cyrilzakka/clinical-trials huggingface dataset:
Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

The lower bone mineral density that has been described in patients with HIV-infection has not meant an increase of long term complications. Nevertheless, it could involve an increase if the associated co-morbidity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That is why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined.

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of zoledronic acid. If the annual use of endovenous zoledronic acid obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. The annual administration can improve compliance in patients who are receiving a big quantity of drugs, as HIV-infected patients do, and who probably have to be treated for life. Moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what makes of zoledronic acid a very promising alternative. Finally, there is no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bisphosphonates.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older.
2. Documented HIV-1 infection, with or without antiretroviral treatment.
3. Presence of WHO osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter (DEXA in the last 6 months is needed).
4. Willing to follow the study protocol.
5. Informed Consent signature.

Exclusion Criteria:

1. In women, pregnancy or breastfeeding.
2. Other possible causes of secondary osteoporosis.
3. Creatinine over 2.3 mg/mL.
4. Glomerular filter less than 50 mL/min (estimated through MDRD).
5. Treatment for Osteoporosis in the last 4 months.
Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum

In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.


Eligibility Criteria:
Inclusion Criteria:

* CRT:

  * LVEF \< 35%
  * LVEDD \> 5.5 cm
  * NYHA 3-4
  * QRS \> 120 ms
  * Optimal medical treatment
  * Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D)

Exclusion Criteria:

* Not fulfilling inclusion criteria or not written consensus
Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria

The aim of the study is to evaluate differences in pregnancy outcomes and medical costs depending on gestational diabetes diagnostic criteria used (one vs two-step approach).

Due to Hyperglycemia and Adverse Pregnancy Outcomes study results, a new gestational diabetes mellitus (GDM) diagnostic criteria was defined using a one-step approach (75-g oral glucose tolerance test -OGTT-).

However, not all scientific societies have accepted and have implanted this new diagnostic criteria. The lowest glycemia cut-off of this criteria regarding the two-step approach entails an increase in GDM incidence with discordant studies about its cost-effectivity.

It will be assessed if pregnancy outcomes and medical costs are different depending on diagnostic criteria used.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* No expectation that subject will be moving out of the area of the clinical center during the next year
* Informed Consent Form signed by the subject

Exclusion Criteria:

* Preexisting type 1 or 2 diabetes
* Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucose solution.
Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.

Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. Antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects.

The aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults men and women
* Followed for diabetic foot infection (grades 2 to 4 of IWGDF classification)
* That accepted to take part in the study

Exclusion Criteria:

* Legal safeguard
* Pregnant women
* Patient that can't accept to take part in the study because can't be informed
* Exclusive surgical treatment
Medication Adherence Enhancement in Heart Transplant Recipients

Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.


Eligibility Criteria:
Inclusion Criteria:

* all eligible patients with follow-up at our outpatient clinic
* written informed consent
* sufficient German language skills to read and answer a battery of questionnaires
* \> 18 years
* minimum 6 mts post HTX

Exclusion Criteria:

* illiteracy
Registry of Emergent Large VeSsel OCclUsion DuE to IntraCranial AtherosclerosiS

The aim of this study is to develop an international multicenter registry of patient data and outcomes for patients undergoing mechanical thrombectomy for emergent large vessel occlusion with residual underlying stenosis following successful revascularization.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing mechanical thrombectomy
* AND have intracranial stenosis
* Patients aged 18-90 years

Exclusion Criteria:

* None
Bone Quality and Quantity Following Guided Bone Regeneration Prior to Dental Implant Placement

Amongst the consequences of missing teeth are change of appearance and difficulties in mastication and speech. Dental implants in the maxilla or mandible provide a common treatment modality by offering anchorage to fixed or removable fixtures. In many cases, the lack of teeth is accompanied by lack of appropriate bone volume in the desired area for dental implant placement. Possible causes for this lack of sufficient bone volume are varied and include earlier bone atrophy, traumatic tooth extraction and bone resorption due to periodontal disease. In such cases, dental implant placement is preceded by alveolar bone augmentation . Guided Bone Regeneration (GBR) is a common bone augmentation technique in which a bulk of bone substitute is placed in the area which needs more volume before placing a dental implant. The bone substitute is covered with an inert membrane and may provide a scaffold and encourage cells from the patient to reach the area and build new bone volume. A common bone substitute in use for that matter is Deproteinized bovine bone mineral (DBBM) which resembles human bone and helps encourage new bone formation. On the contrary its structural stability during placement and early healing is low. Bi-Phasic Calcium-Sulphate is another common bone substitute with easy handling properties and good structural stability during early healing. Its replacement by natural bone contributes to the augmentation process. Although DBBM efficacy in GBR process has been investigated, using DBBM in combination with bi-phasic calcium-sulphate as a binding material during GBR was not examined. This prospective study will examine augmented bone quality and quantity following a GBR procedure with common approved bone substitutes: DBBM (Bio-Oss, Geistlich) alone or in a combination with bi-phasic Calcium-sulphate (BondBone, Augma). The GBR procedures will precede dental implant placement as custom. The quality and quantity of the new formed bone will be assessed by a C.T (computerized tomography) which is done routinely before dental implant placement and by further analyses of bone residues which will follow drilling the dental implant placement site while preparing it (as common).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women over 18 years of age, eligible for signing
* Edentulus Patients who require a GBR procedure previous to an insertion of a dental implant
* Patients who understand the meaning of the treatment (routine Guided Bone Regeneration and dental implant insertion) and the follow up study, and approves participation in booth of them

Exclusion Criteria:

* Pregnant or nursing women.
* C567890-hildren or non judgemental patients
* Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
* Patients with a pathology present near the site of dental implantation
Long-Term Follow-up Protocol

The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP).

Due to the guidelines for gene therapy for vectors which may undergo latency/ reactivation, Krystal Biotech, Inc. has established a Long-Term Follow-up Protocol which will identify and mitigate the long-term risks to the participants receiving their gene therapy products and capture delayed adverse events in participants, annually, for 5-years following the last study visit. Additionally, it will allow the Sponsor to further understand the persistence of the gene therapy products used in their parent treatment protocols.

Eligibility Criteria:
Inclusion Criteria:

* All adult and pediatric participants who received at least one gene therapy treatment in a previous Krystal Biotech, Inc. sponsored study, and have discontinued or completed the parent treatment protocol (which do not have the LTFU embedded into the parent protocol), as applicable.
* Consent/Assent must be obtained by the participants (and, parental/legal representative, when applicable) prior to any study-related data being collected.
* Participant is willing and able to adhere to the protocol requirements.

Exclusion Criteria:

* Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.
Effects of Cocoa on Gastrointestinal Function

This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional brain imaging will be applied to identify regions of brain that are activated or inactivated by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal diet in randomized order. Reference standard methodology will be applied to measure gastric emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, \~500kcal, \~50% fat) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity using FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the number and distribution of radio-opaque markers in the colon. On the fourth day gastric emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a dark or white chocolate mousse test meal (both 150g, \~500kcal, \~50% fat). During both interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and mood will be recorded. Additionally, validated questionnaires will assess digestive comfort and well-bring at the end of each study day. These results will deliver comprehensive information about the effects of cocoa on gastrointestinal transit and sensation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men and women)
* aged 18-65 years
* body mass index 18-30kg/m2.

Exclusion Criteria:

* special dietary requirements incompatible with dietary intervention (food allergies or intolerances)
* clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that preclude intake of test meals
* participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable)
* individuals unwilling to provide written informed consent
* inability to follow the procedures of the study, e.g. due to language problems (all study documents in English)
Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

This is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).

Scheme:

Eligible fosaprepitant sensitive (complete response \[defined as no emesis and no use of rescue antiemetics\] during the overall phase \[0 to 120 hours\] of all cycles of cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1 ratio.

* Weekly Arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy.
* Triweekly Arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* Stage II - IVa NPC patients (according to the 8th AJCC edition)
* Male and no pregnant female
* Scheduled for cisplatin-based induction chemotherapy (cisplatin≥ 70 mg/m2)and concomitant triweekly cisplatin
* Fosaprepitant sensitive (complete response \[defined as no emesis and no use of rescue antiemetics\] during the overall phase \[0 to 120 hours\] of all cycles of cisplatin-based induction chemotherapy)
* Age between 18-70
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<2.0×upper limit of normal (ULN)
* Adequate renal function: creatinine clearance ≥60 ml/min
* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
* Without radiotherapy or chemotherapy
* Patients must give signed informed consent

Exclusion Criteria:

* Evidence of relapse or distant metastasis
* Pregnancy or lactation
* History of prior malignancy or previous treatment for NPC
* Had other current malignant diagnoses apart from non-melanoma skin cancers
* Emesis or clinically significant nausea (moderate or severe) in the 24 h before the first dose of study medication
* Drugs with antiemetic activity were not allowed for the 24 h before receiving the first dose of study medication
* Known history of central nervous system disease (e.g., a seizure disorder or brain metastases )
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice

The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment initiation with vedolizumab.

This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to provide real-world data to describe clinical outcomes and participant-reported symptom experience over 12 months following vedolizumab treatment initiation.

The study will enroll approximately 140 participants. All participants will be enrolled in one observational group:

• Vedolizumab

This multicenter trial will be conducted in Canada. The overall duration of study will be approximately 24 months, including participant's enrolment period of 12 months and follow-up data collection period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
2. Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
3. Scheduled for initial vedolizumab treatment per usual care recommendation.
4. Was biologic-naive at time of initiating vedolizumab treatment.

Exclusion Criteria:

1. Was prescribed vedolizumab as part of a clinical study.
2. Has isolated and active perianal disease in the absence of luminal CD.
The Analysis of BMI, Asthma Prevalence, and Lung Functions of Schoolchildren in Southern Taiwan

The prevalence of obesity and asthma has increased in recent decades. We investigated the relationship between body mass index (BMI) and lung function, and also tried to determine if asthma prevalence differs between obese and non-obese children. We propose this cross-sectional, retrospective analysis to figure out whether the BMI is associated with elevated prevalence of asthma, and how their lung function changes in different BMI groups.


Eligibility Criteria:
Inclusion Criteria:

* students representing all grades in a total of 123 junior high schools in southern Taiwan (Kaohsiung and Pintong) between 1995-1996

Exclusion Criteria:

* failure to obtain ISAAC questionnaire
* failure to preform lung functions study
IPACK Block Versus Adductor Canal Block in High Tibeal Osteotomy

A comparison between IPACK block and adductor canal block in post operative pain management

Two groups of patients between 40 and 60 yrs who are undergoing open wedge high tibeal osteotomy Group 1 will receive IPACK block with 15 ml Bupivacaine, immediately before spinal anaesthesia .

Group 2 will receive adductor canal block ,also with 15 ml Bupivacaine. before spinal anaesthesia. register the time of first pain sensation and firs IV analgesic dose required in each group

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 - 60 years.
2. American Society of Anesthiologist class ( ASA) I - III
3. BMI 18-35 kg/m2
4. Scheduled for primary unilateral open wedge high tibial osteotomy

Exclusion Criteria:

1. Known allergy to local anesthetics
2. Contraindication to local anesthetics injection e.g. infection at the site of injection
3. Contraindication to spinal anesthesia e.g. coagulopathy.
4. Patients with pre-existing motor or sensory deficits in lower extremities.
5. Insulin or noninsulin dependent diabetes mellitus.
6. systemic corticosteroid use within 30-days of surgery
7. difficulties in comprehending visual analog scale (VAS) pain scores
8. history of arrhythmia or seizures
9. severe renal insufficiency
Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

The RUXOREL-MF observational study includes patients with primary and post-essential thrombocythemia/post-polycythemia vera myelofibrosis (MF) being treated with the oral JAK1-/JAK2-inhibitor ruxolitinib in a "real world" setting. Patients are treated according to current indications in Italy (i.e., primary and secondary MF patients with intermediate-1, intermediate-2, and high risk IPSS (International Prognostic Scoring System) scores and symptomatic splenomegaly and/or systemic symptoms). Patients are treated at facilities pertaining to the regional Hematology Network of Lombardy (Rete Ematologica Lombarda) in Italy. Efficacy data, data related to infectious and vascular events, data related to second primary malignancies, data regarding disease progression/transformation, and molecular information in relationship to ruxolitinib treatment will be collected and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of primary myelofibrosis diagnosis according to the WHO 2016 classification or post-essential thrombocythemia/post-polycythemia vera myelofibrosis according to the IWG-MRT 2008 classification
* Patients with an intermediate-1, intermediate-2, or high risk score according to the IPSS (International Prognostic Scoring System)
* Patients treated with ruxolitinib in accordance with current indications in Italy
* Patients eligible or ineligible to hematopoietic stem cell transplant or who have already undergone a hematopoietic stem cell transplant

Exclusion Criteria:

* Diagnoses other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis
* Patients treated with ruxolitinib having a platelet count at treatment initiation \<50 x10\^9/L
* Patients treated with ruxolitinib for conditions other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis