cyrilzakka/clinical-trials huggingface dataset:
a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients

The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.

50 cases of HR-NDMM patients were divided into two groups nonrandomizedly. TE group received hematopoietic stem cell transplantation after induction therapy. Allo-sct for the young patients with suitable donors, Asct for the others. TNE group received consolidation therapy after induction therapy. All patients received PI-based maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of high-risk multiple myeloma

   In addition, patients must meet at least one of the following criteria I-IX (I-VIII at time of diagnosis or pre-autograft):

   I.Complex karyotype

   II.Fluorescent in situ hybridization (FISH) translocation 4:14 or 14:16,

   III.FISH translocation 1q21,

   IV.FISH deletion 17p,

   V.R-ISS III stage,

   VI.Two or more high-risk cytogenetic abnormalities exist

   VII.Plasma cell leukemia

   VIII.Extramedullary plasmacytoma

   IX.Recurrent or non-responsive (less than partial remission \[PR\]) MM after at least 4 cycles of PI/IMids-based chemotherapy
2. candidate for high-dose chemotherapy with stem cell transplantation
3. ECOG performance status score of 0,1,or2 -

Exclusion Criteria:

1. The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia.
2. during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer.
3. according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above:
4. were enrolled within 6 months before had a myocardial infarction, or New York Heart Association (NYHA) III or IV heart failure ,uncontrolled angina, uncontrolled severe ventricular arrhythmias or ECG evidence of acute ischemia or conduction system abnormalities and activity the clinical significance of pericardial disease, or cardiac amyloidosis -
A Study to Evaluate TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.

Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.

Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a histopathological or cytologically diagnosis of HCC
* Subjects who have undergone a curative resection
* High risk for HCC recurrence as protocol defined
* No previous systematic treatment and locoregional therapy for HCC
* Child-Pugh Score, Class A
* ECOG performance status 0 or 1
* Full recovery from surgical resection
* Adequate organ function
* Absence of major macrovascular invasion
* No extrahepatic spread
* Life expectancy of at least 6 months

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Evidence of residual, recurrent, or metastatic disease
* Known history of serious allergy to any monoclonal antibody
* History of hepatic encephalopathy
* Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
* Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment
* Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
* Any active malignancy within 2 years prior to the start of treatment
* Active or history of autoimmune disease
* Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
* Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
* Pregnant or lactating women
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
2. Previous history of solid tumor brain metastasis of any origin
3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
4. Previous radiation therapy of brain metastatic lesion(s)
5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC

Exclusion Criteria:

1. Patients with a history of active hematological malignancy
A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides

The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:

1. Standard knee cutting guides;
2. MRI generated patient specific custom cutting guides.

Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75
* Diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following:
* Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
* Correction of varus or valgus.
* Willing to participate and return for follow-up study visits.

Exclusion Criteria:

* Infection
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurologic disorders who is incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction
* Marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency
* Muscular atrophy
* Neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
* Previous osteotomy
* Diagnosis of rheumatoid arthritis
* Previous patella fracture or surgery
* Previous healed tibia or femur fractures
* Previous joint replacement surgery
* Cannot have an MRI
* Patients receiving single-stage bilateral total knee arthroplasty (TKA)
Thumb and Wrist Proprioception Exercises.

Distal radius fracture is the most common upper extremity fracture with peak incidence among older women after the fifth decade of life. Proprioception is one constituent of a complex Sensory motor control process. Proprioception requires the reception and central integration of incoming afferent signals. Although various sensory and motor deficits have been correlated with significant functional impairment after wrist trauma, limited research exists on the effects of proprioception and multi sensory training after distal radius fracture.

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of distal radius fracture (aged 18 years and above). Both assessor and statistician will remained blinded.

Standard rehabilitation program for distal radius fracture treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group, in addition, will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).

The severity of pain with activity will be measured according to the visual analog scale (VAS). PRWE questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) and force sense (FS) testing, for dexterity Due pegboard test will be used. All outcome measures will be collected at baseline, immediately following the intervention at 3 weeks and at 12 weeks following the end of the intervention.

Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.

All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosis of distal radius fracture.
* Wrist immobilization after lesion (unless 3 weeks)
* Capacity for sing inform concept and understand the exercises

Exclusion Criteria:

* Others associate fractures in hand or upper limb
* Wrist ligaments injuries
* Neurological disorder affecting the upper limb
* Have received previous proprioceptive training for upper limb injury.
A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC

The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures;
* Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female;
* Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified;
* No EGFR sensitive mutations or ALK gene translocations.
* Expected survival ≥ 3 months;
* Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1;

Exclusion Criteria:

* Pulmonary radiation therapy \> 30 Gy within 6 months prior to the first dose;
* Palliative radiation therapy completed within 7 days prior to the first dose;
* Any other form of anti-tumor therapy expected to be required during the study;
* Uncontrolled or symptomatic pericardial effusion, pleural effusion and ascites requiring repeated paracentesis and drainage;
* Presence of metastases to brain stem, meninges and spinal cord or compression;
The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome

Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities.

This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination.

All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone.

The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.

Turner syndrome is associated with short stature, multiple physical stigmata, and absent pubertal development. We propose to: (1) examine the effects of sex steroids (androgen) on multiple variables (growth rate, GH binding protein, IGF-I, and cognitive function), in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination on the above variables.

Eligibility Criteria:
* INCLUSION CRITERIA:

Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria:

Karyotype diagnosis compatible with Turner syndrome.

No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months.

Chronological age of 10.0 to 14.9 years.

Bone age less than or equal to 12 years.

EXCLUSION CRITERIA:

Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.

Y component in peripheral karyotype.
A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia

The goal of the study is to investigate whether adding different doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.

This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

This study will be carried out in six mental health institutes in China and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. The mental health institute at the Second Xiangya Hospital, Central South University.

Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).

Eligibility Criteria:
Inclusion Criteria:

1. Meet The Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
2. First onset or duration of illness less than 3 years with current symptoms exacerbation
3. Hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse)
4. Male and female with aged 18 to 50 years
5. PANSS total \>=75 at 2 weeks. .
6. Signed the study consent for participation

Exclusion Criteria:

1. having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
2. having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
3. taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
5. the routine blood tests showing abnormal renal, liver function or other metabolic results .
6. pregnant or lactating women
Preparative Fasting Before Contrast-enhanced Computed Tomography

The study aims to determine whether there is a need for preparative fasting prior to contrast-enhanced computed tomography (CT).

The use of fasting orders for imaging and other procedures is common, this seemingly benign practice can lead to real harms to patients and poor satisfaction with their care. The nothing per os (NPO) order is sometimes used in CT scans because gastrointestinal tract contents can interrupt visualization of the intestinal lumen, but more commonly NPO orders are are thought to protect all supine patients from aspiration during delivery of intravenous contrast. There is limited evidence to support such practice of NPO orders prior to contrast-enhanced CT scans. The authors' main objective is to determine if there is a need for preparative fasting prior to contrast-enhanced CT scans.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing contrast-enhanced CT scans

Exclusion Criteria:

1. Pateints undergoing CT scans while sedated.
2. Patients under the age of 18 years
3. Patients who suffer from a mental disorder that prevents them:

   1. from understanding what s/he consents to and/ or
   2. from choosing decisively and/ or
   3. from communicating his/her consent
4. Patients who were instructed not to eat due to requirements of a specific study (for example.. computed tomography enterography-CTE)
Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.


Eligibility Criteria:
Inclusion Criteria:

* positive history of ocular allergies and a positive skin test reaction
* positive bilateral CAC reaction

Exclusion Criteria:

* have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
* have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
* had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
* a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
* the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.
* use of any disallowed medications during the period indicated prior to Visit 1 and during the study.
* have planned surgery during the trial period or within 30 days after.
* have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1
Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section

Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.

Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS

Eligibility Criteria:
Inclusion Criteria:

* women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
* age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.

Exclusion Criteria:

* having an underlying disease (heart, liver, kidney, pulmonary, etc.),
* eclampsia and severe preeclampsia
* allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
* coagulation disorders
* refuse or unable to consent
The Effect of Case-Based Learning Method on Perceived Competence and Critical Thinking Levels

Second-year nursing students are randomly assigned to experimental and control groups. The case-based teaching method was applied to the experimental group and the classical teaching method was applied to the control group. After the initiative, both groups observed differences in perceived competence and critical thinking levels. In addition, the focus groups were interviewed with the experimental group and the opinions and suggestions about the initiative were evaluated qualitatively and the total mix method was used.

Nursing secondary school students were randomized into two groups. Case-based training was given to the experimental group, and classical training was given to the control group. Critical thinking scale and self-efficacy scale both before and after the training were applied to both groups. Posttest scores were calculated and compared for both groups. The focus group consultation with 10 people from the experimental group was carried out and the opinions and suggestions about the initiative were taken and evaluated. Permission was obtained in writing from all institutions before and after the participants, and the study was conducted by creating ethical conditions.Four separate training cases were given to the experimental group. the control group continued the classical training and no intervention was made.

Eligibility Criteria:
Inclusion Criteria:

* Become a nursing 2nd year student
* Want to participate in the research
* Not to be in the health profession
* Having passed the course of internal medicine nursing
* Being the first to see the surgical diseases nursing course
* Be able to devote time for case discussions outside of class

Exclusion Criteria:

- Being a foreign national (Unable to speak / understand Turkish effectively)