cyrilzakka/clinical-trials huggingface dataset:
New Serological Markers for Eosinophilic Esophagitis

The purpose of the study is to investigate if serological parameters such as "extracellular Serum-Tryptase (ST)" and "eosinophilic cationic protein (ECP)" are useful for the diagnosis and surveillance of the eosinophilic esophagitis (EE).

The eosinophilic esophagitis (EE) is chronic inflammatory and immunological disease. The diagnosis of EE is based upon large numbers of eosinophils in the esophagus on histopathologic examination (\> 20 eosinophils per high powered field in at least one specimen) despite acid suppression with a Proton-Pump-Inhibitor (PPI) for at least two weeks.

There are no diagnostic serological markers for EE so far, so that the purpose of the study is to investigate serological markers which are established in other allergic diseases.

Eligibility Criteria:
Inclusion Criteria:

* histopathological defined eosinophilic esophagitis
* Age: 18-80

Exclusion Criteria:

* missing consent form
* contraindications for performing esophagogastroscopy/taking biopsies of the esophagus
Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure

This is a prospective, single-center, non-randomized, non-controlled observational study.

The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB).
* Underwent computed tomography (CT) reconstruction for assessment of axillary lymph node status before and after neoadjuvant chemotherapy (NAC).
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Contradiction for adjuvant chemotherapy.
* Contradiction for proceeding surgery.
Laparscopic Hernioplasty in Recurrent Inguinal Hernia

The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.

The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
* Patients between 18 and 70 years old
* Fit for anesthesia.
* Agree to participate in the study
* Both genders were included.

Exclusion Criteria:

* Unfitness for general anesthesia and operation.
* Age \< 18 years or \>70 years.
* Complicated hernias (acute irreducible, obstruction or strangulation).
* The presence of mental or psychological disorders.
* Refusal to participate in the study.
Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty

The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery

Investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary TJA with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.

Eligibility Criteria:
Inclusion Criteria

* Patient will be eligible for the study if they are scheduled for a primary TKA or THA with a BMI \>30 and \<40 kg/m2, or \>40 kg/m2
* Patients refusing bariatric surgery or having had prior bariatric surgery

Exclusion Criteria

* Patients will be ineligible to participate if they have any of the following:
* known topiramate or gabapentin allergy
* history of seizure disorder
* chronic opiate use pre-operatively
* history of nephrolithiasis
* history of acute angle closure glaucoma
* recurrent major depression
* presence or history of suicidal behavior or ideation with intent to act
* current substantial depressive symptoms (Patient Health Questionnaire total score \>10), pregnancy
* child-bearing potential and not on contraception
* age \<18 years
* major neurocognitive disorder
* metabolic acidosis
* incarcerated status
* bilateral surgery
Porphozym in the Treatment of Acute Attacks in AIP

A multi-centre, double-blind, randomized, placebo controlled, parallel group trial, investigating the efficacy and safety of Porphozym (recombinant human porphobilinogen deaminase)in the treatment of acute attacks in AIP.

The primary objective is: To investigate the biochemical efficacy on plasma porphobilinogen (PBG) of Porphozy(recombinant human porphobilinogen deaminase) in subjects with Acute Intermittent Porphyria (AIP) during an attack and the clinical efficacy clinical efficacy of Porphozym™, being the change in pain from baseline to 24 hours after start of treatment. The correlation between the biochemical and clinical efficacy is investigated as well. Further the safety of Porphozym™ is evaluated.

After a screening period lasting as short as possible subjects enrolled in the trial will be randomized to treatment with either Porphozym™ or placebo. Treatment is given over 48 hours. After end of treatment, the subject enters the observation period, which lasts until the discharge from the hospital. Subjects are followed up with visits 14 and 28 days after end of treatment. Additional safety follow-up will be performed 2, 4 and 6 months after end of treatment. At least 36 Subjects will be enrolled in the trial.

The trial drug,is supplied by Zymenex A/S, Denmark in vials for reconstitution in water for injections (WFI).

At start of treatment a bolus injection iv is given to decrease PBG levels ot zero. This is followed by continuous iv infusion of the enzyme over the following 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Confirmed diagnosis of AIP
* Previous attacks with PBG above the reference level of the laboratory AND exclusion of variegate porphyria (florescence emission of plasma samples is maximal at 626 nm in VP) AND exclusion of hereditary coproporphyria (HCP) (increased ratio of fecal coproporphyrin III to coproporphyrin I found in HCP)
* Acute attack of AIP verified by presence of abdominal and/or back and/or limb pain, diagnosed by the investigator as being caused by AIP
* Urine PBG above 6 mmol/mol creatinine (5 times upper reference level of the central laboratory)
* Male or female aged above 18 year

Exclusion criteria are:

* First acute attack in AIP
* Other reasons for abdominal and/or back and/or limb pain as judged by the investigator
* Therapy with human hemin within 7 days prior to administration of trial drug
* Treatment with any investigational drug within 4 weeks prior to this trial
* Known or suspected allergy to the trial product or related products
* Pregnant or breast-feeding women and women who intend to become pregnant prior to or during the trial
* Women of child-bearing potential who are not using acceptable methods of contraception (systemic contraception, IUD, barrier method or GnRH analogues)
* Previous documented renal impairment defined as above 150 mmol/L or 1.7 mg/dL serum creatinine, indicating a reduction in kidney function of 50% or more
* Any disease or condition that the investigator judges would interfere with the trial
* Previous randomization in this trial
FLACS in Pediatric Patients Using FEMTO LDV-Z8

This study is a single center prospective observational case series. The framework of this clinical investigation is post market clinical follow up of pediatric FLACS using the Femto LDV Z8. The intention is to investigate and supervise aspects particular to the pediatric use, and there is hence no alternative patient population.

Primary outcome Related adverse events at the time of surgery, ophthalmic adverse events at 1 week, 1 month, 6 months.

Secondary outcome Achieved vs aimed capsulotomy diameter

* Aimed diameter to be calculated using the Bochum formula
* Achieved diameter will be assessed using a ring caliper (Morcher 4.8 external diameter), (US patent MJ Tassignon)

During the recruitment period, the legal representatives of all patients (and when applicable the patients) at the study site who are eligible for pediatric cataract surgery and fulfilling the eligibility criteria will be informed about the study and offered participation. The aim is to include 12 participants during the recruitment period of 6 months. Inclusion criteria are on purpose chosen very broad, in order to collect data from all types of pediatric cataract surgeries.The majority of the participants will be very young children, who cannot be involved in the informed consent procedure. Participants will nevertheless receive the patient information in a way adapted to their age and mental maturity, from investigators or members of the investigating team who are experienced in working with children. The study procedure is cataract surgery performed with the FEMTO LDV Z8 femtosecond laser. In this clinical investigation the CE marked products (the Femto LDV™ femtosecond laser and the FEMTO LDV™ Surgical Laser Procedure Packs for Cataract Surgery) are used without deviations from the intended use and indication for use. Intraoperatively the achieved capsulotomy diameter will assessed using a ring caliper (Morcher 4.8 external diameter) and compared with the aimed diameter calculated using the Bochum formula. Patients will return for follow-up visits at 1 week, 1 month, 6 months after the surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age \< 18 years at the time of surgery
2. In case of bilateral cataract, only one eye will be included in the study
3. Informed consent of the legal representative of the patient (and as applicable, the patient) documented per signature
4. Planned cataract surgery
5. Accurate baseline biometric measurements
6. Assessed medical status
7. Full pupil dilatation is achieved using Cyclopentolate eye drops

Exclusion Criteria:

1. Eyes with microphthalmia of \< 9 mm diameter white to white
2. Hazy cornea
3. Pregnancy; girls of childbearing age will be tested for pregnancy with urinary analysis (hCG) at the time of inclusion.
Tolerance and Safety of an Oral Nutritional Supplement

This is an open label, non-randomized, interventional, single arm study.

Primary objective is to assess whether the MAG oil (monoacylglycerol oil) containing study formula is well tolerated and safe when used as an ONS in healthy adults and adolescents.

Secondary objectives:

1. Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms
2. Describe changes in stool characteristics, specifically stool frequency and consistency
3. Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
4. Describe changes in blood parameters of lipid metabolism
5. Describe changes in hematological and serum biochemistry parameters
6. Describe daily ONS intake and assess dietary adherence to the study protocol

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI range from \>18 to \<28 kg/m2 for adults with a minimum body weight of 45 kg
* BMI range between the 25th and 90th percentile according to the Swiss growth charts for adolescents with a minimum body weight of 40 kg
* Cohort 1: Adults aged 18+ years (6 males, 6 females)
* Cohort 2: Adolescents aged 12-17 years (6 males, 6 females)
* Deemed able to comply with study protocol for 2 weeks
* Able to obtain written informed consent from participants and /or legal guardians

Exclusion Criteria:

* Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician
* Subjects taking dietary supplements (energy supplements, protein supplements) will be excluded. Subjects can continue taking vitamin or herbal supplements during the study period.
* Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease (IBD), diverticular disease, colon cancer, irritable bowel syndrome (IBS), history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average, or chronic or recurrent diarrhea with loose or watery bowel movements more than 3 times daily.
* Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
* Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
* Prior use of prescription medication(s), in particular antibiotics, antacids, laxatives or other medications impacting gastrointestinal transit time, within 8 weeks prior to enrolment.
* Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
* Known food allergy in particular cow's milk protein allergy (CMPA) or known hypersensitivity/intolerance to any other ingredients in the study product.
* Known alcohol or substance abuse; specifically, alcohol intake \> 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
* Pregnant or lactating women or having given birth in the past 6 months prior to enrolment.
* Family or hierarchical relationships with Clinical Innovation Lab staff.
Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.


Eligibility Criteria:
Inclusion criteria:

* Has consented to participate in this study.
* Taking opioid therapy for persistent non-cancer pain.
* Has bowel dysfunction mainly due to opioids.
* Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
* Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
* Willing to report daily bowel symptoms.

Exclusion criteria:

* Pregnant, lactating, or planning to become pregnant.
* Not ambulatory.
* Participated in another trial with an investigational drug in the past 30 days.
* Taking opioids for the management of drug addiction or cancer-related pain.
* Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
* Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
* HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
Klinefelter Fertility Preservation

Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It appears scar tissue forms in these boys' testicles, leading to progressive destruction over their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm from these individuals, but these methods have a 50% failure rate in adult Klinefelter patients. Younger men have higher success rates, suggesting that adolescence and young adulthood may be the best time to extract sperm, but these techniques have not been studied in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way to predict which Klinefelter patients will have success with these methods and which of them will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range (12-25 years) that has never been studied, with the ultimate hope of improving the potential for fertility in these patients. The specific goals of this study are to determine the ideal age for sperm retrieval in Klinefelter patients and to establish factors that can be used to predict which of these patients will have a higher likelihood of success with advanced reproductive technology. The hypothesis is that younger Klinefelter patients will have higher sperm retrieval rates.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed 47,XXY (Klinefelter syndrome)
* 12-25 years of age

Exclusion Criteria:

* testosterone therapy within past 6 months
* history of surgery, injury, or infection in the testicle
* solitary testicle
Cadet Healthy Personal Skills Intervention Trial

The purpose of this study is to evaluate a new approach to sexual violence prevention by promoting healthy relationships and personal life skills among incoming Air Force cadets at the United States Air Force Academy.

National Health Promotion Associates (NHPA) adapted the Botvin Life Skills Training (LST) program for incoming fourth class cadets at the United States Air Force Academy (USAFA). The resulting adaptation, called Cadet Healthy Personal Skills (CHiPS), provides cadets with the knowledge, attitudes, and skills to enhance their personal resilience, increase their potential for success, help them develop healthy and rewarding personal relationships, and reduce sexual harassment and assault. The CHiPS program includes ten units, spread across three blocks of content, and each block teaches cadets a range of life skills. All incoming fourth class cadets (N=1,203) were invited to participate in this study, beginning in the Summer of 2017, and of those, 1,098 cadets (91.3%) consented to participate in the trial.Twenty-five facilitators were trained to implement the newly adapted CHiPS program. Half of the incoming class \[four Basic Cadet Training (BCT) squadrons\] was assigned to receive the intervention, while the other half (four BCT squadrons) continued to receive standard trainings already in place at USAFA. All cadets completed a self-report survey at pretest, posttest, and at a 12-month follow-up

Eligibility Criteria:
Inclusion Criteria:

* incoming cadet at USAFA

Exclusion Criteria:

* None
Nursing Care for Breathing Discomfort Among Mechanically Ventilated Patients

Breathing discomfort (dyspnea) during mechanical ventilation in the ICU may complicate care.

Patients on ventilators experience a variety of discomforts: symptoms (dyspnea ,fatigue , pain ) ,emotions (depression, anxiety ,panic) and feeling of lack to control .Patients may or may not express this discomfort outwardly with agitation ,restlessness ,grimacing or increase in the vital signs (heart rate ,blood pressure ,breathing frequency).The aim of the present study is to assess the prevalence of dyspnea among mechanically ventilated patients, Describe interventions that may alleviate breathing discomfort and examine its impact on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Intubated or tracheostomized patients who were mechanically ventilated for \>24 hrs.
* Age : 18-60 yrs
* Patients with Respiratory diseases
* Patients during spontaneous breathing trial

Exclusion Criteria:

* • Patients with acidosis, anemia ,drug poisoning,psychogenic disorders or neuro-muscular disorders

  * (non invasive ventilation)NIV
Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors. In usual PN, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

This RCT involves a 2 (group) by 2 (time) repeated measures design with experimental condition (specialized PN+cancer survivorship program over 6 months versus PN only (control condition) as the between-groups factor, and time-point (baseline pre-randomization and post-PN at 6 months follow-up) as the within-groups factor. This RCT involves 2 patient navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors. In usual PN, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

Eligibility Criteria:
Inclusion Criteria:

* report a primary diagnosis of breast cancer
* have completed primary treatment within the past 36 months
* evidence of verbal fluency in English or Spanish
* self-identify as HL

Exclusion Criteria

* evidence of metastatic disease
* current severe mental illness such as psychosis
* substance dependence within the past year
* active suicidality
* ongoing neo-adjuvant therapy
* unavailable for follow-up over the course of the study period
Protective Genetic Factors Against Neurological Diseases

NIH Precision Medicine Initiative, started in May 2018, will enroll one million people through an online portal. It hopes to identify genetic variants affecting a variety of human phenotypic outcomes. A giant set of data like this may enable an association of genetic variants with a certain phenotype. However, the association is often compromised due to the collection of phenotypic data that is not well controlled or standardized creating "noisy" data. These phenotypic "noises" can be largely eliminated in clinical studies with stringent criteria and standardization of outcome measurements.

In this study, by looking mainly at genetic information and nerve conduction speed, we hope to eliminate the extra "noises" in the data set. Eliminating the extra "noises" should allow us to be able to determine if there are genetic differences between neurological disorders and healthy controls, and if these genetic differences can be attributed to the speed of the nerve conduction.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a neurological disorder - Inherited Peripheral Neuropathy, Charcot Marie Tooth, Multiple Sclerosis, or Parkinson's Disease
2. Healthy volunteers with no history of medical conditions known to afflict the nervous system will be recruited as normal controls.
3. Age 18-100 (Inclusive)
4. Able to undergo MRI
5. Medically Stable

Exclusion Criteria:

1. Any subject unwilling to undergo genetic testing (DNA sampling)
2. Any subjects with history of peripheral nerve diseases or conditions known to affect the CNS, such as diabetes, stroke, thyroid disease, chemotherapy, renal failure, etc.

Note: This study holds no additional risk for pregnant women and they will not be excluded.