cyrilzakka/clinical-trials huggingface dataset:
Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis

Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.

This study will randomize patients with first episode of acute diverticulitis of the colon with extraluminal air and/or abscess as defined by CT scan following nonoperative management (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* older than or equal to 18
* history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol
* the diagnosis confirmed by colonoscopy
* Signed informed consent

Exclusion Criteria:

* Prior episode of diverticulitis
* Right sided diverticulitis
* Failure of recovery from first episode, defined as recurrence within one month.
* Cancer found at the site on screening colonoscopy
* Comorbidities prohibiting surgery (as measured by colorectal POSSUM score)
* Immunosuppressed patients
* Hinchey I, III, or IV (diverticulitis with peritonitis and/or free air under the diaphragm)
* Patients who are unable to sign the informed consent
The Effect of Progressive Relaxation Exercises on Sleep Quality and Fatigue in Postmenopausal Period

The population of the study will be postmenopausal women who applied to the KETEM unit of a hospital in western Turkey for examination. This study is a two-group randomized controlled study.

The population of the study will be postmenopausal women who applied to the KETEM Unit of a hospital in western Turkey for examination. This study is a two-group randomized controlled study. These groups will be the experimental group to which Progressive Relaxation Exercises (PGE) will be applied and the control group who will continue their routine habits regarding sleep and fatigue problems in the postmenopausal period. Minimum number of women to be assigned to groups in the study; determined by power analysis.

To our knowledge, a sample size of 90 participants was selected and alpha=0.05 was selected to achieve 80% power to detect the traditionally moderate W=0.30 (moderate effect) differences between study groups, as we know of, according to the literature review. 1988; Foul et al, 2007). As a result, it was found that 60 women in total, 30 women in the experimental group and 30 women in the control group, should be included in the study. However, considering the risks such as women leaving the job over time and not being able to reach women, 3 women for each group (10% of the sample) will be included in the study as substitutes and it is anticipated that the research will be completed with a total of 66 women.

In order to provide an equal number of samples in the experimental and control groups and to ensure that both groups are similar in terms of all factors, except for the PGE application whose effectiveness will be examined, those who experience high levels of fatigue (high scores on the Piper Fatigue Scale) and low sleep quality (Pittsburg Sleep Quality Index) Randomization will be made between those who score 5 or more on the scales) and those who are similar in terms of independent variables. Randomizer.org program will be used to determine the women in the experimental and control groups, by choosing the "random randomization method" in order to provide an equal number of samples in both groups.

At the end of the randomization, difference analyzes will be made between the women who will be assigned to the experimental and control groups in terms of sociodemographic, menopausal and PGE-related characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Being in the postmenopausal period,
* Agreeing to participate in the research,
* Being able to read and write,
* Those experiencing high levels of fatigue
* Women with poor sleep quality

Exclusion Criteria:

* Experiencing menopause due to surgery, pharmacological reasons,
* Not being willing to participate in the study,
* Presence of any communication problems,
* Being in premenopause and perimenopause period.
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders
* Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO，of which the degree is moderate to large RLS
* Subjects who have not responded to or cannot take common migraine preventive medications
* Willing to participate in follow-up visits

Additional Inclusion Criteria:

* Transcatheter closure group: Closure of PFO is performed
* Contrast group: Subjects who meet the Inclusion Criteria, but refuse to undergo closure procedure

Exclusion Criteria:

* Seizure disorder
* Other organic central nervous system disease
* Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury
* Evidence of alcohol, drug or substance abuse within the previous year

Additional Exclusion Criteria for Transcatheter closure group:

* Subjects with intracardiac thrombus or tumor
* Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
* Subjects with left ventricular aneurysm or akinesis
* Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
* Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
* Subjects with contraindication to aspirin or Clopidogrel therapy
* Pregnant or desire to become pregnant within the next year
Comparison of Two Psychotherapy Treatments for Depressed Women With a History of Sexual Abuse

This study will compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse.

Depression is a common but serious mental disorder that affects millions of people each year. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affecting people's sleep patterns, concentration, and energy levels. Women with a history of abuse are at an increased risk for developing symptoms of depression. However, treatments such as interpersonal psychotherapy and individual psychotherapy have been known to reduce symptoms of depression. This study will compare the effectiveness of individual and interpersonal psychotherapy in improving depressive symptoms and daily functioning in depressed women with a history of sexual abuse.

Participants in this study will undergo a two-part screening interview at the Strong Adult Ambulatory Clinic. This screening will include both written questionnaires and face-to-face interviews regarding any experiences of sexual or physical abuse; suicidal thoughts; family relationships; and current attitudes, thoughts, or feelings. Participants who meet all criteria will then be randomly assigned to receive one of two treatments: interpersonal psychotherapy or individual psychotherapy, which is considered usual care. All treatment sessions will be held at the Strong Adult Ambulatory Clinic. Participants assigned to receive interpersonal psychotherapy will attend weekly 50-minute sessions with a therapist. Interpersonal psychotherapy will focus on current interpersonal stressors in daily life, such as difficulties in close relationships or at work. Treatment will also help participants examine the relationship between their mood changes and interpersonal problems. Participants assigned to receive individual psychotherapy will undergo cognitive-behavioral therapy, supportive counseling, or a combination of the two. Participants will work with their therapists to decide upon a treatment plan designed to help changes in mood and other difficulties in daily life. The number and length of treatment sessions for this group will be determined on an individual basis. For all participants, evaluations consisting of questionnaires similar to those from the initial screening will be completed at mid-treatment, post-treatment, and 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for unipolar major depressive disorder
* History of childhood sexual abuse before the age of 18
* Seeking outpatient psychotherapy treatment in a community mental health center

Exclusion Criteria:

* Meets DSM-IV criteria for major depression with psychotic features, bipolar disorder, schizophrenia, or mental retardation
* Active alcohol or substance abuse within 3 months of study entry date
Appetite and Adiposity Across a Continuum of Activity

The purpose of this study is to understand what happens when someone either becomes more active or more inactive. This study will measure your energy intake, energy expenditure, and body composition under normal conditions, when you become active, and when you become inactive.


Eligibility Criteria:
Inclusion Criteria:

* Men and women

  * Age 25-35 yrs
  * BMI ≥25.0 to \<35.0 kg/m2
  * Subjective physical activity (pre run-in): Sedentary for the previous 3 months (\< 20min, 3 times/week of structured exercise)
  * Objective physical activity (run-in): daily steps/day \>4500 yet \<7,000 during 7 day run-in period
  * Weight-stable (± 5%) within the previous 3 months
  * Non-smoking for last year
  * Able to provide own transportation to study visits and intervention
  * Not currently involved in any other research study
  * Willing and able to participate in all aspects of the trial including research testing
  * Willing to give informed consent to participate
  * Able to participate in a moderate physical exercise program

Exclusion Criteria:

* Self-reported significant cardiovascular disease including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, myocardial infarction, stroke

  * Other self-reported medical conditions including but not limited to metabolic disorders such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease interfering with exercise, or any serious medical condition that may affect adherence to the protocol or exercising safely, or be aggravated by exercise
  * Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)
  * Excess caffeine use (\> 500mg/day)
  * Restrained eater (\>13) on the restraint section of the three-factor eating questionnaire
  * Current or past diagnosis of an eating disorder
  * Any self-reported contraindications to exercise according to the American College of Sports Medicine criteria
  * Pregnant or actively trying to become pregnant
  * Gave birth in the past 12 months or \<6 months post-lactation
  * Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
  * Known allergy to the metal nickel
  * Known allergies to pasta or tomato sauce
Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia

M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic effect of M0002 has a potential clinical benefit in the treatment of ascites and hyponatreamia in cirrhotic patients.


Eligibility Criteria:
Main Inclusion Criteria:

1. Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months.
2. Dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics.
3. Subjects had to have been on a salt restricted diet (\< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration.
4. Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
5. Child-Pugh B and C liver cirrhosis score lower than 12.
6. Subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1.

Main Exclusion Criteria:

1. Women of child bearing potential (WOCBP)
2. Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
3. Liver transplantation
4. Budd-Chiari syndrome
5. Unstable hepatic disease (acute hepatitis, AST or ALT \> 5 x upper limit of normal, bilirubin \> 10 mg/dL)
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

The aim of this study is to assess longer term safety and effectiveness of Dysport®.


Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
* Returned to pre-treatment status as judged by the Investigator

Exclusion Criteria:

* Pure anterocollis or pure retrocollis
* Known antibodies to botulinum toxin type A
* Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
* Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
Lens Wear Schedules and End-of-Day Comfort

The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has had an ocular examination in the last two years.
* Is an adapted soft contact lens wearer.
* Experiences a decrease in ocular comfort through a lens-wearing day.
* Has a current pair of spectacles.
* Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
* Has astigmatism less than or equal to -1.00 DC.
* Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has any ocular disease.
* Has a systemic condition that may affect a study outcome variable.
* Is using any systemic or topical medications that may affect ocular health.
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
* Other protocol-defined exclusion criteria may apply.
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy


Eligibility Criteria:
Inclusion Criteria:

* Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
* Have a positive CAC reaction at Visit 1
* Have a positive conjunctival inflammation score at Visit 1

Exclusion Criteria:

* May not use disallowed medications in specified washout period
* May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
* May not have active ocular infection
Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy

Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice.

Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy.

We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days.

We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.


Eligibility Criteria:
Inclusion Criteria:

* Age higher than 18
* Protocol directed deresucitation strategy with net ultrafiltration during continuous renal replacement therapy
* Bioelectrical impedance analysis available for the day of the initiation of the deresuscitation strategy and at day 5" -\> "At least two bioelectrical impedance analysis available during the first 5 days of the initiation of the deresuscitation strategy".

Exclusion Criteria:

* Left ventricular assist device
* Patient opposition to the use of his health data
* Invalid bioelectrical impedance analysis
* Advanced directives to withhold or withdraw life-sustaining treatment
Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.

iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood.

The investigators propose to conduct a prospective, single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology. The goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.

Initially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE + FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of MGUS in this population based on mass spectrometry screening.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical patients:

   * ≥18 years old;
   * have concurrent SPEP + SIFE + FLC test results.
2. Individuals undergoing routine physical examinations:

   * ≥30 years old;
   * have concurrent SPEP test results.

Exclusion Criteria:

* NA
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula

The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Eligibility Criteria:
Inclusion Criteria:

* Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
* Birth weight of ≥ 2,500 g and ≤ 4,500 g
* Postnatal age ≤ 11 days at time of enrollment
* Singleton
* Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
* Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, reporting of AEs, and urine collection)
* Caregiver willing and able to sign IRB approved informed consent

Exclusion Criteria:

* Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
* Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
* Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
* Infant receiving prescription medication
* Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
* Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development
* Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder
* Caregiver intent to feed non-study formula or solid food during the study