cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study

Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth

Exclusion Criteria:

Severe congenital malformation Subjects with missing data
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).


Eligibility Criteria:
Inclusion Criteria:

* Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
* Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
* For entry into the Washout Period (for vitamin D receptor activator \[VDRA\] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
* For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.

Exclusion Criteria:

* Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
* Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
* Participant has had a parathyroidectomy within 12 weeks prior to Screening.
* Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to more than \> 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
* Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
* Participant is unable to take oral medications.
Determinants of Success, Characterizing the Facilitators of Integrated Abortion Provision

This national, qualitative study of physicians who provide abortion care aims to better understand the facilitators of abortion provision among generalist clinicians in OB-GYN and Family Medicine.

This is a nationwide qualitative study of 20 to 40 physicians who provide abortion services as part of their scope of practice. Providers will participate in a semi-structured interview using an interview guide that addresses 4 domains of interest including: (1) initiation of abortion services, (2) barriers to abortion provision, (3) facilitators of abortion provision and (4) acquired expertise and coaching for success.

Eligibility Criteria:
Inclusion Criteria:

* Practicing obstetrician-gynecologists and family medicine physicians who currently provide or in the past have provided abortion services (medication abortions, surgical abortions and/or induction abortions) as part of their clinical practice will be eligible for study participation.
* All providers who meet these criteria will be eligible regardless of providers' gestational age cutoff, abortion indication limitations and/or restrictions, or number of abortions provided.

Exclusion Criteria:

* Physicians who work solely at a designated abortion facility, e.g., Planned Parenthood, without an alternate practice site, or who provide only abortions, are not eligible for study participation.
Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue

Mortality rates associated septic shock remains unacceptably high, around 20-50%, with refractory hypotension in half of these patients. Widespread vasodilatation involves the activation of the soluble intracellular enzyme guanylate cyclase (GC) by nitric oxide (NO), resulting in the production of cyclic guanosine monophosphate (cGMP). Initially discovered as an endothelium-derived relaxing factor in blood vessels, NO is made by the enzyme nitric oxide synthase (NOS). It has been suggested that the inhibition of NO generation might be a treatment option for sepsis and septic shock. Methylene blue (MB) is a dye that easily crosses cell membranes, inhibits iNOS, and is capable of inhibiting the GC enzyme in vascular smooth muscle cells.Early use of MB can block the progressive decrease in systemic vascular resistance of patients unresponsive to noradrenaline and mitigate the need for prolonged vasoconstrictor use. The investigators propose to study the effect of methylene blue on cirrhotic adults with sepsis, with refractory vasoplegia unresponsive to maximum doses of noradrenaline and vasopressin.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (\>18 years )
2. Refractory septic shock (Noradrenaline \>0.5mcg/kg/mt )

Exclusion Criteria:

1. Declined consent
2. Pregnancy
3. Less than 18 years old
4. Immunosuppressant patients (e.g. on steroid medication, active anti-cancer chemotherapeutic agent, etc.)
5. Glucose-6-phosphate dehydrogenase deficiency
6. Medication of Serotonin modulator/SSRI
7. Pre-existing Pulmonary Hypertension
8. CKD-Stage IV/V
9. Patients with GI bleed
10. Patients on DNR
11. Patients declared Brain dead
Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck and proximal urethra. Pain management during transurethral procedures is a major concern.Patients who have been catheterized under anesthesia complained of urgency in the postoperative period because of catheter-related bladder irritation. We want to investigate that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in transurethral prostatectomies

Outcome measures USG guided transperineal pudendal block success Postoperative pain score (VAS score) Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.

Postoperative patient's comfort (poor, sufficient, good)

Eligibility Criteria:
Inclusion Criteria:

* ASA I,II,III status
* Who were scheduled to have elective transurethral resection of the prostate

Exclusion Criteria:

* Chronic renal failure
* coagulopathy
* active anorectal disease
* active urinary tract infection
* uncontrolled diabetes
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.

Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safety findings.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
* Historical failure to respond optimally to a GAD treatment

Exclusion Criteria:

* Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
* Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.

Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.

Eligibility Criteria:
Inclusion Criteria:

* Must meet the Migraine diagnosis.
* Age of onset should be before age 50 years.
* Migraine must have been occurring for 1 year preceding entry into the trial.
* The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.
* The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.
* Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.
* Ages 18-65.
* Participant can understand and complete the Headache diary.
* All participants signed the informed consent.

Exclusion Criteria:

* Other migraine prophylactic medication is continued 3 months prior to the drug trial.
* Participants who have taken Tianshu capsule during 1 month prior to Screening stage.
* The number of acute treatment for migraine is more than 10 per month.
* Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.
* Participants who abuse alcohol or other drugs.
* Participants who are resistant to all acute migraine drugs prescribed optimally.
* hypotension or uncontrolled hypertension.
* Severe infections.
* Malignancy.
* Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.
* Known allergies or serious side effects with Tianshu capsule in the past.
* Breastfeeding, pregnant and potentially fertile women participant.
* History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.
* Secondary headaches, including hypertension, post-traumatic brain syndrome etc.
* Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.
* Participants who are taking part in other clinical trials.
Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population

Recently, several conditioning regimens did not include total body irradiation (TBI) anymore, especially in the case of young children due to cognitive sequelae and late effects on growth and height. Thus, such effective chemotherapy conditioning regimens were developed to avoid these complications. Busulfan is one of the major drugs used in these treatments, but, is also administered in high dose chemotherapy followed by autograft. In both situations, long term pulmonary side effects were diagnosed in a few cases. Even if the occurrence is not very frequent, the clinical management is a real challenge regarding the reduced quality of life and life expectancy of these patients. Up to now, no correlation was done between respiratory sequelae and busulfan pharmacokinetics. Hence, in the investigators' pediatric onco-hematological unit, a prospective study will begin and last three years to assess the respiratory side effects due to busulfan and their potential links with individual drug pharmacokinetic measures. These results will be compared to patients treated with TBI during the same period of time.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 3 years old treated by busulfan or TBI in their conditioning regimens before allograft or busulfan in high dose chemotherapeutic regimens followed by autograft will be included after parents informed assent.
Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female 18 y/o and older
2. Female patients must be practicing an effective method of birth control
3. Biopsy-proven AL-amyloidosis
4. Must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment

Exclusion Criteria:

1. Hypersensitivity to boron or mannitol
2. Prior treatment with VELCADE
3. Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
4. Uncontrolled infection
Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis

OBJECTIVES:

I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis.

PROTOCOL OUTLINE: This is a randomized, multicenter study. In the first treatment period, patients are randomized to one of two treatment arms.

Arm I: Patients receive enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules before meals and snacks for 7 consecutive days.

Arm II: Patients receive their usual enteric coated pancreatic enzyme without bicarbonate capsule before meals and snacks for 7 consecutive days.

Patients receive approximately 50% of their usual lipase dose during treatment. Food intake is recorded on days 1-3, food intake is weighed and recorded on days 4-7, and stools are collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion. Anthropometric measurements including height, weight, and skinfolds are assessed.

In the second treatment period, patients are switched to the alternate treatment arm after a 3 day washout period. Patients receive the opposing treatment as per protocol.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinical diagnosis of cystic fibrosis Duplicate sweat chloride measurements greater than 60 mEq/L on samples collected after pilocarpine iontophoresis
* Patients with a history of malabsorption who consume at least 1,000 to 2,500 lipase units/kg/meal

--Prior/Concurrent Therapy--

* No concurrent oral antibiotics, antacids, H2 receptor antagonists, or any drugs known to interfere with digestion

--Patient Characteristics--

* Weight for height greater than the 5th percentile
* No prior meconium ileus with intestinal resection
* No known hypersensitivity to pancrelipase or pork protein
Pharmacist and Family Medicine Physician Collaboration for Pre-Visit Planning and Team Huddles for CCM Patients

This is a novel project which incorporates clinic and community pharmacists in three aspects of the Patient-Centered Medical Home: pre-visit planning, pre-visit care team huddles, and chronic care management (CCM). Patients for the project are enrolled in the NEIFPC CCM program and have Greenwood pharmacy as their primary pharmacy. Community and clinic pharmacists will contribute to pre-visit medication reviews and document their drug therapy recommendations in a shared, templated note in the clinic EHR. NEIFPC pharmacists will attend pre-visit team huddles to relay drug therapy recommendations to the physician. Revenue from CCM services will be prorated and shared between Greenwood pharmacy and NEIFPC. The project will last 9 months. Primary aims are to describe the pharmacist pre-visit planning service, summarize the billing experience of a community pharmacist providing this service, and to describe the drug therapy interventions made by pharmacists.


Eligibility Criteria:
Inclusion Criteria:

* Patient enrolled in Medicare
* Patient enrolled in the Chronic Care Management (CCM) program at the Northeast Iowa Family Practice Center
* Patient's primary pharmacy is Greenwood Pharmacy

Exclusion Criteria:

* Patient not enrolled in Medicare
* Patient not enrolled in CCM program
* Patient's primary pharmacy is any pharmacy other than Greenwood Pharmacy
Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer

This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the impact of current therapies on quality of life (QoL), productivity loss and health care resource utilization in metastatic breast cancer (mBC). This prospective study will estimate patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified according to treatment type, treatment line and disease status (progression vs. progression free) in a real-life setting.

To estimate QoL, work productivity and health care resource utilization of post-menopausal patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting. The secondary objective is to estimate QoL and work productivity of mBC patients' caregivers.

During the course of the study, data will be collected on quality of life and work productivity. Patients and caregivers will be asked to fill a set of questionnaires at their recruitment in the study, at 3 months and at 6 months after recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic breast cancer
* Post-menopausal women
* ER+/HER2- mBC
* Signature of informed consent form
* Ability to read and understand English or French

Exclusion Criteria:

* Participation to a clinical trial
Treatment of Proximal Humerus Fractures in the Elderly

This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

Eligibility Criteria:
Inclusion Criteria:

* Age of 65 years or above
* Proximal humerus fracture
* Informed consent by the patient or legal representatives to participate in the study

Exclusion Criteria:

* More than one fracture, polytrauma
* Suspicion of a pathological fracture in the context of known or unknown malignancy
* Previous surgery of the proximal humerus on the same side
* High energy trauma
* Open Fracture
* Insufficient German language skills
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI

Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.


Eligibility Criteria:
Inclusion Criteria:

* Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²
* Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement
* Native aortic valve annulus measuring 18-29 mm
* Suitability for transfemoral vascular access
* Written informed consent

Exclusion Criteria:

* Life expectancy \<12 months due to comorbidities
* Cardiogenic shock or hemodynamic instability
* History of or active endocarditis
* Contraindications for transfemoral access
* Active peptic ulcer or upper gastro-intestinal bleeding \<3 months
* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
* Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team
* Active infection requiring antibiotic treatment
* Participation in another trial
A Study of Topical Arnica & Ledum on Bruise Reduction in HNV

Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing.

This is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. The trial will be conducted at 5-8 sites with up to 150 subjects. Each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. Subjects and study investigators will be blinded to the order of treatment assignment. Subjects will be asked to come to the clinic for photographic assessments of the bruise. Each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on Day 1. The pad will be applied by study staff immediately after bruise induction (within 5 minutes). The pad will cover the bruised area completely, and then sealed with Tegaderm. All procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. All photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin type 1-3
* BMI 25 kg/m2
* Self described bruisers
* Intact skin in the target area, free of markings, blemishes and hair

Exclusion Criteria:

* Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
* Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
* Inability to forego application of topical products in the target area
* Hair removal by laser, wax or chemicals within one week prior to Day 1
* Avoid tanning beds
* History of allergy to topical gels, Arnica or Ledum
* Active wound or infection in the target area
* History of keloids or hypertrophic scarring
* History of collagen or vascular disease
* History of organ transplant