cyrilzakka/clinical-trials huggingface dataset:
Comparison of Progestin Primed Ovarian Stimulation (PPOS) vs.GnRH Antagonist Methods on IVF Outcomes

The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.

The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.

Ovarian stimulation will be conducted according to the assigned arm protocol.

Both artificially prepared and modified natural cycles will be eligible to be included and the choice will be done according to the doctor's preference and the patient's menstrual cycle regularity.

* For artificially prepared transfers, Estradiol Hemihydrate (Estrofem©, 2mg, Novo Nordisk, Malov/Denmark) 3x1 PO will be started on the day 2 of the menstrual cycle. After 12-14 days of usage, in order not to cancel the cycle, endometrial thickness needs measured at least 7mm and serum progesterone level \< 1.5 ng/mL.
* For luteal support in addition to Progesterone (Progestan Dex©, 25mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 SC once, with a 12-hour interval at day 14 of the menstrual cycle; Progesterone (Progestan©, 200mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 PV will be started and continued for 5 days. Embryo transfer will be performed at 6th day. Estradiol Hemihydrate will be stopped on week 2 and progesterone support will be continued until the 8th week of gestation.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 18 kg/m2 ve \<35 kg/m2
* Couples that accept being included in the study
* Couple accepting thawed embryo transfer

Exclusion Criteria:

* Known chromosomal abnormality in either member of the couple
* Couples with unexplained infertility
* BMI \> 30 kg/m2
* Mullerian malformations
* Undergoing oocyte cryopreservation for medical reasons (such as malignancies)
* Couple insists on fresh embryo transfer
Creation and Setting up of Therapeutic Programs, Interprofessional Communication, Patients' Education and Counseling

The purpose of this study is to suggest system for improving patients' management through a detail analysis of physical therapy departments functioning

First phase:

* Description of the actual patients' management through individual semi directive interviews and focus groups of health professionals, patients, and members of the hospital directory departments.
* Identification of barriers

Second phase: suggestion of system for improving patients' management

Eligibility Criteria:
Inclusion Criteria:

* For doctors: affiliation to physical therapy and rehabilitation departments, age, career and function
* For other health professionals: affiliation to physical therapy and rehabilitation departments, service length, age, gender
* For patients: age, gender and therapeutic programs

Exclusion Criteria:

- Persons not wishing to participate
Expressed Beliefs About the Cause of Pain in a Paediatric Population

The aims of this study are to explore what beliefs children and adolescents manifest about the cause of the pain they describe; to compare whether if there are differences between beliefs by age and by persistence of pain; and to relate explanations of the cause of pain with current scientific evidence to determine if these beliefs are erroneous.

Design:

Mixed (explanatory sequential). The primary endpoint of the study were explanations of the cause of pain recorded by means of an open-ended question.

Setting:

The participants were school-age children attending a charted school in the province of Barcelona.

Participants:

Of the 345 potential school participants, 306 agreed to participate. 36 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 270.

Eligibility Criteria:
Inclusion Criteria:

* to be schooled at the El Cim school
* to be between 10 and 16 years old (both included)
* to have or have had pain in the last month; to be able to read and write in Catalan and/or Spanish.

Exclusion Criteria:

* had an intellectual disability and/or cognitive impairment that interfered with their participation
* had not submitted the informed consent form duly completed and signed by their legal guardians
A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata

The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Two randomized controlled trials exist assessing topical steroid efficacy in this disorder, both have methodological limitations. The question remains as to which topical steroid is safe and efficacious for use. We performed a double blinded controlled trial to assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.


Eligibility Criteria:
Inclusion Criteria:

* Age 2 to 16 years
* New patients presenting to The Hospital for Sick Children
* Clinical confirmation of alopecia areata
* Hair loss between 10 -75%

Exclusion Criteria:

* Skin or medical problems requiring use of oral steroids
* Immunosuppressants or PUVA for 4 weeks prior to the study
* Use of inhaled and or intranasal steroids for 14 days prior to trial
* Topical medicaments for 7 days prior to the trial
Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation

Vascular and skeletal muscle function decline with age and are associated with decreased nitric oxide (NO) bioavailability. Dietary nitrate supplementation in the form of beet root juice increases NO bioavailability and improves exercise tolerance in younger adults, yet its effects on fatigability in older adults are largely unknown. The proposed research will investigate the impact of increased NO bioavailability on vascular function, skeletal muscle bioenergetics, and fatigability in older (≥65 yrs) men and women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women ≥ 60 years old

Exclusion Criteria:

1. body mass index ≥40 kg/m2;
2. type 1 or type 2 diabetes or HbA1c \>6.5%
3. uncontrolled hypertension;
4. active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years;
5. coronary artery disease;
6. cardiovascular disease (e.g., PAD, PVD);
7. abnormal and untreated thyroid function;
8. chronic and/or regular nonsteroidal anti-inflammatory drugs (NSAID) consumption,
9. tobacco use (includes smoking);
10. any condition that presents a limitation to exercise (e.g., severe arthritis, COPD, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's Disease, severe untreated sleep apnea).
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Drug-eluting transcatheter arterial embolization (dTACE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The anti-VEGF combined programmed cell death protein-1 legend 1 (PD-L1) inhibitor were effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy (dTACE/HAIC) combined with Bevacizumab and Atezolizumab inhibitor in patients with huge hepatocellular carcinoma who can not receive radical therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
9. Prothrombin time ≤18s or international normalized ratio \< 1.7.
10. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. Diffuse HCC;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
7. Eastern Cooperative Group performance status (ECOG) score of ≥2;
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Interaction Between ABT-335, Rosuvastatin and Warfarin

This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) is 19 to 29, inclusive.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Written informed consent prior to the initiation of screening or study-specific procedures.

Exclusion Criteria:

* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
* Subjects taking concomitant medications.
* Subjects with a recent history of surgery or trauma.
* Subjects with a history of any bleeding disorder.
Reliability of Pachymetry Measurement With FD-oCT, ORA, Confoscan 4 and Ultrasound

The purpose of this study is to assess the repeatability, reproducibility, and agreement of central corneal thickness measured by Fourier Domain Optical Coherence tomography (FD-OCT, OptoVue, USA) with anterior corneal module, 20MHz ultrasound pachymetry equipped with Ocular response analyzer (ORA, Reichert Ophthalmic Instruments, USA) and 10MHz Ultrasound Pachymetry (USP).

Corneal thickness measurements are clinically important. Variation in corneal thickness affects the accuracy of applanation tonometry. A meta-analysis by Doughty and Zaman showed that a 10% change in central corneal thickness may result in an approximately 3.4-mmHg change in intraocular pressure.1 Accuracy of corneal thickness measurement is also important in considering eligibility for refractive surgery, and the amount of correction that can safely be performed. Underestimation of corneal thickness may lead to eligible patients being excluded for primary or enhancement refractive procedures. Overestimation may lead to over-ablation and inadvertent thinning of the stroma, thereby increasing the risk of iatrogenic keratectasia. Hence, studies assessing corneal thickness measurements by various instruments are of high clinical relevance.2-9 Fourier domain optical coherence tomography (FD-OCT, OptoVue, U.S.A), Confoscan 4 (CS-4, Nidek, USA) and ocular response analyzer (ORA, Reichert, USA) are non-invasive medical devices that have recently received FDA approval for measurement of the cornea thickness. However, the repeatability and reproducibility of these instruments remains unproven in the clinical settings. To our knowledge, this is the first study to describe agreement, repeatability and reproducibility in corneal pachymetric mapping between FD-OCT, ORA, CS-4 and conventional ultrasound (US), which has been the current reference corneal pachymetric mapping system for the majority of refractive surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* Patients who had history of prior ocular surgery, ocular abnormalities other than cataract or refractive error or were unable to cooperate in the examination were excluded.
Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy

To evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy.

This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy. The intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-IC GTV group) or post-induction chemotherapy tumor extension (the post-IC GTV group). The objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* histologic confirmation of nonkeratinizing nasopharyngeal carcinoma; no previous treatment for cancer; nondistant metastatic, newly diagnosed stage III to IVa disease that was staged according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); planned to receive 3 cycles of Induction Chemotherapy (regimens included docetaxel and cisplatin; docetaxel, cisplatin, and fluorouracil; and gemcitabine and cisplatin); and adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

* younger than 18 years or elder than 70 years; receipt of treatment with palliative intent; a history of cancer; receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx or neck; lactation or pregnancy; or severe coexisting illness; had disease progress after IC
Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Functional dyspepsia is a very common disorder of great challenge to clinical management. A therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct current stimulation (tDCS) is a novel therapy that pursues these properties, besides its safety and easy adherence. There is a great need of new treatments for functional dyspepsia. There is no current study evaluating tDCS for this disease.

Functional dyspepsia is a high prevalent disease with substantial costs to health system. There are many available treatments, but disappointing results are reported in clinical trials.

TDCS is a noninvasive, secure and painless technique of brain stimulation. It is delivered by a battery-operated device that transfers low intensity electrical current to all surface of the brain. Then there is a modulation of cortical excitability and influence on central neurological functions. It has been reported its efficacy for the treatment of many diseases such as depression and chronic pain.

Impairment of central mechanisms of interpretation and threshold of pain are related to functional dyspepsia. Therefore, tDCS may benefit dyspeptic patients.

This study is a double blind randomized controled trial to test tDCS effectiveness on functional dyspepsia. Seventy functional dyspeptic patients will be enrolled, being randomized to either tDCS or sham tDCS.

Eligibility Criteria:
Inclusion Criteria:

* functional dyspeptic patients according to Rome IV criteria
* clinical investigation reporting absence of organic causes of functional dyspepsia

Exclusion Criteria

* history of brain trauma, haemorrhage or ischemia
* implantable devices such as pacemaker
* alcohol or drug abuse
* epilepsy
* severe chronic disease
* non-acceptance to sign up the term of consent.
The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest

Median nerve stimulation (MNS), a non-invasive brain stimulation technique, has been widely adopted in clinical arousal therapies and multiple clinical investigations have attested to the efficacy of this technique; nevertheless, evidence concerning the application of MNS in improving the neurological prognosis of patients with return of spontaneous circulation (ROSC) following cardiac arrest (CA) remains scarce. The current study endeavors to assess the safety and efficacy of MNS treatment in enhancing the neurological prognosis of CA patients after ROSC and it is designed as a multicenter, prospective, randomized controlled trial with an estimated sample size of 400 patients. Eligible patients will be randomly allocated in a 1:1 ratio to either receive MNS treatment or sham stimulation treatment for 8 hours per day for 14 consecutive days and the primary outcome measure is the proportion of patients in each group with a Cerebral Performance Category (CPC) score ranging from 1 to 2, 6 months after randomization, which will help to determine the effectiveness of MNS in providing neuroprotection for patients with ROSC after CA.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Hemodynamics remains continuously stable for ≥ 7 days.
3. There is still a lack of purposeful movements after the return of spontaneous circulation following cardiopulmonary resuscitation.
4. Advanced life support is provided within 6 hours after the return of spontaneous circulation (ROSC).

Exclusion Criteria:

1. Patients with hemodynamic instability.
2. Pregnant patients.
3. Those who have abnormal anatomical structures on the median nerve conduction pathway and are unable to receive electrical stimulation.
4. Patients with a confirmed history of epilepsy before admission or during hospitalization.
5. Patients with severe arrhythmia or those who have pacemakers implanted.
6. Patients whose family members do not agree to their enrollment in the study.
Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions - 2

The purpose of the HD-SLEEP2 study is to help researchers understand sleep in African Americans. The investigators also want to know what factors may affect sleep.

African Americans who self-report poor sleep (n=80) will be invited to complete questionnaire based self-assessment of known factors and comorbidities contributing to alterations in sleep such as demographic characteristics, anthropometrics, depression, insomnia, and food habits in conjunction with objective and subjective measures of sleep via 7-day accelerometry (sleep duration), overnight oximetry (sleep apnea), and sleep questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American
* Age range: \>18 years (inclusive)
* Sex: Both males and females will be allowed to participate in the study
* Self-perceived poor sleep

Exclusion Criteria:

* Unable to provide written informed consent
* Unable to understand English
Effectiveness of Interdisciplinary Care Compared to Usual Care in Patients With Immune-Mediated Inflammatory Diseases

The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared to usual care in a population of patients with two or more Immune-mediated inflammatory diseases (IMIDs).

Immune-mediated inflammatory diseases (IMIDs) such as psoriasis, hidradenitis suppurative, spondyloarthritis, and inflammatory bowel disease, are associated with increased risk of somatic and psychiatric comorbidities as well as reduced socioeconomic status and a risk of further autoimmune diseases. The unmet needs in the care of patients with IMIDs are caused by a lack of patient-centricity in the usual specialized siloed approach to these diseases. The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared to usual care in a population of patients with the IMIDs: psoriasis, hidradenitis suppurativa, spondyloarthritis, ulcerative colitis, and Crohn's disease. This trial is designed to determine if the interdisciplinary intervention works in a real-world setting and thus has several pragmatic elements. The hypotheses will be tested in a randomized, usual care controlled, parallel-group clinical trial. Consecutively enrolled subjects are randomly assigned in a 2:1 ratio to either treatment in the interdisciplinary combined clinic or usual care in a hospital clinical setting. 300 subjects (anticipated) will be randomized to either multidisciplinary combined clinic intervention (200 subjects, anticipated) or usual care (100 subjects, anticipated). The study will consist of a 24-Week active intervention period and an additional 24-Weeks follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from the subject prior to randomization.
2. Age 18 and above.
3. Diagnosis of at least two IMIDs\* or diagnosis of one IMID and clinical suspicion\*\* of another IMID\*

   * including and limited to: Psoriasis, HS, UC, CD, axSpA, PsA \*\* substantiated by e.g. clinical findings, imaging, biochemical results or histological examination at the discretion of the investigator.

Exclusion Criteria:

1. Non-Danish speaking
2. Expected to be unable to comply with the study protocol
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy

The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.


Eligibility Criteria:
Inclusion Criteria:

* patients candidate for PRK, 17\<age\<70

Exclusion Criteria:

* use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding