cyrilzakka/clinical-trials huggingface dataset:
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients

This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.


Eligibility Criteria:
Eligibility Criteria:

* Diagnosis of breast cancer.
* Mass must be visible on ultrasound and \> 5 mm from skin.
* Not undergoing surgery, because:

  * Patient has a medical condition that would not allow sedation or general anesthesia
  * Surgery is not clinically indicated due to unresectable and/or metastatic disease
  * Surgery is not clinically indicated for another reason
  * Patient declines surgery
* At least 18 years old.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction

Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Eligibility Criteria:
Inclusion Criteria:

- chronic medium-severe periodontitis

Exclusion Criteria:

* pregnancy
* breast-feeding
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia

Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).

Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.

Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).

Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.

Only patients who were diagnosed between the 1st July 2021 and 1st July 2022 will be included. Patients should have at least 12 months of follow-up data. In case patient died within the first 12 months of diagnosis, these data from date of mBC diagnosis until patient's death should also be included. It will be multicenter study

Eligibility Criteria:
Inclusion Criteria:

* Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion;
* The diagnosis of mBC was established between the 1st July 2021 and the 1st July 2022;
* Patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis;
* Age ≥ 18 years at the time of inclusion.

Exclusion Criteria:

* Presence of other malignancies within period since diagnosis until the timepoint of data collection;
* Patients receiving trastuzumab deruxtecan currently or in the anamnesis;
* The participation in any randomized controlled trial within period since diagnosis until end of study.
"ALOFT - Aliskiren Observation of Heart Failure Treatment": Efficacy and Safety of Aliskiren Added on Top of Standard Therapy in Adults (≥ 18 Years) With Stable Heart Failure

This study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in their heart failure signs and symptoms and other indicators of heart failure after being treated with aliskiren on top of their current heart failure treatment. Aliskiren is an investigational drug; its safety will also be evaluated in this trial.


Eligibility Criteria:
Inclusion Criteria:

* History of diagnosis or currently have high blood pressure
* Stable heart failure (NYHA Class 2-4) for at least 1 month before study entry. Subject should be on a stable dose regimen of heart failure medication.
* Brain natriuretic peptide (BNP) \> 150 pg/ml at baseline (to be evaluated by physician at first visit)

Exclusion Criteria:

* Previous treatment with aliskiren
* High blood pressure due to secondary reasons or constant low blood pressure (systolic \< 90 mmHg)
* History of heart attack or coronary bypass surgery in the past 6 months

Other protocol-defined exclusion criteria may apply.
Evaluation of the Effectiveness, Safety, and Cost of a Smart Hospital System for Patients With Chronic Obstructive Pulmonary Disease

This study aims to analyze the effectiveness/safety/cost of the Smart Homespital system that provides a service that allows patients with Chronic Obstructive Pulmonary Disease to easily access and use biosignals generated using biosignal collection medical equipment at home.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with COPD who meet the following pulmonary function test results:

1. Pre FEV1 \< 80% \*\*or\*\*
2. Pre FVC \< 80% \*\*or\*\*
3. DLCO \< 60%

Exclusion Criteria:

1. Patients who do not agree to participate in the study.
2. Patients who fail to use the medical device equipment.
3. Patients where tracking during the study period is expected to be impossible.
4. Patients who have difficulty communicating verbally.
5. Patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction.
6. Patients receiving hospital-centered rehabilitation treatment during the study period.
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)


Eligibility Criteria:
Inclusion Criteria:

* Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.
Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer

Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.

* Compare muscle mass values obtained before and after the use of anabolic steroids upon assessment by bioelectrical impedance analysis (BIA).
* Compare the anabolic effect on quality of life (QLo) of the patient before and after the use of anabolic steroids.
* Compare data from laboratory tests such as complete blood count, albumin, C reactive protein and transferrin with drug intervention.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients above 18 years old.
* Patients with tumors in the high gastro-intestinal, hepatobiliary and pancreatic tracts in palliation.
* Patients able to undergo BIA.
* Malnourished patients as per the subjective global assessment produced by the patient (ASG-PPP) and whose score is greater than nine.
* Patients who agree to participate in the study.

Exclusion Criteria:

* Patients with malignant tumors of other metachronous or synchronous location except nonmelanoma skin tumor
* Patients with chronic renal failure.
* Patients on diuretics, recent or chronic.
* Patients on appetite stimulants and anabolic agents.
* Patients using pacemakers, which can interfere with the results of BIA
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.

The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.

The primary endpoint is the 2-year event-free survival (EFS) rate.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Aged ≥18 years, both male and female.
3. Pathologically confirmed CD5-positive DLBCL
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
6. Expected survival ≥3 months.
7. Sufficient bone marrow, liver, and kidney function.

Key Exclusion Criteria:

1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients had previously received BTK inhibitors.
4. The patients have contraindications to any drug in the combined treatment.
5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
6. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
7. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
8. Mentally ill persons or persons unable to obtain informed consent.
9. The investigators think that the patient is not suitable for the study.
Fetal Tracheal Balloon Study in Diaphragmatic Hernia

The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.

Congenital diaphragmatic hernia (CDH) has traditionally been associated with very high mortality rates. Most infants died of pulmonary hypoplasia and severe pulmonary hypertension. This led to correction of CDH and pulmonary hypoplasia before birth. Unfortunately, maternal morbidity of open fetal surgery was significant and fetal mortality was very high (\>60%). Moreover, the results of postnatal therapy for CDH improved dramatically, from less than 20% survival several decades ago to more than 70% today.

Fetal intervention has evolved as well, to a minimally invasive approach that involves a single endoscopic port and occlusion of the fetal trachea. While this has considerably decreased the morbidity and fetal mortality of the in utero procedure, its results do not exceed the overall (i.e., non-stratified) results of contemporary postnatal treatment. Most recently, a multicentric cooperative study under (Eurofoetus) has conducted a clinical trial comparing postnatal treatment with endoscopic fetal tracheal occlusion for the most severe forms of CDH. Results of the Eurofoetus trial and of a recent retrospective review involving European and North-American centers have shown the following: 1) It is possible to identify a specific subgroup of fetuses with CDH in whom survival can be predicted to be less than 10%, despite all current methods of postnatal treatment, 2) Survival of fetuses with predicted postnatal survival of 8% was \>50% following endoscopic fetal tracheal occlusion, and 3) Fetal tracheal occlusion in that group resulted in an increase in lung size (LHR), from an average of 0.7 pre-intervention, to 1.7 post-intervention.

Based on the available research literature, the results of the Eurofoetus trial, and this institution's experience with endoscopic fetal surgery, we hypothesize that in the highest risk group of fetuses with congenital diaphragmatic hernia, where chances of survival is estimated at less than 10%, endoscopic fetal tracheal occlusion in late second trimester, with reversal of occlusion in mid-third trimester, allows catch-up lung growth and maturation and converts the condition into one with intermediate to good prognosis (predicted survival 50-60%). We propose to offer this form of treatment, under an FDA-approved Investigational Device Exemption (G080077), to eligible patients, on a case-by-case basis, after discussion before a multidisciplinary board.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Isolated congenital diaphragmatic hernia
* Normal karyotype (amniocentesis)
* Initial diagnosis before 26 weeks gestation
* Competent cervix
* Severity of CDH: lung-to-head ratio (LHR) ≤0.8 at 22-26 weeks gestation
* Liver herniation in the chest
* Informed consent

Exclusion Criteria:

* Preterm labor, premature rupture of membranes or amniotic leak
* Significant maternal morbidity
* Minor (\<18 years)
Sepsis Trial of Early Physical Therapy Outside the ICU

The purpose of this study is to determine whether an additional physical therapy program can improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an illness in which the body has a severe response to bacteria or other germs and develops worsened function of a major organ such as the kidneys, heart, or lungs).

Patients who are admitted to the hospitalist service at the University of Michigan Hospital will be screened for the presence of severe sepsis. Those who are deemed eligible and provide consent will be enrolled. Study patients will receive additional physical therapy according to a protocol developed for this study in addition to the usual care recommended by their regular treating physician. Additional treatments will be individualized based on enrolled patients' baseline physical function and progress and may include standing, stretching, transferring, and walking - either with assistance or independently. Treating therapists have been trained in the use of the protocol and individualization to maintain the highest standard of patient safety. Patients will be contacted 30 days after discharge to answer questions about their health and ability to perform routine tasks at home.

Eligibility Criteria:
Inclusion Criteria:

* Any English-speaking patient over the age of 18 who is currently admitted to a general care floor under the care of the Medicine Faculty Hospitalist Service at the University of Michigan Health System and has severe sepsis is eligible to take part in this study.

Exclusion Criteria:

* Subjects must be deemed by the study team to give informed consent by being able to state the basic purpose of the study. Consent by a legally authorized representative (LAR) will not be sought.
Evaluation of the Presence and Effects of Kinesiophobia in Multiple Sclerosis

The aim of this study was to evaluate the presence of kinesiophobia in multiple sclerosis and to investigate the effect of kinesiophobia on physical activity, functional status, quality of life and depression.

90 people, including 45 patients and 45 healthy control groups, were included in the study. Demographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), in addition to Multiple Sclerosis group, Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented.

Eligibility Criteria:
Inclusion Criteria:

* Having a definitive diagnosis of MS according to the 2017 Revised McDonald Diagnostic Criteria
* Expanded Disability Status Scale (EDSS) score between 0-6.5
* Be between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Having orthopedic, psychiatric and other chronic diseases other than MS that may affect physical and cognitive status
* Expanded Disability Status Scale (EDSS) score \>6.5
* Being in the MS attack period
Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus

The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old
* American society of anesthesiology (ASA) physical status I-II
* Signed informed consensus

Exclusion Criteria:

* ASA \>II
* Unstable neurological disease
* Diabetic mellitus (DM) type I-II
* Allergy to used drugs
* Opioid chronic treatment
* Consensus refusal or not valid
* Anticoagulant therapy
* Postoperative intensive care required
A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

This study evaluates the safety and efficacy of QTORIN 3.9% rapamycin anhydrous gel in the treatment of adults with Pachyonychia Congenita. This study includes a screening period, baseline period and 6-month treatment period.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult patients, 18 years or older (16 years or older in the UK)
* Diagnosed with Pachyonychia Congenita (PC), genetically confirmed

Key Exclusion Criteria:

* Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications.
* Any significant concurrent condition (including conditions involving or inferior to the ankle) that could adversely affect the patient's participation and/or the assessment of the safety and efficacy in the study.
* Participation in any other interventional clinical research trial within 30 days prior to the screening visit or during the patient's participation in this study
Deprescribing and Health-related Effects

In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients.

The project was approved by the Management in the Municipality of Frederikshavn. According to Danish legislation, no formal permission from the national or regional Committee on Health Research Ethics was required for this type of study, as patients were not treated inferior to usual care and no biological material was collected. It was conducted as a quality improvement project and informed consent was not required for the specific data collected. The study is in compliance with the General Data Protection Regulation and a part of North Denmark Region's record of processing activities (K2023-008).

Eligibility Criteria:
Inclusion Criteria:

* new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.
* patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.

Exclusion Criteria:

* unable to collaborate on follow-up questionnaires
A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.


Eligibility Criteria:
Inclusion Criteria por prenatal clinics:

* Not having a smoking cessation program based on the "5 A's" for pregnant women in place.
* An estimated frequency of women receiving the "5 A's" intervention below 20%
* Having midwives or nurse-midwives as part of the hospital or primary health center staff.
* Having signed a letter of intention to participate in the project.
* Having at least 400 new pregnant women per year.

Exclusion Criteria for prenatal clinics:

* None