cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification

The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.

Patients with Moderate Calcific Aortic Valve Stenosis may be eligible for enrollment in this study. Participation lasts 12 months, which includes a total of 3 study visits (baseline/screening visit, 6 month follow up visit and 12 month follow up visit). During each visit, a blood sample will be taken along with other research related tests (Orthostatic Tolerance Standing Test, CT Scan, Echocardiogram, DEXA Scan). Qualifying Participants will be supplied with 6 months worth of study medication or placebo during visits 1 (baseline/screening visit) and 2 (6 month follow up visit) in which they will take at home daily with food. On visit 3 (12 month follow up visit), any remaining study medication or placebo will be returned to study staff.

Eligibility Criteria:
Inclusion Criteria

1. Age \> 50 years
2. Male or female sex
3. Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2
4. Aortic valve calcium levels greater than 300 AU from chest CT
5. Ejection fraction \>50%

Exclusion Criteria

1. Orthostatic intolerance or symptomatic hypotension prior to study or during study visits
2. Positive pregnancy test during screening visit
3. Nitrate use or α-antagonist medication use within 24 hours
4. Systolic blood pressure \<110 mm Hg
5. Mean systemic arterial pressure \<75 mm Hg
6. Severe mitral or aortic regurgitation
7. Retinal or optic nerve problems
8. Recent (≤30 days) acute coronary syndrome
9. Oxygen saturation \<90% on room air
10. Congenital valve disease
11. Hepatic dysfunction/elevated liver enzymes
12. Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates, etc.)
13. Prescription of Warfarin (Coumadin) for chronic anticoagulation
14. Concomitant participation in other trials at Mayo Clinic or elsewhere
15. Use of phenytoin or related compounds for any indication
16. Chronic midazolam treatment for any indication
17. Use of monoamine oxidase inhibitors for any indication
18. Use of anti-diabetic drugs in the sulfonylurea family
Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)

The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma (HL).


Eligibility Criteria:
Inclusion Criteria:

* Previously histologically confirmed Hodgkin's lymphoma
* Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
* Performance status (ECOG) ≤ 3
* Age ≤ 75 years old
* Number of prior chemotherapies: one or two regimens
* At least one or more uni-dimensionally measurable lesion(s) defined as; ≥ 2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
* Adequate organ functions defined as; ANC \> 1,500/ul, platelet \> 75,000/ul, transaminases \< 3 X upper normal values; bilirubin \< 2 mg/dL
* Written informed consent approved by institutional review board or ethic committee

Exclusion Criteria:

* Previous high dose chemotherapy with autologous stem cell transplantation or allogeneic stem cell transplantation
* Previous chemotherapies with ESHAP regimen
* Any other malignancies within the past 5 years except skin basal cell carcinoma or carcinoma in situ of cervix
* Other serious illness or medical conditions
* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
* History of significant neurologic or psychiatric disorders including dementia or seizures
* Active uncontrolled infection (viral, bacterial or fungal infection)
* Other serious medical illnesses
* Pregnancy or breast-feeding, women of childbearing potential not employing adequate contraception
* Previous history of drug allergy to one of the drugs in the study regimen
A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients

This is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy of BAT2020 in hospitalized patients infected with COVID-19. This study is composed of 2 Parts: a single ascending dose (Part 1) and single dose(s) tested in parallel with a double-blind, placebo-controlled design (Part 2). Patients also will receive best available standard of care (SOC) treatment. A data and safety monitoring board (DSMB) will be set up for the study.


Eligibility Criteria:
1. Male or nonpregnant female adult ≥18 years of age at time of enrollment.
2. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
3. Agrees to the collection of nasopharyngeal swabs for virology assessment.
4. Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception at the time of screening and for 4 months after study drug dosing.
5. Enrollment within 72 hours of hospital admission.
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.


Eligibility Criteria:
Inclusion Criteria:

* Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
* At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.

Exclusion Criteria:

* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
* Treatment with systemic immunosuppressive medications within 3 months of screening or during the study, or biologics within 6 months of screening or during the study.
* Clinical lab results outside the normal range.
Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer

The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.

Patients with cancer may experience a considerable symptom burden, often requiring hospitalizations for symptom management. This study will pilot test an electronic symptom monitoring intervention, "Improving Management of Patient-Reported Outcomes Via Electronic Data (IMPROVED)," versus usual care in hospitalized patients with cancer.

The goal of this study is test a model where patients' symptoms are monitored during their hospital admission electronically via tablet computers. The investigators are studying whether patients whose clinicians receive their patients' detailed symptom reports each day have improved symptom management compared to those whose clinicians do not receive their patients' detailed symptom reports each day.

The study takes place at Massachusetts General Hospital and involves participating in a study for as long as the participants are admitted to the hospital. The information the investigators collect will help them determine if electronic symptom monitoring improves the care of patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosed with incurable cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
* Admitted to Lunder at Massachusetts General Hospital
* Verbal fluency in English

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Admitted electively
* Participated during a previous admission
Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study

In this study, the purpose of this study is to investigate whether prophylactic medical compression therapy in breast cancer patients receiving docetaxel adjuvant chemotherapy could reduce the incidence and severity of lymphedema in the upper limbs that received axillary lymph node resection (sentinel lymph node biopsy or axillary lymph node dissection).


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent radical mastectomy and sentinel lymphctomy or axillary lymphectomy after diagnosis of unilateral breast cancer
2. Patients who are scheduled for adjuvant chemotherapy including Docetaxel after surgery
3. Patients aged 19 to 70
4. Patients who can understand the contents of this study and obtain consent

Exclusion Criteria:

1. Patients with a history of breast-related surgery prior to this breast cancer surgery
2. Patients with metastases to other organs
3. Patients who have undergone neoadjuvant chemotherapy or have previously received radiation therapy
4. Patients with systemic diseases that may not be able to conduct clinical research
5. Patients with skin diseases who cannot receive medical compression treatment
Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas

Before radiation treatment is given to treat chordomas, CT and MRI scans are used to create a three dimensional picture of the tumor using x-rays. The CT and MRI scans are used to determine the size and location of the area that will receive radiation treatment. The purpose of this research study is to see if combining the images from the FMISO-PET scan and the CT and MRI scans in radiation treatment planning changes the size and location of the area that will receive radiation treatment when compared to planning the radiation treatment with CT and MRI scans alone.

* In this research study we are determining whether the positron emission tomography (PET) investigation performed with the investigational radioactive substance FMISO can show areas of tumor with lower oxygen levels. There is evidence that tumor with low oxygen levels are more resistant to radiation therapy. CT and MRI scans are not able to detect these oxygen levels in tumors.
* Participants will be asked to have the FMISO-PET/CT scan at 2 different times. It will be performed 2 weeks before and 3 weeks after the participants first proton radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Skull base and spinal chordomas diagnosis based on pathology review by Department of Pathology at Massachusetts General Hospital
* Patient to be treated with proton or combined photon RT for primary CD or recurrent CD after surgery
* 18 years of age or older
* Karnofsky Score of 60% or greater
* Gross tumor mass larger than 1cm (maximal diameter on MRI)

Exclusion Criteria:

* Recurrences after RT
* Pregnancy
* Allergic reaction to FMISO injection
Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy

- Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II.
* Body mass index \< 35 kg/m2

Exclusion Criteria:

* Patient's refusal.
* Known coagulopathy.
* Known peripheral neuropathy or neurological deficits.
* Known allergy to study drugs.
Lunatocapitate Fusion Versus Four-corner Fusion for SNAC and SLAC Arthritis.

Hypothesis: Lunate-capitate-fusion (LCF) results in comparable outcome (i.e. not worse) to four-corner-fusion (4CF) for Scaphoid Nonunion Advanced Collapse (SNAC) and Scapholunate Advanced Collapse (SLAC) arthritis regarding functional results (grip strength).

Design: Prospective randomised comparison. Inclusion criteria: SNAC or SLAC arthritis requiring a salvage procedure (grade 2-3).

Exclusion criteria: SNAC or SLAC arthritis grade 4 (panarthritis). Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder or drug addiction).

Surgical method:

Patient will be operated in axially plexus with a dorsal approach through the 3d and 4th extensor tendon compartments. The wrist joint capsule will be opened with a Berger incision. After excision of the scaphoid and preparation of the articular surfaces to be fused, the bones will be fixated with k-wires. Bone autograft from the scaphoid, crista or radius will be used according to the surgeon's preference based on the condition of the fusion surfaces. The wrist be immobilized in a short arm plaster cast until the fusions are radiologically healed after10-12 weeks. The k-wires will be extracted in local anesthesia after another 2-6 weeks.

Sample size:

This study will have a power of 80% to show that the mean grip strength for LC fusion is as least as high as the mean for 4CF (non-inferiority). This assumes that the means for the LC fusion and the 4CF are equal (at 70% of the uninjured side) with a common within-group standard deviation of 14 (Salzman et al. 2015), that a difference of 10% or less is unimportant, that the sample size in the two groups will be 25 and 25, and the alpha (1 tailed) is set at 0,05.Formally, the null hypothesis is that the mean for lunocapitate fusion is 10% lower than the mean for 4CF, and that the study has power of 80,1% to reject this null. Equivalently, the likelihood is 80,1% that the 95% confidence interval for the mean difference will exclude a difference of 10% in favor of 4CF.

We aim to include 60 patients to cover for a certain loss to follow-up.

Assessment:

Patients will be assessed regarding range of motion and grip strength and complete the DASH and PRWE questionnaires before surgery (baseline) and 1 and 2 years postoperatively.

Radiology:

Plain anterior and lateral radiographs will be obtained 1 and 2 years postoperatively for purpose of the study. According to the standard treatment protocol, clinical and radiological healing assessment will be conducted 10-12 weeks postoperatively. Radiographs will be analyzed by a radiologist.

Complications will be recorded 1 and 2 years postoperatively.

Analyzes:

The Mann-Whitney and Chi-square tests will be used for non-parametric data (DASH, PRWE and presence of arthritis and complications). T-test will be used for numerical data (ROM, grip strength).

Eligibility Criteria:
Inclusion Criteria:

- SNAC or SLAC arthritis grade 2-3

Exclusion Criteria:

* SNAC or SLAC arthritis grade 4
* Inability to cooperate with the follow-up protocol
Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?

During pregnancy and lactation, the consumption of PUFA n-3, through the consumption of food products that contain more ALA than conventional products, could impact nutritional and non-nutritional breast milk quality (immune criteria, metabolites, hormones), and also the implantation of the intestinal microbiota of the newborn, which is involved in preservation of short term and long term health of the child.


Eligibility Criteria:
Inclusion Criteria:

* women over 18;
* ≤ 28th week of amenorrhea
* having a project of exclusive breastfeeding until at least the 45th day postpartum;
* BMI before pregnancy between 18.5 and 30.0;
* consuming frequently dairy products, eggs, meat (pork, beef, poultry);
* accepting the consumption of all food products delivered;
* written consent received and signed.

Non-inclusion criteria:

* multiple pregnancy;
* eating disorders or suspicion (defined by SCOFF score);
* vegetarian, vegan or flexitarian;
* allergic to food product(s) involved in the study;
* home with more than 2 adults and 3 children (excluding foetus);
* adults on legal protection (guardianship, trusteeship...), persons deprived of liberty;

Exclusion Criteria:

* Interruption of breastfeeding before the 21st postpartum day
* Prematurity: childbirth before the 37th week of amenorrhea
Development and Testing of an Interprofessional, Person-centered Care Concept for People Living at Home With Care Needs.

The aim of the project is to develop and pilot measures to optimize the person-centered cooperation between nursing services, general practitioners and members of the therapeutic professions in the care of people living at home with care needs, so that hospital admissions and the use of unplanned medical and rescue services are avoided, the quality of life is improved and a deterioration in the need for long-term care can be stopped.

This is done by developing an interprofessional person-centered collaboration-concept, perform an explorative mixed-methods-study: interviews, focus groups, expert workshops, survey of best practices, shadowing, questionnaires.

Description of mixed-methods-study:

1. Interviews with

   * 20 patients,
   * 20 relatives,
   * 5 experts of health insurance professionals,
   * and 3 focus groups à 8 persons with general practioniers, nurses, therapists.
2. investigation of best practice cases
3. explorative survey of 100 cases in each group:

   * general practitioner
   * nursing services
   * therapists
   * persons in need of care
   * family members of persons in need of care

The mixed-methods-study is analysed in different ways:

* structured content analysis
* case-based qualitative analysis of interviews
* descriptive analysis

The mixed-methods-study has been approved by the ethics committee and is recruiting.

Eligibility Criteria:
Inclusion Criteria:

* years of age \>18
* receipt of benefits in the form of outpatient care according to SGB XI,
* preliminary / final classification of care ≥level 2
* expected life expectancy \>6 months
* informed consent
* sufficient opportunity to answer answering questions about patient-reported outcomes

Exclusion Criteria:

* Living in nursing home / planned move-in within the following 6 months
* claim acceptance of SAPV
* participation in scientific study
Bevacizumab and Vasoconstriction

Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most common side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear.

Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male 18-50 years old
* normal results of glucose, lipids and creatinine
* informed consent

Exclusion Criteria:

* History of abuse of drugs or alcohol
* History of malignant disease
* First degree relatives with a history of cancer before the age of 50
* First degree relatives with a history of premature cardiovascular disease
* Current use of medication
* Clinical evidence of cardiac of pulmonary disease
* Hypertension ( systolic\>140mmHg, diastolic \>90mmHg)
* Diabetes mellitus
* smoking
* a history of thombosis or a family history of recurrent thrombosis
* abnormality on ECG
Women's Use of Alternative Medicine: A Multiethnic Study

The purpose of this study is to examine socio-cultural factors of women's use of complementary and alternative medicine (CAM). The effects of socioeconomic status, social networks and acculturation on CAM use will be assessed among white, African-, Mexican-, and Chinese-American women.


Eligibility Criteria:
Inclusion criteria:

Experienced one or more of the following health conditions within the last year:

* pregnancy related symptoms
* menopausal related symptoms
* headaches
* back pain
* osteoporosis
* cancer
* high blood pressure
* high cholesterol
* heart disease
* joint pain/arthritis
* insomnia
* uterine fibroids
* urinary tract infection
* vaginal tract infection
* medically diagnosed depression
* menstrual symptoms
The Role of Traditional Music Therapy on Burnout Syndrome Among Healthcare Workers: Psycho-Neuro-Immuno-Endocrine Aspects

The goal of this clinical trial study is to learn about the role of traditional music therapy on burnout syndrome among healthcare workers, based on psychology, neurology, immunology, and endocrinology aspects. The main questions it aims to answer are :

1. How traditional music therapy can improve psychological aspects (emotional exhaustion, depersonalisation, and personal accomplishment) among healthcare workers with burnout syndrome?
2. How traditional music therapy can improve neuroautonom aspects (heart rate variability) among healthcare workers with burnout syndrome?
3. How traditional music therapy can improve immunology aspects (IgA and T cell regulator) among healthcare workers with burnout syndrome?
4. How traditional music therapy can improve endocrinology aspects (cortisol and endorphine) among healthcare workers with burnout syndrome?

The goal of this clinical trial is to learn about the role of traditional music therapy on burnout syndrome among healthcare workers. The investigators will collected about 80 participants, which eventually get divided into intervention (40 participants) and control (40 participants) group. Participants will get examined using Maslach Burnout Inventory-Human Service Survey for rating their burnout sydnrome. Before starting the intervention, both group will get assessed for their heart rate variability, IgA and T cell regulator level, and cortisol and endorphine level. After that, Intervention group will get traditional music therapy and educational video 3 session a week for about 4 weeks. And control group will only get educational video.

Both group will be assessed for their heart rate variability and their laboratory markers three times, 2 weeks after starting the intervention, right after finishing all intervention session on week 4, and 2 weeks after the intervention is done. Investigators will compare the results between control group (educational video only without any music therapy) and intervention group (traditional music therapy and educational video) to see if there are any role of traditional music therapy on burnout syndrome based on psychology-neuroautonom-immunology-endocrinology aspects.

Eligibility Criteria:
Inclusion Criteria:

* Agreed to participate in this study by signing an informed consent sheet
* Above 18 years old
* Doctors or nurses working in RSUP dr Kariadi Semarang
* MBI-HSS score show intermediate-severe burnout
* Meet the requirements for an HRV examination
* Have been working for minimum one year on each instalation

Exclusion Criteria:

* Above 60 years old
* Have history of chronic illness such as cancer, thyroid, and cardiovascular disease
* Taking drugs that affect central nervous system
* Hearing loss and disorder
* Psychosis, anxiety,depression and any other psychological disorder
* Pregnant women
* Does not like music