cyrilzakka/clinical-trials huggingface dataset:
The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"

The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.

The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy

Eligibility Criteria:
4.2 Inclusion Criteria

1. Patients who have signed the informed consent form
2. Patients with performed complete VCE \< 7 days prior to inclusion and diagnosed clinically active mild to moderate small bowel CD and no stricture on previous examinations, as previously proven by barium small bowel follow through, enteroclysis and / or patency test capsule.
3. Patients between 18 - 70 years of age.

4.3 Exclusion Criteria

1. Patients with evidence of other forms of inflammatory small bowel bowel disease, idiopathic proctitis or infectious disease.
2. Patients with known small bowel strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test.
3. Patients with pacemaker due to lack of VCE interaction data.
4. Patients who cannot undergo study procedures due to swallowing disorders.
5. Planned or actual pregnancy or lactation.
6. Women of child-bearing potential who are not using an effective method of contraception, in the opinion of the investigator.

8. Patients receiving maintenance treatment (p.o.) with total daily doses above 2.0g of sulphasalazine, mesalazine or 4-ASA, for 30 days prior to entry into the study.

9. Chronic use of non-steroidal anti-inflammatory drugs (oral and/or rectal routes) in 30 days prior to inclusion in the study (chronic use is defined as drug intake for a minimum of 3 consecutive days).

10. Intake of corticosteroids (oral and/or rectal routes) within the 30 days prior to enrolment in the study.

11. Patients receiving any immunosuppressive (azathioprine, 6-MP, etc) agents during 30 days prior to study enrolment.

12. Patients receiving any Crohn specific biological agents (TNF-alfa) during the last year prior to study enrolment.

13. Patients with any other disease or condition which may interfere with study assessments as judged by the investigator.

14. Alcoholism or drug addiction. 15. Patients participating or having participated in another clinical study in the previous 30 days.

16. Patients with severe renal/hepatic impairment (see section 5.6) as judged by the investigator.

17. Patients who are allergic to salicylate or 5-ASA derivatives. 18. Patients who are unlikely to comply with the protocol. 19. Any patient who has previously taken part in this study. 20. Patients who are unable to write or read local language
Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS)

To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).

Conditioning therapy

* Cytoxan 50 mg/kg/d on d-3 to -2
* Fludarabine 30 mg/m2 on d-6 to -2
* Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT)
* Methylpd 2 mg/kg/d on d-4 to -1

Mobilization and harvest

* G-CSF 10 mcg/kg/d s.c. on d-3 to 0
* Harvest of PBMCs on d 0 to +1

Donor G PBMC infusion

* Infuse G-PBMCs on d 0 to d+1.

GVHD prophylaxis

* Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
* Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Preemptive dose-escalating DLIs

* Begin at d+120 or at least 2 wks after IST discontinuation.
* Failure to achieve full donor chimerism No evidence of GVHD
* CD3+ cell dose increment q 4 wks -+ cell dose: HLA-matched donor HCT (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), HLA-matched unrelated donor HCT (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), HLA-matched familial donor HCT (1 x 105/kg, 5 x 105/kg, 1 x 106/kg)

Eligibility Criteria:
Inclusion Criteria:

* Patients with lower risk MDS (bone marrow blast percentage \< 5%)
* Patients with appropriate hematopoietic cell donor
* Adequate performance status (Karnofsky score of 70 or more; see Appendix II)
* Adequate hepatic and renal function (AST, ALT, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dL).
* Adequate cardiac function (left ventricular ejection fraction of 40% or more on heart scan or echocardiogram)
* Signed and dated informed consent must be obtained from both recipient and donor.

Exclusion Criteria:

* Presence of significant active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy

The emergence of new anti-cancer drugs orally administered has revolutionized the prognosis and modalities of management of several lymphomas over the past decade. Today, half of patients receive oral therapy at home. Ibrutinib, acalabrutinib, idelalisib, venetoclax and lenalidomide are oral therapies used in the treatment of Chronic Lymphoid Leukemia, Follicular Lymphoma, Waldenström's disease and mantle cell lymphoma, in relapsing but soon to be 1st line.

Nevertheless, clinical trials leading to marketing authorizations for these drugs were performed in a small number of patients and very little data is available on their use in real life conditions. Their impact on the quality of life of patients also remains to be assessed.

The aim of this clinical research is to evaluate quality of life of patients at the initiation of the first oral therapy and every year for 5 years. This study will also identify factors (biological and non-biological: quality of life, shared decision-making ...) associated with a good response of patients and follow-up for the occurrence of long-term adverse reactions (5 years).

Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the PK-E3i clinical study OR
* Over the age of 18
* Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib...)
* Be able to understand the objective and the constraints related to research
* Patient having read the information notice and the non-objection form
* Social Security affiliation

Exclusion Criteria:

* Pregnant women
* Persons under legal protection of adults
* Patients under judicial protection
An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms

Multicenter trial conducted in Pharmacy retail centers


Eligibility Criteria:
Inclusion criteria:

1. Men 18 years of age and older.
2. Able to speak, read and understand English.
3. Willing to participate in the study and voluntarily sign an informed consent document.

Exclusion criteria:

1. Subject or anyone in their household is currently employed by a marketing or marketing research company, and advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company as a healthcare professional or healthcare practice.
Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents

The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.

The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.

Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.


Eligibility Criteria:
Inclusion Criteria:

* Senior gynecological surgeons
* At least 4 years of residency in gynecology

Exclusion Criteria:

* Junior residents, fellows, consultants
* Operative procedures due to malignancy
* Women who were not suitable for or denied a laparoscopic approach
* Declined the procedure
* Did not sign a written informed consent form
* Suffering from a gynecologic malignant disease or severe systemic illnesses
* Laparotomic conversion
A Digital Health Intervention to Improve Symptoms and Physical Activity During Breast Radiation

This clinical trial evaluates a digital health intervention for improving symptoms and physical activity among patients with breast cancer undergoing radiation. Cancer-related fatigue is common and strongly associated with quality of life during and after treatment. Increasing emphasis on early symptom detection and management has prompted initiatives to collect patient-reported fatigue from all patients during treatment. Mind-body interventions including physical activity and yoga are recommendations to treat fatigue and comorbid (coexisting) symptoms. Lower socioeconomic status has not only been associated with higher rates of physical inactivity but also with perceptions that it could negatively impact fatigue and quality of life during treatment. A virtual mind-body program called Integrative Medicine at Home (IM@Home) includes cardio fitness and yoga classes in a bundled intervention that has demonstrated decreased fatigue, depression, insomnia, and symptom distress among patients undergoing breast radiation. The IM@Home program may also increase physical activity among patients with breast cancer undergoing radiation.

OUTLINE:

REGISTRY: Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.

INTERVENTION: Patients participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Ability to understand English, or has a caregiver who understands English.
* Ability to understand and willingness to sign a written informed consent document, virtually or in-person.
* Current breast cancer diagnosis.
* Currently receiving radiation with curative intent (including partial breast, whole breast, or regional nodal radiation).

Exclusion Criteria:

* Patients who are non-English speaking that would prevent their participation in IM@Home.
* Patients with metastatic disease (i.e. stage IV).
Microbial Colonization of Oral Probiotics

The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults

This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of lozenges and powders containing two different commercially available probiotic bacteria (S. salivarius K12 ) or S. salivarius M18 with or without 2 different prebiotic sugars or their combinations.

Participants will be randomly assigned to one of the 12 groups consuming probiotic lozenge or powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity) over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion criteria:

1. Male or Female 18y - 80y age
2. In general good health 18 - 80 years of age.
3. Practice good oral hygiene.

Exclusion criteria:

1. Have a history of autoimmune disease or are immunocompromised.
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).
Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria

The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.

Individually randomized, open label, 2-arm, cross-over, clinical trial. Patients are allocated to receive rectal artesunate at admission and intravenous artesunate after 12 hours or intravenous artesunate at admission and rectal artesunate after 12 hours. All patients are treated for severe malaria with intravenous quinine. Frequent blood samples are taken at fixed intervals after the administration of the first and the second dose of study drug. The time frame is 24 hours and thereafter patients continue the standard antimalarial therapy.

Eligibility Criteria:
Inclusion Criteria:

* Weight ≥6 kilograms and ≤ 34 kilograms
* Severe malaria (WHO Guidelines 2013; Appendix 1)
* P. falciparum infection confirmed by Rapid Diagnostic Test (P. falciparum monoinfection or mixed infection with P. ovale or P. malariae)
* Parents or guardian signed Informed Consent

Exclusion Criteria:

* Acute diarrhoea defined as \> 3 liquid stools in the previous 24 hours
* Visible anorectal malformations or a disease of the rectum
* Known hypersensitivity to quinine or artesunate
* A documented history of an effective dose of parenteral antimalarial in the preceding 24 hours or a single dose of rectal artesunate in the previous 12 hours or a dose of an artemisinin based combination therapy in the previous 6 hours
* Co-morbidity which in the judgement of the investigator would interfere with the patient treatment or results of the study or place the subject at undue risk
* Participation in another clinical trial or earlier in the same clinical trial
System Accuracy Evaluation of 6 CE-marked Blood Glucose Monitoring System Following ISO 15197:2013

The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and Accu-Chek Mobile with three different reagent system lots for each BGMS.

The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
* For provoked blood glucose excursions due to insulin dose adjustment:

  * Male or female with type 1 diabetes or
  * Type 2 diabetes and intensified insulin therapy or insulin pump therapy.
* Minimum age of 18 years
* Signed informed consent form
* Legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Incapability of giving informed consent
* \< 18 years
* Legally incompetent
* Accommodated in an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent from investigator or sponsor
* For provoked blood glucose excursions 50 - 80 mg/dl (concentration category 2):
* Coronary heart disease
* Condition after myocardial infarction
* Cerebral incidence
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness
Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism

Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.

Observe safety and efficacy of human menopausal gonadotropin and human chorionic gonadotropin treating congenital hypogonadotropic hypogonadism in teenagers; which as clinic recommendation, may provide clinical basis for establishing standard treatment guideline in the future. Establish technological process and follow-up precept for human menopausal gonadotropin and human chorionic gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers. And find safety and effective dose for teenagers.

Eligibility Criteria:
Inclusion Criteria

Criteria A

* Boy \>14yr without any sign of puberty, testis \<4ml
* BA ≥12yr
* Sex hormone (LH,FSH, T) are pre-pubertal level
* No other hormones problems (other pituitary glands axis are normal except gonad axis)
* No space occupying lesion, No tumor on MRI of pituitary and hypothalamus area
* Kallmann's syndrome(KS) patients may companies with dysosmia or dysplasia of olfactory bulb or olfactory tract on MRI
* Karyotype is 46，XY
* Exclude chronic diseases, malnutrition

Criteria B

* For the boy \<14yr. who companies with micropenis or cryptorchid or hypospadias and they have anosmia or dysplasia of olfactory bulb/olfactory sulcus/olfactory structs on MRI include in.

Criteria C

* As the phenotype of hypogonadotropic hypogonadism are variant, some of them may have partial puberty. So, we enrolled them when they have testis volume \>4ml or the testosterone level \>200ng/L，companies anosmia or dysplasia of olfactory bulb /olfactory sulcus/ olfactory structs on MRI, and the puberty arrested in half a year. These patients can be diagnosed as Kallmann Syndrome.

Exclusion Criteria:

* Any ascertain reason contributes to the non puberty development (Chromosome abnormal, trauma, surgeries) or any ascertain disease such as Prader-Willi syndrome or hypergonadotropic hypogonadism
* Systemic diseases (such as chronic kidney failure, Mediterranean anemia, poor controlled diabetes)
* Protein-energy malnutrition
* Eating disorder (such as anorexia nervosa, binge eating)
* Any brain diseases history: tumors in brain or pituitary or after their surgeries
Biopsy Study for Sculptra (Poly-L-Lactic Acid)

The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.


Eligibility Criteria:
Inclusion Criteria:

* If female, the subject must use appropriate form of birth control.

Exclusion Criteria:

* History of allergies or an allergic reaction to local numbing medications (e.g., lidocaine, etc.), latex, or silicone.
* History of forming large scars following an accident or surgery.
* History of any bleeding problems.
* Redness, swelling, or signs of infection behind the right or left ear between the area of the earlobe and hairline.
* Pimples, rashes, scarring or any other skin changes behind the right or left ear between the area of the earlobe and hairline.
* History of any medical problems (for example, heart attack, stroke, diabetes/high blood sugar, hepatitis, human immunodeficiency virus (HIV), severe asthma, rheumatoid arthritis, emphysema, breathing problems). Subjects with high blood pressure or high cholesterol may qualify for the study if there have been no changes in their medications for three (3) months.
* History of cancer within five (5) years.
* Previous cosmetic surgery or cosmetic procedures affecting the area behind the ear.
* Subject who plans to have any facial or ear surgery within the next year.
* History of alcohol or drug abuse.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Thromboelastography As A Tool for Possible Clopidogrel Resistance in The Patients Treated With Primary PCI for STEMI

Determine usefulness of thromboelastography (TEG) as a valuable tool in ex-vivo assessing platelet response to aspirin and clopidogrel (dual) treatment and on-treatment platelet reactivity during acute ST segment elevation myocardial infarction (STEMI) in an acute phase during primary PCI (PPCI) and also during recovery been on maintenance medical therapy and to determine the correlation between platelet response to clopidogrel treatment and the outcome of patients.

Dual anti-aggregant therapy is recommended standard of therapy applicable to all patient groups undergoing PPCI. The aspirin-clopidogrel regiment is signed to every patient without assessing therapeutic effect. In face of growing evidence of platelet resistance to the standardized therapy there is a demand for reliable diagnostic tool for rapid and accurate assessment of platelet reactivity. TEG is an established technique to assess the quality of clot formation' used mainly in surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be used in cardiology, where it can be a valuable tool to assess a response to antiplatelet therapy and its association with the outcome. However, there is a few data about use of TEG in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and the correlation of this response with the long term outcome.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old STEMI patients admitted to ICCU and in whom the primary PCI is elected as treatment strategy would be enrolled

Exclusion Criteria:

* Patient received thrombolytic therapy, chronic renal failure (GFR\<40 ml/min), any known hematological dyscrasia