cyrilzakka/clinical-trials huggingface dataset:
A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation

One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs.

Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition.

Those patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment.

The study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay.

In order to do so we will compare three groups of COPD patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis
* Respiratory Rate\>25
* PaCO2\> 45 mmHg
* 7.35 \< PH \< 7.38

Exclusion Criteria:

* intubation
* apnea
* glasgow coma scale \< 8
* pneumothorax
* FEV1 \< 50% predicted
* Ischemic Hearth Disease
Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered.

Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic macular hele stage 2 or 3.
* Duration of Symptoms ≤ 12 months.
* Visual acuity ≥ 34 ETDRS letters.
* Intraocular pressure ≤ 23 mmHg.
* Informed consent.

Exclusion Criteria:

* Previous macular hole in project eye
* Macular pucker worse than a cellophane macular reflex.
* Previous surgery or disease in the eye affecting retinal function.
* Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a.
* Amblyopia i project eye.
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

Comparison of two combination chemotherapies in the treatment of patients with SLCL

Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

Eligibility Criteria:
Inclusion Criteria:

* cytological or histological proven SCLC Stage I or II at 1st diagnosis
* no prior chemotherapy
* measurable tumor disease
* karnofsky performance 70

Exclusion Criteria:

* second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
* NYHA III
* chronic diarrhea, obstructive bowel syndrome
Pilot Study of a Multidisciplinary Intervention in ICU Survivors At Risk for Psychological or Physical Morbidity

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

60 adult patients at two hospitals in Region Stockholm (Karolinska University Hospital and Södersjukhuset) with an ICU stay ≥12 hours with increased risk for psychological/physical sequelae will be invited to participate.

Intervention: Early re-assessment and multidisciplinary follow-up, led by an ICU follow-up staff (Case Manager, CM). The CM will support the patient and coordinate the rehabilitation efforts from ICU discharge to primary care with a secondary, deepened assessment of symptoms in the ward, recapitulation and information about the time spent in the ICU, followed by a multidisciplinary discussion with concerned specialists and the set-up of an individual rehabilitation plan communicated to the patient and the informal caregivers. The CM will keep track of the patient during hospital stay and ensure that there is a plan for further primary care rehabilitation after hospital discharge. The CM will contact the patient weekly to follow up on wellbeing and planned primary care activities until 12 weeks. At twelve weeks, patients will be assessed with regards to psychological symptoms (HADS, PTSS-14) and physical disability (BI).

Outcome: The primary outcome is the feasibility of the intervention. Patients and informal caregivers will be invited to participate in semi-structured interviews that will deepen the knowledge about their views upon the intervention, needs and suggested measures to improve the patients' recovery. Resource utilisation will be documented by the CM and feedback collected from involved ICU staff and hospital clinicians. Secondary outcomes are patients' level of psychological and physical problems and health-related quality of life. The results from the pilot study will inform a subsequent randomized controlled trial of an early follow-up intervention.

Eligibility Criteria:
Inclusion Criteria:

- Patients admitted ≥12 hours to the ICU with an increased risk for physical or psychological sequelae (assessed with the PROGRESS-ICU/PREPICS instruments)

Exclusion Criteria:

* Dementia or other major cognitive problems
* Structural brain or spinal cord injury
* Multiple limitations of medical treatment
* Insufficient language skills (Swedish)
Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.

The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.

AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.

METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features.
2. Hamilton Depression Scale (HAM-D) total \>16 with item 1 (depressed mood) \>2.
3. Age 18-70 years, male or female.
4. Competent and willing to give written informed consent.

Exclusion Criteria:

1. No clinical hyper- or hypothyroidism nor other thyroid illness.
2. No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.
3. No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
4. No significant suicidal risk (HAM-D item 3 (suicide) \<3).
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.

In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory values meeting the criteria within the protocol.
* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Exclusion Criteria:

* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan).
* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Eligibility Criteria:
Key Inclusion Criteria:

* Sign an Informed Consent;
* Have dry eye symptoms;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Ocular abnormalities;
* Active ocular infection or inflammation not associated with dry eye;
* History of ocular or intraocular surgery;
* Other protocol-defined exclusion criteria may apply.
Evaluation of the Xen Implant in Glaucoma Surgery

Glaucoma is a blinding optic neuropathy that affects 60 million people around the world. Primary open-angle glaucoma is the most common etiology. The therapeutic arsenal now includes medicated hypotonic treatments, lasers and surgery. The most common glaucoma surgery in France is trabeculectomy and non-perforating deep sclerectomy. These are two filtering surgeries whose principle is to lower the intraocular pressure by creating a way of evacuation of the aqueous humor from the anterior chamber of the eye to the space sub conjunctival creating a bubble of filtration. The short-term complications with these techniques are early hypotonia and its attendant complications (choroidal detachment, maculopathy of hypotonia, haemorrhage...). In the medium term, blood pressure with deep anterior chamber, testify to a scleral flap too tight which may require suture lysis. Finally, the problems of excessive conjunctivo-tenon healing affect 25 to 30% of operated and are responsible for the majority of late blood pressure. In the longer term, the most common complication is cataracts. It can be complicated by a very serious endophthalmitis. A new minimally invasive therapeutic option has been developed that limits per and postoperative complications. In contrast to traditional techniques that have an ab externo approach, the ab interno approach of the proposed new technique involves the implantation of a collagen tube 6 mm in length and 45 μm of light called Xen® through the anterior chamber. This surgery can be performed alone or at the same time as a cataract surgery. The geometry of the Xen® implant has been studied to prevent major hypotonia. This new technique would also avoid the complications associated with conjunctival dissection, while being faster. A Xen® implant is nowadays indicated for simple surgery or combined with cataract surgery for open-angle, early-to-moderate, cataract and non-cataract glaucoma, progressive and unbalanced under local hypotonism therapy. Since June 2017, the Xen® technique is part of the routine at GhPSJ.

The objective of this study is to evaluate the efficacy of surgery with Xen® implantation on intra-ocular pression drop in patients with primary or secondary open-angle glaucoma, beginner to moderate. The study will be proposed to all eligible patients operated between June 2017 and June 2018. After patient's non opposition, clinical data will be collected from patient's medical record.

Eligibility Criteria:
Inclusion Criteria:

* Patient followed for either early or moderate forms of primary or secondary open-angle glaucoma who had undergone surgery for Xen® alone or in combination with cataract surgery for phacoemulisation of the lens
* Patients operated between June 2017 and June 2018

Exclusion Criteria:

* Patient objecting to participate in the study
* Patient with other associated ophthalmological disease, except simple cataract already operated or operated simultaneously with the Xen® break without per or postoperative complication
* History of filter surgery, history of vitrectomy
* Close angle glaucoma
* Patient under tutorship or curatorship
Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department

The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure \<100 or shock index \[heart rate divided by systolic blood pressure\] \>1)

Exclusion Criteria:

* \<18 years old
* Prisoner or ward of the state
* Trauma
* High acuity requiring treatment in resuscitation room
* Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
* Any form of "do not resuscitate" (DNR) order
* Roomed in hall of emergency department (location not amenable to ultrasound protocol)
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown.

The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

In order to attempt to explain the pathogenesis of renal calculi, the investigators videotape and document the location and characteristics of each stone, papillae and calyces. One or more small papillary biopsies are taken for analysis to help determine the point of origin of the kidney stone and histological studies are undertaken to determine tissue differences amongst different types of stone formers. Approximately one month after surgery, metabolic studies are undertaken to further review potential causes of stone formation.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Methodist Urology in Indianapolis, IN who are undergoing endoscopic procedures for nephrolithiasis or other urologic disease.
* Upper urinary tract endoscopic or PERC procedure for kidney stones removal
* General medical health allowing surgical procedure
* Ability to complete all the necessary components of the study
* Able to sign an informed consent

Exclusion Criteria:

* Poor general medical health
* Bleeding diathesis
* Inability or unwillingness to comply with post-surgical follow-up
Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region.

The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or more of age
* planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria:

* malignancy
* infection
Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer

This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer

Pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.The prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.Albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. It has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.It is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 years old, no gender limit;
2. Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology;
3. The patient has not undergone standard systemic treatment in the past, or more than half a year after the end of postoperative treatment.For those who have undergone major surgery or radiotherapy, the interval must be more than 4 weeks and their metastases have not received any local treatment including radiotherapy, chemotherapy, surgical treatment, etc.;
4. At least one measurable lesion (CT scan of tumor lesions with long diameter ≥ 10 mm, CT scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness not greater than 6 mm);
5. The main organs are functioning normally, that is, they meet the following standards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14 days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALB in 14 days), TBIL \<1.5 times the upper limit of normal (ULN);ALT and AST≤3ULN, accompanied by liver metastasis, then ALT and AST\<5×ULN;Cr ≤1.5×ULN or creatinine clearance rate ≥60ml/min;
6. The subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients suffering from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
3. Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients.
4. The patient has clinically significant ascites;
5. Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
6. Patients with active hepatitis B or C;
7. Doctors think it is not suitable for inclusion.