cyrilzakka/clinical-trials huggingface dataset:
The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome

Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. A 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. The Glabal symptom score (GSS), Boston Carpal Tunnel Questionnaire (BCTQ), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.

The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.

Eligibility Criteria:
Inclusion Criteria:

* patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination
* symptoms of carpal tunnel syndrome such as pain and numbness
* those who are willing to sign informed consent form for subjects

Exclusion Criteria:

* (1) Those who have not signed the informed consent
* (2) Patients diagnosed with severe carpal tunnel syndrome
* (3) Those who have had a history of surgery on their hands and palms
* (4) Space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc.
* (5) People with a history of diabetes, rheumatoid arthritis, and hypothyroidism (HbA1c\>6.5, RF positive, Free T4, TSH in abnormal range)
* (6) Patients with end-stage renal disease
* (7) Pregnant and alcoholic patients
* (8) Polyneuropathy patients
* (9) Clinical symptoms with C6\~8 cervical radiculopathy
* (10) Those who are obviously infected
* (11) Those with a serious illness requiring hospitalization
Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging

The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with the primary endpoint being luminal gain assessed by OCT lumen volume measurements.

Subjects will be randomized to treatment with either the Chocolate Balloon catheter or a standard balloon angioplasty catheter. All angioplasty procedures will be conducted with treatment balloon at the full discretion of the physician and according to the standard practice at the hospital and the device Instructions for Use. All patients will undergo baseline OCT imaging in addition to standard angiography. Post-PTA, all patients will then undergo repeat OCT imaging immediately post-procedure and then again at 10-minutes post-procedure to assess for vascular recoil.

Eligibility Criteria:
Inclusion Criteria:

* Reference Vessel Diameter (RVD) between 2.5 and 6.0mm and within treatment range of available balloon at Target Lesion
* Intermittent claudication or critical limb ischemia (Rutherford 3-5)
* De novo stenosis (≥70%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries.
* Lesion successfully crossed with a guide-wire
* Patient has given informed consent to participate in this study

Exclusion Criteria:

* Lesion requiring ablative procedures (i.e. atherectomy or laser) as part of treatment
* Lesion length \>75mm
* Previous bypass or stent at target vessel or proximal to target vessel
* Significant in-flow disease at target lesion
* Known inadequate distal outflow disease or planned treatment of vessel distal to target lesion
* Acute limb ischemia or need for thrombolytic therapy
* Known intolerance to required study medications, contrast media, or nitinol
* Known impaired Renal Function with Glomerular Filtration Rate (GFR) \<45 ml/min per 1.73m2
* Known bleeding disorder or uncontrolled hypercoagulable disorder.
Evaluation of Neuromuscular Morphometry of the Vaginal Wall

In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group.

In this prospective study,who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group. Biopsy material was obtained from the epithelium of the posterior wall of the vagina, including the fascia that fits the Ap point. Immunohistochemical staining with Protein Gene Product 9.5 and smooth muscle α-actin was performed in the pathology laboratory. The epithelial thickness measurement and smooth muscle density parameters obtained with these immunohistochemical stainings were compared between the two groups. The collected data were analyzed using SPSS 23 package program

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-75 years
* Patients operated for prolapse
* Patients who did not have prolapse and who would undergo vaginal intervention for other gynecologic reasons were designed to constitute the control group.
* who had not undergone any vaginal surgery, had not undergone any abdominal uterine suspension surgery, had posterior wall prolapse, and for whom surgery was planned.

Exclusion Criteria:

* Patients whose age was not suitable
* who had previously undergone vaginal surgery, who had undergone abdominal surgery and a uterine suspension surgery, who were not suitable for the specified examination conditions
* who had undergone rectocele surgery, urinary incontinence, or bladder surgery
Vertical Transmission of Hepatitis C Virus

Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.

Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive HCV RNA during pregnancy. Risk factors include: HCV RNA load level, HIV-HCV co-infection, duration of labour, HCV genotype, child gender, and invasive procedures either during pregnancy or at birth. Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) mainly occurs during the last trimester of pregnancy or at birth or around the birth (El-Shabrawi et al., World Journal of Gastroenterology 2013). Currently, using caesarian section to reduce the risk of Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) is still debated and not recommended in International Guidelines (EASL 2012). Spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (Ruiz-Extremera A et al. Hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (Rerksuppaphol S et al. J Gastroenterol Hepatol 2004), justifying the study.

Eligibility Criteria:
Inclusion Criteria:

* HCV chronically infected pregnant women
* with a positive HCV RNA
* who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

Exclusion Criteria:

* negative HCV RNA during pregnancy
* acute HCV infection during pregnancy (previous negative HCV test during pregnancy)
* MTCT not to be tested (early child death for instance)
Investigating the Clinical Consequences of Flutemetamol-PET-scanning

The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Dementia expert considers an Amyloid-scan appropriate according to Amyloid-imaging task force criteria (AIT) after conference with an Amyloid-PET expert
* Preambles of the AIT-Criteria are fulfilled

  1. A cognitive complaint with objectively confirmed impairment
  2. AD as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert
  3. When knowledge of the presence or absence of Abeta pathology is expected to increase diagnostic certainty and alter Management

  <!-- -->

  1. Patients with persistent or progressive unexplained MCI
  2. Patients satisfying core clinical criteria for possible AD because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation
  3. Patients with progressive dementia and atypically early age of onset (65 years or less in age)
  4. other situations where preambles of AIT-Criteria are fulfilled
* Diagnosis was established in a memory clinic or by an experienced physician in dementia diagnostics
* The diagnostic procedures comprise in minimum MRI, neuropsychology, routine blood test for exclusion of symptomatic causes
* MMSE \>15
* Competency to consent
* Trial partner willing to support study physician
* Written informed consent by both patient and trial partner
* Understanding of German language
* Treating physician willing to collaborate with the study team

Exclusion Criteria:

* Cognitive impairment which can be attributed to another underlying medical condition that renders a possibility of Alzheimer's disease very unlikely (thus violating preamble B)
* Clinically significant Depression (decided upon clinical assessment)
* MRI exclusion criteria
* PET exclusion criteria

  1. Allergy to Flutemetamol or any of the excipients of the solution for injections
  2. History of severe allergic reactions to drugs or allergens
  3. Pregnancy or lactation
Amputee Residual Limb Volume Fluctuation

The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases.


Eligibility Criteria:
Inclusion Criteria:

* trans-tibial amputees who have a regular prosthetist and who wear the prosthesis at least five hours per day.

Exclusion Criteria:

* Inability to ambulate continuously with a prosthesis (with or without the use of an assistive device such as a cane or walker) for 10 minutes indoors on a level walkway. 2. Inability to shift from horizontal to vertical posture in 30 seconds.
the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function

This study was the evaluate the efficacy and safety of Spirulina maxima extract on the improvement of Cognitive Function

This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects participated in Spirulina maxima extract or placebo group. To evaluate the changes in the evaluation items when Spirulina maxima extract was taken 12 weeks compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Persons who are at least 60 years of age at screening
* Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
* Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial

Exclusion Criteria:

* Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
* Patients with BMI(Body Mass Index)\<18.5 kg/m\^ or 35 kg/m\^≤BMI(Body Mass Index)
* Patients with alcohol abuse or dependence within the last 3 months
* Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
* Patients with a history of clinically significant hypersensitivity to Spirulina Maxima
* Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
* Patients who ingested Spirulina Maxima extract's health functional food within 1 month before screening
* Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
* Patients who participate in another human trial within 3 months
* Those who show the following results in the Laboratory test

  * AST, ALT \> 3 times upper limit of the normal range
  * Other significant laboratory test opinion
* Patients who are deemed unsuitable for participating in the human trial due to other reasons
S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)

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

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have locally advanced or metastatic penile cancer.

OBJECTIVES:

* Determine the confirmed complete and partial response rate in patients with locally advanced or metastatic epidermoid carcinoma of the penis treated with docetaxel.
* Determine the progression-free and overall survival of patients treated with this drug.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.

OUTLINE: Patients receive docetaxel IV over 15-30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3-5.8 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed epidermoid carcinoma of the penis

  * Distant metastases (M1) OR
  * Pathologically confirmed regional nodal metastases (N1-3)
* Measurable disease

  * Soft tissue disease irradiated within the past 2 months is not considered measurable disease

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-2

Life expectancy

* Not specified

Hematopoietic

* White blood cell (WBC) count at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than upper limit of normal (ULN)
* Aspartate aminotransferase (SGOT) no greater than 2.5 times ULN

  * If SGOT is greater than ULN, alkaline phosphatase must be no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 4 times ULN

  * If alkaline phosphatase is greater than ULN, SGOT must be no greater than 1.5 times ULN

Renal

* Not specified

Other

* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission
* No grade 2 or greater peripheral neuropathy
* No hypersensitivity to drugs formulated with polysorbate 80 (e.g., recombinant interferon alfa-2a, multivitamin infusion, etoposide, infliximab, or NovoSeven factor)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for penile cancer

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered

Surgery

* Not specified
Insulin Glargine "All to Target" Trial

The primary objectives were:

* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60
* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c


Eligibility Criteria:
* Male or female patients
* 30 to 80 years of age
* Body Mass Index \<45 kg/m2
* With Type 2 diabetes mellitus for at least 2 years
* With an HbA1c level at screening of \>7.5% and \>7.0% at randomization
* On stable dual or triple oral therapy for at least 3 months
* Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD, willing and able to perform self-monitoring of BG
* Females of child-bearing potentially were required to be willing and able to use adequate contraception
A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People

The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.

The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.

Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

The study will last for about 10 months in total.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women of non-childbearing potential.
2. Age 18-55 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 18.5 to 29.9 kg/m\^2 (both inclusive) at screening.
4. Body Weight: Greater than or equal to 50 kg at screening.
5. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

1. Known or suspected hypersensitivity to study intervention(s) or similar products.
2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.

   * Alanine Aminotransferase (ALT) above upper normal limit (UNL)
   * Aspartate aminotransferase (AST) above UNL
   * Total Bilirubin (BL) above UNL
   * Creatinine above UNL
   * International normalized ratio (INR) above UNL
   * Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L)
   * C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females)
4. Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.

Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)

The purpose of this trial is to improve the clinical management and outcome of patients with locally advanced cervical cancer by using positron emission tomography-computed tomography (PET-CT) imaging.

There is considerable debate worldwide regarding the utility of PET for staging cervical cancer. Although there are studies on the accuracy (sensitivity and specificity) of PET in cervical cancer, there are currently no prospective randomized studies on how PET information affects treatment decisions and outcomes.

Cervical cancer is the second most common cause of cancer deaths worldwide. In Canada, it is estimated that in 2009 there will be 1,300 new cases of cervical cancer and that 380 women will die of this disease. The corresponding 2009 data for Ontario is 500 new cases and 140 deaths. In Canada, cervical cancer screening with the Pap test allows for the diagnosis and curative treatment of precancerous lesions of the cervix or early cervical cancers. Symptoms of cervical cancer include vaginal bleeding and discharge. Unfortunately these are often associated with more advanced disease.

The costs associated with health care are increasing. PET is an expensive imaging modality. Given that resources for health care are not unlimited, there needs to be high quality evidence of an intervention such as PET's efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Women with newly diagnosed histologically confirmed FIGO Stage IB-IVA carcinoma of the cervix, including squamous, adenosquamous or adenocarcinoma. Women not suitable for surgery due to comorbidities (medical or other conditions) are also considered eligible.
* Age equal to or greater than 18 years
* Being considered for treatment with curative intent using concurrent chemotherapy and pelvic RT.

Exclusion Criteria:

* ECOG performance status greater than 2.
* Other cervical cancer tumour types (e.g. neuroendocrine, serous).
* Carcinoma of the cervical stump.
* Prior hysterectomy.
* Patients who, at the time of the initial evaluation, have already undergone a whole body PET-CT within the last 6 months.
* Contraindications to 18FDG PET-CT or CT of the abdomen and pelvis.
* Inability to lie supine for imaging with PET-CT.
* Contraindication to radiotherapy (i.e., significant Crohn's disease).
* Contraindication to cisplatin chemotherapy (i.e., non-reversible renal failure).
* Inadequate bone marrow function: ANC less than 1.5 X 10\^9, platelets less than 100 X 10\^9.
* Inadequate renal function: Creatinine greater/equal to 150 micromol/L
* Inadequate hepatic function: Bilirubin greater than 1.5 X ULN and SGOT and Alkaline Phosphatase greater than 3 X ULN.
* History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer.
* Other medical conditions that may preclude chemo-radiation therapy.
* Known pregnancy or lactating.
* Inability to complete study or required follow-up.