cyrilzakka/clinical-trials huggingface dataset:
Adult Height Prediction in Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoïds. The treatment consists in supplementing children with hydrocortisone. Despite care for these children has improved substantially across decades, short adult height (AH) still remains an important consequence of the disease. About 20% of patients have an AH below 2 standard deviations compared to their expected AH.

In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH French patients, born between 1970 and 1991 with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, the investigators will build a model which allows to predict their AH using data available at 8 years of age. The growth charts built from this cohort have shown that currently used formula to calculate the predicted AH (Bayley-Pineau's formula) is not applicable to children with CAH.

In this project, the investigators plan to compute an AH prediction model using data from children born between 1970 and 1993, and to validate the model using data from a different cohort (i.e. children born between 1994 and 1998). this choice was due to availability of data for computing the model first, and in a second stage, data from more recently born patients.


Eligibility Criteria:
Inclusion Criteria:

* children with CAH, genetically proven, classical form, virilizing form, with deficit of 21 hydroxylase, 11 beta hydroxylase, or 3 beta ol dehydrogenase, born between 1972-1993 (cohort 1) and 1994-1998 (cohort 2).
* medical charts should be available.

Exclusion Criteria:

* Patients with chronic growth altering disease, Turner syndrome, or other genetic anomaly
* Patients having received any treatment with Growth Hormone (GH)
Physiological Behavior of Respiratory Maneuvers

Introduction: new methods of evaluation of respiratory function, such as electrical impedance tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity, respectively. Analysis of these instruments during maximal respiratory maneuvers with monitoring of esophageal pressure may probably provide additional information on the physiological behavior of the cardiorespiratory system during EIT and OEP maneuvers. Objectives: To describe the physiological behavior of maximal respiratory maneuvers through the electrical impedance tomography and optoelectronic plethysmography in healthy men.

METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The development of the method will take place in 3 stages. The first step corresponds to the characterization of the inspiratory and expiratory curves in the respiratory cycle generated by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation between the variables Step 3: Estimate the dislocated blood volume of the lung through previous analyzes.

The physiological repercussions resulting from the maximal respiratory maneuvers together with the synchronized analysis of the chest cavity mobility, pulmonary volume , pulmonary impedance and measurement of Oesophageal pressure is not known. Therefore, this study aims to describe the physiological behavior of maximal respiratory maneuvers through the synchronization between electrical impedance tomography and optoelectronic plethysmography in healthy men.

Eligibility Criteria:
Inclusion Criteria:

* Will be included in the study male volunteers,
* BMI greater than or equal to 18.5 and less than 25 kg / m2, considered adequate or eutrophic (MS, 2011)
* Chest circumference between 44 and 55 cm if fitted to the electrical impedance tomography (EIT) strap size P or M;
* systolic blood pressure lower than 140 mmHg and greater than 100 mmHg
* diastolic blood pressure greater than 60 mmHg and lower than 90 mmHg (VI Brazilian Guidelines for Hypertension, 2010)
* without reports of cardiovascular or pulmonary diseases and symptoms Last month.

Exclusion Criteria:

* Volunteers who refuse to participate in the study will be excluded from the survey;
* Presence of cardiac dysfunction assessed by echocardiography;
* Altered pulmonary function by spirometry (PEREIRA et al, 2001) and manovacuometry according to predicted values for healthy individuals (PESSOA et al, 2014).
* Presence of tissue injury in the thorax;
* Dysautonomia that may indicate dysfunction of the autonomic nervous system (ANS), with following clinical manifestations: seizures; epilepsy; Anhydrosis and hyperhidrosis; Neurogenic bladder (CASTRO et al, 1992); (Stewart et al., 2004 and 2005)
* individuals who donated blood or had significant blood loss within 30 days prior to the start of the study (Navarro et al, 1997).
Comparing Engage to PST for Late Life Depression

This is a non-inferiority trial of Engage, a new intervention for late-life depression, and problem solving therapy (PST). Patient participants will be randomized to either Engage or PST and receive 9 weeks of either intervention. Interview assessments will be collected at baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from mental health agencies, will be randomized to receive training and certification in either Engage or PST.

Policy reports document that evidence-based psychotherapies are rarely employed and sustained in the community. Several causes of this science to service gap have been identified. One cause, specific to behavioral interventions, is the complexity of interventions and the competencies community clinicians must acquire and sustain over time in order to deliver them. A realistic solution is to streamline behavioral interventions and tailor them to the settings and therapist skill level available in the community. In response to this need, we have developed Engage, which: 1) is streamlined on the basis of concepts and findings on the neurobiology of depression; 2) consists of psychotherapeutic and ecosystem management components of known efficacy; 3) has distilled and simplified these components so as they can be accessible to most depressed older patients and taught to larger numbers of clinicians than available therapies, e.g., Problem Solving Therapy (PST); and 4) is personalized through a structured stepped approach focusing on "reward exposure". Problem Solving Therapy is an evidenced-based intervention shown to be effective in treating late-life depression.

Three hundred (150 per site) patient participants will be randomly assigned to receive 9 sessions of either Engage or PST. Forty-two clinician participants will be randomly assigned to receive training and certification in either Engage or PST. Once certified, clinicians will be assigned a patient participant and administer their assigned intervention.

Eligibility Criteria:
Inclusion Criteria (Patient participants):

* Age ≥ 60 years
* unipolar, non-psychotic major depression (by SCID, DSM-IV)
* MADRS ≥ 20
* MMSE ≥ 24
* off antidepressants or have been on a stable dose of an antidepressant for 12 weeks and do not intend to change the dose in the next 10 weeks
* English speaking
* capacity to provide written consent

Exclusion Criteria (Patient participants):

* Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder
* Newly started use of psychotropic drugs (\<12wks) or cholinesterase inhibitors other than mild doses of benzodiazepines
* Current active suicidal intent/plan
* Current substance abuse
The Needs of Cancer Survivors

A questionaire for cancer patients without an active treatment in order to evaluate their needs and/or demands.

Cancer patients on finishing therapy will be interviewed by a registered nurse by a approved questionaire asking about his /her feeling needs and demands.

Efforts to help them will be trid

It is well known from studies that survivors have unmet medical and non-medical needs that are not met, this includes physical, emotional and practical issues. The purpose of this study is to study them and investigate the methods how to alleviate them.

All patients with breast and colon cancer that are refered to the Rambam Oncology center will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with two common cancers (breast, colon) that have completed the treatment (chemotherapy, radiotherapy)
* Male and Female patients 18-80 years old.

Exclusion Criteria:

* Patients with active disease.
* Recipients of care that matches the criteria of hospice care.
* Patients with a diagnosis of dementia or other cognitive failure
* Patients who do not speak Hebrew
Familial Cancer Registry and DNA Bank

Clinical cancer genetics is an emerging new field in medical oncology, and has been incorporated into routine oncology practice in many leading medical institutions in North America and Europe. Cancer genetics is the study of genetic factors contributing to carcinogenesis. In the last 5-10 years, genes responsible for various well-defined hereditary cancer syndromes have been cloned. These include the BRCAJ/2 genes in hereditary breast and ovarian cancer syndrome, the A4PC gene in Familial Adenomatous Polyposis, and the mismatch repair genes (hMLH1, hMSH2, hPMS1, hPMS2, hMSH6) in hereditary non-polyposis colorectal cancer (HNPCC). One of the goals of a clinical cancer genetics service is to identify families at risk for hereditary cancer syndromes, provide genetic counseling, and offer genetic testing when appropriate. The identification of causative genes in hereditary cancer syndromes together with the advent of genetic testing is starting to have an impact on clinical management. The ability to identify a gene mutation in a cancer family allows predictive testing, stratifying at-risk family members into carriers who will benefit from aggressive surveillance and/or preventive options, and non-carriers who may be spared unnecessary surveillance. Appropriate use of genetic testing will ultimately result in medical cost reduction.

The investigators hypothesize that the clinical characteristics and genetic factors contributing to hereditary cancer in the Singaporean Asian population are distinct from those described for Western patients.


Eligibility Criteria:
Inclusion Criteria:

* Any individual with very early onset cancer (eg diagnosed before age 40).
* Any family with three or more first- or second-degree relatives with the same cancer
* Any individual with two or more different primary cancers
* Any family that fulfils diagnostic criteria for known hereditary cancer syndromes

Exclusion Criteria:

Nil
Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management

Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Scheduled to undergo thoracoscopic lobectomy under general anesthesia.
3. Male or female, aged 18 years and older inclusive
4. Body mass index (BMI) 18-30 kg/m2 inclusive
5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅱ

Exclusion Criteria:

1. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
2. Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
3. Subjects with a history of mental system diseases and cognitive dysfunction
4. Combination of other pain conditions that may affect postoperative pain assessment
5. Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side
6. Clinically significant abnormal clinical laboratory test value
7. Allergic to a drug ingredient or component
8. Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure
9. History of alcohol abuse or prescription and/or illicit drug abuse
10. Subjects with special diets (including tobacco, grapefruit and caffeine)
11. Pregnant or nursing women
12. No birth control during the specified period of time
13. Participated in clinical trials of other drugs (received experimental drugs)
14. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
A Randomized Controlled Clinical Trial to Assess Crestal Bone Remodeling of Four Different Implant Designs

This randomized controlled trial aimed to assess the effect of the implant neck design (microthreaded vs. non-microthreaded) as well as the type of abutment connection (internal conical vs. external flat-to-flat) on long-term crestal bone remodelling and peri-implant health. Four implants used for a bar-retained maxillary overdenture, were followed over a period of at least 6 years.

Twenty-five patients were treated with a bar-retained maxillary overdenture. Four different implants were placed, with respectively: internal connection and microthreads on the implant neck (I MT); internal connection, without microthreads (I NMT); external connection, with microthreads (E MT); and external connection, without microthreads (E NMT). Other design features, s.a. diameter, surface topography, extent of platform switch as well as the surgical and prosthetic treatment protocol were identical. Radiographic crestal bone loss (CBL), plaque score (PS), bleeding on probing (Bop) and probing pocket depth (PPD) were determined at 1 and 6 years after implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous in the maxilla and sufficient bone to harvest four 4 x 9 mm implant

Exclusion Criteria:

* Head -and neck radiation
* Bisphosphonate intake
* Limited prosthetic height
Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

The Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

The Sahara Study is intended to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

Safety of the N-SWEAT Patch will be confirmed by assessing the occurrence of local skin reactions, treatment-related adverse events (AEs) and Serious Adverse Events (SAEs).

Demonstration of effectiveness will be assessed by a significant improvement (reduction) in Hyperhidrosis Disease Severity Score (HDSS) in subjects treated with the N-SWEAT Patch. Secondary and additional endpoints based on complementary clinical instruments, including Quality of Life Measures (QOL) and Gravimetric Sweat Production GSP), have been included to further demonstrate performance.

Eligibility Criteria:
Key Inclusion Criteria:

1. Signed written informed consent
2. At least 22 years old at the time of consent.
3. Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health
4. GSP \>50mg/5min in each axilla
5. Reports a score of HDSS score of 3 or 4

Key Exclusion Criteria:

1. Active skin disease, irritation, or abrasions at either axilla based
2. Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis
3. GSP exceeds 300 mg/5min in either axilla
Post-operative Complications and Smoking Habits in Colorectal Surgery

PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.

The first part of the study is retrospective and data collection will be done the first 6 months. The enrolled patients will be divided into three groups (FT: tobacco smokers; NRT: nicotine replacement therapy; NF: non-smokers) and the data will be compared between groups to evaluate whether there are statistically significant differences regarding postoperative complications. The NF group will also be divided into patients who have never smoked and patients who have stopped smoking. A further analysis of ex-smoking patients will be performed to evaluate whether the incidence of complications differs from that observed in patients who have never smoked. The second part of the study will be prospective and will last one year. Also in this study the enrolled patients will be divided into three groups (NF group, FT group, and NRT group) and data obtained from all recorded variables will be compared between the groups. The data obtained retrospectively and prospectively will be analyzed together for each group.

The hypothesis of the study is that tobacco smoking plays a significant role in the appearance of postoperative complications. In particular, it is hypothesized that the group of patients taking NRT (defined as the group of NRT patients) has a higher incidence of postoperative complications after colorectal surgery than that observed in the control group of non-smoking (NF) or ex-smoking patients and lower to the group of tobacco smoking patients (FT).

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old.
* Patients who have read, understood, accepted and signed the informed consent to the study.
* Patients with benign or malignant colorectal disease.
* Patients undergoing colorectal surgery with any type of approach (open or minimally invasive) in Italy.
* Patients undergoing elective and emergency colorectal surgery.
* Patients NF (non smoker), FT (tobacco smokers), NRT (nicotine replacement therapy). Are considered smokers that patients who have smoked for at least 30 days at the time of surgery

Exclusion Criteria:

* Patients \< 18 years old.
* Patients who have not accepted informed consent.
OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.

If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.

In case of a hysteroscopical benign result the patient will be informed about the result after the operation.

In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal status (more than 1 year of last menopausal bleeding)
* Postmenopausal vaginal bleeding
* Asymptomatic postmenopausal endometrial hyperplasia
* Understanding of the german language
* Signature and consent of the patient

Exclusion Criteria:

* Not able to understand and participate in the study
* Premenopausal status
* no informed consent
Symptomatic Therapy for Patients With Huntington's Disease

Based on the previous symptomatic treatment of Chinese HD patients, this study intends to further optimize the treatment regimen of Chinese HD patients so as to further improve the prognosis of patients.

The purpose of the study is to evaluate symptomatic treatment regimen efficacy based on different disease stages. We previously used symptomatic treatment on Chinese HD patients and most of them got improved both in the motor symptoms and life quality. So this study intends to further optimize the treatment regimen, and set a control group to further evaluate the treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Genetic diagnosis of Huntington's disease
2. Symptomatic patients with Huntington's disease
3. Disease duration less than 5 years -

Exclusion Criteria:

(1) Movement disorder due to other definite causes instead of Huntington's disease (2) Severe Lung, kidney or liver disease (3) Neoplastic Disease

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Exploring Massage Benefits for Arthritis of the Knee for VA Healthcare Users

The purpose of this study is to find out how effective and feasible an 8-week course of Swedish massage is, for reducing pain and increasing function in adults who are VA healthcare users, with osteoarthritis (OA) of the knee.

The goal of this supplement is to enroll n=25 VA healthcare users with knee OA into the initial 8-week EMBARK massage program in order to collect preliminary data on the feasibility, acceptability and efficacy of massage in this patient group, in preparation for a larger grant submission to evaluate the effectiveness of massage for knee OA in the VA healthcare system. All veterans enrolled under this supplement will complete the initial 8-week massage protocol, since this will allow us the maximum opportunity to assess the feasibility and gather preliminary efficacy data. Veterans with symptomatic knee OA will be recruited from the Durham VA Medical Center, and the remaining study activities will be completed at the Duke site of the EMBARK study.

Eligibility Criteria:
Inclusion Criteria:

1. Be a veteran enrolled in care at the Durham VA Medical Center.
2. 35 years of age or greater.
3. Written confirmation of OA of the knee as provided by the participant's physician.
4. Radiographically-established OA of the knee.
5. Pre-randomization score in a specified range on the Visual Analog Pain Scale (0 - 100 mm scale).
6. Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
7. Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
8. American College of Rheumatology defined OA of the knee; specifically:

   a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age greater than 50 years ii. Stiffness \< 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth

Exclusion Criteria:

1. Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
2. Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
3. Signs or history of kidney or liver failure.
4. Presence of asthma requiring the use of corticosteroid treatment.
5. Use of oral corticosteroids within the past four weeks.
6. Use of intra-articular knee depo-corticosteroids with the past three months.
7. Use of intra-articular hyaluronate with the past six months.
8. Arthroscopic surgery of the knee within the past year.
9. Significant injury to the knee within the past six months.
10. Presence of a rash or open wound over the knee.
11. Unable to satisfy the treatment and follow-up requirements.
12. Unable to provide written informed consent.
13. Currently receiving massage therapy on a regular basis (at least twice a month).
14. Knee replacement of study knee (ok if the knee not being studied has been replaced).
15. History of participating in the EMBARK Phase I (2004) or II (2009) studies.