cyrilzakka/clinical-trials huggingface dataset:
Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 50 years of age or older at the time of consent
* Subject must have radiographic evidence (x-ray , MRI and CT scan) of a Type II odontoid fracture
* Subject must have MRI evidence that the fracture occurred within 30 days of study enrollment
* Subject must have VAS neck pain score of greater than 4 (\>4)
* Subject must have radiographic evidence that the fracture is displaced ≤ 5 mm in any direction and/or have a fracture gap of ≤ 3 mm due to angulation
* Subject must use a rigid cervical collar (Miami J, Philadelphia or Aspen) for a minimum of three months post-injury
* Subject must have a DEXA scan within 6 months prior to enrollment (can be done within one week of baseline visit)
* Subject must be willing and able to follow all study procedures and return for all study visits
* Subject must be willing to sign an Informed Consent Document

Exclusion Criteria:

* Subject has undergone systematic administration, within 30 days prior to the fracture, of any type of corticosteroid, antineoplastic, immunostimulation or immunosuppressive agents
* Subject is on chronic anticoagulation, or has a bleeding disorder
* Subject is pregnant, nursing or plans to become pregnant during the study
* Subject has a chronic Type II odontoid fracture that occurred more than 21 days prior to enrollment
* Subject has a Type II odontoid fracture displaced \>5 mm
* Subject has a mental or physical condition that would prevent him from complying with the study protocol, including the physician obtaining an accurate neurologic exam
* Subject was recommended for surgery to treat the fracture but subject refused surgery
* Subject is a prisoner
* Subject has participated in another clinical trial within the last 90 days
To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement

This was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollment of 200 patients with type 1 or type 2 diabetes.

Comparing glucose measurements from the Non-Invasive Glucose monitoring system to venous blood glucose or fingertip blood glucose to evaluate System accuracy capability.

At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were collected from each subject during fasting, after breakfast and after lunch.After the end of blood glucose measurement, the data were recorded, including adverse events and device defects during the test. The subjects were required to stay in the examination room for 5-10 minutes, during which they completed the product use evaluation questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes (type 1 or type 2 );
* Participants who could understand the purpose of the trial and signed the informed consent form.

Exclusion Criteria:

* Conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc.
* Diseases that affect the accuracy of hand measurement, such as Parkinson's disease, upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc.
* Fever (axillary temperature \>37.3℃) and severe dehydration during screening;
* Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent;
* Those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc.
* Those suffering from mental illness, lack of self-control or unable to express their personal willingness clearly;
* Participants who participated in other drug or device clinical trials within 2 weeks before signing the informed consent (except those who failed in screening);
* Other persons deemed by the investigator to be ineligible for clinical trial participation.
PK Study of Sildenafil in Neonate

The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.


Eligibility Criteria:
Inclusion Criteria:

* Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
* Infants who were diagnosed with PAH

Exclusion Criteria:

* Severe allergic reaction to sildenafil
* Inotropics for hypotension within 3 days prior to enrollment
* AST or ALT \> 3x ULN
* Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud
Penn Medicine Healthy Heart

To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll a program that will be evaluated in a clinical trial that is focused on changing patient behavior and powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest Philadelphia and Lancaster.

To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll Penn Medicine primary care patients into the Penn Medicine Healthy Heart, a six-month program for reduction of hypertension and hypercholesterolemia grounded in behavioral economics insights to increase uptake of and adherence to evidence-based interventions to reduce ASCVD risk. Penn Medicine Healthy Heart emphasizes proactive outreach and prevention outside of a traditional visit model using data assets to identify and risk stratify patients. The program aims to relieve overburdened PCPs through automated hovering technology coupled with a centralized, leveraged team of non-clinical navigators and nurse practitioners. The clinical trial will assess Penn Medicine Healthy Heart and will be powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest/Downtown Philadelphia and Lancaster, PA.

Eligibility Criteria:
Inclusion Criteria:

* On the Penn Medicine Primary Care Service Line registry
* Last 2 Blood Pressure readings with Systolic Blood Pressure \>=140 from any outpatient encounter in the last 12 months AND
* ASCVD dx OR ASCVD risk score ≥10% OR Diabetes dx OR A1c ≥6.5 in last year OR Diabetes registry OR Last LDL ≥190 in past five years AND
* Not on a statinor PCSK9, Inclisiran OR on a Low-intensity/moderate-intensity statin) with LDL \>100

Exclusion Criteria:

* Patients on PCSK9 inhibitors
* Documented statin allergy/ or intolerance in the EMR
* Pregnancy
* Breast feeding
* Markedly shortened life expectancy including:

  1. metastatic cancer
  2. hospice
  3. End Stage Renal Disease
  4. Congestive Heart Failure
  5. Dementia
* Is a non-English speaker requiring a translator
* Patients who do not have a cell phone
Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.


Eligibility Criteria:
Inclusion Criteria:

1. Patients having surgery for idiopathic full thickness macular hole
2. Able and willing to posture face-down for 10 days postoperatively
3. Agree to participate in the trial and able to give informed consent

Exclusion Criteria:

1. History of visual loss suggesting a duration of macular hole greater than 12 months
2. Patients unable or unwilling to posture face-down for 10 days postoperatively
3. History of trauma that may have been causative
4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
5. Previous vitrectomy surgery
6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.
Testing of the Apnea Prevention Device

This study is designed to test the ability of a computer-based algorithm to detect and intervene in cases of narcotic-induced respiratory depression.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients

Exclusion Criteria:

* Refusal to consent to study
The Effect of Trauma Informed Care in Childbirth

The aim of this study is to determine the effect of supportive care based on trauma informed care during childbirth on perinatal mental health outcomes.

This is a randomized control experimental study. Data were collected from 100 women who attended supportive care based on trauma informed care or standart care from Turkey between July 2022 and September 2022. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.

Eligibility Criteria:
Inclusion Criteria:

* The ages of 18-40 women,
* At least primary school graduate,
* Mother tongue Turkish,
* Single fetus,
* Term,
* Spontaneous birth,
* Cervical dilatation between 0-5 cm (latent phase) and without a condition that could prevent vaginal delivery.
* Primiparous women
* Not have any disease or complication and agreed to participate in the study were included.

Exclusion Criteria:

* Women who developed a complication with the fetus or themselves during delivery,
* Not be reached during follow-ups by telephone,
* Wanted to withdraw from the study
Milk Protein and Bone Health in Postmenopausal Women

The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. A balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the life-cycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause). Bone turnover is a nutritionally modulated process and the investigators believe a milk-based protein supplement (MBPS) can modulate beneficially the rate of bone resorption over the time period when bone remodeling is most active i.e. late evening/overnight. In this novel approach to the timing of nutrient ingestion, the proposed nutrient intervention seeks to modify (reduce) the rate of bone resorption and promote the rate of bone formation to the benefit of bone health in this at risk population..

Study design:

A block randomised, controlled study among healthy, post-menopausal women with osteopenia receiving a milk-based protein supplement (MBPS) in the evening, or not,(CONTROL) for a period of 24 weeks.

Composition of MBPM - 25g of milk-based proteins + 1000mg dairy-based calcium fortified with 40ug Vit D flavoured and textured. All formulations to be supplied food grade and product tested by Dairygold Co-operative Society, Mitchelstown, Ireland.

Participants:

60 Post-menopausal women with osteopenia as determined by site-specific bone mineral density BMD (DXA) diagnosed and screened by a clinician and for dietary intake of calcium and Vit D by a clinical dietitian.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women aged 50-70y. Assessed by site-specific BMD to be osteopenic. Assessed by clinical screen to be otherwise healthy and free from other illness or current medication likely to influence the study outcome.

Exclusion Criteria:

* Intolerance to dairy-based food products
Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons

This research is designed to assess if problem drinking by treatment seeking individuals can be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.

Men and women participants, ages 21-60 yrs old and seeking treatment for their drinking, but otherwise physically and mentally healthy, will be recruited. Participants must meet criteria for heavy drinking\* and either Alcohol Abuse or Alcohol Dependence according to DSM-IV criteria. Following a baseline period, participants will be randomized to take either kudzu extract or placebo for 10 weeks, and record and report their alcohol consumption. All participants will receive weekly medical management sessions with the study physician.

\*Heavy Drinking according to the National Institute on Alcohol Abuse and Alcoholism (2007) is more than 4 drinks per day and more than 14 drinks per week for men; and for women, more than 3 drinks per day and more than 7 drinks per week.

Eligibility Criteria:
Inclusion Criteria:

* Treatment seeking for alcohol abuse or dependence.
* Non cigarette smokers are preferred, but will accept those who smoke less than 10 cigarettes per day.
* Marijuana use of less than once per week. Other drug use less than 20 lifetime uses.
* Absence of current Axis I disorders except alcohol abuse or dependence. Past diagnosis (greater than 1 year) is acceptable.
* BMI within 18-30.
* Physically healthy (normal physical exam, ECG, blood and urine chemistries).
* Female participants must use medically approved method of contraception. If barrier method is used, must agree to using two methods simultaneously (e.g., diaphragm and condom).

Exclusion Criteria:

* Taking any prescription medication (except oral contraceptives, certain short term anti -fungal agents and some topical creams for dermal conditions).
* On psychotropic medications.
* Drug use (other than nicotine, alcohol or marijuana) greater than 20 lifetime uses.
* Meets criteria for current drug abuse or dependence (other than alcohol and nicotine). Past abuse/dependence (greater than 3 years) is acceptable.
* History of major head trauma.
* History of cardiac problems.
* Pregnancy, lactating, or planning to become pregnant during the study period.
GM-CSF in Patients With Pulmonary Alveolar Proteinosis

This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).

PAP is a rare lung disease characterized by accumulation of surfactant phospholipids and proteins within the lungs. There is no specific pharmacologic therapy for PAP and the current practice of lung lavage under general anesthesia is invasive and has limitations. Although it is unknown if the anti GM-CSF antibody is related to the disease pathogenesis, observations suggest a role for GM-CSF in lung homeostasis as well as in the pathogenesis of PAP.

Patients will receive subcutaneous GM-CSF or placebo once a day and will be followed on an outpatient basis at 2 weeks, and 1, 2, 3, 4, 5 and 6 months after initiation of therapy. Clinical response will determine dosing schedule and will be evaluated by symptom scores, gas exchange data, and chest radiographs.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of primary or idiopathic PAP
* Creatinine no greater than 2 mg/dL
* Bilirubin no greater than 2 mg/dL
* Liver enzymes no greater than 3 times normal
* Women must use an effective method of contraception, be post menopausal, or be surgically sterilized

Exclusion criteria:

* Active respiratory infection
* Active cardiovascular disease (e.g., cardiogenic pulmonary edema)
* Underlying myeloproliferative disorder or leukemia
* Other secondary cause of PAP (e.g., occupational exposure to silica or HIV with PCP)
* At increased risk of side effects from GM-CSF therapy (i.e., rheumatoid arthritis, immune thrombocytopenia, or autoimmune thyroiditis)
* Previous therapy with GM-CSF
* Pregnant or nursing
* Significant renal or liver disease
A Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors

This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22\~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
3. Male or female subjects ≥ 18 years old;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
5. Anticipated life expectancy of ≥ 12 weeks;
6. Adequate bone marrow and organ function

Exclusion Criteria:

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter.
3. Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
4. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
5. Known symptomatic central nervous system (CNS) metastases.
Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma

The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes.

Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries.

The treatment also includes removing lymph nodes from the pelvis.

Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.

↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.

↓ Intraoperative lymphatic mapping with blue dye and gamma probe.

↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
* Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
* Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
* Patients with stage I to \~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
* Patients with clinical stage I endometrial cancer
* Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
* Patients who have signed an approved informed consent.

Exclusion Criteria:

* Patients with history of prior pelvic or para-aortic lymphadenectomy.
* Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
* Patients with recurrent endometrial or cervical cancer.
* Patients with prior pelvic radiation.
* Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
* Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
* Patients with grossly infected primary tumors.
* Patients with known allergy to triphenyl-ethane compounds.
* Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
* Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
* Severe Renal Disease.
Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With BL/DLBCL

The trial SCCCG-BL/DLBCL-2017 is a collaborative prospective, multicenters, non-randomized, observational, cohort clinical study with participating centers of the South China Children's Cancer Group-Non-Hodgkin lymphoma group(SCCCG-NHL). The aim of the study is to evaluate efficacy and safety of stratified treatment based on risk factors of childhood and adolescents Burkitt lymphoma(BL)/diffuse large B-cell lymphoma(DLBCL) patients in china.

Research purposes:

1. To investigate the efficacy and safety of SCCCG-BL/DLBCL-2017 in children with BL and DLBCL.
2. To investigate the effect of rituximab combined with chemotherapy on the survival rate of children with high-risk BL/DLBCL.
3. To investigate the effect of rituximab on immune function in children with high-risk BL/DLBCL.
4. To explore the correlation between MRD detection and the efficacy and survival of children with BL/DLBCL.
5. To explore the role of PET/CT in evaluating residual lesions in children after BL/DLBCL treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \< 18 years old
2. Pathologically confirmed Burkitt lymphoma or diffuse large B-cell lymphoma
3. Newly diagnosed patients
4. Informed consent of guardian of children patients

Exclusion Criteria:

1. Pathological components with follicular lymphoma
2. Immunodeficiency Second neoplasm