cyrilzakka/clinical-trials huggingface dataset:
Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil

The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.

The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.
* Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7
* History of undergoing treatment with sildenafil 100 mg for four sessions.
* Evaluation of IIEF-5 score \< 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4
* Type II Diabetes Melitus with an HbA1c test result of \< 7%.
* Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.
* Patients with undergoing treatment with antidepressant.

Exclusion Criteria:

* Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.
* Active and significant systemic or local infection.
* History of bleeding or blood clotting disorder therapy.
* History of systemic autoimmune disorders and immunosuppressive treatment
* History of prostate surgery, history of malignancy, or a PSA level \> 4 ng/mL.
* Untreated hypogonadism or low serum total testosterone (\<200 ng/dL).
* Uncontrolled hypertension or hypotension (systolic blood pressure \>170 or \<90 mmHg, and diastolic blood pressure \>100 or \<50 mmHg).
* Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).
Antigen-specific Immune Response to Hepatitis B Virus in Utero

This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers.

Despite the development of an effective preventive HBV vaccine, the spread of HBV virus continue, particularly in Asia, where the majority of HBV infection is acquired at birth by vertical transmission from mother to baby. HBV vertical transmission has been hypothesized to cause immune tolerance to HBV and thus promoting the subsequent HBV chronicity. Such hypothesis has never been tested and nothing is known about HBV-specific adaptive immune response occurring before birth in baby born form HBV chronically infected mothers. This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. The characterization of the HBV immune response in utero will provide informations about the cause of HBV chronicity in Asian patients in the management of baby born from HBsAg+ mothers.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with HBsAg+

Exclusion Criteria:

* Pregnant women without HBsAg+
IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation

The purpose of this research study is to investigate the safety and effectiveness of botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection of incobotulinum toxin A into an area of local pain, at or around the area of a post-surgical/post radiation scar, relieves the focal cancer pain.

Please contact the PI for more detailed information.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18- 80 years, both sexes, all races and ethnic groups.
* Diagnosis of post- surgical/post - radiation cancer pain.
* Focal pain duration longer than 3 months
* Pain of moderate to severe intensity ( mean VAS over the previous week \>4 )
* Subjects who are able to read, speak, and understand English.

Exclusion Criteria:

* Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
* Pregnancy or planned pregnancy (determined by urine pregnancy test). Women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
* Active breast feeding.
* Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
* Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication.
* Subjects who are younger than 18 years of age.
* Neuromuscular-junction disorders.
* Axis I diagnosis determined by a neurologist or psychiatrist.
* Use of anesthetic medications within two weeks or corticosteroid injections within 4 weeks of enrollment.
* Received botulinum toxin injections in the past 4 months.
* Patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction ( anticholinergic, muscle relaxants)
* Patients who have unstable pain in/at sites other than areas of planned injection
The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer

The study is designed as an observational cohort study, aiming to evaluate, whether a structured recording of symptoms by a mobile app contributes insight in the follow-up modalities of ovarian cancer patients.

The observational study will examine different follow-up modalities for ovarian cancer patients with the ultimate goal of improving follow-up strategies for an improved well-being and better clinical outcomes. The primary objective is to quantify the effects of conservative clinical diagnostics by collecting symptoms via ePRO in addition to intensive diagnostics (CA-125 testing, imaging diagnostics) during follow-up, on survival, time to clinical recurrence and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 years
* Between diagnosis and the first follow-up visit after the end of their antineoplastic treatment (systemic therapy or surgical treatment) for ovarian cancer.
* German, English, French, or Italian speaking
* Personal smartphone (iOS or Android system); one of the latest three main versions

Exclusion Criteria:

• Patients whose compliance must be questioned, e.g. due to a psychiatric disorder, private life situation or insufficient knowledge on smartphone use and do not have a suitable caregiver to assist them with symptom reporting.
Thrombus Aspiration in Myocardial Infarction

Treatment of myocardial infarction (blood clot in the arteries of the heart) has improved after introduction of 24/7 balloon angioplasty to open the blocked artery. However, the clot itself is not routinely removed but recent data in smaller trials indicate that this might improve recovery and prognosis. In this multicenter study of 5000 patients referred to Scandinavian hospitals for myocardial infarction the investigators test the hypothesis that patients randomized to treatment with thrombus aspiration (removing the blood clot by manual suction) before conventional angioplasty will have a reduced risk of death, fewer rehospitalisations, fewer new myocardial infarctions, reduced risk of heart failure, better coronary artery flow after angioplasty and greater reduction of infarct size compared to patients randomized to conventional angioplasty alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of ST-segment elevation myocardial infarction
* Correspondence between ECG findings and culprit artery pathoanatomy
* A minimum of 50% stenosis in culprit artery by visual estimate
* Possibility to perform thrombus aspiration

Exclusion Criteria:

* Need for emergency coronary artery bypass grafting
* Inability to provide informed consent
* Age below 18 years
* Previous randomization in the TASTE trial
Reference Interval of Spot Urinary Oxalate to Creatinine Ratio in Children

Reference intervals (RI) of oxalate for the Pakistani population are not readily available. The values used by most labs are usually taken from the literature from studies mainly performed on Caucasian or from the manufacturer package insert of oxalate reagent kits \[2\]. RI of an analyte assist the clinician in differentiating between health and disease \[3\]. It is established by testing healthy populations and figuring out what appears to be "normal" for them after defining the reference population demographically. Careful determination and verification or validation of RI by the laboratory are essential to ensure proper utility.

A cross-sectional study was conducted at Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, from June 2018 to October 2019 after approval from Aga Khan University Hospital's ethical review committee.

Inclusion criteria included children less than six years of age, not suffering from any illness during the last two weeks and no hospitalization since the last four weeks. Children on vitamins or history of kidney stones or family history of kidney stones were excluded.

A standardized questionnaire was used, and recommended target sample size was calculated using CLSI Guidelines C28-A3. Non-probability (consecutive sampling) was done. Parents or guardians of each reference individual were invited to participate in the study. An explanation of the study, consent form (written in the local language, in accordance with the guidelines of the local ethics committee), and the procedure for participation were explained to the parents by the primary investigator. Those who consented were provided with a container for urine collection, and the procedure for the collection was explained. A 5ml random morning urine sample was collected and stored at -30 ºC until analysis after adding 6M hydrochloric acid.

Urinary Oxalate was measured on Micro lab 300 using a kit based on the oxalate oxidase principle by Trinity Biotech Plc, Wicklow, Ireland while creatinine was measured by kinetic Jaffe reaction ADVIA 1800 by Siemens Diagnostic, USA. Samples were analyzed in batches with quality control specimen for validating the results. Oxalate to creatinine ratio (Ox: Cr) was calculated. College of American Pathologist, USA accredits clinical Laboratory of Aga Khan University Hospital.

Data were analyzed by EP evaluator and SPSS 23. Subjects were categorized based on ages into five groups. Group I (0-6 months), Group II (6 months-1 years), Group III (1-2 years), Group IV (2-4 years), and Group V (4-6 years). Descriptive data were analyzed for frequencies and median with IQR. P-value \<0.05 was taken as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included children less than six years of age, not suffering from any illness during the last two weeks and no hospitalization since the last four weeks.

Exclusion Criteria:

* Children on vitamins or history of kidney stones or family history of kidney stones were excluded.
Veterans Coping Long-term With Active Suicide

The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an innovative, telephone-based intervention that combines elements of individual therapy, case management, and significant other/family therapy and is designed to be integrated into a VA system.

Suicide is a leading cause of death for military personnel, and for the first time in recorded history, rates of military suicides are exceeding civilian rates. Despite public and patient health costs associated with suicidal ideation and behavior, existing efforts haven't appreciably reduced rates of suicidal behavior in the military. Consequently, finding novel, efficacious, and acceptable methods to reduce suicide behaviors is imperative. The Veteran's Coping Long Term with Active Suicide Program (CLASP-VA) is a unique suicide reduction intervention that directly targets high-risk patients at the time of hospital discharge. It is one of the few empirically-developed and promising interventions (e.g., strong pilot data) for individuals hospitalized for suicide behavior.

The primary objective of this study is to test the efficacy of the CLASP intervention compared to a treatment as usual plus Safety Assessment and Follow-up Evaluation (SAFE) control condition. Efficacy will be determined by primary outcomes including: number of attempts, number of re-hospitalizations, severity, and chronicity of suicidal ideation. A secondary objective is identifying the types of patients who receive the most benefit from the CLASP-VA intervention.

Eligibility Criteria:
Inclusion Criteria:

* suicide attempt or suicidal ideation with any methods, plan, and/or intent to make a suicide attempt within 1 week of hospitalization
* age greater than 18
* have a telephone
* ability to speak, read, and understand spoken English sufficiently well to complete the procedures of the study

Exclusion Criteria:

* long-term psychiatric disorder
* diagnosis of borderline personality disorder
* cognitive impairment which would interfere with adequate participation in the project (MMSE \<20)
Pediatric Asthma Control Under Community Management Model in China

The purpose of this study is to learn the pediatric asthma control status under community management model. To learn the differences of pediatric asthma control status when subjects assigned to community hospitals or Shanghai Childrens Medical Centre. To learn the treatment adherence and the frequency of asthma attack under community management model.

Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. Asthma medicine will be prescribed by the investigator according to patient's asthma severity and control status. The subject will be assigned to the nearest community hospital or Shanghai Children's Medical Center, whichever is nearer to the subject's home, for their future onsite visits. The patient's caregiver will be instructed to install the study-specified application program (APP) at their smart phone and learn how to use this APP.

During the study, patients will receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children".

The patients' caregiver will be prompted to fill out an asthma control questionnaire and asthma control test via their smart phone APP every month.

Patients will be requested to visit prearranged community hospitals at month 1, 3, 6, 9 and arrange their last visit back to Shanghai Children's Medical Center at month 12. During each onsite visit, asthma-related information will be collected by the investigators.

Meanwhile, subjects will receive PEF (\>5 years old) and FENO tests for evaluation of lung function and inflammation level. After comprehensive assessment of the patient's symptom control, risk factors, occurrence of exacerbations, and practical issues (cost, ability to use the device, and adherence), the investigator will make the decision on whether stepping up or stepping down asthma treatment.

This study ends up without follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Out-patient, female or male, aged less than 18 years old
2. Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children"
3. Consent should be obtained by subjects' guardian
4. The subjects or subjects' caregiver must have a smart phone at their disposal

Exclusion Criteria:

1. Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc.
2. Allergy to any inhaler cortical steroid
3. Subject with other diseases that may interfere the study results judged by the investigators.
4. Participation in any analogous clinical study within 3 months
Preoperative Optimization to Improve Functional Status

This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients.

The two specific aims of this study are to conduct an initial pilot study with the following goals:

1. To obtain information on feasibility and utilization of the program
2. To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure

Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment
* Age\>65 y/o

Exclusion Criteria:

* Impaired cognition that would limit participation in the program
* History of spontaneous pneumothorax
* Any other physician judgement
Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.

The primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value.


Eligibility Criteria:
Inclusion Criteria:

1. Female and/or male
2. Aged between 12 months to 11 years
3. phototype: I to IV
4. Subject or parent(s)/legal representative(s) must be registered with health social security or health social insurance.
5. Parent(s)/legal representative(s) having signed their written Informed Consent form (ICF) for their children's participation in the study
6. Subject and / or parent(s)/legal representative(s) able to understand the language used in the investigation centre and the information given
7. Subject or parent(s)/legal representative(s) able to comply with the protocol, follow protocol's constraints and specific requirements and able to follow the medical recommendation regarding the pathology and its requirements (treatment, social eviction etc)
8. Subjects presenting non severe and non complicated chicken pox

Exclusion Criteria:

1. Subject or parent(s)/legal representative(s) who is (are) unable to understand the information (for linguistic or psychiatric reasons) and to give his/her (their) consent to his/ her (their child) participation
2. Subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
3. Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
4. Subject or parent(s)/legal representative(s) admitted in a sanitary or social facility
5. Subjects planning a hospitalization during the study
6. Severe or complicated chicken pox (surinfection, profuse eruption, pneumonia, etc)
7. Having an acute, chronic, or progressive disease or dermatological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
8. Having personal medical history liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
9. Being under any treatment for a severe or complicated chicken pox considered by the Investigator liable to interfere with the study data or incompatible with the study requirements (antiviral (Herviran) or antibiotics...)
10. Having taken any previous treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
11. Systemic antibiotics within 1 week before the inclusion or required during the study
12. Systemic immunosuppressive treatment within 6 months before the inclusion or required during the study
A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers

Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Methodology Validation

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Normoresponsive airways - histamine PC20\>16mg/mL
* Able to complete sputum induction successfully

Exclusion Criteria:

* Non (or ex) smokers
* No LPS challenge in previous 4 weeks
Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension

Flatter Me is a product that includes digestive enzymes in a way to support digestion of macronutrients and their constituents and provides herbs traditionally used for digestive health support. This trial aims to test Flatter Me against a placebo pill to examine differences in both subjective outcomes (feelings of bloating and indigestion) and changes in waist circumference (abdominal distension) after eating a test meal.


Eligibility Criteria:
Inclusion Criteria:

* Self Report bloating or stomach distension at least once per day after eating

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Currently taking any prescribed medication meant to treat gut health
* Currently taking any medication for fluid balance (i.e., Aldactone)
* Currently suffers from any pre-existing condition that would prevent them from adhering to the protocol.
* Currently suffers from any pre-existing condition that would prevent them from consuming cheese pizza.
* Use of an antibiotic in the previous 3 months.
* Taking an iron supplement with \> 65mg of iron in the last week.
* Diagnosed with any of IBS, chronic constipation, GERD, Crohn's Disease, ulcerative colitis, celiac disease, liver disease, kidney disease, heart failure.
* Lactose Allergy or Intolerance
* Any food allergies
* Current smoker
* Wears dentures
A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients

This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients


Eligibility Criteria:
Inclusion criteria:

1. Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy
2. Age 18 years or older
3. Eastern Cooperative Group performance score of 2 or less
4. Child-Pugh score of 7 or less
5. Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

1. Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II)
2. More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I)
3. Uncontrolled or refractory ascites to adequate medical therapy
4. Bilirubin greater than 1.5 times upper limit of normal
5. Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal
6. Absolute neutrophil count less than 1500/microliter
7. Platelet count less than 75000/microliter
8. Hemoglobin less than 9 g/dL
9. Serum creatinine greater than 1.5 times upper limit of normal