cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Termination of Pregnancy and Psychiatric Implications

25 parental couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before TToP and after one year from the procedure. Women and unborn's fathers were also subjected to different psychometric questionnaires (HAM-D, HAM-A, BDI-II, PCL-5, IPDS, CTQ, CD-RISC-10).

The therapeutic interruption of pregnancy (TTOP) may have psychiatric outcomes like depression, anxiety and post-traumatic stress disorder (PTSD). Personality issues, childhood traumas and paternal consequences are too little investigated in current Literature.

The investigator's aim is exploring the contribution of maternal personality disorders and maternal history of childhood traumas to psychiatric outcomes after a TToP, paternal psychiatric outcomes and their role on their partner's psychopathological and psychiatric outcomes.

25 couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before TToP and after one year from the procedure. Women and unborn's fathers were also subjected to different psychometric questionnaires (HAM-D, HAM-A, BDI-II, PCL-5, IPDS, CTQ, CD-RISC-10).

At the time of first contact (T0) only women were subjected to a psychiatric clinical examination in order to evaluate their legal eligibility to TToP, according to Italian Law n. 194/78. At T0 women were also subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) the parental couples were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF).

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Prenatal diagnosis of fetal abnormality
* Adequate comprehension
* Legal eligibility to TToP procedure after psychiatric clinical evaluation
* Acceptance on a voluntary basis

Exclusion Criteria:

* Incapacity
* Acute psychosis
A Study of TopSpin360 Training Device

This research is being done to investigate the novel neck strengthening device, TopSpin360 and its effectiveness on measures of neck strength and cognitive function.

The neck plays a very important role in head positioning, stabilization, and decrease risk and severity. Neck extension strength measure has been associated with a decrease in concussion risk in male rugby players. Neck muscle characteristics may play a vital role in mitigating head accelerations due to contact thus reducing head impact severity. We hypothesize enhanced neuromuscular characteristics of cervical muscles will decrease brain impairments due to repeated contact.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English Speaker.
* Medically cleared to play ice hockey.

Exclusion Criteria:

* Clinically documented hearing issues.
* In-ear hearing aid or cochlear implant.
* Implanted pacemaker or defibrillator.
* Metal or plastic implants in skull. lack of verbal fluency in the English language.
* History of seizures.
* Allergy to rubbing alcohol or EEG gel.
Pilot Study of NASHA/Dx Gel for Fecal Incontinence

The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.


Eligibility Criteria:
Inclusion Criteria:

1. Fecal incontinence with at least 2 episodes/week
2. Symptom duration at least one year
3. Failed attempt of conservative therapy
4. Age 18-80
5. Written informed consent
6. Available for follow-up
7. Fully compliant with protocol

Exclusion Criteria:

1. Active inflammatory bowel disease
2. Total external sphincter defect at ultrasound and clinical examination
3. Bleeding diathesis or anticoagulant therapy
4. Rectal prolapse or intussusceptions
5. Present anal sepsis
6. Anorectal implants
7. Recent anorectal surgery (within 6 months)
8. Rectal anastomosis
9. Pregnancy, postpartum (one year) or breast feeding
Clinical Trial Preference Study

Population subgroups experiencing health disparities are often also underrepresented in clinical trials. These groups include individuals from minoritized racial and ethnic groups, people from lower socioeconomic backgrounds, and men or women, depending on the study area. Identifying approaches to reduce health disparities will remain stalled until clinical trials can recruit and retain diverse clinical trial participants. To improve recruitment across studies, there is a need to understand how diverse populations view specific clinical trial attributes that could be manipulated to increase interest in trials. To address this need, this project will use a discrete choice experiment to identify and prioritize specific trial attributes under investigators' control that could be leveraged to enhance clinical trial participation rates in underrepresented groups. This project will evaluate participants' preferences of 1) return of full versus limited results to participants, 2) balancing a study's participant burden with its ability to address multiple research aims, 3) incentivizing clinical assessments vs. conducting homebased assessments, and 4) results generalizable to specific social groups versus the broader population. This experiment will be conducted with a sample of potential clinical trial participants (N = 800) that is diverse in terms of self-reported gender, racial and ethnic identity, education, and chronic disease status. The results of this study will be used to design a randomized comparison of enhanced clinical trial attributes across multiple health conditions to evaluate whether using the enhanced trial features can more efficiently recruit underrepresented participants into clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Internet access with audio and visual capabilities
* Reside within the United States
* Read and speak English

Exclusion Criteria:

* Under 18 years of age
* No internet access
* Reside outside of the United States
* Do not read and speak English
Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study

This research will enhance our knowledge and understanding of Cerebrospinal Fluid (CSF) circulation around the Central Nervous System (CNS) (brain and spinal cord).

The main objective is to obtain flow velocities using Phase Contrast (PC) MRI over the entire subarachnoid space (SAS). This will enable us to develop and validate a numerical model of the SAS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of agreement
* Free subject, without guardianship or curatorship or subordination
* Patients benefiting from a Social Security scheme or benefiting from it through a third party
* Informed consent signed by the patient after clear and complete information about the study

Exclusion Criteria:

* 3T MRI contraindications (pacemaker, cochlear implant, metallic splinter, etc)
* History of neurological pathology
* Previous operations involving the central nervous system (spinal surgery, neurological surgery, etc.)
* Current pathology or treatment that may interfere with the CSF or subarachnoid spaces (CSF dysregulation, disc herniation, hydrocephalus, Chiari malformation, etc.)
* Concurrent participation in another clinical research study
* Persons not covered by Social Security or not covered by Social Security through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)

Exclusion criteria during the study:

- Discovery of a contraindication to 3T MRI (pacemaker, cochlear implant, metallic splinter, etc)
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients

The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.

1. Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients.

   Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients
2. Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
3. The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients

All end points will be evaluated within 4 months from end of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age and above

  * Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months :

    * Colonoscopy
    * Capsule endoscopy of the small bowel or colon
    * Other radiology tests
    * Clinical symptoms with elevated positive inflammatory markers ;ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin
  * Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
  * Subject is able and agrees to sign the Informed Consent Form

Exclusion Criteria:

* • Subject has dysphagia

  * Subject has congestive heart failure
  * Subject has renal insufficiency
  * Subject has cirrhosis
  * Subject is known or is suspected to suffer from intestinal obstruction
  * Subject has known previous stricture/obstruction of the SB or colon
  * Chronic use of laxatives
  * Subject has a cardiac pacemaker or other implanted electro medical device.
  * Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  * Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  * Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
  * Subject has any condition, which precludes compliance with study and/or device instructions.
  * Subject suffers from life threatening conditions
  * Subject is currently participating in another clinical study
  * Subject has known slow gastric emptying time or GI transit time.
  * Subject is allergic or contraindicated to any of the study medications
Maintenance Therapy of Narrow-band UV-B Therapy in Patients With Vitiligo

Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy.

The aim of this study was to evaluate the efficacy of Narrow-band UV-B therapy for the prevention of relapse in vitiligo.

For a total period of 12 months, perform Narrow-band UV-B treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.

An independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age of 19 years or older
2. Patients of generalized vitiligo with lesions on the trunk
3. Patients who had treated with Narrow-band UV-B therapy previously and achieved more than 75% lesion improvement
4. Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

1. Patients under the age of 19
2. Patients with localized vitiligo and segmental vitiligo
3. Patients who are in a state of physical or mental impairment to perform treatment or pregnant
4. Patients with spreading of vitiligo lesions
5. Patients who do not want to do thie study or who refuse to write a consent form
6. Any other person deemed unsuitable for the examination at the discretion of the examiner
Mediterranean Diet and Bacterial Translocation and Immune-activation in Patients With HIV

Evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4\> 500cells/ml.

Mediterranean diet supplemented by nuts and extra virgin olive oil has shown to reduce mortality, cardiovascular diseases, and breast cancer in HIV uninfected individuals. It is likely that changes in the microbiome could play a role in this effect. The goal of the study is to evaluate if a change to a Mediterranean diet supplemented with nuts and olive oil decreases bacterial translocation and immune activation by a change in the microbiome in successfully treated HIV-1 infected patients with CD4\> 500cells/ml. One hundred and two patients who will be randomized to continues usual diet or to a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months. Throughout the study a specialized dietician will monitor the patients. Blood samples will be collected to assess parameters of bacterial translocation, inflammation and immune activation. To assess compliances with diet, urine samples will be collected too, and stool samples to study changes in gut microbiota. All the samples will be collected at the beginning and 90 days after the inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age;
* To sign voluntary informed consent;
* Male or female patients with a negative pregnancy test before inclusion in the study;
* Proven HIV infection (with HIV-1 positive antibodies);
* Patient should be on stable treatment with cART for at least 1 year
* The mean of all CD4 measurements during the year prior to the initiation of cART should be equal to greater than 350 cells / mm3
* The number of CD4 + at the time of recruitment must be equal to or greater than 500 cells / mm3;
* HIV viral load should be undetectable at least 6 months prior to study inclusion, and less determinations (occasional blips above the undetectable level are allowed).

Exclusion Criteria:

* Acquired Immunodeficiency Syndrome.
* Active opportunistic diseases.
* Patients coinfected with HCV or HBV
* Coagulopathy
* Renal insufficiency (creatinine\> 1.5 mg / dL)
* Pregnancy or breastfeeding
* Inability to sign informed consent
* Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
* Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gammaglobulins or chemotherapy within 90 days prior to the screening visit;
* Use of anticoagulant medication;
* Use of any type of experimental medication during the 90 days prior to study entry;
* Uncontrolled psychiatric disorder;
* Patients with uncontrolled active autoimmune diseases;
* Usual use of antibiotics
Buprenorphine and Naloxone Combination Study - 10

The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Eligibility Criteria:
Inclusion Criteria:

Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.

Exclusion Criteria:

LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.
Percutaneous Deep Vein Arterialization Post-Market Study

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be \> 21 and \< 95 years of age
* Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
* Assessment that no conventional surgical or endovascular treatment is possible
* Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed
* Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits

Exclusion Criteria:

* Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
* Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
* Life expectancy less than 12 months
* Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
* Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
* Patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment
* Patient unable to give consent
* Pregnant or breastfeeding women
* Documented myocardial infarction or stroke within previous 90 days
* Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
* Patients with vasculitis and/or untreated popliteal aneurysms
* Patients with acute limb ischemia
* Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
* Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
* Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
* Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
* Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of \< 40%, NYHA Classification III-IV)
Luteal Phase Administration of Paroxetine for the Treatment of PMDD

The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric disorder has been established. We proposed to test the hypothesis that intermittent treatment with paroxetine administered during the luteal phase of the menstrual cycle only is more effective than placebo in improving symptoms of PMDD. This was a double-blind, placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women 18 years of age or older who met criteria for inclusion in the study were randomized to one of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine 20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of intermittent treatment of paroxetine in women with PMDD.


Eligibility Criteria:
Inclusion Criteria:

* PMDD according to DSM-IV criteria

Exclusion Criteria:

* Women were excluded if they were taking oral contraception, breast-feeding, pregnant, or planning to become pregnant during the study period.
* Women were also excluded if they met DSM-IV criteria for any Axis I disorder, were deemed a suicidal risk, had a history of SSRI use for premenstrual symptoms, were taking ongoing medication that could affect PMDD symptoms, had a clinically significant abnormality on screening blood tests, or had a baseline Montgomery-Asberg Depression Rating Scale score of equal to or greater than 10 during the follicular phase of the menstrual cycle.
Expression of TIM-3 on Lymphocytes in Sepsis

The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe sepsis
* patients undergo invasive spine surgery
* healthy volunteers

Exclusion Criteria:

* patients with immunodeficient diseases
* patients who accept glucocorticoid or immunosuppressant
* patients with an age older than 18 years
* patients providing the informed consent