cyrilzakka/clinical-trials huggingface dataset:
Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.

Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.

Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnostic colonoscopy;
* Subjets able to provide informed consent

Exclusion Criteria:

* Prior partial or complete colectomy;
* Patients who decline to participate;
* Patients with poor bowel preparation;
* Contraindications of the colonoscopy
Bioavailability of Green Tea and Coffee Polyphenols

There is little information on the dietary intake, absorption, metabolism and bioavailability (degree to which a substance becomes available to the target tissues upon administration) of polyphenols (natural substances present in a variety of foods) in human participants.

This study assessed the bioavailability in healthy participants of polyphenols from 2 supplements containing green tea and green coffee extracts.

Eleven participants were recruited and their habitual diet was assessed to estimate polyphenol intake. After completing a 24-hour urine collection, participants were given six green tea extract and three green coffee extract tablets, which they took daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour urines were collected at 2, 4, 8 and 12 weeks.

Participants were required to attend HNR (medical laboratory) the day after each 24hour urine collection. At these visits, they were asked to bring along their urine collections, completed documents (urine collection sheet, checklist for tablet intake/side effects) and any remaining supplements, which were used to assess tablet compliance.

The investigators identified and quantified the amount of polyphenols in the supplement tablets as well as the amount of polyphenols and their metabolites in urine. The investigators then evaluated polyphenol bioavailability from the relationship between their dietary intake and urinary output.

Evidence from this research could inform future intervention studies by providing data on the bioavailability of green tea and coffee polyphenols, and on the individual differences related to phenolic intake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women.
* 18-45 years of age.
* BMI between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

* Smoking.
* Allergy or intolerance to intervention supplements.
* Chronic, acute or active inflammatory conditions, haematological disorders, or any other systemic illness of renal, hepatic or gastrointestinal origin.
* Major surgical operations in the gastrointestinal tract or medical treatment for gastrointestinal problems.
* Active cancer or diagnosis of malignancy within the last five years.
* Pregnant, lactating, contemplating pregnancy.
Safety and Efficacy of Xalkori ROS1

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.


Eligibility Criteria:
Inclusion Criteria:

* patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive

Exclusion Criteria:

* Patients with past history of hypersensitivity to any of the ingredients of XALKORI
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_VA Only

This study will examine the effects of psychotherapy as treatment for PTSD. This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will receive 8 weeks of group therapy in MBCT or MRT. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide a saliva sample. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.

Note: due to COVID precautions, treatment shifted from in-person to remote ("Zoom" videoconferencing)

Eligibility Criteria:
Inclusion Criteria:

* Meets current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for PTSD (with or without Major Depressive Disorder) or subsyndromal PTSD (qualifying trauma, and at least one intrusive, one avoidant, one negativity, and one arousal symptoms, and significant impairment or distress); type of trauma shall include interpersonal violence - combat, physical assault, sexual assault, etc.

Exclusion Criteria:

* Dissociative PTSD
* Delayed-onset PTSD
* Magnetic Resonance Imaging (MRI) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.)
* Serious medical or neurologic conditions (e.g. stroke, seizures)
* Suicide risk
* Psychosis
* Life history of schizophrenia
* Life history of bipolar disorder
* Current severe substance use disorder
* Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia Optimization Study

Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.

* Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles.
* Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points.
* Evaluate skin effects and adverse event rate.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female between 18 and 75 years of age
* Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
* Understanding of the clinical investigation, agree to cooperate with the investigational procedures and are willing to return for all the required follow-up visits.
* Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit
* Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment.
* Clinically diagnosis of typical sebaceous hyperplasia.
* Minimum of four SH lesions.
* Undergo all study procedures including consent for photographs of the treated SH sites.
* Agrees to refrain from using all other SH lesion removal products or treatments (topical medication including over-the-counter medications) during the study period.

Exclusion Criteria:

* Implantable electronic devices (i.e., pacemaker, implantable cardioverter defibrillator)
* Active infection or history of infection in designated test area within 90 days prior to first treatment.
* Not willing or able to sign the Informed Consent.
* Known to be immune-compromised.
* Known to be a keloid producer.
* Taking blood thinning medications.
* Insulin dependent, Type I diabetics.
* Allergies to Lidocaine or Lidocaine-like products.
* Employed by the sponsor, clinic site, or entity associated with the conduct of the study.
* Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
* Known prior inability to complete required study visits during treatment period.
* Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Phase 3 dose of indoximod in combination with pembrolizumab or nivolumab in subjects with unresectable or metastatic melanoma and evaluate PK. Subsequently the efficacy, safety and tolerability of indoximod plus pembrolizumab or nivolumab versus placebo plus pembrolizumab or nivolumab will be studied in subjects with unresectable or metastatic melanoma in the Phase 3 portion of the trial.

The phase 3 study will not proceed per Sponsor decision.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
* At least one radiologically measurable lesion as per RECIST 1.1
* Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
* ECOG performance status 0 or 1
* Ability to ingest oral medications

Exclusion Criteria:

* Has Ocular Melanoma
* Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.
* Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
* Has received prior radiotherapy within 2 weeks of therapy.
* Is pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
* Patients who have active, chronic, or on active treatment for Hep B or Hep C are excluded.
A Trial of SHR - 1906 in Healthy Subjects

This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight ≥ 45 kg.
4. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria:

1. History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.
2. Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial.
3. Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).
4. Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or \<60 mmHg on a single measurement
5. Positive urine drug screening at baseline;
6. Use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial.
7. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as having consented and used other investigational drugs (including placebo) or trial medical devices.
8. Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening.
9. Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
10. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.
Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study

Non-operative treatment of pelvic fractures is possible. Immobilisation implies different adjustment processes. Patients with pelvic ring fractures and partial weight bearing have to obtain theses. The aim of this pilot study was to prove the additional effect of the anti-gravity treadmill in patients with non-operatively treated pelvic fractures.

We prospectively included patients with non-operatively treated pelvic fractures as the intervention group (IG) and healthy volunteers of different age, sex and body mass index (BMI) as the reference group (RG).

Patients of the IG participated in a training session every three days with an anti-gravity treadmill (Picture 1, alterG®, www.alterg.com) for a total of 40 days in addition to physiotherapy, lymph drainage massage and manual therapy.

Patients were evaluated on three successive dates: Baseline (S1), after mobilization without crutches with full weight-bearing (20 days, S2) and after 40 days (S3)

Eligibility Criteria:
Inclusion Criteria:

* patients with non-operatively treated pelvic fractures

Exclusion Criteria:

* pregnancy, neuromuscular disorders, preexisting muscle atrophy
Nitrate Mouth Rinse and the Oral Microbiome

The study is aimed to determine if changes to the oral microbiome occur after the use of a nitrate rich mouth rinse. Participants with be asked to use either a controlled (water) mouthrinse once daily for 2 weeks while maintaining normal oral hygiene practices, or use the nitrate rich mouthrinse once daily for 2 weeks.

Primary Outcome measures:

-changes in the composition of the oral microbiome

Secondary Outcome measures

* Blood Pressure
* Salivary Nitric Oxide Levels

Nitrate is found in high concentrations in beet root, and as such we will use a beet root based product as a daily mouth rinse (Swish and Spit) as a part of the participants daily oral hygiene regimen and collect the participants biofilm before and after 2 weeks of regular use. We will then analyze the data using 16s rRNA sequencing to evaluate the changes in alpha diversity, beta diversity and the absolute and relative differential abundance of nitrate reducing bacteria in the oral microbiome. We will also collect salivary samples to evaluate NO levels, as well as measure blood pressure pre and post treatment.

After this study's completion, we expect to have gained new knowledge on nitrate's influence on the oral microbiome's composition. Gaining this knowledge will allow better public understanding of the effects oral hygiene products have on their oral and systemic health. In addition, the knowledge gained could encourage further investigations into how to better formulate oral hygiene products for improved health and performance.

Eligibility Criteria:
Inclusion Criteria:

* You are between the ages of 18 and 40. Have no uncontrolled systemic diseases.

Participants with mild chronic conditions such as:

* Asthma
* Type 1 Diabetes Mellitus

Exclusion Criteria:

* You are under the age of 18.
* You have uncontrolled systemic diseases, or acute infections.
* You are taking prescription, antibiotics, probiotics, or antimicrobial mouthrinses.
* You have a documented true allergy (i.e Hives, Swelling of lips/throat) Soy, Nuts, Seeds, Dairy, Egg products, Fish/Shellfish or Wheat.
* The presence of acute or chronic oral conditions including:

  * Herpes Simplex Virus (recent cold sores)
  * Stomatitis
  * Oral Lichen Planus
  * Angular Cheilitis
  * Candidiasis
  * Necrotizing Gingival Diseases
  * Other inflammatory or infectious pathologies
  * Active dental caries "cavities"
  * Any other periodontal diagnosis other than 'Healthy Periodontium' or localized gingivitis
Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus)

The acceptability of vulvar vibration therapy has been evaluated in women with vulvodynia, and found to be acceptable, however has not been assessed in women with a primary complaint of vaginismus.

This proposed study looks at the feasibility and acceptability of using clitoral vibration therapy, alongside current therapy, for women with vaginismus. It is likely that many, if not most, of these women will also have an element of vulvodynia. The investigators propose that the use of external clitoral or vulval vibration therapy is likely to be acceptable in most women with vaginismus, based on acceptability of vulvar vibration therapy in women with vulvodynia.

It is proposed that vibrator therapy may help women with female sexual dysfunction to use vaginal dilators.

This is a nonrandomized controlled trial, with the initial cluster of patients receiving standard therapy, and the second cluster receiving standard therapy plus vibrator. Recruitment will be an initial 15 participants who will receive standard therapy, and then another 15 who will receive an external vibrator.

This study will take place over approximately 12 months. Enrollment of patients will be from a joint psychosexual clinic led by a medical doctor and a clinical psychologist. Female patients are referred to this clinic by General Practitioners, from within the Sexual Health service, or via Gynaecologists, frequently with complaint of difficulty or pain with penetrative sex. Exclusion criteria will be: patients unable/ unwilling to consent, transgender male or on testosterone therapy, unable to understand written and/or verbal English, current dermtatological skin conditions requiring active treatment, genital herpes simplex virus within 3 months, or not reporting symptoms of vaginismus with no evidence of vaginismus on clinical examination.

Trial information will be given at the initial appointment. If the patient wishes to enrol, than an initial baseline questionnaire will be given, and a follow up questionnaire will be filled out by phone contact at 3-4 months afterward the initial consultation at the patients consent.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give informed consent (additional measures have to be in place if children, vulnerable adults or adults unable to give consent are included)
* Female
* Over the age of 18
* With symptoms and clinical signs consistent with vaginismus/ vaginismus and vulvodynia.

Exclusion Criteria:

* Unwilling or unable to give consent
* Transgender male / on testosterone therapy
* Inability to understand written and / or verbal English
* Current dermatological skin conditions requiring active treatment
* Genital herpes simplex virus symptoms within preceding 3 months
* Not reporting symptoms of vaginismus, and no evidence of vaginismus on clinical examination.
Retroviral Insertion Site Methodology Study

Adenosine deaminase (ADA) is an enzyme involved in the development and functioning of the immune system. Deficiency of ADA results in severe combined immunodeficiency (SCID), a fatal inherited immune disorder. Strimvelis is a gene therapy that aims to insert ADA function into blood cells and halt or reverse the conditions caused by decreased ADA enzyme levels, such as impaired immune function. It is important to consider long term follow-up of patients who have received Strimvelis, including evaluation of the risk of insertion near certain genes that may lead to unexpected activation of those genes (oncogenesis). The objective of this study is to evaluate the use of a new technique to identify where Strimvelis has become inserted in the genetic sequence, and potential implications for patient care. This new technique is known as sonication linker mediated polymerase chain reaction (SLiM-PCR) for retroviral insertion site (RIS) analysis. The study will recruit at least 15 pediatric or adult patients with ADA-SCID who have been treated with Strimvelis, either in previous clinical trials or as a registered product. Recruitment for the study may remain open for up to 2 years even if 15 subjects are recruited sooner. Study participation will last for up to 5 years. A total of 5 blood samples will be collected from each subject at approximately annual intervals.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, pediatric or adult, subjects with ADA-SCID, who have been previously treated with Strimvelis.
* Capable of giving signed informed consent or signed informed consent provided by the subject's parent or legal guardian.

Exclusion Criteria:

* Presence of concomitant condition(s) that in the Investigator's opinion makes participation in the study unsuitable or may prevent compliance with the protocol requirements.
* Unlikely to comply with the requirements of the protocol (i.e. attendance for blood sampling on an approximately annual basis).
* Transportation of viable samples to the European Union (EU) central laboratory from the subject's home country is not possible.