cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy for Patients With Stage IV Melanoma

This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.


Eligibility Criteria:
* Must have Stage IV melanoma
* Must have had all clinically-detectable disease surgically removed
* Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
* Cannot have HIV or Hepatitis A, B, or C
Physical Function in Patients With Chronic Obstructive Pulmonary Disease

The aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation.

Patients with COPD who are participating at pulmonary rehabilitation (PR) at Haukeland University Hospital will be asked and consecutive enrolled to the study. Before and after PR the six-minute walk test, incremental- and endurance shuttle walk test, 30 sec sit-to-stand test and stair test will be used to evaluate change in physical capacity and -performance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD, Forced expiratory volume in 1 sec (FEV1)/Forced vital capacity (FVC) \<0.7 and FEV1\<80% of predicted value.
* Able to walk corridor and stairs
* Norwegian speaking

Exclusion Criteria:

* COPD exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion
* Not safe to exercise (e.g unstable angina)
* mental illness and drug abuse that makes group treatment not suitable
Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome

The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. As secondary objectives, we also seek to determine if the postsurgical grip and pincer strength and the Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques.

It will be a randomized clinical trial with a sample size of about 80 patients. It will have two study groups: the experimental group (in which 40 patients will be included) where a Z-plasty technique will be applied; and the control group (another 40 patients) who will undergo the conventional technique of complete section of the transverse carpal ligament. The main variable will be the presence or absence of post-surgical pillar pain and, as secondary variables, the recovery of grip and pincer strength and the improvement in the BCTQ score will be studied.

The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs , Phalen and Tinnel positive) and with a positive electromyogram test classified as "moderate" or "severe". As inclusion criteria, patients \>18 years of age with moderate-severe carpal tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed conservative treatment will be considered. Those who have already undergone a previous surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or congenital sequelae in the hand or who do not have the capacity to understand the process or the tests to be performed will be excluded.

The total expected duration of each patient in the study will be 6 months and the following visits and procedures will be carried out: clinical study and quality questionnaires prior to surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with repetition of clinical examination and quality questionnaires.

The incidence of pillar pain (defined as pain/sensation of allodynia in the area of the thenar and/or hypothenar eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, dysesthesia at rest) will be analyzed applying the principle of intention to treat, using the Mann Whitney test to compare the score in the tests used.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Moderate-severe carpal tunnel syndrome
* Symptoms that hinder the patient's daily activities
* Correct conservative treatment without success

Exclusion Criteria:

* Previous surgical intervention for carpal tunnel syndrome
* Traumatic or congenital sequelae of the hand
* Incompetence to understand the process and the tests to be carried out
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair

Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old
* In case of 6 weeks after receiving arthroscopic rotator cuff repair
* When the participants wishes to enroll in the study

Exclusion Criteria:

* 65 years old or older
* If the tear area is large and augmentation is performed
* If there is a previous surgical history at the surgical site
* Osteoarthritis in the shoulder joint
Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes

Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be HIV infected
* must be \&#8805;18 years old
* must have been taking the same combination ARV regimen (\&#8805;3 drugs) for at least 3 months.
* Must be experiencing virologic failure (viral load \&#8805;50 copies/mL on two occasions at least 2 weeks apart).
* must be changed to a salvage antiretroviral regimen
* Patient has to have signed and dated a full infomred consent.

Exclusion Criteria:

* Patient with any of the following abnormal laboratory test results in the previous 3 months:
* Hemaglobin \&lt;100 g/L
* Platelet count \&lt;20,000 cells/L
* INR \&#8805;3.5 IU
* PTT \&#8805;60 IU
* Patient with other significant underlying disease (non-HIV) that might impact immune markers ( eg. advanced liver disease, malignancy).
Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support

The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.


Eligibility Criteria:
Inclusion Criteria:

* infants that require greater than 2 litres per minute (LPM) high flow nasal canula or CPAP with a max setting of 6cm H20 FiO2 30% or less for at least 72 hours or more
* Tolerating enteral feeds of 120 ml/kg/day

Exclusion Criteria:

* Major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations)
* Metabolic disorder
* Major gastrointestinal surgeries
* Patent ductus arteriosus (PDA) ligation surgery
* Outborn deliveries greater than 7 days old
Neopterin in Acute Coronary Syndrome Patients

Measurement of neopterin in ACS patients

1. Detect level of neopterin in ACS patients to detect whether there is relation or not between ACS and neopterin
2. Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS patients
3. Detect relation between neopterin level and in hospital events

Eligibility Criteria:
Inclusion Criteria:

* All patient of sample size admitted to cardiology departmentof Assiut university hospital with :

  1. Acute typical chest pain
  2. Positive cardiac enzymes
  3. ECG show recent ischemic changes
  4. ECHO show SWMA

Exclusion Criteria:

1. Patients not fulfill inclusion criteria.
2. Patients with other diseases which may cause increase of neopterin level as viral infections, intracellular bacteria or parasites infections, certain malignancies, allograft rejection
Effect of Highly Bioavailable Curcumin on Subjective Tinnitus

This study will assess the effectiveness of highly bioavailable curcumin in suppressing subjective tinnitus based on pre- and post-treatment evaluations using the validated Tinnitus Functional Index (TFI) and Tinnitus Handicap Inventory (THI) surveys.

Subjects with severe, subjective tinnitus due to sensorineural hearing loss will complete both TFI and THI surveys prior to starting therapy. Subjects will then be randomized to a treatment or placebo group. The treatment group will be provided with a supply of capsules containing 500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidylcholine, which increases curcumin bioavailability. Subjects in the treatment arm will be instructed to take 1 capsule by mouth twice daily for 30 days. Placebo group subjects will be provided with a placebo compound with instructions to take the same number of capsules by mouth for the same period of time. Both the active compound and the placebo will be provided by Smartceuticals, Inc (910 W. Van Buren St. Ste 100-376 Chicago, IL 60607) to the outpatient pharmacy at Ascension Providence Park (Novi, MI), which will be responsible for storage, distribution and tracking. After 30 days, patients will be asked to return bottles to the pharmacy with any unused capsules to confirm and monitor compliance. Placebo and active agent capsules and bottles will be identical in appearance with the exception of a unique alphanumeric code on the bottle label that identifies whether the distributed capsules contain active agent or placebo. This code will be matched to the participating subject by the pharmacy and will be used at the end of the study to determine which treatment arm each subject was in. To facilitate blinding, the master list of alphanumeric codes will be maintained by the manufacturer. At the completion of therapy, subjects from both groups will re-take the TFI and THI.

Eligibility Criteria:
Inclusion Criteria:

* Adults with subjective tinnitus due to sensorineural hearing loss as determined by routine audiogram.

Exclusion Criteria:

* Adults with subjective tinnitus due to another cause
* Sensitivity or allergy to test compounds
* Use of other off-label medications, substances, treatments specifically for tinnitus mitigation (e.g., anti-depressant/anxiety medications, GABA-inhibitors, psychiatric-based interventions/counseling)
* Pregnancy
* Patients taking anticoagulants to minimize risk of drug-drug interactions.
Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

The purpose of this study is to determine if there is a measurable change in visual function as a direct result of the application of osteopathic cranial manipulative medicine. The study will also attempt to determine whether any changes noted remain after withdrawal of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* free of active ocular or systemic disease
* refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount
* normal best-corrected visual acuity at 20/40 or better
* normal amplitude of accommodation
* willing to undergo osteopathic cranial manipulative medicine

Exclusion Criteria:

* pregnancy
* history of previous closed head trauma or brain injury
* prior cranial manipulative treatment/craniosacral therapy
* students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry
Clinical Implication of the Tunable Crack Sensor

\[Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane: a pilot study\] Comparison of blood pressure via tunable crack sensor and invasive pressure wire

To develop a diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane, we will compare the blood pressure measured via a tunable crack sensor and that measured by a invasive pressure wire

Eligibility Criteria:
Inclusion Criteria:

A case of suspected coronary artery disease at Seoul National University Hospital for the purpose of coronary angiography

* At least 19 years old
* If he/she hears enough explanation about clinical research and intends to participate in clinical research himself

Exclusion Criteria:

* Under 19 years old
* Refusal to participate in clinical studies
* If the cognitive function is weak enough not to understand the explanation of the clinical study and to make voluntary decisions accordingly
Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

As clinical primary endpoints we assessed whether existed differences in:

1. PSA recurrence rate stratified according to treatment modalities
2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities
3. PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.

As secondary clinical endpoints we assessed whether existed differences in:

1. prostate cancer-specific mortality according to treatment modalities
2. prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.

For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs IC50 values among the groups stratified for EGFR and HER2/Neu levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage T3a disease with (2) Gleason sum of 7 with a predominant component of 4 (i.e., Gleason 4 + 3 = 7) or (4) Gleason sum of 8, 9 or 10.

Exclusion Criteria:

* Prior hormonal therapy,
* Prior radiation,
* Prior investigational agents,
* Prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.
A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy

Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.

The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old;
2. diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;
3. Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;
4. without receiving immunosuppressive therapy for thyroid eye disease before.

Exclusion Criteria:

(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months
Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain

There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy, for treatment of patients with chronic neck pain. In our clinical practice, a favorable effect is observed on patients with chronic neck pain, but there are no published studies evaluating the results of this techniques on pain, mobility and disability.

The objective of this trial is to evaluate if the suboccipital manual techniques, provides further improvement in pain intensity, neck disability, range of motion, on patients with chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated with physiotherapy. For this purpose, investigators conduct a double-blind (patient and evaluator) randomized controlled trial, in a Public Primary Care Center.

Seventy four subjects will be randomized (computer application) into three groups: Mobilization Group, Maintained pressure Group and Control Group. All the three groups receive the same protocolized physiotherapeutic treatment during three weeks and, additionally, the Mobilization Group receives six sessions (two sessions in a week during three weeks) of translational dorsal glide mobilization technique grade III of the atlanto-occipital joint and the Maintained pressure Group receives six sessions (two sessions in a week during three weeks) of pressure maintained suboccipital Inhibition technique. The Control Group receives the protocolized physiotherapeutic treatment only.

Pain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through a Global Rating of Change (GROC) scale, and evaluation of headache disability (HIT-6).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic mechanical neck pain.
* Flexion-rotation test positive (less of 32 degrees or 10 degrees difference between the two sides)
* Sign the informed consent form.

Exclusion Criteria:

* Presenting one or more positive safety cervical test .
* Carriers of pacemaker or defibrillators.
* Previous history of severe trauma to the cervical region of the spine.
* Inflammatory arthritis.
* Inability to maintain supine position.
* Inability to tolerate flexion-rotation test
* Poor Language and communication skills making difficult to understand the informed consent.
* Pending litigation or legal claim.
Manual Chest Physiotherapy and Active Cycle of Breathing Techniques (ACBT) in Patients of Cystic Fibrosis

Cystic fibrosis is a genetic disease (autosomal recessive) which involves malfunction of the exocrine glands, leading to abnormal secretions in the body. It is a progressive disease that causes persistent lung infections and limits the ability to breathe over time. Clinical symptoms include persistent coughing, at times with phlegm, wheezing or shortness of breath, fatigue, difficulty with bowel movements sinus infections, poor growth, clubbing of the fingers and toes, and infertility in most males. The disease must be managed throughout life with diet, medication and preventive chest physical therapy as soon as any symptoms are noted in the young child. The purpose of the study was to evaluate the difference between the effects of Manual Chest Physiotherapy (CPT) and Active Cycle of Breathing Techniques (ACBT) in patients of Cystic Fibrosis. The tools of our study were Modified Borg Dyspnea Scale and Quality of well-being Scale. The total sample of our study was 14 out of which 7 were included in GROUP A and 7 Group B. SPSS 23 was used for statistical analysis and parametric tests were used for analysis


Eligibility Criteria:
Inclusion Criteria:

* Age limit 5-25
* Patients with confirmed diagnosis of Cystic Fibrosis
* Male and female.
* Clinically Stable Patients

Exclusion Criteria:

* Hypertensive patients.
* Intolerant patients.
* Compromised Renal Function.
* Other Comorbidities
Exploring the Suitability of Movement and Sound in Couple Therapy: A Proof-of-Concept Trial

The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of immediate sound feedback for physical distance and touch between individuals as a potential means to complement existing methods in couple therapy. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial.

According to early 20th century psychoanalysis, the "unsaid" becomes apparent in the relationship between patient and therapist, as well as in metaphors and symbols revealed through unintended utterances, imaginative techniques, and dreams. To convey emotions and thoughts, this method relies on the use of spoken language. Likewise, spoken language remains central to the practice of psychotherapy in subsequent decades, as clinicians and researchers sought to translate and transform major claims of psychoanalysis into newer paradigms, the most prominent of them being cognitive-behavioral, client-centered and family-systems psychotherapy. Inspired by somatic psychology and neuroscience evidence, more recent approaches focus on body and movement to target the "unsaid" beyond spoken language. Funded by the German Federal Ministry of Education and Research, the "Sentire" project attempts to provide immediate sound feedback for physical distance and touch between individuals (www.sentire.me). The present phase-IIA waiting-list controlled proof-of-concept trial aims to explore the adequacy of "Sentire" as a potential means to complement existing methods in couple therapy. The results obtained will determine the design of a subsequent phase-IIB randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* In couple relationship for at least six months;
* Living in shared household or close daily contact.

Exclusion Criteria:

* Currently acute episode of any mental disorder.