cyrilzakka/clinical-trials huggingface dataset:
Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab

The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed consent,
* Patient aged over 18 years
* Patients with a WHO performance status ≤ 2,
* Colon cancer or upper aero-digestive tract cytologically or histologically proven
* Patients with an indication to the theoretical use of cetuximab for colon neoplasia or upper aero-digestive tract,
* Haematological and biochemical compatible with combination therapy with cetuximab.

Exclusion Criteria:

* Patients previously treated with cetuximab,
* A person deprived of liberty or under supervision.
Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block

The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.

The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a one-injection nerve block of the lower part of the lumbar plexus and the upper part of the sacral plexus (Suprasacral Parallel Shift, SSPS) to achieve analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 with SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound by estimating sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the terminal nerves in healthy volunteers.

The secondary objective is to estimate a) preparation and b) procedure time, c) injection site and d) depth, e) discomfort, f) change in MAP, g) plasma lidocaine pharmacokinetics, h) motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine added gadotorate meglumine on MRI, and l) cost-effectiveness of SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound.

The investigators hypothesize that block success is higher for SSPS guided by ultrasound/MR image fusion than for SSPS guided by ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Volunteers who has given their written and oral informed consent to participate in the study after having fully understood the content and the limitations of the protocol.
* Normal healthy person (American Society of Anesthesiology \[ASA\] Classification I)

Exclusion Criteria:

* Volunteers not able to cooperate in the study
* Volunteers not able to understand or speak Danish
* Daily use of analgesics
* Allergy against the medicines used in the study
* Drug abuse (according to the investigator's judgement)
* Alcohol consumption greater than the recommendations of the Danish National Board of Health
* Contraindication for MRI including pregnancy
* Volunteer in whom nerve blocks are not possible due to technical reasons
* Volunteer who are incompetent (ie. surrogate consent is not accepted)
Minimizing Pain Experience In Trigger Finger Steroid Injection.

To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.

compare pain experience of trigger finger steroid injection between 26 gauge needle and 23 gauge needle.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 year old
* Male or female(non-pregnant)
* Single trigger finger
* Clinically diagnosed trigger finger- Green classification Grade I or II
* No prior surgery to the involved finger
* Subject is able to provide voluntary, written informed consent

Exclusion Criteria:

* Age less than 18 year old
* Allergy to lignocaine or corticosteroid
* Trigger finger with Green classification grade III or IV
* Previous surgery on the affected finger
* Any wound, neurovascular injury, or skin disease at injection site
* Concomitant ipsilateral fingers/wrist/forearm/arm injury
* Preexisting congenital/acquired deformities of hand (such as rheumatoid arthritis, contracture)
* Insensate hand
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C

OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C.

II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.

PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio.

The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued.

The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative
* No decompensated cirrhosis

--Prior/Concurrent Therapy--

* No concurrent immunosuppressives At least 1 year since interferon

--Patient Characteristics--

* Hepatic: No other cause of liver disease
* Other: Not HIV positive
The Expecting Study

The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30
* \>18 years of age
* Singleton pregnancy
* Less than 12 weeks gestation
* Sedentary
* Conceived without assisted fertility treatments
* Cleared by physician to exercise

Exclusion Criteria:

* Women with pre-existing medical conditions as determined by the PI to affect the outcomes of interest
* Women who are using recreational drugs, tobacco, or alcohol during pregnancy
* Women with contraindications to exercise during pregnancy
Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic or recurrent salivary gland cancer.

OBJECTIVES: I. Estimate the response rate in patients with metastatic or recurrent salivary gland cancer treated with paclitaxel (Taxol, TAX) by 3-hour infusion. II. Describe the toxicity of TAX in these patients.

OUTLINE: Single-Agent Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, TAX, NSC-125973.

PROJECTED ACCRUAL: Up to 32 patients/histology will be entered. If no response is observed in the first 14 patients in a particular histology, accrual to that group will close; if after 18 months annual accrual is less than 10 patients/histology, accrual to that group may close.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed salivary gland carcinoma that is metastatic or recurrent, including the following types: Mucoepidermoid carcinoma Adenocarcinoma Pathology review required Measurable disease required Lesion in a previously irradiated field must be progressing and biopsy- proven

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,000/mm3 ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hb at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No MI within the past 6 months No CHF No unstable arrhythmia No current antiarrhythmic, inotropic, or antianginal medication Other: No history of allergy to Cremophor No prior malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer Curatively treated in-situ cancer of the cervix No concurrent malignancy Not pregnant or nursing Effective contraception strongly advised for fertile patients Blood/body fluid analyses to determine eligibility and imaging studies and scans/x-rays for tumor measurement completed within 14 days prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifier therapy allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed with recovery Surgery: Prior surgery allowed with recovery
PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics

This project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns attributes associated with successful implementation.

Aim 1: To develop and determine the impact of a Community of Practice (CoP) on stakeholder and healthcare worker engagement and knowledge of integrated pre-exposure prophylaxis (PrEP) delivery.

Aim 2: To determine the impact of a 3-component scale-up package on implementation outcomes and PrEP patient outcomes among pregnant and postpartum populations.

Aim 2a: To determine the impact of the scale-up package on PrEP implementation outcomes, including reach, service penetration, adoption (primary outcomes), and PrEP fidelity and maintenance (secondary outcomes).

Aim 2b: To determine the impact of the scale-up package on PrEP patient outcomes, including PrEP initiation and continuation.

Aim 3: To identify difference-making bundles of facility- and regional-level attributes and implementation processes that influence reach, fidelity implementation, and maintenance.

Eligibility Criteria:
Inclusion Criteria:

Health Care Workers:

* work at a facility involved in study
* involved in PrEP service delivery
* \>=18 years

Clients:

* female clients seeking health services at study facilities
* pregnant or postpartum
* \>15 years (includes emancipated minors)

Exclusion Criteria:

* N/A
Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab

This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.

This was a four cohort, multicenter, open-label, prospective study of 34 (optionally up to 60) patients who had relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The maximal duration of the study for an individual patient was 22 months.

* The first cohort was RMS patients receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine prior to starting ofatumumab treatment.
* The second cohort was participants receiving SARS-CoV-2 mRNA vaccine (initial vaccinations or booster vaccines) as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose).

Cohort 1a - Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.

Cohort 1b - Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.

Cohort 2a - Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).

Cohort 2b - Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).

Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies were investigated for up to 18 months after the participants' vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing Multiple Sclerosis (RMS) diagnosis
* eligible for ofatumumab treatment
* willing and eligible to receive SARS-CoV-2 mRNA vaccine

Exclusion Criteria:

* known prior or current COVID-19 infection
* previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab
* no previous vaccination with a non-modRNA SARS-CoV-2 vaccine.

Other protocol-defined inclusion/exclusion criteria may apply
A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.

This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K \[015K-CL-RAJ1 (hereinafter referred to as study RAJ1)\], Phase III Study of ASP015K \[015K-CL-RAJ3 (RAJ3)\], or Phase III Study of ASP015K \[015K-CL-RAJ4 (RAJ4)\]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study".

Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy.

The duration of treatment with the study drug was differed depending upon the participants.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
* The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

* There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
* Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
* Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
* Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
* Subject has QTc \< 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc \< 300 msec at retest.
Community Based Study of Adult Onset Asthma

To identify the role of irritant exposure in adult-onset asthma by simultaneously using both clinical and case control methods in a community-based perspective study of asthma incidence.

BACKGROUND:

Asthma incidence is increasing, and in adults work-related exposures may be an important factor-occupational asthma (OA) incidence increased 70 percent over the last decade according to a recent registry based study. The true contribution of occupational exposures to adult-onset asthma is unknown because the methods for measuring OA give conflicting results. Methods based on surveillance of clinically diagnosed OA account for less than one to five percent of adult-onset asthma. However, case-control methods of measuring asthma risk by industry suggest that six to 33 percent of adult-onset asthma is caused by workplace exposures. The conflict may occur because of two factors: physicians often fail to diagnose and report OA, and irritant exposures may increase the risk the risk of asthma without causing cases that meet the clinical definition. Both factors have important implications for proper treatment and prevention of asthma in adults.

DESIGN NARRATIVE:

Clinical and case control methods were used to identify the role of irritant exposure in adult-onset asthma in a community-based prospective study of asthma incidence. The study cohort was a typical US working population enrolled in an HMO. Additional benefits of the study design were the opportunities to validate a questionnaire for exposure assessment and for detection of work-related asthma. Specifically, the study: 1) Investigated incident cases in a cohort of over 80,000 adults over three years and determined the proportion that met a clinical definition of occupational asthma (OA); 2) Used a nested case-control study to determine the incidence of all asthma by occupation and workplace exposure; 3) Determined whether clinical OA accounted for the excess incidence of adult-onset asthma associated with workplace exposure to sensitizers and irritants; 4) Prospectively followed asthmatics for two years after diagnosis to determine the impact of adult-onset asthma on lung function, employment, income, and quality of life, and to determine whether prognosis differed for clinical OA and for asthma associated with workplace irritant exposure; 5) Tested an intervention designed to increase appropriate clinical diagnosis, and thus secondary prevention of OA.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.


Eligibility Criteria:
Inclusion Criteria:

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion Criteria:

* Symptoms of OAB due to a neurological reason
* Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
* Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
* Use of botulinum toxin therapy of any serotype for any urological condition
* Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
* History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
* Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
Parkinson's Foundation PD GENEration Genetic Registry

Development of a central repository for PD-related genomic data for future research.

The purpose of this study is to develop a central repository for PD-related genomic data by individuals who consent to deposit their data and bank their residual DNA obtained through clinical genetic testing for future research use.

Eligibility Criteria:
Inclusion Criteria:

* Study Population 1: PWP (open for recruitment)

  1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
  2. Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
  3. Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination.
  4. Able to perform study activities (including completion of either online, in-person or paper surveys).

Study Population 2: People at risk of developing PD (not open for recruitment)

1. Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory.

Exclusion Criteria:

1. Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
2. Individuals who have received a blood transfusion within the past 3 months.
3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.
4. Individuals who have had a bone marrow transplant within the past 5 years.
5. Under the age of 18
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain

To determine if Pain Neuroscience Education (PNE) would result in positive clinical changes in patients presenting with acute or sub-acute low back pain (LBP).

Background: Pain neuroscience education (PNE) has shown efficacy in treating chronic pain. Clinicians may believe PNE is not suitable for acute and sub-acute pain. Subgroupings of low back pain (LBP) imply some patients with LBP may respond favorably to PNE.

Objective: To determine if PNE would result in positive clinical changes in patients presenting with acute or sub-acute LBP.

Methods: Eighty consecutive patients with LBP \< 3 months were enrolled in the study. Patients completed a demographics questionnaire, leg and LBP rating (Numeric Pain Rating Scale - NPRS), disability (Oswestry Disability Index), fear-avoidance (Fear-Avoidance Beliefs Questionnaire), pain catastrophization (Pain Catastrophization Scale), central sensitization (Central Sensitization Inventory), pain knowledge (Revised Neurophysiology of Pain Questionnaire), risk assessment (Keele STarT Back Screening Tool), active trunk flexion and straight leg raise (SLR). Patients received a 15-minute verbal, one-on-one PNE session, followed by repeat measurement of LBP and leg pain (NPRS), trunk flexion and SLR.

Eligibility Criteria:
Inclusion Criteria:

* a complaint of LBP with or without leg pain less than 3 months, and
* a willingness to participate

Exclusion Criteria:

* a) were under age 18 (minor);
* b) had undergone lumbar surgery;
* c) could not read or understand the English language;
* d) presented with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.),
* e) declined to participate or
* f) presented with a medical etiology (red flag) associated with their LBP.
Nutritional Aspects of Rett Syndrome

OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in healthy controls.

II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining, sitting, and standing, by whole-room indirect calorimetry and isotope dilution.

III. Quantify activity patterns by time-motion studies using 24-hour activity records and 12-hour videotaping.

IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term oxygen consumption.

V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.

VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.

PROTOCOL OUTLINE:

All participants undergo extensive nutritional and metabolic assessment with body composition evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate, and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a hemogram and hand x-ray.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Patients aged 5 to 18 with Rett syndrome Able to sleep and awaken alone