cyrilzakka/clinical-trials huggingface dataset:
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
* OAB symptoms not adequately managed by 1 or more anticholinergic agents

Exclusion Criteria

* OAB caused by a neurological condition
* Use of anticholinergics or other medications to treat OAB symptoms within 7 days
* Current use of indwelling catheter or clean intermittent catheterization to empty the bladder
* Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
* Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
microRNA Expression in Renal Cell Carcinoma

In this study, renal cell carcinoma (RCC) related miRNA and the target genes of related miRNA will be examined in order to investigate the role of miRNA in the formation of RCC and look for the biomarker of RCC.

Due to the lack of specific indicators for the early diagnosis of RCC, the RCC patients often have distant metastasis when diagnosed and their five-year survival rate is much low. Therefore, the biological markers of RCC are needed for early detection, early treatment and improvement of the survival rate of RCC patients.

MiRNA and tumor are closely related. MiRNA can control the important cancer-related genes and participate in the tumor cell proliferation, apoptosis, invasion and angiogenesis.

In this study, RCC related miRNA and the target genes of related miRNA will be examined,and the relationship between RCC related miRNA and the RCC pathological types, TNM (tumor-nodes-metastasis) stages and prognosis will be analyzed. The purpose of this study is to investigate the role of miRNA in the formation of RCC and look for the biomarker of RCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary renal cell carcinoma.
* Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Patients with secondary renal cell carcinoma.
* Subjects who refuse to participate in the study and sign the informed consent.
Temperature Measurement Using a Non Invasive Device

Main study objectives:

1. To compare the temperature measured using Medisim's thermometers to the temperature measured using mercury or equivalent reference thermometers.
2. To develop more accurate algorithms for measuring on the forehead as well as behind the ear.
3. To test the difference between various forehead measurement locations in order to allow more convenient measuring that is not depended on the exact location.


Eligibility Criteria:
Inclusion Criteria:

* Patients arriving to the emergency room
* A signed consent by the patient or the guardian.

Exclusion Criteria:

* The medical staff decides that patient is not allowed to participate.
* The patient refuses to participate.
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function

The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From the study results it should be possible to assess if there is an altered Risk: Benefit in patients with moderate hepatic impairment


Eligibility Criteria:
Inclusion:

* Are aged between 18-70 years, inclusive.
* If Female, you must be incapable of becoming pregnant.
* Show FEV1 of more than 70% of the predicted normal at screening.
* Are able to correctly use a DISKUS at the screening visit.
* Have Body Mass Index within the range of 19-33 kg/m2 inclusive.
* Do not show a positive pre-study urine drug screen.
* Do not show a positive pre-study blood alcohol test.
* Demonstrate a clinically normal 12-lead ECG at screening.
* Do not show a positive blood test for HIV.

If you are a Healthy Volunteer you must also:

* Have no significant abnormality on clinical examination.
* Have Liver Function Tests within the reference range at screening.

If you are a Patient Volunteer you must:

* Have moderate hepatic impairment
* Have no significant abnormality on clinical examination apart from hepatic impairment.

Exclusion:

* Suffered an upper respiratory infection in the 4 weeks before the screening visit.
* Suffered a lower respiratory infection in the 6 weeks before the screening visit.
* Taken oral corticosteroids in the 8 weeks before the screening visit.
* Taken inhaled, intranasal or topical steroids in the 4 weeks before the screening visit.
* A prolonged heartbeat (QTc interval \>470msec).
* High blood pressure (systolic \>160mmHg or diastolic \>90mmHg) or as defined by the Investigator.
* Known sensitivity to corticosteroids.
* A history of lactose intolerance.
* A history of severe milk protein allergy.
* Donated blood in the last 3 months, or more than 1500mL (1000mL if female) in the last 12 months (including the amount taken for this study).
* Participated in a clinical trial within the last 3 months where you are/were exposed to a drug or device.
Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

The overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.

The study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of MRD should reduce both treatment-related toxicities and relapse risk.

The patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. There are no experimental drugs in this study. All the drugs used are standard established treatment for childhood ALL for the last 30 years. The difference in treatment is by changes in the frequency and dose of the chemotherapy drugs.

The overall study treatment lasts for about 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of non-Burkitt B-lineage ALL
2. 1 to 17 years of age (before 18th birthday)
3. Renal function within normal range for age
4. Liver function within normal range for age
5. Able to participate in the full 2 years of treatment

Exclusion Criteria:

1. Age less than one year or age greater than/equals to 18 years
2. Previous treatment with cytotoxic agents or high-dose steroids
3. Mixed phenotype acute leukemia (MPAL)
4. ALL as secondary malignancy
5. Abnormal renal or liver function
6. Doubtful compliance or unable to afford full course of therapy
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.

This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.

The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, male and female adults, 18-55 years of age at screening
* With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
* Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
* Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
* Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
* Demonstrate ability to use a DPI and MDI inhaler properly after training
* Females must be not pregnant, not lactating, and using a clinically acceptable form of birth control
* Properly agree to participate in the trial

Exclusion Criteria:

* A smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit
* Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
* Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
* Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
* Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
* Known intolerance or hypersensitivity to any ingredients of the study drug DPI or Proventil MDI (i.e.: Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid and ethanol)
Potential Effects of Intermittent Fasting to Metabolic Syndrome

The survey is designed to investigate whether 8 weeks of discrete two-day intermittent fasting per week will impact gut microbiota and cardiovascular risks of metabolic syndrome subjects.

Intermittent fasting was demonstrated to optimize energy metabolism and promote health. However, the benefits of intermittent fasting to gut microbiota are remain unclear. Further evidence is needed in understanding the effects of intermittent fasting to gut microbiota and cardiovascular risks in subjects with metabolic syndrome

Eligibility Criteria:
Inclusion Criteria:

* Local residents aged between 30 to 50 years old
* Stable body weight (change \<±10% of body weight) for 3 months before the study
* Central obesity: waist circumference ≥90 cm in males or ≥80 cm in females; plus any two of the following four conditions:

  1. Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L)
  2. Reduced HDL cholesterol: serum HDL-c \<40 mg/dL (1.03 mmol/L) in males or \<50 mg/dL (1.29 mmol/L) in females
  3. Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or receiving medication of hypertension
  4. Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

* History of cardiovascular and cerebrovascular diseases
* Acute or chronic infectious diseases within 4 weeks
* Known malignant tumor
* Alcohol abuse (weekly consumption of alcohol is more than 70 g in females or 140 g in males)
* Regular therapy with antihypertensive drug, hypolipidemic agents, hypoglycemic agents, hormonal agents and antidepressants within 6 months
* Use of probiotics, prebiotics or antibiotics within 3 months and in progress of study
* Use of antiinflammatory drug in progress of study
* Following a vegetarian diet or veganism
* Women who are pregnant or intend to be pregnant during the research
αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT). Patients will receive an allogenic HSCT from a matched unrelated donor (MUD), mismatch unrelated donor (MMUD) or a mismatched related (haploidentical) donor. Patients will receive a granulocyte-colony stimulating factor (G-CSF) ± Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS® αβT cell/CD19+B cell depletion. Cluster of Differentiation 34 (CD34) and αβT cell content of the graft is determined based on the transplant indication.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 30 years
* Patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor.
* Karnofsky Index or Lansky Performance Scale ≥ 60 % on pre-transplant evaluation.
* Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients ≤ 16 years of age.
* Patient or legal guardian must give informed consent if patient is ≥ 18 years. Legal guardian must give informed consent (and patient must give assent if appropriate) if patient is \< 18 years.
* Adequate organ function (within 4 weeks of initiation of preparative regimen). For patients receiving Myeloablative conditioning (MAC) on this platform, they should meet organ function to tolerate MAC. Similar if patients are receiving Reduced intensity conditioning (RIC).
* High resolution human leukocyte antigen (HLA) available

Exclusion Criteria:

* Patient does not have a suitable donor who is willing and able (meets donor criteria).
* Patient reports a history of allergic reactions to murine protein
* Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. Female patients of childbearing potential females ≥11 years of age or post- menarche and should have a negative pregnancy test
* Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation. Viremia by Pluripotency Check (PCR) analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic -
* Patients receiving umbilical cord blood and matched sibling donor transplants
Gynecological Health Improvement of Adult Women With Cystic Fibrosis

Following the results of the research team's cross-sectional study conducted in 2014 describing insufficient gynecological care, the research team implemented an on-site gynecological consultation in the adult Cystic Fibrosis (CF) centre in 2015. The study aimed to compare the results of two surveys conducted successively in 2014 and in 2017 on a cohort of women with CF attending the Lyon CF adult referral centre. All the women attending the adult CF center in 2017 were asked to complete the same self-report written questionnaire that was completed in 2014 about their contraceptive choices, gynecological follow-up and cervical screening. Questions concerning gynecological comorbidities were added to the 2017 questionnaire.

This current study aimed to evaluate the impact of the implementation of an on-site gynecological consultation on gynecological health of women with CF, as measured through 3 indicators: the proportion of women with regular gynecological follow-up, cervical screening coverage, and contraceptive coverage. The identification of specific gynecological comorbidities was the other objective of this study.


Eligibility Criteria:
Inclusion Criteria:

* women with cystic fibrosis
* subjects followed by the Cystic Fibrosis Adult Referral Centre in Lyon, France in 2017

Exclusion Criteria:

* None
DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment

This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>18y;
2. ECOG physical status 0-1;
3. The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
4. According to the RECIST 1.1 standard with measurable or evaluable lesion;
5. Accept swallow oral drug;
6. WBC≧4.0×10\^9/L;ALC≧0.8×10\^9/L;ANC≧1.5×10\^9/L;PLT≧100×10\^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L;
7. The expected survival time of more than 3 months;
8. good compliance;
9. Provide written informed consent.

Exclusion Criteria:

1. Vital organs (heart,liver,kidney) function is serious dysfunction;
2. Patients received organ transplantation;
3. Patients with other malignant tumors or have occurred brain metastasis;
4. Patients with history of autoimmune disease;
5. Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
6. Patients with acute infection disease or in chronic active stage;
7. Patients with clear history of drug allergy or belong to allergic constitution;
8. Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;
9. Patients received other clinical trials in 4 weeks.
Evaluation of Transperineal Ultrasound Technic for Diagnostic Shorted Cervical Length for Pregnant Women (2nd and 3rd Trimester) Compared to Endovaginal Technic (Gold Standard)

Endovaginal ultrasound is currently the gold standard to diagnose a shorted cervical length and, by extension, assess the risk of preterm labor. The major inconvenient is that this is an invasive method of diagnosis that tends to be poorly accepted by some patients. This study aims to evaluate the accuracy of a noninvasive transperineal ultrasound cervical measurement in comparison to the endovaginal technic in 2nd and 3nd trimester pregnant women where a cervical ultrasound is indicated.

The cervical length is a crucial part of the diagnostic of premature labor. The gold standard technic is the endovaginal ultrasound. This is a technic with good reproducibility and good precision. Some authors have found the transperineal technic to present the same characteristics, without being as invasive. The aim of the study was to compare the results of the less invasive technic to the current invasive gold standard in pregnant women who consult for contraction, or for whom cervical modification is suspected in order to determine whether the former could replace the latter.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 2nd and 3rd trimester consulting in obstetric emergency for whom a cervical ultrasound is indicated

Exclusion Criteria:

* minor patients
* mentally deficient persons
Percutaneous Cryoablation Peripheral Lung Cancer

This study is focus on percutaneous cryoablation,which was for the treatment of medically inoperable Peripheral lung cancer.The patients who were agreed to attend the study will accept the operation. After the operations,they will follow up according to the plan.

The patients who were agreed to attend the study conclude early stage lung cancer and solitary metastatic lung cancer.

Eligibility Criteria:
Inclusion Criteria:

medically inoperable peripheral lung cancer Diameter no more than 3cm

Exclusion Criteria:

1. Refusal of participation
2. tendency to bleed to that can't receive percutaneous cryoablation.
3. Severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.
GS3-007a Oral Solution in Healthy Subjects

To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects aged 18-45 years (including boundary values), male and female;
* Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;

Exclusion Criteria:

* Patients with a history of substance abuse and substance dependence;
* Family history of sudden death;