cyrilzakka/clinical-trials huggingface dataset:
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.


Eligibility Criteria:
Inclusion Criteria:

Entry criteria include the following:

1. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven:

   1.1 Baltimore Criteria- Bilirubin ≥2 mg/dL and at least 2 of the following clinical findings:
   * Ascites (radiographic or physical exam)
   * Weight gain of ≥5% compared to the day of conditioning-- if this value is not available, the weight on the date of admission to the SCT unit may be used)
   * Hepatomegaly; increased over baseline.

   1.2 Modified Seattle Criteria: At least two of the following
   * Bilirubin ≥2 mg/dL
   * Ascites (radiographic or physical exam) and/or weight gain ≥5% above baseline weight (defined as weight on the first day of conditioning- if this value is not available, the weight on the date of admission to the SCT unit may be used)
   * hepatomegaly increased over baseline

   1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible.
2. Patient must also provide written informed consent.

Exclusion Criteria:

* Use of any medication which increases the risk of hemorrhage is disallowed. Use of heparin or other anticoagulants is disallowed within 12 hours unless being used for routine central venous line management, fibrinolytic instillation for central venous line occlusion, intermittent dialysis or ultrafiltration of CVVH.
* Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring \> 15 cc/kg of packed red blood cells (e.g., a pediatric patient weighing 20 kg and requiring \> 300cc of packed red blood cells/24 hours, or an adult patient weighing 70 kg and requiring \>3 units of packed red blood cells/24 hours) to replace blood loss, OR bleeding from a site which in the Investigator's opinion constitutes a potential life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of amount of blood loss, at any point from the date of SCT through the date of severe VOD diagnosis.
* Hemodynamic instability as defined by a requirement for multiple pressors, or inability to maintain mean arterial pressure (for children: to maintain mean arterial pressure within 1 standard deviation of age-adjusted levels) with single pressor support.
* Woman who are pregnant.
A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)
* Type 2 diabetes for ≥6 months according to the World Health Organization classification
* HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory
* Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening
* Body mass index of 23 to 50 kilograms per square meter

Exclusion Criteria:

* Type 1 diabetes
* Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
* History of acute or chronic pancreatitis
* Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
* Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure.
* Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.
Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).

The secondary objectives of the study are:

* To characterize the safety profile of cemiplimab + ISA101b
* To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)


Eligibility Criteria:
Key Inclusion Criteria:

1. Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
2. Has histologically confirmed recurrent or metastatic HPV16 positive cervical cancer as determined by an investigational HPV16 PCR assay, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol
3. Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
4. Patient must have measurable disease as defined by RECIST 1.1.
5. Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
6. ECOG performance status of 0 or 1.
7. Has adequate organ and bone marrow function as defined in the protocol.
8. Anticipated life expectancy ≥20 weeks.

Key Exclusion Criteria:

1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
2. Prior treatment with other systemic immune-modulating agents as defined in the protocol
3. Major surgery or radiation therapy within 14 days of first administration of study drug
4. Has received treatment with an approved systemic therapy within 4 weeks of first dose of study drug, or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
5. Has another malignancy that is progressing or requires active treatment and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug as defined in the protocol
6. Has any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 4 weeks prior to the first dose of study drug. 7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
Vitamin D Supplementation on Outcome and Disease Activity.

To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs old
* RA diagnosed by ACR/EULAR 2010
* low to moderate disease activity
* on stable NSAIDs and DMARDs for at least 1 month
* Received Prednisolone less than or equal to 7.5 mg/day
* serum calcium, phosphorus and ALP are within normal limit.

Exclusion Criteria:

* Chronic kidney disease stage 3 or higher
* History of TB
* History of Chronic liver disease
* Pregnancy or breast-feeding
* adjustment of immuno-suppressive drugs, steroid
* other connective tissue disease
* Vitamin D allergy
* received other drugs which have vitamin D component
* serum Vitamin D less than 10 ng/mL
A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)

This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Chronic, compensated HCV GT 1 hepatitis C
* IL28B CC genotype
* Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
* No evidence of cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (FibroScan and/or FibroTest)
* Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)

Exclusion Criteria:

* Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype
* Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
* Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
* Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
* Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
* Diabetes and/or hypertension with clinically significant ocular examination findings
* Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders
* Clinical diagnosis of substance abuse
* Current or history of seizure disorder, stroke, or transient ischemic attack
* Immunologically-mediated disease
* Chronic pulmonary disease
* Clinically significant cardiac abnormalities/dysfunction
* Active clinical gout within the last year
* Hemoglobinopathy or myelodysplastic syndromes
* History of organ transplants
* Poor venous access
* Indwelling venous catheter
* History of gastric surgery or malabsorption disorder
* Severe concurrent disease
* Evidence of active or suspected malignancy, or under evaluation for malignancy, or history of malignancy, within the last 5 years
* Pregnant, lactating, or expecting to conceive or donate eggs
* Male participant whose female partner is pregnant
* Member or a family member of the investigational study staff or sponsor staff directly involved with this study
* History of chronic hepatitis not caused by HCV
Evaluation of Colonic Diminutive Polyps With Electronic Filters

Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed.

The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.

Any diminutive polyps encountered during a colonoscopy will be examined with the use of electronic filters and magnification and assigned by the endoscopist to a adenoma/non adenoma category, resected and retrieved: a follow up surveillance period will be assigned on the basis of the endoscopic appearance of the polyps.

Each polyp will then be sent separately to Pathology for the histologic evaluation, and a surveillance interval period will be determined accordingly.

Eligibility Criteria:
Inclusion Criteria:

* All subjects undergoing colonoscopy

Exclusion Criteria:

* Patients assuming oral anticoagulant therapy
Dural Puncture Epidural Technique During Cesarean Section

DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the likely positioning of the epidural needle tip within the epidural space, and by avoiding direct intrathecal administration of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local anesthetics into the epidural space via the epidural catheter, where the dural puncture created a conduit for translocation of local anesthetics from the epidural space to the subarachnoid space which was a unique feature of DPE technique.

Our study assessed the efficacy of DPE with pencil point spinal needle (25-27 G) during elective CS. Primary outcome was the onset time of surgical anesthesia which is defined as the time from the end of the initial dose injection to when the bilateral sensory block level reached the T6 dermatome. secondary outcomes were number of patients with cranial sensory block toT6 Level, number of patients with a modified bromage score reaching 3 at 15 min, intraoperative IV analgesia, local anesthetic volume, incidence of vasopressor administration and maternal \&fetal complications.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women (ASAI\&II) with singleton vertex presentation cephalic presentation foetus at 38 to 42 weeksꞌ gestation.
* Age: 20-35 years old.
* Weight: 57-85 Kg.
* Height: 155-170cm.

Exclusion criteria

* Non-elective CS.
* Known foetal anomalies.
* Patient refusal or uncooperative patients.
* Patients with history of drug abuse and maternal diseases (i.e. diabetes mellitus, cardiac disease, heart block/dysrhythmia, hypertension, chronic obstructive respiratory disease, preeclampsia, eclampsia, placenta previa, placental abruption, coagulation abnormalities or hematological diseases).
* Spinal deformities, previous spinal surgeries, allergy to amide type of local anesthetics, localized skin sepsis at spinal lumbar region, neurological diseases, peripheral neuropathy, neuromuscular diseases, psychiatric diseases, hepatic and renal diseases, metabolic and endocrinal diseases and Raynaud's disease.
* Severe hypovolemia, severe hemodynamic instability and patients with anemia (Hb \<10 gm %).
* Morbidly obese (BMI \> 35 kg/m2) patients.
* Those who are very short (\<150cm) or very tall (\>170 cm).
* Patients on therapy with adrenergic receptor antagonist, anticoagulants, calcium channel blocker, and/or ACE inhibitor.
Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction

The aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.

A total of 56 patients were evaluated. Among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study.

The patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope.

Those who selected a double-digit number were assigned to the manual therapy (MT) group (n:18) and those with a single-digit number to the splint therapy (ST) group (n:18).

After the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 MT and 14 ST) who completed the 4-week treatment process.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 50 years old,
* Patients with a diagnosis of myofascial TMD with Bruxism according to the diagnostic criteria for temporomandibular disorders (DC/TMD),
* Having pain severity ≥3 according to the Visual analogue scale (VAS),
* Probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment.

Exclusion Criteria:

* Patients with a diagnosis other than myofascial TMD according to the research DC/TMD,
* a history of surgery associated with cervical and/or TMJ problems,
* a proven specific pathological condition such as cervical and/or TMJ malignancy, fracture, or systemic rheumatoid disease,
* a history of facial paralysis, a diagnosed psychiatric disease,
* if they were undergoing orthodontic treatment,
* had received physiotherapy within the last 3 months,
* or could not be co-operative.
SPYRAL GEMINI Pilot Study

The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.

This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts:

* Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and,
* Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds

There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).

Eligibility Criteria:
Inclusion Criteria:

All Subjects (both cohorts):

1. ≥18 and ≤80 years of age.
2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.

Exclusion Criteria:

1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
2. Prior renal or hepatic denervation.
3. Prior stroke or transient ischemic attack (TIA).
4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.
5. Secondary cause of hypertension.
6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
7. Estimated glomerular filtration rate (eGFR) of \<40
8. Pregnant, nursing or planning to become pregnant during the study.
9. Primary pulmonary arterial hypertension.
10. History or evidence of active / suspected chronic liver or biliary disease.
11. Current or chronic pancreatitis.
Efficacy of an Early Antipsychotic Switch in Case of Poor Initial Response to the Treatment of Schizophrenia

The main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic

The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day.

Those participants who have not responded to treatment at two weeks (PANSS improvement \<25%) will be randomised to a 6 week double blind flexible dose phase:

1. Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)
2. Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV TR) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
* PANSS total score at baseline \> 75, at least two PANSS psychosis items ≥ 4, Clinical Global Impression of severity score moderately ill or more (≥4)
* Increase in the level of care (outpatient care to day clinic or inpatient care)

Exclusion Criteria:

* contraindication to study drugs
Cognitive Rehabilitation in Post-COVID-19 Condition

Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs). Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19. The study is a randomized controlled trial (RCT), comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent cognitive sequela in post-COVID-19 condition. The study aims to recruit 120 participants aged 18 to 65 years with a history of laboratory- or home-test confirmed, SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life that have lasted for at least two months and that cannot be explained by an alternative diagnosis. Participants will be randomized to either group-based GMT (n = 60) or WL (n = 60). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered weekly (five weeks). The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version, a self-report measure assessing everyday EF difficulties, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures and rating scales of cognition, emotional health, quality of life, and fatigue.

Secondary aims include to explore to what extent potential early change predicts outcome, and to examine what characterize those who profit from GMT, in addition to describe the neurocognitive and emotional health in a Covid-19 sample. The investigators will also examine potential effects of GMT at 2- and 5-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* history of laboratory- or home-test confirmed, SARS-CoV-2 infection
* perceived cognitive difficulties (attention, memory, EF) affecting everyday functioning that have lasted for at least two months and that cannot be explained by an alternative diagnosis
* age between 18-65 years

Exclusion Criteria:

* ongoing alcohol- or substance abuse, premorbid insult and/or comorbid neurological disease, severe neurocognitive problems interfering with the capacity to participate, sensory disorders biasing cognitive assessment, psychotic disorders, lack of proficiency in Norwegian, and being previously enrolled in a GMT trial.