cyrilzakka/clinical-trials huggingface dataset:
Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception.

In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy

Exclusion Criteria:

* vaginal bleeding at the time of the procedure
* known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
* epilepsy
* significantly impaired respiratory or cardiac conduction functions
* hypertension
* glaucoma
* renal failure
* acute liver disease
* uncontrolled diabetes mellitus
* pregnancy or suspicion of pregnancy
* pelvic inflammatory disease
* cervical operation history
* vaginismus.
Post-extubation Dysphagia

Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED) is unknown. This exploratory pilot study is the first step that aims to fill this knowledge gap to ultimately improve current treatment and prevention of post-extubation dysphagia.

Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients within 24 hours after extubation will be studied.

Observational study model:

The group of healthy subjects will be recruited using posters at the local university and the internet. The healthy subjects will be studied before the group of patients to assess the feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then, the group of patients will be studied. They will be recruited from the Intensive Care Unit. See In- and Exclusion criteria for details.

Eligibility Criteria:
Inclusion Criteria (patients):

* age \> 18 years
* informed consent
* extubated after endotracheal intubation for more than 5 days
* Richmond Agitation-Sedation Scale (RASS) between -2 and 2
* able to sit right up
* no respiratory insufficiency/failure (for this study defined as oxygen saturation (SpO2) \< 92% with a minimum of 3 L nasal oxygen)

Inclusion Criteria (healthy subjects):

* age \> 18 years
* informed consent

Exclusion Criteria (both patients and healthy subjects):

* pre-existing dysphagia (according to medical record and screening)
* tracheostomy or previous tracheostomy
* history of prior intubation \< 3 months ago
* head/neck surgery, head/neck radiation or head/neck disease
* pre-existent esophageal disorder
* coagulopathy (thrombocytes \< 50\*10\^9 /l, or prothrombin time (PT)/activated partial thromboplastin time (APTT) \> 1.5 times the reference value, or fibrinogen \< 1000 mg/l, or use of therapeutic anticoagulant drugs)
* allergy for xylometazoline (only in case its use is indicated)
* known pregnancy
* known G6PD deficiency
Caffein Consumption and Response Inhibition

With the abundance of energy-dense foods that are designed for ease of consumption in the current environment, it is of importance to better understand the factors that may undermine the control of energy intake at healthy levels.

One of the factors that is potentially important in response inhibition is caffeine.

The aim is to assess the direct effects of caffeine on response inhibition, using a No Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as pictures, modulate response inhibition different in restrained vs. non-restrained eaters.

In a blinded, randomized cross-over design, participants will receive either a capsule with caffeine or placebo at two separate occasions whereupon study tasks will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Only males
* 18 ≤ 35 years
* Healthy (self rated)
* Used to drink caffeine
* Used to eat breakfast regularly (≥ 5 times a week).
* Non-smokers

Exclusion Criteria:

* BMI outside the range of 18,5 ≤ 25
* hypersensitivity for the ingredients of the foods under study
* being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea
* Presence of any chronically disease and/or treatment with medication
Development of an Artificial Intelligence Model for Optimising Therapy in Gliomas Gliomas

Artificial intelligence (AI) undoubtedly represents the main tool currently available in the definition of complex algorithms and its use in the medical field is becoming increasingly strategic.As reported in the literature, it is increasingly difficult to find new therapeutic strategies for neoplasms, especially neurological ones. Molecular characterisation is therefore increasingly essential, as is the use of new predictive methods.

With this in mind, the aim of this study is to assess, by means of AI algorithms applied to genomic data, in what percentage molecular alterations are susceptible to potential drug therapies, compared to the literature data that does not consider AI algorithms for this purpose.

Artificial intelligence (AI) undoubtedly represents the main tool currently available in the definition of complex algorithms and its use in the medical field is becoming increasingly strategic.As reported in the literature, it is increasingly difficult to find new therapeutic strategies for neoplasms, especially neurological ones. Molecular characterisation is therefore increasingly essential, as is the use of new predictive methods.

With this in mind, the aim of this study is to assess, by means of AI algorithms applied to genomic data, in what percentage molecular alterations are susceptible to potential drug therapies, compared to the literature data that does not consider AI algorithms for this purpose.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histopathological diagnosis of glioma for whom it is possible to have cryopreserved or fixed in formalin and embedded in paraffin biological material. Specimens may result from incisional biopsy and/or surgical resection and/or blood. Whole blood is taken for germinal analysis;
2. Age \>=18 years;
3. Patients must understand and provide written informed consent;
4. Life expectancy \>3 months;
5. Presence of biological material from resection and blood considered sufficient by quality and quantity to proceed to molecular characterisation in the opinion of the Investigator Principal Investigator;
6. Presence of available and accessible clinical and histopathological data.

Exclusion Criteria:

1. Refusal of informed consent;
2. Uncooperative patients;
3. Presence of other neoplastic diseases in the last 5 years;
4. Pregnant and/or breastfeeding women
Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3

This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds


Eligibility Criteria:
Inclusion Criteria:

* Subject with bilateral, symmetrical NLF and wish for correction. Documented severity of NLF score 2 or 3 at screening on the Merz Wrinkle Severity Rating Scale II

Exclusion Criteria:

* Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal). Subject suffering from diabetes mellitus, autoimmune and rheumatic diseases, clinically relevant coagulation disorders, recurrent angina, or severe psychic, neurological or mental disease
* History of malignancy within the last 5 years before the study
* Infection, inflammations or active dermatological disease in the face
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
* Participant meets Adult Treatment Panel (ATP) III High Risk criteria

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Participant consumes more than 14 alcoholic beverages per week
* Participant has been treated with an investigational drug within the last 30 days
* Participant has congestive heart failure (New York Heart Association \[NYHA\] Type III or IV)
* Participant has had gastric bypass
* Participant is newly diagnosed with type 1 or 2 diabetes
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant has a history of drug or alcohol abuse within the last 5 years
Emapalumab Efficacy in Children With Primary Hemophagocytic Lymphohistiocytosis

The goal of this retrospective study is to assess efficacy and safety of emapalumab prescribed for the treatment in children with refractory from of pHLH.

Primary hemophagocytic lymphohistiocytosis (pHLH) encompasses a group of genetically determined disorders, characterized by severe, often fulminant systemic inflammation, cytopenia and multiple organ involvement. The disease manifests predominantly in the early childhood, has high mortality rate and in most cases requires hematopoietic stem cell transplantation (HSCT) as the only currently available curative option. Yet, HSCT outcomes are dependent on the state of remission of the underlying systemic inflammation and infections complications, as well as organ damage due to the side effects of the chemotherapeutic drugs received prior to it. For years the gold standard of HLH treatment has been the dexamethasone and etoposide-based HLH-2004 protocol, yet it failed to uniformly control the disease. An alternative regiment combining antithymocyte globulin and corticosteroids demonstrated good results but barely improved survival. Also, no universally accepted treatment exists for relapsed or refractory hemophagocytic lymphohistiocytosis. Advances in availability of biologic treatments open up new possibilities of HLH therapy, with several targets proposed in recent years. Interleukin 6 inhibitor tocilizumab, interleukin 1 inhibitor anakinra, Janus-kinase inhibitor (JAKinib) ruxolititnib have been used for HLH treatment, with variable results.

Mounting evidence provides support for the pivotal pathogenic role of interferon-γ (IFNg) in hemophagocytic lymphohistiocytosis. Emapalumab is a fully human IgG1 anti-interferon-γ monoclonal antibody that binds free and receptor-bound interferon-γ and inhibits its biologic activity. The data accumulated from the phase II/III clinical trial and reports of the small groups of patients demonstrate its efficacy in pHLL.

The study will collect and analyze information of the effectiveness and safety of emapalumab treatment that was previously prescribed in a cohort of seven pediatric patients with pHLH.

Criteria for inclusion in the study were:

1. age from 0 to 18 y.
2. the diagnosis of pHLH ( established according to the Histiocytic society criteria).
3. treatment with empalumab for at least 2 weeks
4. signed informed consent for participation in the study Exclusion criteria - not applicable.

Eligibility Criteria:
Inclusion Criteria:

Criteria for inclusion in the study were:

1. age from 0 to 18 y.
2. the diagnosis of pHLH ( established according to the Histiocytic society criteria).
3. treatment with empalumab for at least 2 weeks
4. signed informed consent for participation in the study

Exclusion Criteria:

not applicable. signed informed consent for participation in the study
Affecting the Epidemiology of HIV in Uganda

The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.

The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model of HIV Preventive Behavior.

Intervention development will be iterative: In Phase 1, the investigators will identify an intervention content "map." Then, online focus groups (FG) will be conduct online with Ugandan young adults (n = 40-80) to confirm program components (e.g., social support via Text Buddy, optimal time of delivery of daily text messages) and saliency of intended program topics.

In Phase 2, the investigation team will "translate" content into a bank of text messages that will be reviewed for comprehensiveness and inclusion of the most pertinent topics. The final pool of messages among Ugandan young adults will be tested in the Content Advisory Council (CAC; n = 30) to assess their reactions to the content, scope, style, and tone of the messages.

In Phase 3, the investigators will merge the content with the software program developed to deliver the intervention and then internally conduct a functionality test of the programmed messages. Following, the protocol and program will be tested in a beta test of 20 Ugandan adults.

In Phase 4, the investigators will test the intervention in a randomized controlled trial of 200 Ugandan young adults randomly assigned to either the intervention (n = 100) or control (n = 100) arms. The main outcome measures will focus on feasibility (e.g., recruitment and retention rates) and acceptability (e.g., Text Buddy). The primary efficacy outcome measures, measured at 3-months post-intervention, will be: (a) frequency of unprotected sex acts; (b) sustained sexual abstinence, and (c) increased HIV testing rates.

Specific Aims are as follows:

Specific Aim 1: Design a 6-week text messaging-based HIV prevention and healthy sexuality program for adolescents 18-22 years old.

Specific Aim 2: Pilot test the intervention for feasibility and acceptability among 18- to 22-year-old Ugandans.

Specific Aim 3: Obtain preliminary data needed for a larger-scale controlled trial services study to examine program efficacy.

Eligibility Criteria:
Inclusion Criteria:

* living in Uganda
* aged 18-22 years
* able to read English
* exclusive owner of a cell phone
* using text messaging for at least 6 months
* intended to have the same phone number or the next six months
* able to access the Internet (to complete online surveys)
* able to provide informed consent

Exclusion Criteria:

* no other exclusion criteria will be applied
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis

The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for mixed type deep venous thrombosis (DVT), and determine whether it can achieve similar therapeutic effects as central type DVT.

Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach for mixed type DVT, and determine whether it can achieve similar therapeutic effects as central type DVT. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-85 years old;
2. Acute DVT occurred no more than 14 days since the onset of disease;
3. DVT treated by percutaneous mechanical thrombectomy
4. Informed consent signed by patients.

Exclusion Criteria:

1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
2. Women during pregnancy and lactation;
3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<6 months);
4. Patients who are unable or unwilling to participate in the study.
Acupuncture for Breast Pain

This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnosis criteria of cyclic breast pain.
* Female patients aged between 18 and 55.
* Relatively regular menstrual cycle.
* Cyclic breast pain lasting for 3 consecutive menstrual cycles or more.
* The score of worst pain ≥5 on Numerical Rating Scale and any level of breast pain lasting 5-21 days during the run-in period of one menstrual cycle.
* No previous experience of acupuncture for breast diseases.
* Willing to use nonhormonal contraceptives if any risk of pregnancy.
* Volunteer to the trial and signing written informed consent.

Exclusion Criteria:

* Noncyclic breast pain.
* Extramammary pain only.
* A history of breast cancer or suspicious of malignancy breast disease by examinations.
* The Breast Imaging Reporting and Data System (BI-RADS) category 4-6 in ultrasound or mammography examinations.
* Combined with mastitis.
* Breast pain following injury, surgery, hormones, and/or other drugs.
* Usage of hormones (including hormonal contraceptives) in the past three months.
* Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
* A history of bilateral ovariectomy or premature ovarian failure.
* Pregnancy, lactation, or wishing to conceive before the end of the trial.
* Poor adherence.
Internal Jugular Vein Distensibility to Predict Fluid Responsiveness in Patients After Cardiac Surgery

The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size and distensibility as an index of fluid responsiveness in mechanically ventilated patients after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* hypotension
* oliguria
* high lactate level

Exclusion Criteria:

* cardiac arrhythmia
* clinically relevant tricuspid or mitral regurgitation, clinically relevant right heart failure
* thrombosis in any large upper body veins
* bilaterally inserted venous catheters
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%

Exclusion Criteria:

* Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
* History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
* Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
* Metastatic disease
* Inadequate bone marrow, hepatic, or renal function
* Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* History of severe allergic or immunological reactions, such as difficult-to-control asthma
* Pregnant or lactating women
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
* Willingness to avoid pregnancy or fathering children
* In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
* Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
* Documented relapsed, refractory, or PD after treatment with systemic therapy
* ECOG performance status of 0 to 2

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Any histology other than FL and MZL or clinical evidence of transformed lymphoma
* Prior non-hematologic malignancy
* Congestive heart failure
* HCV positivity, chronic HBV infection or history of HIV infection
* Active systemic infection
* CNS lymphoma involvement
* Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
* Prior use of lenalidomide in combination with rituximab