cyrilzakka/clinical-trials huggingface dataset:
Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo) Under Exercise

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on pulmonary artery pressure and right heart function (echo) under exercise.

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis. Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo under exercise.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting partial oxygen pressure (PaO2) ≤7.3 kilopascal (kPA) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \[5-FU\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

This study was conducted in 2 parts: An initial 2-arm part in which patients were randomized to 1 of 2 different treatment groups (XELOX or FOLFOX-4), and a subsequent 2 x 2 factorial part, added to the study through a protocol amendment, in which additional patients were randomized into one of 4 different treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, or FOLFOX-4 + bevacizumab). Due to the comparison of the oral agent capecitabine with bolus and infused fluorouracil, the study was not blinded with respect to these 2 treatments. The study was double-blind with regard to the administration of bevacizumab, ie, there was a placebo control for bevacizumab in the second part of the study.

The study consisted of 3 phases, a Primary Study Treatment Phase, a Post-Study Treatment Phase, and a Follow-Up Phase.

Primary Study Treatment Phase

Patients were to receive up to 16 cycles (2-arm part of the study) or 24 cycles (4-arm part of the study) of treatment during the Primary Study Treatment Phase (48 weeks).

Post-Study Treatment Phase

Patients who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Patients who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the patient withdrew consent.

Follow-up Phase

Patients who terminated study treatment during the primary or post-study treatment phase were followed until disease progression or death.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Metastatic colorectal cancer.
* ≥ 1 target lesion.

Exclusion Criteria:

* Previous treatment with oxaliplatin or bevacizumab.
* Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
* Progressive disease during or within 6 months of completion of previous adjuvant therapy.
Study of Treatment Response on IgG4 Related Disease (IgG4RD)

This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.

Patients with IgG4-RD will be randomized in two therapeutic groups: Prednisone alone and combination therapy with Prednisone and Mycophenolate mofetil. These patients will be followed in 12 months. Treatment response and relapse will be recorded, as well as side effects.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Aged 18 to 70 years old with informed consent
* All patients must meet the following diagnostic criteria of IgG4RD (2011):

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L);
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
  4. exclusion of other diseases.

Exclusion Criteria:

* Patients will not be included if meets any of the following criteria:

  1. Patients who were diagnosed as other autoimmune diseases;
  2. Patients who were diagnosed as malignant diseases;
  3. Pregnant and lactating women；
  4. Active infection: HIV, HCV, HBV, TB；
  5. Serious organ function failure, expected life time less than 6 months.
  6. Presenting with Mikulicz disease without other manifestations.
Efficacy of Manual Therapy Techniques and Electrotherapy Modalities in Individuals With Non-specific Low Back Pain

Low back pain is the fifth most common reason for doctor visits, affecting about 60-80% of people in their lifetime. Despite this, there are not enough diagnostic and treatment methods in the literature to fully elucidate non-specific low back pain. In this case, the research showed that non-specific low back pain should be handled with a biopsychosocial approach, and its relationship with fascia and myofascial meridians should be investigated.

According holistic that approach patients with non-specific low back pain. Instead of examining the problem of low back pain in the society only in the form of muscles, joints, ligaments, etc.; should evaluate low back pain over the fascia. It is seen that most studies in the literature only examine the painful area and tissue problems in its immediate vicinity, and therefore they approach low back pain with symptomatic treatment. In recent studies, however, the main problem is not limited to the painful area only; It has been determined that the tissue response caused by the problems in different parts of the body is transmitted to more distant regions via the fascia and myofascial meridians.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-60
* Volunteering to work
* The person has a complaint of low back pain for more than 3 months
* Diagnosis of chronic low back pain by the doctor
* Being able to read and write and be cooperative.
* Not having received treatment for the lumbar region in the last 3 months
* having an MRI in the last 6 months.

Exclusion Criteria:

* Not having any lumbar surgery or vertebral fracture
* Having neurological, radiculopathy, inflammatory, etc. disease
* Having spinal deformities such as scoliosis, kyphosis
* Having a vestibular or respiratory disorder
* Having auditory or cognitive impairment
* Medication that will affect the balance (sedatives, etc.)
* Patients with lower extremity amputation
* Those who want to quit working during the study period, those who do not attend regularly.
* Conditions such as cancer, infection, etc. in the spinal region
A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, aged ≥ 30 and \< 80 years at informed consent
* Subject has idiopathic Parkinson's Disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, and the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of Parkinsonism
* Subject has motor fluctuations such as wearing, dyskinesia
* Subject has experienced nocturias for at least 3 nights within 7 days prior to Baseline
* Subject is taking levodopa (L-DOPA, immediate and/or controlled release) in combination with benserazide or carbidopa and has been on a stable dose of L-DOPA for at least 28 days prior to Baseline (Visit 2)
* Subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least 28 days prior to Baseline (Visit 2)

Exclusion Criteria:

* Subject is receiving therapy with tolcapone or budipine
* Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine
* Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within the 6 months prior to Baseline (Visit 2)
* Subject has a known hypersensitivity to any components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis
* Subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not surgically sterile, or, (ii) not using adequate birth control methods \[including at least one barrier method\] or, (iii) not sexually abstinent, or (iv) not at least 2 years post menopausal)
* Subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants

The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation.
* Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

* Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
* Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
* Have clinically significant abnormalities on ECG, as determined by investigator.
* Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
* Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Infected Patients

HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. The main purposes of this study are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection.

Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses contribute to the control and potential clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies have shown that the vaccine induces strong CTL responses in animal models. This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy (HAART) and have a CD4 count of 350 cells/mm3 or more and fully suppressed viral replication on stable HAART.

Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4, 8, and 16. Participants will be randomly assigned to receive either vaccine or placebo. Ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.

Eligibility Criteria:
Inclusion Criteria

* Documented HIV-1 infection
* Taking HAART for 6 months or longer and on stable HAART for at least 4 weeks
* Plasma HIV-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry
* CD4 count of 350 cells/mm3 or more within 30 days of entry

Exclusion Criteria

* Immunomodulatory agents
* Prior receipt of experimental HIV vaccines in the 5 years prior to study entry
* Hepatitis B surface antigen or hepatitis C virus antibody positive
Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019)

This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent disease on stable dose regimen of statin with or without other lipid-modifying therapy. The two year extension to this study will further evaluate the long-term safety profile and efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a statin with or without other lipid-modifying therapy.

The 76 week treatment period is followed by a 12 week reversibility phase which can be extended by up to another 12 weeks in order to allow participants who have completed their week 88 visit to continue in the study until the Extension study is ready to be implemented.

In the optional extension, participants will be assigned to the same treatment arm to which they were assigned in the base study. The total duration of the extension study will be up to 116 weeks; which will include a 2 year treatment period, followed by a 12 week reversal phase. A post-extension study follow-up phone call will be completed 12 weeks after discontinuation or completion of study treatment. Participants previously treated with anacetrapib or placebo will be invited in a 4:1 ratio in an optional extended reversal phase. The total duration of the extended reversal phase will be 1 year.

Participants previously treated with anacetrapib in the DEFINE study will be followed periodically for up to 4 years to determine plasma levels of anacetrapib. Participants will also be invited to participate in a sub-study consisting of one clinic visit to measure anacetrapib levels in the plasma and the subcutaneous adipose tissue.

ACRONYM: DEFINE= Determining the EFficacy and Tolerability of Cholesteryl ester transfer protein (CETP) INhibition with AnacEtrapib

Eligibility Criteria:
Inclusion Criteria:

* Base Study:

  * Patient has Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease and is treated with a statin, with well controlled LDL-C
* Extension Study:

  * Patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks).
  * Patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study

Exclusion Criteria:

* History of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease.
* History of mental instability, drug/alcohol abuse within the past 5 years
* Pregnant or breast-feeding
* History of cancer within the last 5 years
* HIV positive
* Donated blood products within 8 weeks
* Currently participating or have participated in a study with an investigational compound within the last 30 days
Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Metformin monotreatment
* HbA1c greater than 7%
* Treatment according to SPC
* Informed consent obtained

Exclusion Criteria:

* Any contraindication to the use of repaglinide (according to the SPC)
Normative Biomechanical Measures of Reaching in Able-Bodied Adults

A study to obtain normative values and repeatability measures during functional reaching tasks in able-bodied individuals with no functional limitations.

The study has three main aims: 1) Define the data collection methods, and calculate the repeatability, of joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance during seated and standing reaching activities. 2) Collect normative values of joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance during seated and standing functional reaching tasks in 40 participants with no functional limitations. Descriptive statistics will include calculating the mean, median, standard deviation, and range of the outcome variable values. 3) Compare joint angles, muscle activation magnitudes, seating pressure, foot pressure, and reach distance collected during a seated reaching task to those collected during a standing reaching task.

The data collected may be used in the future as baseline reference and repeatability values of outcome measures against which to compare values from individuals with functional limitations to quantify their functional ability.

Eligibility Criteria:
Inclusion Criteria:

• 20-59 years of age at time of enrollment

Exclusion Criteria:

* Failure to give consent or follow simple commands
* Score of 7 or above on the QuickDASH Outcome Measure
* Score of 5 or above on the Oswestry Low Back Disability Questionnaire
* Score of 76 or below on the Lower Extremity Functional Scale
* Diagnosis of a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis, fibromyalgia)
* Diagnosis of an inner ear balance disorder (e.g., benign paroxysmal positional vertigo)
* Insufficient active range of motion of bilateral shoulders or hips that results in inability to perform forward or lateral reaching tasks
* Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study
Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes

The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.

Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.

For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.

Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.

At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 15 and 25 years old
* Type 1 diabetes since at least 1 year at the moment of instauring HCL
* At least 3 months of HCL use

Exclusion Criteria:

* Informed patient that have been opposed for their data collect