cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Triple Combination Therapy of Zemidapa Tab. and Metformin in Type 2 Diabetes Mellitus Patients

The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus


Eligibility Criteria:
Inclusion Criteria:

* type 2 DM Patients who are receiving one of the following three therapies during which the patients are prescribed with Zemidapa Tab. for the first time at the discretion of the attending physician:

  1. Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin)
  2. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor)
  3. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and Sulfonylurea \[SU\])
* patients with HbA1c results and who signed the written consent form

Exclusion Criteria:

- Patients contraindicated for the approved use of Zemidapa Tab. or have participated in another clinical study within 12 weeks
Visualization Engineering Platform for TCM Pulse Diagnosis - Pulse Diagnosis Based on Federated Learning to Diagnose Slippery and Choppy and Other Pulses Waveform Image Features to Assist in the Study of TCM Pathological Logic Analysis

The diagnoses processes of Traditional Chinese Medicine (TCM) focus on the following four main types of diagnoses methods consisting of inspection, olfaction, inquiry, and palpation. The most important one is palpation also called pulse diagnosis which is to measure wrist artery pulse by TCM doctor's fingers to detect patient's health state. The pulse diagnosis has three parts, namely 'Chun', 'Guan' and 'Chy', with the location. Wrist measurements correspond to different parts of the body's organs. In this project, it is to classify pulse types by using specialized pulse measuring instruments. The measured pulse wave (Measured Pulse Wave, MPW) was segmented into arterial pulse wave curves (APWC) by the image suggestion method. The research object of this project is to collect and group patients diagnosed by traditional Chinese medicine practitioners, namely slippery pulse, choppy pulse group and normal pulse control group, with at least 80 cases for each group. The research purpose of this project is mainly to carry out the visualization engineering platform of TCM pulse diagnosis - based on the pulse diagnosis of federated learning to diagnose the pulse waveform image features such as slippery pulse and choppy pulse to provide auxiliary TCM pathological logic analysis research and back-end cross-federal learning of TCM pulse diagnosis Implementation of the node system. In other words, it is expected that the pulse wave characteristics measured by TCM physicians who cooperate with experts in the field can be collected from many TCM pulse diagnosis federated learning nodes, and analyzed by the Multiple-Expert Repertory Grid Elicitation (MERGE) method. Finally, the artificial intelligence model based on FL is trained to carry out TCM pathological logic analysis and related research. The results will be provided to TCM physicians as an important reference to assist clinical diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Already sign test consent permit.
2. More than 20-year-old.

Exclusion Criteria:

1. There is a wound or inflammation at the wrist skin measurement.
Surgical Treatment of Long Bone Metastases

To provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Eligibility Criteria:
Inclusion Criteria:

* bone metastases of the extremity

Exclusion Criteria:

* bone metastases of the spine
Adolescent Fibromyalgia Study

This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia
* 12-17 years of age

Exclusion Criteria:

* Patients with other pain conditions
* Previous treatment with pregabalin
* Patients taking excluded medication
Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* All postmenopausal (\> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment

Exclusion Criteria:

* Women who do not wish to participate
* Women who are medically unfit for hysteroscopy
* Women who are medically unfit for participation in any clinical trial
* Women who do not have a medical indication for hysteroscopy
* Women who have previously had, or currently have breast or gynaecological cancer
* Women who have a medical contraindication for locally applied oestradiol
* Women who are currently using hormone therapy
* Women who are unable to communicate in Norwegian, and
* Women with a known allergy to misoprostol
Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

This is a randomized placebo-controlled trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* 10 years of age or older
* Executed informed consent
* Documented diagnosis of HAE (Type I or II)
* Presentation at the site within 8 hours of patient recognition of an moderate to severe HAE acute attack

Exclusion Criteria:

* Receipt of an investigational drug or device, within 30 days prior to study treatment
* Receipt of non-investigational C1-INH within 7 days of treatment
* Receipt of DX-88 (ecallantide) within 3 days prior to study treatment
* Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)
* Pregnancy or breastfeeding
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancies
* women booked for elective C.S
* full term pregnancies
* primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )

Exclusion Criteria:

* blood disorders
* multiple pregnancy
* placenta previa
* polyhydramnios
* marked maternal anemia
* contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
* previous 2 or more C.S
A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients

The purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.

The information was processed from culture results that were processed to compile an antibiogram for a laboratory.

Eligibility Criteria:
Inclusion Criteria:

-Patients with chronic wounds.

Exclusion Criteria:

-Patients without chronic wounds.
An East Asian Study of LDE225

The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of advanced solid tumor (including medulloblastoma and basal cell carcinoma)
* blood work criteria

Exclusion Criteria:

* patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
* positive HIV, hepatitis B or C
* impaired intestinal function
* impaired heart function
* pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply
An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis

The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Participants will be randomly assigned to 2 groups: tramadol/APAP group and non tramadol/APAP group. Participants in tramadol/APAP group will receive celecoxib 200 milligram (mg) and fixed dose combination of tramadol (37.5 mg)/APAP (325 mg) as add on therapy, while the participants in non-tramadol/APAP group will receive celecoxib 200 mg only. The total duration of the study will be 4 weeks. The participants in both the groups will be given celecoxib 200 mg once daily for 4 weeks. In addition, the participants in the tramadol/APAP group will be given add-on tramadol/APAP doses 3 times a day for 4 weeks. Participants will be asked to return for follow-up at Weeks 2 and 4. Efficacy will be assessed using 100 millimeter (mm) Visual Analog Scale (VAS) while QOL will be assessed using the Oswestry Disability Index (ODI). Participant safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic osteoarthritis of knee or hip for greater than (\>) or equal to (=) 1 year (based on the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (\>=50 millimeter \[mm\] in 100 mm Visual Analog Scale \[VAS\])
* On any Cyclooxygenase - 2 (COX-2) inhibitors for at least 2 weeks preceding the study
* Women with childbearing potential must have negative pregnancy test
* Women of child bearing potential must agree to use accepted methods of contraception
* Participant has signed the written informed consent form

Exclusion Criteria:

* Participants taking Monoamine oxydase (MAO) inhibitors, neuroleptics or drugs for seizures
* Severe hepatic impairment (the impaired ability of the liver to fulfill its role in metabolism)
* On maintenance tramadol and/or paracetamol(APAP)
* On sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants
* Pregnant, lactating or breastfeeding participants
Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players

The investigators primary objective is to acquire preliminary data on one-hundred former NFL veterans with at least one full year of professional service using brain SPECT imaging in order to assess the degree to which NFL football puts players at risk for traumatic brain injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects.

The investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said TBI.

The investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of TBI.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age
* Each subject must have been on an active NFL roster for a minimum of one year

Exclusion Criteria:

* Any subjects who could not cease taking psychoactive medications (recreational or otherwise) for an appropriate washout period prior to scanning were excluded from the study
High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation

Cigarette smoking is a major public health problem causing significant morbidity and mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break their addiction.

The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the mesolimbic dopamine systems in both animals and humans. For this reason, we investigated whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex can help people to withdraw smoking in comparison to placebo rTMS.

Smokers seeking to quit are recruited through newspaper advertisements. Participants were randomized to 10 days of either real or placebo high frequency rTMS.


Eligibility Criteria:
Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

-
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss

Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Have no clinically significant disease or abnormal laboratory results taken at the screening visit.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Any clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Dermatologic condition in donation and/or study areas.
* Prior surgery in the treatment area.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
Study on OsseoSpeed™ TX Implants in a Chinese Population

To investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible is a safe and predictable procedure.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. Aged 20-75 years at enrolment
3. History of edentulism in the posterior mandible, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
4. Neighboring tooth to the planned bridge must have natural root.
5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
7. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Earlier graft procedures in the study area
3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
4. Uncontrolled pathologic processes in the oral cavity
5. Known or suspected current malignancy
6. History of radiation therapy in the head and neck region
7. History of chemotherapy within 5 years prior to surgery
8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
9. Uncontrolled diabetes mellitus
10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
11. Smoking more than 10 cigarettes/day
12. Present alcohol and/or drug abuse
13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
14. Previous enrolment in the present study.
15. Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.
16. Subjects that are unable to give informed consent
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent and assent (for subjects under legal adult age).
2. Age ≥9 years.
3. Primary palmar hyperhidrosis for at least 6 months duration.
4. Average sweat severity score of ≥4 at Baseline.
5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
6. Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
7. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.

Exclusion Criteria:

1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
2. Prior surgical procedure for hyperhidrosis.
3. Iontophoresis for the palms within 4 weeks of Baseline.
4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
6. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
7. Known history of Sjögren's syndrome or Sicca syndrome.
8. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
9. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.