cyrilzakka/clinical-trials huggingface dataset:
The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the anxiety and stress levels of postpartum women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Postpartum anxiety scale and the perceived stress scale were applied to women in both groups to determine their anxiety and stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Postpartum anxiety scale and the perceived stress scale were administered to the women in both groups to re-determine their anxiety and stress levels.

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the anxiety and stress levels of postpartum women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 128 women should be included in the study. Considering that there may be losses, it was decided to include 160 women in the study. By providing randomization, 160 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 80 experimental and 80 control. At the beginning of the study, the Postpartum anxiety scale and the perceived stress scale were applied to women in both groups to determine their anxiety and stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Postpartum anxiety scale and the perceived stress scale were administered to the women in both groups to re-determine their anxiety and stress levels. In the study, 7 women from the experimental group and 9 women from the control group were excluded for various reasons. The study was conducted with 73 experimental and 71 control groups. The process of making analyzes and writing the final report continues. This study is financially supported by Atatürk University Scientific Research Coordination Unit. In addition, this study is carried out as a master's thesis accepted by Atatürk University Health Sciences Institute.

Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 19-45
* Giving birth by vaginal / Caesarean section
* 1 month after birth
* Having a healthy baby
* Not experiencing any complications during birth and postpartum
* At least primary school graduate
* Not having a diagnosed psychiatric disease

Exclusion Criteria:

* Having a medical condition (hypertension, wound complication, etc.)
* Not regularly attending laughter yoga sessions (for the experimental group)
* Applying another alternative method to reduce anxiety and stress in the postpartum period
Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity

This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Completion of Study GEN-003-002
2. Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-002.
3. Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study GEN-003-002.
4. Willing and able to provide written informed consent.
5. Willing to perform and comply with all study procedures, including attending clinic visits as scheduled.
6. For each swab collection period, willing to not use HSV-2 antiviral therapy from 14 days before the swab collection period through the end of the period.

Exclusion Criteria:

1. Any important protocol deviation in Study GEN-003-002.
2. Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period 1.
3. Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period 1.
4. Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days before the beginning of Swab Collection Period 1.
5. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the Visit 1, any dose of corticosteroids within 30 days before Visit 1, or high-dose inhaled corticosteroids \[\>960 µg/day of beclomethasone diproprionate or equivalent\]) or other immunosuppressive agents.
6. Presence or history of autoimmune disease, regardless of current treatment.
7. Receipt of a vaccine containing HSV-2 antigens other than GEN-003.
8. Pregnant women.
9. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
10. Onset of an AESI since Month 12 in study GEN-003-002.
11. Other active, uncontrolled comorbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
Extension of Study ZPV-200

The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. Normal, or abnormal but non-clinically significant, transvaginal ultrasound. History of menstrual events occurring in regular cycles.
* Agreement not to attempt to become pregnant.
* Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit.
* Ability to complete a daily subject diary and study procedures in compliance with the protocol.
* Agrees to use the condoms provided and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) over the course of the study.
* Has a negative pregnancy test at the Screening and Baseline visits. An exception for the pregnancy test requirement will be granted for subjects providing verification of surgical sterilization.
* A Body Mass Index (BMI) between 18 and 39 inclusive.
* Is available for all treatment and follow-up visits.
* Subject is able to insert vaginal suppositories.
* Subject is willing to exclusively use sanitary napkins (no tampons) during study duration.

Exclusion Criteria:

* Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
* Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period.
* Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5x ULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).
* Received an investigational drug in the 30 days prior to the screening for this study.
* Women with a history of PCOS.
* Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
* Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
* Has an IUD in place.
* Women currently using narcotics.
* Women currently taking cimetidine or spironolactone.
* Clinically significant abnormal findings on screening examination or any condition, which in the opinion of the investigator, would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.
* Participation in study ZP-204.
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
* Patient is currently participating in KVD900-302.
* Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
* Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.

Exclusion Criteria:

* Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.
Effect of Aldosterone on Energy Starvation in Heart Failure

We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).

Preliminary results showed reduced subendocardial myocardial perfusion reserve in NIDCM compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Nonischemic dilated cardiomyopathy
* Left ventricular ejection fraction 35% or less
* Stable heart failure symptoms
* Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
* Able to tolerate treatment with spironolactone

Exclusion Criteria:

* Serum potassium \>5.0
* Serum creatinine \>2.5
* Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.
Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms

Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.


Eligibility Criteria:
Inclusion Criteria:

* .all patients with adenoid hypertrophy causing airway obstruction.

Exclusion Criteria:

* 1. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
* 2 . Systemic medical problems interfering with surgery.
* 3 . Refusal of parents to participate.
* 4. Craniofacial abnormalities.
* 5. Down syndrome.
the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle

The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.

The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.

The hypothesis for advantage of the investigational post-operative therapy is based on:

Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16-60 years
* No prior ankle surgery
* Able and willing to comply with follow-up
* Capable of provide informed consent
* Medically fit for surgery
* Lesions on preoperative CT Scan \< 1.5cm
* Symptomatic (ie:pain, restricted activities, inability to WB, decreased ROM)
* Single Isolated lesion
* Failure of conservative treatment (3 months of limited activities and/or weight bearing and/or immobilization)

Exclusion Criteria:

Age less than 16 years or greater than 60 years

* Inflammatory arthritis
* Diffuse osteoarthritis of affected joint
* Associated fracture
* Prior ankle surgery for current injury (including arthroscopy)
* Unable to comply with follow-up
* Unable to provide informed consent
* Bernt \& Hardy class IV (amenable to ORIF)
* Multiple osteochondral defects in one ankle or touching osteochondral lesions of tibia and talus
* Prior osteochondral defects of the affected ankle
Investigation of Immediate Efficacy of Kinesiology Taping

Shoulder protraction is the forward tilt of the head with hyperextension of the cervical spine and is associated with lengthening of the sternocleidomastoid and scalene muscles. With the lengthening of the flexor muscles, the weakened and shortened trapezius, levator scapula, and serratus anterior muscles lead to extra flexor torque and sustained contraction.

Weakness in the rotator cuff muscles, especially infraspinatus and supraspinatus muscles, has been observed in individuals with scapular dyskinesia and who frequently use overhead movements in their daily lives. The most important point to be considered in the treatment of scapular dyskinesia is the effective evaluation and treatment of primary and secondary symptoms and conditions. The preference of shoulder rehabilitation programs in which the scapula is also included in the treatment program will provide great benefits to physiotherapists in terms of treatment. Effective treatment can be provided by taping, exercise and many other treatment methods.

Eligibility Criteria:
Inclusion Criteria:

* Those with neck pain
* Being between 18-60 years old

Exclusion Criteria:

* Hypertension
* Cardiopulmonary disease
* Pregnancy
* malignancy
* Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
* Spine surgery
* Psychological discomfort
* Neurological and orthopedic deficits
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.

Eligibility Criteria:
Inclusion Criteria:

* Pre-randomization mRS \</= 3
* Confirmed diagnosis of chronic subdural hematoma
* Completed informed consent

Exclusion Criteria:

* Acute subdural hematoma
* Prior treatment of target subdural hematoma
* Markwalder assessment \>/= 3
* Glasgow Coma Scale \< 9
* Presumed microbial superinfection
* CT or MRI evidence of intracranial tumor or mass lesion
* Life expectancy \< 1 year
* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
* Current involvement in another clinical trial that may confound study endpoints
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-1b)

Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. This study aims to assess the infarct volume after ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
* Previous mRS ≤ 2;
* Baseline NIHSS ≥ 6;
* Baseline ASPECTS ≥ 6;
* With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery;
* Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA;
* Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

* Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
* Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
* Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
* \> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy;
* Moderate/severe residual stenosis (≥ 50%) in the offending artery after thrombectomy;
* Patients with contraindications to MRI;
* Other conditions that the investigator considered inappropriate for inclusion.
Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients

The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power.

First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.

At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.

Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed uni- or bilateral age-related cataract
* Age 40 to 95
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Corneal abnormality (Corneal scaring)
* usage of artificial tears/eyedrops 24h before the examination
* necessity of any topical therapy of the eye (i.e. glaucoma)
* active ocular or nasal allergies or corneal or conjunctival infection
* abnormality of the nasolacrimal drainage apparatus
* dry eye severity level 4 (severe and/or disabling constant discomfort and visual symptoms, marked conjunctival injection, filamentary keratitis, mucus clumping, tear debris, ulceration, trichiasis, keratinization, symblepharon)
* lid deformities
* Preceding ocular surgery or trauma
* Pregnancy
* Lactation
* Uncontrolled systemic or ocular disease
e-Nose and Colorectal Cancer

Colorectal cancer (CRC) is the third most common new cancer diagnosis and a major cause of morbidity and mortality throughout the world. Early detection and treatment are critical factors in the course and prognosis of CRC, and screening programs have proven to be an important means to reduce both CRC related mortality and secondary economic burden.

The diagnostic accuracy of non-invasive screening tests is still limited and a follow-up colonoscopy is required for confirmation of the diagnosis. The faecal occult blood test (FIT) is the most commonly used fecal screening test worldwide, but sensitivity for CRC ranges between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced adenomas is disturbingly low (39%-57%).

The aim of this study is to evaluate the diagnostic accuracy of the AeonoseTM to distuinguish people with CRC from healthy controls.

Rationale: An electronic nose (eNose) is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. Exhaled human breath is mainly composed of inorganic compounds, inert gases and VOCs. VOCs are exhaled in very low concentrations and reflect pathological processes such as inflammation, oxidation, infection and neoplasms. The perspective is that metabolic and biochemical processes in several pathological situations cause different endogenous VOCs to arise, were they can serve as non-invasive biomarkers for certain diseases.

Primary objective: To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with colorectal cancer from healthy controls using the previously established breathing pattern.

Secondary objecitves:

* To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with polyps (e.g. advanced adenomas, sessile serrated lesions).
* To determine the influence of colonic cleansing (laxative use) on breathing patterns.

Study population: Adult patients referred for colonoscopy.

Estimated sample size: 66 patients with CRC.

Intervention: Participants will be asked to breath through the AeonoseTM for 5 minutes. There are no risks, nor benefits for the participants.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy

Exclusion Criteria:

* Subjects with other known malignancies
* Subjects with established inflammatory bowel disease