cyrilzakka/clinical-trials huggingface dataset:
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.

OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose chemotherapy.

OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and then tapered. Patients are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched, sibling donor for BMT available No current CNS disease No history of more than 2 episodes of active CNS disease

PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients must use effective contraception No concurrent debilitating medical or psychiatric illness that would preclude compliance No prior malignancy except curatively treated skin cancer or carcinoma of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
STERN FIX Device As a Sternal Fixation System

Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Patient who must have surgery in which a medium sternotomy is indicated.
* Subjects able to give their voluntary informed consent to participate in clinical research and from which written consent has been obtained.
* The subject is able to meet the requirements of the protocol and is willing to do so.

Exclusion Criteria:

* Patient with suspicious or known allergies or intolerance to implant material (PEEK - polyetheretherketone).
* Patient with limitations in blood supply, insufficient bone quantity or quality, severe osteoporosis, osteomalacia or other serious bone structural damage, which, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
* Degenerative bone diseases.
* Patients with a latent or active infection or inflammation in the operating area that, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
* Patients with fever or leukocytosis.
* Patient with spinal abnormalities that, according to the surgeon's discretion, prevent the use of the product, such as bone tumors located in the implant region.
* Patients who are pregnant or interested in becoming pregnant within 6 months of surgery.
* Nursing patients.
* Patients with life expectancy less than 6 months.
* Patients who are participating in or participating in the previous 4 weeks in another interventional clinical study
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.


Eligibility Criteria:
Inclusion Criteria:

* Stable without clinically significant disease

Exclusion Criteria:

* Use of NSAID within 2 weeks
* Type 1 or 2 DM
* GI disorder
Prevalence and Risk Factors of Women Mental Health Disorders

Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. On the other hand, Depressive disorder in women mainly occurs during the first year after childbirth. It takes many forms according to the onset, severity, and duration of the symptoms including; Postpartum blues (PPB), Postpartum depression (PPD), and Postpartum psychosis (PPP). Lack of access to mental health services during the perinatal period is a significant public health concern that may worse outcome.

So, we aimed to study prevalence of women mental health in Assiut governorate and evaluate possible risk factor for it


Eligibility Criteria:
Inclusion Criteria:

* age 18 years -50 years.
* No previous history of psychiatric, neurological or medical disease

Exclusion Criteria:

* intelligence equation less than 80
* have history of psychiatric, neurological or medical disease
Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100

The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 \< 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed HIV-1 infection.
* Age 18 years or over.
* No previous antiretroviral therapy.
* CD4 lymphocyte count of \< 100 cells/mL.
* Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.

Exclusion Criteria:

* Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
* Currently undergoing treatment for an opportunistic infection (parenteral administration).
* Any formal contraindication to treatment with the study drugs
Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy

The presence of an adnexal mass is a frequent reason for a woman to be referred to a gynaecologist. The discrimination between benign and malignant adnexal masses is central to decisions regarding clinical management and surgical planning in such patients. Patients with malignant tumours should be referred to a gynaecological oncologist, as the quality of cytoreductive surgery and surgical staging/lymph node dissection are important prognostic factors in ovarian cancer. These specialized surgical procedures require the specific skills and experience provided by gynaecologic oncology surgeons. Furthermore, appropriate and timely referral to a gynaecologic oncologist has been proven to increase survival in patients with ovarian cancer.Conversely, patients believed to have a benign mass requiring surgery are able to have this performed by a general gynaecologist. A standardized method for preoperative identification of probable malignant masses would allow optimization of first-line treatment for women with ovarian cancer. A risk of malignancy index would be valuable for the selective referral of relevant patients to specialized oncology centres. Currently, clinical examination, ultrasound assessment, and assays of tumour markers are part of the standard work-up for an adnexal mass. Although none of these indicators alone is very sensitive or specific for detecting malignancy, an index developed by Jacobs et al. incorporates information about the patient's menopausal status and serum Cancer antigen A-125 levels, and ultrasound characteristics of the mass to predict the risk of malignancy with greater sensitivity and specificity than any one factor alone.Some of the potential advantages of risk malignant index include rapid triage of patients through the referral system and fewer operations for benign masses being performed by gynaecologic oncologists.


Eligibility Criteria:
Inclusion Criteria:

1. Age at menarche to 60 years.
2. Presence of ovarian mass clinically by vaginal or bimanual examination.
3. Presence of sonographically diagnosed ovarian mass.
4. Accepting and signing the informed written consent.

Exclusion criteria

1. Known diagnosis of nature of mass by previous biopsy or ovarian malignancy scheduled for second look operation.
2. Patient unfit for surgery or inoperable.
Vitamin D Supplementation in Acne

The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:

• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.

Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.

Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included.

Exclusion Criteria:

* Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs)
* Those with obesity
* Individuals employing vitamin supplementation
* Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to letrozole or any comparable or similar product.
The Euro-CRAFT Registry

The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR \>0.80.
* Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature.

Exclusion Criteria:

* Unable to provide consent
* Unstable hemodynamics
* Ongoing chest pain.
* Previous CABG
* Moderate to severe valvular heart disease
* Uncontrolled or recurrent ventricular tachycardia.
* Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
* Comorbidity with life expectancy \<= 2 years.
* Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2.
* Subject is currently participating in another investigational drug or device clinical study.
* Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Current Opioid-User Population

The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.

To test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of Fairview Medical Group and University of Minnesota Physicians.

The study has two parallel components. The decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. Four sets of analyses will be conducted separately: one for the opioid-naïve group using EHR data, one for the current opioid-user group using EHR data, one at the PCP-level using web survey data, and one at the PCP-level using MN Prescription Drug Monitoring Program (PDMP) data.

Eligibility Criteria:
Inclusion Criteria:

- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics

Exclusion Criteria:

- Primary care providers who work less than 20% full time equivalent (FTE)
CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF

The study is a randomized controlled trial of a cognitive behavioral interventions and an art-based stress reduction treatment protocol (CB-ART) with 100 women, identified with elevated perceived stress, before undergoing IVF treatment; in order to examine its effect on perceived stress, plasma CFD, telomere length and pregnancy rates.

CB-ART is a 6-session treatment protocol that has been utilized with women coping with stress, depression and pain and is effective in reducing these indicators, developed and evaluated by our research team. The treatment protocol emphasizes processing together with the client's recalled image, symptom or memory (ISM) pertaining to a current distressing mental or physical state. CB-ART is a multi-method model that integrates cognitive behavioral interventions and art-based stress reduction interventions. The innovation in this method is the transformation of imagined and drawn images and memories rather than solely verbally discussing their contents. The focus is on changing compositional elements that comprise each image and memory, thus providing a therapeutic venue to reframe and transform stress producing, recalled images and memories and reduce symptoms of perceived stress. Art making is beneficial for eliciting an emotional response and provides a concrete platform to conduct the cognitive processing that initiate change on the paper and then in the mind. Furthermore, the soothing qualities of interacting with art making foster and enhance behavioral relaxation techniques.

Our study population, women with infertility problems, who are designated to undergo IVF treatment and have been identified to have elevated perceived stress scores on the Perceived Stress Scale (above 15) will be randomized and allocated to receive the CB-ART intervention tailored to reduce stress or treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* Hebrew speaking nulliparous women
* between the ages of 18-35
* without an axis I psychiatric diagnosis

Exclusion Criteria:

* Women over 35
* Do not speak Hebrew
* Have an Axis I psychiatric diagnosis that would prevent them from participating in the intervention
Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with stage III to IV non-treated high grade ovarian cancer or recurrent high grade ovarian cancer
* Adequate haemoglobin rate ≥ 9 g/dL
* Patient who can benefit from an additional blood sample of 20ml. The total volume of each sample meets with the indications of the Order in force establishing the list of researches mentioned in 2 ° of Article L. 1121-1 of the Public Health Code.
* Availability of tumor samples from biopsy or surgery
* Patient affiliated to a social security scheme
* Ability to provide written informed consent

Exclusion Criteria:

* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Contraindication to a blood sample of 20 mL
* Pregnant or breast-feeding women
* Ongoing treatment for the newly diagnosed cancer or the recurrence
* Patient pre-treated with poly-ADP-ribose-polymérase-1 (PARP) Inhibitors
* Patient under guardianship or curatorship or deprived of liberty.
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

Exclusion Criteria:

* Comorbidities
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers

The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.

FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. If this study gives evidence showing the vaccine is acceptable in preventing cervical HPV infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. Vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among FSWs and also among all other sex partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to complete the vaccine regimen.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18 and 26 years
* Registered female sex worker living in Lima
* Healthy with no known immune deficiency
* Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months
* Willing to provide informed consent

Exclusion Criteria:

* Currently pregnant or planning to get pregnant in the next six months
* Known immune deficiency disorder
* Current receipt of immunosuppressive drugs
* Allergy to yeast or known contraindication to HPV vaccine
* Women who have had their cervix removed
* Previous HPV vaccination
* Current fever over 100 degrees Fahrenheit
Identification of the Risk of Remote Pulmonary Hypertension in Preterm Births.

This study aims to learn about the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely, at birth and at a distance, and the association with the development of pulmonary bronchodysplasia, so that screening programs can be set up in the future and proper treatment can be initiated in a timely manner.

This study aims to learn about the prevalence of pulmonary hypertension and right ventricular dysfunction in patients born prematurely, at birth and at a distance, and the association with the development of pulmonary bronchodysplasia, so that screening programs can be set up in the future and proper treatment can be initiated in a timely manner. Enrolled patients, should asymptomatic pulmonary hypertension be diagnosed, will be able to be taken to dedicated outpatient clinics and initiate appropriate treatment if indicated. The primary goal of this study is to evaluate the incidence of late pulmonary arterial hypertension and/or right ventricular dysfunction in a cohort of former preterm patients. The study will also provide a greater awareness of the epidemiology of pulmonary hypertension and right ventricular dysfunction in these patients and allow appropriate screening and follow-up to be planned.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with prematurity with gestational age less than 30 weeks evaluated at outpatient clinics dedicated to neonatal follow-up of participating health care providers during the study data collection period.
* Obtaining informed consent.

Exclusion Criteria:

* Prenatal or postnatal diagnosis of genetic disease;
* Concomitant presence of congenital heart disease except interatrial defect or patency of the ductus arteriosus;
* Concomitant presence of diaphragmatic hernia