cyrilzakka/clinical-trials huggingface dataset:
Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN).

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN). The study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. Once enrolled, patients will be randomized to undergo treatment using either the Da Vinci Xi platform (Intuitive Surgical) or the HUGO™ RAS platform (Medtronic) according to block randomization.

Patients with prostate cancer (Group A), enrolled according to inclusion criteria, will be randomized to undergo RP treatment with the Da Vinci Xi platform (control group) or RP treatment with the HUGO™ RAS platform (study group).

Patients with kidney cancer (Group B), enrolled according to inclusion criteria, will be randomized to undergo PN treatment with the Da Vinci Xi platform or PN treatment with the HUGO™ RAS platform.

If the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the HUGO RAS platform prove to be equivalent to those obtained with the Da Vinci Xi platform, it should lead to a progressive increase in the use of the HUGO RAS platform, resulting in a reduction in the overall costs associated with robotic urological surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients with Prostate Cancer (Group A)

* Age ≥ 18 years.
* Life expectancy greater than 10 years.
* Diagnosis of prostate cancer following prostate needle biopsy.
* Clinical stage cT1-T3b, N0-1 disease.
* Positive anesthetic fitness assessment for robot-assisted radical prostatectomy.
* Provision of informed consent for the study.

Patients with Kidney Cancer (Group B)

* Age ≥ 18 years.
* Radiological diagnosis of organ-confined kidney cancer at clinical stage T1a or T1b.
* Underwent CT and/or MRI of the abdomen with contrast medium.
* Positive anesthetic fitness assessment for robot-assisted partial nephrectomy.
* Provision of informed consent for the study.

Exclusion Criteria:

Patients with Prostate Cancer (Group A)

* Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
* Metastatic prostate cancer (M1).
* Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

Patients with Kidney Cancer (Group B)

* Indication for radical nephrectomy.
* Metastatic kidney cancer (M1).
* Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.
Faecal Bacteriotherapy for Ulcerative Colitis

The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent.

The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.


Eligibility Criteria:
Inclusion Criteria:

* Left-sided ulcerative colitis \> 15cm ongoing more than 3 month
* Mayo score \< 10
* Endoscopic Mayo score ≥ 2

Exclusion Criteria:

* Anti-TNF medication in the previous 6 months
* Cyclosporine in the previous 4 weeks
* Methotrexate in the previous 2 months
* Prednisone \> 10mg
* The real risk of colectomy in the near future
* Positive stool culture (Salmonella, Shigella, Yersinia, Campylobacter, pathogenic E. coli)
* CMV infection
* Pregnancy, breastfeeding women
Effect of Functional Assessment and Immediate Rehabilitation of ED Admitted Elderly With Reduced Functional Performance

Background: Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.

The aim of this study is to investigate the effect of a systematic functional assessment in the emergency departments (ED) of elderly medical patients with reduced functional performance when combined with immediate post-discharge rehabilitation.

Method/design: The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: 1) functional assessment and immediate rehabilitation; 2) functional assessment and usual rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and usual rehabilitation.

Primary outcome: 30-second chair-stand test administered at admission and two weeks after discharge.

We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in sustained or improved performance in comparison to regimen in which neither of these interventions are offered.


Eligibility Criteria:
Inclusion Criteria:

* medical patients of 65 years of age or older admitted to the ED
* Can speak and understand Danish
* Resident in either of the two included municipalities
* Can report personal data and decide on consent
* Are able to sit on an chair and perform ≤ 9 repetitions at the 30-s. chair-stand test

Exclusion Criteria:

* Patients suffering from a progressive neurological or cognitive deficit or disease.
* Patients ordinarily unable to walk
TOcilizumab and Covid-19 : Risk of Severe INfection

SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18 months. The virus' capacity for dissemination and its virulence are responsible for significant morbidity and mortality. The initial lack of knowledge of the pathogen and of the pathophysiology underlying the potential severity of the disease, particularly in the respiratory tract, led to numerous therapeutic attempts in this emergency context, centered on the control of an obviously exaggerated inflammatory response. A large number of studies remained of insufficient quality to lead to relevant and applicable conclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in two trials. Although Dexamethasone remains the only corticosteroid to improve survival, these results have reinforced the hypothesis of the interest of treatments reducing the inflammatory response, particularly cytokine. The widespread use, in the absence of scientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) has been structured around studies whose results remain uncertain to this day because of the heterogeneity of the population treated and the results observed. A possible survival benefit seems to emerge for resuscitation patients who have not yet required invasive ventilation, the other situations being probably associated with the absence of effect or even the potential danger of this treatment. Tocilizumab is notably associated in the literature with the risk of secondary infections and mucosal healing abnormalities, favoring bleeding complications and digestive perforations. The objective of this study is to evaluate the risk of digestive complications (hemorrhage, perforation, diverticulitis) and infectious complications related to the use of Tocilizumab according to the severity of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* French-speaking patient
* Patient with COVID-19 documented by PCR test or chest CT scan

Exclusion Criteria:

* No confirmation of suspected COVID-19
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his/her data for this research
Heparin Solution and INTEM/HEPTEM Analysis

Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management.

Exclusion Criteria:

* heparin hypersensitivity
* hematologic disease
* anticoagulant medication
The COMBAT HBV Feasibility Trial

This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC). HBV-infected pregnant women will be randomized to either receive tenofovir or placebo beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Women will be followed every 4-6 weeks throughout the prenatal and postpartum period to evaluate for side effects related to the medication. Infants will receive a birth-dose of HBV vaccine, ideally within 24 hours. Participants will be followed longitudinally through 6 months' postpartum.

The overall study design is a randomized, double-blind, placebo-controlled trial among two groups of mother-infant dyads: women who receive TDF vs placebo in late pregnancy and the postpartum period (beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum). While official World Health Organization (WHO) recommendations are to continue TDF at least through delivery, a range from delivery through 12 weeks' postpartum is possible; the investigators will continue therapy through 4 weeks' postpartum in this study. This feasibility trial will evaluate the acceptability, safety and preliminary effectiveness of a TDF-for-all approach to prevent MTCT of HBV in low-resource settings. HBsAg-positive pregnant women will be enrolled at 28-32 weeks' gestation, and will present for regular medication checks, with a study closeout visit at 24 weeks' postpartum. Study activities at monthly medication checks will include medication refills, assessment of adherence (via pill counts and verbal surveys), and evaluation for side effects. All infants will receive a birth-dose of HBV vaccine within 24 hours of life. MTCT of HBV will be defined as the proportion of infants with positive HBsAg testing at 6 months. This pilot study will provide preliminary data for sample size calculations, including safety and effectiveness data, to prepare for larger RCTs to determine the effectiveness of a tenofovir-for-all approach, as well as the added benefit of tenofovir over birth-dose vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥18 years of age who present for routine prenatal care between 28-32 weeks' gestation and who test HBV-positive by point-of-care hepatitis B surface antigen test. Women must intend to seek maternity and postpartum care exclusively at one of the Kinshasa-based study maternity centers.
* Infants born to enrolled women will be included in the study

Exclusion Criteria:

* Individuals with abnormal creatinine by point-of-care testing
* Any woman who plans to move outside of Kinshasa Province during the study period.
* Any HIV-positive individual, determined by routine point-of-care screening at antenatal care visits
Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation

Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.

We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.

Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness

Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Breast feeding
* Prior history of surgical large bowel resection
* Severe medical condition such as severe cardiac
* Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
* Drug addiction or major psychiatric illness
* Suspected bowel obstruction or ileus
* Allergy to PEG
* Refusal of consent to participate in the study.
A Study of Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES)

This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in combination with first-line chemotherapy. Second-line metastatic CRC patients are also eligible. Patients who started their Avastin containing therapy \<4 months prior to enrollment are eligible.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology)
* Eligible for Avastin as a component of intended therapy
* First-line chemotherapy (or second-line chemotherapy for CRC) plus Avastin initiated ≤ 4 months prior to study enrollment

Exclusion Criteria:

* Any medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to provide informed consent or comply with the treatment and follow-up, as specified by the investigator
* Enrollment in a blinded, placebo-controlled bevacizumab trial
Biological Standardization of Lolium Perenne Allergen Extract

The objective of this study is to determine the biologic activity of a Lolium perenne allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Four concentrations of Lolium perenne allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
* Subject can be male or female of any race and ethnic group.
* Age \> 18 years and \< 50 years at the study inclusion day.
* Positive skin prick test with a standardized commercially available preparation of Lolium perenne allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
* A positive test for specific IgE to Lolium perenne (CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
* Allergic symptoms during the pollen season of Lolium perenne.
* Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

Exclusion Criteria:

* Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).
* Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
* Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent).
* Pregnancy.
* Dermographism affecting the skin area at the test site at either study visit.
* Atopic dermatitis affecting the skin area at the test site at either study visit.
* Urticaria affecting the skin area at the test site at either study visit.
* Participation in another clinical trial within the last month.
Trauma and Truth Interventions (NET) Versus Conflict Resolution and Social Skills Trainings for Vulnerable Youths in Northern Uganda

More than 300,000 children are fighting in armed conflicts all over the world. In Uganda an estimated number of 25,000 children have been abducted and forced to fight or work as porters and sex slaves on the side of the rebels during the conflict between the Lord's Resistance Army (LRA) and the Ugandan government. Each year, thousands of former child soldiers have returned to their communities after they had fled or were freed from the rebels. It is well known that a high percentage of these youths are suffering from mental health problems. This could be one of the possible reasons why they are facing difficulties to reintegrate into their communities.

The main aim of the proposed project is two-fold. On the one hand, the investigators want to systematically explore the relationship between mental health and important variables for reintegration into the communities like aggression, hostility, feelings of revenge, compromises and conflict behaviour and readiness for reconciliation in formerly abducted and other vulnerable youth (orphans, child mothers and handicapped youths) in Northern Uganda. On the other hand, the investigators want to probe the efficacy of existing and newly developed interventions for formerly abducted and other vulnerable youths that are supposed to foster their mental well-being as well as their reintegration into the society and therewith are part of the long-term prevention of new conflicts in Northern Uganda.


Eligibility Criteria:
Inclusion Criteria:

* for individual NET Treatment: PTSD diagnosis
* for group interventions: all youths in the selected vocational training centres will be included
Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)

The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour.

The COVID-19 pandemic resulted in a lockdown and social distancing in most countries all over the world. The impact of this national intervention on cardiovascular prevention behaviour (physical exercise, nutrition, smoking) is unknown. The COLA Trial aims to help clarifying these questions.

An online survey was distributed among bavarian students with standardized questions about physical activity, nutritional behavior, smoking and alcohol intake before and during lockdown.

Eligibility Criteria:
Inclusion Criteria:

healthy adults over 18 years

Exclusion Criteria:

any condition that does not allow physical activity
EFFECTS OF BODY-BLADE EXERCISES ON NECK POSTURE, FUNCTION, AND MUSCLE STRENGTH IN FORWARD HEAD POSTURE

This study will be conducted to determine the effect of adding Body-blade exercises to traditional treatment on posture, scapular muscles strength, neck pain, and function in individuals with forward head posture

Many studies have proposed that the Body-blade may be a more effective tool for activating the muscles employed during the training and rehabilitation of the shoulder and trunk than traditional interventions such as cuff weights and Therabands. There is few literature which studied the effect of Body-blade exercises on neck problems. So there is insufficient evidence for their effectiveness on improving forward head posture.

Eligibility Criteria:
Inclusion Criteria :

1. Participants with FHP of both genders
2. Age range from 20-40 years
3. craniovertebral angle (CVA) less than 52 degrees

Exclusion Criteria :

1. Patients with a previous diagnosis of a musculoskeletal system disease over the last 6 months,
2. severely unstable spine
3. osteoporosis
4. vascular disease
5. cervical or shoulder neurological movement disorder
The Duluth Model and ACTV for Domestic Violence

The purpose of this research is to compare the effectiveness of two interventions for intimate partner violence (IPV). In most states, men who are convicted of domestic assault court-mandated to complete a Batterers Intervention Program (BIP) as part of their sentencing. The most commonly used BIP is based on The Duluth Model, which has been shown to decrease the recidivism of IPV offenders, but only marginally. The Duluth Model is a group intervention based on feminist theory and cognitive behavioral therapy. A new BIP called Achieving Change Through Values-Based Behavior (ACTV) has recently been developed by the PI as an alternative to Duluth. ACTV is currently being used statewide within the Department of Corrections (DOC) in Iowa. ACTV is a group intervention that utilizes acceptance and mindfulness techniques in addition to techniques from cognitive behavior therapy. The current study will use a randomized control trial to compare Duluth and ACTV, in order to assess the interventions' relative impact reducing IPV behaviors (physical aggression, psychological aggression, stalking, harassment, etc). Data on these outcomes will be collected via official criminal justice reports (i.e., criminal charges) as well as reports from victims. Other processes and outcomes of interest (attitudes toward women, emotion regulation, parenting behaviors, etc) will be collected from offenders.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* First time domestic assault offender
* Domestic assault must be against an intimate partner
* Must be on supervision/probation

Exclusion Criteria:

* Participation in any previous ACT-based or Duluth Model programming