cyrilzakka/clinical-trials huggingface dataset:
A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).


Eligibility Criteria:
Inclusion criteria:

* Participant has participated in a prior vaniprevir clinical trial
* Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

* More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
* Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
* Participant received any investigational therapy for HCV after participating in the prior study
A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Clinical Characteristics of Lung Cancer in China

This study is a single-center, real-world and large-population-based retrospective study. In the current study, the investigators not only describe the changes of demographic and basic clinicopathological characteristics of lung cancer during recent years but delineate the correlation between clinicopathological features and common clinical blood tests in such a large population.

In this study, the investigators will collected all lung cancer patients diagnosed in Shanghai Pulmonary Hospital from 2012 to 2020. By conducting this population based study, the investigators would like to delineate changes of characteristics of lung cancer in Chinese patients during these years. Meanwhile, the investigators will compare clinicopathological features, routine blood tests, blood biochemical tests and coagulation status among participants at different stages. This comparing will assist the investigators to understand systemic changes during lung cancer progression. The same comparison will also be conducted among participants having different driver mutation through which the investigators will further understand the characteristics of different patients and treat patients more precisely.

Eligibility Criteria:
Inclusion Criteria:

1. Patients have medical records in our hospital.
2. Patients were diagnosed as lung cancer by pathological examination.

Exclusion Criteria:

1. Patients were lack of accurate pathological diagnoses.
2. Pathological diagnosis was benign disease or metastatic cancer from other organs.
Molecular Genetic Study of Mayer-Rokitansky-Kuster-Hauser Syndrome

In order to understand the molecular mechanisms leading to Mayer-Rokitansky-Kuster-Hauser syndrome (MRKH), the research team has to identify molecular bases of this anomaly.

Toward this goal, the research team would like to include in the study patients with MRKH syndrome, as well as their healthy relatives, in order to perform genetic analyses, especially whole exome sequencing.

This study has been set up in order to collect biological samples from patients with MRKH and their relatives.

The MRKH is a congenital and rare malformation characterised by the absence of the uterus and of 2/3 of the vagina. The incidence is 1 in 4500 female children (46,XX) and a genetic component has been identified.

In order to understand the molecular mechanisms leading to this disease, the research team has to identify the genetic abnormalities.

This study will be led by the research team of the Imagine Institute and the clinical teams associated with the Reference Center for Rare Diseases PGR (Rare Gynecologic Diseases). Both groups are based on the Necker Hospital campus, and already closely collaborate on research into MRKH syndrome.

This collaboration will allow to :

i) collect biological samples from the propositus and their relatives,

ii) have a medical expertise.

The clinicians involved in the study will recruit patients, whose participation will involve providing a biological sample, ie, a blood sample and/or uterine tissue collected during surgical ablation, in the event that surgery is performed during clinical follow-up of the patients. No specific intervention will be planned for the purposes of this study.

In order to perform genetic analysis on trios, the healthy relatives of the patients (parents, brothers, sisters) will also be included. Blood samples will be taken once for healthy relatives.

Genetic analysis, especially whole exome sequencing, will be performed on blood samples by the research team of Imagine Institute.

Eligibility Criteria:
Inclusion Criteria:

* Patient with MRKH syndrome OR healthy relative of patient included
* Having signed the Informed consent form (or parents in case of patient under 18 years)

Exclusion Criteria:

* Refusal to participate in genetic analyses
* Participation in a therapeutical clinical study in the 30 days prior to inclusion in the present study.
Sleep Schedule Intervention Study Among Night Shift Workers

This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. In the second week the participants will be randomly assigned to morning sleep or evening sleep time, and will change to the other in the third week. We will compare sleepiness, sleep quality, daytime vigilance score changes using mixed method ANOVA. We will also examine the interaction effect of chronotype and sleep schedule on sleep-related outcome.


Eligibility Criteria:
Inclusion Criteria:

* Shift work disorder

Exclusion Criteria:

* Neuromuscular disorder
* Taking hypnotics
* Pregnancy
Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial

While tremendous progress has been made against HIV, both in preventing the infection and in treating AIDS, the disease it causes, AIDS-related malignancies like Kaposi sarcoma (KS) remain a significant health burden, in both the U.S. and especially the developing world. In many cases, multiple KS lesions develop simultaneously, and may progress and regress independently. Photographs are an essential part of the evaluation for KS, as reflected in their formal usage described in the KS Tumor Assessment Manual of Procedures. However, acquiring a clear, informative photo is not trivial, since anatomy is 3D and conventional imaging is 2D. The importance of accurate, quantitative 3D information is especially pronounced for the treatment of KS because when a tumor responds positively to treatment, the initial change is usually a flattening of the lesion, without any significant change in the projected 2D area. To evaluate the vertical space, along with other characteristics of a KS lesion, we have created an innovative imaging system, SkinScan3D, utilizing new commercial liquid lens technologies and AI based image analysis software, with strategies borrowed from astronomical imaging techniques previously used on NASA space telescopes. In this study, the investigators will develop and demonstrate a protocol for recording measurable 3D parameters, which may be used in a longitudinal study to rigorously monitor therapeutic responses of KS and statistically compare with that of the conventional AMC criteria.


Eligibility Criteria:
Eligibility Criteria:

* Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (KS).
* Has at least 3 cutaneous Kaposi sarcoma lesions.
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.
Physiological Characteristics of High Altitude Climbers

Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40
* Member of the national high altitude climbing group

Exclusion Criteria:

* Any diseases incompatible with hypoxic exposure, exercise testing
* Pregnancy
Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma

The objective of this NIS is to evaluate medical resource utilization, where data is rare in all cohorts, patient's QoL and effectiveness of zanubrutinib treatment in adult patients with WM, CLL, MZL and FL in a real-world setting.

ARIADNE will collect and analyze data of adult patients with WM, CLL, MZL or FL in need of treatment. The study will explore the medical resource utilization during therapy with zanubrutinib (Brukinsa®). Further aims are to assess effectiveness, safety and tolerability of the treatment as well as treatment satisfaction and biomarkers. These data will be supplemented by the assessment of patient-reported outcomes (PROs)/ health-related quality of life (QoL).

Since treatment options for MW, CLL, MZL or FL are limited and the most important factor is to keep or improve QoL of the patients, there is an urge for real-world clinical data of patients treated with zanubrutinib, especially focusing on patients already treated upfront with a BTK inhibitor, older patients and patients with comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Waldenström's macroglobulinemia (all treatment lines) OR
* Chronic lymphocytic leukemia (all treatment lines) OR
* Marginal zone lymphoma (≥2 treatment line and at least one anti-CD20 antibody-based previous therapy)
* Follicular lymphoma (≥3 treatment line)
* Signed and dated informed consent form
* Treatment with zanubrutinib according to current SmPC for WM, CLL and MZL
* Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC
* Treatment decision before inclusion into this non-interventional study
* Age ≥18 years.

Exclusion Criteria:

* Contraindications according to SmPC for patients with WM, CLL, MZL or FL
* Participation in an interventional clinical trial during zanubrutinib treatment.
TFL Driven Urinary System Treatment Study

The goal of this observational study is:

To assess the use of Coloplast TFL Drive in daily practice

To confirm:

* the safety and efficacy of the Coloplast TFL Drive and its GUI (Graphical User Interface) with pre-embedded settings in Laser lithotripsy
* the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for enucleation of prostate as treatment of benign prostate hyperplasia
* the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for ablation of urological tumors


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient, for which TFL laser is indicated for treating a urological disease (e.g. kidney or ureteral stones, urological tumor, BPH (Benign Prostate Hypertrophy...)

Exclusion Criteria:

* Any condition when TFL laser should not be indicated as per the TFL user manual (untrained surgeon on laser use, patient's conditions)
* Patients with no signed consent form
* Patients \<18 years old
* Patients under tutorship or guardianship
* Patients who already took part in the study
* Pregnant or breastfeeding women
* Patient undergoing 2nd step laser procedure at inclusion
* Subject already included in another study
Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings

This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.


Eligibility Criteria:
Inclusion Criteria:

* Age group 28:42 years.
* Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
* With a single living fetus in the current pregnancy.
* A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
* Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

Exclusion Criteria:

* Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
* Maternal chronic medical disorders( diabetes mellitus, hypertension)
* Patients presented with severe attack of bleeding.
* Patients presented with rupture of membrane.
* Emergency delivery regardless the cause.
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia

This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).

This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.

Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.

Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of up to 40 kg/m2
* Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
* Diagnosis of PBH
* At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia

Exclusion Criteria:

* Other cause of endogenous hyperinsulinism other than PBH
* Metabolic or bariatric surgical procedure other than RYGB
* History of non-RYGB upper GI surgery
* Use of agents that may interfere with glucose metabolism
Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care

Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The main objective is to show in patients hospitalized in intensive care for acute exacerbation of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3 months, an antibiotic strategy guided by the PCT in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years
* Documented or suspected clinically COPD according to the criteria of GOLD
* In acute exacerbation
* Suspect of lower respiratory tract infection
* With or without pulmonary criteria defined as the presence of a radiological infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, fireplace clinical auscultation, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
* Admitted to the hospital for less than 48 hours
* ICU Admission
* Informed Consent signed by the patient or his representative

Exclusion Criteria:

* Other than acute exacerbation etiology with or without pulmonary disease as suspected cause of ICU admission
* Patient immunocompromised neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV seropositivity
* Severe Acute Asthma
* Moribund patient or a disease with an estimated survival time of less than three months
* Therapeutic limitation Existence
* minor patient or under guardianship or custody
* Pregnant woman
* Refusal to participate in the study
* The inclusion of the subject in another biomedical research protocol in progress or for less than 30 days
A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer

The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.

Eligibility Criteria:
Inclusion Criteria:

1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
3. Her-2/neu negative (Phase II)
4. Negative pregnancy test for female subjects
5. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
6. Male or female for phase I and female for phase II, \>19 years of age and any race.

Exclusion Criteria:

1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
2. Known brain metastases
3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
4. Active infection requiring antibiotic therapy
5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
6. Grade 2 or greater motor or sensory neuropathy
7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
9. Known or suspected hypersensitivity to azacitidine or mannitol
10. Pregnant or breast feeding
11. Patients with advanced malignant hepatic tumors
12. Malignancy other than breast carcinoma (phase II)
13. Known HIV infection or chronic hepatitis B or C
Pedometers for the Enhancement of Post Cesarean Mobility

This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.


Eligibility Criteria:
Inclusion Criteria:

* Patients following cesarean delivery
* Consent to participation
* No medical recommendation for bed rest and limited mobility
* Meet any of the following criteria for high risk for thromboembolic complications - preeclampsia, chronic disease (reumatic, inflammatory bowel disease), obese, smoker \> 10 cigaretts a day, age \>35, substantial limb varicose, multiple gestation, multiparity (\> deliveries), emergent surgery, thrombophilia.

Exclusion Criteria:

* Refusal to participate
* Medical recommendation to limit mobility
A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).


Eligibility Criteria:
Inclusion Criteria

* Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
* Documented diagnosis of multiple myeloma (MM), and must:.

  i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.

ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).

iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.

iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.

* Must have measurable disease (as determined by central laboratory).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.

Exclusion Criteria

* Active, uncontrolled, or suspected infection.
* Known current, or history of, central nervous system involvement of multiple myeloma.
* History or presence of clinically relevant CNS pathology.
* Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
* Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change

Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. After surgery, the subjects will be observed for any surgical site infections.

Infection rate study.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will be enrolled in the study.