cyrilzakka/clinical-trials huggingface dataset:
Non-Inferiority Study to Compare the Effectiveness of the Seldinger Over-the-Wire Technique and the Modified Seldinger Technique

Peripherally inserted central venous catheter lines (PICC-line) are successfully used since many years in patients who need long-term frequent IV therapy. The PICC placement is performed under fluoroscopy The study objective is to compare the effectiveness and safety of the Seldinger wire technique (over-the-wire) using a 145 cm guidewire with the modified Seldinger technique using a 70 cm guidewire.

The referral of patients with indication to PICC-line implantation at the institute of diagnostic and interventional radiology occurs through different departments of the University Hospital Jena. The patients are registered for radiological treatment and checked again by a radiologist if a PICC-line implantation is indicated. If this is the case, the radiologist conducts an informed consent discussion with the patient about possible complications and risks during intervention and informs him also about a possible study participation. After signature of the written informed consent, the patient is included. He can, at any time, withdraw his consent. On the intervention day, the patient is randomly assigned to one of the two study arms through envelope (145 cm vs 70 cm). The intervention time is documented. After intervention, the patient is transferred back to the ward or sent home. The examination of the puncture site before discharge is performed by a ward physician or by the family doctor.

Within 2 weeks after PICC-line implantation, the treating physician is contacted and questioned about possible complications (catheter occlusion, haematoma, infection of the puncture site, arm vein thrombosis, pain, etc.), that are then thoroughly documented.

Eligibility Criteria:
Inclusion Criteria:

* female, male
* adults ≥ 18 years
* medical indication for Power-PICC-Line catheter implantation because of chemotherapy or parenertal nutrition
* in- and outpatients

Exclusion Criteria:

* age \< 18 years
* systemic infection
* local infection of the interventional location
* known allergy to used material
* general contraindication of Power-PICC-Line catheter implantation
Acupuncture for Residual Insomnia Associated With Major Depressive Disorder

The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on residual insomnia in major depressive patients.

This is a randomized single-blinded controlled trial. Patients will be randomly assigned to one of the three groups. One is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. Patients will be put into groups and then compared. The chance of getting into each group is 1:1:1, i.e. equal chance.

Eligibility Criteria:
Inclusion Criteria:

* Willing to give informed consent;
* Hong Kong resident;
* Age 18-65 years;
* Previous DSM-IV Major Depressive Disorder as confirmed with the Structured Clinical Interview for DSM-IV;
* Hamilton Depression Rating Scale scores of 18 or below for at screening and baseline visit;
* A chief complaint of insomnia;
* Able to comply with the trial protocol.

Exclusion Criteria:

* Any symptoms suggestive of specific sleep disorders, including loud snoring, periodic leg movement, parasomnia;
* A diagnosis of sleep apnea or periodic limb movement disorder (PLMD) as assessed by overnight polysomnography (PSG);
* Presence of suicidal risk;
* Previous history of schizophrenia, other psychotic disorders, and bipolar disorder;
* Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception;
* Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe.
Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 capsules total) or matching placebo capsules QD for 6 months.

The study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study \[EOS\] visit.) The treatment phase consists of 4 scheduled study visits: visit 1 (baseline/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4 (EOS (month 6).

Primary objective:

To compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 1.5 g QD, as compared with placebo.

Secondary objective:

To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared to placebo in the maintenance of remission from mild to moderate UC.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month
* Greater than 18 years of age

Exclusion Criteria:

* Allergy/intolerance to aspirin, mesalamine, or other salicylates
* Prior bowel surgery other than appendectomy
* Pregnancy, at risk of pregnancy, or lactating
* HIV or hepatitis B or C
Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)

The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease the rate of Muscle Pain in patients with previous statin related Muscle Pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms

Exclusion Criteria:

* Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.
Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates

Objective: To study the feasibility and validity of a two-step telephone screening procedure for symptomatic knee and hip osteoarthritis (OA) in the general population.

Method: The screening questionnaire was based on signs and symptoms, previous diagnosis of OA, and validated OA criteria. A random sample of telephone numbers was obtained and, at each number, one individual aged 40 to 75 years was included. A physical examination and knee or hip radiographs were offered when the screen was positive. A sample of individuals with negative screens was also examined. The diagnosis of hip/knee OA was based on either American College of Rheumatology criteria for signs and symptoms and Kellgren-Lawrence radiographic stage 2 or greater. Prevalence rates were estimated with correction for the performance of the screening procedure.


Eligibility Criteria:
Inclusion Criteria:

* Individual aged 40 to 75 years
Effect of Core Stability Exercise Versus Whole Body Vibration in Improving Vitamin D Absorption in Women

This study was conducted to explore the influence of core stability exercise versus whole body vibration in improving vitamin D absorption in women.

This study was conducted to explore the influence of core stability exercise versus whole body vibration in improving vitamin D absorption in women.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D concentration was less than 12ng/ml and age between 20 and 50 years and Their BMI less than 30

Exclusion Criteria:

* Vitamin D concentration was greater than 20ng/ml, Their BMI greater than 30 and exhibited a history of significant medical diseases such as rheumatoid diseases, uncontrolled high blood pressure, serious heart or lung issues, chronic viral infections including herpes and hepatitis
Postoperative Pain Score of Laparoscopic Gynecological Surgeries

In this study, it was aimed to compare the embryonic route, the umbilicus, and the sub-umbilicus incision in terms of postoperative pain scoring. For this purpose, in laparoscopic hysterectomies performed for benign reasons, it is planned to measure the pain score at the 8th hour and 1st day postoperatively in the umbilicus and subumbilical incision. Visual analog scoring system will be used for pain scoring.

In this prospective randomized study, Baskent University Adana Dr. Turgut Noyan Application and Research Center for benign reasons (myomas that cause abnormal uterine bleeding, resistant to medical and hysterescopic surgery, treatment-resistant adenomyosis in which the uterus reaches 12 weeks of gestation, recurrent endometrial hyperplasia, endometriosis, stage 1 endometrial cancers that only underwent hysterectomy) in laparoscopic hysterectomies; at the entrance to the abdomen, it is planned to apply the umbilicus, which is the anatomical route, to some of the patients, and to the other part of the sub-umbilicus incision. It will be compared in terms of pain score on the 8th hour and 1st day after surgery. The minimum quorum for each group was determined by calculating 41 and taking a total of 82 patients. The simple randomization technique will be applied in the distribution to the study sets. Based on the studies, it is thought that the anatomical path may be less painful.

Eligibility Criteria:
Inclusion Criteria

1. Patients who underwent laparoscopic hysterectomy for benign reasons
2. Stage 1 endometrial cancers that only underwent hysterectomy

Exclusion Criteria:

1. Malign disorders
2. Uterus larger than 12 weeks of gestation
Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.

To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 6 to 8 years on the day of inclusion
* Informed consent form (ICF) signed by parent(s)/legal representative
* Able to attend all scheduled visits and to comply with all trial procedures
* Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus toxoids and whole cell Pertussis vaccine (DTP)
* Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of DTP or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, one of the following adverse events

  1. encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose
  2. temperature of \> 40.5 °C within 48 hours not due to another identifiable cause
  3. collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
  4. persistent, inconsolable crying lasting \> 3 hours, occurring within 48 hours
  5. seizure with or without fever occurring within 3 days
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the past 3 months
* Any vaccination in the 4 weeks preceding the trial vaccination (except Oral Poliomyelitis Vaccine \[OPV\])
* Any vaccination planned during the present trial period (except OPV)
* History of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically)
* Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine
* Clinical or serological evidence of systemic illness including Hepatitis B, C or Human Immunodeficiency Virus (HIV)
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (axillary temperature ≥ 37.4 °C) or acute illness on the day of inclusion
Characteristics and Prognostic Outcomes of Diaphragmatic Ultrasound in Myasthenia Gravis

The goal of this observational study is to learn about the characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis. The main question it aims to answer is:

Does diaphragmatic ultrasound predict prognosis of myasthenia gravis in six months? Participants diagnosed as myasthenia gravis will take the diaphragm ultrasound examinations.


Eligibility Criteria:
Inclusion Criteria:

* 1: Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors

  2: Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins

  3: Repeated electrical stimulation examination showed a decrease in wave amplitude.

Exclusion Criteria:

* 1: Patients with lung disease or heart failure, or a history of non-invasive ventilator or tracheotomy
Autologous Bone Marrow Stem Cells in Ischemic Stroke.

The aim of the study is to determine the safety and tolerability of an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (TACS/PACS).

The proposed trial will involve the recruitment of a total of 10 patients.

The cells will be collected from each subject recruited, via bone marrow sampling. CD34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of Good Manufacturing Practice. The CD34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery.

Initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. Thereafter, they will revert to their previous treatment regime in the clinic.

Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs of clinically definite acute stroke
* Time of stroke onset is known and treatment can be started within 7 days of onset
* CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
* The stroke is severe and conforming to the TACS phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or PACS phenotype (two out of the three TACS criteria)
* An age range of 30-80 years old
* Stroke confined to MCA territory on CT or MRI brain imaging
* NIHSS score \>/= 8

Exclusion Criteria:

* Known defect of clotting or platelet function (but patients on anti-platelet agents can enrol)
* Haematological causes of stroke
* Severe co-morbidity
* Hepatic or renal dysfunction
* The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
* Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is \< 3.0 or \> 20.0mmol/L
* Patient is likely to be unavailable for follow-up e.g. no fixed home address
* Patients with evidence of life threatening infection (e.g. HIV) or life threatening illness (e.g. advanced cancer)
* Patient was already dependent in activities of daily living before the present acute stroke
* Patients who have been included in any other clinical trial within the previous month
Project BITE: Binge Intervention Target Effectiveness

The primary aim of this study is to determine how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome.

Binge eating disorder (BED) is characterized by reoccurring binge eating episodes that consist of eating a subjectively or objectively large amount of food over a period of time accompanied by a sense of loss control over eating, in the absence of recurrent compensatory behaviors (e.g., purging). Cognitive behavioral therapy (CBT) is the current gold-standard treatment for reducing binge eating episodes in BED patients. The first-line of recommended CBT treatment is a self-guided intervention called CBT-Guided Self-Help (CBT-GSH). However, for a substantial minority of patients, CBT-GSH fails to reduce binge episodes after treatment. Preliminary findings of the literature suggests that individuals with BED possess deficits in inhibitory control as it relates to food-stimuli. We are studying how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome.

This study involves a brief phone screen and research assessment (approximately 5 hours) to determine eligibility. Eligible participants will receive CBT-GSH, which will include a one-hour clinical intake followed by 6 therapy sessions (approximately 30 minutes each). Participants will also complete research assessments at mid-treatment, post-treatment, and 3 month follow-up intervals. Research assessments include a battery of questionnaires, computerized tasks, interviews, and a task using functional Near Infrared Spectroscopy (fNIR) imaging.

Eligibility Criteria:
Inclusion Criteria:

* Speak, write, and understand English
* Body Mass Index (BMI) of 30 kg/m2 or greater
* Experience objectively or subjectively large binge eating episodes once per week or more for the past three months
* If applicable, have stable psychiatric medication for the past three months
* For the optional ecological momentary assessment, participants must own a smartphone compatible with PACO mobile application

Exclusion Criteria:

* Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)
* Acute suicide risk
* Are currently receiving psychological treatment for binge eating
* Are currently receiving weight loss treatment
* Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
* Diagnosis of intellectual disability or autism spectrum disorder
* History of neurological condition or traumatic brain injury
* Current pregnancy
* History of bariatric surgery
* Are currently using a stimulant medication
Emtricitabine for Prevention of Vertical Transmission of HBV in Chinese Pregnant HBsAg Positive Patients

This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant HBsAg positive patients in prevention of HBV vertical transmission. Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery.

Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery, which include HBeAg positive patients. Patients and their newborns were followed till 48 weeks after delivery to evaluate the efficacy of prevention of vertical transmission.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive for more than 6 months
* HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
* HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
* HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* Nucleoside/nucleotide naive paitents
* Diagnosed as ≥ 28 weeks pregnancy

Exclusion Criteria:

* Diagnosed HCC with AFP and ultrasound, CT or MRI
* Creatine \>130μmol/L or Ccr \< 70mL/min
* Hemoglobin \<100g/L
* Coinfected with HAV,HEV,HCV,HDV or HIV
* ANA \> 1:100
* Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
* Drug abuse or alcohal addiction
* Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
* Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
* Underwent liver transplantation or liver transplantation in schedule
* Allergic to nucleoside or nucleotide analogues
* family history of genetic defects disease
* Abnormal results in fatal defects screening
* HBsAg positive sperm provider pregnancy
Delving Into Borderline Personality Disorder Clinical Trial Experiences

Taking part in medical study usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical research experience of borderline personality disorder patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future borderline personality disorder patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Clinical diagnosis of Borderline Personality Disorder
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* No diagnosis of Borderline Personality Disorder confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form