cyrilzakka/clinical-trials huggingface dataset:
Study of Parkinson's Early Stage With Deferiprone

The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

This study will enroll 140 patients who have been diagnosed with Parkinson's disease within the last 3 years and are currently taking antiparkinsonian medication. There are four dosage cohorts, with patients in each cohort receiving either deferiprone tablets or placebo. At the baseline visit, participants will be randomized to a dosage cohort and to either active product or placebo within that cohort, and will take the assigned study product twice-daily for 9 months. They will come back to the study site for assessments at Months 1, 2, 3, 4, 5, 6, and 9, and will need to have their blood count checked weekly, at either the study site or a local laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 to \< 80 years
* Body weight ≥60 kg but ≤100 kg
* Parkinson's disease diagnosed
* Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L (≥1.0 x 10\^9/L for Black population) at screening
* On a stable dose for at least 3 months prior to the screening visit of any of the following treatments at an L-dopa equivalent daily dose of up to 600 mg:
* Dopaminergic agonist alone
* L-dopa alone
* Combination therapy with dopaminergic agonist and L-dopa
* Rasagiline
* At an early stage of the disease, without motor fluctuations and/or L-dopa-induced dyskinesia

Exclusion Criteria:

* Diagnosis of Parkinson's disease more than 3 years prior to screening visit
* Hoehn and Yahr stage ≥ 3
* Atypical or secondary Parkinsonism without dopa-sensitivity (e.g., vascular parkinsonism, supranuclear palsy, multisystem atrophy)
* Progressing Axis I psychiatric disorders (psychosis, hallucinations, compulsive disorders, substance addiction, bipolar disorder, severe depression, anxiety) as assessed in a semi-structured interview in accordance with the Diagnostic and Statistical Manual of Mental Disorders
* Not stabilized in terms of the current antiparkinsonian therapeutic regimen: already requires dose adaptation and/or is likely to require any change in dopamine therapy over the duration of the trial
* Current treatment with bromocriptine
* Current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria
* Current treatment with coenzyme Q10 or idebenone. (Patients who are on these medications but stop taking them at least 2 weeks prior to baseline may be enrolled.)
* Current use of a Deep Brain Stimulation (DBS) system. (Patients who previously had a DBS system but have had it removed may be enrolled.)
Pre-extractive Inter-radicular Implant Bed Preparation Versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars

Pre-extractive Inter-radicular Implant Bed Preparation versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars


Eligibility Criteria:
Inclusion Criteria:

* Patients with badly decayed posterior molar teeth.
* Distance from height of inter-radicular furcation of mandibular molars to the mandibular canal should be equal to or more than 10 mm

Exclusion Criteria:

* Distance from height of inter-radicular furcation of mandibular molars to the mandibular canal equal to or less than 8 mm.
* Heavy smokers more than 20 cigarettes per day.
A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)

An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.


Eligibility Criteria:
Inclusion Criteria (For renal impaired subjects):

* Classification by renal function based on eGFR
* Clinical, ECG, and laboratory findings consistent with renal dysfunction
* BMI of 18.0 to 38.0 kg/m2 inclusive
* Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
* Slightly different inclusion criteria are defined in the protocol for healthy subjects

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
* Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
* Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
* Any major surgery within 4 weeks of study drug administration.
* Other protocol defined exclusion criteria could apply
A Comparative Study of KSO-0400 in BPH Patients With LUTS

The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.


Eligibility Criteria:
Inclusion Criteria:

* BPH patients with LUTS

Exclusion Criteria:

* Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia
* Patients with prostate cancer or suspected prostate cancer
* Patients who have any clinically relevant cardiovascular, hepatic or renal disorder
Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer

RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.

OBJECTIVES:

* Evaluate the efficacy of reinforced versus standard follow-up care and the utility of follow-up CEA assessments in patients with fully resected stage II or III colorectal cancer.

OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.

* Standard follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo abdominal ultrasound every 3 months until year 3 and then every 6 months until year 5; chest x-ray every 6 months until year 3 and then annually until year 5; and colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
* Reinforced follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo alternate assessments every 3 months comprising thoraco-abdomino-pelvic CT scan or abdominal ultrasound until year 3 and then every 6 months until year 5. They also undergo colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.

Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.

* CEA measurement: Patients undergo measurement of CEA levels every 3 months until year 3, every 6 months until year 5, and at least yearly thereafter.
* No CEA measurement: Patients do not undergo CEA measurement. Blood and tissue blocks of normal and tumor tissues are collected for the validation of protein serum, genetics, or immunologic markers predictive for relapse.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed adenocarcinoma of the colon or rectum

  * Stage II or III disease
  * No distant metastatic disease
* Has undergone curative resection for no residual tumor
* Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No inflammatory bowel disease
* No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix
* No genetic syndromes

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists

This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.

Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Age ≥60 years (conventional definition of older age in AML)
* Newly diagnosed AML
* Considering treatment
* Able to provide informed consent
* English-speaking

Inclusion Criteria for Caregivers:

* Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient.
* Able to provide informed consent
* English-speaking

Inclusion Criteria for Oncologists:

* A practicing oncologist
* At least one of their patients are recruited to the study
* English-speaking

Exclusion Criteria: None
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance

The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.

The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
* Patients with grade II or higher adverse events.
* CML patients not suitable for stem cell transplantation.

Exclusion Criteria:

* Patients in blast crisis.
* Pregnant women
* Patients without a contraception method.
Effects of Corrective Exercises and Postural Education on Forward Head Posture

Forward head posture is one of the most common postural problems that we face today. Sitting for long periods in poor posture and the excessive use of electronic devices has become a high risk for this postural abnormality.

The goal of this \[interventional study\] is to \[provide the participants with simple and easy corrective exercises for this abnormal posture which they can do anywhere at any time and to provide postural education and awareness on the matter.

Forward head posture is one of the most common postural problems that we face today. Sitting for long periods in poor posture and the excessive use of electronic devices has become a high risk for this postural abnormality.

The goal of this \[interventional study\] is to \[provide the participants with simple and easy corrective exercises for this abnormal posture which they can do anywhere at any time and to provide postural education and awareness on the matter. Also, this study aims in comparing both the treatment and education.\] in \[the people who have forward head posture or are more likely to develop it\]. The main question\[s\] it aims to answer are:

* Does corrective exercises have any effect on improving forward head posture?
* Does postural education has any effect on improving forward head posture?

Participants in \[-Exercise group will perform corrective exercises for 6 weeks

* Postural Education group will follow postural guidelines while doing daily tasks for 6 weeks
* Control group will do nothing in 6 weeks\]. Researchers will compare \[Corrective Exercise group with Postural Education group and control group\] to see if \[corrective exercise group or postural education group has any effect on forward head posture and compare the results with the control group\].

Eligibility Criteria:
Inclusion Criteria:

1. Consent to participate in the study.
2. Young \& Middle-aged Adults between the ages of 20-40 years
3. Craniovertebral angle less than or equal to 50°
4. Shoulder Angle less than or equal to 52°

Exclusion Criteria:

1. History of Trauma
2. Acute Neck Injuries e.g., Whiplash
3. Surgical history
Discriminative Validity of Strain Elastography of the Supraspinatus Tendon

This study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological Supraspinatus tendon due to tendinopathy

The case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by MRI and 48 healthy subjects.

In this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with MRI and conventional ultrasound.

Patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \< 30
* Symptomatic: Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins.
* Asymptomatic: No shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins).

Exclusion Criteria:

* Shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand Danish. Biceps rupture, labrum lesions, supraspinatus tears (\> 1/3 of the vertical tendon height) and calcifications (\> 2 mm in length) (MRI).
Vitamin D for the Prevention of Diabetes Type 2

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance

Exclusion Criteria:

* Serious heart disease
* Renal stone disease
* Hypercalcemia
* Sarcoidosis
The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients

Gastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can effectively block gastric acid secretion but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. The aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.

Gastroesophageal reflux disease(GERD) is a common disease, mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, chest pain and globus hystericus. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. Proton pump inhibitors (PPI) can effectively block gastric acid secretion and promote the repair of esophagus, but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. Recently there are many instruments used to analyze personal physical status. Meridian energy analysis device ( Ryodoraku ) is used to assess the energy of meridian system by analysis of resistance of the skin surface, as well as the wrist-worn heart rate monitor (ANSWatch) used to assess the autonomic nervous system by analysis of heart rate variability. Therefore, the aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.

Investigators will recruit 120 patients with GERD in clinic who have to receive PPIs for four weeks and assess each volunteer before and after taking the medication. Assessment methods : 1. ANSWatch to assess the autonomic nervous system, 2. Ryodoraku to assess the energy of meridian system, 3. Upper gastrointestinal endoscopy to assess the grade of reflux esophagitis, 4. gastroesophageal reflux disease questionnaire to assess the severity of GERD. Investigators analysed and compared the database from the assessments between before and after taking the medication.

Investigators anticipate to substantiate that the changes of Ryodoraku and ANSWatch are good predictors for the clinical efficacy of PPI in patients with GERD.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age of 20-75 years
* patients with GERD who have to receive PPIs for four weeks

Exclusion Criteria:

* Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus
* previously underwent the esophagus, stomach or duodenum surgery
* Lactating women or pregnant women
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Shoulder Surgery

Aim is to assess the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing shoulder surgery.

There were three randomized groups: Group 1 (no block-control group, n=12) Group 2 (SPSIPB-2nd rib targetted, n=12), Group 3 (SPSIPB-3rd rib targetted, n=12). All patients had standard general anesthesia. Group 2 and Group 3 had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) before the surgery. Local anesthetic was injected between 2nd rib an serratus posterior superior muscle in Group 2 and it was injected between 3rd rib and same muscle in Group 3. All patients had 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients had ibuprofen 3x400 mg in postoperative 24 hours. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol was administered as a rescue analgesic in all patients.Total tramadol consumption was calculated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who underwent open or arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Effect of Feedback and Practice on Probabilistic Decision Making in Attention Deficit and Hyperactivity Disorder

The purpose of this study is to determine how feedback and practice affect decision making in adolescents with attention deficit and hyperactivity disorder.

Participants will have to choose between low and certain outcome and a higher but uncertain outcome, with or without serial feedback after each trial. Participants will perform the task twice to examine practice effects.


Eligibility Criteria:
Inclusion Criteria:

* ADHD

Exclusion Criteria:

* Current major depression,
* Psychosis,
* Autism,
* Tourette syndrome
Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa

The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy.

Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.


Eligibility Criteria:
Inclusion Criteria:

* Non-myeloid malignancies
* Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy
* Plan to receive cyclic chemotherapy for an additional 8 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate renal and liver function
* Ability to participate in the MHST based on clinical judgement of investigator
* At least 18 years of age

Exclusion Criteria:

* Iron deficiency
* Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment
* Unstable cardiac disease
* Current active condition creating clinical danger for the subject to participate in the MHST
* known positive test for HIV infection
* Previous hematologic disorder associated with anemia
* Currently receiving beta-blockers
* Use of drugs or devices not approved by the FDA for any indication
* Pregnant or breast feeding
* Known hypersensitivity to any recombinant mammalian-derived product
The Effect of Implant-supported Prosthesis on Acoustic Voice Quality

The primary aim of this study was to compare the acoustic sound quality of edentulous patients rehabilitated with two-implant overdentures or the all-on-4 concept. The secondary aims were to evaluate the effect of implant and prosthetic success on acoustics.


Eligibility Criteria:
Inclusion Criteria:

* No voice disorder or speech therapy
* The implant prosthesis was made at least one year ago, delivered to the patient, and continues to be used

Exclusion Criteria:

* Smoking (\>10 cigarettes/day) or substance use
* History of acute or chronic respiratory diseases
* Overdenture prosthesis on three or 4 implants
* History of speech and hearing problems
* Patients who have lost any implants before the control