cyrilzakka/clinical-trials huggingface dataset:
The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC

Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and cisplatin or carboplatin chemotherapy.

Inclusion Criteria:

1. Patients aged 18 years -75 years, male or female;
2. histologically or cytologically confirmed non-small cell lung cancer;
3. consistent with the indication of chemotherapy
4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 \* 109/ L;
5. the expected survival was more than 3 months;
6. patients must have the ability to understand and the willingness to sign a written informed consent;
7. to be able to follow the study and follow-up procedures

Exclusion Criteria:

1. pregnant or lactating women;
2. patients who had severe allergic history on biological preparation;
3. the existing serious acute infection without control;
4. Patients receiving radiotherapy;
5. more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 \* 109/ L on the screening period on the seventeenth day of the screening period;
6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;
7. Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;
8. tumor metastasis was found in the central nervous system;

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years, Male or females
* Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin
* Platele counts ≤ 50×109/L during Screening chemo cycle
* ECOG PS score is ≤ 2
* The predicted life expectancy ≥3 months
* Written informed consent

Exclusion Criteria:

* Pregnant or nursing women
* Known history of severe anaphylactic reaction to biologics
* Uncontrolled severe infection
* History of bone or central nervous system metastasis
* History of platelet disorder
* Active bleeding
REmotely Supervised Exercise Therapy Trial 2

Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing.

During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist.

RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.

Design A single centre, pilot, randomised controlled trial at Mid and South Essex Hospitals Foundation Trust. The study is unfunded and sponsored by Mid and South Essex Hospitals National Health Service Trust.

Sample size This is a pilot randomised controlled trial to generate a sample size calculation for a larger trial.

Based on the feasibility data from RESET1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups.

With alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (MedCalc statistical software, Belgium).

The sample size will be 20+20 patients from Mid and South Essex Trust vascular outpatient clinics.

Follow up There will be 3 assessment visits: baseline, 3 months and 6 months performed with a study clinician.

The primary endpoint will be measured blind to treatment allocation by asking the patient to walk along a flat, hospital corridor until they need to stop due to leg pain. This will be measured at 0, 3 and 6 months.

The secondary endpoint will be through patient questionnaires and scored by an independent observer at baseline, 3 and 6 months.

Ankle-brachial pressure index will be measured by an independent vascular scientist at the start and end of the study.

Patient satisfaction will be measured at 3 months using a self-reported questionnaire.

Adherence to exercise will be measured through submission of walking logs at 1, 2 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Arterial claudication with ABPI \<0.9 or post-treadmill pressure drop of \>20mmHg
* Able to walk 50 metres unaided
* Willing to try and give up smoking
* Willing to take antiplatelet, rivaroxaban and statin
* Has a smartphone or pedometer or watch
* Has an email account
* Adult \> 18 years old
* Able to give informed consent

Exclusion Criteria:

* Nocturnal foot pain or tissue loss
* Use of walking stick, frame or wheelchair
* Severe COPD or heart failure or arthritis
* Home oxygen
* Major amputation and non-limb wearer
* Severe hearing or visual impairment
* Prior failed exercise regime
* Prior falls
* Cognitive impairment
* Unable to work due to severity of claudication
Acupuncture for Chemotherapy-induced Peripheral Neuropathy

The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma.
* Patients must have chemotherapy-induced peripheral neuropathy greater or equal to 2 according to CTCAE (Common Terminology Criteria for Adverse Events) v 3.0 scale (Appendix A) in spite of previous conventional medications, e.g. Neurontin, Cymbalta and/or Lyrica. Patients receiving any of conventional medication for this symptoms must remain on the same medications throughout the study period.
* Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent.
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, or 2.
* If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception.

Exclusion Criteria:

* Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV.
* Current active treatment for lymphoma or multiple myeloma
* Ongoing local infection at or near the acupuncture point adopted in this trial.
* Severe immunocompromised patients, leukopenia ( \< 4,000/㎣) or neutropenia ( \< 1,500/㎣)
* Known coagulopathy, thrombocytopenia (\< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose.
* Serious emotional or mental problems that precludes study entry.
* Mental and physical disability that precludes accurate acupuncture.
* Serious systemic diseases such as active infection, severe heart disease, uncontrolled hypertension and diabetes mellitus.
* Cardiac pacemaker.
* Pregnant or breastfeeding
* Acupuncture therapy within the previous 30 days
* Concurrent other complementary and alternative therapy such as herbal agents, high dose vitamins, and etc.
Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato

Data on reinfections with B. burgdorferi sensu lato in humans are scarce; they are limited to case reports and a few small groups of patients, mostly from the USA and less frequently from Europe. In these reports, the clinical manifestation of reinfection was usually erythema migrans and was most often documented after successful treatment of a previous infection (almost always erythema migrans). The clinical manifestations of Lyme disease in reinfection appear to be similar to those of primary infection, but there are no studies on possible differences in serological or immunological responses.

The current study has 3 primary objectives:

* To determine the frequency of clinically detectable reinfections and to identify the circumstances under which they occur;
* To determine possible differences between primary and reinfection in clinical presentation, disease course and outcome, and specific serum antibody response;
* To determine the aetiology of clinically detectable reinfections by comparing Borrelia isolates recovered from the skin of the same patient at primary and reinfection.

The current study will encompass all patients aged ≥18 years who were treated at the Department of Infectious Diseases, UMC Ljubljana for proven, clinically well-defined Lyme borreliosis in the period 1989 - 2023. Organised data collection in patients with Lyme borreliosis started in 1986 when we established an Outpatient Lyme borreliosis Clinic and introduced uniform approaches to diagnosis, treatment and follow-up of the disease course, thus obtaining a database of high quality clinical and laboratory data in a large number of patients.

The aims:

1. To determine the frequency of clinically detectable reinfections and to identify the circumstances under which they occur (in a cohort of \~15000 European patients with erythema migrans and \~1500 patients with early extradermal or late Lyme disease).
2. To determine possible differences between primary and reinfection in clinical presentation, disease course and outcome, and specific serum antibody response (by comparing clinical findings and serological test results in \~1500 patients who were diagnosed with erythema migrans more than 1 time).
3. To determine the aetiology of clinically detectable reinfections by comparing Borrelia isolates recovered from the skin of the same patient at primary and reinfection (\~100 patients and 200 isolates, respectively).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definitive Lyme borreliosis

Exclusion Criteria:

* /
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
* Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).
* Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
* Must satisfy the approved therapeutic indications for Tysabri as per Product Monograph.
* Must either be treatment naïve or have been treated with disease modifying therapy DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia, Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.
* Decision to treat with Tysabri must precede enrollment.

Key Exclusion Criteria:

* Any prior treatment with Tysabri.
* Contraindications to treatment with Tysabri as described in the Product Monograph.
* History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
* History of diagnosis of Primary Progressive Multiple Sclerosis \[PPMS\] and/or Secondary Progressive Multiple Sclerosis \[SPMS\].
* Receiving immunomodulatory or immunosuppressive therapy.
* Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab).
* Immunocompromised at the time of enrollment.
* Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
* Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception.
* Inability to comply with study requirements.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
TQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis

In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;
3. No gender limitation;
4. Histologically confirmed hepatocellular carcinoma;
5. Meet resectable surgical criteria;
6. Child-Pugh:A or B;
7. According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;

Exclusion Criteria:

1. Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;
2. Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;
3. No radical resection could be performed after adequate imaging evaluation;
4. Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);

6. Hepatitis B combined with hepatitis C; 7. Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;
A Multi-center Study for Eradication of Refractory Helicobacter Pylori

Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. pylori is still existing, although patients have good compliance and receive standardized treatment. This phenomenon is likely attributed to the different ratio of sensitive and resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. In order to solve the refractory infection of H. pylori, investigators performed a muti-center study together with other 14 institutions. In this study, investigators will select the patients with refractory infection of H. pylori after two standardized treatment from patients with first eradication therapy of H. pylori infection. Then, investigators will perform a high-throughput sequencing for patients in groups. Finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
2. Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
3. Unused antibiotics, bismuth, H2 receptor antagonists or PPIs by nearly 4 weeks
4. 13C-labelled urea breath test positive.
5. Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
6. Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.

Exclusion Criteria:

1. Severe heart, liver, kidney dysfunction.
2. Pregnant or lactating women.
3. Complications of bleeding, perforation, pyloric obstruction, cancer.
4. Esophageal,gastrointestinal surgery history.
5. Patients can not properly express their complaints,such as psychosis, severe neurosis.
6. Taking nonsteroidal antiinflammatory drugs (NSAIDs) or alcohol abusers.
7. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)

The purpose of this study was to analyze the efficacy of massage therapy and kinesiotherapy, applied by the parents of hospitalized preterm infants, in the improvement of the biological state, neuromotor activity and other associated factors.

Premature infants are prematurely deprived of the cutaneous stimulation provided during intrauterine development and of the continuous contact with their parents. It has and adverse effect on both psychological and biological development of the child.

Knowledge of these factors has led many neonatal units to begin to introduce therapeutic massage protocols to facilitating satisfactory neuromotor and anthropometric development of preterm infants.

In this study, premature newborns were assigned to one of two groups:

A: Control Group. B: Massage and kinesiotherapy Group, 15 minutes twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 26 to 37 gestational weeks.
* Low birth weight, less than 2249 grams.
* Weight of at least 1250 grams at time of entry into study.
* Must be at least 48 hours of age.
* Must have hemodynamic stability.
* Absence of congenital and genetic anomalies.
* Absence of alterations of the central nervous system.
* Intact skin.
* Stable parameters (according to the neonatologist´s criteria) to participate in the intervention.

Exclusion Criteria:

* Family refusal to participate in the study.
* High frequency mechanical ventilation.
* Fraction of Inspired Oxygen (FiO2)\>70%.
* Inotropic support.
* Septic shock.
* Persistent tachycardia.
* Persistent bradycardia.
* Gastrointestinal disorders.
Probiotics to Prevent Relapse After Hospitalization for Mania

The purpose of this study is to determine if taking a probiotic supplement versus a placebo will lower rates of relapse and improve the clinical course among participants who have been hospitalized for mania. Relapse and clinical course are measured by time to re-hospitalizations, new mood episodes, and changes in mood-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Capacity for written informed consent
* Currently admitted to a Sheppard Pratt inpatient or day hospital for symptoms of mania
* Primary Axis I diagnosis (DSM-IV) at time of admission of Bipolar I Disorder (single manic episode, most recent episode manic, or most recent episode mixed) OR Schizoaffective Disorder, Bipolar type (manic or mixed state)
* Proficient in the English language
* Available to come to Sheppard Pratt Towson for follow-up visits
* Participated previously in one of our screening studies

Exclusion Criteria:

* Diagnosis of mental retardation
* Symptoms of mania secondary to a general medical condition
* Any clinically significant or unstable medical disorder as determined by the investigators including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition
* History of IV drug use
* Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last 3 months, or has a positive drug toxicity screen
* Participated in any investigational drug trial in the past 30 days
* Pregnant or planning to become pregnant during the study period
* Receipt of antibiotic medication within the previous 24 hours (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics)
* Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care). Of note, we are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as we intend to look at these levels as a predictor of response.
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.


Eligibility Criteria:
Inclusion Criteria:

* 21 years and older
* Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty
* Ability to walk independently prior to injury
* Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP)
* Willing and able to comply with post-operative protocol and return for follow-up.
* Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation
* Signed informed consent

Exclusion Criteria:

* Additional ipsi- or contralateral lower extremity fracture
* Any kind of implant at the ipsilateral proximal femur
* Pre-existing malunion or nonunion of the ipsilateral lower extremity
* Segmental bone defect requiring bone grafting
* More than 4 weeks between injury and surgery
* Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
* Polytrauma
* Active malignancy
* Any not medically managed severe systemic disease
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the study period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study