cyrilzakka/clinical-trials huggingface dataset:
Fitness Improvement in Obese, Pregnant Women: an Intervention Trial

In pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the development of co-morbid conditions such as hypertension, maternal and childhood obesity, gestational diabetes, pre-eclampsia, cesarean section and delivery of large-for-gestational-age infants (LGA).

The aim of this study is to test the hypothesis that obese, pregnant women following a supervised moderate intensity physical conditioning program during the 2nd trimester of pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as compared to women in the control group. We will also conduct a pilot study on the feasibility to examine the effects of the intervention on maternal fitness and neonatal anthropometry.

Looking at the multiple needs of pregnant women with obesity, physical conditioning may offer a great opportunity to improve fitness and to decrease cardio-metabolic disturbances, to prevent excessive weight gain, to improve general health status, and to reduce health care utilization. Furthermore, beneficial effects of fitness on adverse maternal health outcomes related to obesity might decrease the development of long-term obesity and metabolic repercussions in the offspring.

The Society of Obstetricians and Gynaecologists of Canada (SOGC) recommends that all women without contraindication be encouraged to participate in aerobic and strength-conditioning exercises as part of a healthy lifestyle during pregnancy. Despite these recommendations, obese women are inactive during pregnancy and are currently still at high risk of poor physical fitness.

Thus, although exercise clearly improves maternal health status and thus potentially prevents adverse perinatal outcomes, obese pregnant women poorly adhere to experts' recommendations about the need for exercise during pregnancy. Therefore, this situation justifies the need to develop adapted strategies aimed at increasing the implementation of guideline recommendations in this population.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women 18 years or older
* single pregnancy
* delivery at Centre Hospitalier Universitaire de Québec
* pre-pregnancy BMI ≥30 kg/m2

Exclusion Criteria:

* multiple pregnancy
* diabetes or chronic hypertension prior to pregnancy
* uncontrolled thyroid problems
* exercise contraindications
CLEAN Frontline: A Stepped Wedge Cluster Trial

Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. The only recommended training on environmental hygiene for low resourced facilities, TEACH CLEAN, uses a training of trainers model. A selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. Early pilot data to test its effectiveness of this training package are very promising.

The main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in Cambodian hospitals.

The latest TEACH CLEAN will be implemented across all hospitals (13) of three provinces in Cambodia. A stepped wedge randomised trial will be used to evaluate the effectiveness of TEACH CLEAN to improve microbiological cleanliness in Cambodian hospitals. All facilities will receive the intervention. Hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. The design will include ten months of data collection. We expect one month gap between the training of champions and the training of staff at the facility level. The main outcome is microbiological cleanliness (\<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total Aerobic Colony Counts (ACC/cm2). With 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness.

Evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. This would be the first randomised trial on environmental hygiene in low resource settings.


Eligibility Criteria:
Inclusion criteria for surfaces sites selected for primary outcome measurement

* Surfaces within the patient zone which frequently touched surfaces of the targeted wards: maternity, pediatric and general medicine

Exclusion Criteria:

* Surfaces outside the patient zone
* Surfaces not in the wards of interest
Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.

This study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers. The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase. Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women. Within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days. The dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment. This 21-day gap will be applied to all subsequent groups. Each volunteer will participate in the study for approximately 58 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2
* Volunteers must be non-diabetic as confirmed by fasting plasma glucose \<126 mg/dL
* Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)

Exclusion Criteria:

* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
* History of gastric banding, gastric bypass or other gastric-reduction surgery
* History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment
ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care

Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.

At Skåne University Hospital approximately 6000 individuals are treated for acute abdominal diseases each year. Given the high number of patients, there is an urgent need to optimize acute surgical care. Lower complication rates would decrease hospital stay, health care costs as well as personal suffering.

Assessment instruments for risks and frailty are not validated for the acute setting and the investigators hypothesize there is room for improvement in prophylactic interventions and risk assessment. The investigators will study cohorts of patients with three different surgical diagnosis: acute pancreatitis, gastrointestinal bleeding and perforated ulcer aiming to identify risk factors for complications or death and to investigate assessment tools in this population. Using propensity score analysis, the investigators will try to identify treatment options associated with better outcome for subcohorts defined by frailty, comorbidity, age or gender. Specific factors of interest include: time to- and kind of treatment, handling of ongoing pharmacological therapy (anticoagulants, corticosteroids) and need for further treatments on a long time basis. The results from this project will be used in a future prospective study where prophylactic treatments and specific treatment options are studied.

Eligibility Criteria:
Inclusion Criteria: Patients admitted to Skåne University hospital in need of acute surgical care -

Exclusion Criteria: Below 18 years old

-
Pilates Exercises and Down Syndrome

Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children.

the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome

Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes.

Group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attended the intervention program three times/week for 3 months

Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosed with Trisomy 21 through genetic testing, (2) aged 6 to 11 years and (3) able to follow a minimum of two-step instructions. The minimum motor ability of participants with DS was independent locomotion.

Exclusion Criteria:

* (1) medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, (2) orthopaedic instability, including those associated with DS (e.g. atlanto-axial instability) and (3) behavioural issues that hindered instruction.
Respiratory Training in Individuals with Ankylosing Spondylitis

This study was designed to investigate and compare the effects of standard diaphragmatic breathing and physiotherapy exercises versus 360-degree expandable diaphragmatic breathing and physiotherapy exercises on respiratory functions, respiratory muscle strength, clinical course of the disease (such as thoracic mobility, flexibility), and functional status in individuals with Ankylosing Spondylitis (AS).

One of the primary problems in Ankylosing Spondylitis (AS) is decreased thoracic expansion. For this reason, breathing exercises, especially thorax expansion, should be included. Moreover, according to Pascal\&#39;s principle, the pressure applied to a closed fluid must be transmitted to every part of the fluid and to the walls of the space in which it is located, without decreasing (13). For this reason, it is thought that the disrupted breathing pattern cannot be adequately corrected by standard diaphragm exercises, in which the patient\&#39;s hand is placed on the abdomen and the anterior abdominal wall is pushed forward/outward, and the diaphragm descent to the caudal level during inspiration with 360-degree expansion of the thoraco-abdominal cavity may not be sufficient (14). The aims of this study are as follows:

1. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises and 360-degree expanded diaphragm exercises and physiotherapy exercises on respiratory function in individuals with AS.
2. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on inspiratory and expiratory muscle strength in individuals with AS.
3. To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on spinal mobility and the clinical course of the disease in individuals with AS.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-60 years
* Diagnosis according to the 1988 Modified New York criteria
* Voluntary participation
* BASDAI score of 3 or 4
* No mental problems that could hinder cooperation and understanding

Exclusion Criteria:

* Presence of a neurological disease
* Other respiratory system diseases that could affect chest expansion (COPD, asthma, etc.)
* Regular exercise within the last 3 months Additionally, individuals who miss four consecutive exercise sessions or require a change in treatment will be excluded from the study.
Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)

The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO) in combination with Rituximab are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).

Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14). Platelet count (PC) was monitored every three or four days until day 22, followed by tests every week. Platelet transfusion was administered to patients with active bleeding symptoms or to those whose PC\<10×10\^9/L. Patients were followed for 3 months, and any adverse effects were recorded during the period of treatment and during the follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \<30×10\^9/L, and with bleeding manifestations.
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
8. Patients who are deemed unsuitable for the study by the investigator.
Comparison of Post Operative Endodontic Pain in Patients with Irreversible Pulpitis Treated with and Without Dexamethasone.

Root canal procedure is a common procedure in dentistry. Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain.

Potential Solution: The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain.

Research Goal: Pain score of patients treated with dexamethasone infiltration will be less compared to patients treated with NSAIDS alone after canal instrumentation.

Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. The peak inflammatory response occurs after 24 - 48 hours of root canal instrumentation. As management of post-endodontic pain is still a challenge for clinicians several drugs which include NSAIDs, acetaminophen, opioids and steroids are used to reduce the inflammatory response. Corticosteroids possess anti-inflammatory efficacy, and they prevent the production and release of inflammatory mediators at the site of tissue injury thus reducing the signs \& symptoms of inflammation such as pain, swelling \& loss of function. Dexamethasone is a potent corticosteroid that has the ability to reduce the production of proinflammatory cytokines. Dexamethasone can be administered orally, or as an intraosseous, intra ligament periapical \& intracanal injection. Dexamethasone is effective in alleviating pain in first 24 hours post endodontic treatment. Previous research on the effect of dexamethasone injection on post-endodontic treatment pain in patients presenting with necrotic pulp treated with single visit endodontic treatment reported 25% post operative pain occurrence and 9% when treated with dexamethasone.

Study Goal : The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain as compared to the prescription of NSAIDs only. If dexamethasone infiltration is effective in pain relief after endodontic treatment, it can be a useful adjunct in managing patients presenting with acute pulpal pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients of age 18-50 years
* Maxillary molar and premolar teeth
* Pt diagnosed with irreversible pulpitis with or without apical periodontitis

Exclusion Criteria:

* Teeth with calcified canals.
* Teeth with incompletely formed apices.
* Teeth requiring retreatment.
* Taking analgesics, anti-inflammatory, or tri-cyclic anti-depressants for their medical conditions.
* Teeth with grade II or III mobility (more than 2 mm)
* Pregnant patients
* Pt who are immunocompromised (uncontrolled diabetes mellitus, renal impairment)
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients, of age 18 - 54 years
* Patients diagnosed with stage 1 or stage 2 essential hypertension
* Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

* Secondary hypertension or severe hypertension
* History of Type 1 diabetes mellitus
* A medical contraindication to discontinuing a current antihypertensive therapy
* Clinically significant respiratory disease that prohibit use of a beta blocker
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* 18-80 years old
* For females of childbearing potential, use of an effective method of contraception: abstinence; surgical sterilization; oral contraceptives; barrier contraception with either a condom, sponge, or diaphragm in conjunction with spermicidal gel; an intrauterine device (IUD); or contraceptive hormone implant or patch
* Type 1 or 2 diabetes mellitus
* Single, full-thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot below the malleolus that does not involve bone, tendons, ligaments, or muscle
* Chronic ulcer with a duration of ≥ 4 weeks but \< 6 months
* Ulcer area with sharp debridement of ≥ 1.0 cm\^2 and ≤ 4.0 cm\^2
* Ankle-brachial index (ABI) of ≥ 0.6 and ≤ 1.2 on the study foot
* Glycosylated hemoglobin A1c (HbA1c) of ≤ 12%

Exclusion Criteria:

* History of neoplasia or current neoplasia (with the exception of non-melanoma skin cancer)
* Proliferative diabetic retinopathy or wet age-related macular degeneration
* Active ulcer infection or cellulitis of any ulcer
* Ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult)
* Connective tissue disease
* Active osteomyelitis of the study foot
* Subjects with ulcers related to an incompletely healed amputation wound
* Subjects with Charcot or other deformity of the study foot involving the study ulcer
* Immunosuppressive treatment, including radiation therapy, non-inhaled corticosteroids (inhaled corticosteroid ≤ 1000 ug daily dose is acceptable), and chemotherapy
* Pregnancy or lactation
* Multiple ulcers in the study foot
* Renal failure (serum creatinine of \>3.0 mg/dL)
* Poor nutritional status (albumin of \<3.0 g/dL)
* Known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel (trehalose dihydrate, polysorbate 20, succinic acetic acid, succinic acetic acid disodium, and hexahydrate)
* Known prior inability to complete required study visits during treatment period
* Use of any other investigational drug or therapy on the study foot within the past month
* Previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months