louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02455154: Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy
Official title: Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Osteoporosis
Keywords: Chinese Traditional Medicine
Osteoporosis
adjuvant endocrine therapy
early breast cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 278
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Detailed description: Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive breast cancer;
* Post-surgery, primary lesion been removed;
* Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
* Histologically confirmed ER and/or PR positive ;
* Receiving adjuvant AIs therapy in the following one years;
* Leukocyte ≥ 3\*10(9)/L; Platelets ≥ 75\*10(9)/L;
* Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) \<2.5 times of upper limit of normal range;
* Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
* Written informed consent according to the local ethics committee equirements;

Exclusion Criteria:

* Metastatic Breast Cancer;
* Received Neo-Adjuvant Endocrine Therapy;
* History of pelvic fracture or bone metabolic disease;
* Received drugs interfering bone metabolism in the last 12 months;
* Baseline Bone Mineral Density: T \< -2SD;
* With other primary malignant disease;
* With severe non-malignant co-morbidity that will influence long-term follow up;
* Known severe hypersensitivity to any drugs in this study;

Primary outcomes:
measure: Change of Bone Mineral Density
timeFrame: 1 year
Secondary outcomes:
measure: Bone Frature Rate
timeFrame: 1 year
measure: Bone Metabolism
timeFrame: 1 year
measure: Disease Free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Kunwei Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05746754: Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Official title: Phase II Study of Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leptomeningeal Metastasis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

Brief summary: Leptomeningeal metastasis is a rare but serious complication to cancer, with a grave prognosis. No efficient treatment exists.

Recent data suggest that craniospinal radiotherapy lead to superior survival and CNS control compared to focal photon radiotherapy. We want to offer Danish patients the new treatment, but within a protocol, as this is new data with an new treatment principle

Detailed description: Patients must be referred from Danish Departments of Oncology with radiotherapy service.

Patients with leptomeningeal metastasis from both solid and hematological cancers will be offered proton radiotherapy with 30 Gy in 10 fractions to the entire craniospinal axis. Patients will be followed with registration of side effects, neurology and MRI scans every 3 months until 1 year.

Eligibility criteria: Inclusion Criteria:

* Metastasis to the leptomeningeal space (LM) surrounding the brain and/ or spinal cord
* Metastasis verified by MRI or CSF cytology
* Karnofsky \>=60 (requiring some help, can take care of most personal requirements)
* Adequate bone marrow function

  * Haemoglobin \> 5 mmol/l
  * Absolute neutrophil count \>1 10\^9/l
  * Platelet count \> 100 10\^9/l
* Patient consent
* Female subjects must either be of non-reproductive potential ( ≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a pregnancy test within 2 weeks prior to starting treatment.
* Patient at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

* • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)

  * Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
  * Patient with extensive systemic disease and without reasonable systemic treatment options
  * Patient who is unable to undergo MRI brain and spine with gadolinium contrast
  * Pregnant or lactating women.

Primary outcomes:
measure: CNS control
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 1 year
measure: CNS-PFS dependent on tumor site
timeFrame: 1 year
measure: Symptomatology
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Oncology, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT04966754: Data Driven Behavior Intervention and Medical Outcome Evaluation of Patients' Comprehensive Monitoring
Official title: Data Driven Behavior Intervention and Medical Outcome Evaluation of Patients' Comprehensive Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Metabolic Disturbance
Metabolic Complication
Infection
Obesity
Diabetes
Keywords: metabolic
diabetes
obesity
infection
complication
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Guangdong Provincial People's Hospital
name: Guangzhou Huyun Hospital Management Co., Ltd
First posted: 2021-07-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metabolic syndrome (obesity, diabetes, etc.) cause acute disease attacks (infection, diabetes complications, etc.).

Brief summary: During the study, the resuscitation room, general wards and ICU were installed fixed or mobile acquisition devices in the resuscitation room, the emergency department of Peking Union Medical College Hospital, and the collection platform was set up. Patients with acute diseases (infection, diabetes complications, etc.) caused by metabolic syndrome (obesity, diabetes, etc.) were selected after informed consent. All medical intervention behaviors, relevant medical records and medical outcome records within the collection scope of the device platform were collected prospectively . And regular follow-up, guidance of patients with metabolic syndrome control, while collecting all the lifestyle characteristics of patients, some patients with metabolic cabin research, and observe the relevant medical outcomes. After that, all the collected data were coded, and the influence of all lifestyle and medical behavior interventions on patients' medical outcomes was studied by artificial intelligence method.


Eligibility criteria: Inclusion Criteria:

* Diabetes and / or obesity (BMI\>=28).
* Emergency room / emergency ward / EICU;
* Be able to understand and agree the research protocol and sign the informed consent

Exclusion Criteria:

* Pregnant women / lactation period;
* The estimated survival time was less than 1 year;
* Long term follow-up is not guaranteed;
* Failure to comply with the protocol or procedure;
* The collection of medical behavior data can not complete the de privacy or label after de privacy;
* Other researchers think that it is not suitable for inclusion

Primary outcomes:
measure: Rate of metabolic complications
timeFrame: 6 weeks
measure: Complication control
timeFrame: 3 weeks
measure: Rate of mortality
timeFrame: 6 months
Secondary outcomes:
measure: Total cost of treatment
timeFrame: 3 weeks
measure: Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03977454: Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
Official title: Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Arthropathy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).

Detailed description: To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes:

Primary outcome: Daily opioid consumption

Secondary outcomes:

Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays.

Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection.

When results were entered, the detailed description was updated to reflect the outcome measures used in the study.

Eligibility criteria: Inclusion Criteria:

* Elective unilateral primary THA
* All surgical approaches
* American Society of Anesthesiologist (ASA) status I, II and III.

Exclusion Criteria:

* Patient refusal;
* Age less than 18 years
* Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team;
* Coagulopathy;

Primary outcomes:
measure: Daily Opioid Consumption
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Change in Pain Intensity While in Hospital
timeFrame: Up to 2 days
measure: Length of Stay
timeFrame: Up to 5 days
measure: Harris Hip Score
timeFrame: 2 weeks post operation
measure: Brief Pain Inventory: Interference
timeFrame: 2 weeks post operation
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital St Raphael
state: Connecticut
Study officials:
affiliation: Yale University
name: Jinlei Li, MD PhD FASA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04995354: Efficacy of EGF-loaded Self Healing Gel in Treatment of Oral Mucositis
Official title: Self Healing Gel as a Vehicle for Recombinant Human Epidermal Growth Factor in Treatment of Oral Mucositis Following Cancer Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Oral Mucositis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.


Eligibility criteria: Inclusion Criteria:

* Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.

Exclusion Criteria:

* Patients with hematologic malignancies or those with known allergic reactions to the drug.

Primary outcomes:
measure: The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
timeFrame: Baseline
measure: WHO grade of mucositis
timeFrame: Baseline
measure: The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
timeFrame: After 7 days of treatment
measure: WHO grade of mucositis
timeFrame: After 7 days of treatment
measure: The European Organization for Research and Treatment of Cancer Quality of Life questionnaire
timeFrame: After 14 days of treatment.
measure: WHO grade of mucositis
timeFrame: After 14 days of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer at the Faculty of Dentistry - Cairo University
name: Basma AA Zakaria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790554: Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting
Official title: Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome in Dar es Salaam, Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Monitoring
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2016-06-06
Enrollment: 2973
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, Tanzania.


Eligibility criteria: Inclusion Criteria:

* Women admitted in labor

Exclusion Criteria:

* Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission

Primary outcomes:
measure: Frequency of abnormal fetal heart rate detection
timeFrame: Up to delivery
Secondary outcomes:
measure: Mode of delivery: vaginal versus operative
timeFrame: Up to delivery
measure: Time interval from abnormal fetal heart rate detection to delivery in minutes
timeFrame: Up to delivery
measure: Neonatal outcome dead versus alive
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili National Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Hege L. Ersdal, Md PhD
role: STUDY_DIRECTOR
References:
citation: Kamala B, Kidanto H, Dalen I, Ngarina M, Abeid M, Perlman J, Ersdal H. Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania. Int J Environ Res Public Health. 2019 Jan 24;16(3):315. doi: 10.3390/ijerph16030315.
Clinical trial NCT02387554: Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405
Official title: A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension(HTN)
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2015-03-13
Enrollment: 33
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* 19\~45 years old
* Healthy men

Exclusion Criteria:

* Gastroentestinal disease affecting drug absorption

Primary outcomes:
measure: AUClast
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
measure: Cmax
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Secondary outcomes:
measure: AUCinf
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
measure: Tmax
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
measure: T1/2
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
measure: CL/F
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
measure: Vz/F
timeFrame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr
Other outcomes:
measure: Number of Paticipants With Adverse Events
timeFrame: 3 months
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT01169454: Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?
Official title: Ventriculostomy in SAH: ICP Open or Not?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Subarachnoid Hemorrhage
Keywords: Cerebral Spinal Fluid
Ventriculostomy
Subarachnoid hemorrhage
Vasospasm
Human Subjects
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2010-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subarachnoid hemorrhage

Brief summary: The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have ICP monitoring. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

Detailed description: Patients diagnosed with subarachnoid hemorrhage (SAH) who require intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage will be eligible for this study.

Subjects will be randomized to receive one of two currently accepted methods of ICP management. The first is ICP monitoring with intermittent CSF drainage and the second is through continuous CSF drainage at set pressure thresholds.

Eligibility criteria: Inclusion Criteria:

* Admitted to Duke University NCCU
* Adult (18 years of age or older)
* Primary diagnosis is Subarachnoid Hemorrhage
* Intraventricular catheter in situ

Exclusion Criteria:

* Glasgow Coma Score = 3
* Hunt and Hess Score = 5
* Prisoners
* Ventriculostomy \> 72 hours

Primary outcomes:
measure: Cerebral artery vasospasm
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: DaiWai M Olson, PhD RN CCRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olson DM, Zomorodi M, Britz GW, Zomorodi AR, Amato A, Graffagnino C. Continuous cerebral spinal fluid drainage associated with complications in patients admitted with subarachnoid hemorrhage. J Neurosurg. 2013 Oct;119(4):974-80. doi: 10.3171/2013.6.JNS122403. Epub 2013 Aug 20.
Clinical trial NCT03487354: Medical Abortion With Single Daily Dose of Misoprostol
Official title: Medical Abortion With Multiple vs Single Daily Dose of Misoprostol in First Trimester Miscarriage: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Miscarriage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.


Eligibility criteria: Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age less than 13 weeks.
* Hemoglobin \>10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Missed abortion.
* Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age more than 12 weeks.
* Hemoglobin \<10 g/dL.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25kg/m2 and more than 35kg/m2.
* Coagulopathy.
* History or evidence of adrenal pathology.
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Primary outcomes:
measure: Complete miscarriage
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References: