cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss

evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss

1. Mean gestational sac diameter (MSD) is determined by measuring the mean of 3 diameters (longitudinal, antero-posterior and transverse) which are measured from inside of the sac excluding the decidual reaction from the measurement. It is normally eccentric in location embedded in endometrium, and has a smooth; round or oval shape.
2. Yolk sac is measured by placing calipers on the inner limits of the longer diameter. It usually appears at the periphery of the gestational sac and should not be floating within the sac. Size of the sac, shape, echogenicity of the rim and center of sac, its number and degenerative changes such as calcification will be evaluated. YS having diameter between 3-7mm, rounded shape, absence of degenerative changes, presence of echogenic rim and hypoechoic center are considered normal. Any deviation from above parameters is considered abnormal.
3. Crown-rump length (CRL) is the length of the embryo from the top of its head to bottom of torso excluding the yolk sac and the extremities, to be measured in sagittal plane of the embryo and recorded as an average of three measurements.
4. The MGSD-CRL ratio was calculated as the difference between the MGSD and the CRL if less than 5 mm are prone to first trimester miscarriage.
5. Embryonic heart rate by M-mode calculated as beat per minute using software of ultrasound machine after measuring by electronic calibers of distance between 2 heart waves on frozen M-mode image.
6. Uterine artery Doppler with measurement of systolic/diastolic (S/D) ratio, resistance index (RI) and pulsatility index (PI) of uterine arteries.

Eligibility Criteria:
Inclusion Criteria:

* A positive pregnancy test result.
* Single intrauterine pregnancy.
* Gestational age by last menstrual period of 6-10 weeks in patients with regular cycles and sure of her last menstrual period date.
* History of recurrent pregnancy loss which is defined as three or more consecutive pregnancy losses.

Exclusion Criteria:

* Women who are uncertain of her last menstrual period date.
* Women with irregular menstrual cycles.
* Multiple pregnancies
Cytokine-Associated Depression and Social Pain

Recent research has demonstrated a relationship between depression and immune system activity, specifically proinflammatory cytokine activity. Although experimentally-induced immune activation leads to increases in depressed mood, the neural correlates associated with these changes have remained largely unexplored. Based on relationships between cytokine activity, depression, and heightened physical and social pain sensitivity, I propose to investigate the effect of proinflammatory cytokine activation on the neural correlates of socially painful experience that may contribute to depression. Our previous work has shown that the dorsal anterior cingulate cortex (dACC), typically associated with physical pain distress, also plays a role in the distressing feelings associated with social rejection or social loss. Moreover, recent pilot data has revealed that individuals with elevated levels of baseline proinflammatory cytokines report feeling more distressed and show more dACC activity during social rejection. To investigate the causal role that cytokines may play in the heightened social pain sensitivity that can contribute to depression, participants will be randomly assigned to receive either endotoxin (which increases proinflammatory cytokine activity) or placebo. Subsequently, participants will complete a neuroimaging study in which they will be rejected during an online ball-tossing game. We hypothesize that individuals exposed to endotoxin will report more social distress and depression following rejection and will show more dACC reactivity during rejection. The proposed study is the first to investigate the effect of systemic inflammation on neural reactivity related to social and affective processes that may increase the risk of depression.


Eligibility Criteria:
Inclusion Criteria:

* right-handed

Exclusion Criteria:

* 1) BMI greater than 30,
* 2) presence of physical health problems or medication use,
* 3) evidence of an Axis I psychiatric disorder based on the SCID assessment,
* 4) evidence of recreational drug use from a positive urine test,
* 5) positive pregnancy test, if female,
* 6) abnormalities on screening laboratory tests (blood cell count, liver function),
* 7) claustrophobia,
* 8) metal in body,
* 9) history of allergies, autoimmune, liver, or other severe chronic diseases,
* 10) current use of prescription medications,
* 11) nightshift work or time zone shifts (\> 3hrs) within the previous 6 weeks.
Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery

The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.

Up to 300 eyes at up to 5 investigational sites will be enrolled in one of the two cohorts of this clinical investigation - up to 50 eyes in Cohort 1 and up to 50 eyes in Cohort 2. Only one eye per subject will be enrolled into the study. This is multicenter, multi-cohort, prospective clinical study designed to provide longitudinal, observational, non-comparative clinical outcome data for mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.

Participants who meet the inclusion and exclusion will be asked to enroll in the study. The investigator or designee will explain the study purpose, procedures and responsibilities to the potential participant and provide sufficient opportunity to ask questions, while allowing adequate time for consideration of the information provided. Upon participant confirmation of interest, written informed consent will be obtained and the subject will be enrolled in the study. One copy of the informed consent document (ICD) will be retained with the subject's medical records and one copy will be provided to the subject.

Study subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).

Subjects will be seen at the screening visit, intraoperative visit, and at post-operative days 1, 7, and 30.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits
2. Willing and able to understand and complete the informed consent document
3. Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery
4. Subjects ≥ 18 years of age
5. Clear intraocular media, other than cataract

Exclusion Criteria:

1. Polar cataracts
2. Zonular instability
3. History of dry eye treatments/devices and or dry eye medications other than artificial tears.
4. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit
5. Subjects that are pregnant, lactating or planning to become pregnant during the course of the study
Community-associated Highly-Resistant Enterobacterales

This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-HRE will be compared to those from hospitalized patients with healthcare-associated HRE (HA-HRE). In addition, community spread of CRE will be determined.

Patients who are discharged home from the hospital and meet criteria for possible CA-HRE will be recruited. These index participants will be interviewed to determine the epidemiologic network, and will be mailed a monthly BioWipe kit to screen for ongoing HRE intestinal carriage. Contacts of the index participant will also be approached and mailed a BioWipe kit to screen for the presence of HRE and/or carbapenemase gene(s) that were present in the index patient. If this initial sample is negative, the contact is not further interviewed or tested. If the initial screening is positive for the carbapenemase gene of interest, then the contact will be asked to answer the same questions as the index patient and will receive a monthly BioWipe kit. For each positive contact, a second-generation network of contacts will be constructed, who in turn will be approached for screening.

An additional subset of participants, those with CDC-defined HRE isolated during hospitalization who are not discharged home will also be included. All HRE isolates that are isolated from the patient as part of routine clinical care will be sub-cultured and shipped to the central research laboratory. A limited data set will be collected.

Eligibility Criteria:
Inclusion Criteria:

Category 1: Patients who live at home and meet the following criteria:

* CDC-defined HRE isolated during a previous hospitalization or outpatient visit
* Home origin
* First positive HRE culture within 48 hours of admission (in case of hospitalization)

Category 2: Hospitalized patients with CDC-defined HRE isolated during hospitalization who are not discharged home and who meet any of the following criteria:

* Admitted from other care facility (not home origin)
* Do not have first positive HRE culture within 48 hours of admission

Category 3: Patients with CDC-defined HRE isolated during a previous hospitalization or outpatient visit who are eventually discharged home and who meet any of the following criteria:

* Admitted from other care facility (not home origin)
* Do not have first positive HRE culture within 48 hours of admission (in case of hospitalization)

Category 4: Participants who meet the following criteria:

• Community contact of a participant in Category 1 and/or 3.

Exclusion Criteria:

In all categories, participants who meet the following criteria will be excluded:

• Age \<18 years

In category 1, the following are exclusionary:

* pre-existing renal failure
* pre-existing liver disease
* immunocompromised
* history of malignancy
* pregnancy

In addition, in category 1, 3 and 4, who meet the following criteria will be excluded:

• Unable to provide informed consent
Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
* Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
* Patient not randomized in parent study that meet inadequate response criteria

Exclusion Criteria:

* Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
* Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study \[including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)\].
* In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies
* HCV genotype 1 infection
* Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

Exclusion Criteria:

* Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Discontinuation of the prior DAA treatment for reasons other than virologic failure
* Confirmed presence of hepatocellular carcinoma
* Abnormal lab tests
Water Intake and Weight Control in Older Adults

This study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different diet prescriptions: 1) pre-meal water consumption (500 ml, before each main meal) with a hypocaloric diet; 2) 1500 ml water consumed throughout the day with a hypocaloric diet; 3) hypocaloric diet with no instructions regarding water consumption. Smart water bottles will objectively assess water intake timing and volume. Urine osmolality, urine volume, and serum osmolality will be used as objective indicators of compliance with the water intake prescription. We will investigate changes in perceived hunger and fullness and appetite-regulating hormones as potential mechanisms by which premeal water could improve appetite regulation. We will also investigate the impact of water consumption and hydration on executive function capabilities, which may influence intervention adherence. Although increasing water intake could be an effective weight management strategy, no evidence-based recommendations exist for the timing of water intake needed for this benefit.


Eligibility Criteria:
Inclusion Criteria:

* aged 50+ years
* BMI ≥25 kg/m2
* weight stable (+/- 2 kg) in past 6 months
* willing to provide consent and comply with study protocol

Exclusion Criteria:

* usual plain drinking water intake \>1500 ml/d
* uncontrolled hypertension (\>159/99 mmHg)
* medical condition requiring specialized diet prescription (eg, T2D, CHF wih fluid restriction)
* medical condition that precludes participating in a physical activity program (eg, orthopedic injury)
* current or history of GI disease (eg, Crohn's), GI surgery, or medications which impact GI function
* allergies or aversions to foods included in the test meals
Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract

The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow.

1. Patients with \>=38 degrees C, \>=15,000/mm3 or \<=3,000/mm3 of WBC and \>=10mg/dL of CRP
2. Patients who have no abscess on the abdominal image
3. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
4. Patients who are 20 years old or older
5. Patients who have signed the agreement for participation in this study

Exclusion Criteria:

1. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
2. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
3. Patients who were administered immunoglobulin within 1 month before entry
4. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
5. Patients with IgA deficiency
6. Patients with hereditary fructose intolerance
7. Patients with history of allergy or adverse effect for antibacterial agents
8. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study
9. Patients who are or could be pregnant
10. Patients who have noninfectious fever, fungal infection or viral illness
11. Other patients who are judged to be inadequate to participate in this study by their physician
AI-based Low Dose CBCT Reconstruction for Clinical Application

The goal of this clinical trial is to learn if AI-based low dose CBCT reconstructed images can guide lung puncture effectively. The main questions it aims to answer are:

1. Does the AI-based low dose CBCT reconstruction model reconstruct high quality images?
2. Is it possible that low-dose CBCT reconstructed images can guide lung puncture procedures without compromising the efficiency of the procedure? Researchers will compare AI-based low dose CBCT reconstructed images to a placebo (conventional CBCT images) to see if AI-based low dose CBCT reconstructed image can guide lung puncture procedures without compromising the efficiency of the procedure.

Participants will:

1. Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images
2. Be followed up for 1 week postoperative to obtain patient complications


Eligibility Criteria:
Inclusion Criteria:

* Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
* Participants whose physical condition is suitable for PLP.
* Participants are willing to sign informed consent.

Exclusion Criteria:

* Participants have metallic implants in the body, which severely affects the image quality.
* Participants are pregnant or breastfeeding.
* Participants are unwilling or unable to sign informed consent.
Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.

Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.

Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years and \<90 years
* ASA (American Society of Anesthesiologists) score between I and IV
* Patients who will undergo femoral neck fracture surgery

Exclusion Criteria:

* Previous local anesthetic allergy
* Those with bleeding diathesis disorder
* Having a mental disorder
* Those who are allergic to the drugs used
* Patients who did not consent to participate in the study
* Presence of infection in the block area
* Body mass index \>30
* Preoperative or intraoperative general anesthesia
* Patients for whom consent cannot be obtained
* Pregnant patients
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity

Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a woman's last menstrual cycle. PMB represents one of the most common reasons for referral to gynaecology services. Approximately 10% of women with PMB will be found to have endometrial cancer. The gold standard of investigation of PMB is ambulatory gynaecology through the outpatient hysteroscopy clinic, which is often combined with Pipelle biopsy for endometrial sampling.

Up to 60% of women that present with PMB will have an atrophic-appearing cavity at hysteroscopy. This provides a challenge in obtaining a histological sample through both dilatation \& curretage (D\&C) and Pipelle biopsy. Often, scant tissue that is insufficient for clinical diagnosis is obtained.

Pipelle biopsy is associated with patient discomfort. It is also associated with costs related to the purchasing of equipment and the processing of samples in the laboratory to the sum of approximately 30 euro per sample. It is rare that a sample taken from an atrophic cavity will return any clinically meaningful result. A negative hysteroscopy reduces the probability of endometrial cancer to 0.6%.

This study aims to compare patients with PMB and atrophic-appearing cavity that undergo pipelle biopsy to those that do not. Differences in pain scores, cost saving and differences in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients with PMB and atrophic-appearing cavity.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Postmenopausal bleeding
* Tolerates hysteroscopy

Exclusion Criteria:

* Premenopausal
* Any lesion requiring biopsy at time of hysteroscopy
* Obvious cause of bleeding from the vagina or cervix at time of hysteroscopy
* History of endometrial hyperplasia/cancer