cyrilzakka/clinical-trials huggingface dataset:
CVI Drug Coated Balloon First In Human Trial

The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.

The primary endpoint for this analysis is late lumen loss at six (6) months.

Prospective, controlled, multi-center, open, single arm study

Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

Eligibility Criteria:
Inclusion Criteria:

* Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery
* De novo or restenotic lesion(s) \>70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation).
* Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation).
* Rutherford classification of 2, 3 or 4

Exclusion Criteria:

* Lesion length is \<3 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
* Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
* Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates

Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. But there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already known for their function in fetal lung and gut development. To our best of knowledge, no study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid therapy on the presence and severity of HMD and feeding intolerance in premature neonates.

This study is a randomized controlled trial and held in Cipto Mangunkusumo Hospital.

Pregnant women 28-34 weeks of gestational age, who fulfill the inclusion criteria, divide into two groups. Subjects from both groups receive the hospital protocol of preterm birth, 4 doses of 6 mg of dexamethasone, intravenous 12 hours apart to support lung maturation. Subjects in intervention group receive oral single-dose beta-carotene 25,000 IU, oral single-dose vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels before and after intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded. Neonates showing any signs of HMD and/or abdominal distension will need to undergo additional chest/abdominal x-ray procedures.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who has preterm birth in 28-34 weeks gestational age

Exclusion Criteria:

* Multiple pregnancy
* Drug allergy
* Fetal congenital malformation
* Maternal gestational diabetes mellitus
Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction

This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.

Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function.

This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.

The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with

* intended revascularization (PCI or CABG)
* Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole
* Signs of left heart insufficiency and pulmonary congestion
* Signs of impaired organ perfusion with at least one of the following:

  * Altered mental status
  * Cold, clammy skin
  * Urine output \<30 ml/h
  * Serum lactate \>2mmol/l
* Informed consent

Exclusion Criteria:

* Resuscitation \> 60 minutes, ischemia \> 10 minutes
* No intrinsic heart action
* Cerebral deficit with fixed dilated pupils
* Mechanical infarction complication
* Onset of shock \> 12 h
* Severe peripheral artery disease
* Aortic regurgitation \> II.°
* Age \> 80 years
* shock of other cause
* Other severe concomitant disease
* participation in another trial
TMTP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

investigators aimed to determine the validity of our novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of laparoscopic SLN mapping


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, married, without childbearing requirements at the time of consent.
* FIGO stage IA1-IIB cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
* Subject has provided written informed consent.

Exclusion Criteria:

* Breast-feeding or pregnant
* Ongoing participation in another clinical trial with an investigational drug with 3 months
* Own allergy towards ICG and/or alcohol
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency
Application of ERAS Protocol in Emergency Surgery

This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

Exclusion Criteria:

* age \<18
* emergency surgery for post-operative complications of post diagnostic procedures
Life-Stress Interview for Women With Chronic Urogenital Pain Conditions

The goal of this study is to test the efficacy, feasibility, and acceptability of providing an experiential assessment interview that targets health, and emotional and stressful experiences in a tertiary care setting specializing in women's urology.

In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals identify the links between their stress, emotions, and physical symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotion is likely to influence their physical and psychological well-being.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a chronic urogenital pain condition

Exclusion Criteria:

* non-English speaking
* unable to read
* psychosis
* dementia
* mental impairment
Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers

The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent prior to any study specific procedures;
* Male volunteer aged 18 to 50 years at Screening, both inclusive;
* Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)

Exclusion Criteria:

* Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
* Blood donation within 3 month before administration of the IP;
* Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Prostate cancer is the second most incident cancer among male population worldwide. Radiation therapy by itself or along with surgery and chemotherapy are the main treatments for prostate cancer however prostate cancer cells are only modestly responsive or even unresponsive to the cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in this area and it is not yet known whether radiation therapy is more effective with or without curcumin supplements in treating patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. Age range of 50-80
3. ECOG performance status 0-1
4. Life expectancy \> 5 years
5. Must be enrolled in a social security program
6. No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
7. No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm Hg)
8. No contraindication to luteinizing hormone-releasing hormone agonists
9. No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
10. No hip prosthesis
11. Must not be deprived of liberty or under guardianship
12. No geographical, social, or psychological reasons that would preclude follow up

Exclusion Criteria:

1. Clinical stage T3 or T4
2. Gleason score ≥ 8
3. Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL
4. other prior surgery for prostate cancer
5. concurrent participation in another clinical trial which would require approval upon entry to this trial
6. Gastrointestinal disorders such as IBD, reflux and peptic ulcers
7. Any adverse reaction to curcumin
Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years

Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The objective of this study is to document effects of oxytocin intranasal administrations on behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.

Two groups of patients will be constituted according to their age; "Group 1" children aged from 3 to 6 years (n = 20) and "Group 2" children aged from 7 to 12 years (n = 20). Within each group, subjects will be randomized to receive either oxytocin or placebo for 12 consecutive weeks. A second period of 12 consecutive oxytocin treatment weeks will then be performed for all patients, followed by a 4-week observation period to document effects after discontinuation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patient with a complete genetic diagnosis of Prader-Willi syndrome
* patient treated by growth hormone for at least 1 year
* patient naïve for oxytocin for at least 5 years

Exclusion Criteria:

* patient who do not accept intranasal administrations (major behavioural trouble)
* patient with hepatic insufficiency : serum transaminases (SGOT, SGPT) higher than 3 times normal values for age
* patient with renal insufficiency : serum creatinine higher than 3 times normal values for age
* patient with an antecedent of abnormal electrocardiogram
* patient with arterial hypertension or hypotension
* patient with type 1 or 2 diabetes
Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing

Women were instructed not to use the mobile phones for 24 hours before carrying out the initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace recording was done followed by umbilical artery Doppler ultrasound using high resolution ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of spontaneous decelerations.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 40 years pregnant between
* singleton fetus
* 32-38 weeks' gestation . They were classified into two groups. Group (A) included 120 women with normally growing fetuses. Group (B) included 70 women with growth-restricted fetuses.

Exclusion Criteria:

* presence of medical disorders or obstetric complications (in group A), anomalous fetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios
Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001

The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.

This correlative science study will be a minimum risk assessment of tumor and plasma samples collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to enrollment or at the time of signing consent in the Phase II trial, patients will be approached to participate in the correlative science study. Patients who agree to participate will be assigned a separate study number which will be used to identify their molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples. Clinical outcome results from the accompanying Phase II trial will be used for correlative assessments in this study, however, results from this correlative science study will be kept separate from the assessments and reporting of the clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at the time of enrollment onto this study.
Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring

This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.

Type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling conditions. The onset of type 2 diabetes is a gradual shift from normal to abnormal, giving rarely noticeable symptoms at its early stages or even in later stages when damage has already been caused. Due to the gradual onset, the diagnosis is often delayed, and as much as half of the asymptomatic patients remain undetected. The diagnostic criteria for diabetes are based on artificial boundaries reflecting the risk of complications related to diabetes. The golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is both time consuming and costly. This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test \>7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose \> 7.0 mmol/l and/or 2h plasma glucose \> 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (\<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP (Prevalence, Prediction, Prevention)-Botnia Study in Finland.
* Age 40-75 years

Exclusion Criteria:

* Medication with: insulin, glucagon-like peptide-1 (GLP-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (LHRH) analogues
* Pregnancy
* Known changes in retinal fundus photographs
* Known, microalbuminuria
* HbA1c \>8%
* Fasting plasma glucose \>10 mmol/l
* Medication with metformin, glitazones, gliptins (or acarbose) is allowed but gliptins and acarbose need to be stopped 2 days before testing and during the study
A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy

Colonoscopy is a key technique in the detection and diagnosis of lower gastrointestinal diseases. High quality endoscopy results in better disease outcomes. However, the operant level of different endoscopists is significantly different.This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.

This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.Criteria for inclusion and exclusion are determined prior to endoscopic examination. Candidates who meet all inclusion criteria as well as do not meet all exclusion criteria are bring into the study. Participants randomized before the examination, they are divided into the exposed group assisted by Endo.Angel or the non-exposed group without Endo.Angel. Followup are conducted after the examination.Study will be finished when all followup is done,and the examination result collected from participants will send to an independent review data analysis group.

Eligibility Criteria:
Inclusion criteria:

1. Male or female aged 18 years or above;
2. Colonoscopy is needed to further characterize gastrointestinal diseases;
3. Ability to read, understand and sign informed consent forms;
4. The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.

Exclusion criteria:

1. Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials.
2. Participate in a drug clinical trial and during the elution period of the trial or control drug
3. Drug or alcohol abuse or mental disorder in the last 5 years;
4. Pregnant or lactating women;
5. Patients with multiple polyp syndrome;
6. Patients with known space-occupying tumor or intestinal stenosis;
7. Patients with known perforation or colonic obstruction;
8. A history of anaphylaxis with antispasmodic has been documented;
9. The researchers did not consider the subjects suitable for colonoscopy;
10. The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of chronic maxillary sinusitis

Exclusion Criteria:

* Previous antrostomy
* Sinonasal tumours
* Cystic fibrosis
* History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
* Pregnant or breastfeeding females
* Currently participating in another drug or device study
Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the written informed consent
* Subject is 18 years of age or older.
* Subject meets the ACR criteria for fibromyalgia
* Subject is willing to discontinue prohibited by the protocol
* Subject agrees to use only non-sedating over-the-counter (OTC)medication
* Subject is willing to abstain from the ingestion of alcohol for the duration of the trial.

Exclusion Criteria:

* Subject has protocol prohibited medical \& psychiatric conditions that would exclude subject
* Subject has a current or past history of a substance use disorder including alcohol abuse
* Subject has a clinically significant history of seizure disorder either past or present
* Female subject who is pregnant, nursing or lactating.
* Subject is diagnosed with sleep apnea
* Subject is unable to discontinue protocol prohibited medications
* Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
* Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form.
* Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid).
* Subject is on a sodium-restricted diet.
* Subject has abnormal liver function test or other abnormal lab values
* Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed.
* Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms.
* Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.