cyrilzakka/clinical-trials huggingface dataset:
Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

The goal of this observational study is to assess the birth outcomes of HIV-positive women delivering in hospitals in Eswatini who are receiving dolutegravir (DTG) or other anti-retroviral (ARV) drug regimens. The main question the study aims to answer is, what is the proportion of neural tube defects among live and stillborn infants delivered by:

* HIV-positive women on DTG at conception
* HIV-negative women
* HIV-positive women on non-DTG ARV at conception

Participants will be interviewed for information on HIV testing and antiretroviral therapy history, other medical history of selected conditions (e.g., diabetes, malaria, TB) and potential birth defect exposures. Photographs will be taken of the infants. Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) will be collected from patient records.

This is an observational study conducted at five high volume hospitals in Eswatini, in which birth defect and other data will be collected at the time of delivery (or hospital admission for miscarriages and medical abortions) for all women. The overall aim of this study is to evaluate the birth outcomes of HIV-positive women who are receiving DTG or other ARV drug regimens. The primary research objectives are to: 1) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on DTG at conception; 2) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-negative women; and 3) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on non-DTG ART at conception. Secondary objectives are to determine overall general prevalence of major external birth defects and other pregnancy outcomes and any associations with other factors (e.g., maternal age, gravida). Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) are collected from patient charts, registers, reporting forms and databases for all women. Women of live or stillborn infants with birth defects are consented for interviews capturing detailed history and exposure data and photographs of newborns' birth defects. Data collection will be for approximately 24 months. Blinded interview data and photographs are reviewed by a medical geneticist for confirmatory defect diagnosis. We will describe rates and 95% confidence intervals (CI) for birth defects among infants by maternal HIV and ART status.

Eligibility Criteria:
Surveillance component includes all deliveries/admissions as defined in study population description. For a subset of the population recruited for additional data collection:

Inclusion Criteria:

* women whose live or stillborn infant has birth defect as identified by a midwife or other clinician at the study hospital
* willing to provide informed consent

Exclusion Criteria:

* unable to provide informed consent
Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain

Osteoporotic pain is the most common clinical symptom in elderly patients. The course of pain is prolonged and the effect of clinical treatment is limited. This study will observe the therapeutic effect of thymosin alpha 1 on elderly patient with osteoporotic pain and explore its immunotherapy mechanism.

About 70% of the elderly patients suffered osteoporotic pain, mainly involving the limbs and low back. The pain prolonged and varies from mild to severe, and the effect of the clinical treatment is poor which has become a serious social problem. Recent studies have put forward a new point of "bone Immunology", which suggests that immune system, especially CD4+ T cell system, are involved in the regulation of bone formation, bone resorption and bone remodeling. So, in this study, the investigators will observe the therapeutic effect of thymosin alpha 1 on osteoporotic pain in elderly by observing the improvement of VAS score before and after the treatment, as well as the changes of proportion of peripheral blood CD4+ T lymphocyte subsets, bone mineral density, serum bone biochemical index, neuropeptides, RANKL and other cytokines levels will be evaluated. The clinical safety of thymosin alpha 1 in elderly patients with osteoporotic pain will also be observed.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffered osteoporotic pain diagnosed by specialists
* VAS scores greater than 5
* Normal reading and understanding ability
* Communicate normally
* Volunteer to participate

Exclusion Criteria:

* Mental illness
* Serious physical disease
* Unwilling to cooperate
Different Types of Suture for Sacral Colpopexy

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.


Eligibility Criteria:
Inclusion Criteria:

* patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion Criteria:

* Age \> 75 years
* Severe cardiovascular or respiratory disease
* Pregnancy
Effectiveness of Physical Therapy for Pain Relief in Footballers With Muscle Injuries: a Prospective Study

The objective of this study was to evaluate the efficacy of cryoultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in male professional soccer players with muscle injuries. The main questions it intends to answer are:

• Is this combination of treatments effective in these patients in terms of pain relief?

Participants will receive a rehabilitation treatment consisting of cryo-ultrasound therapy and high intensity laser. Researchers will compare the group of participants, called the treatment group, with a control group to see if:

• Is the combined treatment of cryoultrasound therapy and high intensity laser more effective in these patients than the combination of diathermy and high intensity laser?


Eligibility Criteria:
Inclusion Criteria:

* age 18-21 years;
* professional footballer in a competitive club;
* presence of a grade III A muscle lesion, according to the Mueller-Wohlfart classification, confirmed by ultrasound examination and occurring during sports activity at least 5 days before inclusion in the present study;
* no previous muscle injuries in the last 6 months;
* signature of the written informed consent for participating in the study.

Exclusion Criteria:

* previous muscle injuries or bone fractures of the lower limbs in the last 6 months;
* knee instability due to previous rupture of knee ligaments;
* active neoplastic or infectious diseases;
* congenital anomalies of the lower limbs.
Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.

Bisphosphonates can reduce fracture risk in patients with osteoporosis. However, many patients may not start and adhere to bisphosphonates, consequently losing independence, quality, and length of life. We hypothesize that a decision aid that efficiently improves patient education and communication with their provider about fracture risk, and about using bisphosphonates to reduce that risk, will improve the quality of treatment decisions. We anticipate that patients will become more involved in the decision-making process and decisions will be more consistent with patients' values and health care goals. We expect this will lead to increased bisphosphonate start and adherence and improved patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Female, post-menopausal women aged 50 to 90.
* Have a bone mineral density (BMD) evaluation resulting in a T-Score of \<-1.0.
* Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM.
* Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment)
* Enrollment is open to females of diverse racial backgrounds.

Exclusion Criteria:

* Currently taking a bisphosphonate.
* Not available for 6 month follow-up phone call.
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease

Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment.

Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.

This study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for Its treatment potential.

Bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.

The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.

The Spss(v16) software will be used for data analysis.

Kienböck's disease is characterized by avascular necrosis of the lunate wrist There is probably no single cause of avascular necrosis of the lunate. Its origin may involve multiple factors, such as the blood supply (arteries), the blood drainage (veins), and skeletal variations.

Current treatments are: at the early phase only observation. In the more advanced phases surgical techniques such as bone decompression.

A potential therapeutic strategy would be cell therapy, A source of such cells with a regenerative potential could be mesenchymal stem cells (MSCs).

The investigators will evaluate safety and efficacy of implantation of autologous BM-MSC (bone marrow-derived mesenchymal stromal cell) in 30 patients with Kienböck's disease in combination with bone decompression surgery. These patients will be followed up and data will be analyzed with spss(v16).

Eligibility Criteria:
Inclusion Criteria:

* Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
* Both genders
* Visual Analogue Scale of 4 or higher
* Hematological and biochemical analysis with no significant alterations that contraindicates intervention
* The patient is able to understand the nature of the study
* Informed written consent of the patient

Exclusion Criteria:

* Age over 65 or under 18 or legally dependent
* Infection signs or positive serology for HIV, hepatitis and syphilis
* Allergy to gentamicin, or to bovine, cattle or horse serum
* Pregnancy or lactating
* Pregnancy or breast-feeding
* Neoplasia
* Immunosuppression
* Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
* Other conditions that may, according to medical criteria, discourage participation in the study
Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis

The aim of the study was to evaluate the short- and long-term effects of spa therapy on quality of life and pain in patients aged 65 years and older with osteoarthritis.

70 patients with osteoarthritis referred to spa treatment in south-eastern Poland were enrolled in the study. Spa treatment lasted 3 weeks.

All the patients benefited from spa therapy.

VAS pain scale, the Laitinen scale and WHOQOL-BREF questionnaire were used to assess the condition of the patients. The examinations were performed three times: at the beginning of the spa treatment, after three months and one year after the first examinations.

In an interventional study design, there have been examined patients aged over 65 years with the diagnosis of osteoarthritis who were prescribed a first spa therapy course in spa resorts in south-eastern Poland, between April 2016 and July 2016.

Patients were assessed by an experienced physicians on the first day of the spa therapy (study 1), after three months (study 2) and one year (study 3) after the completion of the spa therapy.

All patients who had been enrolled to the study, were asked to fill out the appropriate questionnaires (on the first day of the spa therapy). The investigators ensured that questionnaires were properly completed, under the supervision of researcher previously trained for their application. Second (study 2) and third (study 3) stages of the study were performed after three months, and one year after the first study, respectively (participants were interviewed by telephone survey).

Interventions Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).

Eligibility Criteria:
Inclusion Criteria:

* age over 65
* diagnosis of osteoarthritis,
* completion of 3 weeks of spa treatment
* patient's consent to participate in the study

Exclusion Criteria:

* failure to complete 3-weeks spa treatment,
* significant random events during follow-up
* diagnosed other diseases during follow-up,
* other forms of therapy implemented during follow-up,
* refusal to participate in II or III stage of the study
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Eligibility Criteria:
Inclusion Criteria:

* Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
* Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min

Exclusion Criteria:

* Unwilling to provide informed consent or complete follow-up assessments
* Life expectancy of \< 2 years
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Unable to tolerate right heart catheterization
* Severe aortic, mitral or pulmonary valve regurgitation
* Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
* Systemic infection or localized infection/rash at planned access site at time of procedure
* CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months
Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

The objectives of this study is 1) To compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) To compare the cost-benefit, adverse effects and patient preference of two different regimens of progesterone therapy.

Design: Multi-center, randomized, open-label trial

Eligibility Criteria:
Inclusion Criteria:

* With a history of prior spontaneous preterm birth or short cervix length
* Spontaneous preterm birth: preterm birth \<37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (PPROM)
* Short Cervix length : cervix length \<25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation

Exclusion Criteria:

* Multiple gestations
* Major congenital anomalies
* Elective prophylactic cervical cerclage \<16 weeks of gestation during current pregnancy
* Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction
* Diabetes, hypertension, other severe medical diseases
Study of Fat Malabsorption by Lipiblock Versus Xenical

Obesity is a chronic condition with fat-rich diets playing a major role in its etiology. Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to study the intestinal lipase blockade by partial inhibition of fat absorption after treatment with two commercials formulations of Orlistat.

The overweight and obesity epidemic affects approximately 1.6 millions of people worldwide. Obesity is a chronic condition, associated with premature death, co-morbidities, risk factors for main cardiac disease, stigmatization and significant economic costs. The causes of obesity are complex and include the interplay of environmental, social, economic and genetic factors. Besides fat-rich diets also play a significant role in the etiology of obesity. Correct diet orientation associated with physical exercise usually did not lead to expected result in weight loss and maintenance. Pharmacological therapy has been proposed as an adjunct to achieve the ideal weight. Orlistat acts in reduction of lipids absorption by inhibition of gastric and pancreatic lipases in gastrointestinal tract leading to sustained weight loss. This is a double blind study, randomized, of 2 weeks. The aim of this study was evaluate the intestinal lipase blockade by decrease of fat absorption of fecal fat after treatment with two commercials formulations of Orlistat in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Obesity
* BMC (Body Mass Index) between 30 to 40 kg/m2
* Women
* 18 to 45 years
* Premenopausal stage

Exclusion Criteria:

* Relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopatHy or neoplasm in the last three years)
* Chemical or natural laxatives
* Weight variation greater than 5% in the preceding 3 months
* Surgery for weight reduction
* Drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old,
* quadriplegia elicited by spinal cord injury (SCI) at the C5, C5-C6, C6, or C6-C7 level,
* complete infra-lesional motor deficit according to the ASIA impairment scale with finger and forearm flexor muscles paralysis,
* post-traumatic period \>6 months (since a motor recovery plateau is usually reached at 6-month post-SCI

Exclusion Criteria:

* non-stabilized hypertension or pathological autonomic nervous system dysfunction (e.g., orthostatic hypotension),
* cerebral damage and/or cognitive deficit,
* elbow or shoulder joint amplitude restriction, upper limb para-osteoarthropathy,
* participation to another study
* presence of metallic objects within the body incompatible with MEG or functional magnetic resonance imaging (fMRI) recordings.
The Effect of Interactive Multimedia Versus Illustrated Booklet on Behavior to Prevent Lower Back Pain in Working Nurses.

The present study was conducted to compare the effect of interactive multimedia and illustrated booklet methods on knowledge, attitude and improvement of behavior in preventing lower back pain amongst lower back pain amongst nurses.

In this single blind randomized controlled trial, 153 eligible nurses working in hospitals during 2019 were enrolled. The participants were randomly allocated into three parallel groups: interactive multimedia (n=55), illustrated booklet (n= 55), and the control (n= 43). The study samples were blinded to intervention and control groups. A researcher-made questionnaire was completed by the eligible subjects before, after, and four weeks after the intervention to assess their knowledge, attitude and behavior in preventing chronic lower back pain amongst working nurses.

Eligibility Criteria:
Inclusion Criteria:

* Minimum education level of bachelor's degree in nursing
* Employment in governmental hospitals
* Willing to participate in the study and complete the informed consent
* Minimum knowledge of working with computers

Exclusion Criteria:

* Congenital anomalies
* low back pain
* History of back surgery
* History of trauma to the back
* Pregnancy
* Severe osteoporosis
Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway

The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.

This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded)
* Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study
* Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration.
* Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance:

  * Patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance
  * Patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel AND cabazitaxel or have a contraindication to discontinue treatment.
* Patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide)
* Patients may have been treated with a poly (ADP-ribose) polymerase inhibitor (PARP)
* Performance Status \<2
* Metastatic disease progressive

Exclusion Criteria:

* Absence of previous treatment with taxane in situation of sensitivity or resistance to castration.
* Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment)
* No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment
* Previous treatment with platinum
* Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.