cyrilzakka/clinical-trials huggingface dataset:
Aerobic Exercise in Women With Gestational Diabetes

A few, small randomized controlled trials have investigated the effects of exercise on blood glucose levels in women with gestational diabetes (GDM), with inconsistent results.

To assess the effects of supervised exercise in women with GDM, 48 women with gestational diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after exclusion of subjects with contraindications to exercise. These subjects will be randomly assigned to two groups: structured exercise intervention or standard care.

Women in the intervention group will perform low intensity aerobic exercise three times per week at 30% HRR (heart rate reserve), under continuous heart rate monitoring. Duration of each session will progress from 26 minutes the first week to 40 minutes (increasing 2 min/week). Women in the control group will receive standard diet and physical exercise recommendations.

In all women, clinical, metabolic and anthropometric features will be assessed before, during and at the end of the study. Newborn data will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy,
* Gestational diabetes diagnosis between 18th and 28th week of gestation,
* Caucasian.

Exclusion Criteria:

* Hemodynamically significant heart disease,
* Restricted lung disease,
* Incompetent cervix/cerclage,
* Persistent second or third trimester bleeding,
* Placenta previa,
* Threatened preterm labor,
* Ruptured membranes,
* Preeclampsia,
* Hypertension,
* Severe anemia,
* Cardiac arrhythmias,
* History of epilepsy,
* Chronic bronchitis,
* Orthopedic limitations,
* Overt hyperthyroidism/ hypothyroidism,
* Type 1 diabetes mellitus,
* Drugs that interfere with metabolic control (such as cortisone)
Clinical Decision Support to Identify Pediatric Patients With Undiagnosed Genetic Disease

This study will evaluate the effectiveness of SIGHT as a clinical support system to prompt provider/patient discussion and shared decision making regarding the need for genetic testing in the form of a chromosomal microarray. Identifying patients at high predicted probability of needing a test in clinical settings will be examined to determine if it decreases the duration of time to testing and increases diagnostic yield. SIGHT requires only data already collected in routine clinical encounters and is calculated prior to a clinical visit at VUMC.


Eligibility Criteria:
Inclusion Criteria:

* All patients \> 1 year old, \< 20 years of age with a scheduled visit to the VUMC pediatric primary care.

Exclusion Criteria:

* Patients who have been programmatically excluded due to having already received a chromosomal microarray at VUMC and patients \> 20 years of age or \< 1 year of age.
Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

In order to assess the important issue of the safety of antiangiogenic TKI in geriatric population we set up this project which aims to identify, among clinical, biological, pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 70 year-old.

This is a prospective cohort with collection of biological samples, including 300 patients \> 70 year-old treated in multicenter with antiangiogenic TKI regularly approved for metastatic cancers. Data on clinical and biological characteristics of the patient, disease and treatment as well as pharmacogenomics will be centrally collected at the beginning of the treatment. Drug exposure-safety analyses will be performed through assessment of drug through levels (Cmin). Primary endpoint is severe toxicity defined as treatment-related death, hospitalization or disruption of treatment for more than three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Treatment with pazopanib, regorafenib, sorafenib, sunitinib,axitinib in the context of market authorization
* Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

* Patient treated in a context of clinical trial
* Patient with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient consent
Correlation Between Occlussion Types , in Patients With Temporomandibular Disorders.

study to find if there is correlation between occlusion types and TMD or not

The relationship among occlusion, condylar position and temporomandibular disorders (TMDs) has been part of an extensive discussion in the dental field. There is a strong belief that the discrepancy between the centric relation (CR) and the intercuspal position (ICP) could predispose to the presence of TMDs . It was suggested in the past in the earlier studies that TMD is more common among the individuals who have Angle class II and class III , malocclusion , open bite , and cross bite . In the 1990s, studies suggested that some occlusal and skeletal characteristics as anterior open bite, unilateral posterior crossbite, overjet greater than 6-7mm, absence of five or more posterior teeth and CR to maximum intercuspation (MI) discrepancy greater than 2mm could be considered occlusal risk factors for TMDs . In their study, Oyetola et al. reported that 25% of the evaluated TMD patients had malocclusion Yet, recently with studies and systematic reviews , this idea ( alocclusion is the main cause of TMD) started to lose its support, and many studies showed that sensitivity to nociceptive stimulations and psychological factors are of more importance in the etiology of TMD

Eligibility Criteria:
Inclusion Criteria:

1. Patients above 16 years old and below 50
2. Patients with TMD diagnosed (stage 2 Wilkes classification , anterior disc displacement with reduction, )
3. Provided informed consent.
4. No history of systemic condition affecting TMJ
5. No previous orthodontic ttt

Exclusion Criteria:

1. Ear diseases.
2. History of facial trauma.
3. Neurological or oncological disease.
Strength Training for Osteoporosis Prevention During Early Menopause

The goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. The main question it aims to answer are:

-Is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition)

Secondary aims include examining changes in bone health, muscle strength, and menopausal symptoms.

Participants will participate in a 9-month progressive, supervised, resistance training intervention. Researchers will compare secondary outcomes between the exercise group and a wait-list control group.

The STOP-EM trial will examine a 9-month supervised, progressive, resistance training program in peri- and early menopausal females. Primary outcomes include recruitment rates, protocol adherence, and attrition. A waitlist control group will allow us to examine the effect of the exercise program on bone density, structure, and strength, muscle strength, and menopausal symptoms. Participants will be randomized to the exercise or control group. The exercise group will attend twice weekly, in-person, supervised, progressive resistance training and build up to 80-90% of estimated 1 repetition maximum (1RM). The study will take place at the University of Calgary. Findings will be used to decide whether to continue to the definitive trial.

Eligibility Criteria:
Inclusion Criteria:

* 45-60 years old.
* Menopause status of peri- or early menopausal: stages -2 or -1 of the stages for reproductive aging 10+ staging system or are within 5 years of their last known menses.

Exclusion Criteria:

* Females who are pregnant or planning pregnancy within the next year.
* Orthopaedic conditions that may be made worse with exercise.
* Has low back pain, hypertension, lipidemia, diabetes, or cardiovascular disease.
* Has a history of metabolic bone disease.
* Has had an osteoporotic fracture within the last 5 years.
* Had previous treatment with osteoporosis pharmacotherapy.
* Has active glucocorticoid use.
* Is currently participating in progressive resistance training or has in the previous 6 months.
* Has low serum vitamin D (25(OH)D) \< 30 nmol/L or serum calcium \<2.10 mmol/L.
Treatment Efficacy for Drug Abuse and AIDS Prevention - 2

The purpose of this study is to assess the safety and effectiveness of buprenorphine for treatment of concurrent intravenous heroin and cocaine dependence.


Eligibility Criteria:
Please contact site for information.
Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics

Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics

Patella instability induces repetitive patella dislocation, which impairs day-to-day life. Surgery is commonly used to stabilise the patella during knee flexion. However proofs of efficacy of surgery on patello-femoral kinematics have not yet been found. Analysis of the patello-femoral kinematics is crucial to understand, assess et correct the patella instability. The investigators have developed, validated and published a 3D analysis method from biplanar X-rays (EOS 3D imaging). Our aim in this study is to assess the correction of the patello-femoral kinematics after surgery using the EOS 3D imaging method.

Eligibility Criteria:
Inclusion Criteria:

* Age above 15 years and 3 months (minimal age to be allowed for adult orthopedic surgery in the hospital)
* Patients with patello-femoral instability (at least one patella dislocation)
* Patients with corrective surgery planned
* Patients must be covered by public health insurance
* Signed informed consent form by the patient or by the parents or legal guardian of the patient (if patient is under 18)

Exclusion Criteria:

* Previous existing surgery for patella instability on the same knee
* Previous existing surgery on the extensor apparatus of the knee
* Female patients with pregnancy
* Patients deprived of liberty by administrative or court order
Hyperbaric Therapy and Deep Chemical Peeling

To evaluate whether treatment with Hyperbaric oxygen can accelerate skin recovery after deep peeling, and decrease frequency and severity of local side effects and complications.

20 post peel patients will recieve 5 daily hyperbaric treatments, starting from day 7 to peel.Patient's followup will include self- filling questionnaire and photographs

The study will include 40 post-deep peel women (exoderm), older than 18 years old, treated by the same dermatologist.

The treatment group will recieve 5 consecutive daily hyperbaric treatments, 1 hours long each, at 2 ATF, starting from day 7 to peel. Prior to treatment, each patient will be signed on informed consent and will have complete physical examination.

The control group will be matched by the following parameters: age, skin color and type, and indication for peeling, and will be picked up by the dermatologist.

Patients will be excluded if they have known middle ear disease, chronic lung disease or claustrophobia.

Follow -up:

The same dermatologist will follow-up, on regular dates: the follow-up examination will start at day 1 to mask\\occlusive dressing removal (equivalent to day 7 post-peel), and at days 7, 28, and after 3 months. All follow-up examinations will take place at noon (04-08 pm) regularly.

Efficacy parameters:

All patients will be asked to fill up a daily questionnaire on the first week after peel, and score the severity of pain, pruritus and tightness of facial skin (1 to 5). They will also mention the daily analgesic usage.

Parameters that will be evaluated by the dermatologist during the study will be: tightness of the skin, pain/burning, pruritus/stinging, swelling/edema, erythema, crusting, and scaling, assessed on a 4-point severity scale (0- best, 3- worst).

Photographs:

Photographs of the patients in 5 angles views will be taken on the day of peel, day of mask removal (7), day 28 and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* The study will include 40 post-deep peel women (exoderm), older than 18 years old, treated by the same dermatologist (dr. Landau).
* The treatment group will receive 5 consecutive daily hyperbaric treatments, 1 hours long each, at 2 ATF, starting from day 7 to peel. Prior to treatment, each patient will be signed on informed consent and will have complete physical examination.
* The control group will be matched by the following parameters: age, skin color and type, and indication for peeling, and will be picked up by the dermatologist.

Exclusion Criteria:

* Patients will be excluded if they have known middle ear disease, chronic lung disease or claustrophobia
Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.

The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics.

The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale. Improvement of Nugent scores should be considered the primary end point of the study. The outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.

Eligibility Criteria:
Inclusion Criteria:

Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with Nugent scores between 4 and 6

Exclusion Criteria:

Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.
Immediate Ambulation Versus Short-time Bed Rest in Sub-fertile Women Undergoing Embryo Transfer

Bed rest after embryo transfer (ET) has been clinically advised without robust scientific evidence. In investigators' unit, post ET instructions are given immediately after ET to sub-fertile women while lying in bed. The aim of the study is to compare the reproductive outcome of this practice compared with immediate ambulation and giving instructions after emptying the bladder.

Bed rest after embryo transfers has been clinically advised without robust scientific evidence. Most of the assisted reproductive units routinely recommend a variable period of bedrest immediately after embryo transfer (ET) procedure without clear scientific evidence of its benefit. Three Randomized controlled trials (RCT) that included 712 embryo transfers with variable duration of bedrest did not report a benefit in pregnancy outcome. Only one study, however compared bedrest with no bedrest. In contrast, a 2013 RCT reported a harmful effect on the pregnancy outcome.

However, data on patients using embryos derived from their own oocytes are limited. In addition, there was no subgroup analysis to exclude confounding factors like number of oocytes retrieved and quality of embryos transferred. Few of these studies included embryos transferred after preimplantation genetic diagnosis.

The rationale behind bedrest come from the belief that decreased physical activity will help in embryo retention within the uterine cavity after replacement6. Ultrasound examination before and after ET with immediate ambulation did not show any uterine displacement of the air bubble. if gravity displaces transferred embryos, then staying with full bladder in supine position will make the anteverted ante flexed uterus more horizontal and increase the gravity effect.

Moreover, although bed rest is one of the most practiced treatments to improve reproductive outcome, most clinicians consider it the least crucial factor.

In investigators' unit, post ET instructions, which, may take up to 5 minutes, are practiced immediately after ET to patients while lying in bed. The aim of the study is to compare the effect of this practice with immediate ambulation and giving instructions after emptying the bladder in a sitting position on the reproductive outcome in patients undergoing assisted reproductive treatment.

Eligibility Criteria:
Inclusion Criteria:

* Couple undergoing In vitro fertilization, Intracytoplasmic sperm injection, Frozen embryo replacement or Frozen Intracytoplasmic sperm injection
* Age between 20 to 40-year-old
* Couples who are willingly accepting to participate in the study. Both husband and wife will sign the consent.

Exclusion Criteria:

* Women with diminished ovarian reserve (AMH \< 1.2 ng/ml or AFC \< 7)
* Women with unilateral or bilateral hydro salpinx
* Women with bilateral endometriomas
* Women with adenomyosis
* Women with large (more than 3 cm uterine fibroid)
* Women with fluid or polyp in the uterine cavity
* Women with known chronic endometritis
* Women with H/O recurrent \>2 pregnancy loss or implantation failure
* Were enrolled in this study before
The Impact of Germanium-Embedded Knee Brace on Patient Recovery After Knee Arthroscopy

Anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for Major League Soccer players. Authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. In addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. Thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. Knee Arthroscopy rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. The presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after Knee Arthroscopy.

Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing Knee Arthroscopy. Patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. Inclusion criteria will include skeletally mature individuals undergoing primary Knee Arthroscopy. Exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. The presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after Knee Arthroscopy. The primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. Secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years old
* Male or female
* Compliant patient
* BMI less than 35
* Undergoing Knee Arthroscopy within 30 days

Exclusion Criteria:

* Rheumatoid Arthritis
* Poorly controlled diabetes (HgA1c \> 7.5)
* Previous blood clots
* BMI greater than 35
* Varicosities on operative leg
A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL

The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.

This is a phase IIa, open-label, multi-center, clinical trial of interfering the binding of MDM2 oncoprotein with the tumor suppressor P53 protein, leads to increased P53 and P21 protein expression and activates P53-mediated apoptosis. The hypothesis is that APG-115 monotherapy and in combination with APG-2575 will shows good safety and efficacy in patients with R/R T-PLL and NHL

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients with relapsed/refractory T-PLL who have active disease and have received at least one prior therapy; Patients with histologically confirmed diagnosis of NHL, NHL Patients must be either relapsed, refractory, intolerant, or are considered ineligible for therapies known to provide clinical benefit;
3. Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting APG-115 and/or APG-2575. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
4. Absolute neutrophil count (ANC) ≥ 500/mm˄3; hemoglobin ≥ 60 g/L; platelet count ≥ 30,000/mm˄3
5. Patients with adequate organ function;
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
7. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his/her legally authorized representative is required prior to their enrollment on the protocol.

Exclusion Criteria:

1. Patient previously treated with a murine double minute 2 (MDM2) inhibitor.
2. Known active, uncontrolled central nervous system (CNS) malignancy
3. Patients require graft versus host therapy, or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose of study drug).
4. Patients who have any conditions or illness that, according to the opinions of the Investigators or the medical monitor, would compromise patient safety or interfere with the evaluation of safety and efficacy to the study drug(s).
5. Patients who have used strong CYP2C8 inhibitors, or moderate or strong CYP3A4 inhibitors or inducers within washout period of 14 days or 7 half-lives before the first administration of study drugs, whichever is longer.
Chronic Migraines and Neurofdeeback Mindfulness

As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of chronic migraine from a clinician or have met the criteria for a chronic migraine diagnosis based on ICHD-3
* reside in Saskatoon area
* have a smartphone and internet connection for accessing the MUSE app
* have no frequent background experience of meditation

Exclusion Criteria:

* Comorbidity of Raynaud's syndrome or diabetes
* Current use of a preventative migraine treatment over 6 months