cyrilzakka/clinical-trials huggingface dataset:
Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome

The objective of study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

The embryo implantation rate in assisted reproduction procedures is 20%, which leads to a low clinical pregnancy rate (35%), and even lower live birth rate (25%), per cycle started. Low embryo quality, poor endometrial receptivity, difficulties during the blastocyst hatching process are frequently denoted as the main reasons for the low implantation rate in humans.

The artificial rupture or thinning of the zona pellucida before embryo transfer-assisted hatching (AH)-has been proposed to foster spontaneous hatching and improve embryo implantation rates. Despite great effort, the clinical relevance of AH remains controversial and elusive.

There is a great importance of AH during frozen embryo cycles. Due to previous studies there is no precise answer about the value of AH performed on cryopreserved-thawed embryos. As far as is known, there is no clinical data to indicate the effects of AH on vitrified-warmed embryo transfer.

The objective of this prospective study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.

Eligibility criteria: women age 18-42, cleavage-stage embryo transfer, less than seven IVF cycles with fresh embryo transfer, high quality embryos.

Procedure: mechanical Assisted Hatching

Primary Outcome: delivery rate Secondary Outcome: implantation rate, pregnancy rate and delivery rate.

Eligibility Criteria:
Inclusion Criteria:

* women age 18-42,
* cleavage-stage embryo transfer,
* less than seven IVF cycles with fresh embryo transfer,
* high quality embryos.

Exclusion Criteria:

* out of 18-42 y.o.
* blastocyst embryo transfer
* more or equal to seven IVF cycles with fresh embryo transfer
* low quality embryos
Evaluation of Treatment of Fractures of the Humerus With a Plate.

The purpose of this study is to study with the use of clinical and radiological parameters the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device (Fischer Medical).

We shall measure the following clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):

1. Pain
2. Activities of Daily Living (ADL)
3. Range of Motion (ROM)
4. Muscle strength

We shall measure the following radiologic parameters:

1. Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
2. Plate migration with use of MB-RSA
3. Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
4. Correlation between bone density and prosthesis migration (and tuberculum migration)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with three-part and four-part proximal humeral fractures
2. Aged 50 years or older and fit
3. Informed, written consent
4. A functioning shoulder preoperatively -

Exclusion Criteria:

1. Patients found unsuitable preoperatively for a shoulder Philos Plate
2. Patients aged 85 or older
3. Patients with rheumatoid arthritis
4. Patients who previously had undergone shoulder plastic or other major shoulder surgery
5. Patients unable to avoid NSAID after surgery
6. Patients requiring regular systemic steroid treatment
7. Female patients taking hormone substitution
8. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
9. Patients with metabolic bone disease -
Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy

The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent.

Secondary purposes are:

* To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences defined in primary purpose
* To evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (LVEF often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (LVEF often normal).

Cardiac angioscintigraphy is an examination for a simple, precise and reproducible measurement of left ventricular ejection fraction (LVEF). It needs injection of 99mTc labeled albumin or red cells and unfortunately injected activities must be relatively considerable (≈ 900 MBq) for image recording times shorter than 10 minutes. This examination is thus quite irradiant (10 mSv) but this inconvenient could be eliminated with new semiconductor cameras.

These new cameras allow a better image quality than conventional Anger cameras (better spatial resolution and energy) and their detection sensitivity is almost 10 times higher. However, these new cameras can record only 3D images whereas with conventional cameras angioscintigraphy is usually performed in bidimensional way with a possible higher precision and reproducibility of LVEF measurement.

In this study, patients needing the routine examination for LVEF measurements will undergo the conventional examination followed by examination with semiconductor camera (without supplementary injection).

If LVEF measurement with semiconductor camera will be as precise and reproducible as with conventional camera, angioscintigraphy could be performed with these new cameras with a lower body irradiation of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients present in Nuclear Medicine department for measurement of LVEF by cardiac angioscintigraphy for known or suspected cardiomyopathy or for a chemotherapy supervision with heart initially considered healthy
* Without guardianship, signed informed consent
* Not in life-and-death emergency and with a stable clinical state
* Affiliated to social security
* Preliminary medical examination

Exclusion Criteria:

* Patients having rhythm disorders (atrial or ventricular extrasystoles in more than 20% cardiac cycles, atrial fibrillation)
* Incapable to stay in strict decubitus position during image recording times
* Pregnant or breastfeeding women
Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder

The efficacy of cognitive behavioral therapy(CBT) in treatment of methamphetamine use disorder

Methamphetamine (MA) use is a serious public health concern in many countries and is second to cannabis as the most widely abused illicit drug in the world.

Over the past few years; there is an alarming increase in crystal methamphetamine (Shabu) abuse in the Egyptian market and The Egyptian government is annoyed from this issue because youth within the age of productivity were targeted.

Regular methamphetamine use can be associated with a range of psychiatric symptoms, particularly psychosis, anxiety, and depression.

No FDA approved pharmacological treatments are available for Meth addiction up till now and despite great advances achieved in understanding the neurobiology of drug addiction, the therapeutic options are severely limited . Consequently, the only available treatment at present is psychosocial intervention.

The effectiveness of CBT for other substance-use disorders (e.g. alcohol-, opioid- and cocaine-use disorders) has been well documented and as such this basic treatment approach has been applied to amphetamine-type stimulant (ATS)-use disorder .

Currently, there is not enough evidence to establish the efficacy of CBT for amphetamine -type stimulant( ATS) -use disorders because of a paucity of high-quality research in this area.

The present study will examine the efficacy of Cognitive behavioral therapy in reducing methamphetamine use in comparison to medical treatment usually taken in methamphetamine use disorder

Eligibility Criteria:
Inclusion Criteria:

* patients who meet the criteria for methamphetamine use disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) (10)
* aged of 15-49 years' old
* more than 9 year of education
* urine drug screening positive for methamphetamine

Exclusion Criteria:

* other Axis I disorder of DSM-V criteria such as bipolar disorder, schizophrenia, depression
* Had a legal case pending resulting in inability to commit to 12 weeks of treatment.
* Refusal to participate
* poly drug dependence.
Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method

Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged 18 years of age and older as demonstrated by selfreported medical history, concurrent medication, and a brief dermal skin assessment of the test sites;
2. Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information;
3. Subject has normal healthy skin on the either volar forearm.

Exclusion Criteria:

Subjects must be excluded if any of the following conditions exist:

1. Self-reported pregnant or nursing at the screening visit;
2. Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
3. History of drug abuse or current drug user;
4. Treatment with antihistamine or steroid (any route) administered within the last 7 days;
5. History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax);
6. Persistent severe/ unstable asthma;
7. Subjects on beta blockers and/or ACE inhibitors;
8. Medical condition which in the opinion of the Investigator would compromise the safety of the subject or confound study results (Subjects with the following conditions: chronic renal failure, CVA, cancer, spinal cord injury, diabetic neuropathy, recent anaphylaxis, limbs affected by lymphoedema, paralysis, or neurogenic abnormalities;
9. Diabetic (type 1 or 2);
10. Subjects taking the following: Antidepressants such as doxepin, other tricyclics, Phenothiazines, and tetracyclics within the last two weeks;
11. Subjects taking OTC cold and flu remedies, "sinus" analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen);
12. Prolonged use of topical corticosteroids;
13. Use of topical moisturizers on the volar forearms;
14. Dermographism "writing on the skin" - common localized hive reaction, characterized by the abrupt onset of welts and hives where the skin is exposed to pressure, scratching, itching, or stroking;
15. Investigator deems the subject an unsuitable candidate for this study.
A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects

The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.


Eligibility Criteria:
Eligibility Criteria:

Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.
A Study of Cerebral Perfusion with TDCS in Chronic Hypoperfusion

This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow which may provide a clinical benefit such as improving cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Vasculopathy leading to imaging evidence of hypoperfusion
* Cognitive impairment

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI or tDCS including metallic implanted objects.
* Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
Prevention of Post-traumatic Seizures With Levetiracetam

Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years old
2. Patient with severe brain injury defined as follow:

   * Initial Glasgow Coma score (assessed on the scene of the accident) \<= 8 related to the brain injury
   * Stage 2 to 4 on the TDM US TCDB classification
3. Initial brain CT scan performed within 48 hours after hospital admission
4. Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline)
5. Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure

Exclusion Criteria:

1. Isolated extradural hematoma
2. Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.)
3. Current participation in an other protocol or within one month before study entry
4. Previous treatment with Levetiracetam
5. Patient's follow-up judged to be difficult by the investigator
6. Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients
7. Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
Risk Factors for Shoulder Pain and Emesis After Laparoscopic Cholecystectomy

Risk factors for postoperative shoulder pain after laparoscopic cholecystectomy were not clear. Moreover, risk factors for postoperative emesis specially for this surgery were not detailed and accurate. The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

The present study is a prospective cohort study to identify risk factors for shoulder pain and emesis within 24 hours in Chinese patients after laparoscopic cholecystectomy under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* \> 21 years old,
* Chinese patient

Exclusion Criteria:

* current pregnancy,
* patients with history of upper laparotomy,
* inability to communicate before operation,
* persistent emesis or shoulder pain before operation,
* patients who converted to open cholecystectomy,
* receiving postoperative ventilator support,
* unstable postoperative condition or major complications.
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
* The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
* FEV1 between 60 and 90% predicted at visit 1
* No change in asthma treatment within 4 weeks prior to visit 1

Main Exclusion Criteria:

* Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
* Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
* A history of lower airway infection in the four weeks prior to visit 1
* A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
* Heavy smoker currently smoking \>20 cigarettes per day and/or \>10 pack years or the patient is an ex-smoker who has smoked \>10 pack years
* Patients using \>8 puffs/day relief medication regularly prior to visit 1
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
* Patients with chronic heart failure class III or IV (New York Heart Association)
* Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
* A history of alcoholism or substance abuse within the 12 months prior to visit 1
* Pregnancy or women of childbearing potential who are not using a reliable method of contraception
Enhance of Language Learning with Neurostimulation

The purpose of this study is to test the effect of transcranial direct current stimulation over the motor cortex of the language dominant hemisphere on language learning in healthy subjects and stroke patients with aphasia. We hypothesize that anodal stimulation enhances the learning of action words compared to sham and cathodal stimulation.

The motor cortex is involved at different levels of language processing. It has been demonstrated that the perception of action words activates motor representations in the language-dominant hemisphere. However, it is not known whether modulation of excitability has an effect on learning new action words. Thus, we hypothesize that transcranial direct current stimulation over the motor cortex of the language-dominant hemiphere modulates the acquisition of new action words. The results bear the potential to design new rehabilitative strategies in stroke patients with aphasia. The motor cortex might offer an access to the language network that can be used for interventional approaches such as neurostimulation.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 and \< 86 years
* contractual capability
* ischemic stroke excluding motor cortex (stroke patients)
* minimum time since stroke 9 months
* aphasia (stroke patients)
* severe aphasia that impedes understanding of instructions (stroke patients)

Exclusion Criteria:

* sever head trauma in the past
* seizures
* pace maker
* metal implants in the head/neck region
* severe comorbidity, especially neurologic and psychiatric diseases
* intake of illegal drugs
* Mini Mental State examination score \< 27
* neuroactive substances, e.g. antidepressants
* pregnancy
Whey Protein and Carbohydrates in ERAS for Recovery After Thyroidectomy: A Cohort Study

Exploring the effects of whey protein combined with carbohydrates in an Enhanced Recovery After Surgery (ERAS) protocol on the postoperative recovery of thyroid cancer patients undergoing lateral neck dissection, aiming to provide more precise research and guidance for the perioperative accelerated recovery plan in such patients. The goal is to accelerate postoperative recovery and reduce postoperative complications for thyroid cancer patients undergoing neck dissection.

Perioperative dietary management was differentiated between the two groups:

Experimental Group:

6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal).

2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal).

After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery.

Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.

Control Group:

Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery.

Discharge Criteria: The discharge time was determined by the surgeon based on the patient's postoperative drainage condition and the presence or absence of complications.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older;
* Differentiated thyroid cancer with lateral lymph node dissection;
* Written informed consent provided by the participant.

Exclusion Criteria:

* History of chronic liver or kidney disease, ischemic heart disease, or diabetes;
* Previous neck surgery or history of iodine-131 radiation;
* Allergy to soy or whey protein;
* Intraoperative chylous leak;
* Other special types of thyroid cancer.
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide

To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
* Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).

Exclusion Criteria:

* Clinically relevant ophthalmic or systemic conditions may be excluded.