cyrilzakka/clinical-trials huggingface dataset:
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.

Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (auto-HCT)\]. Post-infusion support includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. Participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic HCT (allo-HCT). For allo-HCT, a sibling donor that is fully matched for human leukocyte antigen (HLA-matched) is identified. Participants receive a single dose of total body irradiation (TBI) 200 centigray (cGy) as well as immunosuppression with cyclosporine (CSP) 6.25 mg/kg and mycophenolate mofetil (MMF) 15 mg/kg. The HLA-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to Day 0, with apheresis collections on Day -1 and Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV and diphenhydramine 50 mg IV. CSP will be tapered beginning Day 56 with a goal of discontinuing CSP on Day 180, adjusted as needed.

Eligibility Criteria:
PATIENT INCLUSION CRITERIA

* Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease
* Patient has HLA-identical sibling donor
* Age ≤ 70 years
* No prior therapy which would preclude the use of low-dose total body irradiation
* Pathology review and diagnosis confirmation by Stanford University Medical Center
* Karnofsky performance status (KPS) \> 70%
* DLCO ≥ 60% predicted
* ALT and AST \< 2 x upper limit of normal (ULN)
* Total bilirubin \< 2 mg/dL
* Serum creatinine \< 2.0, or 24-hour creatinine clearance ≥ 60 mL/min
* HIV-negative
* Signed informed consent document

PATIENT EXCLUSION CRITERIA

* Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis
* Severe psychological or medical illness
* Prior allogeneic hematopoietic cell transplantation
* Pregnant or lactating

ALLOGENEIC DONOR INCLUSION CRITERIA

* Age ≥ 17
* HIV-seronegative
* Signed informed consent document

ALLOGENEIC DONOR EXCLUSION CRITERIA

* Serious medical or psychological illness
* Pregnant or lactating
* Prior malignancies within the last 5 years, except for non-melanoma skin cancers
Supporting Methods in Cardiovascular Diseases Rehabilitation

The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. This study aims to evaluate the influence of the used therapeutic approaches on psychological outcomes and to compare the effectiveness of these therapies.

Depression, anxiety, and high levels of perceived stress are increasingly common problems associated with cardiovascular disease (CVD). The relationship between anxiety-depressive disorders and the risk of CVD is confirmed by behavioral and physiological mechanisms. According to the American Heart Association, depression is a negative prognostic factor at all stages of treatment of CVD. The most important risks in people with CVD and anxiety-depressive disorders, as comorbidities, are an increased risk of recurrent cardiovascular events and increased mortality. However, psychological disorders in patients with CVD are still not sufficiently diagnosed and, consequently, are not adequately treated. Therefore, it is necessary to look for effective methods to support cardiac rehabilitation from a psychological perspective.

The first group of patients will receive relaxation-therapeutic recordings (referred to as the Recording Group) in addition to monitored cardiac physical training. The second group will receive virtual reality (VR) therapy (referred to as the VR Group) alongside monitored cardiac physical training. The third group (referred to as the Control Group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.

The aims of the study:

1. The evaluation of the influence of relaxation-therapeutic recordings on the anxiety-depressive symptoms and the stress level of the patients undergoing second stage of cardiac rehabilitation.
2. The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.

Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Disease;
* the second stage of cardiac rehabilitation conducted in outpatient settings

Exclusion Criteria:

* inability to self-complete the research questionnaires;
* presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
* initiation of psychiatric treatment during the research project;
* contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
* the patient's refusal at any stage of the research project.
Lifestyle Intervention to Treat Diabetes in the Marshall Islands

The Republic of the Marshall Islands has the highest prevalence of type 2 diabetes (T2D) in the world. This clinical trial tested whether a community-based, intensive, plant-rich lifestyle intervention with exercise is more effective for treating and managing T2D in the Republic of the Marshall Islands than the standard of diabetes care. The intensive lifestyle intervention consisted of a plant-rich diet and moderate exercise. It centered around a 12-week program of counseling and instruction on healthy eating, exercise, and stress management, as well as hands-on cooking classes and prepared meals. Cardiometabolic outcomes were assessed throughout the intervention and at 24 weeks. The present study is the first randomized clinical trial ever conducted in the Republic of the Marshall Islands and the first lifestyle intervention trial conducted in Micronesia.


Eligibility Criteria:
Inclusion Criteria:

* Resident of the Republic of Marshall Islands
* Aged 18 - 75 years
* HbA1c ≥ 8.0% or diagnosed with T2D and taking diabetes medication
* Medical clearance to participate from Diabetes Wellness Center (DWC) physicians.

Exclusion Criteria:

* Recent (≤3 months) change in a diabetes-related medication dosage
* A physical or medical condition that would impede participation in the lifestyle intervention (e.g., wheel-chair bound, unstable angina)
* Evidence of significant coronary heart disease
* Previous participation in an intensive lifestyle intervention
Baerveldt Plate Area Comparison (BPAC)

This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant.

A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).

Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Intra-Ocular Pressure (IOP) \> 18 mm Hg and \< 40 mm Hg on medical therapy
* Previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy)
* Consent signed

Exclusion Criteria:

* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
* Pregnant or nursing
* Neuro-Linguistic Programming (NLP) vision
* Iris neovascularization or proliferative retinopathy
* Epithelial or fibrous downgrowth
* Chronic or recurrent uveitis
* Steroid-induced glaucoma
* Severe posterior blepharitis
* Previous cyclodestructive procedure
* Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation.
* Functionally significant cataract
* Need for Baerveldt implant combined with other ocular procedures (ie cataract surgery,penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
* Prior glaucoma drainage device (tube) implant
* Prior retinal surgery with remaining silicone oil
* Prior scleral buckling procedures
Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers

Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS.

Safety and tolerability were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>=18 and \<=55 years
* Laboratory examinations within a clinically defined reference range
* Helicobacter pylori negative
* Able to tolerate pH probe application
* Body mass index (BMI) \>=18.5 and \<=29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* Surgery of gastrointestinal tract (excluding appendectomy)
* History of orthostatic hypotension, fainting spells or blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator including study drugs
* History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
* Intake of drugs with a long half-life (\> 24 hours) within 1 month or 10 half lives of that drug, whichever is longer, prior to administration of study drugs or during the trial
* Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
* Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within 5 days of study drug administration
* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
* Smoker
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood or plasma donation (\>400 ml) within 1 month prior to administration or during trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Following specific laboratory findings: aspartate aminotransferase, alanine transaminase, Gamma-glutamyl-transferase above the reference range
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions
Comparison of Classification Standards of BPD in Premature Infants

Bronchopulmonary dysplasia of premature infants is a common respiratory disease in premature infants. Long-term complications such as recurrent respiratory infection and abnormal lung function may occur in the survivors, and may increase the risk of dysplasia of the nervous system. In the past 30 years, although the monitoring and treatment technology of premature infants has been significantly improved, the incidence of BPD still shows no downward trend, and effective treatment and prevention methods for BPD are still lacking. The progress of clinical research on BPD is slow, one of the important reasons is that the definition of BPD is still not consistent, and its diagnostic and grading standards lack objectivity. To summarize the development of diagnostic criteria for BPD in the past 30 years, there are still the following disadvantages. 1. 2. In the above study, all proposed alternative BPD classification standards did not completely separate HFNC and NIV. In view of this, this study separated HFNC and other NIV to form a new revised BPD classification standard. On this basis, a nested case-control study was conducted to compare the differences between the newly proposed classification standards and NICHD standards in 2001, Rosemary standards in 2018 and Jensen standards in predicting long-term respiratory outcomes and other systemic complications in premature infants, so as to provide a standard for more accurate diagnosis and evaluation of BPD in premature infants.


Eligibility Criteria:
Inclusion Criteria:

* premature infants whose gestational age is less than 32 weeks;
* hospital stay ≥14 days;
* complete clinical medical records, including effective follow-up information

Exclusion Criteria:

* congenital heart and lung malformation and specific chromosomal diseases;
* children abandon treatment halfway;
* death of children due to factors other than respiratory system.
Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis

The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).

Subjects will be randomly assigned to receive either NVC-422 or Vehicle.

This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").

Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:

* Visit 1: Screening, Day 1
* Visit 2: Day 3
* Visit 3: Day 6
* Visit 4: Day 11 End of Treatment (EOT)
* Visit 5: Day 18 Test-of-Cure (TOC)
* Visit 6: Day 42 Follow-up

Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.

Eligibility Criteria:
Inclusion Criteria:

* Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
* Bulbar conjunctival injection
* Other inclusion criteria per protocol

Exclusion Criteria:

* Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye
* A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
* Other exclusion criteria per protocol
Effects of Textured Insoles and Exercise in Children With Joint Hypermobility

Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children.

It was planned to include 40 children with joint hypermobility in the project. Children's joint hypermobility will be determined by the Beighton Score. Children will be divided into two groups. Children in both groups will be offered an exercise program consisting of home and park activities that will improve their motor and sensory aspects. Children in the intervention group will be asked to additionally use textured insoles. Before and after the study, children's plantar foot tactile sense, balance, foot load distribution and quality of life will be evaluated. Pre- and post-treatment values and change values in both groups will be compared with each other.

Eligibility Criteria:
Inclusion Criteria:

* Children with a Beighton score of 6 and above
* Being between the ages of 5-18
* Being cooperative in the assessments and treatment
* Having a body mass index between 18.5-24.9

Exclusion Criteria:

* Having had any surgery or trauma in the last 6 months
* Having any neurological, metabolic, rheumatological or chronic disease.
* Having a vestibular system problem
* Being diagnosed with Ehlers-Danlos Syndrome
* Having foot wounds and anomalies that may affect sole sensation
* Having chronic pain.
Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy

Compare efficacy and safety of 10-day triple therapy (rabeprazole, clarithromycin and amoxicillin) plus N-acetylcystein versus 10-day concomitant therapy (rabeprazole, clarithromycin, amoxicillin and metronidazole) for re-eradication for gastric Helicobacter pylori infection.

Background: Antimicrobial resistance has decreased the eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%). Such treatment for patient previously with treatment failure, the retreatment eradication rate is less then 50%. Some studies showed the Helicobacter pylori form biofilm to prevent entry of antibiotics, and the N-acetylcystein is helpful to dissolve the biofilm.

Objective: To determine the eradication rate of the common used triple therapy after adding N-acetylcystein for second line treatment for adults infected with Helicobacter pylori in Eastern Taiwan.

Design: Randomized, open-label, prospective controlled trial.

Patients: who are previously failed the primary treatment for eradication and still infected by Helicobacter pylori.

Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

Intervention: patients with Helicobacter pylori eradication treatment failure are recruited and randomly assigned to receive one of the following therapeutic schemes: 1) study group: rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + N-acetylcystein 0.6g bid for 10 days; 2) control group: rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for 10 days. Repeat upper endoscopy for histologic evaluation, rapid urease test or 13C-urea breath test after 4 week of treatment to assess the treatment result. The influence on the hybrid therapies of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host were determined.

Expected results: The new second line treatment for eradication of Helicobacter pylori is effective, and to determine the relation of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host to the treatment result.

Eligibility Criteria:
Inclusion Criteria:

* Patient after treatment for Helicobacter pylori eradication.
* Still clinically with evidence of gastric Helicobacter pylori infection.

Exclusion Criteria:

* woman in breast feeding or pregnancy.
* allergy to drugs used in study.
* never treated for H. pylori.
* intolerance to fructose, lactose.
* patients with hematologic, brain or spinal disorders.
* patients under 20 years old.
* patients with malignancy or with decompensated function of vital organs.
Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with hypercholesterolemia who satisfy the following criteria:

  * Participants who have used any of the following 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose low density lipoprotein (LDL)-cholesterol level during the treatment had not reached lipid management target
  * Age: 20 years of age or older (at the time of obtaining informed consent)
  * Sex: both males and females
  * Inpatient/outpatient: Out-patient

Exclusion Criteria:

* Participants for whom any of the following is applicable:

  * Participants whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
  * Participants with homozygous familial hypercholesterolemia
  * Participants with creatine phosphokinase (CPK) \> 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
  * Participants with serious hepatic disorder, or participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x ULN measured at the start of the observation period or the treatment period.
  * Participants with a history of hypersensitivity to any ingredient of ezetimibe tablets or atorvastatin tablets
  * Pregnant, nursing women, women who may be pregnant, or participants wishing to be pregnant during the study.
  * Participants who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the participant had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
  * Participants who are using cyclosporine from after the start of the observation period
  * Participants with a history of ezetimibe use
  * Participants with hyperlipidemia associated with the following diseases:

    * Hypothyroidism
    * Obstructive gall bladder or biliary disease
    * Chronic renal failure
    * Pancreatitis
  * Participants with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
  * Participants who have received an investigational drug within 4 weeks of the start of the observation period
  * Other participants deemed not appropriate for study entry by the investigator