cyrilzakka/clinical-trials huggingface dataset:
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake

To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving loop diuretic injection at a dose equivalent to furosemide 20 mg/day or higher
* CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
* Patients who are judged by the investigator or subinvestigator to have difficulty or be incapable of oral intake, including patients who are judged by the investigator or subinvestigator to require nothing by mouth(NPO) management
* Patients who are currently hospitalized or who are capable of being hospitalized from the time of informed consent until the end of the treatment period
* Patients who are capable of giving informed consent

Exclusion Criteria:

* Patients who are on a ventricular assist device
* Patients who have difficulty with spontaneous respiration or who have been on tracheal intubation under sedative therapy
* Patients with severe disturbed consciousness (ie, coma or stupor)
Effect of Dietary Fiber on Glucose & Lipids in Non Insulin Dependent Diabetes Mellitus (NIDDM)

Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non insulin dependent diabetes mellitus.

Two diets will be compared,a low fiber diet and a high fiber diet. These two diets will differ only in the content of total dietray fiber derived from natural food products. The diets will be identical in terms of total energy, percentage of total energy as proteins, fat and carbohydrates.

Eligibility Criteria:
Inclusion Criteria:

* NIDDM
* age 35 to 80 years
* stable oral hypoglycemic treatment for at least one month
* fasting triglycerides \< 500 mg/dl

Exclusion Criteria:

* insulin dependent NIDDM
* insulin dependent diabetes
* hepatic disease
* significant hepatic dysfunction
* signifiacnt renal dysfunction
* presence of significant hematological, neurological, cardiovascular or gastrointestinal disorder, unless stable for past 6 months,
* serious intercurrent illness or anticipated major surgery
* female pregnant or likely to become pregnant
* chronic drug abuse, alcoholism or psychaitric disorder within the past 2 years
* treated with beta adrenergic blockers
* on lipid lowering drugs
Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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

PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens.

OBJECTIVES: I. Evaluate the clinical effectiveness of oral perillyl alcohol given to patients with androgen independent metastatic prostate cancer. II. Assess the toxicity of this treatment in these patients.

OUTLINE: Patients receive oral perillyl alcohol 4 times a day for 4 weeks. Patients continue treatment in the absence of severe toxicity and disease progression. Patients are followed every 3 months for survival after disease progression.

PROJECTED ACCRUAL: This study will accrue 20-40 patients in approximately 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed progressive metastatic or progressive regional nodal adenocarcinoma of the prostate Regression of tumor following hormone therapy If on antiandrogen therapy, must fail to respond to withdrawal or have progressive disease following withdrawal of antiandrogen No CNS disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WCCC 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1200/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 times upper limit of normal Other: At least 5 years since prior malignancy other than: Inactive nonmelanoma skin cancer Adequately treated stage I or II cancer in complete remission No other serious illness No spinal cord compression symptoms

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy required Endocrine therapy: Failed one secondary hormonal manipulation for metastatic disease Concurrent testicular androgen suppression (LHRH) allowed No concurrent hormonal therapy other than LHRH agonist At least 4 weeks since antiandrogen treatment in order to evaluate for response withdrawal Radiotherapy: At least 4 weeks since prior radiation therapy No prior strontium therapy Surgery: No prior orchiectomy Other: No concurrent cholesterol lowering agents No concurrent supplemental vitamins No concurrent antioxidants
Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?

The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. The main question it aims to answer is:

• Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients?

Participants will be assigned to one of the following groups at random:

* ACB/PACK with PAI
* ACB/IPACK with saline injection

Participants will also be asked to complete pre- and post-operative questionnaires.

Kim et al (2019) have shown that addition of ACB/IPACK to PAI improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents).

It is not clear if the PAI component is necessary, given the theoretically nearly complete analgesic effects of the ACB/IPACK block. Additionally, anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not, without obvious large differences in analgesic outcomes. While there may be a 'belt and suspenders' advantage to using PAI in addition to ACB/IPACK, it is not desirable to perform unnecessary procedures.

In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.

Eligibility Criteria:
Inclusion Criteria:

* Planned use of regional anesthesia
* Ability to follow the major components of the study protocol
* English speaking (Secondary outcomes include questionnaires validated in English only)

Exclusion Criteria:

* Patients younger than 25 years old and older than 80
* Non-English speaking
* Patients intending to receive general anesthesia
* Contraindication to nerve blocks or peri-articular injection
* Patients with an ASA of IV or higher
* Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 30 ml/min)
* Patients with major prior ipsilateral open knee surgery
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
Epilepsy Motion Sensing

Evaluate patient motion during seizures.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
* Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
* Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
* Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary \[idiopathic\] or secondary \[symptomatic\] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.
* Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
* Male or non-pregnant female
* English speaking

Exclusion Criteria:

* Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable
* Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings
* Have a movement disorder that may affect GT3X+ recordings
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates

A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support

Neonatal respiratory distress (NRD) is one of the most common problems in the first few days of neonatal life. NRD has been reported to be prevalent in 5 - 29% of the NICU hospitalized neonates.

High-frequency oscillatory ventilation (HFOV) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. It delivers small tidal volumes to improve gas exchange. As it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies HFOV can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia HFOV is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration Several factors are known to influence cerebral perfusion during HFOV. Hypercapnia increases cerebral blood flow (CBF) while a reduction in PaCO2 leads to cerebral vasoconstriction and decreases CBF, Hypoxia is also known to increase CBF via cerebral vasodilation HFOV with volume guarantee (HFOV-VG) is a promising new ventilator mode for the treatment of respiratory failure in newborns. HFOV-VG is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (VThf), reduces the number of out-of-target pCO2 values and provides fewer hypoxia attacks compared with HFOV alone

Eligibility Criteria:
Inclusion Criteria:

1. Preterm neonates with gestational age ≤ 35 weeks.
2. Neonates with various causes of respiratory failure: respiratory distress syndrome (RDS), air leak syndromes, pneumonia, or pulmonary hemorrhage, failing with conventional ventilation (i.e. when conventional ventilation failed to maintain either oxygenation or ventilation) and are switched to HFOV as a rescue therapy.

Exclusion Criteria:

1. Preterm neonates with major upper or lower airway anomalies.
2. Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory
Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female ≥18 years of age at the screening visit
2. Clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index joint at the screening visit
3. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4
4. A history of 12 weeks of analgesic use for OA of the knee or hip
5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

1. History or presence at the screening visit of non OA inflammatory joint disease
2. History or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fracture during the screening period
3. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
4. Patient is not a candidate for MRI
5. Is scheduled for a joint replacement surgery to be performed during the study period
6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
7. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
9. Pregnant or breast-feeding women
10. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria apply
Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia

Reduction nymphoplasty is the treatment of benign hyperplasia of the labia minora. This surgery is indicated in the event of functional, aesthetic or sexual discomfort. There has been a growing demand for this surgery over the past twenty years. It is necessary to remain vigilant because a request for cosmetic surgery can also be part of an obsession with body dysmorphism, former dysmorphophobia.

Investigators wish to study the postoperative results concerning sexuality, self-esteem and obsession with body dysmorphia in a cohort of patients followed prospectively and at more than 3 years postoperatively.


Eligibility Criteria:
Inclusion Criteria:

Patients informed of the objectives of the study and its progress,

Exclusion Criteria:

Patients in a period of exclusion determined by another study. Patients under judicial safeguard, guardianship or curatorship. Patients for whom it is impossible to give informed information.
Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer.

OBJECTIVES: I. Assess the local recurrence rate, cost-benefit ratio, and acute and late toxicity associated with concomitant preoperative radiotherapy and fluorouracil/leucovorin (5-FU/CF) in patients with locally advanced adenocarcinoma of the rectum. II. Compare the relapse rate, survival rate, disease-free interval, and cost-benefit ratio associated with 6 courses of postoperative 5-FU/CF vs. no further treatment in these patients.

OUTLINE: This is a randomized study. Patients are stratified by tumor stage, age, type of surgery, and participating institution. Patients are randomly assigned to one of two groups. The first group receives radiotherapy to the tumor over 5 weeks and concomitant fluorouracil/leucovorin for 5 consecutive days on the first and fifth weeks. Four to six weeks later, patients undergo complete resection, followed upon recovery by fluorouracil/leucovorin every 4 weeks for 6 courses. The second group receives preoperative chemoradiotherapy followed by surgery, as above, with no postoperative treatment. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 774 patients will be entered on this multicenter study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or mucinous adenocarcinoma of the rectum Distal limit of tumor no higher than 12 cm from the anal verge on proctoscopy Locally advanced (T3-4 M0) tumor by one of the following: Partial fixation Complete stenosis Invasion beyond the muscular stratum on transrectal ultrasound

PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0 or 1 Hematopoietic: WBC greater than 3,000 Platelets greater than 130,000 Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Cardiovascular: No unstable angina No cardiac decompensation Other: No prior or concurrent malignancy

PRIOR CONCURRENT THERAPY: Not specified
The Effectiveness of a Nighttime Positioning Hand Splint in Patients With Rheumatoid Arthritis

The purpose of the present study was to evaluate the effectiveness of a nighttime positioning hand splint in patients with RA in terms of pain, grip and pinch strength, upper limb function, quality of life, and patient satisfaction. The hypothesis is that the stabilization of hand during nighttime could decrease pain and consequently improve quality of life.

The involvment of wrist and fingers is very common in RA and it could affect hand function and, consequently, affect activities of daily living (ADL). Some authors suggest that the rest of hand could decrease pain and inflammation. Splints are external appliances that used in a specific body part provides the best alignment and rest in correct functional position. The goal of a hand, fingers and thumb in RA is stabilize the hand while the patients are not making theirs ADL and try to decrease the pain.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis classified according to the ACR criteria.
* Use of the same remissive drugs for at least 6 months before the intervention and the same doses of the same corticosteroids and nonsteroidal anti-inflammatory drugs for at least one month before the study.
* A score ≥ 3 and ≤ 7 on a visual analog scale (VAS) for pain in the more aching hand.
* Agreement to participate in the study, and signing of a free informed consent form.

Exclusion Criteria:

* Presented deformities in the more aching hand that did not permit fabrication of the splint.
* Patients using any other type of upper limb splint.
* Patients with a surgery scheduled within 6 months after the study.
* Patients allergic to the splint material.
* Patients with mental deficiency.
* Patients who lived in inaccessible areas.
A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)

The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)

The study is a randomized, open-label, phase III clinical trial. The main objective is to compare the efficacy of JS004 plus Toripalimab with Investigator-Selected Chemotherapy in treating patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL). The study will assess the safety and tolerability of JS004 combined with Toripalimab.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be enrolled:

* Age at least 18 years old, both males and females are eligible
* Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR/PR in recent treatment) or refractory (failure to achieve CR/PR in recent treatment) status.
* Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb)
* ECOG: 0-2
* At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.

Exclusion Criteria:

* Known allergy or contraindication to the investigational drug or its components
* Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions.
* Presence of central nervous system (CNS) metastasis.
* Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)
* Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years
A New Clinical Model for the Engagement of Latinx Youth with Suicidal Behavior

This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.

The objective of this proposal is to test a New Clinical Model to engage Latinx/Hispanic (L/H) youth and their caregivers in a culturally centered, evidence-based treatment for suicidal behaviors (SB). The Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) is an affirmative and culturally relevant treatment with empirical evidence supporting its use for L/H youth with suicidality. The New Clinical Model consists of the addition of community health workers (CHWs) to the SCBT-SB. CHWs are trusted members of their communities who provide education and connection to resources to L/H families in their native language. A community based participatory research approach is proposed and the Socio-Cultural Framework for Health Service Disparities will be the theoretical model used.

Eligibility Criteria:
Inclusion Criteria:

* Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country
* Severe Suicidal Ideation (SI), defined as one of the following:
* SIQ-JR \> 22 or endorsing any critical items (2, 3, 4, 7, 8, 9) with at least "about 1x/month"
* CDI-II \> 15 and endorsing "I think about killing myself but would not do it" OR "I think about killing myself."
* PHQ-9 \> 10 \& endorsing the item "Thoughts that you would be better off dead, or of hurting yourself in some way" with a frequency of "several days" or greater or endorsing the item "Has there been a time in the past month when you have had serious thoughts about ending your life?
* Suicidal crisis within the past 12 months
* Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate

Exclusion Criteria:

* Participants will be referred to a different treatment program if their main clinical complaint is any of the following:
* Behavioral (e.g., conduct disorder, or substance use disorder)
* An eating disorder
* Obsessive-compulsive disorder
* A developmental issue (e.g., speech, occupational, families looking for assessments, treatment for autism) or a significant cognitive delay that may require specialized treatment adjustments.
Postoperative Troponin in Children With Congenital Heart Disease

The aim of the study is to evaluate the value of postoperative troponin in the prediction of mid term and long term mortality and morbidity in children with congenital heart disease undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* all children with congenital heart disease between 0-10 years admitted for elective or emergency corrective or palliative cardiac surgery

Exclusion Criteria:

* parental refusal
* children older than 10 years