cyrilzakka/clinical-trials huggingface dataset:
Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

The summary of this research study is to test the effectiveness of a rapid "rescue" acupuncture technique as a non-pharmacologic alternative treatment for the reduction of post-traumatic stress disorder (PTSD) symptoms in affected individuals as a means to improve warfighter health and enable a more rapid return to duty, especially in austere environments. Patients will receive acupuncture as a research-related course of treatment for PTSD. The PCL-5 questionnaire will be used to assess the presence and severity of PTSD symptoms. A PCL-5 questionnaire will be administered at the beginning of the first treatment of "rescue" acupuncture and after the last treatment. Following the acupuncture treatment, a PCL-5 questionnaire will be initiated at the beginning of the first week of treatment and the end of the second week of treatment at the participating Mental Health Clinic (pMHC).

"The objective is to treat three ARMS of PTSD patients: ARM 1: Newly untreated diagnosed PTSD patients referred from a participating Mental Health Clinic (pMHC) who have not yet received any PTSD treatment for a 2-week therapy of ""rescue"" acupuncture (six 30 minute sessions Monday, Wednesday, and Friday); ARM 2: Newly diagnosed PTSD patients referred from the pMHC but already placed on pharmacological therapy (i.e. Prazosin, SSRI, sedative, etc.) prior to their enrollment in the pMHC; and ARM 3: newly diagnosed PTSD patients with or without medications referred to pMHC but have a mild traumatic brain injury that does not impede their judgment ability. ARMs 2 and 3 will follow the same ""rescue"" acupuncture program as ARM 1. A PCL-5 questionnaire will be administered prior to and after ""rescue"" acupuncture. ARMs 1, 2, and 3 patients will return to the pMHC (after 2 weeks of ""rescue"" acupuncture) to start or continue pharmacological and/or non-pharmacological therapy(s) and will also be evaluated by a PCL-5 questionnaire at the start and after 2 weeks. Statistical analysis of the PCL-5 questionnaire will compare the three ARMS together as to whether acupuncture is a benefit or not to the patient following therapies received for 2 weeks in the pMHC. The lowering of the PCL-5 symptomatic questionnaire score is a favorable indication of a benefit.

Eligibility Criteria:
Inclusion Criteria:

Active duty and retired military referred from a participating Mental Health Clinic

-

Exclusion Criteria:

Pregnancy Participated in a form of acupuncture in the last 3 months
Efficacy and Safety of Lobeglitazone Versus Sitagliptin

Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.

Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.

Eligibility Criteria:
Inclusion Criteria:

* ≥19 years old
* Waist line: male ≥ 90cm, female ≥ 85cm
* Applied to 1 or more categories listed below (NCEP-ATP III)

  1. SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control
  2. HDL-C: male \< 40mg/dl, female \< 50mg/dl and/or taking drug for HDL-C increase
  3. TG ≥ 150mg/dl and/or taking drug for TG control
* At visit 1: Applied to 1 or more categories listed below

  1. Type 2 DM Patients who does not need stabilization period : 7% ≤ HbA1c ≤ 10%, if treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study → Visit 3(Randomization)
  2. Type 2 DM Patients who need stabilization period : 7% ≤ HbA1c ≤ 10%, if not treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study (Applied to 1 or more categories listed below) ① Drug Naïve ② Taking Metformin \< 1000mg monotherapy and/or Taking Metformin \< 12 weeks prior to this study ③ Taking OHA
* At visit 2(After 12 weeks of stabilization period): 7% ≤ HbA1c ≤ 10%
* Patients who signed informed consent form

Exclusion Criteria:

* Type 1 DM Patients or secondary DM
* Patients with ketoacidosis
* Patients with taking insulin \> 7 days within 12 weeks
* Hypersensitive to biguanide and/or glitazone and/or DPP4-inhibitor
* Patients with taking corticosteroid \> 7 days within 4 weeks
* Patients with lactic acidosis
* Patients with galactose intolerance and/or Lapp lactase deficiency and/or glucose-galactose malabsorption
* Patients with innutrition and/or starvation and/or weakness and/or pituitary insufficiency and/or addisons disease
* History of malignant tumor within 5 years
* History of drug or alcohol abuse within 12 weeks
* Patients with congestive heart failure(NYHA class III\~IV) or uncontrolled arrythmia within 6 months
* Patients with acute cardiovasvular disaese with 12 weeks
* Applied to 1 or more categories listed below

  1. AST and/or ALT ≥ 3\*ULN
  2. Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl
  3. Hb \< 10.5g/dl
* Women with pregnant, breast-feeding
* Childbearing age who don't use adequate contraception
* Patients who have participated in other clinical trials
* Not eligible to participate for the study at the discretion of investigator
Evaluation of Clinical Characteristics and Pathological Findings in Patients With Suspected Appendicitis

As we know, one of the most common reasons for people to visit health centers and hospitals (15%) is abdominal pain, and appendicitis is at the top of their diagnosis in the 2-4th decade of age, which in most cases For treatment, considering the patient's condition and the need for surgery, appendectomy is the first method. One of the things that helps us a lot in this area is the epidemiology and incidence of this disease in the target society, which sometimes varies in different regions. One of the things that can be checked in this disease is the age and gender of the person and its incidence in different age ranges.

appendicitis is one of the most important reasons for people to go to the hospital, and 15% of the visits to the hospital are for this reason, and sometimes patients end up undergoing appendectomy. The mortality rate of this disease is 0.2-1% among young people and 8% among people over 65 years old In some people, depending on the sex, age, pregnancy and related diseases and even the weight of the people, the location of the appendix is different and this issue is very important during surgery. Different positions of the appendix, such as retro-scapular, subhepatic, pelvic, etc., create different challenges during surgery, so investigating the possibilities of the location of the appendix is an important issue in the decision-making and preparation of the patient and the surgical team.

Also, laboratory criteria such as wbc, diff, plt, crp can also help in diagnosing this disease. In this project, in addition to the above, the chief complaints and accompanying symptoms of people have also been examined

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of appendicitis
* appendectomy

Exclusion Criteria:

* Lack of required information in medical documents
Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition

This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to acute inpatient medicine unit
* Ambulatory without assistive device prior to hospitalization
* Medical clearance to ambulate on the unit
* Active MyChart account or willing to activate MyChart account
* iOS or Android device

Exclusion Criteria:

* Patients less than or equal to 65 years old
* Not Admitted to acute inpatient medicine unit
* Ambulatory with assistive device prior to hospitalization
* No Medical clearance to ambulate on the unit
* Inactive MyChart account and not willing to activate MyChart account
* No iOS or Android device

In addition, an individual who meets any of the following criteria will be excluded from participation in this study:

* Oxygen requirement at rest
* Lower extremity prosthesis
* Admitted for joint replacement surgery
* History of frequent falls
* Admitted for syncope.
* If patients have specifically opted out of being contacted about research (visible in the Epic header while in their chart)
* Admitted from nursing home
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate.

The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8 months. The screening period is 28 days and each cycle of treatment is 21 days.

The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Has a pathologically documented unresectable or metastatic gastric or GEJ adenocarcinoma, or breast cancer, with HER2 expression \[immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +\] that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
* Has a left ventricular ejection fraction (LVEF) ≥ 50%
* Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

* Has a medical history of myocardial infarction within 6 months before enrollment
* Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions
* Has uncontrolled or significant cardiovascular disease
* Has any other history or condition that might compromise:

  1. Safety of the participant or offspring
  2. Safety of study staff
  3. Analysis of Results
A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.


Eligibility Criteria:
Key Inclusion Criteria

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 45.0 kg/m2

Participants with Hepatic Impairment

* Considered to have mild, moderate, or severe hepatic impairment by Child-Pugh Score classification and has been clinically stable for at least 1 month prior to Screening
* Chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Participants must also remain stable throughout the Screening period

Key Exclusion Criteria

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator

Participants with Hepatic Impairment

* Have a QTcF \>480 msec for males and \>490 msec for females at Screening or Check-in. If any parameter is out of range, the ECG may be repeated for confirmation
* Any evidence of progressive liver disease that has worsened or is worsening, as determined by the investigator, within 1 month prior to Screening
* Demonstrated evidence of hepatorenal syndrome
* Ascites requiring paracentesis or other intervention up to 3 days prior to the study
* Hepatic encephalopathy Grade 2 or above
COA-APTIC Caregiver Concept Elicitation Study

This is a concept elicitation study to identify important aspects of pain assessment, treatment, and response to treatment in children under than 3 years of age from a caregiver's perspective.

The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials for acute pain therapeutics in infants and young children from a caregiver's perception. Study team members will conduct phone-based qualitative interviews, using a semi-structured interview guide, with 42 primary caregivers of pediatric patients under 3 years of age who are experiencing or have experienced acute pain. Once participants give verbal consent, they will fill out a demographics form. Interviews will last about one hour and will address the participant's experience recognizing and managing their child's acute pain. The investigators will use these concept elicitation interviews to identify important aspects of acute pain assessment, treatment, and response to treatment in children who are under 3 years old. Interviews will be audio recorded and transcribed with participant permission. Transcripts or interviewer notes will be reviewed by two analysts and will be double coded until inter-rater reliability is reached by agreement of at least 80%. The study team will conduct a thematic analysis of the coded transcripts. This is a minimal risk study. All information will be kept confidential and information will be stored on a secure network which is only accessible to the study team.

Eligibility Criteria:
Inclusion Criteria:

1. Cares for a child who is both:

   * Between 0 and \<3 years of age
   * Experiencing or has experienced acute pain in one of the following categories:
   * Malignant or non-malignant visceral or hematologic disease
   * Surgery (or other procedure)
   * Trauma or injury
   * Congenital conditions
2. Is over the age of 18 years old.
3. Can speak and understand English.
4. Is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record.

Exclusion Criteria:

1. Lack of access to a telephone or computer for interview
2. Has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.

Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

Inclusion Criteria:

* 30 to 75 years old patient
* Parkinson disease's diagnosed since 5 years
* Treated by deep brain stimulation
* Patient with at least 6 degree lateral deviation
* Without vestibular troubles nor peripheral sensorial trouble.

Exclusion Criteria:

* Dementia (Mattis \< 130 ou MMS \<24), or severe depressive episode according to DSM IV-R criteria
* Camptocormia or incompatible anteflexion with the dispositive of measure device
* Pregnant woman, nursing mother

Eligibility Criteria:
Inclusion Criteria:

* 30 to 75 years old patient
* Parkinson disease's diagnosed since 5 years
* Treated by deep brain stimulation
* Patient with at least 6 degree lateral deviation
* Without vestibular troubles nor peripheral sensorial trouble.

Exclusion Criteria:

* Dementia (Mattis \< 130 ou MMS \<24), or severe depressive episode according to DSM IV-R criteria
* Camptocormia or incompatible anteflexion with the dispositive of measure device
* Pregnant woman, nursing mother
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison

The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, remeasurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.

Current evidence-based guidelines in VA recommend one of three beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) that have been shown to reduce mortality in heart failure patients with systolic dysfunction, with recommended target doses. However, Pharmacy Benefits Management (PBM) data indicate that prescribing for beta-blockers in heart failure patients that is not in accordance with guidelines is substantial, both in terms of the agent selected and the dose. Sites will be recruited and randomized to two different intensities of intervention to promote adherence to guidelines.

Eligibility Criteria:
Inclusion Criteria:

* VA sites
* Males and females

Exclusion Criteria:

none
Neuroscience Education in Shoulder Pain: Clinical Trial

Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain.

A randomised controlled trial was performed. Fifty-five patients satisfied eligibility criteria, agreed to participate, and were randomized into an experimental group (n = 27) or control group (n =28). A manual therapy and exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).

Eligibility Criteria:
Inclusion Criteria:

* Being 18-70 years of age.
* History of shoulder pain of more than 3 months duration.
* Presence of a painful arc
* Medical diagnosis of shoulder pain with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test

Exclusion Criteria:

* Diagnosis of fibromyalgia.
* Pregnancy.
* A history of traumatic onset of shoulder pain.
* Other histories of shoulder injury.
* Torn tendons.
* Ligamentous laxity based on a positive Sulcus and apprehension tests.
* Numbness or tingling in the upper extremity.
* Previous shoulder or cervical spine surgery.
* Systemic illness.
* Corticosteroid injection on the shoulder within 1 year of the study.
* Physical therapy 6 months before the study.
Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial

The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.

The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).

A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will be women over the age of 18 presenting for office hysteroscopy.

Exclusion Criteria:

Exclusion criteria included patients with visual or auditory impairment that would interfere with their ability to use the virtual reality set, English language non-fluency, history of opioid dependence/abuse, current narcotic use, or desire for narcotic use during the procedure.
Evaluation Coroacromial Ligament Thickness

In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients.

The coracoacromial ligament, which is part of the coracoacromial arch, plays an important role in shoulder biomechanics, joint stability and proprioception. Age-related changes due to chronic stress and cellular impairment may contribute to thickening and stiffening of the coracoacromial ligament to rupture the rotator cuff and development of shoulder pathologies such as impingement syndrome. In this study, it was aimed to determine the relationship between pathologic findings and coracoacromial ligament thickness in magnetic resonance imaging in shoulder pain patients. Secondary purpose is whether the thickness of the coracoacromial ligament is indicative of shoulder pathologies.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 15 years diagnosed with shoulder pain

Exclusion Criteria:

* Sensation and reflexes loss in the upper extremity
* Limitation in passive shoulder movements on physical examination
* Systemic rheumatic disease
* Diabetes mellitus
* Malignant disease
* Active infection
* Intraarticular injection
* Trauma
* History of surgery
Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth

when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.

Patients who have irreversible pulpitis and need pulpotomy will be selected randomly from the out patient clinic. they will be assigned randomly to different study and control groups. pulpotomy will be performed in the second primary molar and 1 of the five materials will be put in the pulp chamber (aloe vera, nigella sativa, thymus vulgaris, turmeric and formocresol). It will be covered with a restoration and a stainless steel crown. Patients follow up will be done after 1,3,6 and 12 months to assess clinical and radiographic signs and symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 4 to 7 years old
* Patients who are medically free
* Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy.
* No clinical signs or symptoms as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling.
* No radiographic signs of any periapical pathosis or signs of internal or external root resorption.

Exclusion Criteria:

* Patients who have any medical condition.
* Teeth that are badly broken down, that cannot be restored.
* Presence of uncontrolled bleeding.
* Clinical evidence of non-vitality such as presence of an abscess or a sinus or premature mobility.
* Radiographic evidence of bone resorption, internal or external root resorption and periapical or interradicular radiolucency.