cyrilzakka/clinical-trials huggingface dataset:
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory

PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.

This is a prospective observational study in which patients with positive PET scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . In the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.

Eligibility Criteria:
Inclusion Criteria:

* Patients confirmed Hodgkin's lymphoma at refractory at first line therapy, relapse early or late;
* Age \> 18 years;
* Life expectancy \> 3 months;
* Cardiac, pulmonary, renal and liver functions with normal range;
* Written informed consent.

Exclusion Criteria:

* Any psychological, familiar or geographical conditions that could potentially hinder the compliance to the protocol;
* renal failure as creatinine\> 1.2 mg/dl or creatinine clearance \<60 ml/min;
* AST/ALT or bilirubin\> 2.5 times the norm;
* HCV positivity with signs of ongoing viral replication (HCV PCR + AST\>1.5-2x normal);
* Heart disease clinically significant: eg. severe hypertension not controlled, multifocal uncontrolled cardiac arrhythmias, symptomatic ischemic heart disease or congestive heart failure class NYHA class III-IV (Annex 2), previous acute myocardial infarction;
* Ventricular ejection fraction \<45%;
* decompensated diabetes mellitus not controlled by insulin therapy; Disease with significant pulmonary function defined as FEV1 \<65% of predicted or DLCO \<50% of predicted value;
* HIV positive patients;
* Patients with uncontrolled infection;
* Neoplasia in the last 3 years except carcinoma in situ uterus, neck and basal skin cancer or prostate cancer in early stage localized exeresi treated with surgery or brachytherapy with curative intent, a good prognosis DCIS breast treated with surgery alone;
* Drug addiction or alcoholism.
The Core Ultrasound Applications for Nurse Practitioners

This project aims to establish point-of-care ultrasound (PoCUS) training course for nurse practitioners in Taiwan, and standardized evaluation modules. The study subjects are nurse practitioners across different hospital levels.

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This project aims to establish point-of-care ultrasound (PoCUS) training course for nurse practitioners in Taiwan, and standardized evaluation modules. The study subjects are nurse practitioners across different hospital levels.

Eligibility Criteria:
Inclusion Criteria:

nursing practitioners who are interested in PoCUS.

Exclusion Criteria:

nursing practitioners who are not interested in PoCUS.
Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump

Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices

Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including advanced hybrid closed loop (HCL) insulin pumps. The results of the AHCL insulin pump based studies published so far are very encouraging, including that Medtronic-sponsored study performed at our center "Transition of CSII/CGM naïve patients directly into AHCL (780G) insulin pump: the impact on glucose patterns and quality of life measures" (1-6). Unfortunately there is little data concerning the usage of AHCL systems in older patients. The management of these individuals is particularly challenging as older adults with type 1 diabetes are especially vulnerable to hypoglycaemia. The recent ADA/EASD consensus underlines that the use of advanced technologies in older individuals is useful and should not be discontinued or a priori excluded because of the older age (7). Since the AHCL systems are very effective in hypoglycemia prevention they could be considered the treatment of choice in older patients with T1DM. The open question is how effectively would older individuals adopt this advanced technology, how would they accept it, and if the simplicity in terms of everyday usage of AHCL versus less advanced technologies would be appreciated by older individuals with T1DM. Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices

Eligibility Criteria:
Inclusion Criteria:

1. Age over 65 years
2. T1DM
3. Willing to participate in a study for the specified duration
4. Willing to perform ≥ 4 finger stick blood glucose measurements daily
5. Willing to wear the system continuously throughout the study
6. Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
7. Treated with MDI/CSII (with exclusion of 780G)
8. Willing to perform at least 4 BGM/day, when on MDI/CSII
9. Lack of advanced complications of diabetes, eGFR\>30

Exclusion Criteria:

1. Severe concurrent illness
2. Laboratory abnormalities, or medications that might affect study participation,
3. Severe renal impairment (eGFR\<30)
Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor (α1-PI). This pharmacokinetic study will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects will be enrolled into the study. Overall study duration will be approximately 6-8 months.


Eligibility Criteria:
Inclusion Criteria:

* The subject or subject´s legally authorized representative has provided written informed consent
* Subject is 18 years of age or older
* Subject has a documented, endogenous plasma Alpha1-PI level \< 8 Micromolar
* Subject is of the genotype Pi\*Z/Z, Pi\*Z/Null, Pi\*Null/Null, Pi\*Malton/Z, or others, dependent on the approval by the Sponsor
* If the subject is female or of childbearing potential, the subject has a negative urine test for pregnancy within 7 days prior to first study product administration and agrees to employ adequate birth control measures for the duration of the study
* Laboratory results obtained at the screening visit, meeting the following criteria:

  * Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) \<= 2 times the upper limit of normal (ULN)
  * Serum total bilirubin \<= 2 times ULN
  * Proteinuria \< +2 on dipstick analysis
  * Serum creatinine \<= 1.5 times ULN
  * Absolute neutrophil count (ANC) \>= 1500 cells/mm3
  * Hemoglobin \>= 10.0 g/dL
  * Platelet count \>= 10\^5/mm3
* If the subject is treated with any respiratory medications, including inhaled bronchodilators and inhaled or oral corticosteroids, the subjects´ medication doses were unchanged for at least 14 days prior to first study product administration
* Nonsmoker for a minimum of 3 months prior to first study product administration

Exclusion Criteria:

* The subject has received any Alpha1-PI augmentation therapy (including Aralast and investigational Alpha1-PIs, by any route including intravenous and inhaled) within 42 days prior to first study product administration
* The subject has received an investigational drug or device within 1 month prior to first study product administration, or the subject is currently receiving an investigational drug
* The subject has a known selective immunoglobulin A (IgA) deficiency (IgA level \< 15 mg/dL) and/or antibody to IgA
* The subject has a pulmonary exacerbation or had a pulmonary exacerbation in the past 14 days prior to first study product administration
* The subject is pregnant or lactating, or intends to become pregnant during the course of the study
* The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Eligibility Criteria:
Inclusion Criteria:

* Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to \<38 kg/m2.
* Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
* Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening.
* Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any drug.
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
* Prior therapy for the treatment of HCV.
* Any current or past clinical evidence of cirrhosis.
* Any cause of liver disease other than chronic HCV-infection.
* HCV genotype co-infection with any other HCV genotype.
* Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events
* Polymorphonuclear neutrophils (PNN) ≥ 1200/mm3, platelets ≥ 100000/mm3, hemoglobin (Hb) ≥ 10 g/dL
* Bilirubin ≤ 30 μmol, SGOT/SGPT \< 3N
* Fully signed informed consent

Exclusion Criteria:

* Pain due to bone fracture
* Metastatic disease
* Hormone therapy other than anastrozole
* Incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life
* Hypersensitivity to letrozole or its components

Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
* Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
* For Part 1 and Part 2:
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
* Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
* Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant

Exclusion Criteria:

* Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
* Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
* If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
* Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
* Pregnancy
* Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
* Evidence of intracerebral macrohemorrhage
* Part 2: Participants who have been discontinued from Part 1 of the study
Observational Study, Use of Canakinumab Administered Subcutaneously in the Treatment COVID-19 Pneumonia

The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all COVID-19 pneumonia patients treated with canakinumab administered subcutaneously.


Eligibility Criteria:
Inclusion Criteria:

* patients with COVID 19 who have received or are candidates to receive treatment with canakinumab subcutaneously
* Age\> 18 years
* Pneumonia diagnosed with Chest X-ray / or Chest CT

Exclusion Criteria:

* Patients with Covid19-related pathology in the context of another cause of major admission (trauma, surgery)
Comparison of the Efficacy of PENG Block in Combination With LFCN Block and Wound Infiltration

The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries.

The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries. However, it fails to provide cutaneous analgesia on the anterolateral surgical incisional site. This study compares the effects of wound infiltration and lateral femoral nerve blocks in combination with PENG blocks for postoperative pain in patients undergoing total hip arthroplasty for coxarthrosis.

Eligibility Criteria:
Inclusion Criteria:

* Coxarthrosis
* Total hip replacement
* Patients agreed to receive PENG block
* LFCN or wound infiltration performed combined with PENG blocks

Exclusion Criteria:

* Other kinds of hip surgeries
* Total hip replacement performed for other indications
* Patients refused to receive PENG block
Treatment of Acute Stroke With Cromolyn(Single Dose)

Mastocytes were proven to have a central rule in their development of the lipoid plaque of the vascular system. Mastocytes also has an important role in the stabilisation of the plaque in the building of the brain barrier. Different animal studies show that the inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic stroke.It was also shown that post stroke inflammation process was also blocked by the inhibition of mastocytes.Other studies showed up to 100% decrease in the brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors.

Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used in the previously mentioned studies.


Eligibility Criteria:
Inclusion Criteria:

1. Infarction of the anterior Circulation system.
2. Both genders
3. Age \> 20 years
4. NIHSS \> 5 -

Exclusion Criteria:

1. Non- ischaemic stroke
2. Additional disease of the CNS
3. Known allergy to cromolyn
4. Diseae of mastocytosis
5. Renal or Hepatic failure (acute or chronic)
6. Inability to sign consent form (dementia or sensory aphasia)
7. Lacunar infarctions
8. INfarction present in cerebellum or brain stem -
An Observational,Prospective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC, PCSK1 or LEPR Genes

This is an observational study. There are no protocol-defined visits, although patients are expected to have routine office visits approximately every 6 months. Upon signing of informed consent/assent and study enrollment, historical data will be abstracted from the patient's medical chart. The patient will then be observed prospectively for up to 5 years, with additional data collected from routine healthcare encounters and direct-to-patient questionnaires (where local laws allow), including laboratory tests, physical exam and patient reported outcomes/quality of life measures. Patients will be consented/assented to provide blood samples for biomarker assessments, DNA sequencing and archiving.


Eligibility Criteria:
Inclusion Criteria:

1. Age 2 years or older
2. Study participant and/or parent or guardian is able to communicate well with the investigator, to understand and comply with the requirements of the study, and be able to understand and sign the written informed consent/assent.
3. Have documented results of DNA sequencing for the three genes of interest: POMC, PCSK1 and LEPR.
4. Bi-allelic, homozygous or compound heterozygous (a different gene mutation on each allele) genetic status for either the POMC or PCSK1 genes, resulting in a severe POMC deficiency obesity clinical phenotype, or a similar bi-allelic gene status for the LEPR gene leading to identified LEPR deficiency obesity.
5. Patients who are willing to come in for routine office visits approximately every 6 months.

Exclusion Criteria:

1. Participation within the past 3 months in a clinical trial of any investigational medicine for obesity.
2. Confirmed diagnosis of Prader-Willi syndrome, Bardet-Biedl syndrome, Alström syndrome, or other syndromic form of genetic obesity.
Acute Effects of Exercise Combined With Ketone Ester Supplement

To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults.

The prevalence of excess body weight and associated medical burdens (i.e., cardiometabolic and neurocognitive impairments) have been rising over the past several decades globally. The combination of exercise and ketone supplementation has been recently proposed as one of the solutions with potential clinical value, of which the interventional effects and underlying mechanisms remain unclear. The current study aims at (1) investigating the additive effects of ketone ester supplements to exercise in aspects of cardiorespiratory fitness, metabolism, and neurocognitive status, and (2) examining how the exercise type (HIIE \[high-intensity interval exercise\] vs. MICE \[moderate-intensity continuous exercise\]) influences the cardiometabolic and neurocognitive responses of the exercise-diet regime. For each of the 30 participants, six experimental trials will be performed in a randomized trial with a counterbalanced order: (1) HIIE-KT condition (HIIE with ketone supplements); (2) MICE-KT condition (MICE with ketone supplements); (3) NE-KT condition (non-exercise with ketone supplements); (4) HIIE-PLA condition (HIIE with taste-matched placebo); (5) MICE-PLA condition; and (6) NE-PLA condition. Cardiometabolic and neurocognitive parameters will be assessed before and after 30, 60, and 90 min subsequently ketone ester supplements.

Eligibility Criteria:
Inclusion Criteria:

* body mass index \> 25 kg/m\^2;
* right-handed.

Exclusion Criteria:

* psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
* addicts to alcohol, nicotine, or drugs;
* oral contraceptive or any medication intake during the past 6 months;
* current engagement in any resistant exercise.
HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500 patients, the study began recruiting premenopausal patients only. The primary objective of the extended study is to compare disease free survival in premenopausal patients with early breast cancer. Patients receive triptorelin and are randomized in a 1:1:1 fashion to receive tamoxifen or letrozole, or letrozole + zoledronic acid.

The purpose of the HOBOE study, Version 1, was to compare the adjuvant hormonal therapy treatments of Tamoxifen, Letrozole and Letrozole + Zoledronate for their effects on bone loss in breast cancer patients. Postmenopausal and premenopausal patients were eligible, the latter also receiving monthly triptorelin. Upon reaching the enrollment of the first 500 patients in March 2010, the study began recruiting premenopausal patients only.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of breast cancer
* Surgical resection of breast cancer (breast conserving surgery or mastectomy)
* No evidence of disease
* Indication for adjuvant hormonal therapy (ER and/or PgR positive with IHC exam in at least 1% of primary tumor cells, according to St. Gallen criteria)
* Patient age at least 18 years
* Written informed consent . Premenopausal status defined as LMP within 12 months of randomization (FSH, LH will not be considered as determinants of menopausal status due the chemotherapy induced reversible ovarian suppression)

Please note that patients who have received neoadjuvant or adjuvant chemotherapy and/or locoregional radiation therapy may be included in the study

Exclusion Criteria:

* Performance status (ECOG)\>2.
* Previous or concomitant malignancy (with the exception of adequately treated nonmalignant skin cancer and carcinoma in situ of the uterine cervix
* Metastatic breast cancer
* Creatinine \> 1.25 times the value of upper normal limit
* Pregnant or lactating females
* Clinical or radiologic evidence of bone fractures
* Treatment with systemic cortisone therapy within 12 months prior to randomization
* Treatment with drugs that could alter bone metabolism (calcitonin, mithramycin, gallium nitrate) within 2 weeks prior to randomization
* Previous treatment with tamoxifen or aromatase inhibitors
* AST and/or ALT \> 3 times the value of upper normal limit with clinical and laboratory findings that indicate a grade of hepatic insufficiency that could potentially increase the risk of assuming letrozole
* Any concomitant conditions that would, in the Investigator's opinion, contraindicate the use of any of the drugs used in this study
* Inability to provide informed consent
* Inability to comply with followup
* Patient undergoing invasive dental work at time of baseline evaluation or foreseen during the course of adjuvant therapy
Intervention for Comorbid Substance Use and Bipolar Disorders

This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.


Eligibility Criteria:
Inclusion:

* Diagnosis of a bipolar-spectrum disorder
* Diagnosis of a substance use disorder
* Taking at least one mood-stabilizing medication

Exclusion:

* Unable to speak and read English
* Younger than age 18