cyrilzakka/clinical-trials huggingface dataset:
Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Somatostatine is also known to decrease acid production with significant increase of intragastric pH. In this way, somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder emptying and decreasing acid secretion.

Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that cannot be controlled with classic therapy.

Patients presenting with persistent esophagitis on endoscopy while on proton pump inhibitors (PPI) treatment will receive a maximal therapy consisting of 2 x 40 mg of PPI before the meals (morning and evening) and a H2 blocker before bedtime (standard practice). They will be reevaluated endoscopically and clinically 2 months later (standard practice). If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study.

Lanreotide autogel 120 mg deep subcutaneously every 4 weeks will be added to the treatment. A total of 3 injections per patient have been foreseen in this proof of concept study.

Patients will be reevaluated clinically after 2, 4 and 8 weeks. At the end of the study a new upper gastrointestinal endoscopy and impedancemetry will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg (before breakfast and dinner) and 300 mg of H2 blocker ranitidine (at bedtime).

The Los Angeles classification (LA) will be used to evaluate endoscopic reflux. Any distal esophageal ulcer with negative biopsy is also diagnostic for reflux.

Persistent reflux is defined as:

No reflux complaints but continuing endoscopic lesions and positive impedancemetry.

Reflux complaints with continuing endoscopic lesions and positive impedancemetry.

Reflux complaints without endoscopic lesions but positive impedancemetry.

Exclusion Criteria:

* Pregnancy or inadequate anticonception, breast feeding.
* Negative impedancemetry.
* Diabetes.
* Placement of a gastric ring for weight loss.
Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice

There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously treated with Lenalidomide and Bortezomib, due to poor prognosis.

This observational study focuses on the collection of data concerning the safe and optimal usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage and efficacy will be performed.

This knowledge could lead to a optimization of Pomalidomide usage and treatment.

There is a high unmet medical need for further anti-myeloma therapy in patients with RRMM who have previously been treated with Lenalidomide and Bortezomib containing regimens that is both active and tolerable, as these patients have a poor prognosis. Hands-on experience with Pomalidomide is very limited in Austria and a non-interventional study enhances the attention paid to safe use and handling of the product as well as increase knowledge about optimal adverse event (AE) management substantially.

A detailed record of the medical history including. co-morbidities and pre-treatment regimens will allow analysis of the impact there of on tolerability, dosage and efficacy.

Beside the collection of data on efficacy and tolerability this observational drug utilization study could give insight into the clinical practice and the routine use of Pomalidomide.

Eligibility Criteria:
Inclusion Criteria:

* Signed IC
* age ≥ 18 years
* relapsed/refractory MM
* cohort A (combination pomalidomide und dexamethasone):

  ≥2 antimyeloma treatments (including lenalidomide and bortezomib), induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment
* cohort B (combination pomalidomide, bortezomib and dexamethasone):

  ≥1 antimyeloma treatments (including lenalidomide) induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment
* refractory to last antimyeloma treatment
* adequate contraception according to RMP
* adequate thrombosis prophylaxis

Exclusion Criteria:

1. Pregnant or Lactating Females
2. Known hypersensitivity to Imnovid
Medication Development in Alcoholism: Acamprosate Versus Naltrexone

The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.

This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 18 and ≤ 55 years of age
* Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence
* Does not desire treatment
* Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
* Able to complete and understand questionnaires and study procedures in English
* Verbal I.Q. estimate ≥ 85
* Signed informed consent

Exclusion Criteria:

* Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
* Significant medical disorders that will increase potential risk or interfere with study participation
* Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
* Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
* Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
* Liver function tests more than three times normal or elevated bilirubin
* No fixed domicile and/or no availability by telephone or beeper
* Current involvement in or plans for treatment prior to study completion
* Patients who have a history of adverse drug reactions to the study drugs or their ingredients
* Failure to take double-blind medication as prescribed
* Inability to understand or comply with the provisions of the protocol or consent form
Microtransplantation in Older Patients With Acute Myeloid Leukemia

The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.


Eligibility Criteria:
Inclusion Criteria:

* de novo acute myeloid leukemia
* age 60-90
* have HLA mismatched donor

Exclusion Criteria:

* have no suitable donor or donor refused
* patient refused to accept donor cells
ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.

The ILMA Fastrach™ is a widely accepted and intensively investigated supraglottic airway device that is inserted blindly. It may be used to facilitate intubation and secure the airway in routine practice, in difficult airway scenarios or in emergency situations. Endotracheal tube insertion may be blind or fiberoptic scope guided, the latter raises the success rate. The i-gel™ is a newly developed supraglottic airway device and is also introduced blindly. Insertion of an endotracheal tube may be blind or fiberoptically guided.

So far, prospective randomized controlled trials comparing their performance are not yet published. There are case reports about intubating over the i-gel.

In this prospective, randomized, controlled trial, we are going to evaluate the performance of intubation through both devices. In 250 patients undergoing elective surgery, we will place either the ILMA or the i-gel according to randomization and then intubate with the help of a fiberoptic scope, using the specific ILMA tracheal tube or a normal tracheal tube for the i-gel. In order to remove the supraglottic airway devices, we will use the ILMA stabilizer rod.

Eligibility Criteria:
Inclusion Criteria:

* elective operation with intubation
* ASA I-IV
* speaks German
* at least one predictor for difficult intubation

Exclusion Criteria:

* weight \<30kg
* Risk Aspiration
* Risk bleeding orally
* known or highly suspected difficult mask ventilation
* Mouth opening \< 20mm
Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

Outcome measures

1. MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
2. Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 1-3 years
2. no diarrhea-related symptoms
3. the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
4. the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
5. parent or guardian signed informed consent (6）Not used in children with related traditional Chinese medicine injection

Exclusion Criteria:

1. diarrhea in the group, or 2 weeks before admission into children with diarrhea
2. children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
3. receiving immunosuppressive agents in children
4. Children who received any probiotic preparation 2 weeks before enrollment
Endometriosis Group Care

The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain. The main question\[s\] it aims to answer are:

* Is PEEPS effective at decreasing pain interference and improving patient-reported quality of life outcomes?
* What are the barriers and facilitators to PEEPS implementation? Participants will engage in eight weekly 2-hour sessions led by an endometriosis specialist, pain psychologist, pelvic floor physical therapist, and yoga instructor. At these sessions they will participate in peer support, education, mindfulness, and yoga.

This is an 8 week interdisciplinary, integrative group care program conducted through the Department of Obstetrics and Gynecology (OB/GYN) at Washington University in St. Louis (WUSTL). The program, called PEEPS, incorporates mindfulness, physical therapy, yoga, physical activity, nutrition, and education. Additionally, PEEPS will provide peer support and demonstrate investment of individual clinicians and the healthcare system.

The program focuses on equipping participants with pain management and coping skills so they have an expanded toolkit to manage their pain after completing the program.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-48 years
* Operative confirmation of endometriosis
* Chronic pelvic pain (defined as pain perceived to originate from the pelvis, lasting ≥6 months)
* No plan to have surgery in next 12 weeks
* Be able to attend eight 2-hour weekly sessions on the Washington University campus

Exclusion Criteria:

* Non-English speaking
* Currently pregnant
* Severe physical impairment
* History of hip or spine surgery
* Opioid use ≥ 5 days in the past 3 months, other than for the 6-week post-operative period
* Current or history of psychiatric disorder with psychosis
* Vulvadynia or vaginismus
Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

1. Background and rationale It is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain.
2. Trial objectives and Design 2.1 Trial objectives With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

   2.2 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain.

   2.3 Secondary endpoints A possible correlation between the resected volume and the severity of the pain.
3. Selection and withdrawal of subjects

3.1 Inclusion criteria

* All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
* Age between 14 and 50 years old
* Women of child bearing age can be included: the study has no effect on their methods of contraception.

3.2 Exclusion criteria

* A history of a tibia plateau fracture or severe deformity of the knee
* Rupture of the ACL/PCL/collateral ligaments of the knee
* Focal cartilage defects of the knee

Eligibility Criteria:
Inclusion Criteria:

* All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
* Age between 14 and 60 years old
* Women of child bearing age can be included: the study has no effect on their methods of contraception.

Exclusion Criteria:

* A history of a tibia plateau fracture or severe deformity of the knee
* Rupture of the ACL/PCL/collateral ligaments of the knee
* Focal cartilage defects of the knee
Youth Mayo Clinic Anxiety Coach Pilot Study

This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.

This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting. Therapist will provide CBT to patients with infrequent face-to-face contact and then will examine the acceptability, ease of use and need for contact.

Eligibility Criteria:
Inclusion Criteria:

1. Age 7 to 17
2. Primary diagnosis of:

   1. social phobia,
   2. separation anxiety disorder,
   3. panic disorder with and without agoraphobia,
   4. specific phobia, or
   5. obsessive compulsive disorder
3. A parent or other primary care giver available to participate with the child in all assessment and treatment activities
4. Estimated average intelligence
5. English speaking

Exclusion Criteria:

1. History of and/or current diagnosis of:

   1. psychosis,
   2. autism,
   3. bipolar disorder,
   4. mental retardation,
   5. oppositional defiant disorder,
   6. PTSD,
   7. selective mutism, or
   8. major depressive disorder
2. Current suicidality or recent suicidal behavior
3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
4. Starting or changing the dosage of a psychiatric medication in the last two months
Quality Control of CE-Certified Phonak Hearing Aids - 2020_26

Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Eligibility Criteria:
Inclusion Criteria:

* Hearing Loss range: N3-N4
* experienced hearing aid user
* willingness to wear behind the ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* the audiogram is not in the fitting range of the intended hearing aid
* first time user
* limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* participant is not able to describe experiences and hearing impressions
* allergies against the material of the hearing aid
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers

This is a single center, double blinded, randomized, controlled trial. Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.

The objective of this study is to comparatively evaluate the effects of Colgate Total® toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed. Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will be assessed at baseline and after 2, 6 and 12 months of product use. Peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).

Eligibility Criteria:
Inclusion Criteria:

1. Subject males or females 18 to 50 years old.
2. Availability for the 12 months duration of the clinical research study.
3. Subject able and willing to follow study procedures and instructions.
4. Subject read, understood and signed an informed consent form.
5. Subject present with at least 20 natural teeth in the functional dentition (excluding third molars).
6. Initial probing pocket depth of \>4mm in at least one tooth/quadrant.
7. Good general health.
8. Subjects willing to disclose information on medication.

Exclusion Criteria:

1. Subject with concomitant periodontal therapy 6 months prior to enrollment.
2. Subject with orthodontic appliances.
3. Subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination\*.
4. Subject treated with antibiotics within 3 months prior to enrollment.
5. Subject necessitating antibiotic prophylaxis.
6. Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator\*.
7. Subject with known allergy to oral care products or ingredients in oral care products.
8. Subject with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity (determined by the examiner).
9. Subject diagnosed with aggressive periodontitis or acute necrotizing ulcerative gingivitis.
10. Participation in any other clinical study or test panel within the one month prior to entry into the study.
11. Subject pregnant at point of enrollment.