cyrilzakka/clinical-trials huggingface dataset:
Description of the Uterine Cavity in Patients With Recurrent Miscarriages

To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester.

These miscarriages often needs medical evacuation or a D \& C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility.

Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women.

Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.

The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.

Eligibility Criteria:
Inclusion Criteria:

* Correctly diagnosed with recurrent miscarriages

Exclusion Criteria:

* Known course of the condition
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of ADHD
* Males and females aged 6-12

Exclusion Criteria:

* Inability to understand or follow instructions
* Is pregnant
* Diagnosis of tic disorder
* History of seizure disorder
LUNA-EMG to Enhance Motor Functions in Neurological Disorders

The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the upper limb in stroke This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG) or in the control group (standard care).

The effect of the training will be measured with the EMG, the upper limb motor function and the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Having signed the informed consent

Exclusion Criteria:

* Acute pain syndrome
* Severe cognitive deficits
* Risk of fracture or unconsolidated fracture
* Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints
* Severe ataxia and apraxia
* Epilepsy
* Pacemakers and similar implants
* Insufficient skin conditions
High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Compared to end-stage heart failure, a patient's situation is usually greatly improved after a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term, ranging from 50 to 70% in most studies. While effective rehabilitation, including regular exercise, is considered an effective tool of improving health related quality of life (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of different rehabilitation programs among HTx recipients is limited. Exercise training is considered one of the most central parts in rehabilitation, but the mode of exercise used in different studies varies considerably. It is documented that high intensity interval training (HIT) has superior effects compared to training with moderate intensity in cardiac and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered unphysiological. However, the investigators have recently demonstrated highly beneficial effects on exercise capacity, muscle strength, body composition, reduced progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study the investigators want to test the hypothesis that systematic aerobic exercise with high intensity improve exercise capacity also in newly transplanted recipients, and secondarily that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable HTx recipients approximately 8-12 weeks after HTx.
* Age \> 18 years, both sexes
* Received immunosuppressive therapy as per local protocol.
* Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 9- 12 months.

Exclusion Criteria:

* Unstable condition or postoperative complications
* Recent severe rejection episodes
* Physical disabilities which prevent participation
* Other diseases or disabilities that contradict/refrain from exercise.
Intensive Pediatric Group Intervention

The purpose of the Mizzou emPOWER program is to meet the curricular needs of entry-level doctorate of physical therapy students by providing them the real-world experience of implementing recent evidence surrounding physical therapy dosing for children with cerebral palsy (CP) for power, strength, and gait interventions while meeting an unmet community need.

Beginning in Fall 2024, the investigators will recruit 6 children with CP, Gross Motor Function Classification System Levels I-III, ages 7-17 years old, to participate in the program. Two students will be assigned to each participant, rotating every 4 weeks due to the structure of the pro-bono clinic. A total of 3 faculty members will supervise. The group will meet for 2 hours, 2 times per week for 15 weeks. Each session will include a 10-minute game-based warm-up, 45 minutes of gait interventions to include treadmill and overground walking as well as other aerobic activities, 45 minutes of resistance training (power and strength training as appropriate for their individual goals), and a 10-minute cool-down incorporating yoga and breathing activities. Participant assessments will be completed during the first week, 7th week, and 15th week. Other programmatic assessments will include students' written reflections on their experiences providing this program, caregiver satisfaction surveys, and participant and caregiver interviews.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory children 7-17 years old, children who are participating in emPOWER program
* GMFCS Levels I-III
* Able to follow 2-3 step directions
* English Speaking

Exclusion Criteria:

* Orthopedic surgery in the past year
* Significant visual impairment
* Significant hearing impairment
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.

A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)
* Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
* ECOG performance status \<1

Exclusion Criteria:

* Prior therapy with an anti-CSF1R antibody
* Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression on prior kinase inhibitor)
* Liver function tests (including ALT, AST, and total bilirubin), outside of the range of local laboratory normal at Screening
* Inadequate organ or bone marrow function
* History of congestive heart failure or myocardial infarction \<1 year prior to first study dose administration
* Significant abnormalities on ECG at Screening
* Contraindications to MRI and use of intravenous gadolinium-based contrast agents
* Creatine Kinase ≥ 1.5x the upper limit of normal
* Positive test for latent TB at Screening (Quantiferon test)
* Active known or suspected autoimmune disease
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.

Exclusion Criteria:

* Fetal anomaly
* Pregestational diabetes
* GDM diagnosis without a 3-hour OGTT
* Multifetal gestation
* Treatment with non-inhaled steroids within 7 days
* Allergy to glyburide, metformin or sulfa
* History of severe pulmonary (pulmonary requirement for oxygen therapy or daily treatment for restrictive of obstructive pulmonary disease)
* Hepatic (LFT's greater than two times of upper normal range)
* Renal (serum creatinine higher than 1.2 mg/dL) disease
* History of heart failure or myocardial infarction
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.

An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
3. Prior radiation therapy for head and neck cancer
4. Disease must be considered surgically resectable or candidate for curative reirradiation
5. Adequate diagnostic workup
6. Zubrod Performance Status 0-2
7. Life expectancy 12 weeks
8. Age 19, 9. Adequate laboratory data.

Exclusion Criteria:

1. Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
2. Patients who are pregnant or lactating
3. Psychological condition that renders the patient unable to understand the informed consent
4. Any situation or condition that will interfere with adherence to study activities.
Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa.

The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group.

There is a digital platform called GGtude, which is composed of different modules, each of them aimed at working with different mental health problems. The goal is to provide an easy-to-use tool as a CBT complement to work on the self-dialogue that relates to the core beliefs associated with the psychological problem in particular. To achieve this target, a cognitive training exercise is performed: different sentences appear in the form of beliefs, and the person must identify and accept those beliefs that are functional, adaptive and positive, dragging them to the lower part of the screen; and reject those that are dysfunctional, maladaptive and negative dragging them to the upper part of the screen.

There are different modules, for example, to work self-esteem, eating disorders, depression, body image or obsessive-compulsive disorder, that have proven their effectiveness. The GGON app has not efficacy studies. So, it is relevant to evaluate its effectiveness with an RCT study.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 65.
* Have a dispositive with Internet access.

Exclusion Criteria:

* None
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate.
* Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
* Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following:

  * PSA progression
  * Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
* Have adequate organ function.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

* Prior therapy with cytochrome P450 (CYP)17 inhibitors.
* Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitors.
* Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer \[mHSPC\] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions.
* Currently enrolled in a clinical study involving an investigational product.
* Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
* Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).
Incidence and Effects of Sleep Apnea on Intracerebral Aneurysms

Patients with intracerebral aneurysm will be screened for sleep apnea using out of center polysomnography/polygraphy. Baseline blood pressure and medication will be assessed. Patients will be followed for up to 5 years to examine the increase in aneurysm size, rupture rate and changes in medication.

Patient presenting to the outpatient center for neurological of neurosurgical management of intracerebral aneurysm will be recruited. Sleep apnea will be assessed by questionnaire and out of center polygraph/polysomnography. Medication, comorbidities and blood pressure will be recorded. Change in aneurysm size and blood pressure medication will be evaluated annually for up to 5 years. Frequency of subarachnoid hemorrhage and increase in aneurysm size will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Intracerebral aneurysm
* Age \>= 18yrs.
* Ability to give informed consent

Exclusion Criteria:

* Stroke within 3 month of study inclusion.
Endocuff Adenoma Detection Rate Pilot Study

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon.

The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
* Ability to understand the nature and requirements of the study and to provide written informed consent.

Exclusion Criteria:

* Contraindication to undergo standard colonoscopy.
* Severe active colitis.
* Known colonic stricture
Evaluation of Impacts of Access to Credit and Loan Size for Microcredit Clients in South Africa

This study involves randomization of individuals who were initially rejected from a micro-lending organization in South Africa. Subjects were placed into two arms: (1) not receiving a loan; (2) being reconsidered for a "second look." Of those in the second arm, 53% were then selected by the organization's loan officers to receive a standard loan for first-time borrowers. Mental health and financial data were collected at one timepoint: approximately 6-12 months after the subjects first applied for the loan.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were recruited from those who had been rejected from a lending organization for non-fraudulent or non-overindebtness reasons.

Exclusion Criteria:

* None.
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)

The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.

The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups:

  * Age \> 60
  * Age \> 45 with amenorrhea \> 1 year with intact uterus
  * Status post bilateral oophorectomies
  * FSH/estradiol levels in postmenopausal range for the institution
* DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method.
* There must be available tissue from the diagnostic biopsy to perform molecular markers.
* Baseline mammogram within 8 weeks of study entry.
* Serum creatinine less than or equal to 2.0 mg/dl.
* Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl
* Peripheral neuropathy grade 0-1.
* No prior therapy for DCIS.
* SWOG performance status of less than or equal to 1
* All patients must provide informed written consent

Exclusion Criteria:

* Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry.
* Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment.
* History of DVT or Pulmonary Embolism