cyrilzakka/clinical-trials huggingface dataset:
Non Invasive Measurement of Cardiac Index by Impedance Cardiography

Pulmonary hypertension (PH) is defined as a pulmonary arterial mean pressure (meanPAP) ≥ 25 mmHg in the right heart catheterization.

There are different forms of PH defined in the classification of Dana Point 2008.

PH is diagnosed with right heart catheterization but there are other non invasive methods which can be used for screening like echocardiography, stress echocardiography and cardio pulmonary exercise testing.

For prognosis of PH patients the limitation of the pulmonary circulation is very important. Therefore the cardiac index (CI) is a good parameter for the right ventricular function. The gold standard for CI measures is the thermodilution, an invasive method performed during right heart catheterization.

In this study the investigators want to evaluate the impedance cardiography (ICG) as a non invasive method for CI measurement. An alternating current of max 400µA and 45 kHz is conducted through the body. The way of the smallest resistance is the blood in the aorta. The impedance changes with the pulsatile blood flow. Out of the Impedance change there can be calculated the CI.

Eligibility Criteria:
Inclusion Criteria:

* patients who have right heart catheterization written informed consent

Exclusion Criteria:

* patients who don't have right heart catheterization no written informed consent
Perineal Massage Performed During the Labour

In this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain.

In this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain. Perineal massage was administered to all pregnant women in the experimental group during both the labor and resting phases between contractions. The participants received an average of 5-10 minutes of perineal massage two, four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. These women continued to receive perineal massage at every push throughout the second stage of labor. Before perineal massage, the researcher wore sterile gloves, placed two fingers into the 3-4-cm wide-open vagina and applied Vaseline routinely to lubricate the vagina in the delivery room. . Perineal massage was applied using all three of the "from one edge to the other", "U shape" and "pressure" massage techniques. The researcher gently applied a rhythmic "U" pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock. Each pressure movement was maintained laterally for 1-2 minutes towards the rectum.

Eligibility Criteria:
Inclusion Criteria:

* Having no complications for vaginal delivery
* Having no dystocia affecting the birth process (e.g., prolonged labor, precipitate labor, shoulder dystocia)
* Having a singleton pregnancy,
* Having a fetal head with an anterior cephalic position,
* Being at the latent phase of labor,
* Having no perineal scar tissue,
* Having no diagnosis of vaginal fungus or infection,
* Having a fetus with a birth weight between 2500 and 4000 g,
* Having no communication problems.

Exclusion Criteria:

-All pregnant women who developed fetal distress during labor or had to undergo cesarean delivery were excluded from the study.
tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective and safe in the treatment Bipolar depression.

Randomized, double-blind Controlled Clinical Trial. Subjects Adults (between 19 and 65 years of age) with Bipolar depression who meet the inclusion criteria and who agree to participate in the study Will recruit from clinical referrals.

* Active tDCS Anode - left DLPFC Cathode - right DLPFC Electric current is 2mA - Current is applied for 30 min
* Sham tDCS Same assembly is used Current is applied for 1 min

Both groups 30\~42 stimulation sessions on consecutive days.

Baseline(visit 1), 2 week(visit 2), 4 week(visit 3), 6 week(visit 4), and 12 week(visit 5) Check compliance with mobile application(MINDD-CONNECT) connections.

Assessment:

Depression rating scale: HAM-D(Hamiltion Depresiion Rating Scale), HAM-A(Hamilton Anxiety Rating Scale) Maniac rating scale: YMRS(Young Mania rating scale) CGI-BP(Clinical Global Impression-Bipolar) Q-LES-Q-SF(Quality of Life Enjoyment and Satisfaction Short form) Q-LES-Q-Q(Quality of Life Enjoyment and Satisfaction Questionnaire) qEEG(Quantitative Electroencephalography)

Check compliance with mobile application(MINDD-CONNECT) connections.

Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II of bipolar disorder meets the current major depression diagnostic criteria in DSM-5
* CGI Severity of lightness score ≥ 4 points
* Taking mood stabilizers for at least four weeks before the day of screening

Exclusion Criteria:

* A history of clinically significant internal neurological disorders or head injury
* mental retardation or cognitive impairment that will affect to make a consent form.
* Patients at risk of suicide that may require hospitalization as determined by clinicians
* A person who is determined to be excluded for using tDCS medical device for other reason (e.g. metal plate is inserted on head, etc.)
* A person who is determined to have problems with scalp deformation, inflammatory response or brain wave and attachment of direct current because of other dermatological problem
* A woman who disagree with medically allowed contraception\* until 24 weeks after the application of investigational device among woman subject who is possible to get pregnant

  \* Medically allowed contraception: condom, oral contraception for at least 3 month, injection or insert contraception, Intrauterine Device, etc.
* pregnant woman or lactating woman
* A person who is not suitable for this clinical trial based on principal investigator's determination other than above reasons
Nonviolent Communication for Parents

This randomised controlled trial (RCT) aims to evaluate the effectiveness of face-to-face Nonviolent Communication (NVC) intervention in improving parents' mental well-being and NVC skills, reducing parenting stress, depression and anxiety symptoms, and child emotional and behavioural problems.

A total of 172 parents with primary-school-age children will be recruited and randomly assigned to an intervention group or a waitlist control group. The intervention group will receive six weekly 1.5-hour face-to-face NVC training sessions delivered by trained social workers.

Five to ten social workers will be trained by professional NVC trainers through a train-the-trainer workshop, including three sessions. Each social worker will be assessed before (TTT1), after (TTT2) the workshops and 10 months (TTT3).

Assessments for participants will be conducted at baseline (T1), immediately post-intervention (T2), and at three-month follow-up (T3). After completing the assessments, the waitlist control group will receive the same sessions. Qualitative interviews will be conducted to explore participants' experiences and perceptions of NVC.


Eligibility Criteria:
Inclusion Criteria:

* 1) parents aged 24-59 years with children of primary school age;
* 2) with mild to severe depressive symptoms (score \>5 on the Patient Health Questionnaire (PHQ)-9) (Kroenke et al., 2001) and/or mild to severe anxiety symptoms (score \>5 on the General Anxiety Disorder (GAD)-7) (Spitzer et al., 2006); and
* 3) Hong Kong residents who can understand Cantonese.

Exclusion Criteria:

* 1) under psychiatric treatment, psychotherapy groups and are classified as unstable cases based on the judgment of the recruiting social workers;
* 2) participating in other related parenting programmes.
A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health

This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4.

Gut health and associated health outcomes, including brain, skin, and immune function, will be evaluated at baseline and at each check-in. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Baseline and endline photos from each study part will be provided by participants.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* 18 years of age or older
* Experience at least one of the following symptoms: regular bloating/gas, irregular bowel movements, heartburn, or poor digestive health
* Generally healthy

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Allergic to bees, bee products, poplar tree products, or balsam of Peru
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding or attempting to become pregnant
* Unwilling to follow the study protocol.
* Has introduced any new forms of medication or supplements targeting gut health within the last 3 months
* Has taken antibiotics in the last 3 months
Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery

An observational study aiming to assess the incidence and possible causes of post phacoemulsification watery eye.

This study will be conducted on patients who will undergo cataract extraction at Sohag university hospitals to evaluate the incidence of watery eyes in patients after phacoemulsification by one week , one month and three month.

* Study Design: observational study.
* Inclusion Criteria:

Patients with age-related cataract.

* Exclusion Criteria:

  1. patients with watering of eyes or ocular surface diseases or watering of the eyes .
  2. patients with previous ocular surgeries.
  3. patients with glaucoma, uveitis, corneal or retinal pathologies.
* Preoperative Evaluation:

Each patient will be subjected to the following:

Detailed history taking and full ophthalmological examination. Fluorescein dye disappearance test. Syringing and probing. Schirmer's test. Tear break up time test. Measurement of punctal diameter by AS-OCT.

* Operative procedures:

  1. regional anesthesia.
  2. phaco technique : stop and shop.
  3. cumulative dissipated energy (CDE ) \&fluid flow.
* Follow-up regimen: will be as follows:

  1. patients will be examined after surgery on: 1st postoperative week, 1st month, 3rd month.
  2. The following will be recorded for each patient:

     1. symptoms of watery eyes, visual acuity, IOP, slit lamp examination.
     2. dye disappearance test.
     3. Schirmer's test.
     4. tear break up time test.
     5. anterior segment OCT.

Eligibility Criteria:
Inclusion Criteria:

* patients with age related cataract.

Exclusion Criteria:

* patients with watering of the eyes or ocular surface disease.

  * patients with previous ocular surgeries .
  * patients with glaucoma, uveitis, cornealor retinal pathologies.
Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.

The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion.

The study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
* Written informed consent

Exclusion Criteria:

* As described in Lucentis® SmPC
* Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)
Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain

The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.

Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 30 to 75 years
* Willingness of following the study protocol
* Clinical diagnosis of chronic low back pain
* Low back pain since at least 3 months
* Average pain intensity of at least 40 mm on VAS (0-100 mm) in the last 7 days
* In the last 4 weeks only oral NSAD and muscle relaxation treatment
* Effective oral contraception in woman
* Informed consent

Exclusion Criteria:

* Previous treatment with DISCI comp.
* Treatment with other than NSAID
* Routine use of pain drugs for other diseases
* Protrusio or prolapse of one or more intervertebral discs with neurological symptoms
* Previous spine surgery
* (Suspicious) infectious spondylopathy
* Low back pain because of malignant or infectious disease
* Other causes of back pain symptoms (e.g. M. Bechterev, M. Reiter)
* Congenital deformity of spine (without minor lordosis or kyphosis or scoliosis
* (Suspicious) osteoporosis with compression fracture
* (Suspicious) spinal stenosis
* Spondylolysis or spondylolisthesis
* Physiotherapy in the last four weeks or planed during trial
* Begin of a new treatment for low back pain
* Complementary treatment in the last four weeks or planed during trial
* Patients who are not able to cooperate in a sufficient way
* Patients with alcohol or substance abuse
* Participation in another clinical trial
* Severe chronical or acute disease which does not allow study participation
* Patients with bleeding disorders or oral anticoagulation treatment
* Pregnancy and breast feeding
* Patients with application for pension
* Patients involved in planning or coordination of the study
* Hypersensitivity against drug components
Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.

Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.

Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed

Main outcome: to measure changes in urinary urgency and quality of life.

Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of overactive bladder with or without the presence of urinary incontinence.
* Understand the instruments used in the research.

Exclusion Criteria:

* Urinary tract infection
* Neurological disease
* Other previous treatment in the last four weeks
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP

The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.

The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergone ERCP for biliary and pancreatic diseases

Exclusion Criteria:

* Comorbid conditions of ASA class 4-5
* Age under 18 years or over 90 years
* Pregnancy
* Past medication history of benzodiazepine or narcotics
* Known allergy to midazolam or propofol
* hypotension (systolic blood pressure \<90 mmHg), hypoxemia (SaO2 \<90%), or bradycardia (50/min) at baseline measurements
A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy

This study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. In addition, patients will have their self-injection observed and evaluated on up to three visits


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, 18 years of age or older, with diagnosis of RRMS
2. Naive to treatment or previously treated with an IFN.

Exclusion Criteria:

1. Not eligible for treatment based on clinical criteria and current indication.
2. Unable to respond to surveys or provide informed consent.
Genetic Studies in Familial Dementia

The purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. This includes a number of neurological diseases such as early and late-onset Alzheimer disease, mild cognitive impairment, and other dementias.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older
2. Patients diagnosed with dementia, their family members and unrelated healthy controls without dementia.

Exclusion Criteria:

1. Individuals with competing diagnosis such as: Amyotrophic lateral sclerosis, Frontotemporal lobar degeneration, Multiple system atrophy, Corticobasal degeneration, Progressive Supranuclear Palsy, Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc. (unless family members of a dementia affected individual).
Evaluation of DPA for Treatment of Upper Anterior Crowding

Evaluation of effectiveness of direct printed clear aligner in relive crowding in maxillary incisor

The present study will be performed to evaluate the effectiveness of direct 3D-printed aligners in the treatment of maxillary anterior teeth crowding

Eligibility Criteria:
Inclusion Criteria:

* Adult paients .age 18-25y. patients with mild to moderate upper anterior crowding (1mm_6mm)
* Healthy compliant and motivated patient. full dentition except wisdom teeth.

Exclusion Criteria:

* Previous orthodontic treatments. Any systemic disease, pregnancy, or lactating females, with a pocket depth of more than 5mm.
Post-Market Evaluation of the Rotation Medical Rotator Cuff System

The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.


Eligibility Criteria:
INCLUSION CRITERIA

Subjects enrolled in the study MUST meet all of the following criteria:

1. At least 21 years of age
2. Rotator cuff tear requiring surgery that meets either criterion A or B:

   A. Medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair
3. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
4. MRI of the shoulder within 60 days prior to the study procedure
5. Willing to comply with the prescribed post-operative rehabilitation program
6. Willing to be available for each protocol-required follow-up examination
7. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
8. Ability to read, understand, and complete subject-reported outcomes in English

EXCLUSION CRITERIA

Subjects enrolled in the study MUST NOT meet any of the following criteria:

1. Massive rotator cuff tears (≥ 5 cm)
2. Acute rotator cuff tears less than 12 months from injury
3. Previous rotator cuff surgery on the index shoulder
4. Instability of the index shoulder
5. Chondromalacia of index shoulder ≥ Grade 3
6. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2
7. Calcification of the index shoulder rotator cuff
8. Genetic collagen disease
9. History of insulin dependent diabetes
10. History of auto-immune or immunodeficiency disorders
11. History of chronic inflammatory disorders
12. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
13. History of heavy smoking (\> 1 pack per day) within last 6 months
14. Hypersensitivity to bovine-derived materials
15. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
16. Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder
17. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
18. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
19. History of cognitive or mental health status that interferes with study participation