cyrilzakka/clinical-trials huggingface dataset:
UGIST: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling

The purpose of the study is to determine if tunneling standard short-term central lines for a short distance under the skin, with the assistance of ultrasound imaging, reduces the risk of central line infections for catheters placed in the neck vein.

Previous work has shown that these lines can be tunneled without ultrasound guidance. We wish to determine if the use of ultrasound makes the tunneling procedure safer and easier.

More than 250,000 vascular catheter-related bloodstream infections occur annually in the USA with a mortality ranging from 12% to 25% in critically ill patients.

It is also widely accepted that the internal jugular site is associated with a higher risk of catheter related infection if compared with the subclavian site.

Therefore, the benefit of catheter tunneling was best seen at the internal jugular site as described by J F Timsit in 1996 in his prospective randomized multicentre study where it significantly decreased the rate of catheter related sepsis from 11.4% to 3.4%.

At the same time, tunneling catheters did not increase the rate of mechanical complications such as pneumothorax, hematoma, or arterial puncture, but it almost doubled the rate of technical difficulties, such as problems with advancing the catheter or multiple puncture sites, at that time it was a blind technique.

Now, and with the introduction of the ultrasound guidance in our routine central line insertions, we would like to evaluate its benefit in reducing the technical difficulty and mechanical complications that used to be encountered while tunneling the short term central venous catheters at the internal jugular site.

Eligibility Criteria:
Inclusion Criteria:

* Adult ICU patients.
* Likely to need the line for 48 hours.
* Standard central venous catheter.

Exclusion Criteria:

* Mechanical impedance (e.g C-spine protection).
* Absent Internal jugular vessel on U/S.
* Previous line still in place.
* Presence of overlying skin or tissue infection or mass.
* Tricuspid valve vegetation.
* Tumor extending to the right atrium.
* Persistent coagulopathy.
* Newly inserted Pacemaker leads.
* Recent carotid endarterectomy on same side.
* No ultrasound facility available.
* Patients requiring special lines (e.g. Dialysis).
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥50 to ≤75 years of age.
* Subject is healthy.
* Subject has a BMI between 20 and 32
* If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Exclusion Criteria:

* Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
* Subject has an active Helicobacter pylori infection.
* Subject has a prior GI ulcer, bleeding, obstruction or perforation.
* Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
* Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
* Subject has used an investigational agent within the past 30 days.
* Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery

Ciprofol is a novel 2,6-disubstituted phenol derivatives and is proved have much higher potency and tighter binding toward ɣ-aminobutyric acid type A (GABAA) receptor while maintaining a fast on-set and recovery time compared to propofol. Except lower incidence of hypotension and respiratory depression, it has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery in patients receiving total intravenous anesthesia (TIVA) using ciprofol yet. However, according to study, early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. Therefore, the purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between ciprofol-based and propofol-based TIVA in elderly patients undergoing gastrointestinal surgery. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic surgery under endotracheal intubation and general anesthesia
* American Society of Anesthesiologists (ASA) classification: I to III;
* Age ≥ 60 years, BMI \< 30 kg/m2;
* Unconscious speech audiovisual impairment or unable to cooperate;
* Informed consent has been signed.

Exclusion Criteria:

* Taking any sedative, opioid, or sleep aid drugs;
* Psychiatric or neurological disorder;
* Allergic to ciprofol, propofol or soy, or a family history of malignant hyperthermia;
* Severe liver and kidney dysfunction;
* Operation duration \< 2 hours;
* Plan to the intensive care unit with tracheal catheter;
* Have participated in this study or other clinical studies.
Treatment of Postorthodontic White Spot Lesions

Dental caries is the destruction of the tooth structure in the presence of organic acids produced by cariogenic bacteria located in the dental biofilm (Dowker et al., 1999 and Robinson et al., 2000).Tooth enamel comprises 90% substituted hydroxyapatite (Ca10 (PO4)6(OH) 2), which is subjected to consecutive cycles of demineralization and remineralization. This is an interrupted process, with periods of remineralization and demineralization occurring, depending on the state of the oral environment in terms of the prolonged accumulation and retention of bacterial plaque on the enamel surface (Aoba, 2004).

Oral bacteria ferment carbohydrates to produce organic acids which lower the pH and cause the subsurface dissolution of the hydroxyapatite crystals. Under normal physiological conditions (pH7), saliva is supersaturated with calcium and phosphate ions which diffuse into the vacancies created during acid-mediated demineralization episodes (Dowker et al., 1999 and Robinson et al., 2000). The demineralization of enamel (white spot lesions) is a significant problem during and after orthodontic treatment with prevalence 71.1% and various preventive measures have been suggested to minimize the incidence (Derks et al., 2004 and Al Maaitah et al., 2011).

In orthodontic patients, demineralization usually takes place in the form of white or brown spots on the enamel around the brackets and can lead to cavitation (Al Maaitah et al., 2011). White spot lesions compromise esthetics and can be extremely difficult or even impossible to reverse.

Natural remineralization through saliva involving a mineral gain in the surface layer of white spot lesions has little improvement on the esthetic and structural properties of the deeper lesions (Karlinsey et al., 2009 and Cochrane et al., 2010). Management of white spot lesion should involve methods of both preventing demineralization and encourage the remineralization of existing lesions. In both of these processes, the efficacy of fluoride is well established. Fluoride increases the initial rate of remineralization of early enamel lesions. Consequently, it slows down the caries process and arresting the lesion. Fluoride varnish provides a protective coat over the tooth which adheres longer to the tooth surface (Demito et al., 2004 and Ten Cate et al., 2008).

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging 11-16 years.
2. Good general health.
3. Exhibiting at least 2 white spot lesion in buccal surface of their teeth.

Exclusion Criteria:

1. Chronic use of medication causing dry mouth.
2. Oral ulcer, ulcerous gingivitis, acute bronchial asthma.
3. History of allergic reaction to fluoride or other ingredients in varnish.
4. Refusal of the patient to participate in the trial.
5. Any previous treatment done for white spot lesion.
The Influence of Bariatric Surgery on Patients With Obstructive Sleep Apnea (OSA)

Obesity is a very important risk-factor in obstructive sleep apnea (OSA) and other sleep breathing disorders in patients with extreme BMI.

Candidates for bariatric surgery have a high OSA prevalence, ranging from 60-83%. The characteristics of patients with sleep apnea that were evaluated for bariatric surgery and had a full overnight polysomnography (PSG) screening for OSA were described and it was found that a very high prevalence (77.2%) for OSA in all subjects evaluated, regardless of pre-operative risk for OSA. A post-bariatric surgery PSG was not a part of this study.

The investigators would like to demonstrate the impact of bariatric surgery on OSA as a function of time.


Eligibility Criteria:
Inclusion Criteria:

* All candidates for bariatric surgery over 18 yrs of age

Exclusion Criteria:

* Patients that underwent any OSA surgery in the past
* Patient had any bariatric surgery in the past
* Patients with COPD
* Patients with CHD
* Patients who have / had cancer that received chemotherapy or radiotherapy
Lower Extremity Functional Training (LIFT) on Gross Motor Function and Gait in Children With Spastic CP

Cerebral Palsy is a developmental disorder caused by damage to the brain before, during or after birth. Spastic Cerebral Palsy is one of the most common types of cerebral Palsy. It affects about 80% of cerebral palsy. Spastic CP is characterized by increased muscle tone, jerky movements, joint stiffness, and muscle tightness. Spastic Cerebral primarily affects strength, coordination, and balance resulting in gait difficulties and affecting gross motor functioning. These abnormalities affect the very basic activities of daily life (ADLs). Even if the child is able to walk the motor skills are usually disturbed which are very important to improve and maintain gross motor functioning. Physical therapy plays a vital role in overcoming these issues.

In the previous studies the effects of LIFT on the trunk and core has been studies however, the data on the effects on the gross motor skills are very less. In addition to that the effects of lower extremity functional training on the gait have also been limited to a few studies only. The past studies were of very short time period due to which the proper effects of LIFT on the gait and gross motor skills were not very well understood.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are not able to stand
* Age between 7 to 16 years
* Patients living near the designated center

Exclusion Criteria:

* Patients with comorbidities
* Patients with cognitive impairment
* Patients who are not able to follow commands
* Patients with a history of falls
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)

The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women between the ages of 18 and 45 years old

Exclusion Criteria:

* History (including family history) or symptoms of, or risk factors for bleeding
* History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
* Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
* History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.
CT-011 MAb in DLBCL Patients Following ASCT

Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient's age is 18 years or older, both genders.
2. Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
3. The lymphoma is chemosensitive.
4. The lymphoma did not progress since pre-transplant chemotherapy.
5. ECOG performance status 0-1.

Exclusion Criteria:

1. Serious other illness.
2. Active autoimmune disease.
3. Type 1 diabetes.
4. Known immune deficiency.
5. Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
6. Active bacterial, fungal, or viral infection.
7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
8. Pregnant or nursing (positive pregnancy test).
9. Other concurrent clinical study or investigational therapy.
Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia?

10 mm telescope is generally used in laparoscopic cholecystectomy surgery. The use of a 10 mm telescope, although rare, causes the development of a trocar site hernia. İnvestigators thought that the incidence of trocar site hernia would decrease by using a 5 mm trocar, and investigators planned a study.

10 mm telescope is generally used in laparoscopic cholecystectomy surgery. The use of a 10 mm telescope, although rare, causes the development of a trocar site hernia. Investigators thought that the incidence of trocar site hernia would decrease by using a 5 mm trocar, and investigators planned a study.

Elective laparoscopic with a diagnosis of symptomatic cholelithiasis Patients hospitalized in Mogadishu-Somalia Recep Tayyip Erdoğan Training and Research Hospital and Konya Training and Research Hospital General Surgery clinic for cholecystectomy operation will be included in the study and randomized into two groups. In the first group, a 10 mm telescope will be used, and in the second group, a 5 mm telescope will be used. Patients will be followed up for a total of 3 years in 6-month periods for the development of trocar site hernia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic gallstones above 18 years of age

Exclusion Criteria:

* Those with a history of abdominal surgery,
* Open cholecystectomy,
* Patients who develop cholecystectomy complications,
* Those with decompensated systemic disease,
* Patients who do not want to participate in the study
The Home Blood Pressure (BP) Trial

The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of \<140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.

The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Undergoing in-center, thrice weekly hemodialysis for treatment of end stage renal disease (ESRD)
* Greater than 3 months since initiation of dialysis
* No anticipated change to peritoneal dialysis or kidney transplant within 10 months
* Life expectancy greater than 10 months
* Hypertension (defined as mean pre-dialysis SBP \> 140 mmHg over prior 2 weeks or taking BP medications)
* Able to obtain/measure a brachial blood pressure at dialysis and at home (e.g., no left ventricular assist device, blood pressure not been taken routinely in lower extremity at dialysis unit)
* No condition that the primary nephrologist or PIs feel precludes participation

Exclusion Criteria:

* Incarcerated or institutionalized (prohibits home blood pressure measurement)
* Participating in another intervention study that may affect blood pressure
* Pregnant or anticipated pregnancy or breastfeeding (as this will require increase to more than three times a week dialysis and/or preclude use of some classes of blood pressure medications)
Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

The purpose of this study is to evaluate pedometer use by overweight women during pregnancy. The study will show if a pedometer will help women to limit weight gain during pregnancy. It will also show if it there are other benefits such as decreased diabetes, decreased high blood pressure, decreased rates of cesarean section, and decreased complications for the baby.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Pregnant
* Less than 16 weeks gestation
* Body mass index 25 or greater at first prenatal visit

Exclusion Criteria:

* History of spontaneous preterm delivery between 20-32 weeks gestation
* Medical contraindication to exercise or walking during pregnancy
Safety and Efficiency of γδ T Cell Against Lung Cancer

In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated

Lung tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Eligibility Criteria:
Inclusion Criteria:

Age: 18-75 Karnofsky performance status \>50 Diagnosis with Lung Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, gd T cells Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease
Mild Hip Dysplasia

Hip dysplasia is a complex problem that exists on a spectrum from mild to severe disease. Periacetabular osteotomy (PAO) remains the gold standard for most patients with dysplasia; however, the procedure is quite invasive making the decision to proceed in cases of mild disease difficult. Hip arthroscopy (HA) is an alternative minimally invasive technique that can be used to address mild dysplasia. Nevertheless, HA has less capability for correction and in rare instances can exacerbate instability in the dysplastic hip. There is a paucity of data examining outcomes between these two treatment strategies for this challenging problem.

The Bernese periacetabular osteotomy (PAO) remains the gold standard for treatment of symptomatic developmental dysplasia of the hip (DDH) in most patients with closed triradiate cartilage. First developed by Ganz in 1984, this technique utilizes 4 osteotomies to completely mobilize the acetabular fragment 1. Although a technically demanding procedure, it allows optimal correction in all planes and maintains integrity of the posterior column, enabling early weight bearing and mobilization. Several groups have confirmed the long-term efficacy of this joint preservation procedure with a recent report from the inventing institution documented impressive survivorship up to 30 years after surgery 2. Treatment with PAO is more controversial for mild forms of dysplasia where the lateral center-edge angle (LCEA) is 18° - 25° and/or the Tӧnnis angle is 8° - 15°. In these patients the delta correction is more limited, thus creating a more unpredictable result with equally invasive surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of symptomatic mild DDH
* Lateral center-edge angle 18° - 25° and/or Tӧnnis angle 8° - 15°
* Skeletally mature
* Age 18 - 45
* Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
* Ability to receive a standard of care preoperative MRI arthrogram of the hip

Exclusion Criteria:

* Pregnant women
* Neurogenic dysplasia
* Legg-Calvé-Perthes disease
* Previous surgery about the hip including previous hip arthroscopy to address intra-articular pathology
Depression and Anxiety Reduction Treatment for Suicide

The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of several conditions. In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG. Some participants will also be asked to complete four additional EEG assessments. In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.

Eligibility Criteria:
Inclusion Criteria:

* At or above community sample mean on ASI-3
* At or above community sample mean on INQ-R
* English speakers
* 18 years of age or older

Exclusion Criteria:

* Significant medical illness
* Current substance dependence
* Current or past psychotic-spectrum disorders
* Uncontrolled bipolar disorder
* Serious suicidal intent that warranted immediate treatment