cyrilzakka/clinical-trials huggingface dataset:
Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients

The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care.

In this cross-sectional study, the participants will complete 4 times a set of questionnaires and measurements. The data that will be collected is:

age; sex; height; weight; type of tumour; classification of malignant tumours (TNM); progression of tumour and used therapy; blood sample to analyse albumin, creatine, hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm circumference. Based on all these data points a easy to use tool/score for a hospital setting will be created. During the first assessment the measurements will be done in the morning and the evening to test the reproducibility.

Eligibility Criteria:
Inclusion Criteria:

* New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
* New Diagnosed Patients With Metastatic Pancreatic Neoplasms
* New Diagnosed Patients With Metastatic Colonic Neoplasms

Exclusion Criteria:

* Patients With Other Primary Neoplasms
* Patients Already in Therapy
* Patients With Non-metastatic Colonic or Pancreatic Neoplasms
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients

The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools.

At this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study.

350 Crohn's disease patients will be included in the study, targeting 300 evaluable patients. An interim analysis will be performed after 50% of the evaluable patients are recruited.

The primary objective is to evaluate the relation between non-invasive biomarkers (host immunological variables and metagenomic analysis in stools) and AIEC detection in biopsies taken during an endoscopy, in order to develop a predictive algorithm of AIEC carriage.

The secondary objectives are:

* Validation of the AIEC detection algorithm using qPCR technology.
* Assessment of the correlation between the presence of AIEC and the endoscopic and clinical evaluations of the disease (CDEIS, SES-CD, Harvey-Bradshaw Index and Crohn's Disease Activity Index).
* Development and validation of a non-invasive qPCR based diagnostic of Mucosal Healing in CD patients.
* Collection of biological samples associated with all clinical and biological data from CD patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 75 years of age, inclusive;
* With a diagnosis of ileal or ileo-colonic Crohn's disease for a minimum of 3 months prior to inclusion;
* An ileocolonoscopy scheduled prior to study inclusion;
* Agreeing to participate and to sign an informed consent form;
* Able to perform stool collection, at home, according to protocol;
* Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

* Colonic Crohn's disease of L2 phenotype based on Montreal classification;
* Extensive small bowel resection (\> 100 cm) or short bowel syndrome
* Bowel strictures/stenosis contraindicating ilecolonoscopy;
* Currently with an ostomy or an ileoanal pouch;
* Currently receiving total parenteral nutrition;
* Bowel preparation received in the previous 3 months;
* An increased risk of hemorrhage (patients with anticoagulant/antiplatelet therapy)
* History of intestinal carcinoma and colorectal cancer;
* History or presence of alcohol or substance abuse;
* History of chronic uncontrolled disorders;
* Current participation in an investigational product trial;
* Less than 4 weeks since last participation in a clinical trial;
* Subject inapt or unwilling to participate to the study;
* Pregnant or breastfeeding mother;
* Patient under guardianship.
Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks of pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary Diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Study of Codivir in Patients With COVID-19

This is an open-label study to evaluate the safety and preliminary efficacy of Codivir in 12 mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion. Treatment will begin in the hospital, participants will be discharged at Day 4 and continue the treatment up to Day 10 at home and followed up to day 28.

Eligible participants who agree to participate will be submitted to safety assessments, an RT-PCR and a quick test for COVID-19. Everyone will receive the treatments indicated for their case, except for other investigational medications. Codivir will be administered in addition to these treatments at a dose of 20 mg SC twice daily for 10 days. Participants will remain hospitalized for the first 3 days.

If they have progressed well, they will continue the treatment up to Day 10 at home, receiving a nurse's home visit twice a day to administer Codivir and collect vital signs. Participants will be followed up to Day 28 by telemedicine. A doctor will call them periodically to monitor the clinical evolution, collect adverse events, concomitant medication and instruct the participants. In case of unfavorable evolution, the participants will remain hospitalized receiving the appropriate care. The investigator will decide whether or not the investigational medication will continue, considering the participant's health and well-being.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 60 years;
2. Male or female;
3. SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
4. Mild or moderate COVID-19:

   * The oxygen saturation in room air \>93%;
   * \<30 breaths per minute;
5. No signs of hemodynamic decompensation.
6. Absence of pregnancy in women of childbearing age.
7. Able to understand and comply with the requirements of the protocol.
8. Consent to participate

Exclusion Criteria:

1. Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
2. Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
3. Participants in use or expected to use within 24 hours prior to the inclusion of drugs that are under clinical investigation as a therapeutic option for the treatment of COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others) during the study period;
4. Body mass index less than 19.9 or greater than 35;
5. Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study;
6. Concomitant HIV, HBV or HCV infection.
7. Pregnancy or lactation;
8. Participation in another clinical trial in the 12 months preceding inclusion;
9. Anti-COVID-19 vaccination at any time;
10. Vaccination for any other infection in the 4 weeks prior to inclusion;
11. Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Reducing Barriers to Drug Abuse Treatment Services

The broad goal of this study is to assess the effectiveness of two interventions to facilitate treatment linkage and treatment engagement. "Treatment linkage" is operationally defined as completion of agency intake procedures and attendance at the first clinical or therapy session. "Treatment engagement" represents a more comprehensive conceptualization of "treatment retention" and includes measures of the clinical and ancillary services actually received by the client over time; as such, client engagement focuses on the intensity and duration of treatment participation. This study will enhance the CIU concept by conducting a controlled trial, using a three-armed research design, of interventions designed to enhance treatment linkage and treatment engagement. These interventions - a Motivational Intervention and Strengths-Based Case Management - are science-based and have demonstrated efficacy in moving drug abusers towards treatment and supporting treatment engagement.

The Specific Aims of the project are:

1. To conduct a detailed qualitative/ethnographic investigation to study: (a) the processes and factors operant in a person's decision to link with a substance abuse treatment agency once a formal (i.e., professional) assessment and referral have been made; and (b) the processes and factors operant in staying in treatment once it has been initiated.
2. To identify and classify, using quantitative methods, the operant barriers to treatment linkage and engagement. We will assess the factors that are associated with these barriers and examine the effects of the study's interventions on removing them.
3. To evaluate the effectiveness, using a controlled trial, of a Motivational Intervention and Strengths-Based Case Management, compared to the CIU's "standard" referral process, by examining differences between the Standard, Motivational Intervention, and Case Management conditions on treatment linkage and engagement outcomes. The conceptual framework for this controlled trial is the well-studied Andersen model of access and health service use, modified for chemical dependency services (Andersen, 1995). The interventions are designed to affect mutable factors such as perceived barriers to treatment. Data will be collected at baseline, and at 3 and 6 months thereafter. Analyses will examine whether the interventions work better with different groups of clients (e.g. cocaine users versus marijuana users, males versus females, different ethnicities, etc); as well as different treatment modalities (standard outpatient versus intensive outpatient.)
4. To conduct a quantitative investigation of the effects of Individual Level and Health Care System Level factors that predict treatment linkage and engagement in the context of the proposed interventions. This study component will develop comprehensive models to predict how these factors interact with the study's interventions to effect treatment linkage and treatment engagement.

Eligibility Criteria:
Inclusion Criteria:

* substance abuse or dependence per DSM-IVR criteria

Exclusion Criteria:

* active thought disorder
Social Competence Training for Adolescents With Borderline Intellectual Functioning

Emotional and behavioural problems as well as a lack of social competence are supposed to be common phenomena in adolescents with borderline intellectual functioning, consequently impairing their social and vocational integration. Considering the lack of evaluated group interventions for this population, a cognitive-behavioural training is developed and its effectiveness is examined in a population of students attending special vocational schools.

77 adolescents with borderline intelligence are enrolled participated in the study. They are randomized either to the intervention group, who received 9 group sessions over a period of 3 months additionally to the standard vocational training (Social Competence Training for Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only the standard vocational training. Outcome measures at the end of the intervention and at a 6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural observations of cognitive, emotional, and behavioural factors of social competence.


Eligibility Criteria:
Inclusion Criteria:

* age 16 - 23 years
* participating in special vocational training program
* elevated scores in a screening measure of behavioral/emotional disorders (CBCL or YSR T\>59)

Exclusion Criteria:

* major psychiatric disorder (psychosis, major depression, substance abuse)
Efficacy of a Standardised Bilberry Extract in Improving the Night Vision of Healthy Volunteers

Study to determine the Efficacy of Standardised Bilberry Extract in improving the night vision and to evaluate its tolerability and safety.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (volunteers) with normal twilight and night vision
* Age 18+, young and collaborative men or women
* Having given their written informed consent
* Full visual acuity (vision 0.8 or better) according to DIN Standard condition
* Refraction ≤ +/-10.0 in the highest main step
* Normal intraocular pressure (10-20 mmHg)

Exclusion Criteria:

* Diabetes mellitus
* Epilepsy
* Abnormal visual acuity or abnormal morphological eye findings
* Glaucoma and macula degeneration
* Disease of the retina
* Consumption of anthocyan preparations during the past six months
* Opthalmologic pathology: cataract, visus \< 0.8, retinal pathology, maculopathy, intraocular pressure \> 21 mmHg, known acute or chronic eye disease, use of hard contact lenses, eye surgery performed within the last 12 months
* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus, anamnestic indications of diabetic microangiopathy or polyneuropathy, renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension \> 160/100 mmHg), psychiatric disorder, myasthenia gravis, delirious state, albino
* Any treatment that might interfere with the evaluation of the test drug, in particular drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis, ethambutol, chlorpromazine, benzodiazepines or phenothiazine derivatives such as thioridazine, periciazine, perphenazine)
* Known hypersensitivity to any of the ingredients of the study drug
* Drug and alcohol abuse
* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
* Participation in another trial within the past 30 days
Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in Adults

The aim of this study is to evaluate the role of azithromycin as a possible combination partner for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile.

The scientific rationale for the use of this combination is to inhibit the ability of the parasite to synthesise isoprenoids, as precursors of many essential compounds including sterols, carotenoids and ubiquinones. This is effected through blockade of the non-mevalonate pathway by fosmidomycin as a potent inhibitor of 1-deoxy-D-xylulose 5-phosphate reductoisomerase coupled with targeting of protein biosynthesis by azithromycin through binding to the 50S ribosomal subunit. This mode of action contrasts with the ability of the human host to utilise the mevalonate pathway for isoprenoid synthesis and accounts for the safety profiles of both drugs through the mechanism of selective toxicity. Moreover it affords protection against cross resistance with existing chemotherapeutic agents.

The dose of fosmidomycin, equivalent to 30mg/kg twice daily for three days, selected for evaluation in this proof of concept study is derived from the highest dose that was administered in the Phase I safety tolerance studies. While the recommended dose of azithromycin for the treatment of bacterial infections is 250mg daily for three days, higher doses of up to 1500mg daily for three days have been evaluated for the treatment of malaria, in combination with artesunate or quinine.

Eligibility Criteria:
Inclusion Criteria:

* male and female subjects aged 15 to 55 years
* body mass index ≥ 18.5kg/M2
* uncomplicated P falciparum malaria with acute manifestations
* asexual parasitaemia between 500uL and 100,000uL
* ability to tolerate oral therapy
* able to give informed signed consent

Exclusion Criteria:

* signs of severe malaria, according to WHO criteria
* body mass index ≤ 18.5 kg/M2
* pregnancy by history or by positive urine test
* lactation
* mixed plasmodial infection
* concomitant disease masking assessment of response, including diabetes, uncontrolled hypertension, heart failure, hepatic dysfunction (alanine-amino transferase \> 150 U/L), renal impairment (creatinine \> 125 umol/L or 3 mg/dl), haemoglobin \< 8g/dl, white cell count \> 12000/uL
* anti-malarial treatment within previous 28 days
* symptomatic AIDS
Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer

Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. The purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.

Traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. Alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. However, the effects of such interventions are scarcely documented. Thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance.

The study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. Firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. In addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. Pre and post of each of the two week rehabilitation periods the following measurements will be performed: The magnitude of lymphedema by volume measurements of the limbs (by DXA); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Secondary lymphedema in arm or/and leg related to cancer

Exclusion Criteria:

-
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.

The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility for adult haemophilia patients.

Eligibility Criteria:
Inclusion Criteria:A patient must fulfil the following criteria in order to be included in the study:

1. Age ≥18 years.
2. Diagnosis of haemophilia A or B.
3. Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French.
4. Signed informed consent.

Exclusion Criteria:

The presence of any of the following criteria will exclude a patient from inclusion in the study:

1. Joint replacement within last 6 months.
2. Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
3. Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.