cyrilzakka/clinical-trials huggingface dataset:
Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR

Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed.

Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Male or female from all ethnicities;
* At least 6 months post successful, isolated MV repair. S
* Asymptomatic

Exclusion Criteria:

* Pulmonary hypertension \>50 mmHg at rest;
* Atrial fibrillation (AF) at time of study related stress echo test;
* Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing;
* LVEF \<45%;
* NYHA class II and more.
* Other heart valve disease of more than mild severity;
* Concomitant surgery during MV repair, e.g. MAZE, TVP procedure;
* Prior heart valve surgery;
* Congenital heart disease;
* Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD);
* Unable to provide informed consent
Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients

This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.

This is an observational, prospective, non-interventional, single arm, non-comparative, open label, multi-centric, multi-stage study to record the prevalence of KRAS mutations in the Argentine mCRC population. The study is planned to be conducted in 150 centres (50 in each of 3 stages of four months each, enrolling 500 subjects in each stage). Total of subjects: 1500. Demographic information, complete medical history and tumour history related data will be captured in the first visit and if any information is missing, then only another visit will be scheduled. Data captured will be analysed and presented using statistical tools.

OBJECTIVES:

Primary objective:

* To record the prevalence of KRAS mutations in the Argentine mCRC population.

Secondary objective:

* To record and evaluate certain subject and tumour characteristics for association with KRAS mutational status (country, gender, age, performance status, body mass index (BMI), ethnic origin, personal and family history of malignancy, personal and family history of familial polyposis coli, smoking status, exercise, diet, tumour characteristics/location, site of origin of the tissue sample sent for KRAS testing, first line therapy chosen).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have signed written informed consent before any study-related procedure
* Subjects with histologically confirmed adenocarcinoma of the colon/ rectum, T1-4 N0-2 M1 or rT1-4 N0-2 M1
* Subjects with age above 21 years
* Subjects willing to provide information required by protocol
* No previous systemic treatment for mCRC

Exclusion Criteria:

* Subjects with known pregnancy
* Subjects with previous systemic therapy for mCRC
* Subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study
* Subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

Study Classification: Pharmacokinetics/ Pharmacodynamics

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Chronic Hepatitis C, Genotype 1
* HCV RNA \>100,000 IU/mL at screening;
* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
* Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion Criteria:

* Any evidence of liver disease other than HCV;
* Co-infection with HIV;
* Diagnosed or suspected hepatocellular carcinoma;
* Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin
Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis

This study will compare shoulder range of motion assessment using the Kinect motion tracking system vs goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing ultrasound-guided capsular distention procedures (standard of care).

The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

The study will be a single-center, investigator-initiated protocol to assess the reliability of the Kinect Motion Analysis 2.0 Motion Tracking System for Range Of Motion (ROM) assessment in patients with Shoulder Adhesive Capsulitis undergoing ultrasound guided capsular distention procedures (standard of care for adhesive capsulitis). Secondarily, the study will describe the relationship between range of motion of the shoulder girdle in the four quadrants of normalized reachable workspace by the Kinect 2.0, PROMIS person-reported outcome scores for pain, pain interference and function (general mobility and upper extremity function), and VAS pain scores.

Study participants are anticipated to remain in the study for 12 weeks: an initial visit followed by 6- and 12-week follow up visits. Given the nature of scheduling appointments in medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2 weeks longer if needed to successfully complete the follow-up visit.

The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of limited ROM due to adhesive capsulitis
2. duration of symptoms of ≥ 3 months
3. persistent functional limitation (defined as either limitations occupationally, in independent activities of daily living, or activities of daily living)
4. X-rays and MRI excluding alternative diagnosis
5. age 18 years or older.

Exclusion Criteria:

1. prior shoulder surgery on the affected side
2. complete rotator cuff tear (based on clinical history, examination, and imaging) or planned surgical intervention on the affected side
3. ipsilateral subacromial injection within the last 3 months
4. autoimmune or rheumatologic disease affecting the joints
5. lack of scheduled same-day physical therapy appointment
6. inability to complete follow-up appointments or surveys
7. inability to provide informed consent
8. symptomatic glenohumeral or acromioclavicular pathology
9. referred pain from the neck or internal organs
10. generalized myofascial pain syndrome
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Patient is not pregnant or breastfeeding
* Male or female patient unlikely to conceive
* Patient not on an antihyperglycemic drug

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus
* Patient has history of ketoacidosis
* Patient requires insulin within 8 weeks prior to start of study
* Patient on weight loss program and is not in maintenance phase
* Patient taking weight loss medication within 8 weeks prior to start of study
* Patient on or likely to require = 14 days or repeated courses of corticosteroids
* Patient taking immunosuppressive/immunomodulating medication
* Patient taking digoxin or other cardiac medication
* Patient has undergone surgical general anesthesia within 30 days prior to start of study
* Patient taking investigational drug within 8 weeks prior to start of study
* Patient is diagnosed with liver disease
* Patient has chronic myopathy, progressive neurological/neuromuscular disorder
* Patient has with severe cardiac conditions within the last 6 months
* Patient is Human immunodeficiency virus (HIV) positive
* Patient has hematological disorder
* Patient has history of malignancy
* Patient has history of alcohol or drug abuse within the past 3 years
Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia

The study will investigate the potential effect of a supplement of maltodextrin and added dietary carbohydrates on the level of function in patients with apoplexia. The study has an intervention group and a control group. The study is randomized, but not blinded. The primary outcome is level of function measured with Barthel-100. Besides the primary outcome there are several secondary outcomes (see detailed description). All patients are recruited from Rigshospitalet, Glostrup.

The study will investigate the potential effect of a supplement of maltodextrin (20 g for women and 30 g for men) and added dietary carbohydrates on the level of function in patients with apoplexia. The study has an intervention group and a control group. The study is randomized, but not blinded. The primary outcome is level of function measured with Barthel-100. Secondary outcomes are: training intensity, duration and frequency; length of stay; self-training (training without a therapist) and patient's experienced fatigue; and patient's experienced pain. All patients are recruited from Rigshospitalet, Glostrup. The supplement will be administered before and after each training session with a therapist. The supplement is a powder desolved in a glass of juice. The nursing staff will add extra carbohydrates to the patient's meals in the form of potatoes, rice, bread, fruit or other carbohydrate rich food items. All meals will be noted daily and validated the following day by the primary investigators.

Eligibility Criteria:
Inclusion Criteria:

* Patients with apoplexia who are declared suited for rehabilitation at Afs. Neurologisk Afdeling N 35 - Apopleksi or Afs. Neurologisk Afdeling N 45 - Apopleksi, Rigshospitalet, Glostrup
* Patient must be able to consent participation
* Age 50+ years
* Must be able to understand danish
* Must be relevant for physio- or occupational therapy

Exclusion Criteria:

* Diabetes Mellitus type I og type II
* Enteral nutrition (tube feeding)
* Barthel-100 over 80 points
Diagnosis and History Study of Patients With Different Neurological Conditions

This protocol is a screening and natural history protocol, which allows for evaluation of

patients and families where neurological conditions are present for enrollment into other

studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

...

This protocol is a screening and natural history protocol, which allows for evaluation of

patients and families where neurological conditions are present for enrollment into other

studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Patients with neurological disorders and subjects with a family history of neurological conditions OR
* Healthy volunteers: People age 18 or older who are generally in good health.

EXCLUSION CRITERIA:

* Patients \<2 years old.
* Employees of HMCS in NINDS.
Effectiveness of a One-day Psychoeducation Program on Internalized Stigmatization for BPD Patients

Education day on borderline personality disorder (BPD), including a transmission of current scientific knowledge on the disease. A dimensional understanding of BPD is delivered as well as disidentification of oneself to the symptoms of borderline personality disorder (Ducasse 2020 Eur Arch Psychiatry Clin Neurosci). The main objective is to evaluate the impact of borderline education day on self-stigma.

Borderline personality disorder defined as "a pattern of instability in interpersonal relationships, self-image and affects, and impulsiveness marked" concerns 4-6% of the general population. This is the emotional trouble the most associated with the occurence of suicide attempts (85% of these patients make multiple suicide attempts) and death by suicide (10% of these patients). This is a major public health problem.

A large number of patients with borderline personality disorder are not informed of their diagnosis. The main reasons are : the non-recognition of this disorder by health professionals, the belief that borderline personality disorder is a overly stigmatizing diagnosis , or preference to diagnose another disorder - that professionals think respond better to treatments and therefore be of a better prognosis.

Patients with borderline personality disorder often think themselves as "bad people" or the only people suffering from these symptoms. Thus, the ignorance of borderline personality disorder by patients leads to a basis of their altered sense of identity, perceived as defective or isolated. This generate a strong internalized stigma.

Many people diagnosed with borderline personality disorder receive no information about this disorder while psychoeducation has shown its effectiveness in severe psychiatric disorders, including the disorder of borderline personality, by reducing the negative repercussions psychiatric pathology. Moreover, the education of patients suffering from self-stigma makes it possible to in the face of negative beliefs around the disease and the acquisition of knowledge about the disorder and how to deal with it reduces self-stigma in bipolar patients. However, the propensity to feel shame - the stigmatization of oneself as worthless - is strongest in borderline personality disorder compared to all psychiatric disorders and most associated with the occurence of suicidal behaviors. In recommendations with good clinical practice, the investigator propose within the sector a day of education on borderline personality disorder including a transmission of current scientific knowledge on the illness, a dimensional understanding of the disorder, and the dis-identification of self to the symptoms of borderline personality disorder. The investigator hypothesize that this day of psychoeducation makes it possible to decrease self-stigma, which could be a mediator in reducing negative repercussions of borderline pathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Borderline Personality disorder assessed according to SCID II
* Having attended the borderline education day

Exclusion Criteria:

* None
The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients

Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients


Eligibility Criteria:
Inclusion Criteria:

1. Children aged ≥6 months to \<12 years old
2. Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4
3. Wheezing score ≥2
4. Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit

Exclusion Criteria:

1. Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
2. Subjects under treatment with corticosteroids, antibiotics medications
3. Subjects with severe hepatic and renal impairment
4. Subjects with a history of drug abuse
5. Subject with positive results in HbsAg or HCV Ab or HIV Ab tests at screening visit
The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes

This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.

This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Couples undergoing ART with their own gametes.
* Couples having at least one good embryo available for transfer.
* Normoresponder
* Infertility etiology is unexplained
* ovulation triggered by intramuscular injection of 10000 IU of HCG

Exclusion Criteria:

Patients older than 38 years old

* High and poor responder patients
Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.

this is an observational, retrospective, multicentre study. The study is based on the retrospective collection of clinical data from patients undergoing gas tamponade vitrectomy for rhegmatogenous retinal detachment. The collection of such data by the investigators will take place at each participating center anonymously.

demographics, systemic, and preoperative, intraoperative and post-operative data will be collected The sample size was calculated to obtain approximately 200 patients with cystoid macular edema. Since cystoid macular edema has been detected in 13% of patients after retinal detachment gas vitrectomy, and assuming that this event can occur between 10% and 15% of cases, the study will include at least 2000 cases.

Eligibility Criteria:
Inclusion Criteria:

* primary rhegmatogenous retinal detachment treated with vitrectomy with gas tamponade;
* follow-up of 3 months or more;
* age \> 18 years ;
* no previous eye surgery, except cataract surgery performed at least 6 months after hospitalization for retinal detachment;
* anatomical success, i.e. retinal re-attachment, after a single gas vitrectomy;
* no other eye surgery during follow-up;
* availability of optical coherence tomography (OCT) imaging

Exclusion Criteria:

* history of other eye diseases (glaucoma, age-related macular degeneration, uveitis, diabetic retinopathy, maculopathy);
* macular hole;
* recurrent retinal detachment;
* use of silicone oil is used as a tamponading agent
Fascia Iliaca Blocks for Total Hip Arthroplasty

The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age at screening
* Scheduled for unilateral DAA THA
* American Society of Anesthesiologists (ASA) physical status 1, 2 or 3
* Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold
* Able to ambulate
* Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria:

* Previous open hip surgery
* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
* Contraindication to bupivacaine or morphine
* Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments
* Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
* Body weight \<40 kg (88 pounds) or a body mass index \>44 kg/m2
* Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments