cyrilzakka/clinical-trials huggingface dataset:
Pancreatic Duct Stenting to Prevent Postoperative Pancreatic Fistula (POPF) After Distal Pancreatectomy

To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact the incidence of a post-operative pancreatic fistula, as defined by postoperative. If pre-operative pancreatic stenting appears to reduce the formation of Postoperative Pancreatic Fistula (POPF) in this pilot study, this will form the basis of a larger randomized trial in the future. The hypothesis is that pre-operative pancreatic duct stenting can significantly decrease the rate of development of a post-operative pancreatic fistula after distal pancreatectomy.

Prophylactic pancreatic duct stenting is to be offered to all patients deemed a candidate for a distal pancreatectomy. This is a nonrandomized cohort study with a retrospective and prospective control group (Jan 2008 - Dec 2017 or sample size obtained) and a prospective endoscopic intervention group (September 2015 - Dec 2017 or until sample size obtained). We will then compare the rate of development of a postoperative pancreatic fistula between those patients who have preoperative stenting and those who do not. POPF will be defined as the amylase level of drain contents equaling three times or more the serum amylase on postoperative day 3, as defined by the International Study Group for Pancreatic Fistula (ISGPF) or an ICD-9 diagnosis of 577.8. The patient will have a pre-operative visit for stent placement and a post-operative visit for stent removal if still in place 4-6 weeks after distal pancreatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients age 18 years of age and older
2. Patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas.

Exclusion Criteria:

1. Pediatric patients younger than age 18
2. Pregnant patients
3. Patients undergoing distal pancreatectomies performed en bloc for non- pancreatic pathologies (gastric cancer, renal cell cancer, etc).
Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma.
* Received at least one prior systemic therapy other than single-agent corticosteroids.
* Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal.

Exclusion Criteria:

* Received an allogenic stem cell transplant.
* Previous intolerance of lenalidomide or dexamethasone.
* Primary invasive malignancy (other than multiple myeloma) within the last 3 years.
Three Arm Trial of Immune Effects of Echinacea

The goal of this study is to determine if either of two, commercially available, Echinacea purpurea products stimulate the immune system. For the study, 60 healthy adults will be randomized to receive one of the two Echinacea purpurea products or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving either of the Echinacea products will have evidence of immune stimulation and those receiving placebo will not.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult (based on a screening health questionnaire)
* Speaks and reads English.
* If female of child-bearing potential, willing to use contraception to prevent pregnancy during the study.
* No use of any medication (other than multivitamins, essential fatty acids, oral contraceptives and probiotics) for 2 weeks prior to first dose of study.
* Willing to abstain from ingesting edible mushrooms for 2 weeks prior and throughout study.
* Willing to eat less than 2 garlic cloves per day for 2 weeks prior and during the study period

Exclusion Criteria:

* Pregnancy or currently breastfeeding.
* History of autoimmune disease or immune disorders.
* History of asthma.
* History of allergic rhinitis.
* History of physician diagnosed eczema, psoriasis or other skin condition that could mask an Echinacea-induced rash.
* Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago), and sunflower (Helianthus).
* Known allergic reaction to xylitol sweetener, glycerine, citric acid, or citrus fruits
Probiotics Pilot Project

This pilot study is designed to determine if ingestion of Bacillus probiotics can cause alteration in levels of S. aureus colonization in the nose and intestine in preoperative orthopedic patients undergoing elective primary TJA.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (age \>18 years)
2. Undergoing elective primary knee or hip arthroplasty
3. Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing
4. Written informed consent

Exclusion Criteria:

1. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
2. Antibiotic use within 3 months prior to enrollment
3. Active clinical infection
4. Participation in other clinical trials
5. Presence of pregnancy or lactation
Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids

This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore.

A total of 34 participants, including an adjustment for a 10% dropout rate, will be recruited using purposive sampling. The study will last six months. Eligible participants (aged 5-25 years) must have a confirmed VKC diagnosis and be on topical steroids, with exclusions for prior ocular surgery, systemic steroid use, and contact lens wear. Baseline assessments will include demographic data, VKC severity, and CCT measurements via pachymetry and optical coherence tomography. Follow-up evaluations at one and three months will track CCT changes. A paired t-test will compare baseline and follow-up measurements. This study will help understand the impact of topical steroids on CCT in VKC patients.

Eligibility Criteria:
Inclusion Criteria:

* Young adults aged between 5-25 years
* Confirmed diagnosis of VKC
* Currently prescribe topical steroid e.g, dexamethasone, prednisolone
* No prior history of corneal surgery or trauma
* Willing to attend follow-up visits and comply with the treatment protocol.

Exclusion Criteria:

* History of ocular surgery or trauma
* Presence of other corneal pathologies (e.g., Keratoconus)
* Systemic immunosuppressant use or history of systemic steroid use in the past 06 months
* Use of other medications that could influence corneal thickness e.g, antiglaucoma drugs
* Contact lens use within 1 month prior to the study
* Severe dry eye or another ocular surface disease"
Intraoperative Hygiene Measures and Surgical Site Infections

Surgical site infections are associated with high morbidity and cost Hypothesis: Extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures.

Intraoperatively two types of hygiene measures were performed randomly: standard and extensive. Standard hygiene measures included empiric accepted measures (e.g. gloves, masks, disinfection). Extensive hygiene measures included among others: double gloving, astro caps, extensive disinfection, extensive intraoperative rinsing. In addition, intraoperative adherence to the rules of asepsis were registered by an independent observer.

Patients were followed for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied

Exclusion Criteria:

* Previous inclusion into study
Repetitive Transcranial Magnetic Stimulation in Drugs Addiction

This study also aims to develop and apply a standard repetitive transcranial magnetic stimulation (rTMS) protocol on drug users. The investigators want to focus on the effects of rTMS on amphetamine and cocaine as they are the most commonly used types of illicit drugs in Hong Kong.

The primary research question is:

• To examine if rTMS can reduce craving and consumption of the most commonly used illicit drugs (amphetamine, cocaine) among people with drug use disorders in Hong Kong?

The secondary research questions are:

* What is the association between rTMS protocol (frequency, intensity) and drug craving and consumption?
* Would there be gains in executing functioning among participants who have received rTMS treatment?
* Would there be a reduction in depressive and anxiety symptoms among participants who have received rTMS treatment?

The investigators would use a cross-over design (figure 1) to investigate the effects of rTMS. The investigators would recruit participants through community drug rehabilitation and youth outreach services. Participants who meet the selection and exclusion criteria will be invited to join. Upon obtaining their written consent, the investigators would randomize participants to a treatment (rTMS) group and a sham stimulation (placebo) group. Upon completing the first phase (2 weeks), there would be a washout period of 2 weeks. The two groups will swap (treatment becomes sham, and vice-versa) and the second phase will proceed. A double-blinded procedure will be implemented. Outcome measures will be conducted at baseline, after Phase I, at the start of Phase II, and at the end of Phase II.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 60.
2. Illicit drug users in the community (not in institutions).
3. Uses either amphetamine (ice) and/or cocaine frequently (at least 4 times per week).
4. Craving Visual Analogue Scale (VAS, 11-point from 0 - 10) score of at least 5 or above on either amphetamine or cocaine.
5. Interest in participating in drug treatment or rehabilitation or have already engaged in such services offered by health or social services.
6. Not engaged in pharmacological or physical treatment related to substance use disorders in past six months.

Exclusion Criteria:

1. Have a history of seizures or a family history of epilepsy.
2. Have severe mental disorders like bipolar disorder or psychosis.
3. Have brain damage from illness or injury, such as a brain tumor, a stroke or a traumatic brain injury.
4. Have any metal or implanted medical devices in the body.
5. Have frequent or severe headaches.
6. Pregnant or thinking of becoming pregnant.
7. Had prior treatment with rTMS in the past year.
A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen

The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.


Eligibility Criteria:
Inclusion Criteria:

Exhibit systolic blood pressure \> 160mm Hg OR a diastolic pressure \> 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes).

Exhibit proteinuria \> 1+; Have not given birth, or be \<24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be \> 18 years of age Give informed consent for study participation

Exclusion Criteria:

Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine \>1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if \>1.2 mg/dL in order to have a proper dose adjustment.
Navigation System for in Vivo Measurement of the Kinematics of the Knee

The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up 30%) say disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be poor adaptation of the implants to the patient's anatomy, resulting in a non-physiological kinematics for the patient. Multiple studies try to obtain an individual adaptation of the intervention according to multiple criteria. The measurement of the kinematics of the knee before surgery could participate in this process.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total hip knee prosthesis.

Exclusion Criteria:

* Patients under 18 years
Post Operative Pain After Endodontic Retreatment

Clinical Trial The aim of this clinical study was to evaluate the effect of different root canal sealers on post operative pain after a single session endodontic retreatment of the teeth have single root and canal with chronic apical periodontitis.

The main questions aimed to be answered are:

Which of the patients treated with AHplus, Sureseal and Sealapex root canal sealers had more postoperative pain after endodontic retreatment?

Which of the patients that treated with AHplus, Sureseal and Sealapex root canal sealers required more analgesic intake after endodontic retreatment?

Participants:

Undergo a single session of endodontic retreatment using one of AH plus, Sureseal or Sealapex root canal sealers.

Visit the clinic one week later after endodontic retreatment Write the condition of analgesic intake and pain score at 6, 12, 24 hours and 2, 3, 4, 5, 6 and 7 days after treatment using a visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* Patients who did not have any systemic disease, pregnancy or breastfeeding,
* Patients who were older than 18 years,
* Patients who had not used analgesics, anti-inflammatory or antibiotics in the last 7 days and cortisone in the last 6 months,
* Patients who had improved communication skills and were at a mental level to express pain scoring clearly,
* Patients who did not have bruxism problem or primary contact were included in the study.
* Teeth with more than 60% of the root canal filled have preoperatively asymptomatic single root and single canal with previous root canal treatment and chronic apical periodontitis and periapical index (PAI) scores 2-4

Exclusion Criteria:

* Teeth had root resorption,
* Teeth had crown damage
* Teeth had severe malocclusion,
* Teeth had PAI scores 1 and 5
* Immature teeth
Open Label Extension to Bridging Study CTBM100C2303

This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.


Eligibility Criteria:
Inclusion Criteria:

* Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study.
* Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
* Forced Expiratory Volume in One Second (FEV1) at screening (study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

* Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
A Phase III Study to Efficacy and Safety of DWC202405/DWC202313 and DWC202314 in Patients with Hypertension

A Multi-center, Randomized, Double-blind, Parallel design, Phase III study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405


Eligibility Criteria:
Inclusion Criteria:

* Average systolic blood pressure (MSSBP) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg are applied to patients with the following diseases.

Exclusion Criteria:

* If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg
* Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
Comparative Effects of Sensory Re-education and Neural Mobilization in CTS Patients

The aim of study is to compare the effects of sensory re-education and neural mobilization in CTS patients.

This study will be randomized clinical trial that will be conducted at Services Hospital Lahore and Government Teaching Hospital Shahdara. In this study 48 participants with CTS will be included as per sample size calculation through non-probability convenience sampling technique. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Sensory Re-education therapy, strengthening exercises and Kinesio taping for 60 minutes, Group B will be given neural mobilization techniques, strengthening exercises and Kinesio taping for 60 minutes with short rest intervals. Both treatments will be given 3 days per week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders age 20-50 years with mild and moderate carpal tunnel syndrome.
* Patients having positive score on CTS specific test (Phalen's test and Tinel's test).
* Patients with pain, paresthesia and hyperesthesia at the course of median nerve.
* Patients that are clinically diagnosed with carpal tunnel syndrome by physician. Patients having BMI \>25 (kg/m2).

Exclusion Criteria:

* Patients with polyneuropathies.
* Patients with carpal tunnel syndrome due to any systemic illness (diabetes mellitus, thyroid diseases and R.A).

Patients having cervical radiculopathy.

Patients with history of wrist fracture.

Patients getting steroid injections and after CTS surgery.

Obese and pregnant female with carpal tunnel syndrome.

Patients with any cognitive or neurological problems are excluded from study.
Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101

Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).

Participants who receive EBT-101 in a parent protocol will be eligible to participate in this LTFU study (EBT-101-002). All participants will have follow-up visits every six months until Year 5 post EBT-101. Thereafter, all participants will have follow-up visits annually on the anniversary of EBT-101 administration until study completion at Year 15.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written, signed informed consent
* Participants who received the investigational study intervention EBT-101 in a parent study

Exclusion Criteria:

• Participants who did not receive EBT-101 in a parent study
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.

This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).

The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a unilateral gait disorder as a result of a specified CNS lesion (e.g., stroke)with stable neurological deficit for at least 6 months
* Medically stable, able to and agree to undergo a surgery
* Able to stand and walk at least 5 meters
* Agree to attend frequent study scheduled visits
* Able to provide verbal or written feedback
* Have provided written informed consent
* Have intact tibial and common peroneal nerves

Exclusion Criteria:

* Pregnant or nursing women
* Medically insufficiently stable to undergo surgery
* Poor range of motion of affected ankle or fixed ankle
* Foreseen need for Magnetic Resonance Imaging (MRI)
* Significant mental or psychiatric impairment
* Cannot understand or provide signed informed consent
* Cannot provide verbal or written feedback
* Have been implanted with a pacemaker or other active medical device
* Must continuously take anticoagulants
* Uncontrolled heart or cardiovascular-related disease conditions
* Have been diagnosed with muscle atrophy and/or peripheral polyneuropathy