cyrilzakka/clinical-trials huggingface dataset:
Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics-

1. To evaluate the incidence of adverse events for the patients with long-term use
2. To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PAH receiving Adcirca

Exclusion Criteria:Patients who meet the criteria of contraindication

* patients with hypersensitivity to tadalafil
* patients who are using any form of organic nitrate
* patients with severe renal impairment
* patients with severe hepatic impairment
* patients taking strong inhibitors of CYP3A4
* patients taking strong inducers of CYP3A4
Longterm Outcome of the Delta III Inverse Prosthesis

The aim of the study is to describe the results after \> 10 years due to a prosthesis implant.

The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (\> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.

Eligibility Criteria:
Inclusion Criteria:

* implantation of a Delta III - prothesis
* timeframe (Oct 1998 - Dec 2002)
* delta-pectoral approach
* written informed consent

Exclusion Criteria:

* Implantation because of a revision
* Complaints, which make it difficult to follow instructions or even prevent
Assessment of Annabella Breast Pump Performance

This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.

50 women who are 2-5 months post-delivery will be included in the study following appropriate consent. Women will be randomly allocated to two groups for the type of pump used on the first session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. During each visit, milk will be expressed once a day from each of the two breasts (left \& right). During the 4 first visits (at least 1 day apart) Annabella or the control pump will be used. After at least 3 days washout period, milk will be expressed for additional 4 days, once a day from each of the two breasts, using the other breast pump. An expression session will last until no milk is expressed for 3 min continuously but not for longer than 25 min. Participants will be serving as their own control. Milk will be collected for volume and quality assessment. Maternal comfort at the end of each visit will be assessed using questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years old
* Women whom are 2-5 months post delivery
* Lactating women - Breastfeed with no more than formula feeding twice a day and no solid food feeding (which replace breastfeeding) during the study period.
* Breastfeed or pumping at least 5 times a day
* Mother to healthy infant born at ≥ 37 weeks of gestation age.

Exclusion Criteria:

* Woman who consumes under 1,500 kcal/day (on a diet)
* Report a high mental stress condition and/or depression
* Use of estrogen oral contraceptives
* Pregnant women
* Suffer from chronic diseases that can impact breast feeding
* Participate in another clinical trial
* Mothers of babies who may develop feeding difficulties according to the investigator decisions (such as cleft pallet, autism).
* Woman with Sunken/ flat nipple or inverted nipple. or any other physiological condition that may disturb breast feeding.
* Woman that declares at time of recruitment that she is unable to extract more than 25ml per breastfeeding (overall from both breast)
Doxycycline in Type II Diabetes

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden


Eligibility Criteria:
Inclusion Criteria:

* Male or female sex more than 40 years old Newly diagnosed type II diabetes. HbA1c more than 6.5

Exclusion Criteria:

* Patient with chronic kidney disease, hepatic disorders, mental and psychiatric disorders, pregnancy, and lactation
Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010 Criteria).
* EDSS ≤ 3.0.
* Must fulfill Tysabri indication (relapse and MRI criteria).
* Decision to start treatment with Natalizumab must precede enrollment.
* Up to four natalizumab infusions.

Key Exclusion Criteria:

* Any prior treatment with Natalizumab.
* Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate, Cyclophosphamide, Mycophenolate, Cladribine, Rituximab).
* Contraindications to treatment with Natalizumab.
* History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
* Immunocompromised at the time of enrollment. Known active malignancies.
* Inability to comply with study requirements.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer

This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies.

This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies. Primarily, the study will evaluate health related quality of life and resiliency in patients throughout the perioperative course of a radical cystectomy for bladder cancer.

The primary objective will be the correlation of the Connor-Davidson Resilience Scale (CD-RISC-25) and the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-BL-Cys) score.

Patients will be identified and undergo consent and baseline assessments, including completion of surveys prior to their cystectomy. A retrospective chart review will also be completed to record information regarding patient's cancer stage, treatment status, diagnosis date, insurance type, and related medical conditions and medications. Data from retrospective chart review will be collected and recorded in a secure REDCap database for all eligible patients.

Subsequent surveys will be administered again at approximately 10-30 days postoperatively, as well as 60-120 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of bladder cancer
* Patients electing to undergo radical cystectomy as treatment
* ≥ 18 years of age
* Able to speak and read English
* Willing and able to provide informed consent
* Functioning telephone number or access to one

Exclusion Criteria:

* Patients opting to not undergo radical cystectomy
* Minors
BAY38-9456 - Pivotal Trial for Diabetes Patient

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.


Eligibility Criteria:
Inclusion Criteria:

* Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
* Diabetes for more than 3 years

Exclusion Criteria:

* Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
* Spinal cord injury
* History of surgical prostatectomy (excluding TURP)
* Patients with an HbA1c \> 12% at Visit 1
* Use of nitrates
* Use of potent CYP3a4 inhibitors
* Severe liver disease
* Presence of Peyronie's Disease
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses

The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

Subjects who met the inclusion/exclusion criteria were enrolled into the placebo run-in phase of the study on Day -7 (prerandomization, Visit 1). Baseline symptom scores were established during this run-in phase.

Subjects with moderate nasal congestion who took at least 80% of their study medication during the run-in phase were eligible for enrollment in the two-week double-blind phase of the study and were randomized on Day 1 (randomization, Visit 2). They were treated for two weeks with their assigned medication. The severity of signs/symptoms were evaluated by the subjects every morning and night and by the investigator at each visit on Day 7 and Day 14.

In addition, the subject and investigator provided a global evaluation of response to treatment on Day 7 and Day 14. Safety was evaluated by adverse events reported during the study, vital signs, and the incidence of somnolence.

Eligibility Criteria:
Inclusion Criteria:

* otherwise healthy males and females
* 12 to 65 years of age
* hypersensitivity to specific pollens for a minimum of 2 years prior to study start
* appropriate SAR sign/symptoms scores

Exclusion Criteria:

* pregnancy, lactation and contraception issues
* contraindicated medications or therapies
* evidence of clinical, dietary, lifestyle or psychiatric issues, which in the opinion of the investigator, could increase the risk to the subject or research staff, or interfere with the interpretation of study results
ACHIEVE GRX Registry

This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.

This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Subject has a clinical indication for Peripheral Vascular Intervention (PVI).
3. Subject is deemed appropriate for robotic-assisted PVI.
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
5. Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.

Exclusion Criteria:

1. Failure/inability/unwillingness to provide informed consent.
2. The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.
3. Women who are pregnant.
X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas

The aim of the study is to evaluate the effect of the procedure of medical acupressure of the suboccipital muscles according to the Atlas-Standard method on the normalization of the position of the first cervical vertebra and the angles of the spinal column in patients with diagnosed chronic subluxation with objectification of the results by radiography and inclinometry.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic subluxation of the first cervical vertebra with complaints of pain in the occiput/cervical/thoracic/lumbar spine/limitation of head rotation in one or both directions.
* Scoliotic deformity of the spine 1-2 degrees.

Exclusion Criteria:

* Pregnancy
* Fractures of the first / second cervical vertebra in history
* Fractures of the spine in any of the departments in the anmenesis
* Assimilation of the atlas with the occipital bone or the second cervical vertebra
* Operations on the spine using metal structures
* Scoliosis 3-4 degree
* Botulinum toxin injections in the suboccipital region within the last year
* Taking muscle relaxants
* Corrective surgery on muscles and bones
* Braces
* Active period of dental implants installation
* Postoperative period (any operation, including on the eyes) less than 6 months
* Acute infectious diseases - less than 2 weeks from the start of recovery
* Skin diseases with inflammatory manifestations in the neck
* Oncological diseases
* Recovery period after injury (cervical and brain injury) or stroke less than a year
* Established mental illness
* Extreme malnutrition (cachexia)
Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair

The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:

* Does mesh reinforcement reduce the incidence of incisional hernias?
* What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.

Participants will:

* Undergo clinical follow-ups and abdominal ultrasounds to detect IH.
* Complete quality-of-life questionnaires (EQ-5D and PROMIS).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024
* Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data
* Attendance at a clinical follow-up examination at least one year after the procedure
* General informed consent signed for the use of medical data for research purposes

Exclusion Criteria:

* Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data
* Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.
* Patients who did not attend the required clinical follow-up examination at least one year postoperatively.
Testing Delivery Channels of Brief Motivational Alcohol Intervention

The aim of this study is to investigate whether motivation-tailored alcohol interventions are more effective when delivered by person or by computer-generated feedback letters. A sample of 920 general hospital inpatients with risky drinking will be recruited through a computerized screening procedure. Patients with more severe alcohol problems will be excluded from the study. Participants will be allocated by time frame randomization to one of three study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert system intervention that generates individualized feedback-letters, and (3) control group (treatment-as-usual). The interventions differ in their channel of delivery, but not regarding their content. Both intervention groups receive interventions at three time points: directly after the baseline-assessment at the general hospital, and 1 and 3 months later by mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after baseline.


Eligibility Criteria:
Inclusion Criteria:

* General hospital inpatients with risky drinking (AUDIT-C \>= 4/5 (women/men) and AUDIT \< 20)

Exclusion Criteria:

* Patients already recruited during an earlier hospital stay
* Patients physically and mentally not capable of participating in the study
* Patients with a hospital stay of less than 24 hours
* Patients with insufficient language/ reading skills
* Patients employed at one of the departments participating in the study or conducting the study
* Patients with more severe alcohol problems (AUDIT \>= 20)
Baduanjin With Resistance Training Program

The purpose of this study is to improve symptoms of Lumbar Disc Herniation (LDH) and Osteoporosis (OP) by implementing an evidence-based Baduanjin exercise to reduce pain and increase muscle strength and quality of life in Chinese patients. This study will provide new sights of exercise of elderly patients with LDH and OP for elderly patients.

Participants in the control group will continue with their conventional post surgery treatment as follows: comprehensive post-operative care and educational handouts that include guidelines for lumbar and back exercises to improve recovery and promote spinal health. In addition, participants will receive three interactive Q\&A sessions before discharge (pre-operation, post-operation, and on the day of discharge). During these sessions, patients can discuss their concerns and ask questions about their recovery.

Participants in the experimental group will continue to receive their conventional post surgery treatment in addition to BDJ as follows: Individual session training (admission to week 1 post-surgery), no training week 2, Group session I (week 3 and 4), Group session 2 (week 5-12) and perform independent exercises during which participants will have to keep an exercise diary (week 13-24).

Data collection will be conducted through in-person visits at baseline and Week 1, followed by phone calls at Week 12 and Week 24.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with LDH and OP based on the chart and clinical diagnostic criteria.
* Age of female patients ≥ 45 years，age of male patients ≥ 50 years.
* Visual analogue scale (VAS) ≥ 3 points.
* Surgical operation will be performed during the 7-day admission period.
* Mandarin speakers.

Exclusion Criteria:

* Severe primary diseases: ulcerative colitis, gastrointestinal bleeding, pancreatitis, lung cancer, pneumonia, acute respiratory distress syndrome or psychosis, depression, anxiety or substance abuse, identified by diagnosis and interview.
* Current engagement in regular physical activity routines over the past 3 months: aerobic exercises for at least 30 minutes, at least 3 times per week.
* Taken drugs within 3 months before enrollment: bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin, etc.
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog treatment on psoriatic skin lesions in patients with type 2 diabetes.

The objective of this study is to analyse short and medium-term efficacy on clinical, immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to severe psoriasis plaques in a group of patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin and presenting stable psoriasis plaques for at least one year, which failed to respond to previous systemic and/or topical treatments.

Exclusion Criteria:

* Type 1 diabetes
* Secondary diabetes
* Liver, renal or pancreatic disease
* Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents
Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study

Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.

The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with soft tissue sarcoma
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Refusal of consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Any serious and/or unstable pre-existing medical disorders
A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery

This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participant with age ≥ 18 years at the time of screening.
* Subject must have a clinical indication for anterior vitrectomy.
* Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
* Subjects must be willing and able to comply with all treatment and follow-up study procedures.

Exclusion Criteria:

* Subjects who have experienced any significant trauma in the operative eye within the past month.
* Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
* Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP\>30mm Hg) in study eye.
* Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
* Female subjects of child bearing potential with positive urine pregnancy test
* Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.
Topical Therapy for Prevention of Infections in Preterm Infants

The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.

The skin of babies who are born too early is not mature, which means they are at risk for infections of the skin or in the body. Their skin also become very dry, leading to cracking and breakdown, and this may feel painful or uncomfortable for the infant.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants

Exclusion Criteria:

* Full-term infant