cyrilzakka/clinical-trials huggingface dataset:
Framing and Decision Making in Neonatology

The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions.

There have been many advances in neonatal care in recent decades. However, the investigators do not know if these children will grow up to be healthy or if they will have problems with mental retardation, behavior or physical handicaps. In these circumstances, where the medical profession cannot predict what sort of life a child will have, parents have a choice of having intensive care started or of allowing the baby to die naturally. The age most often cited by physicians at which this care is optional and under parental discretion is 23 weeks gestation.

The purpose of this study was to ask people, recruited through the world wide web, what they would want for the doctor to do in the case of a hypothetical 23 week premature delivery in order to evaluate the decision process and the presence of autonomous choice. This study had two parts. The first part, presented outcome information in 2 different ways -either as survival and lack of severe disability or as mortality and presence of severe disability. The results of the first part have been published (Message Framing and Perinatal Decisions, Pediatrics, 2008). The second part, investigated whether the way in which the way in which delivery room management options were presented- either as agreeing with a course of action or opting out- impacted resuscitation decisions. This part was administered as a separate survey to a different sample of participants at a later date. The remainder of the questionnaires asked demographic and opinion questions as a means to assess variables that may influence how people respond to the information they receive.


Eligibility Criteria:
Inclusion Criteria:

\>18 yo

Exclusion Criteria:

\<18 yo
Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)

Primary aim of the trial

1. to verify safety and tolerability of expanded human fetal neural stem cells
2. to verify safety and tolerability of a microsurgery human fetal neural stem cells transplantation model
3. to recognize each change in patient's quality of life

Secondary aim of the trial

1. assessment of the impact of human neural stem cells transplantation on the disability of ALS in a clinically significant and measurable way
2. Assessment of the impact of human neural stem cells transplantation on mortality (all causes)

18 patients diagnosed as definite ALS according to the El Escorial criteria will be recruited during two years. The patients will be divided into 3 groups with different severity. Each group will be less compromised than the group that went before them. Their breathing measurements must be at least 60%. Subjects will receive injections of the human foetal neural stem cells into the spinal cord. A variety of tests and examinations will take place every month for the first year and every three months for the next two in order to monitor the course of the disease and the adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite or possible ALS according to revised EL Escorial criteria
* Age: 20-75 years
* documented progression of disease during the last 6 months.
* Absence of concomitant diseases
* Adequate assurances of adherence to protocol
* The patient must be able to communicate verbally or with the use of non-verbal communication system

Group 1

* maximum score of 1 on walking item of ALS functional rating scale
* forced vital capacity \> or equal to 60

Group 2

* forced vital capacity \> or equal to 60
* ambulation difficulties (maximum score of 2 on walking item of ALS functional rating scale)

Group 3

* Independent ambulation (score 4 on a scale ALS-FRS)
* forced vital capacity \> or equal to 70

Exclusion Criteria:

The presence of at least one of the following will lead to patient exclusion.

1. psychiatric diseases or other neurological diseases different from ALS
2. other systemic diseases
3. Neoplasms or other diseases reducing life expectancy
4. Antecedent polio infection
5. corticosteroids, immunoglobulin or immunosuppressive treatment
6. involvement in other clinical trials
7. 2 or more critical items in MMPI
8. neuropsychological evaluation suggestive of mental deterioration or cognitive sphere disturbance.
9. Impediments to MRI
10. patients unable to understand informed consent form and study aims.
11. women who are pregnant or childbearing potential for the duration of the study. Non-pregnant status will be documented by beta-HCG negative test 7 days before treatment start
Genotype-phenotype Correlation in Junctional Epidermolysis Bullosa

This study will collect genetic and clinical information of junctional epidermolysis bullosa (JEB) patients. Computer analysis will be performed on genetic mutations found in these patients and this will be correlated with their clinical characteristics.

Junctional epidermolysis bullosa (JEB) is a rare genetic skin disease where genetic defects in skin proteins result in extensive blistering in response to mild mechanical stress. Patients are often affected at birth or from early childhood, and suffer from varying degrees of severity depending on the specific mutations that they have and the proteins that are affected. This ranges from severe widespread blistering and death within the first few years of life, to minimal localised blistering and survival to adulthood. Diagnosis is confirmed by genetic testing, and this is often used to predict the likely clinical course. However, it is not always straightforward to make accurate predictions from genetic information, as our understanding of these proteins and mutations at the molecular level is currently incomplete.

The main aim of this project is to systematically collect genetic and clinical data of junctional epidermolysis bullosa (JEB) patients and to explore whether there are any relationships between participants' genetic defects and the severity of disease. This will help in establishing links between genetic defects and clinical characteristics, which is essential for accurate prognostication, genetic counselling and prenatal diagnosis.

This study will also aim to develop pipelines for analysis of how mutations may affect corresponding protein structure and function using computer prediction tools. This will improve our understanding of how these proteins function, and could partly explain the variation in disease severity of patients with this condition. It could also lead to identification of important regions of the protein, which could be investigated further in subsequent studies.

Eligibility Criteria:
Inclusion Criteria:

Adults and children with a diagnosis of JEB or LOC syndrome, which has been confirmed with genetic testing. A mutation is present in one of the following genes: LAMA3, LAMB3, LAMC2 or COL17A1.

Current JEB patients, or JEB patients within the last 5 years who have used the EB service at Solihull hospital or Birmingham Women's and Children's Hospital. This includes patients who are living and also those who passed away in the last 5 years (eg from severe JEB).

Exclusion Criteria:

Adult patients who are unable to give informed consent. Child patients who do not assent and/ or have no one appropriate who can consent on their behalf.

Persons who might not adequately understand verbal explanations or written information given in English.
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 18-75 years of age
* Identified as eligible for elective surgery for single (1) level, posterolateral spinal fusion between L1 and S1 in which the spine stabilization is accomplished by pedicle screws and rod.
* Male patients and female patients (not pregnant or lactating). Patients should use an appropriate form of contraception while participating in the study.
* Patients able to give informed consent.
* Normal organ and marrow function

Exclusion Criteria:

* Patients with hypophosphatasia, primary or secondary hyperparathyroidism caused by chronic renal insufficiency or osteomalacia.
* Patients with osteoporotic vertebral fractures.
* Patients with a prior spinal fusion at the level to be treated.
* Concomitant use of BMP, or devices containing BMP, or electronic growth stimulators.
* Any active infection of any clinical significance will be excluded from the study.
* Positive for HIV, HTLV and/or syphilis.
* Active Hepatitis B, or Hepatitis C infection at the time of enrollment.
* Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the ex-vivo cell production process.
* Patients who require systemic corticosteroid therapy after surgery.
* Pregnancy or lactation; positive of hCG.
* Body Mass Index (BMI) of 40 Kg/m2 or greater.
* Patients unable to tolerate general anesthesia defined as an ASA criteria of \>2.
* Patients with poorly controlled diabetes mellitus (HbA1C \>7%).
* Rationale for Exclusion of Certain Study Candidates

  1. Patients with other diseases are excluded to avoid confounding factors that might impact evaluation of safety and efficacy of TRC cell therapy in posterolateral spine fusion.
  2. More extensive surgery requiring more than one (1) level fusion is contraindicated in this study, to avoid confounding factors that might impact evaluation of safety and efficacy of TRC cell therapy.
* In the opinion of the investigator, the patient is unsuitable to cellular therapy or unable to continue with this study.
* Patients that drink more than 2 alcoholic drinks per day or have a history of illicit drug use at the time of enrollment shall not be enrolled in the study.
* Patient known to be non-euthyroid at baseline.
* Patients undergoing active cancer therapy.
* Bisphosphonate Therapy

  1. Patients that have undergone bisphosphonate therapy within the last 10 years.
  2. Initiation of bisphosphonate therapy in patients during this study is prohibited.
* Patients with a known diagnosis of osteoporosis with recorded BMD less than -2.5.
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis

The aim of this study is to observe the clinical efficacy and safety of abatacept combined with JAK inhibitor in the treatment of D2TRA patients


Eligibility Criteria:
Inclusion Criteria:

1. Meet the above diagnostic criteria for refractory rheumatoid arthritis
2. The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and abatacept combined with a JAK inhibitor is required treated patients

Exclusion Criteria:

1. Patients with tumors, hematological diseases, and other autoimmune diseases
2. Those who have a history of allergies to the drugs selected in this study
3. Those who cannot adhere to abatacept combined with JAK inhibitor therapy, or who have serious adverse reactions and did not complete the observation period prescribed by the study
Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious disease and there may be a bidirectional association of SDB and CTEPH.

This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will be analyzed and CTEPH patients for possible PAP treatment will be defined.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed untreated CTEPH
* NYHA I-III

Exclusion Criteria:

* Age\<18
* Pulmonary Hypertension other than CTEPH
* Previous diagnosis of SDB
* Ongoing PAP treatment
* Use of nasal oxygen
Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

* Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy.
* Compare the toxicity of these regimens in these patients.
* Compare the response rate, time to progression, and survival of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses.
* Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses.

Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)

  * Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
  * Progressive disease
  * Must have received prior chemotherapy
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic:

* Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN

Renal:

* Creatinine no greater than 1.25 times ULN

Cardiovascular:

* No prior or concurrent cardiovascular disease that would preclude study

Pulmonary:

* See Disease Characteristics
* No prior or concurrent pulmonary disease that would preclude study

Other:

* No prior or other concurrent illness or medical condition that would preclude study
* No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No prior docetaxel
* At least 3 weeks since other prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy allowed
* No concurrent radiotherapy

Surgery:

* Prior radical surgery for NSCLC allowed
* Concurrent palliative surgery allowed
Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)

The purpose of this study was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. A total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics, Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often than those by Synthes and Medartis Footprint. Plate position with the Medartis design was significantly more proximal to the Watershed line compared to its companion design, the Medartis Footprint plate. Plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.

This is a retrospective multicenter study involving several orthopedic surgeons with a trauma surgery practice within the public hospital centers of the department of Finistère. These include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.

Eligibility Criteria:
To be included, patients had to have a digital radiographic file that could be used for the Soong classification. Among the volar plate fixation cases retrieved from the databases, we excluded patients that were not treated with a locking plate and those with a lateral x-ray that could not be interpreted. The inclusion criteria for lateral radiographs were alignment of the radius, lunate, capitate and third metacarpal bones, combined with radial-ulnar overlap (the ulnar styloid process projecting into the middle of the ulnar head).

Exclusion criteria:

Patient refusal No postoperative radiograph N=40 Poor quality radiograph N=214
SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)

To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure \> 161; \< 221; 140/90 mm Hg But \< 180/110 mm Hg)
* Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure \> 180/110 mm Hg but \< 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
* Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure \> 161;\< 221; 130/80 mm Hg But \< 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure \> 161;\< 221; 140/90 mm Hg But \< 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure \> 161;\< 221; 130/80 mm Hg But \> 161;\< 221; 150/90 mm Hg
* The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion Criteria:

* Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
* Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
* Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine \> 130 Ìmol/L Or Creatinine Clearance \< 45 Ml/Min, Ast \> 3 Times Above The Normal Range, Alt \> 3 Times Above The Normal Range, Serum Potassium \< 3.5 Or \> 5.5 Meq/L
* Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
Heart Rate Variability in Response to Metformin Challenge

Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later.

Doctors need to develop tests which inexpensively and reliably evaluates brain metabolism. Current diagnostic tests sample other tissues which often run on different fuels (fats), utilize unproven and often insensitive brain imaging scanners, or sequence thousands to millions of base-pairs of DNA. All of these tests are expensive. None of these tests accurately or completely capture the interactions between the 1000s of proteins involved in brain metabolism.

The investigators suspect that mathematical analysis of the resting heart rate may provide some insight into brain metabolism. The brain controls heart rate in response to changes in blood pressure and blood gases like carbon dioxide and oxygen. Tight control of heart rate is necessary to make sure that the brain has the right mix of fuel and air. Because the brain can't respond instantly to changes in its fuel supply, this system acting as a biological carburetor has a natural oscillatory rhythm that can be monitored just like frequencies on the radio.

The investigators propose to amplify these rhythms by modestly metabolically stressing the brain with metformin, a inhibitor of complex 1 in the mitochondria.

Eligibility Criteria:
Inclusion Criteria:

EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

Exclusion Criteria:

* recent infection,
* renal failure,
* pre-existing cardiac disease,
* chronic obstructive pulmonary disease
* inability to participate in informed consent,
* lack of transport to return home from study site,
* severe fasting intolerance or hypoglycemia,
* history of stroke-alike episode,
* uncontrolled migraine or cyclic vomiting,
* diabetes on insulin or sulfonylurea,
* non-English speaker,
* medications with strong effects on baseline heart rate variability
A Pilot Study Evaluating a Clinically Managed Weight Loss Program

This is a pilot study evaluating a clinically managed weight loss program. The program consists of a 17-week weight loss program which involves a multidisciplinary team where personalized interventions are given to participants from the team based on the participants goals.

The clinically managed weight loss program is managed by a clinical team including a Program Manager, Registered Dietitians, Canadian Society of Exercise Physiology-Certified Personal Trainers, Clinical Psychology Associate or Cognitive Behavioural Therapist, and a Physician. The team will collaborate together to prescribe a plan best suited for the participants' needs with the focus on lifestyle changes, such as, sleep, mental health, and behaviours. Outcome measures will be collected as part of the pilot study, such as, anthropometric measurements and body composition, cardiovascular assessment, clinical chemistry, physical activity, nutrition, and behaviour and health screening questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial.
* Male or female, aged 18 years or above.
* Are overweight or obese (BMI over 24.9)

Exclusion Criteria:

- Female participant who is pregnant or lactating.