cyrilzakka/clinical-trials huggingface dataset:
Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl \[Cidophage®; Chemical Industries Development(CID), Cairo, Egypt\], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.

Eligibility Criteria:
Inclusion Criteria:

* CC resistant PCOS

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors
Knee Injury Decision

At this time, there is no standardization for knee trauma care in children. Each physician is free to resort or not to radiography to verify or dispel bone fracture, depending on radiographic device availability. This decision is based on trauma severity, clinical features, and physician experience.

Knee traumatisms are a common reason of consultation. In emergency departments, radiographic use is widespread for those traumatisms, but not in private practice.

Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no details. Yet, radiography exposes bone fracture which may require a specific orthopaedic care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in order to identify severe knee traumatisms, requiring radiography to assess bone fracture.

Those criteria should have a sensibility close to 1, and the highest specificity. Such criteria could significantly decrease the number of radiography thus irradiation, emergencies waiting time, and consultation expenses without missing bone fracture.

Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both immediately and in the emergency department. Presence of one of those criteria required front and profile radiography to assess bone fracture.

However, few studies have been conducted among children, and they do not confirm the use of those criteria targeting fracture screening. Data are contradictory and they do not allow concluding that such criteria could be of benefit for children. Moreover, studies only consider adults clinical criteria. This study would be the first to implement specific paediatric criteria, which make this study original.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 1 to 17 years old included
* Knee traumatism (distal third of femur and proximal third of tibia/fibula)
* Traumatism not older than 7 days

Exclusion Criteria:

* Isolated knee wound
* Loss of awareness
* Paraplegia
Double-blind, Randomised Study of A3384 in BAM/BAD

The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).


Eligibility Criteria:
Inclusion Criteria:

* Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea
* Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable

Exclusion Criteria:

* Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
* Patient needs medications prohibited as specified in the protocol
Clinical Performance of Advanced Self- Adhesivee Resin Composite Hybrid Restorations.

Clinical performance according to modified USPHS criteria of advanced self-Adhesive resin composite hybrid restorations is evaluated for 1 year versus conventional resin composite restorations in posterior teeth.


Eligibility Criteria:
Inclusion Criteria:

* Patients with carious proximal cavities in molars
* Good oral hygiene.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Severe periodontal problems.
Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Primary diagnosis of Major Depressive Disorder (MDD)
* Completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)
* Hamilton Rating Scale for Depression, 17-item (HRSD17) score less than or equal to 14 and/or Clinical Global Impression - Severity (CGI-S) score less than or equal to 3
* Self-reported difficulties with cognition and/or concentration, and an Inventory for Depressive Symptomatology Clinician-Rated, 30-item (IDS-C30) item #16 (Concentration and Decision Making) score less than or equal to 2
* Ability to read and write in English (required because instructions for cognitive testing and several questionnaires are available only in English)

Exclusion Criteria:

* Presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
* Presence of known cardiovascular disease or seizure disorder.
* Presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or Not Otherwise Specified \[NOS\]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)
* Presence of organic brain injury or dementia, based on a cutoff score of \< 20 on the Mini Mental Status Examination (MMSE).
* Concomitant pharmacological or psychotherapeutic treatment (in addition to one SSRI as described in Inclusion Criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
* Hospitalization for mental illness within the past year.
* For women, currently pregnant or planning to become pregnant in the next year.
Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)

The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury.

Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established in either the acute or post acute setting. Citicoline is a naturally occurring endogenous compound. This compound offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery after TBI.

The primary goal of this study is to assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

1. Non-penetrating traumatic brain injury.
2. Age 18 (19 in Alabama) - 70 years.
3. GCS criteria on/off paralytics as specified in protocol
4. Reasonable expectation of completion of outcomes measures at a network center at six months post-injury.
5. Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury.
6. Reasonable expectation of enrollment within 24-hour time window.
7. English-speaking

Exclusion Criteria:

1. Intubated patients with GCS motor score = 6 and not meeting CT criteria.
2. Bilaterally fixed and dilated pupils
3. Positive pregnancy test, known pregnancy, or currently breast feeding
4. Evidence of diseases that interfere with outcome assessment
5. Current acetylcholinesterase inhibitor use (Appendix 1)
6. Imminent death or current life-threatening disease
7. Currently enrolled in another study
8. Prisoners
Red Blood Cell ATP Release and Vascular Function in Humans

Previous work demonstrates that the red blood cells of older adults do not release a potent vasodilator (ATP) as well as the red blood cells of younger adults. The investigators are targeting a pathway within the red blood cell using fasudil hydrochloride to determine if both the release of ATP from red blood cells and blood flow responses to low oxygen (hypoxia) and exercise in older adults can be improved.

Participants will initiate contact with the investigators by responding to flyers placed in the community either by phone or email. The first correspondence (phone or email) will provide a brief description of the research and ask a series of screening questions to determine age, height, weight, and any medications participants may be taking as well as the current health status (diagnoses, basic health history, and physical activity level) of participants. If they qualify, a two hour screening visit is scheduled during a time when the participant will be examined by the physician. All participants will undergo informed consent in a face to face private meeting with the research coordinator. Following informed consent, participants will be evaluated by a physician and undergo a treadmill stress test to rule out cardiovascular disease.

During the study, heart rate will be monitored with a 3-lead ECG and blood pressure will be monitored noninvasively with a blood pressure cuff on the finger (finometry). Venous blood will be collected at multiple time points via a catheter inserted into a forearm vein draining skeletal muscle circulation for measurement of blood gases (0.5 mL/sample) and plasma \[ATP\] (2 mL/sample), with less than 100 mL of blood being drawn in total (\~60mL total). Blood flow at rest and in response to hypoxia and exercise will be measured non-invasively using Doppler ultrasound of the brachial artery. Hypoxia trials will be performed by having participants breathe a low oxygen gas mixture via a mouthpiece that is hooked up to gas tanks and an anesthesia monitor to decrease their oxygen saturation to \~80% (similar to hiking a 14er) for 10 minutes. Exercise trials will last for approximately 15 minutes and will involve participants performing graded-intensity rhythmic handgrip exercise by lifting weights (corresponding to a low, moderate, and high workload) using a pulley system. The drug treatment used in this study (fasudil) is being given because it may improve red blood cell ATP release in older adults. This is a double-blinded placebo controlled study, thus participation will occur on two randomized experimental days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Sedentary to moderately active
* 18 to 30 years old for young subjects
* 60 to 80 years old for older subjects

Exclusion Criteria:

* Obesity (BMI ≥ 30 kg/m\^2)
* Cardiovascular disease
* Metabolic disease
* Use of medications that can influence cardiovascular function
* Blood pressure greater than or equal to 140/90
* Smoker
* Use of hormone replacement therapy
The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women

the effect of acupressure on labor pain and anxiety levels during labor in primiparas women


Eligibility Criteria:
Inclusion Criteria:

* Primiparas women aged from 20 to 30 years old,
* gestational age of between 37 and 40 weeks according to ultrasonography.
* A fetal weight of between 2500 and 3500 g according to ultrasonography or clinical examination .
* They are transferred to labor room if active labor is in progress (defined as cervical dilatation 3 cm and the presence of regular uterine contraction,
* having a single and healthy fetus in the vertex position

Exclusion Criteria:

* who were needing an emergency C-section.
* Women having a current or previous high-risk pregnancy
* who have experienced pregnancy complications
* Women with a systemic disease during pregnancy . Women with a psychological disorder
Efficacy of Early Multimodal Physiotherapy in Patients with Reverse Shoulder Prosthesis

The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.

Background: Shoulder fractures, shoulder osteoarthritis and rheumatoid arthritis have a high prevalence and many times they require a surgery, in which a reverse shoulder phrostesis is colocated. Nonetheless, nowadays there is no a clear consensus protocol in order to manage the prehabilitation and rehabilitation of this patient, so each physiotherapist use different techniques to treat this pathology.

Objective: This study aims to evaluate the effectiveness of an original intervention program (REMOVE program) focused on an early intervention based on therapeutic exercise, manual therapy and education to improve the functionality of these patients after surgery.

Methods: This study is a randomized controlled trial with parallel groups. The control group receive standard care, and the experimental group is subjected to the REMOVE program. Both groups are evaluated five times, pre-surgery, at baseline, at 6 weeks, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults with a reverse shoulder prosthesis.
* Age between 18 and 90 years.
* Signed informed consent.

Exclusion Criteria:

* Language or cultural barriers.
* Other upper limb injury.
* Treatment that affect physical activity capacity.
Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction

The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.

The prospective, randomized, controlled study involves the enrollment of cataract patients with corneal endothelial dysfunction. All the patients will be randomly assigned with equal probability to the following two groups: 1. Staged group: phacoemulsification + IOL implantation is performed individually and DMEK is performed secondarily according to the corneal status of patients. During cataract surgery, viscoelastic materials and anterior lens capsule are used to protect the compromised corneal endothelium during phacoemulsification. After phacoemulsification and removal of all the lens material, a one-piece foldable IOL is implanted into the lens capsule. 2: Combined group: phacoemulsification + IOL implantation and DMEK is performed simultaneously. Standard procedures of phacoemulsification + IOL implantation are the same as in the staged group.

Patients enrolled into the study will be followed for one year and will have study visits at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects are older than 18 years.
2. Subjects have corneal endothelial dysfunction combined with cataract.
3. Subjects have mild to moderate cortical and/or nuclear cataract.
4. Subjects are able and willing to provide informed consent.

Exclusion Criteria:

1. Subjects have corneal stromal opacity and/or neovascularization.
2. Subjects have other intraocular disease that disturbs visual rehabilitation.
3. Subjects have corneal infection, perforation or scarring.
4. Subjects are pregnant.
5. Subjects have concurrent disease that could confound the response to therapy.
6. Subjects are unlikely to comply with the protocol or likely to be lost to follow-up.
7. Subjects have known hypersensitivity or intolerance to the proposed therapy.
8. Subjects use concomitant therapy that affects either tear function or ocular surface integrity.
9. Subjects have had surgical or other manipulation of the eye that could confound the outcome parameters or interfere with the mechanism of action of the proposed intervention to be studied.
The Progression From Dysmenorrhoea to Chronic Pelvic Pain

This is a cross-sectional observational study.

For participants resident in Adelaide, South Australia.

The study consists of 3 visits to the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH).

A total of 56 participants will be recruited for this study.

The study will involve a screening visit followed by two visits to PARC for blood sampling and questionnaires.

At the baseline visit, blood samples to assess biomarkers and confirm hormonal status will be taken.

From screening until the final study visit a total of approximately 120 mL in blood samples will be taken from each participant.

The study aims to further knowledge in the presence of severe pelvic pain in young women which is an area that has been under-researched with regard to it's impact on society.

The study proposes to enroll 7 groups of 8 healthy nulliparous women aged 18-35 with the following characteristics:

Mild or absent dysmenorrhoea (pain scale 0-3) and no other pelvic pain symptoms. (3 groups)

* Group 1, without contraceptive pill use
* Group 2A , contraceptive pill user and with a history of mild or absent dysmenorrhoea prior to pill use
* Group 2B, contraceptive pill user and with a history of severe dysmenorrhoea (pain scale 7-10) prior to pill use

Severe dysmenorrhoea (pain scale 7-10), but without chronic pelvic pain. (2 groups)

* Group 3, without contraceptive pill use
* Group 4, contraceptive pill user

Chronic pelvic pain and severe dysmenorrhoea (2 groups)

* Group 5, without contraceptive pill use
* Group 6,contraceptive pill user

Eligibility Criteria:
Inclusion Criteria:

* Age between 16 to 35 years old

Exclusion Criteria:

* Irregular menstrual cycles
* Use of any reproductive hormonal preparations (other than the combined oral contraceptive pill), thyroxine, insulin or corticosteroids
* Presence of an inflammatory process, or clinically significant infection in the 4 weeks
* Clinically significant renal, hepatic, cardiac, auto-immune disease
* Current use of immunosuppressant medication such as hydroxychloroquine, methotrexate or azathioprine
* Inability to read or comprehend the written information provided
* Current use of medications known to affect TLR responsiveness including amitriptyline or minocycline
* Current use of any analgesics, including non-steroidal anti-inflammatory medications and opioids for 5 drug half-lives prior to the day of testing
* Current or previous pregnancy
* Body Mass index less than 18 or more than 30
Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

OBJECTIVES:

* To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
* To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.

OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with Wilms tumor
* Specimens from African-American and from Caucasian children
* Specimens from each ethnicity who relapsed
* Specimens from each ethnicity who did NOT relapse

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups

Twenty-four patients participated in the study. Patients received direct composite build-ups for diastema closure.

The restorations were performed separately by grounding and ungrounding the enamel on the proximal surfaces in symmetrical teeth.

Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene, no periodontal or pulpal disease, interarch tooth size discrepancies (Bolton discrepancy) after orthodontic treatment

Exclusion Criteria:

* uncontrollable parafunctions, insufficient or poor oral hygiene, periodontal or gingival disease