cyrilzakka/clinical-trials huggingface dataset:
Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure

Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment of thin endometrium or in women with recurrent implantation failure in ICSI cycles

Prospective analytical study which will be conducted at a private IVF center starting from june 2016.

the study will be recruited from both the fertility clinics and centers by fulfilling inclusion and exclusion criteria , all patient will be subjected to complete history taking medical and fertility history including previous induction or implantation failure.

patients will be randomized into two groups, group A will be treated with neupogen 30 international unit (IU) and group B will be treated with clexane 40mg and estrogen.

study procedure: ovaries were stimulated with standard protocol (long GnRH Agonist) or gonadotrophic releasing hormone (GnRH Antagonist, when at least 3 follicles achieved 18 mm diameter, Human chorionic gonadotrophic (hCG) (10000 IU) was administered for ovulation triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hCG . the oocytes were fertilized by intracytoplasmic sperm injection (ICSI) method. the thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which containing (300 mcg/1 ml) GCSF (neupogen) was infused slowly in the uterine cavity and after 5 days (before embryo transfer) endometrial thickness was evaluated again. all patients received oral and parenteral progesterone for luteal phase support.

Eligibility Criteria:
Inclusion Criteria:

* male partner with normal semen analysis according to world health organization (WHO) 2010.
* female partner under the age of 36 presented with: a-thin endometrium (less 7 mm on transvaginal ultrasound) or b- previous history multiple unexplained
* female with no history of Asherman's syndrome , fibroids, and polyps in diagnostic hysteroscopy

Exclusion Criteria:

* women with sickle cell disease, renal insufficiency, upper respiratory infection or pneumonia, chronic neutropenia, known past or present malignancy
A Registry Study of Participants With Multiple Myeloma in Latin America

The purpose of this study is to characterize the multiple myeloma (MM) population concerning demographics and clinical characteristics (for example. frailty, risk strata, manifestations of target organ damage \[TOD\]) in 6 countries (that is Argentina, Brazil, Mexico, Chile, Colombia and Panama); and to profile the treatment landscape of Latin American MM participants, including factors associated with health-care provider (HCP) selections of different treatment regimens. These factors can include a participant's demographic and clinical characteristics and availability of different therapy options per institution in each country.


Eligibility Criteria:
Inclusion Criteria:

* Incident diagnosis of MM between 01 January 2016 and 31 December 2020 (that is the first observed diagnosis noted in the medical charts)
* An informed-consent form (ICF) or participation agreement must be signed before any data are collected only if a waiver is not permissible. For deceased participants who did not provide consent before death, the permission to research on their information should satisfy the local requirements (that each study site's ethics committee and each country's regulatory authority)

Exclusion Criteria:

* Failed to satisfy one or more of the foregoing inclusion criteria or
* Only with diagnosis of smouldering myeloma between 01 January 2016 and 31 December 2020 in the medical charts
Training to Reconnect With Emotional Awareness Therapy

To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.

Phase II randomized, Waitlist Control (WLC) trial with 3-month follow-up to further establish proof of concept and early efficacy of TREAT (1:1 alexithymia treatment) for post-TBI alexithymia. It is anticipated that our target sample size is 44. The purpose of this study is to examine differences in post-treatment self-reported alexithymia and emotional self-awareness in participants with TBI randomized to TREAT or WLC. In addition to examining the differences in post-treatment self-reported emotion regulation (general), anxiety, anger, depression, positive affect (PA), global emotional function and quality of life in participants with TBI randomized to TREAT or WLC.

Eligibility Criteria:
Inclusion Criteria:

* TBI (injury due to a external physical force)
* Complicated mild, moderate, or severe TBI (defined by Glasgow Coma Scale (GCS) in Emergency Department (ED) (≤12), or Post traumatic amnesia (PTA) (≥1 day),Loss of Conscientious (LOC) (≥30 minutes),or positive head CT scan consistent with TBI)
* At least 18 years or older
* ≥1 year post-injury
* Adequate vision, hearing, speech, and comprehension
* Reliable mode of transportation
* Available for treatment during regular business hours
* Have moderate to high screening alexithymia score (TAS-20 ≥52)
* If participating in active psychological treatment prior to enrollment, their participation must be ongoing for 4 or more weeks

Exclusion Criteria:

* Diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, Alzheimer's disease, Parkinson's disease); does not include controlled seizures
* Diagnosed with major psychiatric disorder (e.g., schizophrenia, Borderline Personality Disorder)
* Severe Depression and/or perceived risk to self or others
* Developmental disability (e.g. autism, developmental delay)
* Unstable or anticipated medication changes related to mood or emotion during study participation
* Having started psychological treatment less than 4 weeks prior to enrollment
* Actively participating in the Traumatic Brain Injury Model System (TBIMS) alexithymia outcome module
Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant

The purpose of this study is to assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant.

Specific Aims: The goal of this study was to assess the safety and efficacy of risperidone augmentation in patients with major depression who failed to respond, or only partially responded, to an adequate trial of an antidepressant medication. Patients who met this criteria received adjunctive risperidone (1- 3 mg.) for an additional four-week treatment trial.

Subject Population: A total sample of 84 patients completed the study at two sites (Rhode Island Hospital/Brown University, n=42, Emory University, n=42).

Methods/Design: Patients who met criteria for unipolar depression and failed to respond, or partially responded, to an adequate trial of antidepressant medication were randomized to risperidone or a placebo for an additional 4 week treatment trial while continuing on the same dose of their antidepressant medication. Randomization was at a 2:1 ratio of risperidone to placebo.

Data Analysis: Patient outcome (recovery status) of the two treatment conditions were compared using a MADRS rating \< 10 to denote remission while improvement was defined as a 50% decrease from baseline to end of study. Odds ratio were examined to see if risperidone augmentation significantly affected the chance of recovery from depression at the end of 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with major depression or partially remitted depression
* currently receiving an adequate trial of an antidepressant

Exclusion Criteria:

* diagnosis of bipolar I or bipolar II disorder
* psychotic features
* substance dependence or abuse in the past three months
The Effect of Colonoscopy on Resting Energy Expenditure

The Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure (REE).


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals before colonoscopy

Exclusion Criteria:

* None
Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity

To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity


Eligibility Criteria:
Inclusion Criteria

* Males and females with ages between 18 and 65 years old, inclusive
* Except for obesity, otherwise healthy
* Body mass index (BMI) greater than or equal to 30.0 kg/m2 and less than or equal to 40.0 kg/m2 at screening
* Other Inclusion criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study
* Women of childbearing potential
* History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Other Exclusion criteria may apply
A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2

To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.

This study intends to carry out multicenter, observational cohort clinical research, using maleic acid pyrrole for his piece of HER-2 positive treatment of advanced breast cancer treatment, observation and verification maleic acid pyrrole for his piece for a line or a single drug resistance by bead in the real diagnosis and treatment in patients with advanced breast cancer environment and the efficacy and safety of new treatments. Biomarkers of breast cancer prognosis are of great significance in predicting the degree of malignancy, metastasis and recurrence of breast cancer, as well as guiding clinical treatment programs.This study will explore the prognostic factors and curative effect of breast cancer patients from multiple aspects, explore the dominant population of breast cancer patients with pyrrolidone maleate, and provide the theoretical basis for individualized treatment for clinical treatment practice.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients .
2. Confirmed by pathological examination of breast cancer patients with positive her-2 expression
3. The researchers determined that the standard neoadjuvant regimen was ineffective in the treatment of patients with locally advanced her-2 positive breast cancer or that the standard neoadjuvant regimen was not applicable.
4. Patients should be voluntary to the trial and provide with signed informed consent
5. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories
2. Pregnant or lactating women
3. Patients with Pyrotinib maleate tablets contraindications
4. Patients of doctors considered unsuitable for the trial
To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
* Japanese males

Exclusion Criteria:

* ECG findings outside normal reference ranges.
* Potassium outside normal reference ranges.
Reliability and Validity of Urdu Version of Ronald Morris Disability Questionnaire in Patients With Low Back Pain

Purpose of this Research is to convert Ronald Morris Disability Questionnaire into Urdu language and check the accuracy and logic in Pakistani low back pain population. Also check its correlation with Oswestry Disability Index and Visual Analogue Scale.

The Ronald Morris Disability Questionnaire will be translated into Urdu and culturally adapted for people with low back pain. Ronald Morris Disability Questionnaire will be given to 80 people who will be chosen by using a convenient sampling method. Method of sampling based on pre-determined inclusion and exclusion criteria. To examine intra-observer reliability of the final Ronald Morris Disability Questionnaire, two observers will fill out Oswestry Disability Index and Visual Analogue Scale questionnaires on the same day to test inter-observer evaluation. After 30 minutes of the initial treatment, the second application will be applied. The first observer will do the third assessment after seven days. Statistical Package of Social Sciences Version 24 will be used to enter and analyse data. The alpha value of Cronbach's alpha will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Average Age of patient 48 years.
* Patient with chronic low back pain have at least 3 month duration .
* Patient with mechanical Low Back Pain

Exclusion Criteria:

* Patient with non - mechanical Low Back Pain
* Patient have neurological deficits .
The Effect of a Posture Shirt on Muscle Activity During Functional Tasks

This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and standing repetitive upper limb task

Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort. This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and a standing repetitive upper limb task.

Eligibility Criteria:
Inclusion Criteria:

* Pain free healthy participants
* Able to speak, read and understand Danish

Exclusion Criteria:

* Pain from the back, neck or shoulder area during the past 6 months
* Experience of delayed onset muscle soreness (DOMS) on the day of testing
* Current or previous chronic or recurrent pain condition
* Regular use of analgesics
* Previous neurologic, musculoskeletal or mental illnesses that may influence the results
* Lack of ability to cooperate
Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and in overweight/obese children with or without a family history of diabetes mellitus.

The patient participates in the study for a total duration of approximately four hours. The study nurse will do a nursing assessment, including measuring the patient's height, weight, waist circumference, hip circumference, blood pressure, and pulse, along with evaluation of acanthosis nigricans and striae rubrae. The patient's percent body fat, fat mass and lean mass may also be measured using a Tanita scale. The nurse will obtain a family and medical history from the patient and/or the patient's parent/guardian. In addition, before starting the oral glucose tolerance test (OGTT), the nurse will request a urine sample from the patient for analysis of microalbumin and creatinine.

The patient will receive 1.75 g/kg to a maximum of 75 g of a sugar drink, orally (Glucola). The patient will have one intravenous line. "Emla" or a local anesthetic (0.1cc buffered lidocaine) will be applied before the placement of the IV catheter. Blood will be drawn 10 times over three hours. Should abnormal glucose results be found, appropriate referrals will be made. We will draw approximately 80 cc of blood during this study. The blood will be analyzed for glucose, lactate, insulin, proinsulin, c-peptide, interleukin-6, tumor necrosis factor-α(TNF), free fatty acids (FFAs), enhanced lipid profile, leptin, and adiponectin as well as an optional 10 cc sample to be stored for future undetermined analysis.

Eligibility Criteria:
Inclusion Criteria:

* ages 7-21
* family history of type 2 diabetes mellitus

Exclusion Criteria:

* Children will be excluded if they have previously been treated for another endocrinopathy or are on any chronic medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil.
* Lean (not overweight or obese) will be defined as a body mass index (BMI) (kg/m2) less than the 85th percentile specific for age and gender, overweight will be defined as a BMI between the 85th and 95th percentiles, and obesity will be defined as a BMI greater than the 95th percentile.
* Children will be excluded from participating in the genetic analysis if they are treated oral glucocorticoids or antirejection or chemotherapy (e.g. tacrolimus, Lasparaginase.
Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis

The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.

This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.

Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.

Eligibility Criteria:
Inclusion Criteria:

Ages 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.

Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.

Exclusion Criteria:

Older than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?

The investigators intend to measure compliance with attending pelvic floor physical therapy (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute educational video or reading a handout explaining the therapy.

Patients who have been interviewed, examined, and a plan has been made by the treating physicians in the Female Pelvic Medicine \& Reconstructive Surgery practice will be invited to participate at the end of the visit if the patient and physician mutually agree that PFPT is the treatment modality to pursue.

If she agrees to participate, she will be consented and randomized. If she is randomized to standard counseling, she will be given the standard handout to read. If she is randomized to the intervention, she will receive the standard handout and view the 4-minute educational video on an iPad.

At the conclusion of the counseling, patients will be asked if they have any additional questions, and these will be recorded and answered. The patient will also fill out a visual analog scale about how informed she feels regarding PFPT.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine \& Reconstructive Surgery practice

Exclusion Criteria:

* Patients ≤ 18 years old
Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS

This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.

The primary hypothesis being tested in this study is that Ultravision facilitates the utilization of lower pneumoperitoneal pressures whilst maintaining an adequate visual field throughout the procedure with low demand for CO2 replenishment to maintain pneumoperitoneal pressure. Comparisons in terms of surgical field visualization, procedure times, and CO2 consumption will be conducted in order to determine whether or not any clinical benefits are derived from the use of the Ultravision™ System compared to the Airseal® iFS. Low pressure laparoscopy for this study is set at 10mmHg. This is a prospective, open-label, randomized controlled study. The study will include two study arms. Patients undergoing laparoscopic cholecystectomy will be randomized to either "Ultravision" (study arm 1) or Airseal® iFS (study arm 2). Both groups will conduct the procedure at 10mmHg, considered to be low pressure/low impact laparoscopic surgery. The study will enroll 30 patients, 15 per group. Both devices are being used according to their cleared label claims.

Eligibility Criteria:
Inclusion Criteria:

* Is 18 years or older
* Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
* Agrees to attend all follow-up assessments
* Is indicated for elective laparoscopic cholecystectomy

Exclusion Criteria:

* Existing comorbidities that would contraindicate them for laparoscopic surgery
* Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
* Body Mass Index \> 50
* Be pregnant (if female)
* Has a condition of unrelated chronic pain requiring medication
Physical Activity in Persons With Parkinson's Disease

Parkinson's disease (PD) is a leading neurodegenerative health condition in Sweden and a public health concern. Although no cure exists, functional independence and participation in society remain top priorities, and can be achieved through targeted physical activity (PA) interventions. To date, few longitudinal cohort studies have been conducted, using PA as main outcome in therapy research, partly due to the complex nature of predicting and controlling this phenomenon. To help address this knowledge gap, the overall purpose of the future long-term (ActivPARK) study is to enhance knowledge of the evolution of PA behavior, and how it is influenced beyond the disease characteristics using a broad explanatory model, in persons with PD from a diversity of settings in Sweden with the aim of prescribing tailored and personalized interventions to enhance functioning, health, and wellbeing throughout the disease progression and recommend potential health care pathway modifications.

The investigators have just established an expert group, comprising researchers, healthcare professionals, and PD organisations (including persons with PD) and reached consensus on essential priority clinical therapy research questions on PA and methodological considerations. The next phase entails performing a multicentre feasibility/pilot study, further developing and refining the assessment battery and research questions linked to the improved explanatory model for PA and methodology, to inform the definite larger clinical cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Mild to severe disease severity ( Hoehn \& Yahr 1-4).

Exclusion Criteria:

* None