cyrilzakka/clinical-trials huggingface dataset:
Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer

This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.

The purpose of this study is to assess the effectiveness and safety of spot-scanning based hypofractionated proton radiotherapy for the treatment of intermediate and low risk prostate cancer. The treatment effectiveness is defined as freedom from biochemical failure. Treatment safety will be documented with acute and late morbidity assessments. Dose volume relationships for late side effects in organs at risk surrounding the prostate will be calculated from the dose volume histogram parameters assessed during treatment planning. Patient assessed Quality of life data including sexual function will be collected to increase our understanding how the reduction of normal tissue irradiation with proton therapy with subsequent decrease in functional impairments will overall affect the patient's life.

Eligibility Criteria:
Inclusion Criteria:

* Pathological (histologically) proven diagnosis of prostatic adenocarcinoma
* Clinical stage T1-T2b
* Prostate specific antigen (PSA) ≤ 20 ng/mL
* Gleason Score ≤ 7
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan)
* Any patient with lymph nodes \> 1.0 cm maximum diameter requires further studies to address eligibility. Positron emission tomography (PET)-CT is recommended for lymph nodes \> 1.0 cm. Positive PET-CT indicates malignant involvement. Hence, the patient will be staged as "high-risk" and therefore declared ineligible for study participation. Negative PET-CT in lymph nodes 1.0-1,5 cm indicates non-involvement and thus eligibility. Negative PET-CT in lymph nodes \> 1.5 cm is equivocal and requires additional work-up, preferably by biopsy.
* Patients must be 18 years of age or older. There is no upper age limit.
* Patient must be able to provide study-specific informed consent prior to study entry.
* Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire to assess Quality of Life.
* Previously initiated Androgen Deprivation Therapy (ADT) is acceptable.
* Patients with history of chronic bowel diseases may be included.
* Patients with previous Transurethral Resection of the Prostate (TURP) performed for urinary retention may be included.

Exclusion Criteria:

* Prior radiotherapy to the pelvic area.
* Prior prostate cancer therapy such as: prostatectomy, cryotherapy or hyperthermia.
* Prior systemic therapy (chemotherapy) for prostate cancer.
* Concurrent cytotoxic chemotherapy for prostate cancer.
* Evidence of distant metastases.
* Regional lymph node involvement.
* International Prostate Symptom Score (IPSS) \> 20
* Hip prosthesis
* Second invasive malignancy (except of basal cell and squamous cell carcinoma of the skin in situ) if not controlled within last two years.
The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer

Through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.

Patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. Take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. Compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women, age ≤ 50 years
2. Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma G1/G2 (including well-differentiated, high-medium and middle-differentiation);
3. Clinical consideration of IA (\<1/2 muscle infiltration);
4. First-time treatment
5. The subject (or his legal representative) must understand the nature of the study and sign an informed consent form.

Exclusion Criteria:

1. At the same time participate in other clinical trials;
2. Can not tolerate surgery;
3. Ovarian suspicious metastasis;
4. Have a family history of ovarian cancer;
5. Incorporate other malignant tumors;
6. Preoperative CA125 abnormal persons
Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)

Several drugs and chemotherapies seem to have an impact on the hematological system. This study investigates reports of hematological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the hematological system and are responsible of a wide range of hematological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare hematological side effects imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 01/02/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Extracorporeal Shock Wave Treatment - Can the Pain be Reduced?

Patients with Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii get the shock wave therapy in our clinic as planned. During our study the investigators want to ask for pain, pain reduction and function.

Patients with either Fascititis plantaris, Achillodynie, Periarthropathia humerosacpularis calcarea or Epikondylopathia humeri /radii get a shock wave therapy in our clinic of rheumatology as planned. During our study the investigators ask for pain, pain reduction and function (all questionnaires).

Eligibility Criteria:
Inclusion criteria:

-Patients with:

* Fascititis plantaris,
* Achillodynie,
* Periarthropathia humerosacpularis calcarea or
* Epicondylopathia humeri /radii, who got the shock wave therapy.

Exclusion criteria:

* Anticoagulation,
* Sepsis
Study of Grass-SPIRE in Subjects With Grass Allergies and Asthma

The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to subjects suffering from both grass allergy and asthma


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years.
* Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation.
* A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to grass for at least the previous two grass seasons.
* Positive skin prick test to grass.
* Grass-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.

Exclusion Criteria:

* History of life-threatening asthma.
* Uncontrolled asthma according to GINA.
* FEV1 of \<70 % of predicted, regardless of the cause.
* Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease).
* History of severe drug allergy or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)

The purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnostic colonoscopy,
* colonoscopy as a follow-up,
* intended therapeutic colonoscopy.

Exclusion Criteria:

* patients younger than 18 years
* pregnancy
* known bowl obstructions
* known inflammatory colon disease
* known kidney disease
* phenylketonuri
* glucose-6-phospat deficiency
Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)

Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea

Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length \< = 25 mm measured by echography between 20 and 28 SA compared to the group controls.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years (legal majority in France)
* Inclusion pessary positioning before 28 WG
* Twin pregnancies, mono or dichorionic, diamniotic
* Transvaginal cervical length ( 25mm between 20 et 28 WG
* Intact membranes
* No signs of infection (negative urine culture, CRP \<10mg/l , blood white cell count \<15000/ml)
* Patient accepting follow-up
* Covered by health insurance for France

Exclusion Criteria:

* Cerclage

  * No more cervix
  * Chorioamnionitis
  * Abnormal CTG
  * Placenta praevia
  * Abruptio
  * Bleeding
  * PROM
  * Singleton or multiple \>2
  * Monochorionic monoamniotic twin pregnancy
  * IUGR
  * Preeclampsia or other PIH
  * TTTS
  * Uncontrolled diabetes
  * Other maternal of fetal pathology responsible for preterm deliveries
  * Patient included in other therapeutic trials
  * Patient without legal freedom to consent
  * Homeless or no fixed address
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign written informed consent.
* Male or non-pregnant and non-lactating females.
* Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
* Must possess a baseline Modified Mayo Disease Activity Index (MMDAI) score between 5 and 10.

Exclusion Criteria:

* History or current diagnosis of Crohn's disease and indeterminate colitis.
* Prior gastrointestinal surgery except appendectomy and hernia.
* Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
* History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
* Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
* Uncontrolled abnormal thyroid function.
* Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
* Hemoglobin levels less than (\<) 7.5 grams /deciliter (g/dL).
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
* Renal disease manifested by greater than (\>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
* History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and human immunodeficiency virus (HIV) or hepatitis B or C.
* Adrenal insufficiency.
* Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
* History of uncontrolled psychiatric disorders or seizure disorders.
* History of asthma requiring ongoing use of inhaled steroids.
* Recent history of drug or alcohol abuse.
* Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
* Vaccination within 28 days prior to randomization.
* Allergies to budesonide or to any other items used in its preparation.
* Participation in another clinical trial in the past 30 days.
* Pregnant or at risk of pregnancy.
* Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
Narrow Band Green Light and Migraine

Study volunteers are asked to use the Allay Lamp routinely during the 6-week study period. A web based survey is provided when the Lamp is purchased for study volunteers to complete. A daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. At the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adults with headaches or migraines.

Exclusion Criteria:

* Not having headaches or migraines
Effects of SAMe in Patients With Alcoholic Liver Disease

Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.

We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for 24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients, 13 in each arm, who completed the 24 week trial.

Eligibility Criteria:
Inclusion Criteria

* ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria with the presence of clinical and laboratory features of established liver disease. Also, willingness to undergo liver biopsies at start and completion of the study, and to comply with study medication or placebo and required clinic visits and blood sampling.
* a history of chronic alcoholism without evidence of liver disease;
* healthy subjects without history of alcoholism or presence of liver disease.

Exclusion Criteria:

* viral Hepatitis B or C
* hemochromatosis
* Wilson Disease
* sclerosing cholangitis
* primary biliary cirrhosis
* other chronic disease
* renal insufficiency
Post-operative Sensitivity of a Self-adhesive Restorative Material

Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years' old
* Teeth are vital
* Teeth are periodontal healthy
* Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth
* Patient did not receive orthodontic treatment
* Good level of oral hygiene.

Exclusion Criteria:

* Non-vital or endodontically treated teeth
* (Profound, chronic) periodontitis
* Deep carious defects (close to pulp, \< 1mm distance)
* Heavy occlusal contacts or history of bruxism
* Poor oral hygiene
* Sustained dentin hypersensitivity
* Taking anti-inflammatory, analgesic, or psychotropic drugs
Dose Response and Efficacy of GW842166 in Pain

The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 18 to 50 years inclusive
* Body Weight \>50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
* Women who are not of child bearing potential

Exclusion Criteria:

* The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
* A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
* Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
* Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
Motivational Interviewing to Enhance Behavioral Change in Older Adults with Hoarding Disorder

This study will compare two behavioral interventions for hoarding disorder in older adults.

Hoarding disorder is a psychological condition with a unique constellation of consequences for older adults, including increased risk of fire and dying in a fire, insect infestation, and medical problems. Dangers related to cluttered living spaces are exacerbated by reduced executive functioning, attention, and concentration. Hoarding psychopathology results from maladaptive cognitions (e.g., desire to keep items others would discard) and maladaptive behavioral patterns (e.g., avoidance of sorting/discarding items).

Extant treatments for hoarding have targeted fear reduction as the mechanism of change, either through cognitive-behavioral therapy focusing on cognitive restructuring or behavior therapy focusing on exposure therapy. Older adults have a lackluster response to cognitive restructuring for hoarding, and, although exposure therapy increases treatment response, both approaches require a lengthy six-month dose. Our preliminary work suggests that fear reduction may not be a universally relevant target mechanism for older adults, and that to be responsive to the specific needs of older adults, other mechanisms need to be identified.

Motivational interviewing is a technique that is already typically incorporated into hoarding treatment and has been demonstrated to increase motivation for behavioral change across a range of health conditions for older adults, including physical activity, diet, and disease management. Because sorting/discarding is at its core a health behavior that hoarding patients lack the motivation to engage in, motivational interviewing is likely to decrease hoarding severity by eliciting increased levels of sorting/discarding.

The proposed project will use a mechanistic clinical trials approach to determine if a four-month intervention combining motivational interviewing with sorting practice can engage the proposed target, motivation for behavioral change, when compared to a four-month dose of sorting practice alone in a sample of rural-dwelling older adults with hoarding disorder.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60+
* Live within a 60-minute driving radius of Starkville, MS
* Have a primary psychiatric diagnosis of hoarding disorder

Exclusion Criteria:

* Major cognitive impairment
* Active psychosis, drug use, or acute suicidal ideation
* Concurrent psychotherapy focused on hoarding
* Changed psychotropic medications within the past three months
Pilot Bleeding Study: Risk and Protective Factors Associated With Bleeding in the Hemodialysis Population

This study is examining the risk and protective factors associated with bleeding in the hemodialysis population.


Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing hemodialysis

Exclusion Criteria:

* This is an observational study. No exclusion criteria required.
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects

The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.


Eligibility Criteria:
Inclusion Criteria:

Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum

Exclusion Criteria:

Occlutech® PmVSD Occluder is contraindicated for the following:

* Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
* Patients less than 10.0 kg
* Patients with sepsis (local or generalized)
* Patients with left ventricle to right atrial shunting
* Patients with right to left shunting through the defect
* Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device
* Patients with complex heart lesions such as tetralogy of fallot
* History of repeated pulmonary infection
* Any type of serious infection 1 month prior to procedure
* Malignancy where life expectancy is less than 3 years
* Demonstrated intracardiac thrombi on echocardiography
* Patients with allergy to anti-platelet or anticoagulant therapy
* Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials
* Patients with intolerance to contrast agents
* Patients with active bacterial infections
* Patients with very small vessels which are not suitable for recommended delivery sheath sizes