cyrilzakka/clinical-trials huggingface dataset:
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
* History of inadequate response, contraindication or refusal to medical therapy for BPH.
* Age from 45 through 80 years.
* Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline.

Exclusion Criteria:

* BMI ≥ 42.
* IPSS total score \<12.
* History of prostate cancer or clinically significant elevated PSA value.
* History of bladder cancer actively treated within 2 years prior to the surgical procedure.
* Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size \>20% of full bladder size).
* Active infection, including urinary tract infection within 72 hours of the treatment procedure.
* Prostatitis treated with antibiotics within 1 year of the surgical procedure.
* Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter.
* Subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
* Clinically significant abnormal serum creatinine measured within 30 days of treatment.
* Maximum urinary flow rate (Qmax) \>15 mL/s or PVR \> 300 mL measured by uroflowmetry test at baseline.
* Subject has been catheterized due to retention within 14 days prior to the surgical procedure.
* Subject has a history of intermittent self-catheterization.
* Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis
* Subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d)
* Any severe illness or psychiatric condition that would prevent study completion or confound study results.
* Subject taking systemic immune-suppressants including corticosteroids; unable to withhold non- steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than 100mg).
* Participants using medications specifically for bladder muscle problems (e.g., irritability). Use of medications with anticholinergic or similar properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
* Participating in another investigational study that could affect responses to the study device.
* Subject is unwilling to accept a transfusion should one be required.
Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease

The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha polymorphism, this study aime to assess their effects and interaction on disease severity of HBV-related chronic liver disease and HCC.


Eligibility Criteria:
Inclusion Criteria:

* HBV-positive patients

Exclusion Criteria:

* HBV-negative patients
Electrolyte Profile, Nutritional Status and Ileostomy Formation.

One of the main reasons for hospital readmission in ileostomy patients is fluid and electrolyte abnormalities. Prospective observational studies have suggested an occurrence rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium and fluid through their stoma effluent. In addition studies have shown that ileostomy construction is a risk factor for renal impairment, occurring secondary to dehydration.

Encouraging patients to increase total fluid intake seems to be a common mistake in clinical practice as this can dilute sodium levels even more, causing greater sodium depletion. In terms of addressing the problem a few small studies have used isotonic drinks of various compositions showing increased electrolyte absorption.

Other dietary complications sometimes include hypomagnesaemia and decreased absorption of B-12 and folic acid, however due to the integrity of the small intestine other nutrient malabsorption is unlikely to occur. As far as body composition is concerned obesity has been shown to be a risk factor for peri- and postoperative complications in colorectal surgery (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining measures that can prevent readmission for dehydration and other nutritional considerations related to this group of patients is definitely required.

Hypothesis:

The administration of an oral rehydration solution will allow a significant decrease in dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.


Eligibility Criteria:
Inclusion Criteria:

* Male of female patients of more than 18 years of age
* Patients who have undergone a rectosigmoidectomy procedure resulting or not in an ileostomy formation

Exclusion Criteria:

* Short Bowel Syndrome
* Diabetic ketoacidosis
* Chronic Renal failure
* Hepatic/Cardiac failure
* Diabetes insipidus
* Diuretic Medication
* Corticosteroid Medication
Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis

This is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male volunteers and Japanese participants with moderate to severe atopic dermatitis.

This study consists of three parts. Part 1 and Part 3 are a single ascending and multiple dose study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male participants. Part 2 is a single-dose study to assess the pharmacokinetics, safety, pharmacodynamics and efficacy of DS-2741a after subcutaneous injection in Japanese participants with moderate to severe atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* For Part 1 and Part 3:

  * Japanese healthy male subjects.
  * Age ≥20 and ≤45 years upon providing informed consent.
  * Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening.
* For Part 2:

  * Japanese Male or female, Age ≥20 upon providing informed consent.
  * Diagnosed with chronic atopic dermatitis (AD) at least 3 years before screening and by the criteria of Hannifin and Rajka at screening.

Exclusion Criteria:

* For Part 1 and Part 3:

  * Having a history of atopic dermatitis
  * Having a history of hypersensitivity to drugs or other substances or being idiosyncratic
  * Having alcohol or drug dependence, etc.
* For Part 2:

  * Having an active dermatological disease other than AD, which, in the investigator's opinion, would affect study assessments.
  * Having a history of serious disease in the study potentially endangering the participant, as judged by the investigator or sub-investigator.
  * Having a chronic or acute infection requiring treatment within 28 days before screening.
  * Having superficial skin infections within 7 days before screening.
  * Having a history of recurrent oral herpes and recurrent genital herpes.
  * Having a history of parasitic infection or invasive, opportunistic infection such as histoplasmosis despite infection resolution, etc.
Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains

The aim of this trial is to test a novel network approach (Bringmann et al., 2013), which enables to investigate the complex, interdependent network of self-control and its influences in everyday life. By adding an intervention to the network, such as mindfulness training, it is also possible to explore the way mindfulness changes connection strengths between network variables.

For six weeks, an ambulatory assessment and additional seven weekly laboratory sessions are conducted with 120 students from the Johannes Gutenberg University Mainz who are randomized to a control (n=60) or intervention condition (n=60). Pre and post measurement sessions take place to assess self-reported trait self-control and mindfulness and a behavioral measure of mindfulness (Levinson, Stoll, Kindy, Merry \& Davidson 2014). Participants of both the experimental and control condition come to five weekly lab meetings in which they fill out questionnaires to assess changes in self-reported self-control and mindfulness. But only participants of the experimental condition take part in weekly computer based mindfulness trainings. During the ambulatory assessment, participants complete questionnaires six times a day via mobile phones that are randomly prompted and answer questions about state self-control, motivation, affect, and current situation.


Eligibility Criteria:
Inclusion Criteria:

* understanding and speaking German
* aged between 18 and 65 years
* knowledge about how to use a mobile phone

Exclusion Criteria:

* psychological disease
* mental or somatic disability that could impair the usage of a mobile phone
Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing

Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥18 years
* Ulcer size 1-64 cm²
* Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
* Ulcer duration \>3 months
* Ulcer located between and including the knee and ankle
* For venous leg ulcers - Venous refilling time \<25s on photoplethysmography or abnormal venous insufficiency Duplex scan
* For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C \< 12%
* Wounds have not been treated with Promogran in the previous 4 weeks
* Patients able to give informed consent

Exclusion Criteria:

* Ankle-brachial index \<0.8
* Ulcer with local or systemic signs of infection
* Patients who have been previously treated with Becaplermin gel
* Receiving corticosteroids or immune suppressants
* History of autoimmune disease
* Uncontrolled diabetes (baseline haemoglobin A1C \> 12%)
* Severe rheumatoid arthritis
* Uncontrolled congestive heart failure
* Malnutrition (albumin \<2.5g/dL)
* Unable to adhere to the protocol
* Known sensitivities to the wound dressings used in the trial
* A history of any previous malignancy
* pregnant or lactating women
Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)

The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1) treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It is being used off-label in the current study and is not FDA approved, nor has it yet been studied in humans for the treatment of SHANK3 deficiency.

Overall, there will be 1-3 screening visits, a baseline visit where study drug will first be administered, and then 10 follow-up visits. Follow-up visits will occur at week 2, week 4, week 8, and week 12 in each treatment phase (IGF-1 or placebo), and then again 4 weeks after study completion, Parents/guardians will be asked to administer the IGF-1/ placebo by injection at home and will also be responsible for monitoring glucose levels in the child. Parents/guardians will be trained in these methods, and will have scheduled phone calls and appointments where the dose and tolerability will be discussed.

Assessments include the following:

* Physical and neurological examination
* Medical and psychiatric history
* X-ray of long bone (e.g., hand) to ensure your child's growth plates are not closed
* Electrocardiography
* Echocardiography
* Pregnancy test if applicable
* Lab safety measures (through blood draw)
* Autism Diagnostic Interview (ADI)
* Autism Diagnostic Observation Schedule (ADOS)
* The Mullen Scales of Early Learning or the Leiter International Performance Scale-Revised
* Vineland Adaptive Behavior Scale (VABS)
* Clinical Global Impressions (CGI) Rating Scales
* The Repetitive Behaviors Scale (RBS)
* Aberrant Behavior Checklist (ABC)
* The Caregiver Strain Questionnaire (CSI)
* Language Environment Analysis (LENA)
* The Macarthur-Bates Communication Inventory (MCDI)
* Unified Parkinson's Disease Rating Scale (UPDRS)
* Quick Neurological Screening Test 2nd Edition (QNST-2)
* Gait Analysis with motion capture video systems and interactive 3-dimensional modeling systems

Eligibility Criteria:
Inclusion Criteria:

* 5 to 12 years old
* pathogenic deletions or mutations of the SHANK3 gene
* stable medication regimens for at least three months prior to enrollment

Exclusion Criteria:

* closed epiphyses
* active or suspected neoplasia
* intracranial hypertension
* hepatic insufficiency
* renal insufficiency
* cardiomegaly / valvulopathy
* history of allergy to IGF-1 or any component of the formulation (mecasermin)
* history of extreme prematurity (\<1000 grams) with associated early neo-natal complications, e.g. intra-cerebral hemorrhage, prolonged hypoxia, prolonged hypoglycemia
* patients with comorbid conditions deemed too medically compromised to tolerate the risk of experimental treatment with IGF-1
Organ Preservation in Locally Advanced Rectal Cancer

PRONAR trial aims to assess if treatment with organ preservation in stage II and III rectal cancer after a complete or almost complete response to neoadjuvant treatment is feasible and safe in our environment.

The main objective of this project is to implement the organ preservation strategy in the treatment of rectal cancer in our environment within a clinical study that allows the analysis of its results in terms of survival.

The secondary objective is to assess local relapse, distant relapse and quality of life.

After pathology confirmed rectal cancer patients with stage II and III (MRI, CT and endoscopy) will be identified in the first visit to Medical Oncology Department. Patients will receive the most appropriate neoadjuvant treatment according to clinical guidelines.

Response to neoadjuvant treatment will be assessed by MRI. Those patients with a complete response in MRI, confirmed by endoscopy, will be offered a "watch and wait" strategy. Patients with a complete response in MRI, with an almost complete response in endoscopy, will be offered transanal endoscopic microsurgery. All patients with complete or near complete response will sign an informed consent before study entry.

Radical surgery will be performed in patients without complete or almost complete response criteria after neoadjuvant treatment.

Patients in organ preserving strategy will be subjected to a more intensive follow up schedule, including MRI and endoscopy, compared to patients with radical surgery.

As the complete histopathologic response rate after neoadjuvant treatment in locally advanced rectal cancer is approximately 15-20%, considering that approximately 40 patients with locally advanced rectal cancer are diagnosed annually in our setting, approximately 6-8 patients per year could be potentially recruited for this project, until reaching an initial sample of 30 patients for evaluation.

The following results will be analyzed:

* Percentage of complete and almost complete responses.
* Percentage of watch and wait and transanal endoscopic microsurgery.
* Disease free survival.
* Overall survival.
* Local relapse rate.
* Distant relapse rate.
* Treatment and outcomes of relapses.
* Colostomy free survival.
* Quality of life.

All data will be obtained from patient's medical records

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed histopathological diagnosis of rectal adenocarcinoma.
* Patients treated with neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy associated or not with induction chemotherapy.
* Patients with evidence of complete or near complete response criteria after completion of neoadjuvant treatment (approximately 8 weeks later). Response criteria should be based on digital rectal examination, flexible rectoscopy and MRI.

Exclusion Criteria:

* Evidence of distant metastases.
The Patients With Gestational Diabetes Were Interfered With Qigong.

The goal of this clinical trial is to learn about in women with gestational diabetes's health conditions.

The main question\[s\] it aims to answer are:

* Can Qigong control blood glucose in women with gestational diabetes?
* Can Qigong improve mood and sleep in women with gestational diabetes? Participants will required to follow the research team for 3 months of qigong practice。 If there is a comparison group: Researchers will compare Qigong groups to see if Qigong's effects.


Eligibility Criteria:
Inclusion Criteria:

* 20 years old≤ age ≤ 40 years old;
* Those with clear awareness, acceptable reading and language expression skills, and barrier-free communication;
* singleton pregnancy;
* gestational age between 24 and 28 weeks, with the upper limit of gestational age set at 28 weeks at the time of inclusion to allow for at least 8 weeks of intervention;
* Body mass index (BMI) is lower than 40;
* Agree to participate in this project and sign the informed consent form.

Exclusion Criteria:

* Those with previous GDM and diabetes;
* Artificial insemination;
* Those with serious obstetric complications and contraindications;
* Participants in other planned and supervised exercise programs or researchers during the study.
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
2. Male or female of age ≥18 and ≤75 years.
3. Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
4. HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
5. Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with \>1cm in diameter, individual diameter \<7cm and less than 10cm in total diameter.
6. no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
7. Preserved liver function (Child-Pugh A or B7).
8. ECOG Performance Status 0 or 1.

Exclusion Criteria:

1. Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as \>50% liver involvement , or arteriovenuous fistula
2. Macrovascular invasion of main or primary branches of portal vein at entry into the study
3. Any contraindication for TACE treatment
4. Any contraindication for Epirubicin administration
5. Advanced liver disease (bilirubin levels \>2 mg/dl, AST or ALT \>5 times upper limit of normal)
6. Renal failure or insufficient renal function (Creatinine levels \>2 mg/dl)
7. Subject unable to receive MRI examination
8. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
9. couldn't commit reliable birth control measures during treatment or within 12 months of treatment
10. Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
11. Subject is not suitable to participate in the study as judged by investigator
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

Subjects are screened between day -14 and day -1.

At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone.

There are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16)

All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)

Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for\> 3 months

Exclusion Criteria:

* Clinically significant outflow obstruction
* Significant post void residual volume
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
* Patient with a neurological cause for abnormal detrusor activity.
* Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses

All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of ≥18.5 and ≤30 kg/m2
* The subject is, in the opinion of the investigator, generally healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The subject is pregnant or breastfeeding.
* The subject has taken any investigational medicinal products 3 months prior to the first dose
* The subject has tested positive at the Screening Visit or at the Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines \[including ecstasy\], barbiturates, benzodiazepines, and cannabinoids).

Other protocol defined inclusion and exclusion criteria may apply