional and esthetic challenges and the most suitable graft to be used remains controversial. UHMWP use in biomedical applications is greatly due to its outstanding mechanical properties and biocompatibility which, when coupled with three D computer guided milling technology to reconstruct complex and large cranial defects, can provide durable patient specific implants (PSI). However, no interventional studies exist in the literature on its application in cranioplasty.

Explanation for choice of comparators:

PEEK as a semicrystalline thermoplastic polymer has a thickness and elasticity comparable to cortical bone making it one of the most commonly used bone substitute materials and is currently recommended as a standard viable option for cranial defects.

Eligibility Criteria:
Inclusion Criteria:

* Cranial defect patients
* Patients eligible for simultaneous craniectomy and cranioplasty.
* ASA I \& II

Exclusion Criteria:

* Active infection.
* Medically compromised patients (ASA ≥3).
* Hydrocephalus/Brain Swelling
A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old.
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have a life expectancy of at least 3 months.
4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. Undergone major surgery within 30 days prior to the first dose of study treatment.
2. Active central nervous system (CNS) metastases.
3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
4. Active Hepatitis B or Hepatitis C.
5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
6. History of severe bleeding tendency or coagulation disorder.
Epidemiology and Immunology of Hemophilia A Inhibitors

To determine the risk factors associated with inhibitor formation in hemophilia A and to study the mechanism of tolerance in the murine hemophilia A model.

BACKGROUND:

The major hypothesis of this study is that suppression of immunoregulatory cytokines will prevent factor VIII inhibitor formation in the hemophilia A murine model: if successful, a treatment protocol could be developed for individuals identified to be at highest risk for inhibitor formation. Through this approach to the epidemiology and immunology of inhibitor formation, the health care of individuals with hemophilia may be improved.

The study is in response to a Request for Applications released in 1998 on the Immunogenetics of Inhibitor Formation in Hemophilia. .

DESIGN NARRATIVE:

A case-control study is conducted comparing prevalent hemophilia patients with inhibitors identified in the HMS Study with three age-matched controls without inhibitors to determine clinical and laboratory characteristics associated with inhibitor development. A histocompatibility study is conducted identifying patterns of HLA Class II antigens by molecular typing in hemophilic subjects identified in HMS, with and without inhibitors, which may be linked to inhibitor formation. An animal tolerance study is conducted in the hemophilia A murine model, evaluating blockade of T cell costimulatory pathways by CTLA4-Ig and anti-CD40L mAb, to prevent inhibitor formation.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria