cyrilzakka/clinical-trials huggingface dataset:
Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures

Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures encountered. There is a substantial amount of controversy surrounding the treatment of these injuries and there is evidence that both operative and non-operative treatment can be successful.

The crux of the problem is determining which of these patients would benefit from early surgical stabilization and which will heal uneventfully without surgery. Many authors site patient pain and inability to mobilize as indications for surgery, although there is conflicting evidence supporting this claim. The presence of chronic pain in the trauma population is a growing area of interest, and there is a push towards controlling pain more effectively in the acute setting. It remains to be proven that surgical intervention is more effective at decreasing acute and longer term pain.

There is evidence in the literature to support both operative and non-operative treatment of patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical stabilization decreases acute pain and narcotic requirements, although patients are often counseled to that effect. The investigators propose to prospectively randomize patients with lateral compression type pelvic fractures to non-operative versus operative treatment and track which group has less pain, less need for narcotic pain medications, and who mobilizes with physical therapy faster.

Eligibility Criteria:
Inclusion Criteria:

* The patient has one of the following pelvic fractures (includes bilateral sacral fractures): Lateral compression type 1, Lateral compression type 2, Lateral compression type 3
* The patient is between 18 and 80 years of age, inclusive
* The patient has reached skeletal maturity
* The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
* The patient/family/guardian is English-speaking
* The patient's surgeon agrees to randomization (the patient is amendable to either operative or non-operative treatment)
* Patient enrollment and, if applicable, patient randomization can occur within 96 hours post injury

Exclusion Criteria:

* The patient has prior surgical hardware in place that precludes intervention
* The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
* The patient received prior surgical intervention for his/her current pelvic injury
* The patient has sacral morphology that precludes percutaneous fixation
* The patient is non-ambulatory due to an associated spinal cord injury
* The patient was non-ambulatory pre-injury
* The patient is currently pregnant
* The patient is enrolled in another research study that does not allow co-enrollment
* The patient is likely to have severe problems with maintaining follow-up
Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.

The study will identify the barriers and facilitators of implementation of the out-of-hospital administration of CAB+RPV LA from the point of view of staff participating in the study.

This substudy will use a qualitative descriptive approach based on Consolidated Framework for Implementation Research (CFIR). Data will be collected using semi-structured interviews among HOLA staff participants until achieving data saturation. Data will be analyzed using Braun \&amp; Clarke\&#39;s thematic analysis method.

Eligibility Criteria:
Inclusion Criteria:

1. Participation throughout the HOLA study until the moment of conducting the interviews and direct involvement in the study procedures in a significant way.
2. Homogeneous sample between the different roles participating in the study.
3. Participants who agree to participate in the substudy and sign the informed consent.

Exclusion Criteria: NONE
The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* male or female
* Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
* ECOG performance status score 0-2 ;
* Expected survival time more than three months ;
* Adequate hematologic parameters and liver and kidney function ;
* Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
* Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
* Renal : serum creatinine ≤ ULN ;
* Informed consent of patients or their agents , and signed informed consent.

Exclusion Criteria:

* For patients allergic to capecitabine ;
* Patients with CNS metastases
* Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
* Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
* Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
* Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
* The researchers believe that this test is not suitable for those who participate .
Paired tVNS With ERP in OCD

In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance efficacy of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD. This data will include tolerability information from therapists and patients with OCD, effect sizes on real world clinical outcomes for the combinatory treatment, and mechanistic data on brain changes associated with treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 55
* Meet DSM-5 criteria for OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity
* Participants must be willing and able to provide informed consent.

Exclusion Criteria:

* Participants with major neurological conditions, autism spectrum disorder, psychosis, major uncorrected sensory deficit, and severe medical disease that may be associated with neurological effects.
* People with an active eating disorder that requires treatment, but we will not exclude people who are in remission.
* Current illicit or prescription drug abuse
* Participants who are receiving pharmacotherapy for their OCD or for other psychiatric disorders will not be excluded
* No medication changes will be allowed during the study, and participants must be on stable doses of medications for at least 6 weeks prior to entering the study. Prior ERP treatment (at least 12 months removed) is acceptable
Association Between Blood Pressure and Risk of PSCI

This retrospective cohort study was designed to explore the relationship between blood pressure and cognitive impairment after stroke

Patients who have been followed up for more than 3 months after stroke will be included in the study. Basic data of patients and factors that may be related to cognitive impairment will be collected, and the relationship between blood pressure and cognitive impairment after stroke will be explored by univariate regression analysis and multivariate regression analysis. Univariate logistic regression model and multivariate logistic regression model were used to explore the relationship between blood pressure level and the risk of cognitive impairment after stroke, and the effect of blood pressure level and cognitive impairment sub-line in different patients was evaluated by subgroup analysis.

Eligibility Criteria:
Inclusion criteria:

1. Patient diagnosed with stroke by CT or MRI,
2. Patients completed the MMSE scale at least once during hospitalization
3. The follow-up time was more than three months after the stroke occurred;

Exclusion criteria:

1. Patients with incomplete data, follow-up time less than three months after the stroke occurred less than 3 months,
2. Patients with pre-existing cognitive impairment before stroke according to their medical records,
3. patients failed to complete MMSE assessment because of aphasia or any other reasons,
4. Patients combined with malignant tumors, patients combined with psychiatric disorders.
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.

This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Signed Informed consent
* Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)

Exclusion Criteria:

* Past history of lumbar surgery
* Patient under anticoagulant or antisludge treatment, or with coagulation troubles
* Patient with unbalanced diabetes mellitus (blood glucose \> 1.30 g/l)
* Patient with unstabilized high blood pressure (\> 160/95 mmHg)
* Patient with evolving infection
* Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
* Porphyria, hypersensitivity to local anaesthetic
* Patient with sphincter troubles showing a cauda equine syndrome
* Untreated psychotic state
* Pregnant women or of childbearing age without effective contraception means
* Impossible 6 months follow-up
* Participation to another trial
* Vulnerable persons protected by the law
* Persons under guardianship
* Persons unable to express their consent
Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy

Romiplostim has been used in clinical trials for the treatment of severe and very severe aplastic anemia (SAA/vSAA) in Asian participants who are either previously untreated with immunosuppressive therapy (IST) or refractory to IST. This study will evaluate the efficacy of romiplostim in the treatment of participants with SAA/vSAA.

The primary objectives of this study are to:

Arm 1: Evaluate the efficacy of romiplostim and IST in adult SAA/vSAA participants who are previously untreated with IST (1L)

Arm 2: Evaluate the efficacy of romiplostim treatment in adult SAA/vSAA participants who are refractory to IST (2L+)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of enrollment
* Diagnosis of SAA/vSAA confirmed by blood, bone marrow, and cytogenetic studies
* An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at screening
* Arm 1 only: participant requires initial treatment for SAA/vSAA, no matched related donor is available for allogenic hematopoietic cell transplantation (HCT) and will begin IST with antithymocyte globulin and CsA
* Arm 2 only: refractory to at least one course of immunosuppressive therapy including horse or rabbit ATG; or ineligible for ATG treatment and refractory to CsA

Exclusion Criteria:

* Diagnosed as having congenital aplastic anemia (AA) (Fanconi anemia, congenital dyskeratosis, etc)
* History of other malignancy within the past 5 years, with exceptions.
* Aplastic anemia with hemolytic paroxysmal nocturnal hemoglobinuria (PNH) (hemolytic predominant is defined as lactate dehydrogenase (LDH) \> 1.5 x the upper limit of site normal
* Arm 1 only: Previously treated with ATG, CsA, or Alemtuzumab
* Previously treated with PEGylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin protein (TPO), romiplostim and other TPO-receptor agonist (eltrombopag, etc)
* Patients who are eligible for allogenic HCT and have an available matched related donor
Observational, Data Collection Study for Subjects With Diabetes Using Insulin Injections

This is an observational, multicenter prospective study including up to 260 subjects with type 1 or type 2 diabetes who use insulin injections (either basal insulin only or multiple daily injections (MDI)) and CGM or SMBG to manage their diabetes. The study aims to generate the database needed for future development and verification of insulin-glucose modules of subjects with diabetes using insulin injections.

During the study, subjects will continue their regular diabetes management using their regular glucose monitoring method (either CGM or SMBG), insulin injections and oral medication (as applicable). Subjects will be requested to document glucose levels and insulin delivery during basal only or basal/bolus insulin treatment. In addition, subjects will have their daily activities recorded (meals, physical activity etc) using electronic log (implemented on the CGM/FGM receiver, Dedicated App, Neura App and/or other logbooks). Data will be captured during regular daily life using Insulin Connected pens and daily diary application software, for a period of 1 month.


Eligibility Criteria:
Inclusion Criteria:

1. Documented T1D or T2D for at least 1 year prior to study enrolment
2. T1D: Subjects aged 1 year or older
3. T2D: Subjects aged 30 years or older
4. A1c at inclusion ≤ 10%
5. Subjects using basal-bolus MDI therapy or basal insulin only - basal insulin Lantus or Tregludec and any short acting insulin.

   * T2D: Insulin pumps will also be accepted.
6. T2D: BMI ≥ 25 kg/m2
7. Subjects willing to follow study instructions:

   1. For SMBG users: measure capillary blood glucose at least 4 times a day and twice a week 7-point profile. Document blood glucose level, insulin delivery, meals and daily activities. Optional: wear blinded CGM.
   2. For CGM users: Document insulin delivery, meals and daily activities. Optional:

   Measure capillary blood glucose in addition.
8. Adult subjects or parents of pediatric subjects willing and able to sign a written informed consent form.

Exclusion Criteria:

1. An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
2. Concomitant diseases/ treatment that influence metabolic control (except diabetes treatment for T2) or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise subject's safety
3. T2D: eGFR \< 60
4. Participation in any other interventional study
5. Female subject who is pregnant or planning to become pregnant within the planned study duration
6. T1D: Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
7. Drug or alcohol abuse.
Robotic-assisted Training After Upper Arm Fracture

In this study, patients with upper arm fracture will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks on the injured arm in addition to conventional physio- and occupational therapy. The supportive treatment and execution of specific exercises on the Armeo®Spring should lead to improved recovery of function and mobility of the upper arm compared to conservatively treated patients.

60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical treatment will be recruited in three different clinics in Germany and randomised into an intervention and a control group. Participants will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and hand (DASH), as well as the range of motion of the affected arm (goniometer measurement), visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up directly after intervention will assess disability of the arm, shoulder and hand (DASH), the range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by a postal follow-up. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.

Eligibility Criteria:
Inclusion Criteria:

* surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11
* movement-stable fracture
* Inclusion between the fourth and the seventh week after surgery

Exclusion Criteria:

* limited cognition as defined by a score in Short-Orientation-Memory-Concentration Test (SOMC) less than 10 points
* inadequate level of pain during movement of the affected shoulder joint (pain score \>5 on a visual analogue pain scale)
* strongly limited vision or hearing
* heart failure (New York Heart Association stage III-IV) or COPD (Chronic Obstructive Pulmonary Disease) Gold stage III-IV
* walking speed \<0.8m/sec
* isolated tuberculum majus fracture of the humerus (AO 11, A1)
* fractures with involvement of the glenoid cavity
* double fractures
* injury of the plexus or the axillaris nerve
To Evaluate the Efficacy and Safety of Anlotinib Combined with Aumolertinib in Lung Cancer

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.

This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
2. Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0\~1; The expected survival time is more than 3 months;
3. The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflects the patient's current genetic status.
4. There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
5. The main organs are functioning well,Adequate laboratory indicators.
6. Women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study period;
7. Patients voluntarily participated in this study, signed informed consent, and had good compliance.

Exclusion Criteria:

1. Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
2. Received chemical or biological drugs after the diagnosis of advanced stage;
3. Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
4. Within 2 weeks before the start of the study, patients were treated with Chinese medicines
5. Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
7. Brain metastases with symptoms or symptom control time less than 2 weeks;
A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.
* Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.
* A waist circumference which makes fitting imto the bore of the MR scanner impossible.

Subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.
Weaning From Mechanical Ventilation in the ICU

The investigators objective is to assess quality of life and functional outcome in patients requiring short-term mechanical ventilation. Additionally, the investigators plan to measure the recovery of peripheral muscle strength and respiratory muscle strength during recovery.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients who require mechanical ventilation for at least 2 days
* the ability to speak English
* willing to participate

Exclusion Criteria:

* patients who require mechanical ventilation at home before hospitalization
* patients previously requiring mechanical ventilation at an LTAC facility