cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan

The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.

Mild hypothermia therapy shows protective effects for damaged brains of animals and post cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no protective effect for severe head trauma but has a risk of complications. In this study, all the participants must be treated with continuous monitoring of cardiac output and jugular venous oxygen saturation to get optimal physiological conditions. Adequate anesthesia such as neuroleptanesthesia is essential to maintain organ function and tissue microcirculation. Participants are randomly assigned to two groups of mild hypothermia (32.0 - 34.0 degree Celsius) and anti-hyperthermia (35.5 - 37.0 C). The body temperature must be kept for at least 72 hours. Hypothermia must be induced within 6 hours after traumatic brain injury. Glasgow outcome score at 6 months after injury and the total medical expenses of the two groups will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury; Glasgow coma score 4-8 (motor 1-5).
* Hypothermia or anti-hyperthermia must be induced within 6 hours after injury.

Exclusion Criteria:

* Systolic blood pressure \< 90mmHg (after resuscitation)
* Thrombocytopenia (platelets \[Plt\] \< 50,000/mm3)
* Pregnancy
* Preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
* Deep drunkenness
Kinesiotaping in Knee Osteoarthritis

Kinesiotape is one of the treatment choices for the patients with knee osteoarthritis. Unlike the brace, it seems to be an important advantage in kinesiotape application in that it permits the movement of the joint. However, kinesiotape is conditionally recommended for knee osteoarthritis in the 2019 American College of Rheumatology treatment recommendations due to limiting the quality of evidence, using various application methods, and the lack of blindness concerning its use is not possible.

The aim of the study is to determine the effects of kinesiotaping on pain, physical performance, knee range of motion, and postural stability in knee osteoarthritis.

Non-pharmacological treatments are recommended as first-line management in knee osteoarthritis. Kinesiotape was regarded as a supplementary intervention for patients with knee osteoarthritis. Although the results are conflicting, regarding knee osteoarthritis, recently published studies indicate beneficial effects of kinesiotape on knee-related health status, pain, quadriceps muscle strength, and range of motion. On the other hand, the measurements were performed immediately following taping or within a short-term period. The inconsistency of the study data still indicates that the efficacy of kinesiotape in knee osteoarthritis should be evaluated in randomized controlled trials. Therefore a study that investigates both short and long-term follow-up results are warranted.

This study aimed to determine the immediate and long-term effects of the single and repetitive application of kinesiotape on pain, knee joint range of motion, postural stability, and physical performance in participants with knee osteoarthritis. The results of this study will support evidence-based reports based on the effectiveness of kinesiotape in knee osteoarthritis and recommendations for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Pain for a minimum of 3 months
* Pain intensity within the last week minimum of 3 according to the visual analogue scale (VAS) at the symptomatic knee
* Grade 2-3 knee OA according to the Kellgren and Lawrence Scale
* Ability to perform the tests

Exclusion Criteria:

* Fragile, very sensitive skin, or lesions in the area
* Inflammatory arthritis
* Inability to perform functional tests
* Pregnancy
* Use of drugs associated with a psychiatric disorder
* Previous joint replacement surgery for knee/hip joints
* Diagnosis with balance disorder
* Disorders that may cause loss of muscle strength in the lower extremities
* Previous experience with the Kinesiotaping method
Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study

The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets' oral administration on postoperative pain and rehabilitation after laparoscopic radical gastrectomy for patients with gastric cancer.

Postoperative pain attracts the attention of surgeons, and optimal postoperative pain management contributes to reducing complications and accelerating postoperative rehabilitation. Traditionally, the opioids were used for postoperative pain control. However, the opioids may increase the time to recover bowel function and lead to postoperative ileus. Multimodal analgesia is recommended in recent years, but studies on multimodal analgesia after gastrectomy are scarce. In this study, we introduced a multimodal analgesia strategy consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this strategy compared with PCIA analgesia which is used widely for pain after gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
2. Patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex.
3. American Society of Anesthesiologists (ASA) physical status I-III.
4. Participants can follow the drug doses and visit plan

Exclusion Criteria:

1. Patients certified by a doctor that doesn't fit to participate in this study.
2. Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc..
3. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function \> II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
4. Patients with gastric cancer with distant metastasis.
5. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \< 25 ml/min).
6. Patients with suspect or have a history of drug abuse.
7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
8. Sponsors or researchers directly involved in the testing or their family members.
9. Patients with conversion, palliative resection.
10. Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery.
A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.

This is a prospective (in which the patients are first identified and then followed forward as time passes), multi-center (study conducted at multiple sites), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to evaluate the effectiveness and safety information of a 5 day decitabine (Dacogen) regimen in patients with Myelodysplastic Syndrome. This study consist of 3 phases; pre-treatment phase, treatment phase and end of treatment (Day 28\~61 after last administration of Dacogen). The patients will receive decitabine intravenous injection 20 mg/m2 one hour once daily for 5 consecutive days for every 4 weeks. Safety evaluations including adverse events and clinical laboratory tests and will be evaluated with adverse events reported for the period ranging from informed consent and during the study to the end of treatment visit including 56 days (8 weeks) after the last administration of the clinical study treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including chronic myelomonocytic leukemia (CMML) with an International Prognostic Scoring System more than or equal to Interferon-1

* Patients who have never treated with hypomethylating agent (azacitidine and decitabine)
* Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations.
* Women of childbearing potential should conduct an effective method of birth control as defined in protocol, in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy

Exclusion Criteria:

* Patients diagnosed with acute myelogenous leukemia (bone marrow stem cell counts exceeding 20 %) or other progressive malignant diseases
* Patients with active infection of virus or bacteria
* Patients who used to be treated with azacitidine or decitabine
* Patients who are hypersensitive to excipients of decitabine
* Patients who are pregnant and breast-feeding
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age (either gender and any race);
* Reported history of dry eye for at least 6 months prior to Visit 1;
* History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* Eye drop use within 2 hours of Visit 1;
* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.
Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)

The aim of this proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal B-cell lymphocytosis (LC MBL), a common premalignant condition affecting up to 17% of European adults age\&amp;gt;40. LC MBL is a precursor to chronic lymphocytic leukemia (CLL), characterized by a circulating population of clonal B-cells. It is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. Studies reported that male sex, age, family history of CLL, and CLL-susceptibility genetic loci were associated with LC MBL risk. These findings were reported in European ancestry individuals and have not been generalized to other thnicities. This study will provide this missing knowledge using a unique multi-ethnic Israeli population of Jews and Arabs that have one of the highest and lowest age-standardized incidence rates of CLL in the world, respectively, and characterized with different genetic backgrounds.


Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age pf 40

Exclusion Criteria:

* Individuals with lymphoproliferative disorder
Systemic Variables in the Saliva of Children Undergoing Liver Transplantation

Saliva is used nowadays as a significant diagnostic tool due to the latest technological developments. The research compares two experimental groups; children after liver transplantation and a control group.

Our objective is to identify from all the parameters that are evaluated, the ones that differ between the two groups. If such parameters will be found and differ statistically, it will be possible to create a non invasive medical examination protocol, which will probably be much more complaint, and being so would help locate individuals in risk groups with the tendency to develop an end-organ liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Children after a successful liver transplantation
Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.

Nasal septum operation cause agitation because of nasal package. This research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients

Exclusion Criteria:

* patients with any sensitivity each drug
Establishment of a Registry of Patients with Parathyroid Disease

Establishment of a registry with which to census all patients under the care of the O.U. Endocrinology for parathyroid pathology in order to longitudinally evaluate biochemical, clinical, radiological, medico-nuclear and histological data in future studies.

Inclusion in the registry will be offered consecutively to any patient with parathyroid pathology (hyperparathyroidism or hypoparathyroidism) diagnosed and evaluated at the Endocrinology Operating Unit through at least two endocrinology visits. The registry will include patients seen from 1/1/2000 for a duration of 30 years. Follow-up duration for each patient is expected to be 10 years, with enrollment until 12/31/2029, and registry update deadline on 12/31/2039.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of hyperparathyroidism or hypoparathyroidism based on biochemical parameters (calcemia, parathormone, phosphormia, creatinine, albumin, vitamin D25OH)
* Obtaining informed consent

Exclusion Criteria:

* none
A Study to Learn if the Study Medicine Called Itraconazole and if Food Changes How the Body Processes the Other Study Medicine Called PF 07258669 in Older Adults or Healthy Adults

The purpose of this study is to learn how the medicine called itraconazole and food changes how the body processes another study medicine called PF-07258669 in older adults or healthy adults.

The study medicine PF-07258669 is developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss. The study has two parts: Part A and Part B.

The study is seeking participants who:

1. Are males or females who can no longer have children.
2. Part A Only: Are at least 65 years old and in reasonably good health. Part B Only: Are at least 18 years old and in good health.
3. Part A Only: Have a body mass index (BMI) of 16 to 27 kilogram per meter squared and a total body weight of more than 40 kilograms (88 pounds). Part B Only: Have a BMI of 16-32 kilogram per meter squared and a total body weight of more than 50 kilograms (110 pounds).

For Part A: Participants will take the study medicine PF-07258669 as tablets by mouth once on Day 1 at the study clinic and stay at the clinic for about 12 days. Then starting on Day 4, participants will take itraconazole as liquid by mouth for eight days. On Day 7, itraconazole will be taken together with PF-07258669.

For Part B: Participants will take the study medicine PF-07258669 as tablets by mouth once on Day 1 without breakfast at the study clinic and stay at the clinic for about 7 days. On Day 4, participant will take the study medicine after breakfast. A different group of participants will follow a similar procedure, but they will take the medicine after breakfast on Day 1 and without breakfast on Day 4.

For Parts A and B: At the clinic, the study team will observe the participants and take urine and blood samples to look at the levels of PF-07258669. The participants will receive a follow up telephone call about one month later.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females who can no longer have children.
2. Part A Only: At least 65 years old. Part B Only: At least 18 years old.
3. In reasonably good health.
4. Part A Only: Body mass index (BMI) of 16-27 kg/m2; and a total body weight \>40 kg (88 lb.). Part B Only: BMI of 16-32 kg/m2; and a total body weight \>50 kg (110 lb.).

Exclusion criteria

1. Evidence or history of clinically significant medical conditions.
2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD

Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy \[i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)\] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.


Eligibility Criteria:
Inclusion Criteria:

* Stable mild COPD,
* FEV1/FVC\<0.7 and FEV1\>60% predicted,
* Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score \<9, MRC dyspnea scale \>2),
* Cigarette smoking history ≥20 pack-years.

Exclusion Criteria:

* Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
* Important contraindications to clinical exercise testing,
* Use of daytime oxygen,
* History of Asthma.
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

All subjects were treated with ND-L02-s0201 or placebo for 24 weeks (a total of 12 doses). Subject's participation in the study was approximately 40 weeks including a Screening and Baseline period of up to 6 weeks, a treatment period of 24 weeks (including the 2 weeks after the last study treatment), and a follow-up period of 10 weeks after End-of-Treatment (EOT).

Eligibility Criteria:
Inclusion Criteria:

* Forced vital capacity (FVC) ≥ 45% of predicted.
* Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥ 30% of predicted value
* Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

Exclusion Criteria:

* Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.
* Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
* Anticipated to receive a lung transplant during the subject's participation in the study.
* Active smoker or smoking cessation within 12 weeks before screening.
* Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
* Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
* Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
* Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
* Pregnant or breastfeeding.
* Medical history of infection with HIV, hepatitis B, or hepatitis C.
* History of alcohol abuse and/or dependence within the last 2 years.
* History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs.

Other protocol defined inclusion/exclusion criteria could apply.
Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients With Liver Cirrhosis

Chest/abdominal wall varices and spider nevi are two common presenting signs of liver cirrhosis. Their prognostic values remain unclear.


Eligibility Criteria:
Inclusion Criteria:

1. Liver cirrhosis.
2. Consecutive admission.
3. Permitted to physical examinations.
4. Informed consents.

Exclusion Criteria:

1. Non-cirrhotic portal hypertension.
2. Malignancy.
3. Uncontrolled infection.
4. Severe chronic diseases.
5. Poor patient compliance.
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 18-65 years of age
* Chronic hepatitis C genotype 1
* HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment
* Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg

Exclusion Criteria:

* Liver cirrhosis
* Decompensated liver disease or impaired liver function
* Medical condition associated with chronic liver disease other than chronic hepatitis C
* Positive for hepatitis B or HIV infection at screening
* History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week