cyrilzakka/clinical-trials huggingface dataset:
Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease

This study is a pilot, phase II, open-label study of the angiotensin II receptor blocker, losartan, in patients with Sickle Cell Disease (SCD) 6 years or older for 12 months. The investigators will enroll 24 patients with SCD over the course of 1 year with a goal to complete all study procedures in 2 years. The short-term goal is to obtain clinical pilot data regarding the safety and efficacy of losartan in stabilizing or decreasing extracellular volume fraction (ECV) after 12 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

1. 6 years old or older
2. Diagnosis of HbSS or Sbeta0-thalassemia
3. Ability to cooperate with and undergo CMR without sedation or anesthesia
4. Ability to cooperate with and undergo echocardiogram without sedation or anesthesia
5. Patients who are on a stable dose of sickle cell disease-modifying therapy: Hydroxyurea, Voxelotor, L-Glutamine, or Crizanlizumab, for 3 months prior to enrollment will be eligible.

Exclusion Criteria:

1. Current chronic transfusion therapy. Patients who received a simple transfusion for an acute event will be eligible 3 months after completion of transfusion
2. SCD genotypes other than specified in inclusion criteria
3. Any contraindication to CMR such as metallic implants
4. Inability to cooperate with CMR or echocardiography imaging
5. Known congenital heart disease
6. Estimated GFR ≤ to 30 mL/min/1.73 m2 by creatinine clearance
7. Pregnant or lactating females or females of child-bearing potential who are unable to use a medically accepted form of contraception throughout the study
8. Treatment with a renin-angiotensin pathway inhibitor during the 2 weeks prior to enrollment
9. Hypersensitivity to angiotensin receptor II blockers
10. Hyperkalemia (K\>5.5 mEq/L) on a non-hemolyzed sample despite low-potassium diet
11. Hepatic dysfunction defined as serum ALT \> 5x the upper normal limit for age
12. Current lithium therapy
13. Chronic daily use of NSAID
14. HIV infection.
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males. Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.


Eligibility Criteria:
Inclusion criteria:

* A male between, and including, 10 and 18 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment
* For subjects below the legal age of consent, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria:

* Previous vaccination against Human Papillomavirus (HPV).
* Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection.
* Cancer or autoimmune disease under treatment.
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 18 to 75 yrs old
* Motivated to stop smoking
* Smoke at least 10 cigarettes/day

Exclusion Criteria:

* Active psychiatric disease
* Severe or unstable cardiovascular or pulmonary disease
* Current or recent treatment to stop smoking
* Previous use of varenicline
Sedation With Remimazolam During Spinal Anesthesia

Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.


Eligibility Criteria:
Inclusion Criteria:

1. Severe cardiovascular or respiratory disease
2. Contraindication to spinal anesthesia
3. Heart block
4. Previous hepatectomy or liver transplant
5. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
6. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
7. Acute narrow angle glaucoma
8. Myasthesia gravis
9. Known allergy to the drugs included in the study

Exclusion Criteria:

1. Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
2. ASA PS 1-3
Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors

The goal of this study is to determine the dose of LY573636-sodium (hereafter referred to as LY573636) that can be administered safely in combination with liposomal doxorubicin in patients with advanced cancer who have failed a prior treatment.

The study consists of a dose escalation phase to the maximum tolerated dose (MTD) and a dose confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have never been treated with doxorubicin.


Eligibility Criteria:
Inclusion Criteria:

* You must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy
* You must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment option
* You must have measurable disease or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
* You must have a serum albumin level greater than or equal to 3.0 grams/deciliter (g/dL) (30 g/L)
* You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* You must have tumor progression after receiving standard/approved chemotherapy
* You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
* Women must be sterile, post-menopausal or on a contraception and men must be sterile or on contraception
* Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory
* Ovarian patients in the confirmation phase must have failed to achieve at least a partial response to a first-line platinum-based therapy (platinum-refractory) or have progression in less than 6 months after a response to a first-line platinum-based therapy (platinum-resistant)
* Ovarian patients in the confirmation phase must have measurable disease by RECIST
* Ovarian patients in the confirmation phase must be liposomal doxorubicin or doxorubicin naive and not amendable to curative therapy

Exclusion Criteria:

* You cannot have received other investigational drugs within the last 28 days
* You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
* You cannot have current hematologic malignancies, acute or chronic leukemia, or brain metastasis
* You cannot currently be receiving warfarin (Coumadin®) therapy
* You cannot have known positive test results in human immunodeficiency, hepatitis B surface antigen or hepatitis C antibodies
* You cannot have a history of cardiac disease or clinical evidence of congestive heart failure
* Ovarian patients in the confirmation phase who have received 2 or more cytotoxic regimens for platinum-resistant disease
* You cannot currently be receiving amiodarone, quinidine, propofol, and clozapine
* If you are taking esomeprazole or pantoprazole you must be able to stop taking this medication within 72 hours before and after LY573636 administration
Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users

Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.

Bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound. Bilateral knee extension strength was measured via handheld dynamometer (Jamar, Bolingbrook, IL, USA). Functional strength and walking were assessed by Step-up-over (SUO) and Walk-across (WA) tests of NeuroCom Balance Master® device (NeuroCom International, Clackamas, OR, USA).

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral transtibial amputation on the right side
2. Using the prosthesis for more than 1 year
3. Able to use the prosthesis without pain and discomfort
4. Able to walk without a walking aid

Exclusion Criteria:

1. Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)
2. Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)
3. Taking medication that is known to affect balance
Evaluating of the Impact of Micronutrient Interventions Among Adolescents in Mozambique

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and the impact of a nutrition curriculum on diet diversity and anemia knowledge among adolescent girls.

This study aimed to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health, and education in Mozambique. In conjunction with the Mozambique Ministries of Health, Education and Culture, we conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm). Each club was comprised of around 18 girls aged 13 to 20 years. Using constrained sampling to balance for age and school, clubs were randomly assigned to one of two intervention groups: 1) Multiple Micronutrient Supplementation (MMS) for five months plus a Nutrition Curriculum, or 2) Iron and Folic Acid Supplementation (IFAS) plus a Nutrition Curriculum. Girls enrolled in the MMS arm consumed supplements daily for 4 months at home and weekly nutrition messages delivered through the clubs. Girls enrolled in the IFAS arm consumed supplements once a week for 4 months at school (the standard of care) and weekly nutrition messages delivered through the clubs. The study evaluated the effects of MMS and IFAS on anemia status and the impact of the nutrition curriculum on diet diversity and anemia knowledge.

Eligibility Criteria:
Inclusion Criteria:

Adolescents aged 13-20 years Enrolled in secondary school at study initiation Member of an IMPACT+ Girls Club at one of the participating schools Consent provided by the parent Assent provided by the adolescent

Exclusion Criteria:

No informed consent from parent or assent from adolescent Self-reported pregnancy
Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors

Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with unknown primary tumors? Can information obtained with PET-CT replace other clinical and radiological investigations? Is PET/CT cost-effective?

Patients who fulfill the international definition of unknown primary tumors can be included, except:

* Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included.
* Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included.
* Women with adenocarcinoma in lymph nodes in the axilla will not be included.

Eligibility Criteria:
Inclusion Criteria:

* Unknown primary tumors

Exclusion Criteria:

* Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included.
* Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included
* Women with adenocarcinoma in lymph nodes in the axilla will not be included
This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas

In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated patients with DLBCL of the breast.
* Patients must have CD20 positive tumors.
* Stage IE or IIE.
* Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
* Patients must have an ECOG performance status 0-2.
* Patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration):

  * Creatinine Clearance \> 50 ml/min
  * Total bilirubin \< 2.0 mg/dl and AST \< 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be \< 3 x ULN, and AST \< 5 x ULN.
  * Absolute neutrophil count \> 1500/mm3 and platelet count \> 100,000/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count \> 500/mm3 and platelet count \> 50,000/mm3.
* Patients must be age \> 18 years.
* Patients must have a normal left ventricular ejection fraction to be eligible.

Exclusion Criteria:

* historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
* pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
* active infection requiring parental antibiotics.
* known HIV infection
An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma

This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor.

Patients will be invited prospectively and sequentially to participate in the study when attending a participating community pharmacy with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor. Therefore, the invitation for the patient to participate in the study will occur only after the therapeutic decision has taken place

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ≥18 years
* Self-reported diagnosis of asthma
* Individual filling a first prescription of IND/GLY/MF with or without sensor in a participating community pharmacy for himself/herself (excluding caregivers).
* Individual capable and willing to perform the study assessments.

Exclusion Criteria:

* No exclusion criteria.
Guilford Genomic Medicine Initiative (GGMI)

* Genomic medicine, using genetic information to improve health outcomes, is heralded as the answer to rising medical costs by focusing on prevention and tailored care. Despite its potential, little investigation has focused on how genomic medicine can be applied in health care. To be effective, it requires new ways to learn, deliver, and communicate medical information. It will also raise new ethical questions.
* The overall goal of Guilford Genomic Medicine Initiative (GGMI) is to identify the specific challenges in "re-structuring" an existing medical system to integrate genomic medicine, and create solutions that can be used by other medical systems, such as the extensive military medical care system. To accomplish this goal, GGMI includes the development of a large-scale genomic medicine education initiative targeted at the community, providers, and patients, and a clinical systems model to implement strategies to facilitate the integration of genomic medicine into several pilot practices.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for an upcoming well or new visit within the next 3 weeks with their primary care physician (at the two implementation clinics).

Exclusion Criteria:

* Non-english speaking
* not consentable
* adopted
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients

The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics
* HbA1c of 7.5-10.5%
* eGFR 30-110 mL/min/1.73m2
* stable ACEi/ARB dose regimen
* stable blood pressure
* BMI less than or equal to 45 kg/m2

Exclusion Criteria:

* non-diabetic renal disease
* history of solid organ or islet cell transplant
* history of malignancy within previous 5 years
* systemic immunosuppression therapy
* clinically significant liver disease, hepatitis B or C or HIV
* monoclonal antibody treatment within previous year
* recent acute renal injury or major surgery
* significant, recent body weight change
* biopsy proven glomerular disease
Urdu Version of Neck Pain and Disability Scale (NPAD)

In this study, the examiners will investigate the reliability and validity of neck pain and disability scale in Urdu language in Pakistani patients with neck pain and related disability.

This study's objective is to translate the Neck Pain and Disability Scale (NPAD) into Urdu and evaluate its reliability and validity in Pakistani neck pain individuals. This cross-sectional survey will employ convenience sampling to choose participants.

This study's findings will assist determine the NPAD's reliability and validity in individuals with neck pain and impairment. This scale's reliability will be evaluated utilising internal consistency and test-retest methods. Cronbach's alpha value checks internal consistency. The interclass correlation will be used to examine the test-retest reliability.

Eligibility Criteria:
Inclusion Criteria

* Individuals including both male and females between age 18 and 65 years.
* Participants with non-specific chronic pain of neck (\>3 months in duration).
* Individuals with sufficient knowledge and understanding of Urdu language.

Exclusion Criteria

* Individuals with history of cervical surgery.
* Individuals with cervical myelopathy or radiculopathy, regional tumors, disc herniation, vertebral fractures, traumatic injuries, cardiovascular and pulmonary diseases, pregnancy or any behavioral problems were excluded
* Individuals with any pertinent comorbidities including heart attack, cancer, cognitive impairment or infection were also excluded. herniation, vertebral fractures, traumatic injuries, cardiovascular and pulmonary diseases, pregnancy or any behavioral problems were excluded
* Individuals with any pertinent comorbidities including heart attack, cancer, cognitive impairment or infection were also excluded.
Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain

Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.It can be conservative, pharmacological and interventional, rarely chirurgic. This study aimed to evaluate the effectiveness of a rehabilitation program combined with Pridinol Mesylate in the treatment of Spondyloarthrosis in elderly patients in terms of pain resolution, improving disability, and quality of life versus single treatment.

A randomized controlled trial was conducted in patients with spondyloarthritis. The patients recruited were divided into three groups: the Combined Group (CG), who received a rehabilitation program combined with Pridinol Mesylate; the Rehabilitation Group (RG), who received only the same rehabilitation program; and the Drug Group (DG), who received only the administration of the drug.


Eligibility Criteria:
Inclusion Criteria:

* age 65-75 years,
* low back pain for at least 3 months,
* NRS ≥ 4,
* radiographic diagnosis of spondyloarthrosis,
* written informed consent.

Exclusion Criteria:

* inflammatory diseases of the spine,
* obesity (BMI 20-30),
* positive radicular tests,
* allergy or contraindications related to taking Pridinol Mesylate.
Effectiveness Study of Hydrotherapy Against Pain and Other Symptoms in Diabetes-induced LEAD

The purpose of the study is to investigate whether the hydrotherapy are effective in against pain and other symptoms in diabetes-induced LEAD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes mellitus
* diagnosis of lower extremity arterial disease

Exclusion Criteria:

* Severe heart disease
* can't hydrotherapy