cyrilzakka/clinical-trials huggingface dataset:
Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are performed on peripheral blood samples.

Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. The aim of the study is to investigate the immune reconstitution in presence of Zinc, focused on thymic reconstitution. Laboratory tests are performed on peripheral blood samples, collected at 4 time-points: two before transplant (at the moment of the enrollment and the day before conditioning) and two after transplant (day +30 and +100).

Eligibility Criteria:
Inclusion Criteria:

* eligibility to stem cell transplantation

Exclusion Criteria:

* allergy to Zinc
* copper deficiency or Wilson's syndrome
* patients who admit zinc assumption in other drugs
Hepatitis C Treatment in Probation and Parole Office

This prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (P\&P office) setting and compare the results with a historic control with referral to care. Research participants will be followed in the P\&P office when they report to their officer during regularly scheduled appointments. Participants will receive treatment without having to travel to a specialist's office. The telemedicine visit will include a consultation with an experienced HCV provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor HCV treatment. The UK specialty pharmacy will be available to participants and the HCV management team through a 24-hour support line. Participants will be treated per HCV guidelines and insurance preference.


Eligibility Criteria:
Inclusion Criteria:

* Clients who will be supervised in the probation and parole office for at least 5 months
* History of hepatitis C
* Able to obtain health insurance
* Capacity to provide written, informed consent
* Life expectancy \>1 year

Exclusion Criteria:

* Negative HCV RNA
* Pregnant or breast-feeding
* HIV or HBV co-infection
* Liver cirrhosis with Child-Turcotte-Pugh score 6 or greater at baseline lab work
* Subjects with impaired capacity to provide informed consent
An Intervention Program to Control Diabetes

Study to evaluate the effectiveness of a structured intervention to improve diabetes control.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* 18-70 adults
* Type 2 Diabetes
* Males and non-pregnant females

Exclusion Criteria:

* Use of exogenous insulin for glucose control
* Use of medications or supplements for weight loss
* Advanced diabetes complications
* Recent history of cardiovascular event
Effect of SNAGs and Scapular Mobilizations in Patients With Scapulocostal Syndrome

To determine the impact of SNAGs and Scapular mobilizations on pain, cervical and shoulder Range of motion and functional outcomes in individuals with Scapulocostal Syndrome.

The rationale for employing SNAGS (Sustained Natural Apophyseal Glides) in treating scapulocostal syndrome is multifaceted. By targeting specific joint surfaces and soft tissue structures, SNAGS aim to address joint dysfunction, alleviate pain, and improve mobility in the scapulothoracic region. These sustained gliding movements not only modulate pain signals but also promote relaxation and reduce muscle tension, thereby enhancing the effectiveness of therapeutic exercises aimed at strengthening the surrounding musculature. Additionally, SNAGS facilitate proper muscle activation patterns, optimizing muscle function and coordination. Their adaptability allows for a patient-centered approach, ensuring tailored treatment that considers individual symptoms, mobility deficits, and treatment goals, ultimately promoting better functional outcomes in individuals with scapulocostal syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age- 18 to 40 years.

  * Male and female both
  * Nonspecific neck pain with a duration of greater than 3 months
  * No pain reproduction on isometric muscle testing in shoulder.
  * Patients who could not achieve 60 degrees of upward rotation when elevating the arms above the head i.e. presence of scapular dyskinesia
  * pain with a referral pattern while receiving manual pressure of at least 3 points on the medial scapular muscles (levator scapulae, rhomboid major, rhomboid minor, and serratus posterior superior) evaluated through Travels and Simon criteria.
  * Discomfort, pain, or limitations in neck extension, neck rotation bilaterally, shoulder forward flexion, shoulder abduction attributed to SCS.
  * Willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Musculoskeletal pathologies affecting the cervical spine or lower extremities (e.g., herniated disc, cervical radiculopathy, cervical stenosis, shoulder labral tear).

  * history of degenerative shoulder joint disease
  * rotator cuff dysfunction
  * Thoracic outlet syndrome
  * Brachial neuralgia
  * shoulder impingement syndrome
  * adhesive capsulitis
  * Pregnant individuals due to potential discomfort.
  * Open wounds, infections, or skin conditions at pain site.
Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone


Eligibility Criteria:
Inclusion Criteria:

* Women affected by adenomyosis with pelvic pain \> 4;
* Negative Pap Smear test

Exclusion Criteria:

* Pregnancy or research of pregnancy
* Refusal or inability to sign informed consent
* Severe underlying comorbidities (hepatic, oncological)
* Pelvic inflammatory disease
* Other cervical or uterine pathologies
* Deep venous thromboembolism
* Hormonal therapy contraindications
* Smoke
Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy

Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer. The only remedy for thrombocytopenia at present is platelet transfusion, which is effective in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be effective in stimulating platelet production. The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and etoposide in children with solid tumors and lymphomas. The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent, refractory, or previously untreated malignant solid tumor or recurrent/refractory lymphoma for which Ifosfamide, Carboplatin, and Etoposide chemotherapy is the most appropriate treatment.
* Adequate liver and kidney function.
* Adequate performance status.
Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.

patients are randomized into 2 groups after meeting the eligibility criteria,

1. Each patient will be given pain scale chart in order to record his /her pain level before any intervention.
2. The tooth is anesthetized, accessed and mechanical instrumentation to be made 3 A) For the experimental group: The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation

B) For the control group :

The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.

4) Obturation is done and postoperative instructions are given to the patient

Eligibility Criteria:
Inclusion Criteria:

i. Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars

* Asymptomatic.
* Non-vital response of pulp tissue (negative response).
* With or without periapical radiolucency.

Exclusion Criteria:

i. Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively.

v. Patients having bruxism or clenching. vi. Teeth that have :

* Vital pulp tissues.
* Association with swelling
* Acute peri-apical abscess
* Periodontally affected teeth
* No possible restorability
* Previous endodontic treatment.
Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.

The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* mechanical ventilation
* an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen
* possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)
* possibility to perform Bioelectrical Impedance Analysis (BIA)
* underlying indication for enteral or/and parenteral nutritional support
* written informed consent from the patient or a legal authorized person

Exclusion Criteria:

* cardiac pacemaker
Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female patients
* Histologically or cytologically confirmed estrogen receptor positive (ER+) breast cancer
* Relapsed or progressed on prior treatment with aromatase inhibitor (AI)
* Metastatic disease must be measurable
* Patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment
* Patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior AI
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1
* Laboratory parameters: a)Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100.0 x 10\^9/L; Absolute Neutrophil Count (ANC ≥) 1.5 x 10\^9/L without the use of hematopoietic growth factors b)Creatinine less than 2.5 times the upper limit of normal for the institution c)Aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of normal for the institution
* Able to understand and give written informed consent and comply with study procedures

Exclusion Criteria:

* Relapse on treatment with non-steroidal AI after less than 12 months for patients in the adjuvant setting
* Progressive disease after less than 3 months treatment with most recent AI for patients with metastatic disease
* Rapidly progressive, life-threatening metastases
* Any palliative radiotherapy to the measurable lesion
* Previous treatment with SNDX-275 or any other histone deacetylase (HDAC) inhibitor including valproic acid
* Allergy to benzamides or inactive components of the study drug
* A history of allergies to any active or inactive ingredients of exemestane
* Any concomitant medical condition that precludes adequate study treatment compliance
* Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
* Patient is currently receiving treatment with valproic acid, Zolinza (vorinostat) or any other HDAC inhibitor or deoxyribonucleic acid (DNA) methyltransferase inhibitor or any systemic anticancer treatment (with the exception of Lupron)
Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors

This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ) and depression questionnaire CES-D.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
* Previous treatment with disease modifying drugs
* Adjustment of disease modifying treatment necessary at the discretion of the investigator
* Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion

Exclusion Criteria:

* Patients not fulfilling the indications in the local prescribing information
* Refusal to sign inform consent
Fibrinogen to Albumin Ratio and C-reactive Protein to Albumin Ratio in Juvenile Idiopathic Arthritis

The fibrinogen to albumin ratio (FAR) and C-reactive protein to albumin ratio (CAR) have emerged as useful biomarkers to predict systemic inflammation. The aim here is to investigate the relation between FAR/CAR and Juvenile arthritis disease activity score (JASDAS27) in Juvenile idiopathic arthritis (JIA)

The JADAS27 includes a selected count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints, hips, knees and ankles.

Eligibility Criteria:
Inclusion Criteria:

* All juvenile idiopathic arthritis fulfilling the criteria of International League of Associations for Rheumatology (ILAR) and age and sex matched healthy subjects

Exclusion Criteria:

* Other systemic inflammatory or autoimmune disorders.
* History of corticosteroid medication in the last 6 months.
* Liver diseases.
* Malignancy.
Effects of Nervous System Mobilization

This study aims to compare the effect of tension neural mobilization versus sliding neural mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and the non-dominant lower limb (not subjected to mobilization) in healthy young participants.

Sixty young and healthy participants will be randomly allocated to receive tension neural mobilization (n=30) or sliding neural mobilization (n=30). Data on heat threshold, cold threshold, pressure pain threshold and lower limb flexibility will be collected before the intervention, immediately after the intervention and at least 24h after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* naïve to nervous system mobilization;

Exclusion Criteria:

* Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.

Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Men and women greater than or equal to 18 years of age;
* A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer requiring systemic chemotherapy
* Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents:

  * Nucleoside analog, including gemcitabine and fluorouracil;
  * Carboplatin or cisplatin;
  * Anthracycline; or
  * Alkylating agent;
* Participant experienced severe thrombocytopenia, defined as 2 platelet counts \<50 x 109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of their current chemotherapy regimen
* ECOG performance status \<=2

Exclusion Criteria:

* Participant has experienced \>=Grade 2 CIT other than during the current chemotherapy treatment regimen within 6 months of Screening;
* Participant has any history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases;
* Participant has received \>2 previous lines of chemotherapy or is receiving whole brain radiation during the study treatment period;
* Participant has a known medical history of genetic prothrombotic syndromes
* Participant has a history of arterial or venous thrombosis within 3 months of screening;
* Use of vitamin K antagonists;
* Participant has previously received a thrombopoietin receptor agonist or recombinant human thrombopoietin for the treatment of CIT within 3 months of screening
Ethanol-Lock Treatment in Preventing Central Venous Catheter Infections in Patients With High-Risk Neuroblastoma

RATIONALE: Ethanol-lock treatment may help prevent central venous catheter infections in patients with high-risk neuroblastoma.

PURPOSE: This phase I trial is studying the side effects of ethanol-lock treatment in preventing central venous catheter infections in patients with high-risk neuroblastoma.

OBJECTIVES:

Primary

* Determine the safety and tolerability of the ethanol-lock strategy (ETL) in preventing central venous catheter infections in patients with high-risk neuroblastoma being treated on clinical trial MSKCC-03077.

Secondary

* Determine whether this strategy increases the likelihood of remaining infection-free for 6 months.
* Determine the cumulative incidence of a single positive centrally-drawn blood culture in these patients and compare to previously obtained historical controls.
* Determine the median time-to-infection of the central line, where infection is defined as any positive centrally-drawn (from the treated line) blood culture.
* Determine the cumulative incidence of central line removals in these patients and compare to historical controls.
* Collate the types of organisms among these patients who develop a positive centrally-drawn blood culture and compare to historical controls.

OUTLINE: This is a prospective, nonrandomized, open-label, historical control study.

Patients receive monoclonal antibody 3F8 on clinical trial MSKCC-03077. In each course of monoclonal antibody 3F8 treatment, patients receive ethanol-lock treatment on days 0-3 (after each monoclonal antibody 3F8 infusion) for up to 6 months for central venous catheter management.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels

  * High-risk disease
* Currently enrolled on clinical trial MSKCC-03077

  * Expected duration of therapy ≥ 6 months
* Surgically-implanted central venous catheter with documented patency

  * Must be able to establish patency of central venous catheter lumen
* No history of culture-positive central venous catheter infection in catheter to be treated

PATIENT CHARACTERISTICS:

* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2.5 times ULN
* Alkaline phosphatase \< 2.5 times ULN
* No history of hypersensitivity to ethanol
* No history or documented active seizure disorder
* No documented acute liver failure

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent total parenteral nutrition or other infusion requiring use of the central line at night
* No concurrent levetiracetam or other anticonvulsants
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.

Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).


Eligibility Criteria:
Inclusion Criteria: Part 1

* Voluntary written informed consent to participate in the study
* Japanese or non-Asian healthy men 18 to \< 50 years at the time of informed consent
* BMI 18.5 to \< 30.0 at screening

Inclusion Criteria: Part 2

* Voluntary written informed consent to participate in the study
* Age 18 years to \< 75 years at the time of informed consent
* Weight over 40 kg and BMI 18.5 to \< 35.0 at screening
* Patients who meet any of the following criteria

  1. Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening
  2. Patients with CLE diagnosed by skin biopsy

Exclusion Criteria: Part 1

* Current illness requiring treatment
* History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cancer.
* History or of current drug allergy

Exclusion Criteria:Part2

* Complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (\>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria \>0.5 g/24 h, pyuria (\>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.)
* Patients with serious complications that are judged by the investigator or sub-investigator to affect the conduct and evaluation of the study.
* Patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent
* Patients with an infectious disease requiring hospitalization or IV administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent