cyrilzakka/clinical-trials huggingface dataset:
Ozone Therapy in Patients With Carpal Tunnel Syndrome

ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy resulting from compression of the median nerve at the wrist level. Various methods are applied in the conservative treatment of CTS. These include modification of daily life, splinting, physical therapy modalities and exercise methods. ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Ozone therapy has trophic effects, analgesic effects, antioxidant, immunomodulator, anti-inflammatory and antitumoral effects. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting. Ultrasonographic examinations of the median nerve cross-sectional area will be performed using a LOGIQ P5 (Healthcare Ultrasound, Korea) and a high frequency 7-12 MHz linear probe. A hand dynamometer will be used to assess the grip strength of the hand.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65 who have been complaining for at least 3 months
* Diagnosed with mild or moderate Carpal Tunnel Syndrome

Exclusion Criteria:

* Cervical disc herniation or radiculopathy,
* Brachial plexus lesion
* Previous hand or neck surgery
* Pregnancy,
* History of fracture at the wrist level
* Inflammatory rheumatic disease
Doppler Flow Classification of Saint-Bonnet

Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

Patients who have Doppler ultrasound scanning in clinical practice currently have a systematic record of Doppler flow on arterial axes of the aorta and right and left lower limbs. The investigators will analyze a posteriori Doppler flow of patients by classifying them using the 3 classifications. The patient will have no constraints related to this study since the recordings are currently performed in clinical routine.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years;
* Social insured
* Patients referred in the department for any arterial examination of the lower limbs.

Exclusion Criteria:

- Patient unfit to understand the instructions of the study
First Time in Human Study With GSK1018921

GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921 differs from other available drugs in its mode of action and it is assumed that it may have an effect in the treatment of so-called positive symptoms such as hallucinations and negative symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in humans until now. This is the first study where this compound is administered to humans; the study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in a separate group of healthy smoker volunteers.

Single-Blind, Randomised, Placebo-Controlled First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Escalating Doses of GSK1018921 in Healthy Volunteers and to assess the effect of a single dose of GSK1018921 on quantitative EEG and Mismatch Negativity in a separate cohort of healthy smoker volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
* For Part B, smokers.

Exclusion Criteria:

* Part A: Smokers, any subject who takes any prescribed or non-prescribed medication/vitamins specified as prohibited in the protocol, substance abuse, clinically significant disease as determined by a responsible physician.
* Part B: Non-Smokers
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled.

Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.

Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.

Objectives:

* Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value
* Utilize shared registry infrastructure to examine smaller groups of interest
* Generate hypotheses for targeted subset analyses and trials based on full genome data

FLEX is an observational (phase IV) study.

Eligibility Criteria:
Inclusion Criteria:

* Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
* Informed consent form signed on the same day or before enrollment
* New primary lesion

Exclusion Criteria:

* Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
* Metastatic disease
* Recurrent disease
* Stage 0 disease
Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.

OBJECTIVES:

* Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
* Assess the toxicity associated with this drug in this patient population.
* Evaluate the survival of this patient population treated with this drug.
* Determine the pharmacokinetics of this drug in this patient population.

OUTLINE: This is a partial dose-escalation study.

Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction. (Cohort I closed to accrual as of 11/1/03.)

* Cohort I (closed to accrual as of 11/1/03): Patients receive a fixed dose of rebeccamycin analogue.
* Cohort II: Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-37 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery

  * Gall bladder carcinoma
  * Cholangiocarcinoma
  * Carcinoma of the ampulla
  * Hepatocellular carcinoma (eligible for cohort II only)
* Measurable disease
* No known brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL

Hepatic:

* Bilirubin less than 3 mg/dL

  * Cohort I (closed to accrual as of 11/1/03)

    * Bilirubin no greater than 1.5 mg/dL
    * AST no greater than 2.5 times upper limit of normal (ULN)
  * Cohort II

    * Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR
    * Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN

Renal:

* Creatinine normal OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent combination antiviral therapy for HIV-positive patients
Spiritual Assessment in Chronic Pain Patients

The World Health Organization's (WHO) understanding of health(care) is incrementally incorporating the spiritual dimensions equivalent to the physical, psychological and social ones. Yet, it remains widely neglected in multi-modal, interprofessional chronic pain therapy. To support gaining access to chronic pain patients' spiritual needs and concerns within therapy, a screening tool has been constructed based on foregoing qualitative research and literature. The screening tool is to be validated with chronic pain patients in clinical settings.

Addressing spiritual concerns and needs in chronic pain therapy is in line with the World Health Organization's (WHO) understanding of health(care) and would improve health care for this patient group. An applicable screening tool for chronic pain patients' spiritual concerns and needs must be empirically based. Based on preceding focus group interviews with patients and with health care professionals in various clinical settings and literature analysis, a screening tool has been constructed. This tool aims at supporting health care professionals as well as chronic pain patients in gaining access to spiritual concerns and needs for incorporation in multi-modal, interprofessional pain therapy. In this project the screening tools' psychometric properties will be tested with in five distinct clinical in- and out-patient settings.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient command of German language as assessed by local study coordinator
* Confirmed medical and/or nursing diagnosis of chronic pain
* Suffering pain for ≥ 6 months
* Pain intensity was≥ 5 on a 11-point numeric Rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the last episode of pain

Exclusion Criteria:

* Life threatening diagnosis (e.g. cancer) that would introduce end-of-life topics as primary aspect
* Cognitive disorders that would impair participation
Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes

The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.

For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.

The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy.


Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 40 who will undergo lung resection due to malignancy

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients with missing preoperative measurements
* Patients with missing 90-day follow-up data
Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy

This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy

OBJECTIVES:

I. To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy.

II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use.

OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 10 weeks.

III. To explore neurologic testing changes in patients receiving scrambler therapy.

Eligibility Criteria:
Inclusion Criteria:

* Pain or symptoms of neuropathy or pain of \>= 1 month (30 days) duration for which the patient wants intervention
* Participants have to relate that tingling or pain was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem and expected to have tingling or pain of at least 4/10 at the time of the first treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
* Life expectancy \>= 3 months (90 days)
* Case review by the study chair, or designate, as a case where treatment should be tried.
* Ability to complete questionnaire(s) by themselves or with assistance - Ability to provide informed written consent

Exclusion Criteria:

* Pregnant women
* Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
* Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
* Patients with a history of myocardial infarction or ischemic heart disease within the past six months
* Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
* Skin conditions such as open sores that would prevent proper application of the electrodes
* Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
* Currently on gabapentin or pregabalin Note: (because of data that support that patients don't do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off of them prior to study initiation. The study team will provide instructions on how to do this).
Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Japanese healthy adult male subjects (Part A and C)
2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
3. Caucasian healthy adult male subjects (Part D)
4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)

Exclusion Criteria:

1. Subjects currently with or with a history of disease
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse
Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Normal platelet count and clotting parameters
* Adequate renal and hepatic function
* Negative serum pregnancy test within 21 days prior to enrollment and negative urine pregnancy test on admission to the clinical research unit (if subject female and of child-bearing potential)
* Agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits (if subject a sexually active male or female of childbearing potential)
* Negative drug and negative alcohol screens

Exclusion Criteria:

* Known antibodies or hypersensitivity to FXIII
* Known bleeding or hematologic disorder
* Known allergy to yeast
* Receipt of blood products within 30 days of screening
* Donation of blood within 30 days prior to enrollment
* Surgical procedure of any type within 30 days prior to enrollment
* History of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
* Treatment with any experimental agent within 30 days of study enrollment
Evaluation of the Efficiency of Touch Massage on the Quality of Life at Work of Nursing Staff Working in a Cancer Center. (Pause "Toucher Massage (TM)")

The goal of this clinical trial is to scientifically confirming the common perception that Touch-Massage (TM) breaks have a beneficial effect on the daily life of paramedics, both psychologically and physically.

The main question\[s\] it aims to answer \[is/are\]:

* Evaluating the efficacy of TM on burnout
* Evaluating the efficacy of TM on anxiety
* Evaluating the efficacy of TM on affect
* Evaluating the efficacy of TM on musculoskeletal disorders Researchers will compare 2 groups : Control group of paramedics who do not have the benefit of TM breaks and an experimental group of paramedics taking TM break.

Participants in the experimental group received one 15-minute TM session per week for 6 weeks and burnout, anxiety, affect, and musculoskeletal disorders (MSDs) will be assessed in participants using questionnaires at different times of the study. Participants in the control group complete only the same questionnaires at the same times as the experimental group.

Participants in the 2 arms are reviewed at 3 and 6 months to complete the questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Nurses or nursing assistant working in the Institut de Cancérologie de l'Ouest's (ICO) medical oncology, surgical oncology, day clinic or early phase unit.
* Employees who have worked at the ICO for at least 9 months.

Exclusion Criteria:

* Employees who have had more than one touch/massage session at the ICO in the last 6 months.
* Pregnant for more than 4 months (declarative)
* Employees who have undergone osteo-articular surgery within the last 3 months.
* Employees with a pre-inclusion MBI score indicating high burnout (emotional exhaustion score \>30 and depersonalisation score \>12 and personal accomplishment score \<33).
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.

This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depression or Dysthymia with Atypical Features
* Age 18-65
* Physically healthy
* HAMD(24) \> 14

Exclusion Criteria:

* Prior experience with Duloxetine
* History of Psychosis or Bipolar Disorder, Borderline Personality Disorder
* Unstable medical disorder; any history of Epilepsy
* Currently taking medication that can interact with Duloxetine
* Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
* Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization
* Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine)
* Pregnancy
* Currently breast feeding
* Fecund women failing to use acceptable birth control
* Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants \[i.e., \>=2/3 PDR maximum dose for at least 4 weeks\] during current episode)
* Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma)
* Currently taking medication deemed effective